Guide for Neuroscientists: Public Comment on OMB Proposed Rule for Federal Financial Assistance

Docket OMB-2026-0034 | Comment Deadline: July 13, 2026 | Published: May 30, 2026

Submission link: https://www.regulations.gov/commenton/OMB-2026-0034-0001

Full proposed rule: https://www.federalregister.gov/documents/2026/05/29/2026-10817/regulation-for-federal-financial-assistance

Provision-by-provision analysis by Elizabeth Ginexi (former NIH program officer): https://elizabethginexi.substack.com/p/summary-of-key-changes-in-ombs-proposed

This guide is a companion to my own comment on Docket OMB-2026-0034. The aim is to make it easy for neuroscience colleagues, and any federally funded scientist, to produce their own comment without starting from a blank page. Pick the sections and arguments that match your lab, your funding, and your discipline. Rewrite in your own voice. Volume of independent voices from working scientists is the goal, not uniformity.

1. What this is and why it is different from everything that came before

On May 29, 2026, the Office of Management and Budget published a proposed binding regulation in the Federal Register that would rewrite 2 CFR, the government-wide rules governing all federal grants, cooperative agreements, and other forms of federal financial assistance. This is not a memo, not agency guidance, not an executive order. It is a proposed regulation under the Administrative Procedure Act, with a 45-day public comment period and a target effective date of October 1, 2026.

The distinction matters. Executive orders can be reversed by the next president. Agency guidance can be withdrawn. A finalized regulation under 2 CFR carries the force of law, applies to every federal science agency (NIH, NSF, DOE, NASA, DOD, ARPA-H), and can only be undone through a new rulemaking process or congressional action. As Elizabeth Ginexi wrote in her provision-by-provision analysis: "What OMB is proposing is not a reform of grants management. It is a complete political control apparatus layered over every stage of the federal science funding lifecycle."

Every policy action the scientific community has been tracking since January 2025 (payline elimination, forward funding, grant terminations, NOFO collapse, Schedule F, keyword screening, indirect cost cap attempts) was implemented through memos, executive orders, or administrative discretion. This rule codifies them into binding regulatory text, government-wide, on a single date.

2. Why your comment matters, and why silence is dangerous

Under the Administrative Procedure Act, OMB must collect all public comments and respond to substantive comments in the final rule. That response becomes part of the formal administrative record. If OMB finalizes the rule without adequately addressing substantive objections, the administrative record becomes the evidentiary basis for legal challenge under APA Section 706(2)(A) (the "arbitrary and capricious" standard).

This is not theoretical. The First Circuit Court of Appeals struck down the 15% indirect cost cap on January 5, 2026, concluding that NIH violated statutory law and its own regulatory procedures. The administrative record, including public comments, was central to that ruling. State attorneys general used the comment record to build their case. The same legal pathway applies here.

A second reason is historical. As one NIH program officer put it during the Strategic Plan RFI (NOT-OD-26-047): "The comments will be ignored by the administration. But they will not be ignored in the historical record. It is important to document where the scientific community stands on these issues. Silence will be inferred as support."

Jeremy Berg, former NIGMS Director and former Editor-in-Chief of Science, has tracked NIH funding policy shifts through Bluesky with more than 14,000 followers and has been quoted across national media. His consistent message throughout 2025-2026 has been that the structural changes to peer review and funding decision-making are acceptable only when institute directors are "selected carefully, without overt political considerations," and that "encouraging or forcing IC directors to prioritize funding decisions based on political as opposed to scientific and portfolio-based criteria is deeply concerning." The proposed rule does exactly what Berg warned against: it replaces IC director scientific judgment with mandatory political appointee pre-issuance review.

Jenna Norton, a program officer in the National Institute of Diabetes and Digestive and Kidney Diseases, stated publicly that Bhattacharya's August 2025 guidelines "open the door to the politicization of NIH research. Peer review is fundamental and makes sure we are doing the best science. If you are going to ignore that, the political appointee gets to make the final call." The proposed rule formalizes exactly this structure in binding regulatory text.

Mark Histed, an NIH senior scientist at NIMH writing in his personal capacity, documented the full sequence of administrative actions in his January 2026 essay "American Biomedical Science in 2026" (published on Don Moynihan's Substack and reprinted by the Union of Concerned Scientists). Histed described how "the Trump administration has decreed grant awards must be approved by presidential political appointees," with "White House or HHS review steps added throughout the agency, from review of contracts, review of formerly-perfunctory employee term renewals, review of travel, and even review of weekly money disbursements to grantees, a process that has always been handled by civil servants without presidential interference." The proposed rule converts these ad hoc interventions into permanent regulatory architecture.

3. The 19 provisions that affect your laboratory

The provisions below are organized by how they affect the daily work of a federally funded PI. Each provision includes the regulatory section number. When you write your comment, begin each point with the section number in brackets (e.g., [200.205]) as instructed by the Federal Register notice. Not every provision will affect every lab. Pick the ones that match your situation.

Provisions affecting how your grants are funded

Political appointee pre-issuance review of every grant (Section 200.205). Senior political appointees must conduct a "pre-issuance review" of every discretionary grant before it is awarded. These appointees are explicitly forbidden from deferring to peer reviewers or routinely ratifying their recommendations. Awards must "demonstrably advance the President's policy priorities." The criteria include blocking awards touching on denial of "the sex binary in humans," illegal immigration, or anything deemed to "promote anti-American values."

