My Public Comment on Proposed OMB Rule: Regulation for Federal Financial Assistance
Submitted by: Elizabeth Ginexi, PhD, Former NIH Scientific Program Official (2003–2025)
In this post I am sharing the comment I submitted to the Federal Register in response to the newly proposed OMB Rule “Regulation for Federal Financial Assistance.”
You do NOT need to write a comment as detailed as mine. Please write based on your perspective and based on your life experiences. That is what I have done. This comment represents my viewpoints and my extensive scientific research career.
First, here is what I wrote in the Comment text box:
I am submitting this comment in strong opposition to the proposed revisions to 2 CFR Part 200 (Docket OMB-2026-0034). My full comment, with detailed analysis and supporting citations to legal authorities, scientific literature, and policy documents, is attached as a PDF document.
I write as a concerned citizen, a scientist with more than 30 years of research experience, and a former NIH Scientific Program Official who spent 22 years managing a portfolio of federal grants totaling hundreds of millions of dollars across multiple institutes and centers. I left NIH in April 2025 because I witnessed firsthand the replacement of a scientifically driven system with one that is politically directed, in ways I believe violate the Public Health Service Act of 1944. As a former federal employee who took the oath of office required by 5 U.S.C. §3331, I understood that oath to include an obligation to speak when federal actions conflict with the Constitution and the laws under which I served. This comment is submitted in that spirit.
This proposed rule is not a grants management reform. It is the most consequential attack on American science and on the integrity of federal grantmaking in the postwar era. It would place political appointees above scientific peer reviewers in every grant funding decision, allow any active grant to be terminated mid-project for undefined political reasons, prohibit international scientific collaboration, ban journal subscriptions and publication costs that have been allowable for over fifty years, and require that every federal grant program align with the current administration’s political priorities rather than with scientific need or congressional mandate.
Critically, this rule does not govern only science grants. It governs every federal grant from every agency, totaling approximately $1.1 trillion annually. Grant funding at risk includes money for state health services, transportation projects, education programs, Head Start, housing assistance, rural broadband, water infrastructure, and environmental protection programs. Every one of those programs would be subject to the same political control provisions described above.
My attached comment addresses the following specific provisions and requests that each not be finalized:
§200.205 and §200.205(d) — Political appointee pre-issuance review and the elimination of binding peer review
§200.340 — Discretionary termination on undefined “national interest” grounds
§200.300 — Replacement of anti-discrimination protections with anti-DEI prohibitions
§200.220 and §200.303 — Foreign collaboration prohibition and E-Verify mandate
§200.202, §200.202(d), §200.202(e) — Program design requirements mandating political alignment
§200.204 — Exemption of grant competitions from public notice
§200.206 — Denial of grants based on organizational affiliations
§200.432, §200.454, §200.461 — Conference attendance, journal subscriptions, and publication costs §200.421 and §200.450 — Public communications and issue advocacy prohibition
The attached comment also documents serious legal concerns including violations of the Administrative Procedure Act, the Public Health Service Act of 1944, the First Amendment, the Spending Clause, the Major Questions Doctrine, multiple civil rights statutes, and the Evidence-Based Policymaking Act of 2018. It further raises concerns about the adequacy of the interagency consultation process through which this rule was developed.
I urge OMB to withdraw this rule in its entirety.
Respectfully submitted,
Elizabeth Ginexi, PhD Former NIH Scientific Program Official (2003–2025)
Second, here is what I wrote in the pdf document that I attached as an upload:
Public Comment on Proposed Rule: Regulation for Federal Financial Assistance
Docket: OMB-2026-0034
Submitted by: Elizabeth Ginexi, PhD, Former NIH Scientific Program Official (2003–2025)
I am writing to express my strongest opposition to OMB’s proposed revisions to 2 CFR Part 200,1 “Regulation for Federal Financial Assistance” published in the Federal Register on May 29, 2026. The proposed revisions would replace the peer-review system of federal investment in science with a political approval process. Indeed, this new political litmus test would extend to all grants issued by any federal agency including funding for science, public services, infrastructure, education, and social welfare programs. Using OMB’s grants management authority as a vehicle for political control over science, public services, and free speech has not been authorized by Congress or the Constitution.
I served the National Institutes of Health (NIH) for 22 years as a Scientific Program Official, shaping biomedical and behavioral health research strategy and safeguarding the taxpayers’ investments. Prior to my work at NIH, I served as a Senior Study Director and Scientist in the private sector conducting health research through federal grants. I hold master’s and doctoral degrees in applied social psychology from The George Washington University, and I completed postdoctoral training under two Public Health Service Grant National Research Service Awards at Children’s National Hospital and the Center for Mental Health Policy at Vanderbilt University. I am also a concerned citizen who values the federal investments in scientific advancement following WWII that helped make our country a leader in science and technology.
I left NIH in April 2025 because I witnessed firsthand the systematic replacement of the statutorily created system driven by scientists with one that is politically directed, in ways I believe violate the Public Health Service Act of 1944 (42 U.S.C. § 201 et seq.)2
As a former federal employee who took the oath of office required by 5 U.S.C. §3331,3 I understood that oath to include an obligation to speak when federal actions conflict with the Constitution and the laws under which I served. This comment is submitted in that spirit.
The proposed revisions to 2 CFR Part 2001 attempt to codify and dramatically expand the violations I witnessed at NIH. The revisions would also violate the statutes that govern every other federal agency with grant-making authority by making funding decisions politically driven, rather than merit driven. At a fundamental level, this proposed rule violates the statutes that Congress passed to create these agencies.
