Hi Mike,
See way down below where OMA asks for information for the OIG and FBI regarding Eco Health Alliance. Emily referred them back to you, based on the nature of their questions. This is a sticky one—and from the beginning, NIAID were told to refer these detailed questions to you given the situation. Is it okay for us to provide her with a response to send that is accurate so that OMA does not have to translate? Or would you like for her to just respond and without context, that will be tricky for OMA and will cause more questions. Let me know…
Michelle
From: Linde, Emily (NIH/NIAID) [E] @mail.nih.gov>
Sent: Thursday, September 10, 2020 11:44 AM
To: Bulls, Michelle G. (NIH/OD) [E] @nih.gov>; Dean, Diane (NIH/OD) [E] @od31em1.od.nih.gov>
Subject: FW: Grant Questions - FBI Inquiry - 1-R01AI110964-01 - 2-R01AI110964-06
Good morning,
I wanted to alert you to this request. I referred them to Mike as we have discussed and just sent the following response to their latest inquiry and will let you know if I hear more.
Thanks,
Emily
From: Linde, Emily (NIH/NIAID) [E]
Sent: Thursday, September 10, 2020 11:40 AM
To: Sanders, Ashley (NIH/OD) [E] @nih.gov>
Cc: Shannon, Mike (NIH/OD) [E] @nih.gov>; Kearse, Deborah (NIH/OD) [E] @nih.gov>
Subject: RE: Grant Questions - FBI Inquiry - 1-R01AI110964-01 - 2-R01AI110964-06
Hi Ashley,
For this award the most relevant and accurate source of information is Dr. Mike Lauer, Deputy Director for Extramural Research.
Thanks,
Emily
From: Sanders, Ashley (NIH/OD) [E] @nih.gov>
Sent: Thursday, September 10, 2020 10:40 AM
To: Linde, Emily (NIH/NIAID) [E] @mail.nih.gov>
Cc: Shannon, Mike (NIH/OD) [E] @nih.gov>; Kearse, Deborah (NIH/OD) [E] @nih.gov>
Subject: RE: Grant Questions - FBI Inquiry - 1-R01AI110964-01 - 2-R01AI110964-06
Importance: High
Hi Emily,
These questions are specific to whether or not this particular NIAID grant was terminated early or ended as per a usual course of action. I’m not clear as to why I would need to go to the Deputy Director of NIH for OER for a response to a question on decisions and grant determinations made by NIAID.
OMA properly and routinely seeks and receives information from IC’s on grants and grant activity in support of audits and investigations, in accordance with Manual Chapter 1754 and 1752, as we are responsible to fully coordinate responses to OIG/FBI/DOJ etc. to support ongoing investigations. I must ensure our response is from the most relevant and accurate source of information, and answered in a timely manner.
Is there a reason these inquiries are being directed outside of the IC?
Thanks for your help,
Ashley
From: Linde, Emily (NIH/NIAID) [E] @mail.nih.gov>
Sent: Wednesday, September 9, 2020 3:26 PM
To: Sanders, Ashley (NIH/OD) [E] @nih.gov>
Cc: Shannon, Mike (NIH/OD) [E] @nih.gov>; Kearse, Deborah (NIH/OD) [E] @nih.gov>
Subject: RE: Grant Questions - FBI Inquiry - 1-R01AI110964-01 - 2-R01AI110964-06
Hi Ashley,
Questions for that nature on this award should be referred to Dr. Mike Lauer, Deputy Director for Extramural Research.
Thanks,
Emily
From: Sanders, Ashley (NIH/OD) [E] @nih.gov>
Sent: Wednesday, September 9, 2020 3:15 PM
To: Linde, Emily (NIH/NIAID) [E] @mail.nih.gov>
Cc: Shannon, Mike (NIH/OD) [E] @nih.gov>; Kearse, Deborah (NIH/OD) [E] @nih.gov>
Subject: RE: Grant Questions - FBI Inquiry - 1-R01AI110964-01 - 2-R01AI110964-06
Importance: High
Good afternoon Emily,
I’m following-up on this inquiry – originally the questions circled around the scientific terms of the grant and Erik Stemmy provided the context to the FBI. In a recent discussion with HHS OIG and the FBI, they noted they received information that the below-grant with Ecohealth Alliance was “suspended” or “terminated”. I’ve reviewed QVR and do not see an indication of that action other than the attached “Closeout of Award” email stating the end of the grant was 4/24/20 with a request for the FFR and FRPPR. Was this just a typical end of term closeout, or was it terminated early? If terminated/suspended, the OIG has the following questions:
1. What information did NIH/NIAID receive, and from whom, that noted a concern for continuing to fund this research?
2. What was the reasoning for NIAID ending the grant and/or collaboration with Ecohealth Alliance?
3. What was communicated to the PI (Dr. Daszak) and/or Ecohealth?
Please let me know if you’re able to provide this information.
Thank you,
Ashley
Ashley M. Sanders, MPS
Supervisor, DPI Program Investigations
NIH, OMA, Division Program Integrity
6011 Executive Blvd.
Rockville, Maryland 20852
Office:
Cell:
@nih.gov
From: Stemmy, Erik (NIH/NIAID) [E] @nih.gov>
Sent: Thursday, May 21, 2020 5:50 PM
To: Sanders, Ashley (NIH/OD) [E] @nih.gov>; Linde, Emily (NIH/NIAID) [E] @mail.nih.gov>
Cc: Shannon, Mike (NIH/OD) [E] @nih.gov>
Subject: RE: Grant Questions - FBI Inquiry - 1-R01AI110964-01 - 2-R01AI110964-06
Hi Ashley,
Since we’ll only have a short time on Tuesday I thought it might be helpful to provide the agent my responses to the original questions. There may be some misunderstanding of gain-of-function experiments, so hopefully this will clarify some things or at least provide a framework for our discussion next week.
Thanks!
Erik
p.s. I’ve also pasted the response directly below in case there is an issue adding an attachment to an encrypted message.
SF 424 AI110964-06 (received date 11/05/2018)
Both SF 424s seem to be describing “gain of function” experiments. On page 192 of SF 424 AI110964-06 (received date 11/05/2018) under P3CO Research, it indicates they are conducting gain of function of SARSr-CoV.
The funding pause on gain-of-function (GoF) experiments was in place from 2014-2017, and explicitly involved work reasonably anticipated to enhance the transmissibility or pathogenicity of influenza, MERS-CoV, or SARS-CoV. As such, that policy would not have applied to SARS-related coronaviruses (SARSr-CoV). The replacement policy, Potential Pandemic Pathogen Care and Oversight (P3CO), requires additional review and oversight of experiments that are anticipated to increase a potential pandemic pathogen’s transmissibility or pathogenicity in humans. The viruses created under this award are chimeric bat viruses, which generally would not be anticipated to cause enhanced disease or transmission in people. When evaluating experiments for potential GoF or P3CO we determine the likelihood of altering one of these attributes compared to the wild-type or circulating viral strain.
Were they also conducting Seemless Cloining and Assembly? From a review of their experimental details, it looks as if they were generating recombinant DNA of the viruses using WIV1 as the backbone but I could not determine if they were
using Seemless Cloning techniques.
I’m not aware of them using seamless cloning. Standard techniques for investigators in this field are to create cDNA molecular clones, which are then expressed in cull culture.
I could not determine exactly where they were conducting these gain of function experiments. I know UNC-Chapel Hill has done these but within the document, I could not determine where this was occurring. Do you know where this was occurring?
GoF experiments were not conducted as part of this award. While chimeric viruses were created via this award, they would not be considered GoF since the results did not confer attributes that were not already exhibited by the wild type versions of the viruses. For example, expressing the spike protein of SARS-CoV in the WIV-1 backbone did not increase the pathogenicity of WIV-1 beyond that of SARS-CoV. This award did not support work to manipulate CoV genomes or create chimeric viruses at Wuhan Institute of Virology; such work was performed at UNC-CH.
It then appears that the recombinant DNA of the virus was then injected into humanized mice. However, again I couldn’t determine where this occurred or was to occur. On page 187 of the same SF 424 under “Vertebrate Animals” it indicates that work with vertebrate animals will be conducted at Wuhan University at the School of Medicine and UNC – CH. Then under “Laboratory Mice” it states that lab mice will be sourced commercially by Wuhan Center for Animal Experiment at Wuhan University and that humanized mice will be bread at University of Wuhan and UNC – CH. Furthermore, the mice will be inoculated with the virus.
Recombinant viral cDNA is not directly injected into humanized mice. Rather, these molecular clones are used to grow virus in culture to create an inoculum used in infectivity studies. Both WIV and UNC-CH performed studies with molecular clones, which included infecting mice with the resulting recombinant viruses.
Under “UNC Facilities where selected agents to be used” it continues with all mouse studies at UNC-CH will be performed….” However, on page 200 of the same SF 424 there is a letter from UNC – CH stating “The work to be performed by UNC-CH does not include animal and/or human research subjects.” I know that was a lot of information but where exactly was the experimentation of injecting the humanized mice with the recombinant DNA occurring?
I believe this to be a typographical error on the part of UNC’s business office. The application describes animal work at UNC. Budget justifications and the consortium agreement also include references to this work. I believe UNC mean to say that the work “… does not include human research subjects.”
SF 424 AI110964-01 (received date 06/05/2013)
In this SF 424 Aim 3 seems indicative of gain of function experimentation (C3a and C3b) although it does not use that exact term.
The receipt date of this application was June of 2013, and the term “gain-of-function” was not widely used before the USG funding pause was announced in 2014. C3a and C3b describe work using pseudovirus assays, which would not have been considered GoF as they do not involve creating full replicating viruses.
On page 119 of AI110964-01 under “C3d) Humanized mouse in vivo infection experiments” it states that humanized mouse in vivo experiments in humanized mice was occurring at the Wuhan Institute of Virology. I did not see the location where these gain of function experiments were being done but if the injections were occurring at WIV then was the recombinant DNA also generated at WIV? Was Seemless Cloning also being done?
This is not GoF work. The humanized mouse experiments described in C3d refer to work with wild type viruses isolated
from wild bats. Refer to the section stating: “We will passage isolated bat-CoVs in permissive cells twice…” This is a
standard virological technique to create an inoculum to infect animals. In no portion of C3d do they describe any manipulation of isolated virus, therefore this does not describe any kind of gain-of-function studies, nor does it involve the creation of any recombinant DNA or viruses. Characterization of naturally occurring viruses was explicitly excluded
from the GoF policy. Further, the USG P3CO Policy Guidance states that “Wild-type pathogens that are circulating in or
have been recovered from nature are not enhanced PPPs, regardless of their pandemic potential.”
RPPR (AI110964-05)
Finally, in the RPPR (6/1/2017-5/31/2018) on page 28 under “In Vivo Infection of Human ACE2 Expressing Mice with SARSr-Cov S Protein variants”, it appears to be showing the results from their gain of function experiments as described in the SF 424. This is more of less the same as the question above, but do you know where this occurred?
These are not the results of GoF experiments. The figure you reference (Fig 35) shows weight loss and lung viral titers of chimeric viruses with bat CoV (wild type WIV-1, SHC014, WIV16, and 4231) spike proteins expressed on the WIV-1 backbone. Weight loss and viral titers were comparable across all chimeras when compared to the wild type (Fig 35a, red series; Fig 35b small box pattern). There are no statistical differences reported, so the chimeric viruses have not gained any function/attribute they did not already exhibit.
From: Sanders, Ashley (NIH/OD) [E] @nih.gov>
Sent: Thursday, May 21, 2020 3:04 PM
To: Stemmy, Erik (NIH/NIAID) [E] @nih.gov>; Linde, Emily (NIH/NIAID) [E] @mail.nih.gov>
Cc: Shannon, Mike (NIH/OD) [E] @nih.gov>
Subject: RE: Grant Questions - FBI Inquiry - 1-R01AI110964-01 - 2-R01AI110964-06
Hi Erik,
Thank you for providing this information. We would like to set up a call with the agent as they may need additional context or have other questions. Would you be available next Tuesday around 11:30AM? I’ll set up a conference line for us and send an invite.
If that time doesn’t work for you, please let me know alternative times you have available.
Thank you,
Ashley
From: Stemmy, Erik (NIH/NIAID) [E] @nih.gov>
Sent: Thursday, May 21, 2020 11:22 AM
To: Linde, Emily (NIH/NIAID) [E] @mail.nih.gov>; Sanders, Ashley (NIH/OD) [E] @nih.gov>
Cc: Shannon, Mike (NIH/OD) [E] @nih.gov>
Subject: RE: Grant Questions - FBI Inquiry - 1-R01AI110964-01 - 2-R01AI110964-06
Hi Ashley,
I would be happy to answer questions related to this award. Would it be best if I just addressed the comments at the end of this email thread? I’ll say generally that NIAID has an extensive review process for P3CO (and formerly for GoF) and that all of this work was formally evaluated by the respective committees and determined not to be gain-of-function, nor
subject to P3CO oversight. We also continually monitored the progress (until the award was terminated) for evidence of
unexpected increases in viral replication.
Erik
Erik J. Stemmy, Ph.D.
Program Officer
Respiratory Diseases Branch
Division of Microbiology and Infectious Diseases NIAID/NIH/HHS 5601 Fishers Lane, Room 8E18 Bethesda, MD 20892-9825
Phone:
Email: @nih.gov
From: Linde, Emily (NIH/NIAID) [E] @mail.nih.gov>
Sent: Thursday, May 21, 2020 6:17 AM
To: Sanders, Ashley (NIH/OD) [E] @nih.gov>
Cc: Shannon, Mike (NIH/OD) [E] @nih.gov>; Stemmy, Erik (NIH/NIAID) [E] @nih.gov>
Subject: RE: Grant Questions - FBI Inquiry - 1-R01AI110964-01 - 2-R01AI110964-06
Hi Ashley,
The Program Official for this grant, Dr. Stemmy, who is copied on this email, would be the most appropriate POC for these questions.
Regards,
Emily
From: Sanders, Ashley (NIH/OD) [E] @nih.gov>
Sent: Wednesday, May 20, 2020 1:00 PM
To: Linde, Emily (NIH/NIAID) [E] @mail.nih.gov>
Cc: Shannon, Mike (NIH/OD) [E] @nih.gov>
Subject: RE: Grant Questions - FBI Inquiry - 1-R01AI110964-01 - 2-R01AI110964-06
Importance: High
Good afternoon,
We are following up on a time-sensitive request for information from the FBI. Please let us know if you are able to accommodate their request or if you can recommend a POC to address the concerns.
Thank you,
Ashley
From: Sanders, Ashley (NIH/OD) [E]
Sent: Wednesday, May 13, 2020 11:59 AM
To: Linde, Emily (NIH/NIAID) [E] @mail.nih.gov>
Cc: Shannon, Mike (NIH/OD) [E] @nih.gov>
Subject: Grant Questions - FBI Inquiry - 1-R01AI110964-01 - 2-R01AI110964-06
Importance: High
Good afternoon Emily,
OMA/DPI received questions related to an FBI inquiry for the following NIAID grants: 1R01AI110964-01 through 2R01AI110964-06. The agent is requesting clarification on the details of the study, where certain aspects were performed, and whether seamless cloning techniques were used. I note you were the last official to sign off on 4/27/20.
Would you be able to provide a response to the below-captured questions and/or be available for a joint call with our office and the agent? If not, who would be the best SME on this matter? I’m sure you understand, since this is a sensitive matter, we need to maintain confidentiality and limit the touch-points within NIH. I’m happy to discuss further if you have any questions.
Thank you,
Ashley
Ashley M. Sanders, MPS
Senior Program Investigations Officer
NIH, OMA, Division Program Integrity
6011 Executive Blvd.
Rockville, Maryland 20852
Office:
@nih.gov
FBI Questions:
SF 424 AI110964-06 (received date 11/05/2018)
Both SF 424s seem to be describing “gain of function” experiments. On page 192 of SF 424 AI110964-06 (received date 11/05/2018) under P3CO Research, it indicates they are conducting gain of function of SARSr-CoV. Were they also conducting Seemless Cloining and Assembly? From a review of their experimental details, it looks as if they were generating recombinant DNA of the viruses using WIV1 as the backbone but I could not determine if they were using Seemless Cloning techniques. I could not determine exactly where they were conducting these gain of function experiments. I know UNC-Chapel Hill has done these but within the document, I could not determine where this was occurring. Do you know where this was occurring? It then appears that the recombinant DNA of the virus was then injected into humanized mice. However, again I couldn’t determine where this occurred or was to occur. On page 187 of the same SF 424 under “Vertebrate Animals” it indicates that work with vertebrate animals will be conducted at Wuhan University at the School of Medicine and UNC – CH. Then under “Laboratory Mice” it states that lab mice will be sourced commercially by Wuhan Center for Animal Experiment at Wuhan University and that humanized mice will be bread at University of Wuhan and UNC – CH. Furthermore, the mice will be inoculated with the virus. Under “UNC Facilities where selected agents to be used” it continues with all mouse studies at UNC-CH will be performed….” However, on page 200 of the same SF 424 there is a letter from UNC – CH stating “The work to be performed by UNC-CH does not include animal and/or human research subjects.” I know that was a lot of information but where exactly was the experimentation of injecting the humanized mice with the recombinant DNA occurring?
SF 424 AI110964-01 (received date 06/05/2013)
In this SF 424 Aim 3 seems indicative of gain of function experimentation (C3a and C3b) although it does not use that exact term. On page 119 of AI110964-01 under “C3d) Humanized mouse in vivo infection experiments” it states that humanized mouse in vivo experiments in humanized mice was occurring at the Wuhan Institute of Virology. I did not see the location where these gain of function experiments were being done but if the injections were occurring at WIV then was the recombinant DNA also generated at WIV? Was Seemless Cloning also being done?
RPPR (AI110964-05)
Finally, in the RPPR (6/1/2017-5/31/2018) on page 28 under “In Vivo Infection of Human ACE2 Expressing Mice with SARSr-Cov S Protein variants”, it appears to be showing the results from their gain of function experiments as described in the SF 424. This is more of less the same as the question above, but do you know where this occurred?
Good Afternoon,
NIAID has been asked to review the attached compiled HHS comments on S.4667 (Risky Research Review Act), as amended. OSP, OER, and ORS also are reviewing. As you may recall, NIAID previously provided NIH OD with comments on the revised bill text, which are attached for your reference, as well as high-level bullets (see email chain below).
ACTION: By 10a Thursday (10/17), please provide any new edits/comments in the attached “HHS points” document.
Please let us know if you have any questions.
Thanks,
Chase
From: Crawford, Chase (NIH/NIAID) [E]
Sent: Monday, September 30, 2024 2:31 PM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; NIAID DCR-OCGR @mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: FYI - Update on TA for revised bill text for Risky Research Review Act
FYI – Bldg. 1 has asked NIAID to provide a few top line bullets outlining the types of comments that were submitted on the redline version of the bill. NIAID plans to share the below bullets and indicate that NIAID shares many of the concerns raised by OER, ORS, and OSP (their top line bullets are copied further below). We will request a copy of the consolidated NIH TA and share it with you if/when we receive. Please let us know if you have any questions at this time. Thanks, Chase
NIAID
NIAID notes that, to avoid confusion, the definitions in the bill pertaining to scientific and/or current policies should be consistent with definitions in science and those policies, including the USG Policy for Oversight of DURC and PEPP (https://www.whitehouse.gov/wp-content/uploads/2024/05/USG-Policy-for-Oversight-of-DURC-and- PEPP.pdf). Further, as written, some definitions are overly broad and could slow research in critical areas, including research on antimicrobial resistance and the H5 influenza outbreak in dairy cattle. NIAID also notes that, as written, the proposed Board may lack essential expertise in infectious diseases and biosecurity. NIAID notes that it is unclear if it is the drafters’ intent to prohibit funding for an entire award prior to Board approval or only work related to potential “high-risk” research. Similarly, there is a later provision that would require a pause in research due to a change in circumstance, but it is unclear if such a pause would apply to an entire award or only work related to potential “high-risk research.
OER
It is unclear what added value the Board may have over current processes. The Board seems redundant with existing/current efforts and/or those being implemented following OSTP’s mandate on DURC/PEPP. The Board’s scope is very broad and may apply to a variety of research areas. We defer to OSP on the included research definitions. The Board will have significant control over funding decisions, which may interfere with existing statute on NIH funding activities.
