GHTC sends letter to OSTP Director ahead of G20 Innovation Ministerial

GHTC submitted the below response to a public hearing on a proposed reorganization of the National Institute of Allergy and Infectious Diseases (NIAID), warning of potential implications and urging the need for transparency throughout any future restructuring efforts.The National Institute of Allergy and Infectious Diseases (NIAID) is one of the world’s leading funders of global health research and development (R&D) and plays a unique role within the National Institutes of Health (NIH). The Institute’s mandate requires it to anticipate and respond to emerging and persistent infectious disease threats, advance understanding of disease mechanisms, and support the development of critical countermeasures. As the Global Health Technologies Coalition (GHTC), a coalition of more than 50 nonprofit organizations, academic institutions, and aligned businesses working to accelerate the development and delivery of new drugs, vaccines, diagnostics, and other health technologies, we are committed to ensuring that NIAID’s structure and mandate sustain this work.The Division of Clinical Research (DCR) is a key component of the research ecosystem, providing the infrastructure, oversight, expertise, and standards needed to translate scientific discoveries into safe and effective interventions for patients. DCR’s centralized structure within NIAID has supported patient safety, scientific integrity, clinical trial operations, and the advancement of medical innovation. These functions are essential for moving promising discoveries from the laboratory into products that can improve and save lives.This is particularly important for global health R&D. Clinical research increasingly spans borders, disease areas, and institutions, with universities, academic medical centers, nonprofit product development partnerships, and other partners contributing essential expertise and infrastructure. International clinical research is necessary to ensure that new tools are effective across diverse populations and can ultimately be developed into affordable, fit-for-purpose products for communities facing the greatest disease burdens. DCR provides multi-disciplinary services across NIAID to help facilitate high-quality clinical trials across the globe. Maintaining strong coordination between domestic and international research efforts is therefore essential to US leadership in biomedical innovation and global health.The proposed reorganization of NIAID, including the dissolution of DCR and redistribution of its core functions, risks undermining this coordination by creating new silos, fragmenting clinical research expertise and oversight, and weakening integration across domestic and international research activities. It could also introduce unnecessary disruption at a time when the United States must strengthen, not weaken, the infrastructure needed to respond rapidly to infectious disease threats and translate scientific advances into effective countermeasures.Additionally, it is critical to ensure that with any restructuring, NIAID maintains transparency, consistency, and strong oversight of clinical operations. Disruptions to established systems and expertise should not contribute to funding and administrative delays, increase burdens on clinical research partners, or jeopardize the timely, safe, and effective conduct of clinical trials. Ultimately, we ask NIAID to ensure these changes do not slow the development of new interventions against some of the world’s most pressing health challenges.NIAID’s ability to connect basic science, clinical research, and product development is a critical component of US biomedical leadership. Preserving the infrastructure and coordination that make this possible—including a strong, centralized clinical research function within NIAID—is essential to protecting research participants, maintaining scientific rigor, advancing global health R&D, and ensuring that US investments in discovery translate into health technologies that reach the people who need them most.

123456455 Massachusetts Ave. NW, Suite 1000 | Washington, DC 20001 | (202) 642-3858 | ghtcoalition.orgJuly 13, 2026Filed electronically via Regulations.govDocket ID: OMB–2026–0034Re: Comments from the Global Health Technologies Coalition on “Regulation for Federal FinancialAssistance” - Proposed Revisions to 2 CFR Governing Federal Financial Assistance (91 Fed. Reg. 32198,May 29, 2026)Summary of Key Concerns & Recommendations to the Office of Management and Budget (OMB)Shift from Peer Review to Political ReviewOMB should preserve peer review as the primary basis for individual funding decisions and limitpolitical appointee involvement to broader strategic priority-setting, ensuring awards remaingrounded in scientific merit and expert evaluation.New and Undefined Risk Factors Enhance SubjectivityOMB should clarify and narrow disqualifying risk factors, particularly “memberships andaffiliations,” to ensure definitions are objective, consistently applied, and do not disadvantagequalified applicants engaged in legitimate scientific collaboration.Mid-lifecycle Termination Authority BroadensOMB should maintain the existing Uniform Guidance framework for suspension and terminationand avoid expanding discretionary termination authority that could disrupt long-term researchand reduce return on taxpayer investment, particularly in clinical and human subjects research.Limitations on International Collaboration and ComponentsOMB should preserve scientifically justified international research and foreign subawards byestablishing clear, stable criteria for covered foreign entities and ensuring that national securitydesignations are transparent, consistently applied, and not