GroundRules
Browse Federal regulations
Read the original sections, or search by topic.
- 21 CFR 4.105 · What are the postmarketing safety reporting recordkeeping requirements for your combination product or constituent part?
- 21 CFR 5.1100 · Agency Organization Information.
- 21 CFR 7.1 · Scope.
- 21 CFR 7.3 · Definitions.
- 21 CFR 7.12 · Guaranty.
- 21 CFR 7.13 · Suggested forms of guaranty.
- 21 CFR 7.40 · Recall policy.
- 21 CFR 7.41 · Health hazard evaluation and recall classification.
- 21 CFR 7.42 · Recall strategy.
- 21 CFR 7.45 · Food and Drug Administration-requested recall.
- 21 CFR 7.46 · Firm-initiated recall.
- 21 CFR 7.49 · Recall communications.
- 21 CFR 7.50 · Public notification of recall.
- 21 CFR 7.53 · Recall status reports.
- 21 CFR 7.55 · Termination of a recall.
- 21 CFR 7.59 · General industry guidance.
- 21 CFR 7.84 · Opportunity for presentation of views before report of criminal violation.
- 21 CFR 7.85 · Conduct of a presentation of views before report of criminal violation.
- 21 CFR 7.87 · Records related to opportunities for presentation of views conducted before report of criminal violation.
- 21 CFR 10.1 · Scope.
- 21 CFR 10.3 · Definitions.
- 21 CFR 10.10 · Summaries of administrative practices and procedures.
- 21 CFR 10.19 · Waiver, suspension, or modification of procedural requirements.
- 21 CFR 10.20 · Submission of documents to Dockets Management Staff; computation of time; availability for public disclosure.
- 21 CFR 10.25 · Initiation of administrative proceedings.
- 21 CFR 10.30 · Citizen petition.
- 21 CFR 10.31 · Citizen petitions and petitions for stay of action related to abbreviated new drug applications, certain new drug applications, or certain biologics license applications.
- 21 CFR 10.33 · Administrative reconsideration of action.
- 21 CFR 10.35 · Administrative stay of action.
- 21 CFR 10.40 · Promulgation of regulations for the efficient enforcement of the law.
- 21 CFR 10.45 · Court review of final administrative action; exhaustion of administrative remedies.
- 21 CFR 10.50 · Promulgation of regulations and orders after an opportunity for a formal evidentiary public hearing.
- 21 CFR 10.55 · Separation of functions; ex parte communications.
- 21 CFR 10.60 · Referral by court.
- 21 CFR 10.65 · Meetings and correspondence.
- 21 CFR 10.70 · Documentation of significant decisions in administrative file.
- 21 CFR 10.75 · Internal agency review of decisions.
- 21 CFR 10.80 · Dissemination of draft Federal Register notices and regulations.
- 21 CFR 10.85 · Advisory opinions.
- 21 CFR 10.90 · Food and Drug Administration regulations, recommendations, and agreements.
- 21 CFR 10.95 · Participation in outside standard-setting activities.
- 21 CFR 10.100 · Public calendar.
- 21 CFR 10.105 · Representation by an organization.
- 21 CFR 10.110 · Settlement proposals.
- 21 CFR 10.115 · Good guidance practices.
- 21 CFR 10.200 · Scope.
- 21 CFR 10.203 · Definitions.
- 21 CFR 10.204 · General.
- 21 CFR 10.205 · Electronic media coverage of public administrative proceedings.
- 21 CFR 10.206 · Procedures for electronic media coverage of agency public administrative proceedings.
- 21 CFR 11.1 · Scope.
- 21 CFR 11.2 · Implementation.
- 21 CFR 11.3 · Definitions.
- 21 CFR 11.10 · Controls for closed systems.
- 21 CFR 11.30 · Controls for open systems.
- 21 CFR 11.50 · Signature manifestations.
- 21 CFR 11.70 · Signature/record linking.
- 21 CFR 11.100 · General requirements.
- 21 CFR 11.200 · Electronic signature components and controls.
- 21 CFR 11.300 · Controls for identification codes/passwords.
- 21 CFR 12.1 · Scope.
- 21 CFR 12.20 · Initiation of a hearing involving the issuance, amendment, or revocation of a regulation.
- 21 CFR 12.21 · Initiation of a hearing involving the issuance, amendment, or revocation of an order.
- 21 CFR 12.22 · Filing objections and requests for a hearing on a regulation or order.
- 21 CFR 12.23 · Notice of filing of objections.
- 21 CFR 12.24 · Ruling on objections and requests for hearing.
- 21 CFR 12.26 · Modification or revocation of regulation or order.
- 21 CFR 12.28 · Denial of hearing in whole or in part.
- 21 CFR 12.30 · Judicial review after waiver of hearing on a regulation.
- 21 CFR 12.32 · Request for alternative form of hearing.
- 21 CFR 12.35 · Notice of hearing; stay of action.
- 21 CFR 12.37 · Effective date of a regulation.
- 21 CFR 12.38 · Effective date of an order.
- 21 CFR 12.40 · Appearance.
- 21 CFR 12.45 · Notice of participation.
- 21 CFR 12.50 · Advice on public participation in hearings.
- 21 CFR 12.60 · Presiding officer.
- 21 CFR 12.62 · Commencement of functions.
- 21 CFR 12.70 · Authority of presiding officer.
- 21 CFR 12.75 · Disqualification of presiding officer.
- 21 CFR 12.78 · Unavailability of presiding officer.
- 21 CFR 12.80 · Filing and service of submissions.
- 21 CFR 12.82 · Petition to participate in forma pauperis.
- 21 CFR 12.83 · Advisory opinions.
- 21 CFR 12.85 · Disclosure of data and information by the participants.
- 21 CFR 12.87 · Purpose; oral and written testimony; burden of proof.
- 21 CFR 12.89 · Participation of nonparties.
- 21 CFR 12.90 · Conduct at oral hearings or conferences.
- 21 CFR 12.91 · Time and place of prehearing conference.
- 21 CFR 12.92 · Prehearing conference procedure.
- 21 CFR 12.93 · Summary decisions.
- 21 CFR 12.94 · Receipt of evidence.
- 21 CFR 12.95 · Official notice.
- 21 CFR 12.96 · Briefs and arguments.
- 21 CFR 12.97 · Interlocutory appeal from ruling of presiding officer.
- 21 CFR 12.98 · Official transcript.
- 21 CFR 12.99 · Motions.
- 21 CFR 12.100 · Administrative record of a hearing.
- 21 CFR 12.105 · Examination of record.
- 21 CFR 12.120 · Initial decision.