We have concerns about the Board reaching out directly to applicants/recipients, which is outside traditional NIH reporting procedures. The required timeline of some Board activities is unclear. Flagged in previous TA, we have concerns about the confidentiality of application information and recommend more details be provided on how such information will be used or protected. Flagged in previous TA, some terms such as “proposal” and “entity” should be updated to better agree with NIH terminology. Flagged in previous TA, requirements for the validation of all applicant attestations related to research risk would be extremely challenging to implement.
ORS
Concern over the confusion and differences between agent listing, some definition and intent of this as compared
to the new DURC PEPP policy and also the current/ transparent process by which select agents are added or
removed. We would recommend alignment 100% in line with the current SA policies and DURC PEPP policies. Curious if this Board would be subject to posting in the Federal Register with public comment, or would function in a more draconian approach. Acknowledging that risk assessment is best when diverse voices are heard, the lack and actually clear refusal to ensure persons with experience in high and maximum containment principles are included would not provide a comprehensive and scientifically robust review of this work. The Board would be all political appointees, and finding someone with no experience in this space would likely select for persons who only do not favor this work. The goals feel less neutral and scientifically based and much more politically centric. The agent listings are highly concerning and would have an immediate negative impact to science and public health. The mention of Influenza A viruses, for example, would include all work with H5N1 viruses which are having a significant impact on our poultry and dairy farms. Research into vaccines, treatment, spread and evolution of these viruses is critical to ensure to curb this outbreak and to prevent those in the future. The same could be said for the inclusion of all mpox. The current outbreak and identification of Clade I is highly concerning and without scientists able to pivot nimbly, the outcome is concerning. Page 18 of the document, line 26-30 appear to replace the work of IBCs and IREs and biosafety professionals across the country. The composition of this board would not have the appropriate expertise, training or experience to appropriately determine these requirements. It also seems quite granular for a board of this nature. Concerns about sensitivity of grant and project submissions from the confidentiality side- defer to OER and OSP. Page 17 regarding employee disciplines. This section would make people charged with compliance consistently and constantly afraid for their jobs. A punitive reporting process would have the opposite impact that I think is intended. Transparency on situations is important but its unclear what would happen because of these reports.
We have significant concerns about this bill and approach this would take for the oversight of biological research. Based on timelines and reviews, plus the lack of appropriate experience, many researchers would likely leave critical research fields and the work would be paused having negative and catastrophic impact to the biomedical enterprise and by extension human and animal health and safety.
OSP
Topline points:
· While some aspects of this bill related to scope are improved, there continue to be significant concerns about the impact on biomedical research.
· Strengthening biosafety and biosecurity oversight of life sciences research is a key priority of this Administration, as outlined in the National Biodefense Strategy. We believe the bill as drafted would significantly undermine life sciences research, and its oversight provisions fail to target the subset of research posing greatest risk. As such, we do not support this legislation.
· The Administration has recently strengthened, streamlined, and expanded oversight of potentially high risk life science research in the May 2024 United States Government Policy for Oversight of Dual Use Research of Concern Pathogens with Enhanced Pandemic Potential (“DURC/PEPP policy”). This policy expands and strengthens a tiered system of oversight for all federally funded research that includes a requirement for
research on pathogens with enhanced pandemic potential to undergo extra departmental review. The policy also:
o Defines an expanded scope of pathogen and toxin research subject to additional oversight by the U.S. Government;
o Provides a unified framework to support the consistent identification and oversight of research proposals that require enhanced oversight that accounts for safety, security, and ethical considerations; and o Delineates the roles and responsibilities of principal investigators, research institutions, and Federal departments and agencies that conduct, fund, or oversee research within the scope of the policy.
· The bill seems to create redundancies with some reforms recently introduced by the DURC/PEPP policy, which was developed following significant interagency discussions directed by Congress and informed by the National Science Advisory Board for Biosecurity, public comment, and other expert input.
· As currently drafted, this legislation has the potential to negatively impact innovation and the U.S. competitive edge in life sciences research, including our ability to attract and retain the best scientists.
· However, the Administration welcomes efforts from Congress to further strengthen biosafety and biosecurity in the life sciences. o For example, we would welcome discussions on how the risk-based oversight processes established in the DURC policy for federally funded research could be extended to non-federally funded research.
· We recognize that biosafety and biosecurity oversight responsibilities are currently shared across many different departments and agencies and welcome discussions on appropriate entities for oversight of the highest risk research.
Some of our concerns with the bill are:
· Scope: While steps have been made toward harmonization of the scope of the Board’s oversight with the new United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (2024 OSTP DURC/PEPP Policy), some of the listed experiments in the “dual use research of concern” definition do not match those in the policy, and other articulated in-scope research in the bill including the “gain of function research” term continues to be in conflict with USG policy. These definition differences will be challenging to deconflict for the research community. Many of the USG definitions were determined following significant interagency discussions directed by Congress and informed by the National Science Advisory Board for Biosecurity, public comment, and other expert input. o This could result in delays to critical biosurveillance efforts such as COVID-19 testing, H5N1 monitoring, and detection of emerging outbreaks of Ebola and other diseases. It could also result in delays for development of vaccines, therapeutics, and biomedical, agricultural, and other life sciences research writ large (including research that is not associated with pathogens or toxins and raises no identified national security threats, such as cancer research). o If the statute only provided the board the responsibility to review federally-funded research involving DURC and PEPP, as defined in the DURC/PEPP policy, it would ensure oversight resources are used most efficiently to assess and mitigate risks to the public while avoiding unintended negative consequences for the nation’s biomedical enterprise. We believe this is the intent of the bill but as written the definitions are not harmonized. (We recommend other definitions in the text be aligned
to current U.S. Government policy, including “life sciences research.”)
o We recommend that the definitions and scope of review be fully harmonized with the DURC/PEPP policy and not include a separate list of pathogens. o A large amount of scientific research involves gain or loss of function; it’s a fundamental process in science. For example, some types of immune therapy cause the immune system to gain function to fight against a disease. Unfortunately, the term “gain of function” has often being misconstrued to suggest all research that causes a gain of function is highly risky, which is inaccurate. In fact, most research involving a GOF does not confer significant additional risk or require additional oversight. NIH does not define the term GOF and current federal policy does not define or operationalize the term. The research that requires strict oversight involves enhancing the transmissibility and/or virulence of a pathogen such that it would pose an increased pandemic potential in humans. The USG policy on oversight of DURC and PEPP (effective May 2025) also does not use the term GOF when describing research that requires additional oversight because of its higher risk. As it appears
the intent of the term “GOF” in this bill is to refer specially to research that has the potential to enhance the transmissibility or virulence of a potential pandemic pathogen, for clarity we would recommend the use of the term “pathogen with enhanced pandemic potential” in the 2024 OSTP policy that addresses this type of research, as well as it’s associated definition. This would help to avoid the ongoing confusion surrounding the term GOF.
· Board processes and makeup: While biosafety expertise is now included, the makeup and processes of the board could introduce a number of issues. For example, the limitations on prior federal service and designation of participation in high-risk research as a “conflict of interest” could limit the board from accessing relevant national security and life sciences expertise. The exclusion of those involved in high-risk research, based on the definition in the draft legislation, could exclude anyone with a current BSL3 or BSL4 program, excluding individuals with key expertise on how to conduct work safely. These limitations may also exclude individuals who work in government with relevant knowledge of intelligence and threat assessments. We also recommend relaxing the limitations on membership of the board and note that a number of the timelines are untenable (e.g., Congressional notification requirements within 3 days of identifying a potential conflict of interest; publishing procedures in the Federal Register within 90 days of the appointment of initial members; etc.). We note that several provisions relating to the membership of the Board or its support staff are vague, including the requirement that Board members be “impartial” and that support staff be prohibited from “directly or indirectly influenc[ing]” the Board. The proposed legislation would also politicize independent peer review by making the constituent members presidential appointees.
· Review process: While a path for expedited review has been added, there could still be major issues with continuity of science due to delays of reviews or membership being confirmed. Among other concerns, in particular, this will significantly impede the USG’s ability to prepare for and detect emerging infectious diseases/epidemics/pandemics and will also significantly impede the USG’s research response to an epidemic/pandemic. We recommend establishing a default rule that research may proceed if a decision is not made within a fixed timeframe to ensure that any lapse in function by the Board (e.g., delays in confirmation) do not result in life sciences research grinding to a halt. We also recommend a formal appeals process and an exemption to public reporting requirements if the information could pose national security risks.
· Review criteria: The bill does not articulate a principle or threshold that guides whether the board should or should not approve a study for funding – for example, should the Board approve research where it determines that the potential public health benefits of the research outweigh the potential risks to U.S. national security? Or should some other standard govern the Board’s review? Any statute mandating this style of review should clarify the applicable standard.
· Classified review and intelligence concerns: We recommend striking provisions that mandate the provision of security clearances to Board members, Board staff, and members of Congress, or that require these individuals to access and review all classified research funded by any agency. Those provisions extend beyond the scope of oversight that is reasonable for this board to take on and they may impinge on the constitutional authority of the Executive to control classified national security information. We also recommend that clauses be included to enable the intelligence community to respond to requests from the Board in a manner consistent with the protection of intelligence sources and methods.
· Enforcement: The enforcement provisions are extreme and may raise significant legal and privacy concerns. Those provisions mandate a suite of harsh penalties for any violations of certain provisions of the statute, including technical or unintentional violations; they allow for no flexibility in determining the severity of punishment; they provide the aggrieved party with no process; and they mandate public identification of aggrieved individuals. These provisions could broadly disincentivize individuals from working in life sciences research and funding agencies, which could send research outside of this country and compromise progress
on public health, safety, and national security. We recommend that enforcement provisions be focused on willful violations and significantly reduced or adjusted.
Given the above concerns, as drafted, this legislation has the potential to negatively impact innovation and delay the development of lifesaving technologies. While the Administration does not support this legislation, we remain committed to working with the Committee on biosafety and biosecurity.
From: Crawford, Chase (NIH/NIAID) [E]
Sent: Wednesday, September 25, 2024 1:45 PM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; NIAID DCR-OCGR @mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: ACTION by COB Friday (9/27): Review revised bill text for Risky Research Review Act
Good Afternoon,
NIAID has been asked to review the revised bill text for the Risky Research Review Act (PDF of bill text and Word doc of the redline are attached). This morning, the attached version of the bill was reported out of the Senate Committee on Homeland Security & Governmental Affairs (HSGAC) and now awaits further Senate consideration.
As you may recall, NIH and other OPDIVs provided comments on a previous version of the bill (previous NIAID comments attached for reference). HHS is now requesting any new comments that OPDIVS may have.
ACTION: By COB Friday (9/27), please review the attached redline and provide any new comments directly in the document.
Thanks,
Chase
From: Selgrade, Sara (NIH/NIAID) [E] @nih.gov>
Sent: Tuesday, July 16, 2024 6:07 PM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: URGENT review by 8am Wed. 7/17: HHS Comments to OMB on Risky Research Review Act
Importance: High
Hello all,
Thank you for your review of the consolidated HHS comments on the Risky Research Review Act. DMID has suggested adding some of the comments NIAID put forward earlier this week. We have incorporated these comments in highlighted text in the attached document. The comments are listed below by page number for ease of review.
Please let us know by no later than 8am tomorrow, Wednesday, July 17th, if you have any concerns with putting forward these previously NIAID-cleared edits.
Thank you again for all your help with this quick turnaround request. Please let me know if you have any questions.
Thanks,
Sara
Re-submitted NIAID comments in the attached document (highlighted in yellow):
p. 1: New NIH comment
p. 2: NIH addition to OASH/OHRP comment
p. 3: New NIH comment
p. 4: NIH addition to OASH/OHRP comment
p. 9: NIH edit to OGC comment to broaden scope to all agencies (previously flagged by OCGR-Leg)
p. 10: NIH addition (from NIAID) to existing NIH comment
p. 12: NIH addition to OIG comment
p. 14: NIH addition to OGC comment
p. 16: NIH addition (from NIAID) to existing NIH comment
From: Selgrade, Sara (NIH/NIAID) [E] @nih.gov>
Sent: Tuesday, July 16, 2024 12:24 PM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: Please review by COB today Tues 7/16: HHS Comments to OMB on Risky Research Review Act
Importance: High
Hello all,
Background
Thank you again for your assistance in reviewing the Risky Research Review Act. HHS has compiled comments on the bill
from throughout HHS to provide them to the Office of Management and Budget (OMB) for consideration. HHS is asking
NIH to review the attached document on quick turnaround.
The comments included in the document provide high-level concerns across HHS. In particular, we have flagged a comment on the bottom of page 9 with a proposed clarifying edit for your review.
Action Item
Please review the attached draft HHS comments on the Risky Research Review Act and provide your concurrence, or any edits, by COB today, Tuesday July 16th. If you have any concerns with OCGR-Leg’s proposed edit to the comment on page 9, please let us know.
Please note that NIH OLPA is also working on a separate request from the Senate Health, Education, Labor, and Pensions (HELP) Committee (Chair: Sen. Bernie Sanders, I-VT) for technical assistance on this bill. OLPA plans to include the specific NIAID comments shared yesterday in this separate request. We anticipate we may be asked to review consolidated NIH comments for the HELP Committee this week.
Thank you for your ongoing assistance with reviewing this bill. Please let me know if you have any questions.
Thanks,
Sara
From: Selgrade, Sara (NIH/NIAID) [E] @nih.gov>
Sent: Monday, July 15, 2024 12:26 PM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: Additional OSP comments: TA on Risky Research Review Act
Hello all,
For your awareness, we are providing the attached comments on the Risky Research Review Act from the NIH Office of Science Policy (OSP). We anticipate receiving consolidated NIH comments on the bill, and we will share these as soon as we have them.
Please let me know if you have any questions.
Thanks,
Sara
From: Selgrade, Sara (NIH/NIAID) [E] @nih.gov>
Sent: Monday, July 15, 2024 10:35 AM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: For review by noon Monday 7/15: Review draft NIAID TA on Risky Research Review Act
Importance: High
Hello all,
Thank you for your quick review of the draft NIAID TA on the Risky Research Review Act. In the attached revised draft, I have incorporated additional edits from DMID/Dr. Erbelding and DEA. If there are no objections, I will submit these to NIH OLPA by their noon deadline today.
I am also attaching for your reference additional comments on the bill provided by NIH OER and NIH ORS/DOHS.
Please let me know if you have any questions or concerns.
Thanks,
Sara
From: Selgrade, Sara (NIH/NIAID) [E] @nih.gov>
Sent: Friday, July 12, 2024 4:06 PM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: URGENT ACTION by 10am Monday 7/15: Review draft NIAID TA on Risky Research Review Act
Importance: High
Hello all,
Background
Thank you very much for your quick work to comment on the Risky Research Review Act. NIH OLPA has asked us to prioritize comments to flag the most urgent or concerning items and/or those needing clarification.
Action Item
We have compiled the comments that meet NIH OLPA’s request into the attached draft technical assistance document. Please note that NIH OLPA has requested examples, where possible. We have tried to add some examples to emphasize key points, but we welcome any suggestions and/or corrections as needed.
We would appreciate your review and any edits by 10am Monday, July 15th. Given the quick turnaround, we are asking the Divisions to review concurrently with the NIAID OD.
Please note that NIH OSP, NIH ORS/DOHS, and NIH OER will also be reviewing and providing comments. We will be sure
to share with you any consolidated NIH comments that we receive.
Thank you for your help with this quick turnaround request. Please let me know if you have any questions.
Thanks,
Sara
From: Selgrade, Sara (NIH/NIAID) [E] @nih.gov>
Sent: Thursday, July 11, 2024 10:51 AM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>;
Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Subject: URGENT ACTION by 12pm Friday 7/12: TA on Risky Research Review Act
Importance: High
Good morning,
Background
HHS has been asked by the Senate Homeland Security and Governmental Affairs Committee (Chair: Sen. Gary Peters, D- MI; Ranking Member: Sen. Rand Paul, R-KY) to provide technical assistance (TA) on the attached draft legislation entitled the Risky Research Review Act.
The draft bill would require the establishment of an independent life sciences research security board to review federal funding for certain proposed life sciences research as defined by the bill. NIAID is mentioned briefly on page 4 in a section describing limitations on membership of the board.
HHS reports that the Committee intends to consider the bill on July 24. A number of HHS OpDivs and offices, including ASPR, CDC, and FDA, have been asked to review the bill along with NIH.
Action Item
By noon tomorrow, Friday July 12, please review the attached draft legislation and provide any technical comments in the attached HHS TA template. Please note that NIH ORS/DOHS and NIH OSP are also reviewing the bill on behalf of NIH.
As you complete your review, please keep in mind the HHS guidance on technical assistance below. Please let me know if you have any questions.
Thanks,
Sara
To ensure that the Department's comments are given full consideration, please observe the following guidelines in
providing your office's comments:
1. Are there provisions of this bill that would conflict with Department or Administration policy, and how?
2. Are there provisions that would pose difficulties for the operation or management of HHS programs, and how?
3. Are there any other significant issues that you can identify?
4. If you recommend specific changes, supply reasons and explanations, if the reasons are not obvious.
For review - Risky Research Review Act Feedback Oct 2024.docx Track changes of feedback.docx For reference -redline2 NIAID comments.docx
@niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: FYI - Update on TA for revised bill text for Risky Research Review Act
FYI – Bldg. 1 has asked NIAID to provide a few top line bullets outlining the types of comments that were submitted on the redline version of the bill. NIAID plans to share the below bullets and indicate that NIAID shares many of the concerns raised by OER, ORS, and OSP (their top line bullets are copied further below). We will request a copy of the consolidated NIH TA and share it with you if/when we receive. Please let us know if you have any questions at this time. Thanks, Chase
NIAID
NIAID notes that, to avoid confusion, the definitions in the bill pertaining to scientific and/or current policies should be consistent with definitions in science and those policies, including the USG Policy for Oversight of DURC and PEPP (https://www.whitehouse.gov/wp-content/uploads/2024/05/USG-Policy-for-Oversight-of-DURC-and- PEPP.pdf). Further, as written, some definitions are overly broad and could slow research in critical areas, including research on antimicrobial resistance and the H5 influenza outbreak in dairy cattle. NIAID also notes that, as written, the proposed Board may lack essential expertise in infectious diseases and biosecurity. NIAID notes that it is unclear if it is the drafters’ intent to prohibit funding for an entire award prior to Board approval or only work related to potential “high-risk” research. Similarly, there is a later provision that would require a pause in research due to a change in circumstance, but it is unclear if such a pause would apply to an entire award or only work related to potential “high-risk research.
OER
It is unclear what added value the Board may have over current processes. The Board seems redundant with existing/current efforts and/or those being implemented following OSTP’s mandate on DURC/PEPP. The Board’s scope is very broad and may apply to a variety of research areas. We defer to OSP on the included research definitions. The Board will have significant control over funding decisions, which may interfere with existing statute on NIH funding activities. We have concerns about the Board reaching out directly to applicants/recipients, which is outside traditional NIH reporting procedures. The required timeline of some Board activities is unclear. Flagged in previous TA, we have concerns about the confidentiality of application information and recommend more details be provided on how such information will be used or protected. Flagged in previous TA, some terms such as “proposal” and “entity” should be updated to better agree with NIH terminology. Flagged in previous TA, requirements for the validation of all applicant attestations related to research risk would be extremely challenging to implement.
ORS
Concern over the confusion and differences between agent listing, some definition and intent of this as compared
to the new DURC PEPP policy and also the current/ transparent process by which select agents are added or
removed. We would recommend alignment 100% in line with the current SA policies and DURC PEPP policies. Curious if this Board would be subject to posting in the Federal Register with public comment, or would function in a more draconian approach. Acknowledging that risk assessment is best when diverse voices are heard, the lack and actually clear refusal to ensure persons with experience in high and maximum containment principles are included would not provide a comprehensive and scientifically robust review of this work.
The Board would be all political appointees, and finding someone with no experience in this space would likely select for persons who only do not favor this work. The goals feel less neutral and scientifically based and much more politically centric. The agent listings are highly concerning and would have an immediate negative impact to science and public health. The mention of Influenza A viruses, for example, would include all work with H5N1 viruses which are having a significant impact on our poultry and dairy farms. Research into vaccines, treatment, spread and evolution of these viruses is critical to ensure to curb this outbreak and to prevent those in the future. The same could be said for the inclusion of all mpox. The current outbreak and identification of Clade I is highly concerning and without scientists able to pivot nimbly, the outcome is concerning. Page 18 of the document, line 26-30 appear to replace the work of IBCs and IREs and biosafety professionals across the country. The composition of this board would not have the appropriate expertise, training or experience to appropriately determine these requirements. It also seems quite granular for a board of this nature. Concerns about sensitivity of grant and project submissions from the confidentiality side- defer to OER and OSP. Page 17 regarding employee disciplines. This section would make people charged with compliance consistently and constantly afraid for their jobs. A punitive reporting process would have the opposite impact that I think is intended. Transparency on situations is important but its unclear what would happen because of these reports.