The modern authority of the NIH was codified in law through the Public Health Service Act of 1944 (42 U.S.C. § 201 et seq.),2 which established a decentralized, expert-led structure to support health-related scientific inquiry. Under this framework, NIH is composed of semi-autonomous institutes and centers (ICs), each led by directors selected through search committees of external scientific experts to prevent politicization (Schulson, 2026).4 The statutory firewall was robust. For decades, only two positions across the entire agency have been presidentially appointed: the NIH Director, appointed by the President with Senate confirmation under 42 U.S.C. §282, and the Director of the National Cancer Institute under 42 U.S.C. §284, a structure established by the National Cancer Act of 1971 and its 1974 Amendments.5 Central to this statutory mission is the mandate for peer review, formalized through the Ransdell Act of 1930 (Pub. L. No. 71-251)6 and expanded after World War II. By law and regulation, NIH uses a two-tiered grant review system in which panels of external scientists evaluate each application’s technical merit, followed by a final layer of oversight from National Advisory Councils. The legislative intent was clear: the government provides the resources, but the determination of what constitutes high-quality science remains the exclusive domain of those with the specialized training to judge it.
For eight decades, NIH decision-making followed this framework built on expert scientific consensus. While not without flaws, this system successfully transformed public health, fueled economic growth, and established the United States as a global leader in biomedical innovation.7 This system guided by science supported 174 Nobel laureates among NIH-funded researchers, along with the sequencing of the human genome, antiretroviral therapy for HIV, vaccines for polio and hepatitis B and HPV and COVID-19, and treatments for cancers that were uniformly fatal within living memory.7 None of those advances were predicted at the time the underlying research was funded. That is not a coincidence. It is the point.
The proposed revisions to 2 CFR Part 2001 attempt to attach sweeping new conditions to NIH awards. The Spending Clause of the Constitution8 gives Congress the power to appropriate federal funds and to attach conditions to those appropriations, not OMB. Under South Dakota v. Dole,9 conditions on federal grants must be unambiguous, related to the federal interest in the program, and not coercive. Many provisions of this proposed rule fail that test. On these grounds alone I urge OMB not to finalize it.
I. This Rule Rests on Questionable Legal Foundations
The most foundational problem is the proposed conversion of OMB guidance into binding regulation. Since 2014, 2 CFR Part 2001 has been explicitly characterized as guidance, commonly known as the “Uniform Guidance.” The existing regulatory text included a sentence stating plainly: “Publication of the OMB guidance in the CFR does not change its nature — it is guidance, not regulation.” The proposed revision deletes that sentence entirely and replaces the word “guidance” with “regulations” across 456 sections of the rule all at once. This transforms what has been a flexible administrative guidance document into binding law, and it does so in a way that makes the full scope of the change easy to miss.
This conversion is legally problematic for several reasons. Converting guidance to binding regulation requires independent notice-and-comment rulemaking for each substantive change being made, as required by the Administrative Procedure Act.10 Doing so across 456 sections in a single action, with a single government-wide effective date of October 1, 2026, denies agencies, grantees, states, and the public the opportunity to comment meaningfully on each specific change. It also eliminates the flexibility individual agencies have historically exercised in implementing OMB guidance in ways appropriate to their specific statutory missions and scientific communities. Under this rule, NIH, NSF, DOE, NASA, and every other federal agency loses the ability to shield their grantee communities from provisions that conflict with their authorizing statutes.
The proposed revisions also raise serious First Amendment concerns11 under the unconstitutional conditions doctrine. The government is allowed to set rules about how its money is spent. What it cannot do (as the Supreme Court made clear in Agency for International Development v. Alliance for Open Society International12) is require organizations to agree with a particular political or ideological position just to qualify for federal funding. That crosses a constitutional line, because it uses money as a tool to force people to adopt views that go beyond anything related to the work being funded. Multiple provisions of this proposed rule cross that line.
The “anti-American values” criterion in §200.205, the issue advocacy prohibition in §200.450, and the DEI prohibition in §200.300 all would condition federal funding on ideological conformity rather than programmatic compliance. Researchers whose work directly informs public policy, such as climate scientists, public health researchers, and behavioral and social scientists, would be effectively prohibited from communicating their own federally funded findings publicly without risking their awards.
Additionally, under West Virginia v. EPA,13 the Major Questions Doctrine requires that agencies have clear congressional authorization for decisions of vast political and economic significance. Restructuring the entire federal grant enterprise, which represents approximately $1.1 trillion annually across every agency, every program, and every recipient, through a single OMB rulemaking, in ways that conflict with dozens of specific congressional mandates, is precisely the kind of major question that requires explicit congressional authorization. No such authorization exists here.
The proposed rule also contains a new provision at §200.101(d)(2) that deserves specific attention. It establishes that wherever the new OMB rule conflicts with an existing agency regulation, the OMB rule takes precedence, unless the agency’s rule is specifically required by a federal statute. For decades, individual science agencies have been able to adapt OMB guidance to fit their specific missions, protecting their research communities from provisions that would otherwise conflict with how they operate. This new provision closes that door. It also creates a default presumption that will push agency staff toward the most restrictive reading of every OMB rule whenever there is any ambiguity. Agencies that are required by law to base their decisions on scientific evidence (e.g., FDA, CDC, EPA) will find that the OMB rule now governs over their own implementing regulations. This is not a grants management provision. It is a mechanism for asserting OMB control over every federal agency’s regulatory operations.