Peer review reduced to advisory status (Section 200.205(d)). The rule states that peer review recommendations "remain advisory and are not ministerially ratified, routinely deferred to, or otherwise treated as de facto binding." This dismantles the post-WWII system in which independent expert peer review was the primary measure of scientific merit at NIH, NSF, DOE, NASA, and nearly every science agency.

"Gold Standard Science" as an undefined compliance test (Section 200.205). All grants must include benchmarks for compliance with "Gold Standard Science" (tied to Executive Order 14303). The standard is never defined in any concrete or measurable way. Agencies must prioritize institutions that have "demonstrated success in implementing Gold Standard Science." Institutional prestige and historical reputation are explicitly deprioritized. Because the standard has no operational definition, the administration retains unguided discretion over what qualifies.

Active grants terminable at any time without cause (Section 200.340). Active grants, including multi-year awards mid-project, can be terminated because a political appointee decides the work no longer aligns with agency priorities. No finding of misconduct, fraud, or noncompliance is required. OMB frames this as analogous to "termination for convenience" in federal contracts, but grants are fundamentally different instruments. Researchers hire staff, enroll participants, and design multi-year protocols around the presumption that a funded grant will run its course.

Program design must align with presidential priorities (Section 200.202). Every new federal grant program must be designed with goals that explicitly align with administration policies and priorities. This is embedded in the regulatory text governing program design, meaning science agencies must structure grant solicitations around the current administration's political agenda rather than scientific need, statutory mandate, or expert consensus.

Agency heads can exempt competitions from public notice (Section 200.204). A federal agency head can approve exemptions from the requirement to post funding opportunities on Grants.gov when "publicly announcing an opportunity would pose a risk to national security or is in the national interest of the United States." The phrase "national interest" has been used expansively by this administration and could justify conducting grant competitions outside public view.

Provisions affecting how you do your science

Publication costs presumptively unallowable (Section 200.461). All journal publication costs, including article processing charges, open access fees, and page charges, are unallowable by default. Exceptions require a specific statutory mandate or case-by-case agency pre-approval. This directly conflicts with the 2022 OSTP memorandum requiring that federally funded research be made publicly available.

Conference attendance requires express pre-approval (Section 200.432). The current presumption that conference attendance related to grant work is a standard allowable cost is eliminated. Every conference must be pre-approved by the agency and written into the award terms. Conferences not anticipated when the award was issued cannot easily be added. The agency has full discretion to deny approval.

Journal subscriptions categorically unallowable (Section 200.454). Subscriptions to professional, academic, and technical journals are made categorically unallowable as direct costs on federal awards. At institutions with constrained library budgets, this could make it difficult to conduct literature-based research.

Professional memberships require prior approval (Section 200.454). Professional society memberships are only allowable if they are "necessary to fulfill the award requirements" and receive prior written agency approval. Memberships in organizations whose primary purpose is lobbying or issue advocacy are unallowable.

Public communications restricted (Section 200.421). All public relations costs are unallowable except those explicitly required by statute, restricting researchers from communicating findings to the public or press.

"Issue advocacy" prohibited (Section 200.450). Federal grant funds cannot be used for any messaging that promotes or opposes a "particular social, political, or public policy position unrelated to the statutory objectives" of the award. Given that the rule's preamble characterizes climate science, public health research, and equity research as "divisive ideologies," this prohibition could be deployed to bar researchers from speaking publicly about their own federally funded findings.

Provisions affecting international collaboration

Broad prohibition on international collaboration (Section 200.220). Federal funds, including indirect costs, cannot support bilateral or multilateral collaboration with "covered foreign countries" or affiliated entities. The rule extends beyond China to all countries on broad sanctions lists, covering travel, research activities, technical assistance, and allocable indirect costs.

Domestic-first framework for research awards (Section 200.202(e)). Any international element in a federally funded R&D grant must be affirmatively justified on a case-by-case basis by agency officials. Foreign entities cannot receive R&D awards at all except with written approval from a senior political appointee.

Provisions affecting your institution

DEI and related topics banned as grant conditions (Section 200.300). All federal award funds are prohibited from being used to "fund, promote, encourage, subsidize, or facilitate" DEI/DEIA policies or practices, "gender ideology" (defined as any theory that "denies the biological reality of sex or the sex binary"), or gender transition assistance for individuals under 19.

E-Verify mandated for all grant recipients (Section 200.303). All recipients and subrecipients must enroll in and use E-Verify for every employee and contractor working on a federal award. Any Final Nonconfirmation must be reported to the federal agency.

Applicants can be denied based on organizational affiliations (Section 200.206). Risk factors agencies may use to deny applications are expanded to include membership in or affiliation with organizations that "advocate for the overthrow of the United States Government" or "undermine public safety or national security."

OMB gains direct binding authority over all agencies (2 CFR restructure). The rule restructures 2 CFR to make OMB guidance a directly binding regulation on all agencies. Individual agencies can no longer shield their communities from any of these changes through their own implementing rules.