We have significant concerns about this bill and approach this would take for the oversight of biological research. Based on timelines and reviews, plus the lack of appropriate experience, many researchers would likely leave critical research fields and the work would be paused having negative and catastrophic impact to the biomedical enterprise and by extension human and animal health and safety.
OSP
Topline points:
While some aspects of this bill related to scope are improved, there continue to be significant concerns about the impact on biomedical research. Strengthening biosafety and biosecurity oversight of life sciences research is a key priority of this Administration, as outlined in the National Biodefense Strategy. We believe the bill as drafted would significantly undermine life sciences research, and its oversight provisions fail to target the subset of research posing greatest risk. As such, we do not support this legislation. The Administration has recently strengthened, streamlined, and expanded oversight of potentially high risk life science research in the May 2024 United States Government Policy for Oversight of Dual Use Research of Concern Pathogens with Enhanced Pandemic Potential (“DURC/PEPP policy”). This policy expands and strengthens a tiered system of oversight for all federally funded research that includes a requirement for research on pathogens with enhanced pandemic potential to undergo extra departmental review. The policy also:
Defines an expanded scope of pathogen and toxin research subject to additional oversight by the U.S. Government;
Provides a unified framework to support the consistent identification and oversight of research proposals that require enhanced oversight that accounts for safety, security, and ethical considerations; and Delineates the roles and responsibilities of principal investigators, research institutions, and Federal departments and agencies that conduct, fund, or oversee research within the scope of the policy. The bill seems to create redundancies with some reforms recently introduced by the DURC/PEPP policy, which was developed following significant interagency discussions directed by Congress and informed by the National Science Advisory Board for Biosecurity, public comment, and other expert input. As currently drafted, this legislation has the potential to negatively impact innovation and the U.S. competitive edge in life sciences research, including our ability to attract and retain the best scientists. However, the Administration welcomes efforts from Congress to further strengthen biosafety and biosecurity in the life sciences. For example, we would welcome discussions on how the risk-based oversight processes established in the DURC policy for federally funded research could be extended to non-federally funded research. We recognize that biosafety and biosecurity oversight responsibilities are currently shared across many different departments and agencies and welcome discussions on appropriate entities for oversight of the highest risk research.
Some of our concerns with the bill are:
Scope: While steps have been made toward harmonization of the scope of the Board’s oversight with the new United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (2024 OSTP DURC/PEPP Policy), some of the listed experiments in the “dual use research of concern” definition do not match those in the policy, and other articulated in-scope research in the bill including the “gain of function research” term continues to be in conflict with USG policy. These definition differences will be challenging to deconflict for the research community. Many of the USG definitions were determined following significant interagency discussions directed by Congress and informed by the National Science Advisory Board for Biosecurity, public comment, and other expert input. This could result in delays to critical biosurveillance efforts such as COVID-19 testing, H5N1 monitoring, and detection of emerging outbreaks of Ebola and other diseases. It could also result in delays for development of vaccines, therapeutics, and biomedical, agricultural, and other life sciences research writ large (including research that is not associated with pathogens or toxins and raises no identified national security threats, such as cancer research). If the statute only provided the board the responsibility to review federally-funded research involving DURC and PEPP, as defined in the DURC/PEPP policy, it would ensure oversight resources are used most efficiently to assess and mitigate risks to the public while avoiding unintended negative consequences for the nation’s biomedical enterprise. We believe this is the intent of the bill but as written the definitions are not harmonized. (We recommend other definitions in the text be aligned
to current U.S. Government policy, including “life sciences research.”)
We recommend that the definitions and scope of review be fully harmonized with the DURC/PEPP policy and not include a separate list of pathogens. A large amount of scientific research involves gain or loss of function; it’s a fundamental process in science. For example, some types of immune therapy cause the immune system to gain function to fight against a disease. Unfortunately, the term “gain of function” has often being misconstrued to suggest all research that causes a gain of function is highly risky, which is inaccurate. In fact, most research involving a GOF does not confer significant additional risk or require additional oversight. NIH does not define the term GOF and current federal policy does not define or operationalize the term. The research that requires strict oversight involves enhancing the transmissibility and/or virulence of a pathogen such that it would pose an increased pandemic potential in humans. The USG policy on oversight of DURC and PEPP (effective May 2025) also does not use the term GOF when describing research that requires additional oversight because of its higher risk. As it appears the intent of the term “GOF” in this bill is to refer specially to research that has the potential to enhance the transmissibility or virulence of a potential pandemic pathogen, for clarity we would recommend the use of the term “pathogen with enhanced pandemic potential” in the 2024 OSTP policy that addresses this type of research, as well as it’s associated definition. This would help to avoid the ongoing confusion surrounding the term GOF.
Board processes and makeup: While biosafety expertise is now included, the makeup and processes of the board could introduce a number of issues. For example, the limitations on prior federal service and designation of participation in high-risk research as a “conflict of interest” could limit the board from accessing relevant national security and life sciences expertise. The exclusion of those involved in high-risk research, based on the definition in the draft legislation, could exclude anyone with a current BSL3 or BSL4 program, excluding individuals with key expertise on how to conduct work safely. These limitations may also exclude individuals who work in government with relevant knowledge of intelligence and threat assessments. We also recommend relaxing the limitations on membership of the board and note that a number of the timelines are untenable (e.g., Congressional notification requirements within 3 days of identifying a potential conflict of interest; publishing procedures in the Federal Register within 90 days of the appointment of initial members;
etc.). We note that several provisions relating to the membership of the Board or its support staff are vague, including the requirement that Board members be “impartial” and that support staff be prohibited from “directly or indirectly influenc[ing]” the Board. The proposed legislation would also politicize independent peer review by making the constituent members presidential appointees.
Review process: While a path for expedited review has been added, there could still be major issues with continuity of science due to delays of reviews or membership being confirmed. Among other concerns, in
particular, this will significantly impede the USG’s ability to prepare for and detect emerging infectious diseases/epidemics/pandemics and will also significantly impede the USG’s research response to an epidemic/pandemic. We recommend establishing a default rule that research may proceed if a decision is not made within a fixed timeframe to ensure that any lapse in function by the Board (e.g., delays in confirmation) do not result in life sciences research grinding to a halt. We also recommend a formal appeals process and an exemption to public reporting requirements if the information could pose national security risks.
Review criteria: The bill does not articulate a principle or threshold that guides whether the board should or should not approve a study for funding – for example, should the Board approve research where it determines that the potential public health benefits of the research outweigh the potential risks to U.S. national security? Or should some other standard govern the Board’s review? Any statute mandating this style of review should clarify the applicable standard.
Classified review and intelligence concerns: We recommend striking provisions that mandate the provision of security clearances to Board members, Board staff, and members of Congress, or that require these individuals to access and review all classified research funded by any agency. Those provisions extend beyond the scope of oversight that is reasonable for this board to take on and they may impinge on the constitutional authority of the Executive to control classified national security information. We also recommend that clauses be included to enable the intelligence community to respond to requests from the Board in a manner consistent with the protection of intelligence sources and methods.
Enforcement: The enforcement provisions are extreme and may raise significant legal and privacy concerns. Those provisions mandate a suite of harsh penalties for any violations of certain provisions of the statute, including technical or unintentional violations; they allow for no flexibility in determining the severity of punishment;
they provide the aggrieved party with no process; and they mandate public identification of aggrieved individuals. These provisions could broadly disincentivize individuals from working in life sciences research and funding agencies, which could send research outside of this country and compromise progress on public health, safety, and national security. We recommend that enforcement provisions be focused on willful violations and significantly reduced or adjusted.
Given the above concerns, as drafted, this legislation has the potential to negatively impact innovation and delay the development of lifesaving technologies. While the Administration does not support this legislation, we remain committed to working with the Committee on biosafety and biosecurity.
From: Crawford, Chase (NIH/NIAID) [E]
Sent: Wednesday, September 25, 2024 1:45 PM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; NIAID DCR-OCGR @mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: ACTION by COB Friday (9/27): Review revised bill text for Risky Research Review Act
Good Afternoon,
NIAID has been asked to review the revised bill text for the Risky Research Review Act (PDF of bill text and Word doc of the redline are attached). This morning, the attached version of the bill was reported out of the Senate Committee on Homeland Security & Governmental Affairs (HSGAC) and now awaits further Senate consideration.
As you may recall, NIH and other OPDIVs provided comments on a previous version of the bill (previous NIAID comments attached for reference). HHS is now requesting any new comments that OPDIVS may have.
ACTION: By COB Friday (9/27), please review the attached redline and provide any new comments directly in the document.
Thanks,
Chase
From: Selgrade, Sara (NIH/NIAID) [E] @nih.gov>
Sent: Tuesday, July 16, 2024 6:07 PM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: URGENT review by 8am Wed. 7/17: HHS Comments to OMB on Risky Research Review Act
Importance: High
Hello all,
Thank you for your review of the consolidated HHS comments on the Risky Research Review Act. DMID has suggested adding some of the comments NIAID put forward earlier this week. We have incorporated these comments in highlighted text in the attached document. The comments are listed below by page number for ease of review.
Please let us know by no later than 8am tomorrow, Wednesday, July 17th, if you have any concerns with putting forward these previously NIAID-cleared edits.
Thank you again for all your help with this quick turnaround request. Please let me know if you have any questions.
Thanks,
Sara
Re-submitted NIAID comments in the attached document (highlighted in yellow):
p. 1: New NIH comment
p. 2: NIH addition to OASH/OHRP comment
p. 3: New NIH comment
p. 4: NIH addition to OASH/OHRP comment
p. 9: NIH edit to OGC comment to broaden scope to all agencies (previously flagged by OCGR-Leg)
p. 10: NIH addition (from NIAID) to existing NIH comment
p. 12: NIH addition to OIG comment
p. 14: NIH addition to OGC comment
p. 16: NIH addition (from NIAID) to existing NIH comment
From: Selgrade, Sara (NIH/NIAID) [E] @nih.gov>
Sent: Tuesday, July 16, 2024 12:24 PM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: Please review by COB today Tues 7/16: HHS Comments to OMB on Risky Research Review Act
Importance: High
Hello all,
Background
Thank you again for your assistance in reviewing the Risky Research Review Act. HHS has compiled comments on the bill
from throughout HHS to provide them to the Office of Management and Budget (OMB) for consideration. HHS is asking
NIH to review the attached document on quick turnaround.
The comments included in the document provide high-level concerns across HHS. In particular, we have flagged a comment on the bottom of page 9 with a proposed clarifying edit for your review.
Action Item
Please review the attached draft HHS comments on the Risky Research Review Act and provide your concurrence, or any edits, by COB today, Tuesday July 16th. If you have any concerns with OCGR-Leg’s proposed edit to the comment on page 9, please let us know.
Please note that NIH OLPA is also working on a separate request from the Senate Health, Education, Labor, and Pensions (HELP) Committee (Chair: Sen. Bernie Sanders, I-VT) for technical assistance on this bill. OLPA plans to include the specific NIAID comments shared yesterday in this separate request. We anticipate we may be asked to review consolidated NIH comments for the HELP Committee this week.
Thank you for your ongoing assistance with reviewing this bill. Please let me know if you have any questions.
Thanks,
Sara
From: Selgrade, Sara (NIH/NIAID) [E] @nih.gov>
Sent: Monday, July 15, 2024 12:26 PM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: Additional OSP comments: TA on Risky Research Review Act
Hello all,
For your awareness, we are providing the attached comments on the Risky Research Review Act from the NIH Office of Science Policy (OSP). We anticipate receiving consolidated NIH comments on the bill, and we will share these as soon as we have them.
Please let me know if you have any questions.
Thanks,
Sara
From: Selgrade, Sara (NIH/NIAID) [E] @nih.gov>
Sent: Monday, July 15, 2024 10:35 AM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: For review by noon Monday 7/15: Review draft NIAID TA on Risky Research Review Act
Importance: High
Hello all,
Thank you for your quick review of the draft NIAID TA on the Risky Research Review Act. In the attached revised draft, I have incorporated additional edits from DMID/Dr. Erbelding and DEA. If there are no objections, I will submit these to NIH OLPA by their noon deadline today.
I am also attaching for your reference additional comments on the bill provided by NIH OER and NIH ORS/DOHS.
Please let me know if you have any questions or concerns.
Thanks,
Sara
From: Selgrade, Sara (NIH/NIAID) [E] @nih.gov>
Sent: Friday, July 12, 2024 4:06 PM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: URGENT ACTION by 10am Monday 7/15: Review draft NIAID TA on Risky Research Review Act
Importance: High
Hello all,
Background
Thank you very much for your quick work to comment on the Risky Research Review Act. NIH OLPA has asked us to prioritize comments to flag the most urgent or concerning items and/or those needing clarification.
Action Item
We have compiled the comments that meet NIH OLPA’s request into the attached draft technical assistance document. Please note that NIH OLPA has requested examples, where possible. We have tried to add some examples to emphasize key points, but we welcome any suggestions and/or corrections as needed.
We would appreciate your review and any edits by 10am Monday, July 15th. Given the quick turnaround, we are asking the Divisions to review concurrently with the NIAID OD.
Please note that NIH OSP, NIH ORS/DOHS, and NIH OER will also be reviewing and providing comments. We will be sure
to share with you any consolidated NIH comments that we receive.
Thank you for your help with this quick turnaround request. Please let me know if you have any questions.
Thanks,
Sara
From: Selgrade, Sara (NIH/NIAID) [E] @nih.gov>
Sent: Thursday, July 11, 2024 10:51 AM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>;
Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Subject: URGENT ACTION by 12pm Friday 7/12: TA on Risky Research Review Act
Importance: High
Good morning,
Background
HHS has been asked by the Senate Homeland Security and Governmental Affairs Committee (Chair: Sen. Gary Peters, D- MI; Ranking Member: Sen. Rand Paul, R-KY) to provide technical assistance (TA) on the attached draft legislation entitled the Risky Research Review Act.
The draft bill would require the establishment of an independent life sciences research security board to review federal funding for certain proposed life sciences research as defined by the bill. NIAID is mentioned briefly on page 4 in a section describing limitations on membership of the board.
HHS reports that the Committee intends to consider the bill on July 24. A number of HHS OpDivs and offices, including ASPR, CDC, and FDA, have been asked to review the bill along with NIH.
Action Item
By noon tomorrow, Friday July 12, please review the attached draft legislation and provide any technical comments in the attached HHS TA template. Please note that NIH ORS/DOHS and NIH OSP are also reviewing the bill on behalf of NIH.
As you complete your review, please keep in mind the HHS guidance on technical assistance below. Please let me know if you have any questions.
Thanks,
Sara
To ensure that the Department's comments are given full consideration, please observe the following guidelines in
providing your office's comments:
Are there provisions of this bill that would conflict with Department or Administration policy, and how?
Are there provisions that would pose difficulties for the operation or management of HHS programs, and how?
Are there any other significant issues that you can identify?
If you recommend specific changes, supply reasons and explanations, if the reasons are not obvious.
@nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: FYI - Update on TA for revised bill text for Risky Research Review Act
FYI – Bldg. 1 has asked NIAID to provide a few top line bullets outlining the types of comments that were submitted on the redline version of the bill. NIAID plans to share the below bullets and indicate that NIAID shares many of the concerns raised by OER, ORS, and OSP (their top line bullets are copied further below). We will request a copy of the consolidated NIH TA and share it with you if/when we receive. Please let us know if you have any questions at this time. Thanks, Chase
NIAID
NIAID notes that, to avoid confusion, the definitions in the bill pertaining to scientific and/or current policies should be consistent with definitions in science and those policies, including the USG Policy for Oversight of DURC and PEPP (https://www.whitehouse.gov/wp-content/uploads/2024/05/USG-Policy-for-Oversight-of-DURC-and- PEPP.pdf). Further, as written, some definitions are overly broad and could slow research in critical areas, including research on antimicrobial resistance and the H5 influenza outbreak in dairy cattle. NIAID also notes that, as written, the proposed Board may lack essential expertise in infectious diseases and biosecurity. NIAID notes that it is unclear if it is the drafters’ intent to prohibit funding for an entire award prior to Board approval or only work related to potential “high-risk” research. Similarly, there is a later provision that would require a pause in research due to a change in circumstance, but it is unclear if such a pause would apply to an entire award or only work related to potential “high-risk research.
OER
It is unclear what added value the Board may have over current processes. The Board seems redundant with existing/current efforts and/or those being implemented following OSTP’s mandate on DURC/PEPP. The Board’s scope is very broad and may apply to a variety of research areas. We defer to OSP on the included research definitions. The Board will have significant control over funding decisions, which may interfere with existing statute on NIH funding activities. We have concerns about the Board reaching out directly to applicants/recipients, which is outside traditional NIH reporting procedures. The required timeline of some Board activities is unclear. Flagged in previous TA, we have concerns about the confidentiality of application information and recommend more details be provided on how such information will be used or protected. Flagged in previous TA, some terms such as “proposal” and “entity” should be updated to better agree with NIH terminology. Flagged in previous TA, requirements for the validation of all applicant attestations related to research risk would be extremely challenging to implement.
ORS
Concern over the confusion and differences between agent listing, some definition and intent of this as compared
to the new DURC PEPP policy and also the current/ transparent process by which select agents are added or
removed. We would recommend alignment 100% in line with the current SA policies and DURC PEPP policies. Curious if this Board would be subject to posting in the Federal Register with public comment, or would function in a more draconian approach. Acknowledging that risk assessment is best when diverse voices are heard, the lack and actually clear refusal to ensure persons with experience in high and maximum containment principles are included would not provide a comprehensive and scientifically robust review of this work. The Board would be all political appointees, and finding someone with no experience in this space would likely select for persons who only do not favor this work. The goals feel less neutral and scientifically based and much more politically centric. The agent listings are highly concerning and would have an immediate negative impact to science and public health. The mention of Influenza A viruses, for example, would include all work with H5N1 viruses which are having a significant impact on our poultry and dairy farms. Research into vaccines, treatment, spread and evolution of
these viruses is critical to ensure to curb this outbreak and to prevent those in the future. The same could be said for the inclusion of all mpox. The current outbreak and identification of Clade I is highly concerning and without scientists able to pivot nimbly, the outcome is concerning. Page 18 of the document, line 26-30 appear to replace the work of IBCs and IREs and biosafety professionals across the country. The composition of this board would not have the appropriate expertise, training or experience to appropriately determine these requirements. It also seems quite granular for a board of this nature. Concerns about sensitivity of grant and project submissions from the confidentiality side- defer to OER and OSP. Page 17 regarding employee disciplines. This section would make people charged with compliance consistently and constantly afraid for their jobs. A punitive reporting process would have the opposite impact that I think is intended. Transparency on situations is important but its unclear what would happen because of these reports.
We have significant concerns about this bill and approach this would take for the oversight of biological research. Based on timelines and reviews, plus the lack of appropriate experience, many researchers would likely leave critical research fields and the work would be paused having negative and catastrophic impact to the biomedical enterprise and by extension human and animal health and safety.
OSP
Topline points:
While some aspects of this bill related to scope are improved, there continue to be significant concerns about the impact on biomedical research. Strengthening biosafety and biosecurity oversight of life sciences research is a key priority of this Administration, as outlined in the National Biodefense Strategy. We believe the bill as drafted would significantly undermine life sciences research, and its oversight provisions fail to target the subset of research posing greatest risk. As such, we do not support this legislation. The Administration has recently strengthened, streamlined, and expanded oversight of potentially high risk life science research in the May 2024 United States Government Policy for Oversight of Dual Use Research of Concern Pathogens with Enhanced Pandemic Potential (“DURC/PEPP policy”). This policy expands and strengthens a tiered system of oversight for all federally funded research that includes a requirement for research on pathogens with enhanced pandemic potential to undergo extra departmental review. The policy also:
Defines an expanded scope of pathogen and toxin research subject to additional oversight by the U.S. Government;
Provides a unified framework to support the consistent identification and oversight of research proposals that require enhanced oversight that accounts for safety, security, and ethical considerations; and Delineates the roles and responsibilities of principal investigators, research institutions, and Federal departments and agencies that conduct, fund, or oversee research within the scope of the policy. The bill seems to create redundancies with some reforms recently introduced by the DURC/PEPP policy, which was developed following significant interagency discussions directed by Congress and informed by the National Science Advisory Board for Biosecurity, public comment, and other expert input. As currently drafted, this legislation has the potential to negatively impact innovation and the U.S. competitive edge in life sciences research, including our ability to attract and retain the best scientists. However, the Administration welcomes efforts from Congress to further strengthen biosafety and biosecurity in the life sciences. For example, we would welcome discussions on how the risk-based oversight processes established in the DURC policy for federally funded research could be extended to non-federally funded research. We recognize that biosafety and biosecurity oversight responsibilities are currently shared across many different departments and agencies and welcome discussions on appropriate entities for oversight of the highest risk research.