The proposed §200.101(d)(2) is independently unlawful for reasons beyond the guidance-to-regulation problem. OMB’s authority under 31 U.S.C. §351114 is limited to financial management and grants administration. It does not extend to overriding the substantive regulatory frameworks that Congress has established for individual agencies through their authorizing statutes. Asserting that OMB grants management regulations take precedence over FDA drug approval standards, EPA environmental standards, and NIH peer review requirements, all of which are grounded in agency-specific statutory mandates, exceeds OMB’s delegated authority. Under FDA v. Brown and Williamson Tobacco Corp., 529 U.S. 120 (2000),15 a general grant of administrative authority cannot override a detailed regulatory scheme that Congress established for a specific agency. Section 200.101(d)(2) attempts precisely that. It is not a grants management provision. It is an assertion of OMB supremacy over the entire federal regulatory enterprise, for which no congressional authorization exists.
The preamble to this proposed rule is itself evidence of arbitrary and capricious rulemaking. Every prior revision to 2 CFR Part 200 since the Uniform Guidance was established in 2013 identified its justifications in administrative assessments, stakeholder consultations, and empirical evidence of programmatic need. This preamble abandons that framework entirely. It characterizes the prior administration’s grants management practices as a “woke policy agenda” that “deliberately favored certain identity groups,” cites Heritage Foundation reports and partisan Senate documents as its primary authorities, and describes decades of peer-reviewed research as “neo-Marxist” and “anti-American.” These are not the findings of a neutral administrative process. They are political accusations. Under the APA’s arbitrary-and-capricious standard, an agency must offer a rational connection between the facts in the record and the choices it makes. A preamble that substitutes partisan rhetoric for evidentiary justification does not meet that standard, and courts reviewing this rule will have a clear record showing that OMB did not engage in the reasoned decision-making the law requires.
I urge OMB to withdraw this proposed rule in its entirety on these grounds. I additionally request that the following specific provisions not be approved or finalized, for the reasons set forth below.
II. §200.205 and §200.205(d) — Political Appointee Review and the Dismantling of Peer Review
These provisions are the most consequential in the rule and the most damaging to the American scientific enterprise.
Section 200.205 would require senior political appointees to conduct a mandatory pre-issuance review of every discretionary grant before it is awarded. These appointees would be explicitly forbidden from deferring to peer reviewers or routinely ratifying their recommendations. The criteria they must apply include blocking awards that touch on denial of “the sex binary in humans,” illegal immigration, or anything deemed to promote “anti-American values,” a term that is never defined anywhere in the rule.
Section 200.205(d) states explicitly that peer review recommendations “remain advisory and are not ministerially ratified, routinely deferred to, or otherwise treated as de facto binding.” This provision expressly violates the laws that mandate scientific peer review to inform grant-making decisions at NIH: specifically, the Ransdell Act of 1930,6 which established NIH as a federal institution, and Section 492 of the Public Health Service Act of 1944,2 which mandates technical and scientific peer review for NIH grant awards followed by Advisory Councils and NIH Institute and Center Directors (all scientists) overseeing the final award decisions. These statutory mandates cannot be overridden by an OMB grants management regulation. Only Congress has the authority to make such a change.
I spent 22 years inside the NIH peer review system. I managed hundreds of grants and co-authored 18 funding initiatives that generated more than $778 million in federally funded research. I can say with direct knowledge that the merit review system these provisions dismantle is the reason the United States leads the world in biomedical discovery, behavioral science, and public health research. It is not a bureaucratic formality. It is a carefully constructed, legally and scientifically defensible process through which thousands of the nation’s best scientists evaluate the quality, innovation, and feasibility of proposed research. No political appointee, regardless of their qualifications, can replicate that judgment.
Scientific peer review is also the primary protection against waste, fraud, and abuse in federal science funding. Replacing it with political review does not improve stewardship of federal funds. It eliminates the most rigorous quality control mechanism federal science has.
This provision creates an additional problem by requiring that all grants include benchmarks for compliance with “Gold Standard Science,” a term tied to Executive Order 14303 but never defined anywhere in the rule. Agencies would have to prioritize institutions that have “demonstrated success in implementing Gold Standard Science,” while institutional prestige and historical reputation would be explicitly deprioritized. Because the standard is never defined, political appointees retain unlimited discretion to favor or disfavor any institution based on political alignment. This is a benchmark that cannot be defined, cannot be met, challenged, or reviewed. Under the void-for-vagueness doctrine,16 a regulatory requirement that fails to give recipients fair notice of what is required is constitutionally unenforceable.
None of the discoveries that defined American scientific leadership over the past eighty years, such as the sequencing of the human genome, antiretroviral therapy for HIV, vaccines for COVID-19, were politically predicted or politically selected. They emerged from a merit-based system that this rule would dismantle.
I request that §200.205 and §200.205(d) not be finalized.
III. §200.340 — Discretionary Termination
Under the current rule, federal grants may be terminated only under limited, defined circumstances: when a recipient fails to comply with the terms of the award, when both parties mutually agree to end it, or when the program loses its legal basis. These protections exist to give researchers, institutions, and communities the certainty they need to make long-term commitments based on awarded grants. The proposed revision to §200.340 would sweep those protections away. Under the new standard, any active federal grant could be terminated because a political appointee determines it no longer serves “the national interest as they exist at the time of the termination.” No finding of noncompliance is required. No finding of fraud or misconduct is required. A brief written rationale suffices.