OMB gains oversight of which institutions receive grants (new reporting provision). OMB can require agencies to submit reports identifying specific recipients of federal awards over any period, giving the White House direct leverage over which institutions receive funding.

4. The internal contradiction you should name in your comment

The rule's preamble identifies three objectives: "(1) improving transparency, accountability, and oversight for use of Federal funds; (2) clarifying the status of the 2 CFR regulatory text as an OMB regulation; and (3) reducing recipient burden."

Every major provision works against objective (1). Replacing peer review with political appointee override eliminates the primary transparency mechanism in federal science funding. Making publication costs unallowable suppresses the mechanism by which findings enter the public record. Requiring conference pre-approval restricts venues where results are challenged and replicated. Making journal subscriptions unallowable limits investigators' access to the literature. Allowing grant termination without cause and without transparent criteria inverts accountability. The Benton Institute noted that the preamble "cites Heritage Foundation reports, op-eds from the Manhattan Institute and City Journal, and Senate Republican committee reports as supporting authority," rather than independent scientific or administrative assessments. Naming this contradiction in your comment matters because it creates the basis for an "arbitrary and capricious" challenge under APA Section 706(2)(A). If the final rule's provisions are internally inconsistent with its stated objectives, courts can vacate it.

5. How to write an effective comment

The comment form at regulations.gov allows 5,000 characters of text plus up to 20 file attachments (docx, pdf, pptx, xlsx, 10 MB each). You can submit as an Individual, Organization, or Anonymous.

What makes a legally substantive comment

Not all comments carry equal weight under the APA. OMB must respond to substantive comments but may dismiss form letters or generic expressions of opposition. A substantive comment does one or more of the following.

Identifies a specific statutory conflict. The PHS Act (42 U.S.C. 289a) requires that NIH funding decisions be based on peer review by qualified experts. Section 200.205 of the proposed rule forbids political appointees from deferring to peer reviewers. Name the conflict. The 2022 OSTP memorandum (the "Nelson memo") requires public access to federally funded research. Section 200.461 makes publication costs presumptively unallowable, creating a direct conflict with the public access mandate.

Provides concrete evidence of harm. State your active grant numbers, your IC, the specific provisions that affect your work. If the publication cost ban would prevent you from disseminating findings, say so and name the journals and approximate costs. If conference pre-approval would have blocked presentations you gave this year, name the conferences. If the international collaboration ban would sever active collaborations, name the collaborating institutions and the scientific rationale.

Demonstrates internal inconsistency. The rule claims transparency as its first objective. Show how the specific provisions reduce transparency.

Proposes an alternative. Courts give more weight to comments that suggest a workable alternative rather than simply opposing the rule.

Structure your comment for maximum effect

Begin each point with the relevant section number in brackets, as the Federal Register notice instructs (e.g., "[200.205] The mandatory pre-issuance review by political appointees conflicts with..."). This ensures your comment is cataloged correctly in the docket.

6. Modular draft arguments you can adapt

Each section below addresses a specific provision. Pick the ones that apply to your situation. Replace bracketed placeholders with your own specifics. Rewrite in your own voice. The goal is independent voices, not identical submissions.

On political appointee pre-issuance review (Section 200.205)

[200.205] The requirement that senior political appointees conduct pre-issuance review of every discretionary grant, with an explicit prohibition on deferring to peer reviewers, conflicts with the Public Health Service Act (42 U.S.C. 289a), which establishes peer review by qualified experts as the basis for NIH funding decisions. The United States built the world's preeminent biomedical research enterprise on merit-based peer review precisely because non-expert political override produces funding decisions optimized for political palatability rather than scientific impact. As a PI holding [number] active NIH grants in [your field], the effect of this provision is to make every funded project, including ongoing multi-year research, contingent on political alignment rather than scientific merit.

On peer review reduced to advisory status (Section 200.205(d))

[200.205(d)] Reducing peer review to explicitly advisory status, with political appointees forbidden from deferring to or routinely ratifying expert recommendations, reverses the foundational principle that has governed federal science funding since 1945. Before 2025, there were only two political appointees at NIH, and even these, the NIH and National Cancer Institute directors, were accomplished scientists. The proposed rule gives nonexpert appointees veto authority over the judgment of hundreds of study sections comprising thousands of domain experts. My field, [your field], requires [specific technical expertise] to evaluate proposals competently. No political appointee possesses this expertise. The provision will produce funding decisions that are scientifically arbitrary and legally vulnerable.

On publication costs (Section 200.461)

[200.461] Making publication costs presumptively unallowable directly conflicts with the August 2022 OSTP memorandum requiring that federally funded research be made publicly available at no cost to the reader. Article processing charges at journals in my field average [$X] per paper. My laboratory publishes approximately [Y] peer-reviewed papers per year. Under this provision, I would need to find [$Z] annually from non-federal sources to comply with the public access mandate while being prohibited from using federal funds to do so. The net effect is suppression of the scientific record. Peer-reviewed publication is the mechanism by which science is validated, challenged, and built upon. Making it financially prohibitive for federally funded researchers to publish their findings serves no transparency objective.