disruptive to ongoing researchpartnerships.Uncertainty Around Relevant Communications on Research FindingsOMB should maintain the current framework distinguishing lobbying from permissible scientificcommunication, ensuring researchers can continue sharing findings and technical expertise sothat taxpayer-funded research can be translated into policy and public health impact.Please refer to the full comment below for additional context and detailed explanations of theserecommendations.455 Massachusetts Ave. NW, Suite 1000 | Washington, DC 20001 | (202) 642-3858 | ghtcoalition.orgAs members of the Global Health Technologies Coalition (GHTC)—a group of more than 50 nonprofitorganizations, academic institutions, and aligned businesses advancing the development of new drugs,vaccines, diagnostics, and other tools for global health—we submit these comments to the Office ofManagement and Budget (OMB) on the proposed rule amending 91 parts of Title 2 of the Code ofFederal Regulations. Given the scope of this rulemaking, which adds 52 new subsections and fullyrestates 375 sections across 456 regulatory provisions, our comments focus on the sections mostdirectly affecting the ability to carry out effective, safe, and efficient global health research anddevelopment across the federal enterprise.We are concerned that several provisions in this proposed rule could undermine long-term researchinvestments and weaken the conditions that enable scientific progress. We respectfully offer thesecomments to ensure OMB fully considers the cumulative impact these revisions could have on theUnited States’ ability to maintain its leadership in biomedical innovation, maximize the return ontaxpayer investment, and continue advancing research that improves health at home and around theworld, while still strengthening transparency, accountability, and oversight in a way that does notfundamentally alter how federal research awards are administered.Shift from Peer Review to Political Review§ 200.205(b) — Pre-issuance review by senior political appointeesFor decades, peer review has been the cornerstone of the federal research funding process, ensuringthat funding decisions are guided by scientific merit, feasibility, and potential impact. This expert drivenprocess has supported major advances in medicine, public health, and biomedical innovation whilereinforcing confidence that taxpayer dollars are allocated effectively based on scientific evidence andexpertise.Section 200.205(b) would introduce a greater role for political appointees in the award approvalprocess, undermining this confidence. Research funding decisions often require highly specializedknowledge of scientific methods, clinical design, and subject-matter context. Career scientists,physicians, and subject-matter experts are best positioned to assess these complex factors. Expandingpolitical involvement in these determinations introduces the risk that considerations beyond scientificmerit may influence outcomes, reducing consistency in this process and discouraging investment inareas of science perceived as more subject to shifting policy interpretation, despite their potential publichealth value.Our community has seen recent examples where post-peer review intervention has delayed ordisrupted otherwise strong public health projects. Even limited instances can create broaderuncertainty, as research and institutions adjust to less predictable funding criteria. Over time thisuncertainty may discourage investment in multi-year, long-term, complex or high-risk research areasand make it more difficult to attract and retain scientific talent, particularly among-early careerresearchers or those in specialized fields, in a global competitive marketplace.GHTC urges OMB to revise Section 200.205(b) to preserve peer review as the primary basis for individualfunding decisions, ensuring that award determinations remain grounded in scientific merit and theexpertise of career scientists to preserve confidence in the fairness, stability, and effectiveness of thefederal research funding system.455 Massachusetts Ave. NW, Suite 1000 | Washington, DC 20001 | (202) 642-3858 | ghtcoalition.orgNew and Undefined Risk Factors Enhance Subjectivity§ 200.206(b)(2) — New disqualifying risk assessment factorsAssessing risk among potential recipients is an important part of responsible stewardship of federalfunds; however, the criteria used should be clearly defined, objective, and applied consistently. Severalof the proposed disqualifying factors in Section 200.206(b) raise concerns because they rely on broadconcepts that may be interpreted differently across agencies, individual decision-makers, oradministrations, creating uncertainty for applicants.GHTC is particularly concerned by the lack of clarity surrounding the proposed consideration of anapplicant's "memberships and affiliations." The rule does not clearly define what constitutes anaffiliation, how such relationships would be evaluated, or what standards agencies would use todetermine whether an organization engages in activities that raise public safety or national securityconcerns. Many researchers—particularly those working in global infectious disease, pandemicpreparedness, HIV/AIDS, and other areas of global public health—routinely collaborate across bordersand maintain professional affiliations with international research institutions, as well as withcommunity-based organizations serving historically underserved populations, as a necessary componentof their work. These partnerships are essential to conducting rigorous, relevant research and deliveringeffective public health interventions. Without clearer definitions and transparent criteria, theseprovisions could be interpreted inconsistently across agencies or over time, leaving