This standard is so broad as to be effectively unlimited. It means that a grant awarded under one set of administration priorities can be canceled by the next political official who reviews it, regardless of the scientific progress being made, the commitments made to participants, the staff hired, or the students mid-dissertation. It converts every multi-year federal research award into an at-will arrangement, making long-term scientific planning legally and financially impossible. Applying this standard retroactively to grants already awarded raises additional due process concerns, as recipients have relied on established rules in making binding commitments to staff, participants, and institutions.
I have seen what mid-project grant terminations do to research programs, to the scientists who depend on them, and to the communities that participate in them. The harm is not abstract. Data sets become scientifically worthless when longitudinal studies are cut off before completion. Clinical trial participants are left mid-protocol. Graduate students abandon their training. The scientific record is permanently diminished and already spent taxpayer dollars are wasted.
Applying this rule to grants that are already underway would raise serious legal problems. When the government changes long-standing rules, courts have consistently held that it must explain why the change is necessary and consider the harm to people who organized their lives and work around the old rules.17 OMB does neither here. Scientists who received multi-year grants under the existing framework made real, binding commitments in good faith; they hired researchers, enrolled participants, signed contracts, and built research programs around the reasonable expectation that awarded grants would be honored. The law requires OMB to grapple with that disruption before changing course.18 It has not. On top of that, giving researchers no advance warning, no chance to respond, and no way to appeal before their grant is canceled raises a fundamental question of basic fairness. The Constitution requires that before the government takes away something it has already granted, people must have a meaningful opportunity to be heard.19 This provision provides none.
The revisions to provision §200.340 will damage the nation’s health, economy, and security, and relinquish our role as the world’s leader in biomedical research and innovation.
I request that the “national interest” termination standard in §200.340 not be finalized, and that the existing provision limiting termination to noncompliance and mutual agreement be restored.
IV. §200.300 and §200.300(b) — Anti-Discrimination Protections Replaced with Anti-DEI Prohibitions
The existing §200.300 protects individuals from unlawful exclusion or discrimination under federally funded programs. The proposed rule retains that language but immediately follows it with a new paragraph prohibiting use of federal funds to “fund, promote, encourage, subsidize, or facilitate” DEI or DEIA policies, “gender ideology,” or assistance with gender transition for individuals under age 19.
What is currently a section protecting people from discrimination would be converted into a section prohibiting programs designed to serve them. This directly conflicts with the statutory purpose of programs Congress created specifically to address health and social disparities, including IDEA,20 Title I,21 Head Start,22 community health centers, and the Ryan White HIV/AIDS Program.23 The administration cannot use a grants management regulation to override what Congress has legislated in those authorizing statutes.
The proposed §200.300(b) also conflicts directly with obligations Congress has already imposed on federal grantees through Title VI of the Civil Rights Act of 1964 (42 U.S.C. §2000d et seq.),24 Title IX of the Education Amendments of 1972 (20 U.S.C. §1681 et seq.),25 Section 504 of the Rehabilitation Act of 1973 (29 U.S.C. §794),26 the Age Discrimination Act of 1975 (42 U.S.C. §6101 et seq.),27 and Section 1557 of the Affordable Care Act (42 U.S.C. §18116).28 An OMB regulation cannot override a congressional statute. To the extent this provision requires grantees to curtail programming that their civil rights obligations require them to provide, it is unenforceable as a matter of law.
I request that the new §200.300 and §200.300(b) prohibitions not be finalized.
V. §200.220 and 200.303 — Foreign Collaboration Prohibition and E-Verify
Provision (§200.220) is entirely new. It would prohibit the use of any federal funds, including indirect costs, for collaboration with entities in “covered foreign countries.” This is defined broadly enough to encompass virtually every significant research partner outside the United States. The prohibition covers travel, technical assistance, research activities, and indirect costs allocable to such collaborations.
I have seen firsthand how international scientific collaboration advances American research. Infectious disease surveillance, genomics, climate science, and epidemiology all depend on data and partnerships that cross borders. The United States became the world leader in biomedical research in part because our scientists could work with the best minds anywhere in the world. This provision would end that, while our primary scientific competitors, including China, face no such restriction and are investing aggressively in exactly these fields.
It also directly conflicts with the congressional mandate of the Fogarty International Center at NIH,29 which was created specifically to fund international health research. The prohibition may also conflict with bilateral scientific cooperation agreements the United States has entered into with allied nations, which contemplate and facilitate joint research programs. An OMB grants management rule cannot nullify a congressional mandate nor can it override treaty commitments. The United States has built global scientific leadership through exactly these kinds of international commitments. This provision would dismantle them.
A separate provision compounds this harm. The proposed rule adds a new paragraph (f) to §200.303, embedding a mandatory E-Verify requirement inside the existing internal controls section, requiring all grant recipients to enroll in and use the DHS E-Verify system for every employee and contractor working on a federal award.
Most major American research universities employ scientists from other countries on work visas. Under this provision, a failed E-Verify check must be reported to the federal agency and could result in termination of the grant. Combined with the foreign collaboration ban in §200.220, the message to international scientists is unmistakable: you are not welcome here. For generations, the United States attracted the world’s best researchers because American universities offered them opportunity, stability, and freedom to do their best work. These two provisions would destroy that reputation and hand our scientific competitors a recruitment advantage they could not have earned on their own.