Some of our concerns with the bill are:
Scope: While steps have been made toward harmonization of the scope of the Board’s oversight with the new United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (2024 OSTP DURC/PEPP Policy), some of the listed experiments in the “dual use research of concern” definition do not match those in the policy, and other articulated in-scope research in the bill including the “gain of function research” term continues to be in conflict with USG policy. These definition differences will be challenging to deconflict for the research community. Many of the USG definitions were
determined following significant interagency discussions directed by Congress and informed by the National Science Advisory Board for Biosecurity, public comment, and other expert input. This could result in delays to critical biosurveillance efforts such as COVID-19 testing, H5N1 monitoring, and detection of emerging outbreaks of Ebola and other diseases. It could also result in delays for development of vaccines, therapeutics, and biomedical, agricultural, and other life sciences research writ large (including research that is not associated with pathogens or toxins and raises no identified national security threats, such as cancer research). If the statute only provided the board the responsibility to review federally-funded research involving DURC and PEPP, as defined in the DURC/PEPP policy, it would ensure oversight resources are used most efficiently to assess and mitigate risks to the public while avoiding unintended negative consequences for the nation’s biomedical enterprise. We believe this is the intent of the bill but as written the definitions are not harmonized. (We recommend other definitions in the text be aligned
to current U.S. Government policy, including “life sciences research.”)
We recommend that the definitions and scope of review be fully harmonized with the DURC/PEPP policy and not include a separate list of pathogens. A large amount of scientific research involves gain or loss of function; it’s a fundamental process in science. For example, some types of immune therapy cause the immune system to gain function to fight against a disease. Unfortunately, the term “gain of function” has often being misconstrued to suggest all research that causes a gain of function is highly risky, which is inaccurate. In fact, most research involving a GOF does not confer significant additional risk or require additional oversight. NIH does not define the term GOF and current federal policy does not define or operationalize the term. The research that requires strict oversight involves enhancing the transmissibility and/or virulence of a pathogen such that it would pose an increased pandemic potential in humans. The USG policy on oversight of DURC and PEPP (effective May 2025) also does not use the term GOF when describing research that requires additional oversight because of its higher risk. As it appears the intent of the term “GOF” in this bill is to refer specially to research that has the potential to enhance the transmissibility or virulence of a potential pandemic pathogen, for clarity we would recommend the use of the term “pathogen with enhanced pandemic potential” in the 2024 OSTP policy that addresses this type of research, as well as it’s associated definition. This would help to avoid the ongoing confusion surrounding the term GOF.
Board processes and makeup: While biosafety expertise is now included, the makeup and processes of the board could introduce a number of issues. For example, the limitations on prior federal service and designation of participation in high-risk research as a “conflict of interest” could limit the board from accessing relevant national security and life sciences expertise. The exclusion of those involved in high-risk research, based on the definition in the draft legislation, could exclude anyone with a current BSL3 or BSL4 program, excluding individuals with key expertise on how to conduct work safely. These limitations may also exclude individuals who work in government with relevant knowledge of intelligence and threat assessments. We also recommend relaxing the limitations on membership of the board and note that a number of the timelines are untenable (e.g., Congressional notification requirements within 3 days of identifying a potential conflict of interest; publishing procedures in the Federal Register within 90 days of the appointment of initial members;
etc.). We note that several provisions relating to the membership of the Board or its support staff are vague, including the requirement that Board members be “impartial” and that support staff be prohibited from “directly or indirectly influenc[ing]” the Board. The proposed legislation would also politicize independent peer review by making the constituent members presidential appointees.
Review process: While a path for expedited review has been added, there could still be major issues with continuity of science due to delays of reviews or membership being confirmed. Among other concerns, in particular, this will significantly impede the USG’s ability to prepare for and detect emerging infectious diseases/epidemics/pandemics and will also significantly impede the USG’s research response to an epidemic/pandemic. We recommend establishing a default rule that research may proceed if a decision is not made within a fixed timeframe to ensure that any lapse in function by the Board (e.g., delays in confirmation) do not result in life sciences research grinding to a halt. We also recommend a formal appeals process and an exemption to public reporting requirements if the information could pose national security risks.
Review criteria: The bill does not articulate a principle or threshold that guides whether the board should or should not approve a study for funding – for example, should the Board approve research where it determines that the potential public health benefits of the research outweigh the potential risks to U.S. national security? Or should some other standard govern the Board’s review? Any statute mandating this style of review should clarify the applicable standard.
Classified review and intelligence concerns: We recommend striking provisions that mandate the provision of security clearances to Board members, Board staff, and members of Congress, or that require these individuals to access and review all classified research funded by any agency. Those provisions extend beyond the scope of oversight that is reasonable for this board to take on and they may impinge on the constitutional authority of the Executive to control classified national security information. We also recommend that clauses be included to enable the intelligence community to respond to requests from the Board in a manner consistent with the protection of intelligence sources and methods.
Enforcement: The enforcement provisions are extreme and may raise significant legal and privacy concerns. Those provisions mandate a suite of harsh penalties for any violations of certain provisions of the statute, including technical or unintentional violations; they allow for no flexibility in determining the severity of punishment;
they provide the aggrieved party with no process; and they mandate public identification of aggrieved individuals. These provisions could broadly disincentivize individuals from working in life sciences research and funding agencies, which could send research outside of this country and compromise progress on public health, safety, and national security. We recommend that enforcement provisions be focused on willful violations and significantly reduced or adjusted.
Given the above concerns, as drafted, this legislation has the potential to negatively impact innovation and delay the development of lifesaving technologies. While the Administration does not support this legislation, we remain committed to working with the Committee on biosafety and biosecurity.
From: Crawford, Chase (NIH/NIAID) [E]
Sent: Wednesday, September 25, 2024 1:45 PM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; NIAID DCR-OCGR @mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: ACTION by COB Friday (9/27): Review revised bill text for Risky Research Review Act
Good Afternoon,
NIAID has been asked to review the revised bill text for the Risky Research Review Act (PDF of bill text and Word doc of the redline are attached). This morning, the attached version of the bill was reported out of the Senate Committee on Homeland Security & Governmental Affairs (HSGAC) and now awaits further Senate consideration.
As you may recall, NIH and other OPDIVs provided comments on a previous version of the bill (previous NIAID comments attached for reference). HHS is now requesting any new comments that OPDIVS may have.
ACTION: By COB Friday (9/27), please review the attached redline and provide any new comments directly in the document.
Thanks,
Chase
From: Selgrade, Sara (NIH/NIAID) [E] @nih.gov>
Sent: Tuesday, July 16, 2024 6:07 PM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: URGENT review by 8am Wed. 7/17: HHS Comments to OMB on Risky Research Review Act
Importance: High
Hello all,
Thank you for your review of the consolidated HHS comments on the Risky Research Review Act. DMID has suggested adding some of the comments NIAID put forward earlier this week. We have incorporated these comments in highlighted text in the attached document. The comments are listed below by page number for ease of review.
Please let us know by no later than 8am tomorrow, Wednesday, July 17th, if you have any concerns with putting forward these previously NIAID-cleared edits.
Thank you again for all your help with this quick turnaround request. Please let me know if you have any questions.
Thanks,
Sara
Re-submitted NIAID comments in the attached document (highlighted in yellow):
p. 1: New NIH comment
p. 2: NIH addition to OASH/OHRP comment
p. 3: New NIH comment
p. 4: NIH addition to OASH/OHRP comment
p. 9: NIH edit to OGC comment to broaden scope to all agencies (previously flagged by OCGR-Leg)
p. 10: NIH addition (from NIAID) to existing NIH comment
p. 12: NIH addition to OIG comment
p. 14: NIH addition to OGC comment
p. 16: NIH addition (from NIAID) to existing NIH comment
From: Selgrade, Sara (NIH/NIAID) [E] @nih.gov>
Sent: Tuesday, July 16, 2024 12:24 PM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: Please review by COB today Tues 7/16: HHS Comments to OMB on Risky Research Review Act
Importance: High
Hello all,
Background
Thank you again for your assistance in reviewing the Risky Research Review Act. HHS has compiled comments on the bill
from throughout HHS to provide them to the Office of Management and Budget (OMB) for consideration. HHS is asking
NIH to review the attached document on quick turnaround.
The comments included in the document provide high-level concerns across HHS. In particular, we have flagged a comment on the bottom of page 9 with a proposed clarifying edit for your review.
Action Item
Please review the attached draft HHS comments on the Risky Research Review Act and provide your concurrence, or any edits, by COB today, Tuesday July 16th. If you have any concerns with OCGR-Leg’s proposed edit to the comment on page 9, please let us know.
Please note that NIH OLPA is also working on a separate request from the Senate Health, Education, Labor, and Pensions (HELP) Committee (Chair: Sen. Bernie Sanders, I-VT) for technical assistance on this bill. OLPA plans to include the specific NIAID comments shared yesterday in this separate request. We anticipate we may be asked to review consolidated NIH comments for the HELP Committee this week.
Thank you for your ongoing assistance with reviewing this bill. Please let me know if you have any questions.
Thanks,
Sara
From: Selgrade, Sara (NIH/NIAID) [E] @nih.gov>
Sent: Monday, July 15, 2024 12:26 PM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: Additional OSP comments: TA on Risky Research Review Act
Hello all,
For your awareness, we are providing the attached comments on the Risky Research Review Act from the NIH Office of Science Policy (OSP). We anticipate receiving consolidated NIH comments on the bill, and we will share these as soon as we have them.
Please let me know if you have any questions.
Thanks,
Sara
From: Selgrade, Sara (NIH/NIAID) [E] @nih.gov>
Sent: Monday, July 15, 2024 10:35 AM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: For review by noon Monday 7/15: Review draft NIAID TA on Risky Research Review Act
Importance: High
Hello all,
Thank you for your quick review of the draft NIAID TA on the Risky Research Review Act. In the attached revised draft, I have incorporated additional edits from DMID/Dr. Erbelding and DEA. If there are no objections, I will submit these to NIH OLPA by their noon deadline today.
I am also attaching for your reference additional comments on the bill provided by NIH OER and NIH ORS/DOHS.
Please let me know if you have any questions or concerns.
Thanks,
Sara
From: Selgrade, Sara (NIH/NIAID) [E] @nih.gov>
Sent: Friday, July 12, 2024 4:06 PM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: URGENT ACTION by 10am Monday 7/15: Review draft NIAID TA on Risky Research Review Act
Importance: High
Hello all,
Background
Thank you very much for your quick work to comment on the Risky Research Review Act. NIH OLPA has asked us to prioritize comments to flag the most urgent or concerning items and/or those needing clarification.
Action Item
We have compiled the comments that meet NIH OLPA’s request into the attached draft technical assistance document. Please note that NIH OLPA has requested examples, where possible. We have tried to add some examples to emphasize key points, but we welcome any suggestions and/or corrections as needed.
We would appreciate your review and any edits by 10am Monday, July 15th. Given the quick turnaround, we are asking the Divisions to review concurrently with the NIAID OD.
Please note that NIH OSP, NIH ORS/DOHS, and NIH OER will also be reviewing and providing comments. We will be sure
to share with you any consolidated NIH comments that we receive.
Thank you for your help with this quick turnaround request. Please let me know if you have any questions.
Thanks,
Sara
From: Selgrade, Sara (NIH/NIAID) [E] @nih.gov>
Sent: Thursday, July 11, 2024 10:51 AM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>;
Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Subject: URGENT ACTION by 12pm Friday 7/12: TA on Risky Research Review Act
Importance: High
Good morning,
Background
HHS has been asked by the Senate Homeland Security and Governmental Affairs Committee (Chair: Sen. Gary Peters, D- MI; Ranking Member: Sen. Rand Paul, R-KY) to provide technical assistance (TA) on the attached draft legislation entitled the Risky Research Review Act.
The draft bill would require the establishment of an independent life sciences research security board to review federal funding for certain proposed life sciences research as defined by the bill. NIAID is mentioned briefly on page 4 in a section describing limitations on membership of the board.
HHS reports that the Committee intends to consider the bill on July 24. A number of HHS OpDivs and offices, including ASPR, CDC, and FDA, have been asked to review the bill along with NIH.
Action Item
By noon tomorrow, Friday July 12, please review the attached draft legislation and provide any technical comments in the attached HHS TA template. Please note that NIH ORS/DOHS and NIH OSP are also reviewing the bill on behalf of NIH.
As you complete your review, please keep in mind the HHS guidance on technical assistance below. Please let me know if you have any questions.
Thanks,
Sara
To ensure that the Department's comments are given full consideration, please observe the following guidelines in
providing your office's comments:
Are there provisions of this bill that would conflict with Department or Administration policy, and how?
Are there provisions that would pose difficulties for the operation or management of HHS programs, and how?
Are there any other significant issues that you can identify?
If you recommend specific changes, supply reasons and explanations, if the reasons are not obvious.
NIAID
NIAID notes that, to avoid confusion, the definitions in the bill pertaining to scientific and/or current policies should be consistent with definitions in science and those policies, including the USG Policy for Oversight of DURC and PEPP (https://www.whitehouse.gov/wp-content/uploads/2024/05/USG-Policy-for-Oversight-of-DURC-and- PEPP.pdf). Further, as written, some definitions are overly broad and could slow research in critical areas, including research on antimicrobial resistance and the H5 influenza outbreak in dairy cattle. NIAID also notes that, as written, the proposed Board may lack essential expertise in infectious diseases and biosecurity. NIAID notes that it is unclear if it is the drafters’ intent to prohibit funding for an entire award prior to Board approval or only work related to potential “high-risk” research. Similarly, there is a later provision that would require a pause in research due to a change in circumstance, but it is unclear if such a pause would apply to an entire award or only work related to potential “high-risk research.
OER
It is unclear what added value the Board may have over current processes. The Board seems redundant with existing/current efforts and/or those being implemented following OSTP’s mandate on DURC/PEPP. The Board’s scope is very broad and may apply to a variety of research areas. We defer to OSP on the included research definitions. The Board will have significant control over funding decisions, which may interfere with existing statute on NIH funding activities. We have concerns about the Board reaching out directly to applicants/recipients, which is outside traditional NIH reporting procedures. The required timeline of some Board activities is unclear. Flagged in previous TA, we have concerns about the confidentiality of application information and recommend more details be provided on how such information will be used or protected. Flagged in previous TA, some terms such as “proposal” and “entity” should be updated to better agree with NIH terminology. Flagged in previous TA, requirements for the validation of all applicant attestations related to research risk would be extremely challenging to implement.
ORS
Concern over the confusion and differences between agent listing, some definition and intent of this as compared
to the new DURC PEPP policy and also the current/ transparent process by which select agents are added or
removed. We would recommend alignment 100% in line with the current SA policies and DURC PEPP policies. Curious if this Board would be subject to posting in the Federal Register with public comment, or would function in a more draconian approach. Acknowledging that risk assessment is best when diverse voices are heard, the lack and actually clear refusal to ensure persons with experience in high and maximum containment principles are included would not provide a comprehensive and scientifically robust review of this work. The Board would be all political appointees, and finding someone with no experience in this space would likely select for persons who only do not favor this work. The goals feel less neutral and scientifically based and much more politically centric. The agent listings are highly concerning and would have an immediate negative impact to science and public health. The mention of Influenza A viruses, for example, would include all work with H5N1 viruses which are having a significant impact on our poultry and dairy farms. Research into vaccines, treatment, spread and evolution of these viruses is critical to ensure to curb this outbreak and to prevent those in the future. The same could be said for the inclusion of all mpox. The current outbreak and identification of Clade I is highly concerning and without scientists able to pivot nimbly, the outcome is concerning. Page 18 of the document, line 26-30 appear to replace the work of IBCs and IREs and biosafety professionals across the country. The composition of this board would not have the appropriate expertise, training or experience to appropriately determine these requirements. It also seems quite granular for a board of this nature. Concerns about sensitivity of grant and project submissions from the confidentiality side- defer to OER and OSP.
Page 17 regarding employee disciplines. This section would make people charged with compliance consistently and constantly afraid for their jobs. A punitive reporting process would have the opposite impact that I think is intended. Transparency on situations is important but its unclear what would happen because of these reports.
We have significant concerns about this bill and approach this would take for the oversight of biological research. Based on timelines and reviews, plus the lack of appropriate experience, many researchers would likely leave critical research fields and the work would be paused having negative and catastrophic impact to the biomedical enterprise and by extension human and animal health and safety.
OSP
Topline points:
· While some aspects of this bill related to scope are improved, there continue to be significant concerns about the impact on biomedical research.
· Strengthening biosafety and biosecurity oversight of life sciences research is a key priority of this Administration, as outlined in the National Biodefense Strategy. We believe the bill as drafted would significantly undermine life sciences research, and its oversight provisions fail to target the subset of research posing greatest risk. As such, we do not support this legislation.
· The Administration has recently strengthened, streamlined, and expanded oversight of potentially high risk life science research in the May 2024 United States Government Policy for Oversight of Dual Use Research of Concern Pathogens with Enhanced Pandemic Potential (“DURC/PEPP policy”). This policy expands and strengthens a tiered system of oversight for all federally funded research that includes a requirement for research on pathogens with enhanced pandemic potential to undergo extra departmental review. The policy also:
o Defines an expanded scope of pathogen and toxin research subject to additional oversight by the U.S. Government;
o Provides a unified framework to support the consistent identification and oversight of research proposals that require enhanced oversight that accounts for safety, security, and ethical considerations; and o Delineates the roles and responsibilities of principal investigators, research institutions, and Federal departments and agencies that conduct, fund, or oversee research within the scope of the policy.
· The bill seems to create redundancies with some reforms recently introduced by the DURC/PEPP policy, which was developed following significant interagency discussions directed by Congress and informed by the National Science Advisory Board for Biosecurity, public comment, and other expert input.
· As currently drafted, this legislation has the potential to negatively impact innovation and the U.S. competitive edge in life sciences research, including our ability to attract and retain the best scientists.
· However, the Administration welcomes efforts from Congress to further strengthen biosafety and biosecurity in the life sciences. o For example, we would welcome discussions on how the risk-based oversight processes established in the DURC policy for federally funded research could be extended to non-federally funded research.
· We recognize that biosafety and biosecurity oversight responsibilities are currently shared across many different departments and agencies and welcome discussions on appropriate entities for oversight of the highest risk research.
Some of our concerns with the bill are:
· Scope: While steps have been made toward harmonization of the scope of the Board’s oversight with the new United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (2024 OSTP DURC/PEPP Policy), some of the listed experiments in the “dual use research of concern” definition do not match those in the policy, and other articulated in-scope research in the bill including the “gain of function research” term continues to be in conflict with USG policy. These definition differences will be challenging to deconflict for the research community. Many of the USG definitions were determined following significant interagency discussions directed by Congress and informed by the National Science Advisory Board for Biosecurity, public comment, and other expert input. o This could result in delays to critical biosurveillance efforts such as COVID-19 testing, H5N1 monitoring, and detection of emerging outbreaks of Ebola and other diseases. It could also result in delays for development of vaccines, therapeutics, and biomedical, agricultural, and other life sciences research
writ large (including research that is not associated with pathogens or toxins and raises no identified national security threats, such as cancer research). o If the statute only provided the board the responsibility to review federally-funded research involving DURC and PEPP, as defined in the DURC/PEPP policy, it would ensure oversight resources are used most efficiently to assess and mitigate risks to the public while avoiding unintended negative consequences for the nation’s biomedical enterprise. We believe this is the intent of the bill but as written the definitions are not harmonized. (We recommend other definitions in the text be aligned
to current U.S. Government policy, including “life sciences research.”)
o We recommend that the definitions and scope of review be fully harmonized with the DURC/PEPP policy and not include a separate list of pathogens. o A large amount of scientific research involves gain or loss of function; it’s a fundamental process in science. For example, some types of immune therapy cause the immune system to gain function to fight against a disease. Unfortunately, the term “gain of function” has often being misconstrued to suggest all research that causes a gain of function is highly risky, which is inaccurate. In fact, most research involving a GOF does not confer significant additional risk or require additional oversight. NIH does not define the term GOF and current federal policy does not define or operationalize the term. The research that requires strict oversight involves enhancing the transmissibility and/or virulence of a pathogen such that it would pose an increased pandemic potential in humans. The USG policy on oversight of DURC and PEPP (effective May 2025) also does not use the term GOF when describing research that requires additional oversight because of its higher risk. As it appears the intent of the term “GOF” in this bill is to refer specially to research that has the potential to enhance the transmissibility or virulence of a potential pandemic pathogen, for clarity we would recommend the use of the term “pathogen with enhanced pandemic potential” in the 2024 OSTP policy that addresses this type of research, as well as it’s associated definition. This would help to avoid the ongoing confusion surrounding the term GOF.
