Standard Regulatory Process

The Standard Regulatory (& “Guidance”) Process

Every regulation (also called a “rule”) is developed under slightly different circumstances, but this is the general process.  (Variations on this process – e.g., IFRs, guidances, Policy Information Notices, and PRA Notices) are discussed below.)

Step 1: The Federal Agency Proposes a Regulation, called a “Notice of Proposed Rulemaking” (NPRM)

The Agency publishes a “proposed rule” (aka NPRM) in the Federal Register (FR) and on regulations.gov.  You can learn when important rules are proposed in the news, on this NACHC website, and from NACHC alerts.  Note that an agency must have official authority from Congress in order to issue regulations on a specific issue.

NPRMs consist of general two parts – the Preamble, and the proposed Regulatory Text.  In the Preamble, the agency explains its thinking – e.g., options it considered, why it chose the action it is proposing, areas where it is actively seeking public input, etc.  The Regulatory Text is at the end, and is much shorter – however, this is the only part that (when finalized) will be binding.

Step 2:  The Public Submits Comments on the Proposed Rule (aka NPRM)

This is your opportunity to express support or concern about the provisions in the NPRM.  Please see the Guidelines for Writing Comments to Federal Agencies* for suggestions about how to write effective comments.  Depending on the NPRM, the public generally has 60 or 90 days from the date the NPRM was published to submit comments.  (For some time-sensitive NPRMs, the agency will provide only 30 days to comment, whereas for some unusually complex NPRMs, it may provide as much as 180 days.)  Comments should be submitted electronically, at www.regulations.gov  see instructions*  and will be available for the public to see.

Step 3: The Agency Considers All Public Comments and Issues a Final Rule

By law, Federal agencies must consider all comments submitted on an NPRM, but they do not have to accept them.  The agency revises the NPRM, and includes a discussion of comments received and how they responded to them.  It then publishes a “Final Rule” in the Federal Register and on www.regulations.gov.  This rule is legally binding as of the effective date (which is often at least 60 days in the future), and there is generally no further opportunity for public comment.  NACHC alerts its members to the publication of important Final Rules via this webpage, email alerts, trainings, etc.

Like NPRMs, Final Rules consist of two main parts – the Preamble and the (now-final) Regulatory Text.  The Final Rule should be a “logical outgrowth” of the NPRM, so that the public is not caught by surprise. The agency is required to explain in the Preamble to the Final Rule why it made the changes to the NPRM that it did.

Step 4: The Regulation is officially added to the Code of Federal Regulations

Once a Final Rule is published, the Regulatory Text is added to the Code of Federal Regulations (CFR). The CFR is the official record of all regulations created by the federal government. It is divided into 50 volumes, called titles, each of which focuses on a particular area. Regulations relating to the community health center grant program, to the Medicare and Medicaid programs and to HHS fraud and abuse laws appear in Title 42.  Regulations relating to the health insurance Marketplaces and to general grants principles appear in Title 45.  Thus, the full citation for most regulations affecting health centers is “42 CFR” or “45 CFR” followed by the number of the specific section.

Variations on the Standard Process:

1.  Interim Final Rules (IFRs):  Sometimes an agency publishes a Final Rule, but has not yet finished its deliberations on a few issues (e.g., some new issues emerged as a result of comments received on the NPRM.)  In this situation, the agency publishes an “Interim Final Rule,” in which most of the provisions are considered final, but a few are still open for comment.  The remaining “open” issues are finalized in a later Final Rule, after the agency receives and responds to public comments.

2.  Guidances: From a legal perspective, a “guidance” is something of a gray area.  Guidances are generally viewed as having less force than a regulation, and different agencies use them differently.  Officially, a guidance is supposed to explain how an agency interprets an existing regulation, but sometimes agencies issue guidances without underlying regulation.

Agencies’ use of guidances can vary enormously.  For example:

  • Some agencies guidances to flesh out the operational details of issues which are addressed more broadly in regulations (e.g., CMS); some agencies do not (or cannot) issue regulations and appear to use guidances as quasi-regulations (e.g., BPHC, 340B.)
  • Some agencies solicit public input on guidances before finalizing them; others do not.
  • Some guidances follow the format of a Regulation (preamble and regulatory text); others do not.

Given that guidances clearly indicate an agency’s intent, NACHC strongly encourages health centers to comment on all guidances that impact them if the agency is accepting comments.

3.  Policy Information Notices (PINs):  The Bureau of Primary Health Care generally issues its policies in the form of PINs.  These documents do not have an official status under Federal Administrative law, but similar to regulations, BPHC generally issues a draft version and solicits public comment before issuing a final PIN.

3.  Paperwork Reduction Act (PRA) Notices:  By law, agencies which seek to collect extensive information from the public must make the information-collection tool (e.g., survey, cost report format) available for public comment.  These opportunities for comment are published in the Federal Register, under the heading “Paperwork Reduction Act Notices.”  The public is asked to comment on: whether the agency needs to collect the proposed information; the “practical utility” of collecting it; and the administrative burden that the data collection creates.  The comment period for PRA notices is generally 30 days, and – unlike the rulemaking process — there is no requirement for the agency to publicly respond to public comments on PRA Notices.