I request that §200.220 and the E-Verify requirement added at §200.303(f) not be finalized.
VI. §200.202, §200.202(d), and §200.202(e) — Program Design Requirements
Under the current rule, federal grant programs must be designed around the purposes Congress established when it created them. Program goals must be evidence-based, consistent with authorizing legislation, and aligned with the agency’s own performance standards. That framework keeps grant programs grounded in scientific need and statutory mission rather than political preference. The proposed revisions to §§200.202, 200.202(d), and 200.202(e) replace that framework with something fundamentally different. Going forward, all federal grant programs would be required to align with “administration policies and priorities.” Agencies could restrict who is eligible to apply by limiting competitions to specific nonprofit categories. And any international element in an R&D award would be presumptively disfavored under a new domestic-first framework, requiring affirmative political justification on a case-by-case basis.
Requiring programs to align with administration priorities at the design stage means the political filter operates before anyone applies. Science agencies would be prohibited from soliciting research on topics that conflict with the current administration’s agenda, regardless of scientific need, statutory mandate, or the advice of the scientific community. This is not a grants management reform. It is a mechanism for suppressing entire fields of scientific inquiry, without scientific justification and without a vote of Congress.
Congress passed laws creating each federal agency’s grant programs and spelled out exactly what they are supposed to accomplish. This rule would allow the administration to ignore those congressionally defined purposes and substitute its own political priorities instead without passing a single new law. The Constitution does not allow that. The power to define what federal programs are for belongs to Congress, not to the President or OMB.30
I request that §§200.202, 200.202(d), and 200.202(e) not be finalized as proposed.
VII. §200.204 — Exemption of Grant Competitions from Public Notice
The current rule is straightforward: every federal funding opportunity must be publicly posted on Grants.gov so that any eligible applicant can find it, read it, and compete for it on equal footing. That requirement has been the cornerstone of open, fair federal grant competitions for decades. It ensures that awards go to the best applicants, not the best-connected ones. The proposed revision to §200.204 would allow agency heads to skip that requirement entirely whenever they decide that public posting poses a risk to national security or is not in the national interest. A national security exception makes sense in narrow circumstances, such as classified defense research. But “the national interest” is an undefined standard that this administration has applied expansively, and it could be used to hide entire grant competitions from public view. When grant competitions are invisible, the public cannot know whether awards are being made on merit or on political grounds. Transparency is not just good governance. It is the primary safeguard against corruption and favoritism in federal spending.
This provision conflicts with two laws Congress has already enacted. The Federal Funding Accountability and Transparency Act of 2006 (FFATA)31 requires that all federal grants be publicly posted and accessible. When Congress passed that law, it specifically limited the national security exception to classified information only. The proposed rule’s much broader “national interest” exception goes beyond what Congress authorized, and OMB does not have the power to expand a congressional exception on its own. Federal grants management law32 also expressly states that public notice requirements written into the statutes that created individual grant programs cannot be overridden by general grants management rules. The laws that established NIH, NSF, and DOE grant programs contain their own public notice requirements. Section 200.204 cannot erase them.
I request that §200.204 not be finalized as proposed.
VIII. §200.206 — Denial Based on Organizational Affiliations
Under current grants management rules, agencies assess applicant risk based on concrete, verifiable factors: past performance on federal awards, financial health, and compliance history. This proposed revision to §200.206 adds a new category: an applicant’s organizational affiliations. Specifically, it would allow agencies to deny grants to any applicant affiliated with an organization deemed to “advocate for the overthrow of the United States Government” or “undermine public safety or national security.” None of these terms are defined anywhere in the rule. Because the rule’s own preamble characterizes climate research, equity research, and public health advocacy as anti-American activity, this vague new standard could be used to disqualify researchers who belong to environmental groups, civil rights organizations, or public health advocacy associations. In effect, it creates a political blacklist with no defined edges and no meaningful limits on its application.
Section 200.206 violates the First Amendment’s protection of freedom of association, as established in NAACP v. Alabama, 357 U.S. 449 (1958),33 by conditioning receipt of a federal benefit on an applicant’s organizational affiliations. It further reflects the principle, developed through cases including Keyishian v. Board of Regents, 385 U.S. 589 (1967),34 that the government may not deny benefits based on mere organizational membership without requiring specific intent to further unlawful purposes. The provision’s undefined terms including “undermine public safety,” “undermine national security,” and “anti-American values” render it unconstitutionally vague under the Fifth Amendment’s Due Process Clause.16 And its disparate impact on researchers affiliated with organizations serving minority communities implicates Title VI of the Civil Rights Act of 1964, 42 U.S.C. §2000d et seq.24
I request that §200.206 not be finalized.
IX. §200.432, §200.454, and §200.461 — Conference Attendance, Journal Subscriptions, and Publication Costs
For decades, scientific conference attendance, journal subscriptions, and publication costs have been standard, routine allowable costs under federal science grants, recognized as essential to conducting research. The proposed rule reverses all three simultaneously. These three provisions (§200.432, §200.454, and §200.461) together would isolate federally funded researchers from their professional communities, deprive them of access to the scientific literature, and make it financially prohibitive to publish their findings.
