(a) The following definitions apply to all components of the Department until the Secretary amends the Food and Drug Administration's good guidance regulations at 21 CFR 10.115 to bring them into conformance with the requirements of §§1.3 through 1.5 of this part:
Guidance document means any Department statement of general applicability, intended to have future effect on the behavior of regulated parties and which sets forth a policy on a statutory, regulatory, or technical or scientific issue, or an interpretation of a statute or regulation. The term “guidance document” does not include rules promulgated pursuant to notice and comment under 5 U.S.C. 553, or similar statutory provisions; rules exempt from rulemaking requirements under 5 U.S.C. 553(a); rules of agency organization, procedure, or practice; decisions of agency adjudications under 5 U.S.C. 554, or similar statutory provisions; internal guidance directed to the Department or other agencies that is not intended to have substantial future effect on the behavior of regulated parties; internal executive branch legal advice or legal opinions addressed to executive branch officials; legal briefs and other court filings; grant solicitations and awards; or contract solicitations and awards. Pre-enforcement rulings, i.e., communications with a person that interpret or apply the law to a specific set of facts, such as letter rulings, advisory opinions, no-action letters, and notices of noncompliance, do not constitute guidance documents. If, however, the Department issues such a document that on its face is directed to a particular party, but the content of the document is designed to guide the conduct of other regulated parties, such a document would qualify as guidance.
Guidance repository means an online database containing or linking to guidance documents.
Issued means the Department initiated or sponsored distribution of information to the public. “Issued” does not include distribution intended to be limited to government employees or agency contractors, or distribution required under law or agency disclosure policies.
Significant guidance document means a guidance document that may reasonably be anticipated to lead to an annual effect on the economy of $100 million or more, or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights or obligations of recipients thereof; or raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles of Executive Order 12866. The term “significant guidance document” does not include the categories of documents exempted in writing by the Office of Management and Budget's (“OMB”) Office of Information and Regulatory Affairs (“OIRA”).
(b) The following definitions apply to all components of the Department:
Civil enforcement action means an action with legal consequence taken by the Department based on an alleged violation of the law. Such actions include administrative enforcement proceedings and enforcement adjudication (which is the administrative process undertaken by any component of the Department to resolve the legal rights and obligations of specific parties with regard to a particular enforcement issue pending before it) but do not include actions taken in the normal course of the Department's regulatory communications or decision-making, for example, decisions on product applications (such as approvals, denials, or withdrawals of approval), claims authorizations, citizen petitions, food or color additive petitions, or public health notifications.
Legal consequence means the result of an action that directly or indirectly affects substantive legal rights or obligations, including by subjecting a regulated party to potential liability in an enforcement action. This includes agency letters or orders establishing greater liability for regulated parties in a subsequent enforcement action, but excludes communications that have no immediate regulatory implications for a person or entity, such as letters (e.g., warning letters) or inspectional observations that serve as an interim step in the agency's compliance communications with a person or entity or that are intended to encourage voluntary compliance.
Unfair surprise means a lack of reasonable certainty or fair warning, from the perspective of a reasonably prudent member of regulated industry, of what a legal standard administered by an agency requires.