On conference pre-approval (Section 200.432)

[200.432] Conference attendance is where scientists present results, receive peer critique, discover new approaches, and build collaborations. In the past [time period], I presented federally funded research at [name conferences]. Under this provision, each of those presentations would have required express agency pre-approval written into my award terms at the time of funding. Conferences not anticipated when the award was issued cannot easily be added. Scientific opportunities, including invited talks, workshop participation, and emerging collaborations, cannot be predicted at the time of award. This provision gives political appointees gatekeeper authority over which scientific communities federally funded researchers can participate in.

On journal subscriptions (Section 200.454)

[200.454] Making journal subscriptions categorically unallowable as direct costs eliminates a standard mechanism by which investigators access the scientific literature foundational to their work. My research requires regular access to [name specific journals or fields]. At institutions with constrained library budgets, individual investigator subscriptions funded through grants fill the gap. This provision restricts access to the very literature that federally funded scientists are expected to build upon, while simultaneously making it harder to publish in that literature (Section 200.461).

On international collaboration (Section 200.220)

[200.220] My research involves active collaboration with [institution/country] on [scientific topic]. This collaboration is essential because [specific scientific rationale, e.g., access to patient populations, unique model systems, specialized equipment, complementary expertise]. The blanket prohibition on using federal funds, including indirect costs, for collaboration with covered foreign countries would terminate this collaboration and [specific scientific consequence]. While legitimate national security concerns exist regarding certain foreign entities, this provision is sweeping enough to sever partnerships that have been foundational to U.S. leadership in [your field].

On grant termination without cause (Section 200.340)

[200.340] The authority to terminate active grants mid-award without a finding of misconduct or noncompliance creates an environment in which no PI can responsibly hire trainees, commit to longitudinal studies, or invest in infrastructure. I currently employ [number] trainees and staff on my active grants. Each of them made career decisions based on the reasonable expectation that funded awards would run their course. Between 2012 and January 2025, NIH terminated fewer than six grants midstream in thirteen years. Since February 2025, HHS has terminated over 1,392 NIH grants totaling $539 million in unliquidated obligations (CRS, April 2026). The proposed rule would convert this unprecedented pattern into permanent regulatory authority.

On the training pipeline (applicable to multiple sections)

The combined effect of Sections 200.205, 200.340, 200.432, 200.454, and 200.461 falls disproportionately on trainees and early-career investigators. Graduate students and postdocs cannot attend conferences without pre-approval, cannot publish without non-federal funds, cannot access journals, and cannot trust that the grants supporting their positions will continue. In my laboratory, [specific example: students advised to seek non-academic positions, recruitment difficulty, cohort reduction]. The 10-to-15-year training cycle from graduate admission to independent investigator means that damage to the pipeline now produces generational, not episodic, losses.

7. What else you can do (parallel actions)

Submitting a comment is the single highest-leverage action available right now because it creates the legal record. The following actions are complementary and should be pursued in parallel.

Contact your House representative and both senators. Ask specifically for peer review protections and grant stability language in FY2027 LHHS appropriations. Markup timelines overlap with this comment period. Congress inserted protective riders in the FY2026 Consolidated Appropriations Act (Section 224, blocking the indirect cost cap; Section 240, capping multi-year obligations at FY2025 levels). The same mechanism can protect peer review. The Senate LHHS Subcommittee is chaired by Sen. Shelley Moore Capito (R-WV) and the Ranking Member is Sen. Tammy Baldwin (D-WI). Arguments framed around medical progress, state economic impact, national security, and administrative decisions that undermine congressional intent are the arguments that move this specific committee.

Contact your state attorney general. State AGs have standing to challenge the final rule under the APA and led the successful litigation against the indirect cost cap. The Massachusetts AG led that challenge. AGs from states with major research universities (Massachusetts, California, New York, Pennsylvania, Maryland, North Carolina, Michigan, Illinois, Wisconsin, Texas) have direct standing because the rule threatens the economic base of their public university systems and academic medical centers. Contacting your AG's office now, before the comment period closes, signals demand for action.

Coordinate with your scientific society. Institutional comments from SfN, FASEB, BMES, AIMBE, AAU, APLU, AAMC, and COGR carry weight in the administrative record. Contact your society's government affairs office and ask whether they are preparing a comment. If they are, your individual comment still matters because it provides specific evidence of harm that institutional letters cannot.

Forward this guide to colleagues, postdocs, and graduate students. The people most affected by these provisions, early-career scientists who lose conference funding, publication funding, journal access, and job stability first, are the least represented in policy feedback. Every independent voice in the record strengthens the legal and political case.

8. What to avoid

Do not submit identical comments. Form letters and copy-paste submissions are cataloged as a single comment. Rewrite in your own voice, even if you use the modular arguments above as a starting point.

Do not use DEI-flagged vocabulary. Terms such as "diversity," "equity," "inclusion," "underrepresented," "disparities" (in a workforce context), and "structural racism" are liabilities in any document entering the federal record under this administration. Translate equity arguments into capacity, stewardship, workforce sustainability, and merit-based language. The functional outcomes are identical. The risk profile is not.

Do not make the comment purely emotional or political. Courts give weight to comments that identify statutory conflicts, provide concrete evidence of harm, and propose alternatives. "This rule is terrible" is not a substantive comment. "Section 200.205 conflicts with 42 U.S.C. 289a because..." is.

