How To Submit Comments

Your Voice Matters in the Federal Regulatory Process

In addition to submitting comments on regulatory proposals affecting research, we strongly encourage other members of the research oversight community to consider weighing in more frequently. We have an important role to play in the policymaking process. When making comments, you are welcome to cite or utilize PRIM&R’s policy comments.

There are a number of different ways to identify proposed regulations and policies on which you might be interested in commenting. PRIM&R will often share relevant comment periods via email, on our social media channels (TwitterFacebookLinkedIn), and on the PRIM&R blog. The federal government also frequently shares proposed polices through agency listservs as well as formally on The Federal Register comes out every business day and contains proposed rules, regulations, guidances, and other policies of interest to the public—as well as their finalized versions. You can search the Federal Register website by agency, date, and what code of Federal Regulations (CFR) might be affected. You can also check out where the government is testing a new way for the public to search for relevant regulatory proposals.

In recent years, the government has also become more forthcoming about what kinds of public comments are more likely to have an impact on regulators as they develop their final rules and policies. In 2018, experts at the National Institutes of Health (NIH) put out “The Insider’s Guide to Effective Commenting on NIH Policies.” The guide emphasizes that submissions that offer comments on specific areas of note, as opposed to a submission of general support or opposition, are more likely to be utilized by federal agencies. For instance, how will the area of concern impact you as an IRB or IACUC? Even if you only have positive things to say, you should still consider submitting comments: regulators can use them to justify advancing their proposed regulations and policies onto the next step. In the alternative, if you’re interested in changing the proposed regulation or policy, consider offering practical suggestions regulators can feasibly implement, like wording changes to proposed policies or asking for additional guidance. When it comes to regulatory policy, “boring” suggestions can be a good thing!

The government also suggests specifying the exact issues you are concerned with, down to the page number/paragraph/phrase, etc. (if possible). This will make it easier for regulators to be responsive to your precise concern. You may also endorse or provide feedback on comments that have already been submitted by other parties. If you choose this approach, you should include the comment ID to allow regulators to more easily cross-reference them. You should also note your credentials or experience (e.g. IRB chair) to help set apart your comments from the others (though keep in mind that comments submitted to the government ultimately become public).

You can also find out where to submit comments on proposed rules, regulations, and guidances on There may be a link to submit comments directly on the proposed rule; in other cases agencies may require you to fill out a short form (often just asking your name, institution, and email) before you submit your comment of choice. You often have the choice to either type your response in a comment box or upload a document. Typically, the public has between 30-90 days to comment.

Federal agencies issue regulations and other draft policies for public comment as they seek to interpret, implement, and enforce laws passed by the United States Congress. Under the Administrative Procedure Act, Congress requires agencies to publicly publish “notices of proposed rulemaking” so that interested parties can take part in the federal government’s decision-making processes. The government consults with the public to consider factors like efficacy, cost, and benefit of proposed regulations. For topics the federal government believes could benefit from public input early in the policymaking process, agencies may even release an “advance notices of proposed rulemaking” or “requests for information,” to solicit public input before they even issue a proposed rule or policy.

Regulators are required to read the comments they receive from the public as well as respond to them in any final regulation’s preamble, although they are not required to accept all of the public’s suggestions. Regulations can be legally challenged in court on the grounds of arbitrariness or capriciousness (e.g., if they “ignore evidence and research contravening their purported effects and benefits”). Thus, those who choose to offer comment on proposed federal regulations can have a sizeable impact on the nation’s public policies by offering their real-world expertise before issues occur.

Despite the impact that public comments can have, many unfortunately do not choose to submit comments—often because of some commonly held misconceptions, including:

  1. To submit regulatory comments (e.g. on a proposed rulemaking or a draft guidance document),  will I have to register as a lobbyist and disclose such acts pursuant to federal law? 
    No. There is an exemption for those who choose to respond to federal agencies’ request for public comments. It is important to note that lobbying laws may be a concern for those who seek to influence legislations Congress is working on. (For more on advocacy work and US lobbying law we encourage you to read this article and related blog post by PRIM&R Board members Holly Fernandez Lynch, JD, MBE and Suzanne M. Rivera, PhD, MSW.)
  2. Do I have to work in a public policy capacity in order to submit comments? Aren't agencies only interested in certain stakeholders' opinions?
    Federal regulators are particularly interested in hearing how their proposed regulations, policies, or guidances will ultimately be used by those “on the ground” in the sectors and communities they regulate, as opposed to a theoretical setting. This means those in the research oversight community who have to actually figure out how to interpret and apply human subjects protection regulations and animal research policies in real-life research settings are well positioned to offer valuable feedback to the agencies.

    For instance, the Food and Drug Administration (FDA) consistently releases draft guidance documents on specific disease research areas. Although guidance documents are legally non-binding, the FDA utilizes them frequently, and many researchers and sponsors rely on them accordingly—which means it is crucial that the final guidance documents convey accurate information. Associations representing medical researchers who conduct the specified research frequently comment on draft guidances, but there is also often language pertaining to IRB issues (e.g. informed consent) that is also worthy of note. For example, in response to FDA draft guidance on research with adolescent patients in adult oncology clinical trials and with pregnant women, PRIM&R highlighted several distinct research ethics issues in our own sets of comments. If your IRB routinely reviews the kind of research discussed in the latest FDA guidance document, then you are likely in an excellent position to comment on the related research ethics issues involved!
  3. Does submitting comments involve a significant time commitment?
    Submitting comments is a relatively easy process; it can frequently be done in less than five minutes. There is also rarely a minimum word requirement (though sometimes the agencies will cap the number of words). If there are listed questions, you are also not required to comment on every issue the agency asks about. Thus, commenters should feel free to keep their submissions succinct and focused on issues they are familiar with—even if it is as short as a few sentences. When regulators review submissions, they are more interested in the substance of the comments than their length. You are also always welcome to cite or utilize PRIM&R’s comments to help you get started.