TOS’ Comments:

1. Proposed § 200.205: Preserve timely, expert-driven, merit-based award issuance for obesity research.

Obesity research depends on a funding system that allows scientifically meritorious projects to move efficiently from peer review to award issuance. Proposed § 200.205 would add a senior political appointee pre-issuance review process for discretionary awards. Even when intended to strengthen oversight, an additional review layer could lengthen the time between scientific review and funding decisions, delaying projects that have already been evaluated by qualified reviewers.

For obesity research, such delays can postpone participant recruitment, staff hiring, data collection, community-engagement activities, and initiation of obesity prevention and treatment studies. In clinical trials, pediatric obesity interventions, lifestyle and behavioral programs, implementation studies in health systems, and community-based prevention initiatives, missed enrollment windows and delayed intervention launches can diminish scientific value and slow the translation of evidence into practice. Obesity research also frequently depends on coordinated timelines across investigators, clinical sites, community partners, data managers, and trainees. Delays at the award stage can therefore create consequences beyond the initial funding decision.

TOS recommends that OMB withdraw or substantially revise proposed § 200.205 to avoid unnecessary delays in award issuance and to preserve expert-driven, merit-based review. If OMB retains any additional pre-issuance review requirement, it should require clear timelines, objective criteria, written justification when reviewer recommendations are not followed, conflict-of-interest safeguards, and assurance that scientific peer review remains a substantive basis for award decisions.

2. Proposed §§ 200.340–200.343: Do not destabilize ongoing obesity research through expanded termination or stop-work authority.

Obesity research often requires multi-year commitments, including longitudinal cohort studies, pediatric obesity interventions, lifestyle and behavioral treatment programs, implementation science initiatives, and clinical trials evaluating the long-term effects of medical, behavioral, and surgical obesity treatments. Proposed expansions of suspension, termination, or stop-work authority could introduce uncertainty after awards are made and could disrupt studies that depend on sustained participant follow-up and stable research infrastructure.

Many obesity studies require years of follow-up to evaluate weight trajectories, cardiometabolic outcomes, treatment adherence, disease progression, durability of treatment response, and longer-term safety and effectiveness. Research interrupted mid-course may be impossible to fully restore. Participant retention can be lost; scheduled data collection windows may be missed; community or clinical site partnerships may weaken; and data integrity may be compromised. In studies involving patients receiving active interventions or ongoing clinical monitoring, sudden funding disruptions can also undermine participant trust and reduce willingness to participate in future research.

As one example, one TOS member shared that they are currently supported by a VA Career Development Award and that abrupt withdrawal of funding could force them to rapidly seek alternate employment, despite having developed a research trajectory and institutional commitments around the award. The member also noted that academic institutions train endocrine fellows and early-career clinician-scientists in an environment where academic physicians often earn less than clinicians in private practice and where recruiting physicians into research is already difficult. This example illustrates how expanded termination or stop-work authority could affect not only one project, but also the workforce pipeline needed to sustain obesity and cardiometabolic research.

Expanded discretionary termination authority also risks reducing the return on taxpayer investment. Federal funds already spent on recruitment, study start-up, training, data infrastructure, and intervention delivery may yield less useful evidence if the study cannot be completed as designed. In obesity research, where benefits often accrue through long-term knowledge generation and translation into clinical and public health practice, funding stability is essential to ensuring that prior federal investments produce usable evidence.

TOS urges OMB to preserve stable and predictable funding mechanisms for approved projects and to avoid policies that allow otherwise compliant obesity research awards to be suspended or terminated without clear, objective standards. If OMB finalizes expanded termination or stop-work authority, TOS recommends requiring written justification, meaningful notice and an opportunity to respond when practicable, consideration of scientific and participant impacts, reimbursement of reasonable wind-down costs, and public reporting of discretionary terminations and stop-work orders.

3. Proposed §§ 200.202 and 200.204: Support long-term obesity research while preserving appropriate agency flexibility.

TOS appreciates OMB’s recognition that multi-year awards can reduce administrative burden and support long-term planning. Many obesity studies—particularly longitudinal cohort research, large clinical trials, implementation studies, and infrastructure investments—benefit from stable funding commitments over multiple years. Multi-year awards can allow investigators to recruit and retain specialized personnel, maintain participant follow-up, build data systems, and sustain partnerships with clinical and community sites.

At the same time, TOS encourages OMB to preserve agency flexibility to determine when multi-year awards are scientifically appropriate. Some obesity research areas, including pilot studies, early-stage mechanistic research, rapidly evolving treatment questions, and programs designed to support a broad portfolio of investigators, may be better served through more traditional funding mechanisms. A one-size-fits-all expectation could unintentionally reduce the number of new awards available in a given year and weaken opportunities for early-career investigators and emerging scientific ideas.