· Board processes and makeup: While biosafety expertise is now included, the makeup and processes of the board could introduce a number of issues. For example, the limitations on prior federal service and designation of participation in high-risk research as a “conflict of interest” could limit the board from accessing relevant national security and life sciences expertise. The exclusion of those involved in high-risk research, based on the definition in the draft legislation, could exclude anyone with a current BSL3 or BSL4 program, excluding individuals with key expertise on how to conduct work safely. These limitations may also exclude individuals who work in government with relevant knowledge of intelligence and threat assessments. We also recommend relaxing the limitations on membership of the board and note that a number of the timelines are untenable (e.g., Congressional notification requirements within 3 days of identifying a potential conflict of interest; publishing procedures in the Federal Register within 90 days of the appointment of initial members; etc.). We note that several provisions relating to the membership of the Board or its support staff are vague, including the requirement that Board members be “impartial” and that support staff be prohibited
from “directly or indirectly influenc[ing]” the Board. The proposed legislation would also politicize
independent peer review by making the constituent members presidential appointees.
· Review process: While a path for expedited review has been added, there could still be major issues with continuity of science due to delays of reviews or membership being confirmed. Among other concerns, in particular, this will significantly impede the USG’s ability to prepare for and detect emerging infectious diseases/epidemics/pandemics and will also significantly impede the USG’s research response to an epidemic/pandemic. We recommend establishing a default rule that research may proceed if a decision is not made within a fixed timeframe to ensure that any lapse in function by the Board (e.g., delays in confirmation) do not result in life sciences research grinding to a halt. We also recommend a formal appeals process and an exemption to public reporting requirements if the information could pose national security risks.
· Review criteria: The bill does not articulate a principle or threshold that guides whether the board should or should not approve a study for funding – for example, should the Board approve research where it determines that the potential public health benefits of the research outweigh the potential risks to U.S.
national security? Or should some other standard govern the Board’s review? Any statute mandating this style of review should clarify the applicable standard.
· Classified review and intelligence concerns: We recommend striking provisions that mandate the provision of security clearances to Board members, Board staff, and members of Congress, or that require these individuals to access and review all classified research funded by any agency. Those provisions extend beyond the scope of oversight that is reasonable for this board to take on and they may impinge on the constitutional authority of the Executive to control classified national security information. We also recommend that clauses be included to enable the intelligence community to respond to requests from the Board in a manner consistent with the protection of intelligence sources and methods.
· Enforcement: The enforcement provisions are extreme and may raise significant legal and privacy concerns. Those provisions mandate a suite of harsh penalties for any violations of certain provisions of the statute, including technical or unintentional violations; they allow for no flexibility in determining the severity of punishment; they provide the aggrieved party with no process; and they mandate public identification of aggrieved individuals. These provisions could broadly disincentivize individuals from working in life sciences research and funding agencies, which could send research outside of this country and compromise progress on public health, safety, and national security. We recommend that enforcement provisions be focused on willful violations and significantly reduced or adjusted.
Given the above concerns, as drafted, this legislation has the potential to negatively impact innovation and delay the development of lifesaving technologies. While the Administration does not support this legislation, we remain committed to working with the Committee on biosafety and biosecurity.
From: Crawford, Chase (NIH/NIAID) [E]
Sent: Wednesday, September 25, 2024 1:45 PM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; NIAID DCR-OCGR @mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: ACTION by COB Friday (9/27): Review revised bill text for Risky Research Review Act
Good Afternoon,
NIAID has been asked to review the revised bill text for the Risky Research Review Act (PDF of bill text and Word doc of the redline are attached). This morning, the attached version of the bill was reported out of the Senate Committee on Homeland Security & Governmental Affairs (HSGAC) and now awaits further Senate consideration.
As you may recall, NIH and other OPDIVs provided comments on a previous version of the bill (previous NIAID comments attached for reference). HHS is now requesting any new comments that OPDIVS may have.
ACTION: By COB Friday (9/27), please review the attached redline and provide any new comments directly in the document.
Thanks,
Chase
From: Selgrade, Sara (NIH/NIAID) [E] @nih.gov>
Sent: Tuesday, July 16, 2024 6:07 PM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: URGENT review by 8am Wed. 7/17: HHS Comments to OMB on Risky Research Review Act
Importance: High
Hello all,
Thank you for your review of the consolidated HHS comments on the Risky Research Review Act. DMID has suggested adding some of the comments NIAID put forward earlier this week. We have incorporated these comments in highlighted text in the attached document. The comments are listed below by page number for ease of review.
Please let us know by no later than 8am tomorrow, Wednesday, July 17th, if you have any concerns with putting forward these previously NIAID-cleared edits.
Thank you again for all your help with this quick turnaround request. Please let me know if you have any questions.
Thanks,
Sara
Re-submitted NIAID comments in the attached document (highlighted in yellow):
p. 1: New NIH comment
p. 2: NIH addition to OASH/OHRP comment
p. 3: New NIH comment
p. 4: NIH addition to OASH/OHRP comment
p. 9: NIH edit to OGC comment to broaden scope to all agencies (previously flagged by OCGR-Leg)
p. 10: NIH addition (from NIAID) to existing NIH comment
p. 12: NIH addition to OIG comment
p. 14: NIH addition to OGC comment
p. 16: NIH addition (from NIAID) to existing NIH comment
From: Selgrade, Sara (NIH/NIAID) [E] @nih.gov>
Sent: Tuesday, July 16, 2024 12:24 PM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: Please review by COB today Tues 7/16: HHS Comments to OMB on Risky Research Review Act
Importance: High
Hello all,
Background
Thank you again for your assistance in reviewing the Risky Research Review Act. HHS has compiled comments on the bill
from throughout HHS to provide them to the Office of Management and Budget (OMB) for consideration. HHS is asking
NIH to review the attached document on quick turnaround.
The comments included in the document provide high-level concerns across HHS. In particular, we have flagged a comment on the bottom of page 9 with a proposed clarifying edit for your review.
Action Item
Please review the attached draft HHS comments on the Risky Research Review Act and provide your concurrence, or any edits, by COB today, Tuesday July 16th. If you have any concerns with OCGR-Leg’s proposed edit to the comment on page 9, please let us know.
Please note that NIH OLPA is also working on a separate request from the Senate Health, Education, Labor, and Pensions (HELP) Committee (Chair: Sen. Bernie Sanders, I-VT) for technical assistance on this bill. OLPA plans to include the specific NIAID comments shared yesterday in this separate request. We anticipate we may be asked to review consolidated NIH comments for the HELP Committee this week.
Thank you for your ongoing assistance with reviewing this bill. Please let me know if you have any questions.
Thanks,
Sara
From: Selgrade, Sara (NIH/NIAID) [E] @nih.gov>
Sent: Monday, July 15, 2024 12:26 PM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: Additional OSP comments: TA on Risky Research Review Act
Hello all,
For your awareness, we are providing the attached comments on the Risky Research Review Act from the NIH Office of Science Policy (OSP). We anticipate receiving consolidated NIH comments on the bill, and we will share these as soon as we have them.
Please let me know if you have any questions.
Thanks,
Sara
From: Selgrade, Sara (NIH/NIAID) [E] @nih.gov>
Sent: Monday, July 15, 2024 10:35 AM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: For review by noon Monday 7/15: Review draft NIAID TA on Risky Research Review Act
Importance: High
Hello all,
Thank you for your quick review of the draft NIAID TA on the Risky Research Review Act. In the attached revised draft, I have incorporated additional edits from DMID/Dr. Erbelding and DEA. If there are no objections, I will submit these to NIH OLPA by their noon deadline today.
I am also attaching for your reference additional comments on the bill provided by NIH OER and NIH ORS/DOHS.
Please let me know if you have any questions or concerns.
Thanks,
Sara
From: Selgrade, Sara (NIH/NIAID) [E] @nih.gov>
Sent: Friday, July 12, 2024 4:06 PM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: URGENT ACTION by 10am Monday 7/15: Review draft NIAID TA on Risky Research Review Act
Importance: High
Hello all,
Background
Thank you very much for your quick work to comment on the Risky Research Review Act. NIH OLPA has asked us to prioritize comments to flag the most urgent or concerning items and/or those needing clarification.
Action Item
We have compiled the comments that meet NIH OLPA’s request into the attached draft technical assistance document. Please note that NIH OLPA has requested examples, where possible. We have tried to add some examples to emphasize key points, but we welcome any suggestions and/or corrections as needed.
We would appreciate your review and any edits by 10am Monday, July 15th. Given the quick turnaround, we are asking the Divisions to review concurrently with the NIAID OD.
Please note that NIH OSP, NIH ORS/DOHS, and NIH OER will also be reviewing and providing comments. We will be sure
to share with you any consolidated NIH comments that we receive.
Thank you for your help with this quick turnaround request. Please let me know if you have any questions.
Thanks,
Sara
From: Selgrade, Sara (NIH/NIAID) [E] @nih.gov>
Sent: Thursday, July 11, 2024 10:51 AM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>;
Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Subject: URGENT ACTION by 12pm Friday 7/12: TA on Risky Research Review Act
Importance: High
Good morning,
Background
HHS has been asked by the Senate Homeland Security and Governmental Affairs Committee (Chair: Sen. Gary Peters, D- MI; Ranking Member: Sen. Rand Paul, R-KY) to provide technical assistance (TA) on the attached draft legislation entitled the Risky Research Review Act.
The draft bill would require the establishment of an independent life sciences research security board to review federal funding for certain proposed life sciences research as defined by the bill. NIAID is mentioned briefly on page 4 in a section describing limitations on membership of the board.
HHS reports that the Committee intends to consider the bill on July 24. A number of HHS OpDivs and offices, including ASPR, CDC, and FDA, have been asked to review the bill along with NIH.
Action Item
By noon tomorrow, Friday July 12, please review the attached draft legislation and provide any technical comments in the attached HHS TA template. Please note that NIH ORS/DOHS and NIH OSP are also reviewing the bill on behalf of NIH.
As you complete your review, please keep in mind the HHS guidance on technical assistance below. Please let me know if you have any questions.
Thanks,
Sara
To ensure that the Department's comments are given full consideration, please observe the following guidelines in
providing your office's comments:
1. Are there provisions of this bill that would conflict with Department or Administration policy, and how?
2. Are there provisions that would pose difficulties for the operation or management of HHS programs, and how?
3. Are there any other significant issues that you can identify?
4. If you recommend specific changes, supply reasons and explanations, if the reasons are not obvious.
the revised bill text, which are attached for your reference, as well as high-level bullets (see email chain below).
ACTION: By 10a Thursday (10/17), please provide any new edits/comments in the attached “HHS points” document.
Please let us know if you have any questions.
Thanks,
Chase
From: Crawford, Chase (NIH/NIAID) [E]
Sent: Monday, September 30, 2024 2:31 PM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; NIAID DCR-OCGR @mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: FYI - Update on TA for revised bill text for Risky Research Review Act
FYI – Bldg. 1 has asked NIAID to provide a few top line bullets outlining the types of comments that were submitted on the redline version of the bill. NIAID plans to share the below bullets and indicate that NIAID shares many of the concerns raised by OER, ORS, and OSP (their top line bullets are copied further below). We will request a copy of the consolidated NIH TA and share it with you if/when we receive. Please let us know if you have any questions at this time. Thanks, Chase
NIAID
NIAID notes that, to avoid confusion, the definitions in the bill pertaining to scientific and/or current policies should be consistent with definitions in science and those policies, including the USG Policy for Oversight of DURC and PEPP (https://www.whitehouse.gov/wp-content/uploads/2024/05/USG-Policy-for-Oversight-of-DURC-and- PEPP.pdf). Further, as written, some definitions are overly broad and could slow research in critical areas, including research on antimicrobial resistance and the H5 influenza outbreak in dairy cattle. NIAID also notes that, as written, the proposed Board may lack essential expertise in infectious diseases and biosecurity. NIAID notes that it is unclear if it is the drafters’ intent to prohibit funding for an entire award prior to Board approval or only work related to potential “high-risk” research. Similarly, there is a later provision that would require a pause in research due to a change in circumstance, but it is unclear if such a pause would apply to an entire award or only work related to potential “high-risk research.
OER
It is unclear what added value the Board may have over current processes. The Board seems redundant with existing/current efforts and/or those being implemented following OSTP’s mandate on DURC/PEPP. The Board’s scope is very broad and may apply to a variety of research areas. We defer to OSP on the included research definitions. The Board will have significant control over funding decisions, which may interfere with existing statute on NIH funding activities. We have concerns about the Board reaching out directly to applicants/recipients, which is outside traditional NIH reporting procedures. The required timeline of some Board activities is unclear. Flagged in previous TA, we have concerns about the confidentiality of application information and recommend more details be provided on how such information will be used or protected.
Flagged in previous TA, some terms such as “proposal” and “entity” should be updated to better agree with NIH terminology. Flagged in previous TA, requirements for the validation of all applicant attestations related to research risk would be extremely challenging to implement.
ORS
Concern over the confusion and differences between agent listing, some definition and intent of this as compared
to the new DURC PEPP policy and also the current/ transparent process by which select agents are added or
removed. We would recommend alignment 100% in line with the current SA policies and DURC PEPP policies. Curious if this Board would be subject to posting in the Federal Register with public comment, or would function in a more draconian approach. Acknowledging that risk assessment is best when diverse voices are heard, the lack and actually clear refusal to ensure persons with experience in high and maximum containment principles are included would not provide a comprehensive and scientifically robust review of this work. The Board would be all political appointees, and finding someone with no experience in this space would likely select for persons who only do not favor this work. The goals feel less neutral and scientifically based and much more politically centric. The agent listings are highly concerning and would have an immediate negative impact to science and public health. The mention of Influenza A viruses, for example, would include all work with H5N1 viruses which are having a significant impact on our poultry and dairy farms. Research into vaccines, treatment, spread and evolution of these viruses is critical to ensure to curb this outbreak and to prevent those in the future. The same could be said for the inclusion of all mpox. The current outbreak and identification of Clade I is highly concerning and without scientists able to pivot nimbly, the outcome is concerning. Page 18 of the document, line 26-30 appear to replace the work of IBCs and IREs and biosafety professionals across the country. The composition of this board would not have the appropriate expertise, training or experience to appropriately determine these requirements. It also seems quite granular for a board of this nature. Concerns about sensitivity of grant and project submissions from the confidentiality side- defer to OER and OSP. Page 17 regarding employee disciplines. This section would make people charged with compliance consistently and constantly afraid for their jobs. A punitive reporting process would have the opposite impact that I think is intended. Transparency on situations is important but its unclear what would happen because of these reports.
We have significant concerns about this bill and approach this would take for the oversight of biological research. Based on timelines and reviews, plus the lack of appropriate experience, many researchers would likely leave critical research fields and the work would be paused having negative and catastrophic impact to the biomedical enterprise and by extension human and animal health and safety.
OSP
Topline points:
· While some aspects of this bill related to scope are improved, there continue to be significant concerns about the impact on biomedical research.
· Strengthening biosafety and biosecurity oversight of life sciences research is a key priority of this Administration, as outlined in the National Biodefense Strategy. We believe the bill as drafted would significantly undermine life sciences research, and its oversight provisions fail to target the subset of research posing greatest risk. As such, we do not support this legislation.
· The Administration has recently strengthened, streamlined, and expanded oversight of potentially high risk life science research in the May 2024 United States Government Policy for Oversight of Dual Use Research of Concern Pathogens with Enhanced Pandemic Potential (“DURC/PEPP policy”). This policy expands and strengthens a tiered system of oversight for all federally funded research that includes a requirement for research on pathogens with enhanced pandemic potential to undergo extra departmental review. The policy also:
o Defines an expanded scope of pathogen and toxin research subject to additional oversight by the U.S. Government;
o Provides a unified framework to support the consistent identification and oversight of research proposals that require enhanced oversight that accounts for safety, security, and ethical considerations; and
o Delineates the roles and responsibilities of principal investigators, research institutions, and Federal departments and agencies that conduct, fund, or oversee research within the scope of the policy.
· The bill seems to create redundancies with some reforms recently introduced by the DURC/PEPP policy, which was developed following significant interagency discussions directed by Congress and informed by the National Science Advisory Board for Biosecurity, public comment, and other expert input.
· As currently drafted, this legislation has the potential to negatively impact innovation and the U.S. competitive edge in life sciences research, including our ability to attract and retain the best scientists.
· However, the Administration welcomes efforts from Congress to further strengthen biosafety and biosecurity in the life sciences. o For example, we would welcome discussions on how the risk-based oversight processes established in the DURC policy for federally funded research could be extended to non-federally funded research.
· We recognize that biosafety and biosecurity oversight responsibilities are currently shared across many different departments and agencies and welcome discussions on appropriate entities for oversight of the highest risk research.
Some of our concerns with the bill are:
· Scope: While steps have been made toward harmonization of the scope of the Board’s oversight with the new United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (2024 OSTP DURC/PEPP Policy), some of the listed experiments in the “dual use research of concern” definition do not match those in the policy, and other articulated in-scope research in the bill including the “gain of function research” term continues to be in conflict with USG policy. These definition differences will be challenging to deconflict for the research community. Many of the USG definitions were determined following significant interagency discussions directed by Congress and informed by the National Science Advisory Board for Biosecurity, public comment, and other expert input. o This could result in delays to critical biosurveillance efforts such as COVID-19 testing, H5N1 monitoring, and detection of emerging outbreaks of Ebola and other diseases. It could also result in delays for development of vaccines, therapeutics, and biomedical, agricultural, and other life sciences research writ large (including research that is not associated with pathogens or toxins and raises no identified national security threats, such as cancer research). o If the statute only provided the board the responsibility to review federally-funded research involving DURC and PEPP, as defined in the DURC/PEPP policy, it would ensure oversight resources are used most efficiently to assess and mitigate risks to the public while avoiding unintended negative consequences for the nation’s biomedical enterprise. We believe this is the intent of the bill but as written the definitions are not harmonized. (We recommend other definitions in the text be aligned
to current U.S. Government policy, including “life sciences research.”)
o We recommend that the definitions and scope of review be fully harmonized with the DURC/PEPP policy and not include a separate list of pathogens. o A large amount of scientific research involves gain or loss of function; it’s a fundamental process in science. For example, some types of immune therapy cause the immune system to gain function to fight against a disease. Unfortunately, the term “gain of function” has often being misconstrued to suggest all research that causes a gain of function is highly risky, which is inaccurate. In fact, most research involving a GOF does not confer significant additional risk or require additional oversight. NIH does not define the term GOF and current federal policy does not define or operationalize the term. The research that requires strict oversight involves enhancing the transmissibility and/or virulence of a pathogen such that it would pose an increased pandemic potential in humans. The USG policy on oversight of DURC and PEPP (effective May 2025) also does not use the term GOF when describing research that requires additional oversight because of its higher risk. As it appears the intent of the term “GOF” in this bill is to refer specially to research that has the potential to enhance the transmissibility or virulence of a potential pandemic pathogen, for clarity we would recommend the use of the term “pathogen with enhanced pandemic potential” in the 2024 OSTP policy that addresses this type of research, as well as it’s associated definition. This would help to avoid the ongoing confusion surrounding the term GOF.