Do not include personally identifiable information you do not want public. Comments and attachments are posted publicly on regulations.gov. Name, institution, and professional details strengthen your comment. Social Security numbers, home addresses, and personal health information should not be included.

Do not wait until July 13. The comment period may feel long. It is not. Coordinating institutional responses, drafting substantive comments, and building the record takes weeks. Start now.

9. Legal remedies that exist

APA litigation. Because this is a proposed regulation under notice-and-comment rulemaking, the final rule is subject to judicial review under APA Section 706(2)(A). The First Circuit's January 2026 ruling striking down the indirect cost cap established precedent that OMB cannot override agency-specific statutory mandates through administrative action. If the final rule contradicts the PHS Act's peer review requirements, contradicts congressional intent in appropriations language, or is internally inconsistent with its stated objectives, courts can vacate it. The administrative record, built from public comments, is central to that challenge.

Congressional appropriations riders. The FY2026 Consolidated Appropriations Act included Section 224 (blocking indirect cost cap changes) and Section 240 (capping multi-year forward funding). Congress can insert analogous protections for peer review, publication funding, and conference attendance into FY2027 appropriations. This is why contacting your representatives matters now, while markup timelines overlap with the comment period.

State attorney general action. State AGs can file suit challenging the final rule and can submit formal comments during the comment period as governmental entities. Both tracks strengthen the legal challenge.

10. Submission checklist

• Comment submitted at https://www.regulations.gov/commenton/OMB-2026-0034-0001

• Each point begins with the relevant section number in brackets (e.g., [200.205])

• At least one specific statutory conflict identified (42 U.S.C. 289a, OSTP 2022 memo, or other)

• At least one concrete example of harm from your own laboratory or institution

• 5,000-character limit for the text box (attach a PDF or Word document for longer comments)

• Attachments under 10 MB each, maximum 20 files

• No personally identifiable information you do not want public

• Submitted as Individual (recommended) or Organization

• Deadline: July 13, 2026
  
  

10.5 Model comment submission

A complete model comment is available for download alongside this guide. It demonstrates how to structure a legally substantive APA comment that references specific regulatory sections, identifies statutory conflicts, provides concrete evidence of harm from a working laboratory, addresses the national security implications of the proposed provisions, and requests specific action from OMB. The model comment includes a 5,000-character text box version (for pasting directly into the regulations.gov form) and a 5-page PDF attachment expanding the arguments with a China competition analysis, void-for-vagueness challenge to the "Gold Standard Science" standard, and documentation of the preamble's reliance on partisan rather than independent sources. Use it as a structural template, not as text to copy. Independent voices in independent language are what build the administrative record.

11. A note to graduate students, postdocs, and early-career investigators

Your voice matters here, perhaps more than anyone's. You are the people most affected by the decisions this rule will encode, and you are the least represented in policy feedback. Do not assume your perspective is too limited or your career too early to count. The comment form accepts anonymous submissions. You do not need to be a PI or have funding to comment.

The provisions hitting you hardest are specific and personal. Section 200.432 means you cannot attend a conference on your grant without express pre-approval. Section 200.461 means you cannot publish your work using grant funds. Section 200.454 means you cannot subscribe to the journals you need to read. Section 200.340 means the grant funding your position can be terminated at any time without cause. Say so in your comment. Name the conference you attended last year. Name the paper you published. Name the journal you need.

Public comment has changed NIH policy before. The BRAIN Initiative K99/R00 career transition awards exist in part because trainees and early-career scientists made the case that the pipeline was failing them. When NIH proposed the Grant Support Index in 2017 to redistribute funding, it was abandoned within a month after well-funded senior scientists mobilized while trainees stayed silent. The lesson is straightforward: the voices that show up in the record shape policy. Silence will be inferred as support.

12. Useful sources

• Elizabeth Ginexi, provision-by-provision analysis of OMB-2026-0034: https://elizabethginexi.substack.com/p/summary-of-key-changes-in-ombs-proposed

• Mark Histed, "American Biomedical Science in 2026" (Don Moynihan Substack, January 2026): https://donmoynihan.substack.com/p/american-biomedical-science-in-2026

• Mark Histed, "The Slow Dismantling of American Science" (Union of Concerned Scientists, April 2026): https://blog.ucs.org/science-blogger/the-slow-dismantling-of-american-science-and-what-we-can-do-about-it/

• Jeremy Berg, Bluesky feed (NIH funding data and policy analysis, 14,000+ followers): https://bsky.app/profile/jeremymberg.bsky.social

• Jeremy Berg, NIH Dashboard (grant obligation tracking): https://jeremymberg.github.io/jeremyberg.github.io/index.html

• Full proposed rule (Federal Register): https://www.federalregister.gov/documents/2026/05/29/2026-10817/regulation-for-federal-financial-assistance

• Comment submission portal: https://www.regulations.gov/commenton/OMB-2026-0034-0001

• Wiley Rein LLP legal analysis: https://www.wiley.law/alert-OMB-Proposes-Sweeping-Overhaul-of-Federal-Assistance-Regulations

• Benton Institute analysis (including note on preamble sourcing from Heritage Foundation/Manhattan Institute): https://www.benton.org/blog/omb-proposes-changes-federal-grant-administration