TOS also notes the tension between encouraging multi-year awards and expanding discretionary termination authority. The value of multi-year funding lies in the confidence it provides investigators and institutions to make long-term scientific commitments. If recipients cannot reasonably rely on continuity of awarded funding, the practical benefits of multi-year obesity research awards are substantially diminished.

TOS recommends that OMB preserve agency discretion to use multi-year awards when the science warrants them, while ensuring that any final rule maintains the funding predictability necessary for long-term obesity research investments.

4. Proposed § 200.218: Preserve the ability to study obesity across diverse populations and settings.

Obesity prevalence, disease burden, treatment access, treatment response, and treatment outcomes vary substantially across geography, rurality, socioeconomic status, age, disability status, insurance coverage, clinical setting, and other population and contextual characteristics. Research examining these differences is essential to understanding disease drivers, identifying barriers to care, improving treatment effectiveness, and developing evidence-based prevention and treatment strategies.

Proposed § 200.218, as drafted, could create uncertainty for researchers seeking to examine differences in outcomes across populations, even when the purpose of the research is to generate evidence rather than to impose liability. In obesity science, measuring differences across populations is not ideological; it is basic evidence generation. Researchers must be able to evaluate whether prevention programs work in rural and urban communities, whether treatment access differs by insurance status or geography, whether children and adults respond differently to interventions, and whether clinical tools and care models perform effectively across patient populations.

Policies that discourage or restrict the study of differences in obesity outcomes could limit researchers’ ability to generate evidence needed to improve health outcomes and reduce healthcare expenditures related to obesity and its complications. Such restrictions could also weaken the evidence base needed to design prevention strategies, improve access to evidence-based treatment, and ensure that federally funded research produces benefits for all patients and communities affected by obesity.

TOS recommends that OMB withdraw or clarify proposed § 200.218 to ensure that federally funded researchers remain able to study differences in obesity prevalence, disease burden, treatment access, treatment response, and outcomes across populations and settings. TOS further recommends that OMB expressly distinguish evidence-generating research from activity intended to establish or advance legal liability.

5. Proposed § 200.205 and related merit provisions: Maintain objective scientific and technical review standards.

Progress against obesity depends on funding decisions grounded in scientific merit, technical expertise, and rigorous peer review. Obesity research spans basic science, clinical trials, pharmacotherapy, metabolic surgery, behavioral interventions, nutrition, physical activity, implementation science, health services research, and public health programs. These areas require reviewers with relevant scientific, clinical, methodological, statistical, implementation, and community-engagement expertise.

Objective merit review is particularly important in obesity research because the field often addresses complex, long-term, and multifactorial questions. Reviewers must be able to evaluate whether proposed studies have appropriate comparison groups, adequate sample sizes, meaningful outcomes, feasible recruitment and retention plans, valid analytic methods, protections for human participants, and realistic implementation strategies. A proposal may appear aligned with a broad policy priority while lacking the technical rigor needed to produce reliable evidence.

TOS recommends that OMB preserve robust, transparent merit-review processes and require reviewer qualification standards appropriate to the scientific and programmatic issues raised by each funding opportunity. Funding decisions for obesity research should remain grounded in objective criteria, including statutory alignment, significance of the health problem, potential public benefit, technical merit, feasibility, and likelihood of generating reliable and useful evidence.

6. Proposed §§ 200.432 and 200.461: Preserve dissemination through conferences and publication/open-access costs.

Scientific meetings such as ObesityWeek® enable investigators to disseminate findings, obtain peer feedback, identify methodological concerns, and build the cross-disciplinary collaborations that obesity research depends on. Conference participation is especially important for trainees and early-career investigators, who use scientific meetings to present federally funded findings, develop collaborations, and enter the research workforce.

Proposed restrictions on conference attendance costs under § 200.432 could reduce the reach and impact of federally funded obesity research if recipients cannot reasonably plan for award-related presentation and dissemination activities. Grant applications are often submitted long before investigators know when findings will be ready to present or which scientific meeting will provide the most appropriate audience. Requiring specific conference approval too early in the award process could create unnecessary administrative burden and discourage timely dissemination.

Similarly, publication costs, including article-processing charges and open-access fees, are often essential to making federally funded obesity research available to clinicians, researchers, policymakers, and the public. Proposed restrictions under § 200.461 could disproportionately burden early-career investigators, smaller institutions, and less-resourced grantees that lack alternative funds for publication.

TOS recommends preserving the allowability of reasonable, allocable, award-related conference and publication costs. OMB can protect federal funds through existing reasonableness, allocability, documentation, and audit standards without categorically restricting dissemination activities that help federally funded obesity research achieve public benefit.

7. Proposed § 200.202(e) and § 200.220: Preserve scientifically necessary collaboration while addressing legitimate research-security risks.

