Engagement in the Rulemaking Process—
ASPET Responds
By Carter L. Alleman, JD, CAE, and Marah Wahbeh, PhD
Rulemaking is the policy-making process for the executive and independent agencies of the federal government. Congress grants rulemaking authority to federal agencies to implement statutory programs through the Administrative Procedure Act (APA). The APA describes a set of procedures that agencies are required to follow when creating regulations through the rulemaking process. Within the rulemaking process, federal agencies are required to provide an opportunity for public comment when creating a new rule. Given this, the National Institutes of Health (NIH) often releases notices to update the science community about funding changes, policy changes, and other important information, and requests public comments on such changes through an official Request for Information (RFI).
RFIs serve as a valuable opportunity for scientists, researchers, and institutions to directly influence the policies and decisions that affect their work. It allows the public to influence federal policy and help shape its implementation. Typically, rules will go through multiple rounds of comments depending on the rulemaking process the agency decides to utilize.
Recently, NIH published NOT-OD-25-138, a Request for Information on Maximizing Research Funds by Limiting Allowable Publishing Costs. Below are brief excerpts of ASPET’s response to the notice:
ASPET commends NIH’s commitment to broad public access to scientific outputs. However, ASPET believes that the proposed policies as currently shared will risk undermining the goals that NIH seeks to achieve.
Proposed Options for Limiting Costs
Option 1: Disallow All Publication Costs
Proposal: Prevent NIH grant funds from being used for any publication costs.
Option 1 will have profound negative consequences. By disallowing all publication costs, NIH-funded investigators would be forced either to pay APCs out-of-pocket or to seek institutional subsidies. Both approaches disproportionately disadvantage researchers at smaller institutions, which lack the robust library budgets or central publishing funds that larger universities maintain.
Disallowing APCs entirely would likely lead to a two-tiered publishing system: well-funded investigators would continue to publish in established journals, while under-resourced researchers would either be excluded from high-visibility venues or pushed toward low-cost, potentially predatory publishers. This would deepen inequities in the scientific workforce and erode trust in the literature.
Small society publishers would be especially harmed. Removing NIH support would cut off a major source of sustainable revenue, jeopardizing journals that focus on specific areas of basic science where commercial publishers see little profit.
Request for Information
5. Other evidence or information not considered here that NIH should consider in its policy on limiting allowable publication costs.
Rigid price caps are price controls which favor large publishers and will consolidate publishing options and suffocate dissemination of niche areas critical to basic research. With the continued rise of AI and paper mills, each new piece of detection software increases the cost of publication. A more flexible approach is needed that is evidence based that accounts for evolving costs, sustains small society publishers, maintains the peer review process, and does not lead to consolidation at either the institutional or publisher levels. A continued conversation is needed between NIH and the publishing community to reach a policy that works for the continued responsible stewardship of public funds and the dissemination of scientific discoveries.
ASPET welcomes and asks for collaboration with NIH on this topic through workshops, working groups, or pilot programs to refine how NIH will approach this stewardship.
Other ASPET RFI responses comments are available below:
Authors
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Marah Wahbeh, PhD is the Manager, Government Affairs & Science Policy at ASPET. She received her PhD in Human Genetics and Genomics from Johns Hopkins University School of Medicine.
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