· Board processes and makeup: While biosafety expertise is now included, the makeup and processes of the board could introduce a number of issues. For example, the limitations on prior federal service and
designation of participation in high-risk research as a “conflict of interest” could limit the board from accessing relevant national security and life sciences expertise. The exclusion of those involved in high-risk research, based on the definition in the draft legislation, could exclude anyone with a current BSL3 or BSL4 program, excluding individuals with key expertise on how to conduct work safely. These limitations may also exclude individuals who work in government with relevant knowledge of intelligence and threat assessments. We also recommend relaxing the limitations on membership of the board and note that a number of the timelines are untenable (e.g., Congressional notification requirements within 3 days of identifying a potential conflict of interest; publishing procedures in the Federal Register within 90 days of the appointment of initial members; etc.). We note that several provisions relating to the membership of the Board or its support staff are vague, including the requirement that Board members be “impartial” and that support staff be prohibited
from “directly or indirectly influenc[ing]” the Board. The proposed legislation would also politicize
independent peer review by making the constituent members presidential appointees.
· Review process: While a path for expedited review has been added, there could still be major issues with continuity of science due to delays of reviews or membership being confirmed. Among other concerns, in particular, this will significantly impede the USG’s ability to prepare for and detect emerging infectious diseases/epidemics/pandemics and will also significantly impede the USG’s research response to an epidemic/pandemic. We recommend establishing a default rule that research may proceed if a decision is not made within a fixed timeframe to ensure that any lapse in function by the Board (e.g., delays in confirmation) do not result in life sciences research grinding to a halt. We also recommend a formal appeals process and an exemption to public reporting requirements if the information could pose national security risks.
· Review criteria: The bill does not articulate a principle or threshold that guides whether the board should or should not approve a study for funding – for example, should the Board approve research where it determines that the potential public health benefits of the research outweigh the potential risks to U.S. national security? Or should some other standard govern the Board’s review? Any statute mandating this style of review should clarify the applicable standard.
· Classified review and intelligence concerns: We recommend striking provisions that mandate the provision of security clearances to Board members, Board staff, and members of Congress, or that require these individuals to access and review all classified research funded by any agency. Those provisions extend beyond the scope of oversight that is reasonable for this board to take on and they may impinge on the constitutional authority of the Executive to control classified national security information. We also recommend that clauses be included to enable the intelligence community to respond to requests from the Board in a manner consistent with the protection of intelligence sources and methods.
· Enforcement: The enforcement provisions are extreme and may raise significant legal and privacy concerns. Those provisions mandate a suite of harsh penalties for any violations of certain provisions of the statute, including technical or unintentional violations; they allow for no flexibility in determining the severity of punishment; they provide the aggrieved party with no process; and they mandate public identification of aggrieved individuals. These provisions could broadly disincentivize individuals from working in life sciences research and funding agencies, which could send research outside of this country and compromise progress on public health, safety, and national security. We recommend that enforcement provisions be focused on willful violations and significantly reduced or adjusted.
Given the above concerns, as drafted, this legislation has the potential to negatively impact innovation and delay the development of lifesaving technologies. While the Administration does not support this legislation, we remain committed to working with the Committee on biosafety and biosecurity.
From: Crawford, Chase (NIH/NIAID) [E]
Sent: Wednesday, September 25, 2024 1:45 PM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; NIAID DCR-OCGR @mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: ACTION by COB Friday (9/27): Review revised bill text for Risky Research Review Act
Good Afternoon,
NIAID has been asked to review the revised bill text for the Risky Research Review Act (PDF of bill text and Word doc of the redline are attached). This morning, the attached version of the bill was reported out of the Senate Committee on Homeland Security & Governmental Affairs (HSGAC) and now awaits further Senate consideration.
As you may recall, NIH and other OPDIVs provided comments on a previous version of the bill (previous NIAID comments attached for reference). HHS is now requesting any new comments that OPDIVS may have.
ACTION: By COB Friday (9/27), please review the attached redline and provide any new comments directly in the document.
Thanks,
Chase
From: Selgrade, Sara (NIH/NIAID) [E] @nih.gov>
Sent: Tuesday, July 16, 2024 6:07 PM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: URGENT review by 8am Wed. 7/17: HHS Comments to OMB on Risky Research Review Act
Importance: High
Hello all,
Thank you for your review of the consolidated HHS comments on the Risky Research Review Act. DMID has suggested adding some of the comments NIAID put forward earlier this week. We have incorporated these comments in highlighted text in the attached document. The comments are listed below by page number for ease of review.
Please let us know by no later than 8am tomorrow, Wednesday, July 17th, if you have any concerns with putting forward these previously NIAID-cleared edits.
Thank you again for all your help with this quick turnaround request. Please let me know if you have any questions.
Thanks,
Sara
Re-submitted NIAID comments in the attached document (highlighted in yellow):
p. 1: New NIH comment
p. 2: NIH addition to OASH/OHRP comment
p. 3: New NIH comment
p. 4: NIH addition to OASH/OHRP comment
p. 9: NIH edit to OGC comment to broaden scope to all agencies (previously flagged by OCGR-Leg)
p. 10: NIH addition (from NIAID) to existing NIH comment
p. 12: NIH addition to OIG comment
p. 14: NIH addition to OGC comment
p. 16: NIH addition (from NIAID) to existing NIH comment
From: Selgrade, Sara (NIH/NIAID) [E] @nih.gov>
Sent: Tuesday, July 16, 2024 12:24 PM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: Please review by COB today Tues 7/16: HHS Comments to OMB on Risky Research Review Act
Importance: High
Hello all,
Background
Thank you again for your assistance in reviewing the Risky Research Review Act. HHS has compiled comments on the bill
from throughout HHS to provide them to the Office of Management and Budget (OMB) for consideration. HHS is asking
NIH to review the attached document on quick turnaround.
The comments included in the document provide high-level concerns across HHS. In particular, we have flagged a comment on the bottom of page 9 with a proposed clarifying edit for your review.
Action Item
Please review the attached draft HHS comments on the Risky Research Review Act and provide your concurrence, or any edits, by COB today, Tuesday July 16th. If you have any concerns with OCGR-Leg’s proposed edit to the comment on page 9, please let us know.
Please note that NIH OLPA is also working on a separate request from the Senate Health, Education, Labor, and Pensions (HELP) Committee (Chair: Sen. Bernie Sanders, I-VT) for technical assistance on this bill. OLPA plans to include the specific NIAID comments shared yesterday in this separate request. We anticipate we may be asked to review consolidated NIH comments for the HELP Committee this week.
Thank you for your ongoing assistance with reviewing this bill. Please let me know if you have any questions.
Thanks,
Sara
From: Selgrade, Sara (NIH/NIAID) [E] @nih.gov>
Sent: Monday, July 15, 2024 12:26 PM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: Additional OSP comments: TA on Risky Research Review Act
Hello all,
For your awareness, we are providing the attached comments on the Risky Research Review Act from the NIH Office of Science Policy (OSP). We anticipate receiving consolidated NIH comments on the bill, and we will share these as soon as we have them.
Please let me know if you have any questions.
Thanks,
Sara
From: Selgrade, Sara (NIH/NIAID) [E] @nih.gov>
Sent: Monday, July 15, 2024 10:35 AM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: For review by noon Monday 7/15: Review draft NIAID TA on Risky Research Review Act
Importance: High
Hello all,
Thank you for your quick review of the draft NIAID TA on the Risky Research Review Act. In the attached revised draft, I have incorporated additional edits from DMID/Dr. Erbelding and DEA. If there are no objections, I will submit these to NIH OLPA by their noon deadline today.
I am also attaching for your reference additional comments on the bill provided by NIH OER and NIH ORS/DOHS.
Please let me know if you have any questions or concerns.
Thanks,
Sara
From: Selgrade, Sara (NIH/NIAID) [E] @nih.gov>
Sent: Friday, July 12, 2024 4:06 PM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: URGENT ACTION by 10am Monday 7/15: Review draft NIAID TA on Risky Research Review Act
Importance: High
Hello all,
Background
Thank you very much for your quick work to comment on the Risky Research Review Act. NIH OLPA has asked us to prioritize comments to flag the most urgent or concerning items and/or those needing clarification.
Action Item
We have compiled the comments that meet NIH OLPA’s request into the attached draft technical assistance document. Please note that NIH OLPA has requested examples, where possible. We have tried to add some examples to emphasize key points, but we welcome any suggestions and/or corrections as needed.
We would appreciate your review and any edits by 10am Monday, July 15th. Given the quick turnaround, we are asking the Divisions to review concurrently with the NIAID OD.
Please note that NIH OSP, NIH ORS/DOHS, and NIH OER will also be reviewing and providing comments. We will be sure
to share with you any consolidated NIH comments that we receive.
Thank you for your help with this quick turnaround request. Please let me know if you have any questions.
Thanks,
Sara
From: Selgrade, Sara (NIH/NIAID) [E] @nih.gov>
Sent: Thursday, July 11, 2024 10:51 AM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>;
Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Subject: URGENT ACTION by 12pm Friday 7/12: TA on Risky Research Review Act
Importance: High
Good morning,
Background
HHS has been asked by the Senate Homeland Security and Governmental Affairs Committee (Chair: Sen. Gary Peters, D- MI; Ranking Member: Sen. Rand Paul, R-KY) to provide technical assistance (TA) on the attached draft legislation entitled the Risky Research Review Act.
The draft bill would require the establishment of an independent life sciences research security board to review federal funding for certain proposed life sciences research as defined by the bill. NIAID is mentioned briefly on page 4 in a section describing limitations on membership of the board.
HHS reports that the Committee intends to consider the bill on July 24. A number of HHS OpDivs and offices, including ASPR, CDC, and FDA, have been asked to review the bill along with NIH.
Action Item
By noon tomorrow, Friday July 12, please review the attached draft legislation and provide any technical comments in the attached HHS TA template. Please note that NIH ORS/DOHS and NIH OSP are also reviewing the bill on behalf of NIH.
As you complete your review, please keep in mind the HHS guidance on technical assistance below. Please let me know if you have any questions.
Thanks,
Sara
To ensure that the Department's comments are given full consideration, please observe the following guidelines in
providing your office's comments:
1. Are there provisions of this bill that would conflict with Department or Administration policy, and how?
2. Are there provisions that would pose difficulties for the operation or management of HHS programs, and how?
3. Are there any other significant issues that you can identify?
4. If you recommend specific changes, supply reasons and explanations, if the reasons are not obvious.
HHS Review of S.4667 Risky Research Review Act As amended by HSGAC on September 25, 2024
HHS appreciates the opportunity to review S. 4667, as amended by the Peters-Paul substitute amendment. Please note this is not formal Department TA or Administrations views. However, as there remain many similarities between the introduced bill and substitute amendment, we are also attaching the formal TA we shared with the committee in July. to the introduced bill, for reference.
While some aspects of this bill related to scope are improved, there continue to be significant concerns about the impact on biomedical research.
Strengthening biosafety and biosecurity oversight of life sciences research is a key priority of this Administration, as outlined in the National Biodefense Strategy. We believe the bill as drafted would significantly undermine life sciences research, and its oversight provisions fail to target the subset of research posing greatest risk.
As currently drafted, this legislation has the potential to negatively impact innovation and the U.S. competitive edge in life sciences research, including our ability to attract and retain the best scientists.
While HHS continues to have serious concerns with this legislation as drafted, we remain committed to working with the Committee and Congress on biosafety and biosecurity.
More detailed concerns are described below by category.
Redundant with DURC/PEPP policy
• The Administration has recently strengthened, streamlined, and expanded oversight of potentially high risk life science research in the May 2024 United States Government Policy for Oversight of Dual Use Research of Concern Pathogens with Enhanced Pandemic Potential (“DURC/PEPP policy”). This policy expands and strengthens a tiered system of oversight for all federally funded research that includes a requirement for research on pathogens with enhanced pandemic potential to undergo extra departmental review. The policy also:
o Defines an expanded scope of pathogen and toxin research subject to additional oversight by the U.S. Government;
o Provides a unified framework to support the consistent identification and oversight of research proposals that require enhanced oversight that accounts for safety, security, and ethical considerations; and o Delineates the roles and responsibilities of principal investigators, research institutions, and Federal departments and agencies that conduct, fund, or oversee research within the scope of the policy.
• The bill seems to create redundancies with some reforms recently introduced by the DURC/PEPP policy, which was developed following significant interagency discussions directed by Congress and informed by the National Science Advisory Board for Biosecurity, public comment, and other expert input.
• However, HHS welcomes efforts from Congress to further strengthen biosafety and biosecurity in the life sciences. For example, we would welcome discussions on how the risk-based oversight processes established in the DURC policy for federally funded research could be extended to non-federally funded research.
Scope/Definitions
• While steps have been made toward harmonization of the scope of the Board’s oversight with the new United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (2024 OSTP DURC/PEPP Policy), some of the listed experiments in the “dual use research of concern” definition do not match those in the policy, and other articulated in-scope research in the bill including the “gain of function research” term continues to be in conflict with USG policy. These definition differences will be challenging to deconflict for the research community. Many of the USG definitions were determined following significant interagency discussions directed by Congress and informed by the National Science Advisory Board for Biosecurity, public comment, and other expert input. We recommend that the definitions and scope of review be fully harmonized with the DURC/PEPP policy and not include a separate list of pathogens. Many of the definitions of research that is
subject to requirements of this proposed legislation are very broad and not all are in line
with existing policies, which is likely to cause confusion in the research community. o This could result in delays to critical biosurveillance efforts such as COVID-19 testing, H5N1 monitoring, and detection of emerging outbreaks of Ebola and other diseases. It could also result in delays for development of vaccines, therapeutics, and biomedical, agricultural, and other life sciences research writ large (including research that is not associated with pathogens or toxins and raises no identified national security threats, such as cancer research). o If the statute only provided the board the responsibility to review federally-funded research involving DURC and PEPP, as defined in the DURC/PEPP policy, it would ensure oversight resources are used most efficiently to assess and mitigate risks to the public while avoiding unintended negative consequences for the nation’s biomedical enterprise. We believe this is the intent of the bill but as written the definitions are not harmonized. o A large amount of scientific research involves gain or loss of function; it’s a fundamental process in science. For example, some types of immune therapy cause the immune system to gain function to fight against a disease. Unfortunately, the term “gain of function” has often being misconstrued to suggest all research that causes a gain of function is highly risky, which is inaccurate. In fact, most research involving a GOF does not confer significant additional risk or require additional oversight. NIH does not define the term GOF and current federal policy does not define or operationalize the term. The research that requires strict oversight involves enhancing the transmissibility and/or
virulence of a pathogen such that it would pose an increased pandemic potential in humans. The USG policy on oversight of DURC and PEPP (effective May 2025) also does not use the term GOF when describing research that requires additional oversight because of its higher risk. As it appears the intent of the term “GOF” in this bill is to refer specially to research that has the potential to enhance the transmissibility or virulence of a potential pandemic pathogen, for clarity we would recommend the use of the term “pathogen with enhanced pandemic potential” in the 2024 OSTP policy that addresses this type of research, as well as it’s associated definition. This would help to avoid the ongoing confusion surrounding the term GOF.
• The list of “high-consequence pathogens” is concerning and would have an immediate negative impact to science and public health. The mention of Influenza A viruses, for example, would include all work with H5N1 viruses which are having a significant impact on our poultry and dairy farms. Research into vaccines, treatment, spread and evolution of these viruses is critical to ensure to curb this outbreak and to prevent those in the future. The same could be said for the inclusion of all mpox. The current outbreak and identification of Clade I is highly concerning and without scientists able to pivot nimbly, the outcome is concerning. We are also concerned with the catchall language that could expand the scope of pathogens and categories the board reviews simply by a majority vote from the board. o Given that certain types of research with any “wild-type or synthetic” pathogen among the listed species would apparently require review by the new Board, this appears to suggest that research with viruses engineered or adapted for decreased pathogenicity (e.g. certain mouse-adapted or tissue-culture-adapted strains) would be considered “high-consequence” even if they have been deliberately altered to decrease the research risk, e.g. for exploration of drug-resistance mechanisms at lower BSL levels. o Category XVIII “any synthetic construct of a pathogen or category of pathogen described in this clause” may be confusing regarding what it adds to the “wildtype or synthetic” pathogens already listed – what is meant by “synthetic construct” in addition to previous use of “synthetic” and does this mean that using only a piece of a “high-consequence pathogen” (e.g. synthesizing the receptorbinding site and studying receptor affinity in vitro, or synthesizing a viral or bacterial enzyme and studying inhibitors in vitro) would potentially still be considered “high-consequence”? o Subparagraph B is auto-referential creating an exclusion for seasonal influenza unless genetic sequences have been introduced from the list of pathogens that includes influenza A – does this mean that any introduction of genetic material
from one seasonal influenza virus into another seasonal influenza virus would be
considered “high-consequence”?
o Some other included pathogens besides influenza may be commonly circulating in the population, and classifying them as automatically “high-consequence” could potentially delay or interfere with clinical diagnosis and care depending on how the other criteria for centralized Board review are interpreted (e.g. all sarbecoviruses, all mpox viruses).
o According to the next section at the bottom of the page, it looks like maybe only experiments that meet DURC/GOF criteria with these agents would need centralized board review, and if it were possible to obtain clarification that non- DURC/GOF experiments are not subject to the Act provisions that might mitigate some of the potential concerns, but there is the possibility that uncertainty about interpretation could still have major impact on willingness to conduct or review research in some of the relevant areas of importance for public health.
• The text of the proposed legislation reads as if the Life Sciences Research Security Board could review all life sciences research. Throughout the text of the proposed legislation, the terms used seem to vary between "high-risk life sciences research," which is defined very specifically, and broader terms like "life sciences research." The scope of review seems far beyond what a single Board could reasonably be able to review especially given the broad definition of life sciences research, even if limited to high-risk life sciences research and even with the Board trying to develop expert committees. Creating such a broad scope of review for the Board risk delays of important research, which does not rise to the level of high-risk life sciences research, that could be adequately addressed at a more local or Agency review level and is already subject to laws, regulations, guidances, and policies.
Expertise/Board Processes and Makeup
• While biosafety expertise is now included, the makeup and processes of the board could introduce a number of issues. For example, the limitations on prior federal service and designation of participation in high-risk research as a “conflict of interest” could limit the board from accessing relevant national security and life sciences expertise. The exclusion of those involved in high-risk research, based on the definition in the draft legislation, could exclude anyone with a current BSL3 or BSL4 program, excluding individuals with key expertise on how to conduct work safely. These limitations may also exclude individuals who work in government with relevant knowledge of intelligence, threat assessments, and biosecurity. Risk assessment is best when diverse voices are heard, the lack and actually clear refusal to ensure persons with experience in high and maximum containment principles are included would not provide a comprehensive and scientifically robust review of this work.
• We also recommend relaxing the limitations on membership of the board and note that a number of the timelines are untenable (e.g., Congressional notification requirements within 3 days of identifying a potential conflict of interest; publishing procedures in the Federal Register within 90 days of the appointment of initial members; etc.). We note that several provisions relating to the membership of the Board or its support staff are vague, including the requirement that Board members be “impartial” and that support staff be prohibited from “directly or indirectly influenc[ing]” the Board. The proposed legislation would also politicize independent peer review by making the constituent members presidential appointees.
• As drafted, the Board will have significant control over funding decisions, which may interfere with existing statute on NIH funding activities.
• We have concerns about the Board reaching out directly to applicants/recipients, which is outside traditional NIH reporting procedures.
• Regarding support from agencies to board personnel, it is unclear how an agency representative can be expected to both provide technical assistance but not indirectly influence the board. Technical assistance should factor into the decision.
• Regarding 7904 (b)(3), if such disclosure is required drafters should be specific as to what laws on protection of commercial confidential information and trade secrets are being waived.
Review Process and Criteria
• While a path for expedited review has been added, there could still be major issues with continuity of science due to delays of reviews or membership being confirmed. Among other concerns, in particular, this will significantly impede the USG’s ability to prepare for and detect emerging infectious diseases/epidemics/pandemics and will also significantly impede the USG’s research response to an epidemic/pandemic. We recommend establishing a default rule that research may proceed if a decision is not made within a fixed timeframe to ensure that any lapse in function by the Board (e.g., delays in confirmation) do not result in life sciences research grinding to a halt. We also recommend a formal appeals process and an exemption to public reporting requirements if the information could pose national security risks.
• The bill does not articulate a principle or threshold that guides whether the board should or should not approve a study for funding – for example, should the Board approve research where it determines that the potential public health benefits of the research outweigh the potential risks to U.S. national security? Or should some other standard govern the Board’s review? Any statute mandating this style of review should clarify the applicable standard.