Obesity is a global health challenge, and cross-border collaboration can improve the quality, applicability, and generalizability of obesity research. International collaboration may be scientifically necessary when researchers need access to unique populations, data sources, clinical experience, specialized expertise, or comparative health-system contexts that are not available within a single domestic setting.

TOS supports appropriate safeguards to protect U.S. interests, research integrity, sensitive data, human-subjects protections, and national security. However, categorical or overly broad restrictions on foreign participation could unnecessarily limit beneficial collaborations that advance scientific understanding of obesity, cardiometabolic disease, treatment response, prevention strategies, and public health implementation.

TOS recommends that OMB use an objective, risk-based framework for evaluating international elements of research and covered foreign collaborations. Such a framework should permit collaborations that serve a legitimate scientific, clinical, public health, or programmatic purpose and that do not expose classified information, sensitive personal or genomic data, proprietary information, controlled biological materials, or other protected federal interests. Review of international elements should be conducted by officials with appropriate scientific, programmatic, grants-management, and research-security expertise.

8. Proposed §§ 200.206 and 200.208: Avoid unnecessary administrative burden and uncertainty for responsible grantees.

TOS supports appropriate stewardship of federal resources and recognizes the importance of risk-based oversight. However, expanded pre-award risk assessments and the ability to add or modify award conditions during the period of performance should be narrowly tailored, consistently applied, and grounded in objective indicators of financial, managerial, and programmatic capacity.

Obesity researchers and research institutions already operate under extensive oversight, including scientific review, human-subjects protections, financial reporting requirements, institutional compliance systems, and agency monitoring. Additional layers of review or shifting award conditions could increase administrative burden and create uncertainty for investigators without necessarily improving stewardship. These burdens may fall especially heavily on early-career investigators, smaller institutions, and community-based partners working to address obesity in underserved areas.

As another example, one TOS member described a research group that worked with a postdoctoral fellow from China who was lawfully in the United States but faced uncertainty related to visa costs and additional paperwork, which delayed and distracted from research activities. The group relied on this individual’s machine-learning expertise to evaluate risk of major adverse cardiovascular events (MACE) among Veterans. Additional administrative requirements, including E-Verify or domestic-purchasing requirements, could create further logistical delays for grantees and could make it harder for obesity and cardiometabolic research teams to retain specialized expertise needed to complete federally funded work.

TOS recommends that OMB ensure any expanded risk-assessment or award-condition authority is narrowly defined, objective, consistently implemented, and accompanied by clear timelines. Oversight should protect taxpayer funds while avoiding unnecessary delay or uncertainty for responsible grantees conducting federally funded obesity research.

9. Workforce development: Preserve the pipeline of future obesity researchers and clinicians.

Early-career investigators rely on research funding, conference participation, publication opportunities, mentorship, and stable career pathways to establish independent research programs. The obesity research workforce already faces challenges recruiting and retaining investigators at a time when obesity prevalence and treatment demand continue to increase. Funding instability, delayed awards, restricted dissemination opportunities, and additional administrative barriers may discourage trainees and early-career scientists from pursuing careers in obesity research and clinical investigation.

Policy should strengthen—not weaken—the pipeline of future obesity researchers, clinicians, and public health professionals. TOS encourages OMB to consider the cumulative effect of the proposed rule on trainees, postdoctoral fellows, junior faculty, clinician-scientists, and community-based investigators working to address obesity and related chronic diseases.

10. Proposed effective date: Allow adequate time for implementation.

TOS is concerned that a sweeping change to federal financial assistance requirements could disrupt ongoing research if finalized and implemented on a compressed timeline. Agencies, institutions, investigators, and research partners would need time to understand new requirements, revise notices of funding opportunities, update award terms, modify compliance systems, and train staff. Rapid implementation could create avoidable confusion and delays in an already complex research environment.

TOS recommends that OMB provide adequate implementation time for any final rule and consider phased implementation for provisions that materially affect award review, award conditions, allowability of costs, termination, collaboration, or reporting. Implementation should avoid disrupting ongoing obesity research and should preserve continuity for already-awarded projects.

Conclusion

Obesity is one of the nation’s most prevalent, costly, and consequential chronic diseases. The federal research enterprise plays an essential role in generating the evidence needed to prevent obesity, improve treatment, reduce complications, support clinical and public health decision-making, and lower long-term healthcare costs. TOS shares OMB’s commitment to ensuring that federal funds are used responsibly and produce meaningful public benefit. The recommendations above are offered in that spirit: to strengthen stewardship while preserving the timely, stable, merit-based, collaborative, and dissemination-oriented funding system needed for obesity research to improve the health of patients and communities.

Thank you for considering these comments. Please contact Jeanne Blankenship, MS, RDN, at [email protected] with questions related to the TOS submission.

Sincerely,

Jackie Stephens, PhD, FTOS
President
The Obesity Society