Section 200.432 would make conference attendance allowable only if expressly pre-approved by the agency and written into the original award terms. Conferences are where scientists present findings, receive peer critique, discover new approaches, and build the collaborations that drive discovery. Requiring political pre-approval for specific conference attendance is completely unreasonable. This provision would essentially give agency officials the power to selectively cut researchers off from their fields.
Section 200.432 also raises serious First Amendment concerns. In Sweezy v. New Hampshire, 354 U.S. 234 (1957),35 the Supreme Court identified academic freedom as a “special concern of the First Amendment” and held that the government should be “extremely reticent to tread” in the areas of academic freedom and political expression. Scientific conferences are the primary forum through which researchers engage in the intellectual exchange that is the essence of academic life. Requiring express political pre-approval for conference attendance, administered by political appointees applying political criteria, constitutes a content-based restriction on speech and association that is presumptively unconstitutional. It will also produce a severe chilling effect, and researchers will avoid conferences on politically sensitive topics rather than risk denial, thus suppressing exactly the kind of free inquiry the First Amendment is designed to protect.
Section 200.454 would reverse a provision that has explicitly permitted journal subscriptions as allowable costs since 1971. The preamble offers no substantive justification for this reversal beyond a generic reference to stewardship. Under the Administrative Procedure Act’s10 arbitrary-and-capricious standard as articulated in Motor Vehicle Manufacturers Association v. State Farm,36 an agency reversing a longstanding policy must provide a reasoned explanation that accounts for the change. This preamble does not meet that standard.
Section 200.461 would make publication costs categorically unallowable by default and directly contradicts the 2022 OSTP open access mandate,37 which requires that federally funded research be made publicly available. OMB cannot simultaneously require open access publication and prohibit the costs of achieving it. This irreconcilable conflict alone is sufficient grounds to withdraw §200.461.
I request that §§200.432, 200.454, and 200.461 not be finalized.
X. §200.421 and §200.450 — Public Communications and Issue Advocacy
Under current rules, federally funded researchers routinely communicate their findings to the public, the press, and policymakers as a standard and expected part of their work. The proposed rule would end that. Section 200.421 would make all public relations costs unallowable except those explicitly required by statute. Section 200.450 would prohibit any communication that could be characterized as taking a position on a social, political, or public policy issue. Together, these provisions would effectively silence federally funded researchers from communicating their findings on any politically sensitive topic. The public invested in this research. It has a right to the results.
Sections 200.421 and 200.450 also violate the First Amendment’s guarantee of free speech. The Supreme Court has ruled, in Legal Services Corporation v. Velazquez, 531 U.S. 533 (2001),38 that the government cannot use its power over funding to silence certain viewpoints or shut down an established channel of communication that a federal program was created to support. Federal science research grants were designed to produce knowledge and share it with the public. They were never intended as a tool for controlling what scientists are allowed to say. Yet that is exactly what these provisions do. Section 200.421 makes it financially impossible for researchers to communicate their findings to the public at all. Section 200.450 prohibits communications on any topic the government decides is political and does so without ever defining where that line is. Together, they give the administration the power to fund research with one hand and silence its results with the other. Because researchers will not know which communications are safe, they are likely to stop communicating altogether rather than risk their grants. The Supreme Court has recognized this kind of self-censorship as a serious constitutional harm in its own right.
The harm from §200.450(c)(1)(v) extends further still. This provision would prohibit federally funded researchers from communicating findings to state agency officials for purposes of influencing state policymaking, rulemaking, or administrative action, unless that communication was specifically written into the original grant as a performance requirement. In practice, virtually no research grant is written that way. The result is that federally funded scientists could be prohibited from presenting their findings to state health departments, state environmental agencies, or state education agencies — the very institutions responsible for translating scientific evidence into public health and safety policy.
This prohibition also conflicts directly with the evidence-based policymaking requirements embedded in multiple federal statutes. The FDA is required by the Federal Food, Drug, and Cosmetic Act39 to base its regulatory decisions on scientific evidence, much of which is federally funded. The EPA is required by the Clean Air Act and Clean Water Act to set standards based on the best available science. OSHA is required to base workplace safety standards on substantial evidence. If federally funded researchers cannot communicate their findings to the agencies responsible for these statutory mandates, those agencies lose the scientific basis on which their own legal obligations depend. More broadly, the Evidence-Based Policymaking Act of 201840 requires federal agencies to use evidence and data in policymaking across the entire government. OMB cannot use a grants management regulation to sever the pipeline between federally funded science and the evidence-based rulemaking that Congress has required.40
The newly added proposed conflict resolution provision at §200.101(d)(2) makes this worse. By establishing that OMB’s grants management rules take precedence over agency-specific regulatory frameworks, it ensures that even agencies with statutory mandates to base their rules on scientific evidence cannot protect the researchers who produce that evidence from the §200.450 prohibitions. Congress required evidence-based policymaking. This rule would make it administratively impermissible to fund it.
I request that §§200.421 and 200.450 not be finalized as proposed.
Conclusion
I spent 22 years at NIH helping to build and sustain one of the greatest scientific enterprises in human history. The system Congress created included scientific peer review, open competition, institutional autonomy, international collaboration, and transparent publication. That system did not happen by accident. It was the product of deliberate, bipartisan policy choices made over eight decades, rooted in the understanding that science serves the public best when it is insulated from political interference.
The proposed revisions to 2 CFR Part 2001 dismantle that system comprehensively, simultaneously, and without congressional authorization, using OMB’s grants management authority as a vehicle for political control of science and of free speech that Congress and the Constitution never intended and does not allow.
