A single line often inverts meaning once you see what it
answers, so neighbouring messages are always shown.
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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-andPEPP.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 'ch ral ed N1 PP 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.
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2024-09-30 14:31
Chase Crawford
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-andPEPP.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. 'ch 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 ral \vU 18, PP es of the 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
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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-andPEPP.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. he new 2up and processes of the board 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