HRA Comments Submitted to OMB

July 10, 2026

The Honorable Russell Vought

Director

Office of Management and Budget

725 17th Street NW

Washington, DC 20503

Dear Director Vought:

Heart Rhythm Advocates (HRA), the advocacy arm of the Heart Rhythm Society (HRS),

appreciates the opportunity to comment on the Office of Management and Budget's

proposed revisions to the Uniform Guidance governing federal financial assistance.

The Heart Rhythm Society is an international organization representing physicians,

scientists, researchers, and allied professionals dedicated to improving the prevention,

diagnosis, and treatment of heart rhythm disorders. HRS members serve as principal

investigators on NIH-funded basic, translational, and clinical research; lead multicenter

cardiovascular clinical trials; develop national and international patient registries; and

generate the scientific evidence that informs FDA approvals, clinical practice guidelines,

and standards of care. Federal investments through the National Institutes of Health (NIH),

National Heart, Lung, and Blood Institute (NHLBI), Centers for Disease Control and

Prevention (CDC), Food and Drug Administration (FDA), and other agencies have been

instrumental in advancing electrophysiology research, including catheter ablation, cardiac

implantable electronic devices, remote monitoring technologies, inherited arrhythmia

syndromes, artificial intelligence-enabled diagnostics, and sudden cardiac arrest

prevention.

HRA supports the goals of ensuring that federal financial assistance is managed

responsibly, transparently, efficiently, and in a manner that maximizes value for patients

and taxpayers. We recognize the importance of strong stewardship of public funds and

appreciate OMB's efforts to improve the consistency and accountability of federal

assistance programs. Because HRS members conduct federally funded research, care for

patients affected by cardiovascular disease, and translate scientific discoveries into

clinical practice, the Society has a strong interest in ensuring that the final rule supports

both sound stewardship and continued biomedical innovation.

While we support OMB's objectives, several provisions of the proposed rule could

unintentionally undermine the stability and predictability of federally supported biomedical

research. We respectfully encourage OMB to revise these provisions in a manner that

preserves scientific excellence while advancing accountability and efficient management

of federal resources.

Protecting Scientific Merit and Peer Review (2 C.F.R. § 200.205)

The proposed revisions to 2 C.F.R. § 200.205 raise our greatest concern.

For decades, independent scientific peer review has served as the foundation of federally

funded biomedical research. Scientific experts evaluate proposals based on

methodological rigor, innovation, feasibility, investigator qualifications, and the potential to

improve patient care. Although awarding agencies appropriately retain final funding

authority, funding decisions should continue to be grounded primarily in scientific merit

and peer review.

Electrophysiology demonstrates the value of this approach. Many of today's standard

therapies, including catheter ablation for atrial fibrillation, implantable cardioverter-defibrillators, cardiac resynchronization therapy, leadless pacing systems, pulsed field

ablation, and contemporary approaches to inherited arrhythmia management, originated

through investigator-initiated research supported by rigorous peer review. Likewise,

advances in artificial intelligence-enabled electrocardiographic interpretation, remote

monitoring, wearable technologies, and clinical decision support have emerged from

investigator-driven scientific inquiry rather than directed research initiatives.

Scientific independence is a public asset. Predictability is equally important. Investigators,

institutions, and research participants undertake multi-year commitments with the

expectation that funding decisions will remain grounded in consistent scientific standards.

Preserving confidence in a stable, merit-based review system encourages innovation,

strengthens public trust, and maximizes the return on federal research investments.

HRA therefore urges OMB to clarify that, while agencies retain final award authority,

independent expert peer review should remain the primary mechanism for evaluating the

scientific and clinical merit of biomedical research proposals.

Preserving Long-Term Cardiovascular Research (2 C.F.R. §§ 200.211 and 200.340)

HRA is also concerned with proposed revisions to 2 C.F.R. §§ 200.211 and 200.340 that

would expand agency authority to modify, suspend, or terminate awards under certain

circumstances.

Cardiovascular research frequently requires years of sustained investment before

meaningful results can be achieved. Clinical trials evaluating new ablation technologies,

implantable cardiac devices, inherited arrhythmia therapies, and heart failure interventions

require prolonged patient enrollment, extensive follow-up, and continuous data collection.

Interrupting these studies midway risks wasting prior federal investment while delaying

improvements in patient care.

Long-term electrophysiology studies frequently evaluate outcomes that may not become

apparent for years, including recurrent arrhythmias, stroke prevention, device

performance, lead reliability, battery longevity, and overall survival. Stability and

predictability are therefore essential components of successful cardiovascular research

programs.