Finally, I want to be clear that this comment, while written from the perspective of a scientist, addresses a rule that extends far beyond science. The regulation being rewritten governs every federal grant from every agency, totaling approximately $1.1 trillion annually. State health services, transportation projects, education programs, Head Start, housing assistance, rural broadband, water infrastructure, and environmental protection programs would all be subject to the same political control provisions documented above. The harm from this rule would reach every community in America.
I urge OMB to withdraw this rule in its entirety. At a minimum, I request that each of the provisions identified above not be finalized. The American scientific enterprise and the public it serves cannot afford otherwise.
Respectfully submitted,
Elizabeth Ginexi, PhD
Former NIH Scientific Program Official and Concerned US Citizen
June 11, 2026
Citations and Legal Authorities
1 2 CFR Part 200 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards — the rule being revised)
2 Public Health Service Act of 1944, Pub. L. No. 78-410, 58 Stat. 682, codified at 42 U.S.C. ch. 6A §201 et seq. — specifically Section 492, 42 U.S.C. §289a (mandating NIH peer review)
3 5 U.S.C. §3331 (Oath of Office) — requires every federal employee, prior to entering upon the duties of their office, to swear or affirm that they will support and defend the Constitution of the United States against all enemies foreign and domestic, bear true faith and allegiance to the same, and faithfully discharge the duties of the office; cited here as the personal commitment that informs this comment and the author’s obligation to speak when federal actions conflict with the Constitution and the laws of the United States
4 Schulson, M. (2026, January 29). At NIH, a power struggle over institute directorships deepens. Undark Magazine.
5 National Cancer Act of 1971, Pub. L. No. 92-218, 85 Stat. 778 (establishing NCI Director as a presidential appointee); National Cancer Act Amendments of 1974, Pub. L. No. 93-352, 88 Stat. 424 (establishing Senate confirmation requirement for NIH Director); codified at 42 U.S.C. §282 (NIH Director) and 42 U.S.C. §284 (NCI Director)
6 Ransdell Act of 1930, Pub. L. No. 71-251, 46 Stat. 379 (establishing the National Institutes of Health as a federal institution)
7 Dzau, V. J., & Yamamoto, K. R. (2025, August 18). Government-funded health and biomedical research is irreplaceable. National Academy of Medicine.
8 U.S. Constitution, Article I, Section 8 (Spending Clause)
9 South Dakota v. Dole, 483 U.S. 203 (1987) — Spending Clause four-part test; conditions on federal grants must be unambiguous, related to the federal interest in the funded program, and not coercive
10 Administrative Procedure Act, 5 U.S.C. §§551 et seq., specifically §706 (arbitrary-and-capricious standard)
11 U.S. Constitution, Amendment I (First Amendment)
12 Agency for International Development v. Alliance for Open Society International, Inc., 570 U.S. 205 (2013) — First Amendment unconstitutional conditions doctrine; the government may not condition receipt of federal funds on recipients affirming a belief that by its nature cannot be confined within the scope of the funded program
13 West Virginia v. EPA, 597 U.S. 697 (2022) — Major Questions Doctrine; agencies require clear congressional authorization for decisions of vast political and economic significance
14 Grayned v. City of Rockford, 408 U.S. 104 (1972) — a law is void for vagueness under the Fifth Amendment’s Due Process Clause when it fails to give persons of ordinary intelligence fair notice of what conduct is prohibited; vague laws that allow arbitrary enforcement are unconstitutional
15 FCC v. Fox Television Stations, Inc., 556 U.S. 502 (2009) — establishes the APA standard for agency reversals of longstanding policy; requires a reasoned analysis that displays awareness of the change, provides good reasons for the new policy, and addresses serious reliance interests that the prior policy engendered; an agency that fails to consider reliance interests when reversing course acts arbitrarily and capriciously
16 Department of Homeland Security v. Regents of the University of California, 591 U.S. 1 (2020) — the Supreme Court held that an agency acts arbitrarily and capriciously under the APA when it fails to assess the existence and strength of reliance interests developed under an existing program and weigh them against competing policy concerns before changing course; directly applicable to the proposed retroactive application of §200.340’s termination standard to grants awarded under the prior framework
17 Mathews v. Eldridge, 424 U.S. 319 (1976) — establishes the governing procedural due process balancing test, requiring courts to weigh the private interest affected, the risk of erroneous deprivation under existing procedures, and the government’s interest in administrative efficiency; the proposed §200.340 termination standard, which requires only a brief written rationale with no notice period, no opportunity to respond, and no administrative appeal, fails this test given the substantial property interests at stake in multi-year federal research awards