• It is unclear if it is the drafters’ intent to prohibit funding for an entire award prior to Board approval or only work related to potential “high-risk” research. Similarly, there is a later provision that would require a pause in research due to a change in circumstance, but it is unclear if such a pause would apply to an entire award or only work related to potential “high-risk research.
Classified review and intelligence concerns
• We recommend striking provisions that mandate the provision of security clearances to Board members, Board staff, and members of Congress, or that require these individuals
to access and review all classified research funded by any agency. Those provisions
extend beyond the scope of oversight that is reasonable for this board to take on and they may impinge on the constitutional authority of the Executive to control classified national security information. We also recommend that clauses be included to enable the intelligence community to respond to requests from the Board in a manner consistent with the protection of intelligence sources and methods.
Enforcement
• The enforcement provisions are extreme and may raise significant legal and privacy concerns. Those provisions mandate a suite of harsh penalties for any violations of certain provisions of the statute, including technical or unintentional violations; they allow for no flexibility in determining the severity of punishment; they provide the aggrieved party with no process; and they mandate public identification of aggrieved individuals. These provisions could broadly disincentivize individuals from working in life sciences research and funding agencies, which could send research outside of this country and compromise progress on public health, safety, and national security. We recommend that enforcement provisions be focused on willful violations and significantly reduced or adjusted.
Please let us know if you have any questions.
Thanks,
Chase
From: Crawford, Chase (NIH/NIAID) [E]
Sent: Monday, September 30, 2024 2:31 PM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; NIAID DCR-OCGR @mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: FYI - Update on TA for revised bill text for Risky Research Review Act
FYI – Bldg. 1 has asked NIAID to provide a few top line bullets outlining the types of comments that were submitted on the redline version of the bill. NIAID plans to share the below bullets and indicate that NIAID shares many of the concerns raised by OER, ORS, and OSP (their top line bullets are copied further below). We will request a copy of the consolidated NIH TA and share it with you if/when we receive. Please let us know if you have any questions at this time. Thanks, Chase
NIAID
NIAID notes that, to avoid confusion, the definitions in the bill pertaining to scientific and/or current policies should be consistent with definitions in science and those policies, including the USG Policy for Oversight of DURC and PEPP (https://www.whitehouse.gov/wp-content/uploads/2024/05/USG-Policy-for-Oversight-of-DURC-and- PEPP.pdf). Further, as written, some definitions are overly broad and could slow research in critical areas, including research on antimicrobial resistance and the H5 influenza outbreak in dairy cattle. NIAID also notes that, as written, the proposed Board may lack essential expertise in infectious diseases and biosecurity. NIAID notes that it is unclear if it is the drafters’ intent to prohibit funding for an entire award prior to Board approval or only work related to potential “high-risk” research. Similarly, there is a later provision that would require a pause in research due to a change in circumstance, but it is unclear if such a pause would apply to an entire award or only work related to potential “high-risk research.
OER
It is unclear what added value the Board may have over current processes. The Board seems redundant with existing/current efforts and/or those being implemented following OSTP’s mandate on DURC/PEPP. The Board’s scope is very broad and may apply to a variety of research areas. We defer to OSP on the included research definitions. The Board will have significant control over funding decisions, which may interfere with existing statute on NIH funding activities. We have concerns about the Board reaching out directly to applicants/recipients, which is outside traditional NIH reporting procedures. The required timeline of some Board activities is unclear. Flagged in previous TA, we have concerns about the confidentiality of application information and recommend more details be provided on how such information will be used or protected. Flagged in previous TA, some terms such as “proposal” and “entity” should be updated to better agree with NIH terminology. Flagged in previous TA, requirements for the validation of all applicant attestations related to research risk would be extremely challenging to implement.
ORS
Concern over the confusion and differences between agent listing, some definition and intent of this as compared
to the new DURC PEPP policy and also the current/ transparent process by which select agents are added or
removed. We would recommend alignment 100% in line with the current SA policies and DURC PEPP policies. Curious if this Board would be subject to posting in the Federal Register with public comment, or would function in a more draconian approach. Acknowledging that risk assessment is best when diverse voices are heard, the lack and actually clear refusal to ensure persons with experience in high and maximum containment principles are included would not provide a comprehensive and scientifically robust review of this work. The Board would be all political appointees, and finding someone with no experience in this space would likely select for persons who only do not favor this work. The goals feel less neutral and scientifically based and much more politically centric. The agent listings are highly concerning and would have an immediate negative impact to science and public health. The mention of Influenza A viruses, for example, would include all work with H5N1 viruses which are having a significant impact on our poultry and dairy farms. Research into vaccines, treatment, spread and evolution of these viruses is critical to ensure to curb this outbreak and to prevent those in the future. The same could be said for the inclusion of all mpox. The current outbreak and identification of Clade I is highly concerning and without scientists able to pivot nimbly, the outcome is concerning. Page 18 of the document, line 26-30 appear to replace the work of IBCs and IREs and biosafety professionals across the country. The composition of this board would not have the appropriate expertise, training or experience to appropriately determine these requirements. It also seems quite granular for a board of this nature. Concerns about sensitivity of grant and project submissions from the confidentiality side- defer to OER and OSP. Page 17 regarding employee disciplines. This section would make people charged with compliance consistently and constantly afraid for their jobs. A punitive reporting process would have the opposite impact that I think is intended. Transparency on situations is important but its unclear what would happen because of these reports.
We have significant concerns about this bill and approach this would take for the oversight of biological research. Based on timelines and reviews, plus the lack of appropriate experience, many researchers would likely leave critical research fields and the work would be paused having negative and catastrophic impact to the biomedical enterprise and by extension human and animal health and safety.
OSP
Topline points:
While some aspects of this bill related to scope are improved, there continue to be significant concerns about the impact on biomedical research. Strengthening biosafety and biosecurity oversight of life sciences research is a key priority of this Administration, as outlined in the National Biodefense Strategy. We believe the bill as drafted would significantly undermine life sciences research, and its oversight provisions fail to target the subset of research posing greatest risk. As such, we do not support this legislation. The Administration has recently strengthened, streamlined, and expanded oversight of potentially high risk life science research in the May 2024 United States Government Policy for Oversight of Dual Use Research of Concern Pathogens with Enhanced Pandemic Potential (“DURC/PEPP policy”). This policy expands and strengthens a tiered system of oversight for all federally funded research that includes a requirement for research on pathogens with enhanced pandemic potential to undergo extra departmental review. The policy also:
Defines an expanded scope of pathogen and toxin research subject to additional oversight by the U.S. Government;
Provides a unified framework to support the consistent identification and oversight of research proposals that require enhanced oversight that accounts for safety, security, and ethical considerations; and Delineates the roles and responsibilities of principal investigators, research institutions, and Federal departments and agencies that conduct, fund, or oversee research within the scope of the policy. The bill seems to create redundancies with some reforms recently introduced by the DURC/PEPP policy, which was developed following significant interagency discussions directed by Congress and informed by the National Science Advisory Board for Biosecurity, public comment, and other expert input. As currently drafted, this legislation has the potential to negatively impact innovation and the U.S. competitive edge in life sciences research, including our ability to attract and retain the best scientists.
However, the Administration welcomes efforts from Congress to further strengthen biosafety and biosecurity in the life sciences. For example, we would welcome discussions on how the risk-based oversight processes established in the DURC policy for federally funded research could be extended to non-federally funded research. We recognize that biosafety and biosecurity oversight responsibilities are currently shared across many different departments and agencies and welcome discussions on appropriate entities for oversight of the highest risk research.
Some of our concerns with the bill are:
Scope: While steps have been made toward harmonization of the scope of the Board’s oversight with the new United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (2024 OSTP DURC/PEPP Policy), some of the listed experiments in the “dual use research of concern” definition do not match those in the policy, and other articulated in-scope research in the bill including the “gain of function research” term continues to be in conflict with USG policy. These definition differences will be challenging to deconflict for the research community. Many of the USG definitions were determined following significant interagency discussions directed by Congress and informed by the National Science Advisory Board for Biosecurity, public comment, and other expert input. This could result in delays to critical biosurveillance efforts such as COVID-19 testing, H5N1 monitoring, and detection of emerging outbreaks of Ebola and other diseases. It could also result in delays for development of vaccines, therapeutics, and biomedical, agricultural, and other life sciences research writ large (including research that is not associated with pathogens or toxins and raises no identified national security threats, such as cancer research). If the statute only provided the board the responsibility to review federally-funded research involving DURC and PEPP, as defined in the DURC/PEPP policy, it would ensure oversight resources are used most efficiently to assess and mitigate risks to the public while avoiding unintended negative consequences for the nation’s biomedical enterprise. We believe this is the intent of the bill but as written the definitions are not harmonized. (We recommend other definitions in the text be aligned
to current U.S. Government policy, including “life sciences research.”)
We recommend that the definitions and scope of review be fully harmonized with the DURC/PEPP policy and not include a separate list of pathogens. A large amount of scientific research involves gain or loss of function; it’s a fundamental process in science. For example, some types of immune therapy cause the immune system to gain function to fight against a disease. Unfortunately, the term “gain of function” has often being misconstrued to suggest all research that causes a gain of function is highly risky, which is inaccurate. In fact, most research involving a GOF does not confer significant additional risk or require additional oversight. NIH does not define the term GOF and current federal policy does not define or operationalize the term. The research that requires strict oversight involves enhancing the transmissibility and/or virulence of a pathogen such that it would pose an increased pandemic potential in humans. The USG policy on oversight of DURC and PEPP (effective May 2025) also does not use the term GOF when describing research that requires additional oversight because of its higher risk. As it appears the intent of the term “GOF” in this bill is to refer specially to research that has the potential to enhance the transmissibility or virulence of a potential pandemic pathogen, for clarity we would recommend the use of the term “pathogen with enhanced pandemic potential” in the 2024 OSTP policy that addresses this type of research, as well as it’s associated definition. This would help to avoid the ongoing confusion surrounding the term GOF.
Board processes and makeup: While biosafety expertise is now included, the makeup and processes of the board could introduce a number of issues. For example, the limitations on prior federal service and designation of participation in high-risk research as a “conflict of interest” could limit the board from accessing relevant national security and life sciences expertise. The exclusion of those involved in high-risk research, based on the definition in the draft legislation, could exclude anyone with a current BSL3 or BSL4 program, excluding individuals with key expertise on how to conduct work safely. These limitations may also exclude individuals who work in government with relevant knowledge of intelligence and threat assessments. We also recommend relaxing the limitations on membership of the board and note that a number of the timelines are untenable (e.g., Congressional notification requirements within 3 days of identifying a potential conflict of
interest; publishing procedures in the Federal Register within 90 days of the appointment of initial members;
etc.). We note that several provisions relating to the membership of the Board or its support staff are vague, including the requirement that Board members be “impartial” and that support staff be prohibited from “directly or indirectly influenc[ing]” the Board. The proposed legislation would also politicize independent peer review by making the constituent members presidential appointees.
Review process: While a path for expedited review has been added, there could still be major issues with continuity of science due to delays of reviews or membership being confirmed. Among other concerns, in particular, this will significantly impede the USG’s ability to prepare for and detect emerging infectious diseases/epidemics/pandemics and will also significantly impede the USG’s research response to an epidemic/pandemic. We recommend establishing a default rule that research may proceed if a decision is not made within a fixed timeframe to ensure that any lapse in function by the Board (e.g., delays in confirmation) do not result in life sciences research grinding to a halt. We also recommend a formal appeals process and an exemption to public reporting requirements if the information could pose national security risks.
Review criteria: The bill does not articulate a principle or threshold that guides whether the board should or should not approve a study for funding – for example, should the Board approve research where it determines that the potential public health benefits of the research outweigh the potential risks to U.S. national security? Or should some other standard govern the Board’s review? Any statute mandating this style of review should clarify the applicable standard.
Classified review and intelligence concerns: We recommend striking provisions that mandate the provision of security clearances to Board members, Board staff, and members of Congress, or that require these individuals to access and review all classified research funded by any agency. Those provisions extend beyond the scope of oversight that is reasonable for this board to take on and they may impinge on the constitutional authority of the Executive to control classified national security information. We also recommend that clauses be included to enable the intelligence community to respond to requests from the Board in a manner consistent with the protection of intelligence sources and methods.
Enforcement: The enforcement provisions are extreme and may raise significant legal and privacy concerns. Those provisions mandate a suite of harsh penalties for any violations of certain provisions of the statute, including technical or unintentional violations; they allow for no flexibility in determining the severity of punishment;
they provide the aggrieved party with no process; and they mandate public identification of aggrieved individuals. These provisions could broadly disincentivize individuals from working in life sciences research and funding agencies, which could send research outside of this country and compromise progress on public health, safety, and national security. We recommend that enforcement provisions be focused on willful violations and significantly reduced or adjusted.
Given the above concerns, as drafted, this legislation has the potential to negatively impact innovation and delay the development of lifesaving technologies. While the Administration does not support this legislation, we remain committed to working with the Committee on biosafety and biosecurity.
From: Crawford, Chase (NIH/NIAID) [E]
Sent: Wednesday, September 25, 2024 1:45 PM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; NIAID DCR-OCGR @mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: ACTION by COB Friday (9/27): Review revised bill text for Risky Research Review Act
Good Afternoon,
NIAID has been asked to review the revised bill text for the Risky Research Review Act (PDF of bill text and Word doc of the redline are attached). This morning, the attached version of the bill was reported out of the Senate Committee on Homeland Security & Governmental Affairs (HSGAC) and now awaits further Senate consideration.
As you may recall, NIH and other OPDIVs provided comments on a previous version of the bill (previous NIAID comments attached for reference). HHS is now requesting any new comments that OPDIVS may have.
ACTION: By COB Friday (9/27), please review the attached redline and provide any new comments directly in the document.
Thanks,
Chase
From: Selgrade, Sara (NIH/NIAID) [E] @nih.gov>
Sent: Tuesday, July 16, 2024 6:07 PM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: URGENT review by 8am Wed. 7/17: HHS Comments to OMB on Risky Research Review Act
Importance: High
Hello all,
Thank you for your review of the consolidated HHS comments on the Risky Research Review Act. DMID has suggested adding some of the comments NIAID put forward earlier this week. We have incorporated these comments in highlighted text in the attached document. The comments are listed below by page number for ease of review.
Please let us know by no later than 8am tomorrow, Wednesday, July 17th, if you have any concerns with putting forward these previously NIAID-cleared edits.
Thank you again for all your help with this quick turnaround request. Please let me know if you have any questions.
Thanks,
Sara
Re-submitted NIAID comments in the attached document (highlighted in yellow):
p. 1: New NIH comment
p. 2: NIH addition to OASH/OHRP comment
p. 3: New NIH comment
p. 4: NIH addition to OASH/OHRP comment
p. 9: NIH edit to OGC comment to broaden scope to all agencies (previously flagged by OCGR-Leg)
p. 10: NIH addition (from NIAID) to existing NIH comment
p. 12: NIH addition to OIG comment
p. 14: NIH addition to OGC comment
p. 16: NIH addition (from NIAID) to existing NIH comment
From: Selgrade, Sara (NIH/NIAID) [E] @nih.gov>
Sent: Tuesday, July 16, 2024 12:24 PM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: Please review by COB today Tues 7/16: HHS Comments to OMB on Risky Research Review Act
Importance: High
Hello all,
Background
Thank you again for your assistance in reviewing the Risky Research Review Act. HHS has compiled comments on the bill
from throughout HHS to provide them to the Office of Management and Budget (OMB) for consideration. HHS is asking
NIH to review the attached document on quick turnaround.
The comments included in the document provide high-level concerns across HHS. In particular, we have flagged a comment on the bottom of page 9 with a proposed clarifying edit for your review.
Action Item
Please review the attached draft HHS comments on the Risky Research Review Act and provide your concurrence, or any edits, by COB today, Tuesday July 16th. If you have any concerns with OCGR-Leg’s proposed edit to the comment on page 9, please let us know.
Please note that NIH OLPA is also working on a separate request from the Senate Health, Education, Labor, and Pensions (HELP) Committee (Chair: Sen. Bernie Sanders, I-VT) for technical assistance on this bill. OLPA plans to include the specific NIAID comments shared yesterday in this separate request. We anticipate we may be asked to review consolidated NIH comments for the HELP Committee this week.
Thank you for your ongoing assistance with reviewing this bill. Please let me know if you have any questions.
Thanks,
Sara
From: Selgrade, Sara (NIH/NIAID) [E] @nih.gov>
Sent: Monday, July 15, 2024 12:26 PM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E]
@niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: Additional OSP comments: TA on Risky Research Review Act
Hello all,
For your awareness, we are providing the attached comments on the Risky Research Review Act from the NIH Office of Science Policy (OSP). We anticipate receiving consolidated NIH comments on the bill, and we will share these as soon as we have them.
Please let me know if you have any questions.
Thanks,
Sara
From: Selgrade, Sara (NIH/NIAID) [E] @nih.gov>
Sent: Monday, July 15, 2024 10:35 AM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: For review by noon Monday 7/15: Review draft NIAID TA on Risky Research Review Act
Importance: High
Hello all,
Thank you for your quick review of the draft NIAID TA on the Risky Research Review Act. In the attached revised draft, I have incorporated additional edits from DMID/Dr. Erbelding and DEA. If there are no objections, I will submit these to NIH OLPA by their noon deadline today.
I am also attaching for your reference additional comments on the bill provided by NIH OER and NIH ORS/DOHS.
Please let me know if you have any questions or concerns.
Thanks,
Sara
From: Selgrade, Sara (NIH/NIAID) [E] @nih.gov>
Sent: Friday, July 12, 2024 4:06 PM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR <NIAIDDIR-
@mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>; Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Erbelding, Emily (NIH/NIAID) [E] @nih.gov>;
Holland, Steven (NIH/NIAID) [E] @niaid.nih.gov>; Hanson, Christopher (NIH/NIAID) [E] @niaid.nih.gov>; Poe, Kelly (NIH/NIAID) [E] @nih.gov>; Gilles, Sharon (NIH/NIAID) [E] @nih.gov>; DDSM Correspondences @mail.nih.gov>
Subject: URGENT ACTION by 10am Monday 7/15: Review draft NIAID TA on Risky Research Review Act
Importance: High
Hello all,
Background
Thank you very much for your quick work to comment on the Risky Research Review Act. NIH OLPA has asked us to prioritize comments to flag the most urgent or concerning items and/or those needing clarification.
Action Item
We have compiled the comments that meet NIH OLPA’s request into the attached draft technical assistance document. Please note that NIH OLPA has requested examples, where possible. We have tried to add some examples to emphasize key points, but we welcome any suggestions and/or corrections as needed.
We would appreciate your review and any edits by 10am Monday, July 15th. Given the quick turnaround, we are asking the Divisions to review concurrently with the NIAID OD.
Please note that NIH OSP, NIH ORS/DOHS, and NIH OER will also be reviewing and providing comments. We will be sure
to share with you any consolidated NIH comments that we receive.
Thank you for your help with this quick turnaround request. Please let me know if you have any questions.
Thanks,
Sara
From: Selgrade, Sara (NIH/NIAID) [E] @nih.gov>
Sent: Thursday, July 11, 2024 10:51 AM
To: NIAID BUGS @niaid.nih.gov>; NIAID DEA DART @mail.nih.gov>; NIAID DIR-OCGR
@mail.nih.gov>; Nealy, Michael (NIH/NIAID) [E] @nih.gov>
Cc: NIAID OCGR Leg @mail.nih.gov>; Auchincloss, Hugh (NIH/NIAID) [E] @niaid.nih.gov>;
Harper, Jill (NIH/NIAID) [E] @niaid.nih.gov>; Parker, Marie (NIH/NIAID) [E] @niaid.nih.gov>; Billet, Courtney (NIH/NIAID) [E] @niaid.nih.gov>
Subject: URGENT ACTION by 12pm Friday 7/12: TA on Risky Research Review Act
Importance: High
Good morning,
Background
HHS has been asked by the Senate Homeland Security and Governmental Affairs Committee (Chair: Sen. Gary Peters, D- MI; Ranking Member: Sen. Rand Paul, R-KY) to provide technical assistance (TA) on the attached draft legislation entitled the Risky Research Review Act.
The draft bill would require the establishment of an independent life sciences research security board to review federal funding for certain proposed life sciences research as defined by the bill. NIAID is mentioned briefly on page 4 in a section describing limitations on membership of the board.
HHS reports that the Committee intends to consider the bill on July 24. A number of HHS OpDivs and offices, including ASPR, CDC, and FDA, have been asked to review the bill along with NIH.