• Science/AAAS coverage: https://www.science.org/content/article/white-house-seeks-tighten-political-oversight-grantmaking

• Scientific American coverage: https://www.scientificamerican.com/article/white-house-proposes-new-rules-giving-political-appointees-final-say-on-research-grants/

• Inside Higher Ed coverage: https://www.insidehighered.com/news/government/science-research-policy/2026/05/29/omb-proposes-rules-establishing-political

• KFF Health News (Norton and Histed quotes, political appointee analysis): https://kffhealthnews.org/news/article/nih-grants-trump-political-appointees-agenda-alignment-peer-review/

• GAO decision B-337203 (Impoundment Control Act finding): https://www.gao.gov/products/b-337203

• Congressional Research Service, NIH Grants Policy Under the Second Trump Administration (IF13131): https://crsreports.congress.gov

• United for Medical Research, 2026 Annual Economic Impact Report (state-specific data): https://unitedformedicalresearch.org/annual-economic-report/

• UMR state toolkits: https://unitedformedicalresearch.org/nih-in-your-state/

• Senate LHHS FY27 Outside Witness Testimony guide (companion document): https://bioniclab.org/news/senate-appropriations-open-comments

• NIH Strategic Plan RFI guide (companion document, NOT-OD-26-047): https://bioniclab.org/news/nih-rfi

Forward this guide to colleagues through LinkedIn, your lab website, email, or Signal. Volume of independent voices by July 13 is the goal. Please forward to every colleague, postdoc, and graduate student in your department. They are the ones who lose conference funding, publication funding, and journal access first.

Takashi D. Y. Kozai, Ph.D. Ernest E. Roth Professor of Bioengineering, University of Pittsburgh Director, B.I.O.N.I.C. Lab 

Example: Submitting in individual capacity

[200.205] The mandatory pre-issuance review of every discretionary grant by senior political appointees, combined with the explicit prohibition on deferring to peer reviewers, conflicts with the Public Health Service Act (42 U.S.C. 289a), which establishes peer review by qualified experts as the statutory basis for NIH funding decisions. I hold continuous NIH PI funding since 2015 with PI-attributable funding exceeding $25 million across NINDS, NIBIB, and the BRAIN Initiative, and I have served on 14 NIH study sections including as Chair. The technical expertise required to evaluate proposals in my field (the biology of chronically implanted neural interfaces) does not exist among political appointees. This provision would place nonexpert reviewers in a position to override domain experts across every federal science agency, producing funding decisions that are scientifically arbitrary and legally indefensible under the PHS Act.

[200.205(d)] Reducing peer review to "advisory" status, with appointees "explicitly forbidden from deferring to peer reviewers," dismantles the system that generated $2.57 in economic return per NIH dollar invested and $94.15 billion in new economic activity in FY 2025 (United for Medical Research, 2026). The rule's own first objective is "improving transparency, accountability, and oversight." Replacing a quantitative, auditable peer review system with discretionary political override achieves the opposite. Every published payline, every summary statement, every study section critique was a transparency mechanism. This rule eliminates all of them while claiming transparency as its purpose. This internal contradiction is not incidental. It is the basis for a challenge under APA Section 706(2)(A).

[200.461] Making publication costs presumptively unallowable directly conflicts with the August 2022 OSTP memorandum (the "Nelson memo") requiring public access to federally funded research. My laboratory publishes approximately 8-12 peer-reviewed papers per year in journals including Journal of Neural Engineering, Biomaterials, and Acta Biomaterialia, with article processing charges averaging $3,000-$4,000 per paper. Under this provision, I would need $24,000-$48,000 annually from non-federal sources to comply with the public access mandate while being prohibited from using federal funds to do so. Peer-reviewed publication is the mechanism by which science is validated. Making it financially prohibitive suppresses the scientific record.

[200.432] Conference pre-approval would have blocked presentations I gave at the Society for Neuroscience annual meeting, the Gordon Research Conference on Neuroelectronic Interfaces, and the Neural Interfaces Conference in the past two years. I co-organize the BRIDGE-STIM workshop series with an NIH R13 conference grant from NINDS. Under this provision, every attendee's travel would require express agency pre-approval written into their individual award terms. Conferences are where results are challenged, collaborations form, and the next generation of scientists is recruited. Giving political appointees gatekeeper authority over conference attendance isolates researchers from their professional communities.

[200.454] Making journal subscriptions categorically unallowable restricts investigators' access to the literature their own federally funded research contributes to. Combined with Sections 200.461 and 200.432, the cumulative effect severs every mechanism by which federally funded scientists disseminate findings, receive critique, and access the work of peers.

[200.340] The authority to terminate active grants without cause creates an environment incompatible with multi-year science. I employ approximately 12 trainees and staff on active NIH grants, each of whom made career decisions based on the reasonable expectation that funded awards would run their course. Between 2012 and January 2025, NIH terminated fewer than six grants midstream in thirteen years. Since February 2025, HHS has terminated 1,392 NIH grants totaling $539 million (CRS, April 2026). This provision converts that unprecedented pattern into permanent regulatory authority.