applicants uncertainabout eligibility and raising concerns that subjective interpretations of an applicant’s internationalcollaborations, institutional partnerships, or community affiliations could inadvertently disadvantagequalified applications or influence funding decisions in ways not clearly tied to objective, merit-basedcriteria or legitimate security concerns.GHTC urges OMB to revise Section 200.206(b) to provide clear, objective definitions and consistentlyapplied standards for disqualifying risk factors—particularly regarding "memberships and affiliations"—to ensure that legitimate national security concerns are addressed without creating unnecessaryuncertainty or disadvantaging qualified applicants engaged in scientifically justified collaborations.Mid-lifecycle Termination Authority Broadens§ 200.340(a)(2) — Expanded discretionary termination authorityResearchers build infrastructure, hire personnel, establish partnerships, and design multi-year scientificprograms with the expectation that, barring scientific, safety, or compliance concerns, federally fundedprojects will be carried through to completion. While unexpected circumstances may occasionallywarrant early termination, Section 200.340(a)(2) introduces a broader level of discretion that createssignificant uncertainty for researchers and institutions undertaking long-term research anddevelopment.These concerns are particularly significant for research involving human subjects and clinical trials.Unlike many other forms of research, clinical trials rely on the voluntary participation of individuals whoassume personal risk and commit to carefully designed study protocols in pursuit of scientificadvancement. They also require years of planning, substantial financial investment, extensive regulatoryoversight, and coordination among research institutions, health systems, and community partners.Premature termination can compromise data integrity, reduce the scientific value of completed work,delay the development of new medical countermeasures, and require costly closeout activities thatfurther diminish the return on prior taxpayer investment. It may also undermine the trust of research455 Massachusetts Ave. NW, Suite 1000 | Washington, DC 20001 | (202) 642-3858 | ghtcoalition.orgparticipants and partner institutions whose continued engagement is essential to future public healthresearch.While there will always be circumstances in which awards must be terminated because of participantsafety concerns, scientific misconduct, or recipient noncompliance, the proposed rule that grantsbroader termination authority across all awards does not distinguish between those involving humansubjects research and other forms of federally funded research, nor does it establish additionalconsiderations or safeguards for studies involving clinical trial participants.GHTC calls for OMB to maintain the existing framework for award suspension and termination under theUniform Guidance, which already provides agencies with robust tools to address performance,compliance, and stewardship concerns, rather than expanding discretionary termination authority inways that introduce unnecessary uncertainty into long-term research and development and reducedreturn on prior taxpayer investment.Limitations on International Collaboration and Components§ 200.202(e) — Domestic-first framework for R&D awards§ 200.220 — Prohibition on covered foreign collaborationsMany of the world’s most pressing infectious diseases do not respect borders, and the United Statescannot effectively prepare for or respond to emerging health threats without conducting researchwhere those diseases occur. International components of R&D awards enable scientists to studydiseases in the populations and environments where they are endemic, generating the evidence neededto develop effective vaccines, therapeutics, diagnostics, and other interventions that ultimately protectAmericans alongside people around the world. These investments also maximize the value of taxpayerdollars by supporting research in the settings where it can generate the most meaningful scientificevidence, strengthening preparedness before health threats reach US borders and reducing the need formore costly emergency responses.The framework proposed in Section 200.202(e) risks narrowing the scope of research in ways that maylimit insight into global health threats. For many longstanding and emerging infectious diseases, insightsinto transmission patterns, intervention strategies, and the evaluation of medical countermeasures canonly be generated through collaboration with international partners and research sites. Thesepartnerships should operate with appropriate oversight, transparency, and compliance with US laws andnational security requirements. However, restricting these collaborations may ultimately diminish thereturn on federal research investments by limiting opportunities to generate the evidence needed toinform prevention, preparedness, and response strategies that protect both US and global health.Section 200.220 raises related concerns by restricting collaborations involving "covered foreigncountries" and "covered foreign entities." While the proposed rule references existing national securityauthorities, it does not provide sufficient clarity regarding which lists will govern these determinations,how frequently those lists will be updated, how changes will be communicated to recipients, or howagencies will apply those changes to ongoing awards. Given that these lists and associated nationalsecurity designations can evolve over time, researchers and institutions may face significant uncertaintyin determining whether existing or prospective collaborations remain permissible throughout the life ofa multi-year project.455 