U.S. Department of Health and Human Services

Preambles to GCP Regulations

Each time Congress enacts a law affecting products regulated by the Food and Drug Administration, the FDA develops rules to implement the law. The FDA takes various steps to develop these rules, including publishing a variety of documents in the Federal Register announcing the FDA's interest in formulating, amending or repealing a rule, and offering the public the opportunity to comment on the agency's proposal. The Federal Register notice explains the legal issues and basis for the proposal, and provides information about how interested persons can submit written data, views, or arguments on the proposal. Any comments that are submitted are addressed in subsequent publications that are part of the agency's decision-making process.

The "preamble" to each of these publications includes all of the printed information immediately preceding the codified regulation. The preamble provides information about the regulation such as why the regulation is being proposed, the FDA's interpretation of the meaning and impact of the proposed regulation, and in those cases where the agency has solicited public comment, the agency's review and commentary on those comments . The preamble can also include an environmental impact assessment, an analysis of the cost impact, comments related to the Paperwork Reduction Act, and the effective date of the implementation or revocation (as the case may be) of the regulation.

The documents posted below include the various publications that contributed to the development of final rules related to FDA's regulations on good clinical practice and clinical trials.

The FDA uses several categories of documents in its rulemaking process:

Advanced Notice of Proposed Rulemaking (ANPRM): The FDA may publish an ANPRM for the purpose of gathering information about a subject that the FDA may be formulating ideas about how to better regulate a specific practice or product. An ANPRM may also be used by the FDA for gathering information about existing rules it may be amend or possibly repeal.
Notice of Proposed Rulemaking (NPRM): After reviewing comments from the public from the ANPRM, the FDA may issue a Notice of Proposed Rulemaking. An NPRM contains proposed changes to the FDA's rules and seeks public comment on these proposals.
Proposed Rule (PR): After reviewing public comments to the NPRM, the FDA may choose to issue a PR regarding specific issues raised in the comments. The PR may also be used to announce the FDA's plans to create, or amend a rule. The PR provides a final opportunity for the public to comment on the proposed rule.
Interim Rule: FDA may propose an interim rule that is like a final rule however it offers the public an opportunity to submit additional comments. An interim rule may be used to help the agency meet specific Congressionally mandated timeframes or to expeditiously address issues of public health concern.
Final Rule: After considering comments to the NPRM, or PR, the FDA issues a final rule. The Federal Register summary provides a summary of comments.