Action Item
By noon tomorrow, Friday July 12, please review the attached draft legislation and provide any technical comments in the attached HHS TA template. Please note that NIH ORS/DOHS and NIH OSP are also reviewing the bill on behalf of NIH.
As you complete your review, please keep in mind the HHS guidance on technical assistance below. Please let me know if you have any questions.
Thanks,
Sara
To ensure that the Department's comments are given full consideration, please observe the following guidelines in
providing your office's comments:
Are there provisions of this bill that would conflict with Department or Administration policy, and how?
Are there provisions that would pose difficulties for the operation or management of HHS programs, and how?
Are there any other significant issues that you can identify?
If you recommend specific changes, supply reasons and explanations, if the reasons are not obvious.
Topline points:
• Strengthening biosafety and biosecurity oversight of life sciences research is a key priority of this Administration, as outlined in the National Biodefense Strategy. We believe the bill as drafted would significantly undermine life sciences research without commensurate security benefit. As such, we do not support this legislation.
• The Administration has recently strengthened, streamlined, and expanded oversight of potentially high risk life science research in the May 2024 United States Government Policy for Oversight of Dual Use Research of Concern Pathogens with Enhanced Pandemic Potential (“DURC/PEPP policy”). This policy expands and strengthens a tiered system of oversight for all federally funded research that includes a requirement for research on pathogens with enhanced pandemic potential to undergo extra departmental review. The policy also:
o Defines an expanded scope of pathogen and toxin research subject to additional oversight by the U.S. Government;
o Provides a unified framework to support the consistent identification and
oversight of research proposals that require enhanced oversight that accounts for safety, security, and ethical considerations; and o Delineates the roles and responsibilities of principal investigators, research institutions, and Federal departments and agencies that conduct, fund, or oversee research within the scope of the policy.
• The Administration also strongly believes in the importance of ensuring the highest level of integrity in scientific and technological processes, and has supported the establishment and enforcement of policies that maintain integrity in the conduct of scientific research and in the collection of scientific or technological data. In support of this, the Administration published a report on Protecting the Integrity of Government Science in January 2022.
• The bill seems to create redundancies with some reforms recently introduced by the DURC/PEPP policy, which was developed following significant interagency discussions directed by Congress and informed by the National Science Advisory Board for Biosecurity, public comment, and other expert input.
• The bill retains a number of problematic details that could negatively impact innovation and the U.S. competitive edge in life sciences research, including our ability to attract and retain the best scientists.
• However, the Administration welcomes efforts from Congress to further strengthen biosafety and biosecurity in the life sciences. o For example, we would welcome discussions on how the risk-based oversight processes established in the DURC policy for federally funded research could be extended to non-federally funded research.
• We recognize that biosafety and biosecurity oversight responsibilities are currently shared across many different departments and agencies and welcome discussions on appropriate entities for oversight of the highest risk research.
Some of our concerns with the bill are:
• Scope: The legislation continues to codify a list of pathogens, which would reduce the flexibility of funding agencies to adapt to changes from natural and anthropogenic evolution. It also continues to enable the board to review routine life science research outside of the “high risk” definition on a case-by-case basis, and it is unclear how this would be implemented in practice without significantly impacting research review timelines.
• Board processes and makeup: The makeup and processes of the board could introduce a number of issues. For example, the limitations on prior federal service and designation of participation in high-risk research as a “conflict of interest” could limit the board from accessing relevant national security and life sciences expertise. The exclusion of those involved in high-risk research, based on the definition in the draft legislation, could exclude anyone with a current BSL3 or BSL4 program, excluding individuals with key expertise on how to conduct work safely. These limitations may also exclude individuals who work in government with relevant knowledge of intelligence and threat assessments.
• Review criteria: The bill does not articulate a principle or threshold that guides whether the board should or should not approve a study for funding – for example, should the Board approve research where it determines that the potential public health benefits of the research outweigh the potential risks to U.S. national security? Or should some other standard govern the Board’s review? Any statute mandating this style of review should clarify the applicable standard.
• Classified review and intelligence concerns: The legislation continues to authorize the board to access and review all classified research funded by any agency, including nonlife sciences research. Those provisions extend beyond the scope of oversight that is reasonable for this board to take on and they may impinge on the constitutional authority of the Executive to control classified national security information.
• Enforcement: The enforcement provisions are extreme and may raise significant legal and privacy concerns. Those provisions mandate a suite of harsh penalties for violations of certain provisions of the statute, including technical violations; they allow for no flexibility in determining the severity of punishment; they provide the aggrieved party with no process; and they mandate public identification of aggrieved individuals. These provisions may dissuade scientists from pursuing any research that might be potentially considered high-risk.
• Authorities: Agencies have raised concerns about how the legislation would conflict with and impede their existing authorities, including those related to grantmaking. For example, DOD has noted the legislation would curtail DOD’s flexibility and weaken DOD’s Title 10 authorities to fund research that is in the best interest of national security. In several places the legislation raises privacy concerns by requiring sharing of information that is normally protected under the Privacy Act. In addition, USAID has noted that ambiguity in the definition of federal funding could imply that contributions to other bodies such as CEPI are required to go through this process, which could limit U.S. Government’s ability to effectively work with such organizations.
Given the above concerns, as drafted, this legislation has the potential to negatively impact innovation and delay the development of lifesaving technologies. While the Administration does not support this legislation, we remain committed to working with the Committee on biosafety and biosecurity.
HHS Review of S.4667 Risky Research Review Act As amended by HSGAC on September 25, 2024
HHS appreciates the opportunity to review S. 4667, as amended by the Peters-Paul substitute amendment. Please note this is not formal Department TA or Administrations views. However, as there remain many similarities between the introduced bill and substitute amendment, we are also attaching the formal TA we shared with the committee in July. to the introduced bill, for reference.
While some aspects of this bill related to scope are improved, there continue to be significant concerns about the impact on biomedical research.
Topline points:
• Strengthening biosafety and biosecurity oversight of life sciences research is a key priority of this Administration, as outlined in the National Biodefense Strategy. We believe the bill as drafted would significantly undermine life sciences research, and its oversight provisions fail to target the subset of research posing greatest risk. without commensurate security benefit. As such, we do not support this legislation.
• As currently drafted, this legislation has the potential to negatively impact innovation and the U.S. competitive edge in life sciences research, including our ability to attract and retain the best scientists.
While HHS continues to have serious concerns with this legislation as drafted, we remain committed to working with the Committee and Congress on biosafety and biosecurity.
More detailed concerns are described below by category.
Redundant with DURC/PEPP policy
• The Administration has recently strengthened, streamlined, and expanded oversight of potentially high risk life science research in the May 2024 United States Government Policy for Oversight of Dual Use Research of Concern Pathogens with Enhanced Pandemic Potential (“DURC/PEPP policy”). This policy expands and strengthens a tiered system of oversight for all federally funded research that includes a requirement for research on pathogens with enhanced pandemic potential to undergo extra departmental review. The policy also:
o Defines an expanded scope of pathogen and toxin research subject to additional oversight by the U.S. Government;
o Provides a unified framework to support the consistent identification and oversight of research proposals that require enhanced oversight that accounts for safety, security, and ethical considerations; and
o Delineates the roles and responsibilities of principal investigators, research
institutions, and Federal departments and agencies that conduct, fund, or oversee
research within the scope of the policy.
• The Administration also strongly believes in the importance of ensuring the highest level of integrity in scientific and technological processes, and has supported the establishment and enforcement of policies that maintain integrity in the conduct of scientific research and in the collection of scientific or technological data. In support of this, the Administration published a report on Protecting the Integrity of Government Science in January 2022.
• The bill seems to create redundancies with some reforms recently introduced by the DURC/PEPP policy, which was developed following significant interagency discussions directed by Congress and informed by the National Science Advisory Board for Biosecurity, public comment, and other expert input.
• The bill retains a number of problematic details that could negatively impact innovation and the U.S. competitive edge in life sciences research, including our ability to attract and retain the best scientists.
• However, HHSthe Administration welcomes efforts from Congress to further strengthen biosafety and biosecurity in the life sciences. o For example, we would welcome discussions on how the risk-based oversight processes established in the DURC policy for federally funded research could be extended to non-federally funded research.
• We recognize that biosafety and biosecurity oversight responsibilities are currently shared across many different departments and agencies and welcome discussions on appropriate entities for oversight of the highest risk research. o Some Scope/Definitions
• While steps have been made toward harmonization of the scope of the Board’s oversight with the new United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential (2024 OSTP DURC/PEPP Policy), some of the listed experiments in the “dual use research of concern” definition do not match those in the policy, and other articulated in-scope research in the bill including the “gain of function research” term continues to be in conflict with USG policy. These definition differences will be challenging
to deconflict for the research community. Many of the USG definitions were determined
following significant interagency discussions directed by Congress and informed by the National Science Advisory Board for Biosecurity, public comment, and other expert input. We recommend that the definitions and scope of review be fully harmonized with the DURC/PEPP policy and not include a separate list of pathogens. Many of the definitions of research that is subject to requirements of this proposed legislation are very broad and not all are in line with existing policies, which is likely to cause confusion in the research community. o This could result in delays to critical biosurveillance efforts such as COVID-19 testing, H5N1 monitoring, and detection of emerging outbreaks of Ebola and other diseases. It could also result in delays for development of vaccines, therapeutics, and biomedical, agricultural, and other life sciences research writ large (including research that is not associated with pathogens or toxins and raises no identified national security threats, such as cancer research).
o If the statute only provided the board the responsibility to review federally-funded
research involving DURC and PEPP, as defined in the DURC/PEPP policy, it would
ensure oversight resources are used most efficiently to assess and mitigate risks to the
public while avoiding unintended negative consequences for the nation’s biomedical
enterprise. We believe this is the intent of the bill but as written the definitions are not harmonized. o A large amount of scientific research involves gain or loss of function; it’s a fundamental process in science. For example, some types of immune therapy cause the immune system to gain function to fight against a disease. Unfortunately, the term “gain of function” has often being misconstrued to suggest all research that causes a gain of function is highly risky, which is inaccurate. In fact, most research involving a GOF does not confer significant additional risk or require additional oversight. NIH does not define the term GOF and current federal policy does not define or operationalize the term. The research that requires strict oversight involves enhancing the transmissibility and/or virulence of a pathogen such that it would pose an increased pandemic potential in humans. The USG policy on oversight of DURC and PEPP (effective May 2025) also does not use the term GOF when describing research that requires additional oversight because of its higher risk. As it appears the intent of the term “GOF” in this bill is to refer specially to research that has the potential to enhance the transmissibility or virulence of a potential pandemic pathogen, for clarity we would recommend the use of the term “pathogen with enhanced pandemic potential” in the 2024 OSTP policy that addresses this type of research, as well as it’s associated definition. This would help to avoid the ongoing confusion surrounding the term GOF. The list of “high-consequence pathogens” is concerning and would have an immediate negative impact to science and public health. The mention of Influenza A viruses, for example, would include all work with H5N1 viruses which are having a significant impact on our poultry and dairy farms. Research into vaccines, treatment, spread and evolution of these viruses is critical to ensure to curb this outbreak and to prevent those in the future. The same could be said for the inclusion of all mpox. The current outbreak and identification of Clade I is highly concerning and without scientists able to pivot nimbly, the outcome is concerning. We are also concerned with the catchall language that could expand the scope of pathogens and categories the board reviews simply by a majority vote from the board.of our concerns with the bill are:
• Scope: The legislation continues to codify a list of pathogens, which would reduce the flexibility of funding agencies to adapt to changes from natural and anthropogenic evolution. It also continues to enable the board to review routine life science research outside of the “high risk” definition on a case-by-case basis, and it is unclear how this would be implemented in practice without significantly impacting research review timelines.
• Board processes and makeup: The
o Given that certain types of research with any “wild-type or synthetic” pathogen among the listed species would apparently require review by the new Board, this appears to suggest that research with viruses engineered or adapted for decreased pathogenicity (e.g. certain mouse-adapted or tissue-culture-adapted strains) would be considered “highconsequence” even if they have been deliberately altered to decrease the research risk, e.g. for exploration of drug-resistance mechanisms at lower BSL levels. o Category XVIII “any synthetic construct of a pathogen or category of pathogen described in this clause” may be confusing regarding what it adds to the “wild-type or synthetic”
pathogens already listed what is meant by “synthetic construct” in addition to previous use of “synthetic” and does this mean that using only a piece of a “high-consequence pathogen” (e.g. synthesizing the receptor-binding site and studying receptor affinity in vitro, or synthesizing a viral or bacterial enzyme and studying inhibitors in vitro) would potentially still be considered “high-consequence”? o Subparagraph B is auto-referential creating an exclusion for seasonal influenza unless genetic sequences have been introduced from the list of pathogens that includes influenza A – does this mean that any introduction of genetic material from one seasonal influenza virus into another seasonal influenza virus would be considered “high-consequence”? o Some other included pathogens besides influenza may be commonly circulating in the population, and classifying them as automatically “high-consequence” could potentially delay or interfere with clinical diagnosis and care depending on how the other criteria for centralized Board review are interpreted (e.g. all sarbecoviruses, all mpox viruses). o According to the next section at the bottom of the page, it looks like maybe only experiments that meet DURC/GOF criteria with these agents would need centralized board review, and if it were possible to obtain clarification that non-DURC/GOF experiments are not subject to the Act provisions that might mitigate some of the potential concerns, but there is the possibility that uncertainty about interpretation could still have major impact on willingness to conduct or review research in some of the relevant areas of importance for public health.
• The text of the proposed legislation reads as if the Life Sciences Research Security Board could review all life sciences research. Throughout the text of the proposed legislation, the terms used seem to vary between "high-risk life sciences research," which is defined very specifically, and broader terms like "life sciences research." The scope of review seems far beyond what a single Board could reasonably be able to review especially given the broad definition of life sciences research, even if limited to high-risk life sciences research and even with the Board trying to develop expert committees. Creating such a broad scope of review for the Board risk delays of important research, which does not rise to the level of high-risk life sciences research, that could be adequately addressed at a more local or Agency review level and is already subject to laws, regulations, guidances, and policies.
Expertise/Board Processes and Makeup
• While biosafety expertise is now included, the makeup and processes of the board could introduce a number of issues. For example, the limitations on prior federal service and designation of participation in high-risk research as a “conflict of interest” could limit the board from accessing relevant national security and life sciences expertise. The exclusion of those involved in high-risk research, based on the definition in the draft legislation, could exclude anyone with a current BSL3 or BSL4 program, excluding individuals with key expertise on how to conduct work safely. These limitations may also exclude individuals who work in government with relevant knowledge of intelligence, threat assessments, and biosecurity. Risk assessment is best when diverse voices are heard, the lack and actually clear refusal to ensure persons with experience in high and maximum containment principles are included would not provide a comprehensive and scientifically robust review of this work. and threat assessments.
• We also recommend relaxing the limitations on membership of the board and note that a number of the timelines are untenable (e.g., Congressional notification requirements within 3 days of identifying a potential conflict of interest; publishing procedures in the Federal Register within 90 days of the appointment of initial members; etc.). We note that several provisions relating to the
membership of the Board or its support staff are vague, including the requirement that Board members be “impartial” and that support staff be prohibited from “directly or indirectly influenc[ing]” the Board. The proposed legislation would also politicize independent peer review by making the constituent members presidential appointees.
• As drafted, the Board will have significant control over funding decisions, which may interfere with existing statute on NIH funding activities.
• We have concerns about the Board reaching out directly to applicants/recipients, which is outside traditional NIH reporting procedures.
• Regarding support from agencies to board personnel, it is unclear how an agency representative can be expected to both provide technical assistance but not indirectly influence the board. Technical assistance should factor into the decision.
• Regarding 7904 (b)(3), if such disclosure is required drafters should be specific as to what laws on protection of commercial confidential information and trade secrets are being waived.
Review Process and Criteria
• While a path for expedited review has been added, there could still be major issues with continuity of science due to delays of reviews or membership being confirmed. Among other concerns, in particular, this will significantly impede the USG’s ability to prepare for and detect emerging infectious diseases/epidemics/pandemics and will also significantly impede the USG’s research response to an epidemic/pandemic. We recommend establishing a default rule that research may proceed if a decision is not made within a fixed timeframe to ensure that any lapse in function by the Board (e.g., delays in confirmation) do not result in life sciences research grinding to a halt. We also recommend a formal appeals process and an exemption to public reporting requirements if the information could pose national security risks.
• criteria: The bill does not articulate a principle or threshold that guides whether the board should or should not approve a study for funding – for example, should the Board approve research where it determines that the potential public health benefits of the research outweigh the potential risks to U.S. national security? Or should some other standard govern the Board’s review? Any statute mandating this style of review should clarify the applicable standard.
• It is unclear if it is the drafters’ intent to prohibit funding for an entire award prior to Board approval or only work related to potential “high-risk” research. Similarly, there is a later provision that would require a pause in research due to a change in circumstance, but it is unclear if such a pause would apply to an entire award or only work related to potential “high-risk research.
Classified review and intelligence concerns
• We recommend striking provisions that mandate the provision of security clearances to Board members, Board staff, and members of Congress, or that require these individuals: The legislation continues to authorize the board to access and review all classified research funded by any agency, including non-life sciences research. Those provisions extend beyond the scope of oversight that is reasonable for this board to take on and they may impinge on the constitutional authority of the Executive to control classified national security information. We also recommend that clauses be included to enable the intelligence
community to respond to requests from the Board in a manner consistent with the protection of intelligence sources and methods.
Enforcement
• : The enforcement provisions are extreme and may raise significant legal and privacy concerns. Those provisions mandate a suite of harsh penalties for any violations of certain provisions of the statute, including technical or unintentional violations; they allow for no flexibility in determining the severity of punishment; they provide the aggrieved party with no process; and they mandate public identification of aggrieved individuals. These provisions could broadly disincentivize individualsmay dissuade scientists from working in life sciencespursuing any research and funding agencies, which could sendthat might be potentially considered high-risk.
• Authorities: Agencies have raised concerns about how the legislation would conflict with and impede their existing authorities, including those related to grantmaking. For example, DOD has noted the legislation would curtail DOD’s flexibility and weaken DOD’s Title 10 authorities to fund research outsidethat is in the best interest of this country and compromise progress on public health, safety, and national security. In several places the legislation raises privacy concerns by requiring sharing of information that is normally protected under the Privacy Act. In addition, USAID has noted that ambiguity in the definition of federal funding could imply that contributions to other bodies such as CEPI are required to go through this process, which could limit U.S. Government’s ability to effectively work with such organizations.
•
Given We recommend that enforcement provisions be focused on willful violationsthe above concerns, as drafted, this legislation has the potential to negatively impact innovation and delay the development of lifesaving technologies. While the Administration does not support this legislation, we remain committed to working with the Committee on biosafety and significantly reduced or adjusted.biosecurity.
•
56 quoted messages inside this reply
Emily Linde· FW: Grant Questions - FBI Inquiry - 1-R01AI110964-01 -Thursday, September 10, 2020 11:44 AM
Emily Linde· RE: Grant Questions - FBI Inquiry - 1-R01AI110964-01 -Thursday, September 10, 2020 11:40 AM
Ashley Sanders· RE: Grant Questions - FBI Inquiry - 1-R01AI110964-01 -Thursday, September 10, 2020 10:40 AM
Emily Linde· RE: Grant Questions - FBI Inquiry - 1-R01AI110964-01 -Wednesday, September 9, 2020 3:26 PM
Ashley Sanders· RE: Grant Questions - FBI Inquiry - 1-R01AI110964-01 -Wednesday, September 9, 2020 3:15 PM
Erik Stemmy· RE: Grant Questions - FBI Inquiry - 1-R01AI110964-01 -Thursday, May 21, 2020 5:50 PM
Ashley Sanders· RE: Grant Questions - FBI Inquiry - 1-R01AI110964-01 -Thursday, May 21, 2020 3:04 PM
Erik Stemmy· RE: Grant Questions - FBI Inquiry - 1-R01AI110964-01 -Thursday, May 21, 2020 11:22 AM
Emily Linde· RE: Grant Questions - FBI Inquiry - 1-R01AI110964-01 -Thursday, May 21, 2020 6:17 AM
Ashley Sanders· RE: Grant Questions - FBI Inquiry - 1-R01AI110964-01 -Wednesday, May 20, 2020 1:00 PM
Ashley Sanders· Grant Questions - FBI Inquiry - 1-R01AI110964-01 - 2-RWednesday, May 13, 2020 11:59 AM
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