Massachusetts Ave. NW, Suite 1000 | Washington, DC 20001 | (202) 642-3858 | ghtcoalition.orgThe proposed rule also provides limited guidance regarding how affiliations with foreign entities will beevaluated in practice or whether exceptions may be available when international collaboration isscientifically necessary to achieve the objectives of a federally funded project. Not all foreign entitiespresent the same level of national security concern, yet the proposed framework does not clearlydistinguish among varying levels of risk or explain how agencies will balance legitimate securityconsiderations with the public health value of continued international research partnerships.Over time, uncertainty surrounding the scope of permissible international engagement and thedefinition of restricted entities may disincentivize participation in global research partnerships. Thiscould reduce the United States’ ability to maintain on-the-ground research presence in regions whereoutbreaks originate, limiting early detection and response capacity. In the context of global infectiousdisease threats, reduced engagement in these settings may inadvertently increase, not decrease,vulnerability to emerging health risks that cross borders.GHTC urges OMB to provide greater clarity regarding the standards governing international researchcollaborations, including the application of restrictions on covered foreign entities, while preserving theability for scientifically justified international research and foreign subawards to remain integralcomponents of federally funded research. The final rule should establish clear, predictable criteria andimplementation guidance that protect national security while enabling US researchers to maintain theinternational partnerships necessary to maximize taxpayer investments, strengthen global diseasesurveillance, and advance the scientific discoveries that safeguard public health at home and abroad.Uncertainty Around Relevant Communications on Research Findings§ 200.450 — Issue advocacy prohibition / communications restrictionsCommunicating research findings is an essential component of translating evidence into impact.Scientific discoveries achieve their greatest public benefit when researchers can share evidence, explainthe significance of findings, and inform decision-makers responsible for translating research into policyand practice. The revisions proposed in Section 200.450, that includes terms such as "issue advocacy,""public messaging," and communications that "promote or oppose a particular social, political, or publicpolicy position," are broad enough that recipients may struggle to distinguish between prohibitedadvocacy and allowable scientific communication.Greater clarity regarding the scope of these restrictions would help ensure that federally funded entitiescan continue communicating scientific evidence and technical expertise while remaining fully compliantwith longstanding prohibitions on lobbying. Preserving the ability to responsibly disseminate researchfindings and inform decision-making is critical to ensuring that taxpayer-funded research translates intoimproved public health policy, stronger preparedness, and better health outcomes.GHTC recommends that OMB maintain the existing framework around messaging by preserving thelongstanding distinction between prohibited lobbying activities and the responsible communication offederally funded research, while providing greater clarity where needed to ensure that taxpayerinvestments continue to translate into evidence-based policy maximizing public health benefit.Conclusion455 Massachusetts Ave. NW, Suite 1000 | Washington, DC 20001 | (202) 642-3858 | ghtcoalition.orgIn considering these revisions, we encourage OMB to evaluate not only the intent and impact of eachindividual provision, but also the cumulative effect of implementing many significant changessimultaneously across the federal grantmaking framework. While each revision may be designed tostrengthen oversight, accountability, or alignment with administration priorities, together they riskintroducing a level of uncertainty that could fundamentally alter how research institutions, investigators,and partners engage with federally funded research and development.The United States has long benefited from a research ecosystem that balances strong oversight withscientific independence, rigorous accountability with flexibility, and domestic leadership with strategicinternational collaboration. Preserving that balance is essential to ensuring that taxpayer investmentscontinue to generate lifesaving discoveries, strengthen preparedness, and sustain America's leadershipin science and innovation.We appreciate OMB’s consideration of these comments and respectfully urge the agency to considerand revise the provisions outlined above before finalizing the rule. If implemented as proposed, theserevisions could discourage participation in federally funded research, disrupt critical collaborations, andslow the development of lifesaving technologies needed to address current and future healthchallenges. Oversight, accountability, and transparency can coexist with the stable and predictablefunding environment that research and development requires, provided that efforts to strengthenstewardship of federal funds do not come at the expense of the conditions that have made the USresearch enterprise a global model for decades.Please do not hesitate to contact GHTC’s US Policy and Advocacy Associate Amanda Reiling atareiling@ghtcoalition.org or GHTC’s Executive Director Dr. Kristie Mikus at kmikus@ghtcoalition.org ifyou have questions or need any additional information.Sincerely,Dr. Kristie Mikus, Executive Director of GHTC on behalf of the Global Health Technologies Coalition