A single line often inverts meaning once you see what it
answers, so neighbouring messages are always shown.
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Good morning, Background HHS has been asked by the Senate Homeland Security and Governmental Affairs Committee (Chair: Sen. Gary Peters, DMI; 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. From: "Ford, Andrew (NIH/NIAID) [E]" {EE Onin. gov> To: "Crawford, Chase (NIH/NIAID) [E]" SER oni. 20> Ce: NIAID OCGR Leg ae "Erbelding, Emily (NIH/NIAID) [E]" nih.gov>, NIAID BUGS niaid.nih.gov> Subject: Re: ACTION by 10a Thurs (10/17): Review compiled HHS comments on revised bill text for Risky Research Review Act Date: Fri, 11 Oct 2024 12:24:59 -0400 Importance: Normal Thanks Chase -- will do
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Good morning, Background HHS has been asked by the Senate Homeland Security and Governmental Affairs Committee (Chair: Sen. Gary Peters, DMI; 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. From: "Crawford, Chase (NIH/NIAID) [E]" {EE oni. cov> To: NIAID BUGS niaid nih gov>, NIAID DEA DART <{f@mail.nih.gov>, "NIAID DIR-OCGR" )mail.nih.gov>, NIAID DCR-OCGR <NIAIDDCRmail.nih.gov>, "Nealy, Michael (NIH/NIAID) [E]" FE )hSi(ststéséa gov>, (NIH/NIAID) [E BE oniaia. nih.gov>, "Parker, Marie (NIH/NIAID) [E]" niaid.nih.gov>, "Read, Sarah )) [E]" BBB ovisia nih gov>, "Billet, Courtney (NIH/NIAID) [E]" \niaid.nih.gov> Ce: )mail.nih.gov>, "Erbelding, Emily (NIH/NIAID) )nih.gov>, "Holland, Steven (NIH/NIAID) [E]" iaid.nih.gov>, "Hanson, Christopher eats ts @riaid inih.gov>, "Poe, Kelk )) [E]" nih.gov>, "Gilles, Sharon Ej" nih.gov>, "DDSM Correspondences" )mail.nih.gov> Subject: ACTION by 10a Thurs (10/17): Review compiled HHS comments on revised bill text for Risky Research Review Act Date: Fri, 11 Oct 2024 12:20:27 -0400 Importance: Normal Attachments: HHS points _on_updated_S4667.docx; For_reference_-redline2_ NIAID _comments.docx 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
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Good morning, Background HHS has been asked by the Senate Homeland Security and Governmental Affairs Committee (Chair: Sen. Gary Peters, DMI; 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? fy? US. nd 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. From: "Crawford, Chase (NIH/NIAID) [E]" {EE oni. cov> To: NIAID BUGS niaid nih gov>, NIAID DEA DART <{f@mail.nih.gov>, "NIAID DIR-OCGR" )mail.nih.gov>, NIAID DCR-OCGR <NIAIDDCRmail.nih.gov>, "Nealy, Michael (NIH/NIAID) [E]" FE )hSi(ststéséa gov>, (NIH/NIAID) [E BE oniaia. nih.gov>, "Parker, Marie (NIH/NIAID) [E]" niaid.nih.gov>, "Read, Sarah )) [E]" BBB ovisia nih gov>, "Billet, Courtney (NIH/NIAID) [E]" \niaid.nih.gov> Ce: )mail.nih.gov>, "Erbelding, Emily (NIH/NIAID) )nih.gov>, "Holland, Steven (NIH/NIAID) [E]" iaid.nih.gov>, "Hanson, Christopher eats ts @riaid inih.gov>, "Poe, Kelk )) [E]" nih.gov>, "Gilles, Sharon Ej" nih.gov>, "DDSM Correspondences" )mail.nih.gov> Subject: ACTION by COB today (10/31): Review updated feedback on Risky Research Review Act Date: Thu, 31 Oct 2024 11:55:03 -0400 Importance: Normal Attachments: For_review_- Risky Research _Review_Act Feedback _Oct_2024.docx; Track_changes_of_feedback.docx; For_reference_-redline2_NLAID_comments.docx Good Morning, HHS has shared the attached updated feedback on S.4667 (Risky Research Review Act). Please review the updated Oct. 2024 feedback and provide any must-change edits only by COB today (10/31). In case helpful, we also have attached a document showing the changes since the last version of feedback that NIAID reviewed as well as a reference copy of NIAID's previous technical comments on the bill text. Please let us know if you have any questions. Thanks, Chase
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Good morning, Background HHS has been asked by the Senate Homeland Security and Governmental Affairs Committee (Chair: Sen. Gary Peters, DMI; Ranking Member: Sen. Rand Paul, R-KY) to provide technical assistance (TA) on the attached draft legislation entitled the Risky Research Review Act. ion A number of HHS OpDivs and offices, including any technical comments in the ng the bill on behalf of NIH. Please let me know if w? nd fy? US. 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
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2024-07-11 10:51
Sara Selgrade
Good morning, Background HHS has been asked by the Senate Homeland Security and Governmental Affairs Committee (Chair: Sen. Gary Peters, DMI; 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 any technical comments in the ng the bill on behalf of NIH. Please let me know if 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