18 Individuals with Disabilities Education Act (IDEA), 20 U.S.C. §1400 et seq.
19 Elementary and Secondary Education Act, Title I, 20 U.S.C. §6301 et seq.
20 Head Start Act, 42 U.S.C. §9831 et seq.
21 Ryan White HIV/AIDS Program, 42 U.S.C. §300ff et seq.
22 Title VI of the Civil Rights Act of 1964, Pub. L. 88-352, Title VI, §601, July 2, 1964, 78 Stat. 252, codified at 42 U.S.C. §2000d et seq. (prohibiting discrimination on the basis of race, color, and national origin in programs and activities receiving federal financial assistance)
23 Title IX of the Education Amendments of 1972, Pub. L. 92-318, Title IX, §901, June 23, 1972, 86 Stat. 373, codified at 20 U.S.C. §1681 et seq., as broadened by the Civil Rights Restoration Act of 1987, Pub. L. 100-259, 102 Stat. 28 (prohibiting discrimination on the basis of sex in educational programs and activities receiving federal financial assistance)
24 Section 504 of the Rehabilitation Act of 1973, Pub. L. 93-112, §504, September 26, 1973, 87 Stat. 394, codified at 29 U.S.C. §794, as amended by the Civil Rights Restoration Act of 1987, Pub. L. 100-259, 102 Stat. 28 (prohibiting discrimination against qualified individuals on the basis of disability in programs and activities receiving federal financial assistance)
25 Age Discrimination Act of 1975, Pub. L. 94-135, Title III, §301, November 28, 1975, 89 Stat. 728, codified at 42 U.S.C. §6101 et seq. (prohibiting discrimination on the basis of age in programs and activities receiving federal financial assistance)
26 Section 1557 of the Patient Protection and Affordable Care Act, Pub. L. 111-148, §1557, March 23, 2010, 124 Stat. 119, codified at 42 U.S.C. §18116 (prohibiting discrimination on the basis of race, color, national origin, sex, age, and disability in health programs and activities receiving federal financial assistance, incorporating the protections of Title VI, Title IX, the Age Discrimination Act of 1975, and Section 504 of the Rehabilitation Act of 1973)
27 Fogarty International Center Authorization, 42 U.S.C. §287b (John E. Fogarty International Center for Advanced Study in the Health Sciences — general purpose statute establishing international health research mission, added by Pub. L. 99-158, §2, November 20, 1985, 99 Stat. 866)
28 Gundy v. United States, 588 U.S. 128 (2019) — in which four justices signaled a willingness to reinvigorate the nondelegation doctrine, indicating that broad delegations of legislative power to the executive branch without an intelligible principle to guide their exercise are constitutionally suspect; cited here for the proposition that requiring all federal grant programs to align with “administration policies and priorities” — without any limiting definition or congressional authorization — constitutes an impermissible delegation of Congress’s appropriations and program-design authority to the executive branch
29 Federal Funding Accountability and Transparency Act of 2006, Pub. L. 109-282, September 26, 2006, as amended by the Government Funding Transparency Act of 2008, Pub. L. 110-252 — requires that all federal grant awards be publicly accessible on a searchable website; contains an explicit national security carve-out limited to classified information only, which is narrower than the “national interest” exception proposed in §200.204
30 31 U.S.C. Chapter 61 (Program Information) — governs federal grants management information requirements and provides that nothing in federal grants management law shall supersede notice of funding opportunity requirements contained in the authorizing statutes of individual competitive grant programs
31 NAACP v. Alabama ex rel. Patterson, 357 U.S. 449 (1958) — landmark First Amendment freedom of association case; the government may not deny a benefit or compel disclosure based on organizational affiliation where doing so would chill constitutionally protected association; means that sweep unnecessarily broadly into protected freedoms are unconstitutional even in pursuit of a legitimate government purpose
32 Keyishian v. Board of Regents of the University of the State of New York, 385 U.S. 589 (1967) — the government may not deny public benefits based on mere membership in an organization without requiring specific intent to further any unlawful purpose; rejected the doctrine that government may attach whatever conditions it pleases to public employment or benefits; confirmed that guilt by association is constitutionally impermissible
33 Sweezy v. New Hampshire, 354 U.S. 234 (1957) — the Supreme Court identified academic freedom as a “special concern of the First Amendment” and held that government should be “extremely reticent to tread” in the areas of academic freedom and political expression; the right to lecture and to associate with others for academic purposes are constitutionally protected freedoms; government interference in university teaching and scholarship requires compelling justification
34 Motor Vehicle Manufacturers Association v. State Farm Mutual Automobile Insurance Co., 463 U.S. 29 (1983) — APA arbitrary-and-capricious standard; an agency reversing a longstanding policy must provide a reasoned explanation that accounts for the change
35 Office of Science and Technology Policy (OSTP) Public Access Memorandum, August 25, 2022 (Nelson Memo) — requires that federally funded research be made publicly available
36 Legal Services Corporation v. Velazquez, 531 U.S. 533 (2001) — the government may not use funding restrictions to impose viewpoint-based discrimination on private speech or to distort an established marketplace of ideas that a federal program was designed to support; a restriction on federally funded private speech that suppresses expression based on viewpoint violates the First Amendment even when the restriction operates through conditional funding rather than direct prohibition
37 Federal Food, Drug, and Cosmetic Act, Pub. L. 75-717, June 25, 1938, codified at 21 U.S.C. §301 et seq. — requires that FDA regulatory decisions including drug approvals, medical device clearances, and food safety standards be grounded in scientific evidence; conflicts with §200.450(c)(1)(iv) to the extent that provision prohibits federally funded researchers from communicating findings to FDA for purposes of informing evidence-based rulemaking
38 Evidence-Based Policymaking Act of 2018, Pub. L. 115-435, January 14, 2019, codified at 5 U.S.C. §311 et seq. — requires federal agencies to use evidence and data in policymaking and to build evaluation capacity across the federal government; directly conflicts with §200.450(c)(1)(iv) and (v) to the extent those provisions prohibit federally funded researchers from communicating scientific findings to federal and state agencies for purposes of informing policy
Thank you! I am a PhD Biologist and lawyer, and am also planning to submit comments.
Thank you for doing this!