[200.220] My research depends on cross-species translation spanning rodent, non-human primate, and human preparations, involving international collaborators whose primate neurophysiology expertise is not replicable domestically. The blanket prohibition on international collaboration, including allocable indirect costs, would fragment the translational pipeline that determines whether neural interfaces work in human patients.

The proposed rule claims transparency, reduced burden, and regulatory clarity as its objectives. Its provisions contradict all three. I urge OMB to withdraw Sections 200.205, 200.205(d), 200.340, 200.432, 200.454, and 200.461 in their entirety.

PDF ATTACHMENT (extended comment)

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Public Comment on Proposed Rule for Federal Financial Assistance

Docket OMB-2026-0034

Submitted by Takashi D. Y. Kozai, Ph.D.

Ernest E. Roth Professor of Bioengineering, University of Pittsburgh

Director, B.I.O.N.I.C. Lab | Co-Lead, UP NExT

Submitted in individual capacity

July [date], 2026

I. Identification and standing

I am a federally funded principal investigator at the University of Pittsburgh with continuous NIH PI funding since 2015 and PI-attributable funding exceeding $25 million across the National Institute of Neurological Disorders and Stroke (NINDS), the National Institute of Biomedical Imaging and Bioengineering (NIBIB), and the BRAIN Initiative. I direct the B.I.O.N.I.C. Lab (Bio-Integrating Optoelectronics, Neural Interfaces, and Computation) and co-lead UP NExT (University of Pittsburgh Neural Engineering Cross-Translation), an institutional initiative spanning 23 faculty across the Swanson School of Engineering, School of Medicine, and Dietrich School of Arts and Sciences. I have served on 14 NIH study sections including as Chair, and hold editorial board positions at the Journal of Neural Engineering (since 2018) and Frontiers in Neuroscience (since 2018). My research develops implantable brain-computer interfaces for patients with paralysis, sensory loss, and treatment-resistant neurological disease. I submit this comment in my individual capacity as a working scientist whose laboratory, trainees, and research program are directly affected by the provisions of the proposed rule.

II. The proposed rule contradicts its own stated objectives

The preamble identifies three objectives: "(1) improving transparency, accountability, and oversight for use of Federal funds; (2) clarifying the status of the 2 CFR regulatory text as an OMB regulation; and (3) reducing recipient burden." Every major provision works against objectives (1) and (3), creating the basis for a challenge under APA Section 706(2)(A) (the "arbitrary and capricious" standard).

Transparency. The post-WWII federal science funding system achieved transparency through three mechanisms: peer review by domain experts, published paylines that allowed the community to audit funding decisions, and summary statements that communicated the scientific basis for each decision. Section 200.205(d) reduces peer review to advisory status. The November 2025 Unified Funding Strategy eliminated paylines. The emergency review modifications (NOT-OD-26-012, NOT-OD-26-069) reduced the study section discussion rate from approximately 50% to 33%. The proposed rule codifies all of these changes into binding regulatory text while claiming transparency as its first objective. No mechanism in the proposed rule replaces the transparency functions it eliminates.

Recipient burden. The proposed rule adds conference pre-approval requirements (Section 200.432), publication cost restrictions requiring alternative funding arrangements (Section 200.461), E-Verify mandates for all employees and contractors on federal awards (Section 200.303), and political alignment documentation requirements (Section 200.205). Each of these provisions increases administrative burden on investigators and institutions. The claim that the rule reduces recipient burden is contradicted by the rule's own provisions.

III. Specific statutory conflicts

[200.205 and 200.205(d)] The Public Health Service Act (42 U.S.C. 289a) establishes peer review by qualified experts as the basis for NIH funding decisions. Section 200.205 requires political appointees to conduct pre-issuance review of every discretionary grant while being "explicitly forbidden from deferring to peer reviewers or routinely ratifying their recommendations." This directly conflicts with the statutory mandate. The technical expertise required to evaluate proposals in fields such as neural interface biology, cortical microstimulation biophysics, or glial-vascular neurocomputation does not exist among political appointees. The provision would produce funding decisions based on political alignment rather than scientific merit, which is the opposite of what the PHS Act requires.

[200.461] The August 2022 OSTP memorandum (the "Nelson memo") requires that federally funded research be made publicly available at no cost to the reader. Section 200.461 makes publication costs, including article processing charges and open access fees, presumptively unallowable. These two requirements cannot both be satisfied simultaneously. My laboratory publishes approximately 8-12 peer-reviewed papers per year with article processing charges averaging $3,000-$4,000 per paper. Under this provision, I would need $24,000-$48,000 annually from non-federal sources to comply with the public access mandate. The net effect is suppression of the federally funded scientific record, because most investigators at public universities do not have access to non-federal publication funds at this scale.

IV. Concrete evidence of harm to my research program

Conference pre-approval (Section 200.432). In the past two years, I have presented federally funded research at the Society for Neuroscience annual meeting, the Gordon Research Conference on Neuroelectronic Interfaces, the Neural Interfaces Conference, and the CMU Neural Engineering Seminar. I co-organize the BRIDGE-STIM workshop series, which has an NIH R13 conference grant from NINDS and an NSF conference grant application pending. Under Section 200.432, every one of these presentations would have required express agency pre-approval written into my award terms at the time of funding. Scientific opportunities, including invited talks, workshop participation, and emerging collaborations, cannot be predicted at the time of award. This provision functionally eliminates the capacity of federally funded scientists to participate in their professional communities.