This concern is especially significant in electrophysiology, where research increasingly

depends upon longitudinal digital health data generated through implantable devices,

wearable technologies, remote physiologic monitoring systems, and artificial intelligence-enabled diagnostics. These datasets become increasingly valuable over time. National

registries and post-market surveillance programs likewise provide critical evidence

regarding device safety, procedural outcomes, and long-term effectiveness that cannot

simply be recreated if interrupted.

Patients who volunteer to participate in federally funded clinical research do so with the

expectation that their participation will contribute to meaningful scientific advancement.

Stable support for ongoing studies helps maintain that trust while ensuring that taxpayer

investments produce the greatest possible public benefit.

Maintaining Scientific Collaboration (2 C.F.R. § 200.220)

HRA supports appropriate safeguards to protect research security and national interests.

At the same time, implementation of proposed 2 C.F.R. § 200.220 should not unnecessarily

impede legitimate scientific collaboration.

Cardiac electrophysiology has benefited enormously from multinational clinical trials,

international patient registries, and collaborative scientific networks. This is particularly

true for rare inherited arrhythmia syndromes, including Long QT Syndrome, Brugada

Syndrome, Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT), and

Arrhythmogenic Right Ventricular Cardiomyopathy (ARVC), where meaningful research

often depends upon assembling patient populations from multiple countries.

International collaboration also plays an increasingly important role in FDA-regulated

device studies, post-market evidence generation, validation of artificial intelligence

algorithms, development of remote monitoring technologies, and international consensus

statements that inform clinical practice worldwide.

Research security and scientific collaboration are complementary objectives. HRA

encourages OMB to ensure that any final rule addresses clearly defined national security

concerns without unnecessarily limiting the scientific partnerships that have advanced

cardiovascular medicine and improved patient outcomes.

Minimizing Administrative Burden

Academic medical centers, hospitals, and physician organizations conducting federally

funded research already operate within an extensive framework of regulatory oversight.

While accountability is essential, additional reporting and compliance requirements

should be carefully evaluated to ensure they provide meaningful improvements in program

integrity without unnecessarily diverting investigators from scientific work.

This issue is particularly important for physician-scientists and clinical investigators.

Cardiovascular researchers balance demanding clinical responsibilities with the

development of new therapies, technologies, and evidence that improve patient care.

Maintaining a strong physician-scientist workforce is itself a matter of national interest.

Increased uncertainty surrounding research funding or expanded administrative burden

risks discouraging early-career clinicians from pursuing research careers at precisely the

time continued innovation is needed to address the growing burden of cardiovascular

disease.

Time devoted to unnecessary administrative requirements means time unavailable for

patient care, clinical investigation, and the development of new therapies.

Recommendations

HRA respectfully urges OMB to:

• Preserve scientific peer review as the primary basis for evaluating and funding

  biomedical research under 2 C.F.R. § 200.205.

• Revise the proposed changes to 2 C.F.R. §§ 200.211 and 200.340 to ensure that

  research awards are not delayed, modified, suspended, or terminated based on

  broad or subjective standards unrelated to scientific merit, recipient performance,

  or statutory requirements.

• Protect ongoing clinical research projects from disruption absent evidence of fraud,

  waste, abuse, or material noncompliance.

• Ensure that implementation of 2 C.F.R. § 200.220 does not unnecessarily impede

  legitimate scientific collaboration.

• Adopt reforms using a risk-based approach that minimizes unnecessary

  administrative burden while preserving appropriate oversight and accountability.

• Continue to support the publication and dissemination of federally funded

  biomedical research so that new discoveries can be translated into clinical practice.

Conclusion

Federal investment in biomedical research has transformed the care of patients living with

heart rhythm disorders. From lifesaving implantable defibrillators and catheter ablation to

remote monitoring technologies and emerging artificial intelligence applications, decades

of federally supported research have fundamentally changed the practice of

cardiovascular medicine and improved the lives of millions of Americans.

HRA shares OMB's goals of responsible stewardship, transparency, and effective

management of federal financial assistance. We respectfully encourage OMB to revise the

proposed rule in a manner that preserves scientific independence, protects rigorous peer

review, supports stable long-term clinical research, enables responsible international

collaboration, and minimizes unnecessary administrative burden.

Ultimately, the value of federal research policy should be measured not simply by how

efficiently grants are administered, but by whether it enables the next generation of

discoveries that improve - and save - patients' lives.

Thank you for the opportunity to provide these comments and for your consideration of

these recommendations.

Sincerely,

Dr. Mina Chung, Co-Chair

Heart Rhythm Advocates

Dr. Andrea Natale, Co-Chair

Heart Rhythm Advocates

Dr. Sana Al-Khatib, President

Heart Rhythm Society