Comments Are Closed on OMB’s Grantmaking Proposed Rule. Now What?

Last night, comments closed on the Office of Management and Budget (OMB)’s proposed rule that would require political appointees to review federal grants and halt those that don’t align with Trump administration objectives.

As of the 11:59 p.m. deadline, nearly 500,000 comments were submitted, many in response to campaigns from several science organizations that hoped to drown the agency with work to vet those comments in an effort to delay the rule. Only about 10% of those have been posted publicly.

As of July 9, of the 51,047 comments that were posted, 94% were opposed to the rule. That’s according to an AI analysis tool developed by independent data engineer Abigail Haddad, and shared with MedPage Today by Chris Marcum, former OMB senior statistician and senior scientist.

The tool showed that 19,574 comments “expressed concern that the rule would be damaging to public health and medical research,” Marcum told MedPage Today.

So what happens next?

The OMB intends for this rule to take effect on Oct. 1, which means the final rule must drop at least 30 days before then, or around Aug. 31. That’s not a lot of time, especially for a rule this consequential, sources said.

First, the OMB must consider all submitted comments, although it does not have to respond to each one, Marcum said.

Only two OMB employees will likely review comments, and that is only part of their duties, said Marcum, whose job involved helping to review this very rule before he quit last July. They may have to get creative to get the job done in time, he acknowledged.

“Can we throw enough sand in the gears to force the agency to slow down or change course?” Cole Donovan, director of science policy and advocacy at the Stand Up for Science Foundation, who worked in the Biden administration, asked rhetorically.

If comments can’t persuade the agency to retreat, several organizations hope to show that the administration failed to follow federal rulemaking protocols, thus paving the way for litigation.

Several scientists interviewed for this story said they don’t think flooding regulations.gov with comments will work.

“You know, it would not be the least bit surprising if it was like, ‘Hey, Chat GPT, please respond to all these comments,'” said Jeremy Berg, PhD, former director of the National Institute of General Medical Sciences at the NIH.

Second, the OMB’s Office of Information and Regulatory Affairs (OIRA) must review any changes to the proposed rule, which it usually gets 90 days to do, Marcum said. However, an Aug. 31 deadline leaves just half that time.

Third, before the final rule drops, OMB is supposed to give the public an opportunity to request an Executive Order 12866 meeting with OIRA representatives to air complaints, although the agency is not required to agree.

The comment process and 12866 meetings are “super important,” and help convey underlying reasons for support or opposition, Marcum said. But from what he knows about this administration’s zeal to get this rule passed, he does not think either process will be an impediment.

The public can also consider pushing to use the Congressional Review Act, a tool enabling Congress to overturn certain federal agency actions if specified timelines weren’t followed during the regulatory process.

“I think stakeholders at this point should be focused on their representatives,” and send them their comment letters, Marcum said. Congress can insert appropriations conditions into the National Defense Authorization Act, “which is a must-pass piece of legislation.”

Legislation can stop this rule after it’s finalized, Donovan said. But it would need a two-thirds majority to override a certain presidential veto.

Jenna Norton, PhD, MPH, a program director at the National Institute for Diabetes and Digestive and Kidney Diseases at the NIH, who spoke in a personal capacity, told MedPage Today that as proposed, the rule may violate certain provisions of the Administrative Procedures Act because of its implications and abbreviated implementation timeframe. Also, “there are questions about how it aligns with the Public Health Service Act … and whether this undermines the NIH requirement for peer review,” she said.

Several legal experts told MedPage Today that beyond these processes, legal protocols probably require that plaintiffs wait until the final rule is released before filing lawsuits. They can’t file preemptively based on fear.

A question some experts raised is whether plaintiffs would have to show they were actually harmed by the rule, which would take time to prove, or whether a threat of imminent harm would be enough to show legal standing.

One potential legal vulnerability for the OMB is the way the agency characterized this rule: it posted a vaguely worded notice earlier this year, 3 months before the proposed rule was published May 29.

On Feb. 26, that notice said the OMB “proposes to revise the Guidance for Federal Financial Assistance to improve government-wide policies and requirements related to the management of grants, cooperative agreements, and other forms of assistance. OMB is proposing revisions that would improve transparency, accountability, and oversight for Federal awards across the Federal Government.”

Despite a potential $1 trillion impact, a related reginfo.gov notice said this: “Economically Significant: No.”

“The obscurity of this rulemaking process is why nobody saw it coming,” Marcum said. “I wonder if the economically non-significant determination is an angle for a lawsuit.”

Linda Morris, senior staff attorney in the Women’s Rights Project of the American Civil Liberties Union, told MedPage Today that lawyers have seen this administration “fail over and over” to observe required protocols for imposing new rules. And while she stopped short of saying the ACLU will be litigating this rule when it’s finalized, “we remain committed to defending against the administration’s attacks,” she said.

Berg was more pessimistic.

“I’m sure they’re confident they’re going to get sued if they implement this,” Berg said. Besides, within the NIH and the National Science Foundation, “they’ve already implemented a lot of the steps — the ability to terminate grants or convert career people to at-will positions who can be fired. It’s not as if it’s going to be a night and day difference once they start implementing.”