Journal subscriptions (Section 200.454). My research requires regular access to journals spanning neuroscience, biomedical engineering, materials science, and clinical neurology. Making journal subscriptions categorically unallowable as direct costs eliminates a standard mechanism by which investigators access the literature foundational to their work. Combined with Section 200.461 (publication cost ban) and Section 200.432 (conference pre-approval), the cumulative effect severs every mechanism by which federally funded scientists disseminate findings, receive peer critique, and access the work of colleagues.

Grant termination (Section 200.340). I currently employ approximately 12 trainees and staff on active NIH grants, including graduate students, postdoctoral fellows, and research staff whose career decisions were made based on the reasonable expectation that funded awards would run their course. The authority to terminate active grants without a finding of misconduct, fraud, or noncompliance creates an environment in which no PI can responsibly hire trainees, commit to longitudinal studies, or invest in infrastructure. Between 2012 and January 2025, NIH terminated fewer than six grants midstream in thirteen years (documented in a dissent by Justice Ketanji Brown Jackson). Since February 2025, HHS has terminated 1,392 NIH grants totaling $539 million in unliquidated obligations (CRS, April 2026). The proposed rule converts this unprecedented pattern into permanent regulatory authority.

International collaboration (Section 200.220). My research depends on cross-species translation spanning rodent, non-human primate, and human preparations. This translational pipeline involves collaborations with international investigators whose expertise in primate neurophysiology and clinical neural interface implementation is not replicable domestically on any short timeline. The blanket prohibition on international collaboration, including allocable indirect costs, would terminate these partnerships and fragment the translational pipeline. The stated national security rationale is undermined by the fact that restricting U.S.-based international collaboration drives talent and knowledge to competitor nations rather than protecting it.

Training pipeline. The combined effect of Sections 200.205, 200.340, 200.432, 200.454, and 200.461 falls disproportionately on trainees and early-career investigators. Graduate students cannot attend conferences without pre-approval, cannot publish without non-federal funds, cannot access journals through grant-funded subscriptions, and cannot trust that the grants supporting their positions will continue for their funded duration. The 10-to-15-year training cycle from graduate admission to independent investigator means that damage to the pipeline now produces generational losses that no future appropriation can backfill. The University of Pittsburgh temporarily halted doctoral admissions in early 2025 while the institutional impact of proposed indirect cost cuts was assessed. The Perelman School of Medicine at the University of Pennsylvania cut Ph.D. admissions by approximately 35%. UMass Amherst reduced its doctoral cohort from 997 to 712 in a single year. These are not temporary adjustments. They are structural contractions driven by exactly the kind of funding instability this rule would codify.

V. The "Gold Standard Science" standard is void for vagueness

Section 200.205 requires that all grants include benchmarks for compliance with "Gold Standard Science" (tied to Executive Order 14303) and that agencies prioritize institutions that have "demonstrated success in implementing Gold Standard Science." The standard is never defined in any concrete, measurable, or reproducible way. A compliance requirement without operational criteria provides no notice to regulated parties of what conduct is required, which is the definition of a standard that is void for vagueness. The administration retains unguided discretion over what qualifies, which converts a purportedly merit-based standard into a political loyalty test.

VI. The preamble relies on partisan sources rather than independent assessments

The Benton Institute for Broadband and Society noted that the preamble "cites Heritage Foundation reports, op-eds from the Manhattan Institute and City Journal, and Senate Republican committee reports as supporting authority" for its characterizations of the prior administration's grantmaking. The preamble characterizes decades of peer-reviewed research on climate, public health, equity, and international collaboration as "woke," "neo-Marxist," or "anti-American." An agency rulemaking that relies on partisan advocacy documents rather than independent scientific or administrative assessments as its evidentiary basis is vulnerable to challenge as arbitrary and capricious under APA Section 706(2)(A).

VII. Requested action

I urge OMB to withdraw the following provisions in their entirety:

1. Section 200.205 (political appointee pre-issuance review and "Gold Standard Science" compliance)

2. Section 200.205(d) (reduction of peer review to advisory status)

3. Section 200.340 (discretionary termination of active grants without cause)

4. Section 200.432 (conference pre-approval requirement)

5. Section 200.454 (categorical prohibition on journal subscriptions and prior approval for memberships)

6. Section 200.461 (presumptive prohibition on publication costs)

7. Section 200.220 (blanket prohibition on international collaboration)

If OMB proceeds with the rule, I request that it address the following in the preamble to the final rule: (a) the specific statutory conflict between Section 200.205 and 42 U.S.C. 289a, (b) the specific conflict between Section 200.461 and the 2022 OSTP public access memorandum, (c) how the rule achieves its stated transparency objective when every provision reduces transparency, and (d) how the "Gold Standard Science" standard provides constitutionally adequate notice of what compliance requires.

Respectfully submitted,

Takashi D. Y. Kozai, Ph.D.

Ernest E. Roth Professor of Bioengineering

University of Pittsburgh

tk.kozai@pitt.edu | 412-383-9044