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- 21 CFR 21.21 · Changes in systems and new systems.
- 21 CFR 21.30 · Records of contractors.
- 21 CFR 21.31 · Records stored by the National Archives and Records Administration.
- 21 CFR 21.32 · Personnel records.
- 21 CFR 21.33 · Medical records.
- 21 CFR 21.40 · Procedures for submitting requests for notification and access.
- 21 CFR 21.41 · Processing of requests.
- 21 CFR 21.42 · Responses to requests.
- 21 CFR 21.43 · Access to requested records.
- 21 CFR 21.44 · Verification of identity.
- 21 CFR 21.45 · Fees.
- 21 CFR 21.50 · Procedures for submitting requests for amendment of records.
- 21 CFR 21.51 · Responses to requests for amendment of records.
- 21 CFR 21.52 · Administrative appeals of refusals to amend records.
- 21 CFR 21.53 · Notation and disclosure of disputed records.
- 21 CFR 21.54 · Amended or disputed records received from other agencies.
- 21 CFR 21.60 · Policy.
- 21 CFR 21.61 · Exempt systems.
- 21 CFR 21.65 · Access to records in exempt systems.
- 21 CFR 21.70 · Disclosure and intra-agency use of records in Privacy Act Record Systems; no accounting required.
- 21 CFR 21.71 · Disclosure of records in Privacy Act Record Systems; accounting required.
- 21 CFR 21.72 · Individual consent to disclosure of records to other persons.
- 21 CFR 21.73 · Accuracy, completeness, timeliness, and relevance of records disclosed from Privacy Act Record Systems.
- 21 CFR 21.74 · Providing notice that a record is disputed.
- 21 CFR 21.75 · Rights of legal guardians.
- 21 CFR 25.1 · Purpose.
- 21 CFR 25.5 · Terminology.
- 21 CFR 25.10 · Policies and NEPA planning.
- 21 CFR 25.15 · General procedures.
- 21 CFR 25.16 · Public health and safety emergencies.
- 21 CFR 25.20 · Actions requiring preparation of an environmental assessment.
- 21 CFR 25.21 · Extraordinary circumstances.
- 21 CFR 25.22 · Actions requiring the preparation of an environmental impact statement.
- 21 CFR 25.30 · General.
- 21 CFR 25.31 · Human drugs and biologics.
- 21 CFR 25.32 · Foods, food additives, and color additives.
- 21 CFR 25.33 · Animal drugs.
- 21 CFR 25.34 · Devices and electronic products.
- 21 CFR 25.35 · Tobacco product applications.
- 21 CFR 25.40 · Environmental assessments.
- 21 CFR 25.41 · Findings of no significant impact.
- 21 CFR 25.42 · Environmental impact statements.
- 21 CFR 25.43 · Records of decision.
- 21 CFR 25.44 · Lead and cooperating agencies.
- 21 CFR 25.45 · Responsible agency official.
- 21 CFR 25.50 · General information.
- 21 CFR 25.51 · Environmental assessments and findings of no significant impact.
- 21 CFR 25.52 · Environmental impact statements.
- 21 CFR 25.60 · Environmental effects abroad of major agency actions.
- 21 CFR 50.1 · Scope.
- 21 CFR 50.3 · Definitions.
- 21 CFR 50.20 · General requirements for informed consent.
- 21 CFR 50.22 · Exception from informed consent requirements for minimal risk clinical investigations.
- 21 CFR 50.23 · Exception from general requirements.
- 21 CFR 50.24 · Exception from informed consent requirements for emergency research.
- 21 CFR 50.25 · Elements of informed consent.
- 21 CFR 50.27 · Documentation of informed consent.
- 21 CFR 50.50 · IRB duties.
- 21 CFR 50.51 · Clinical investigations not involving greater than minimal risk.
- 21 CFR 50.52 · Clinical investigations involving greater than minimal risk but presenting the prospect of direct benefit to individual subjects.
- 21 CFR 50.53 · Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects' disorder or condition.
- 21 CFR 50.54 · Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
- 21 CFR 50.55 · Requirements for permission by parents or guardians and for assent by children.
- 21 CFR 50.56 · Wards.
- 21 CFR 54.1 · Purpose.
- 21 CFR 54.2 · Definitions.
- 21 CFR 54.3 · Scope.
- 21 CFR 54.4 · Certification and disclosure requirements.
- 21 CFR 54.5 · Agency evaluation of financial interests.
- 21 CFR 54.6 · Recordkeeping and record retention.
- 21 CFR 56.101 · Scope.
- 21 CFR 56.102 · Definitions.
- 21 CFR 56.103 · Circumstances in which IRB review is required.
- 21 CFR 56.104 · Exemptions from IRB requirement.
- 21 CFR 56.105 · Waiver of IRB requirement.
- 21 CFR 56.106 · Registration.
- 21 CFR 56.107 · IRB membership.
- 21 CFR 56.108 · IRB functions and operations.
- 21 CFR 56.109 · IRB review of research.
- 21 CFR 56.110 · Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.
- 21 CFR 56.111 · Criteria for IRB approval of research.
- 21 CFR 56.112 · Review by institution.
- 21 CFR 56.113 · Suspension or termination of IRB approval of research.
- 21 CFR 56.114 · Cooperative research.
- 21 CFR 56.115 · IRB records.
- 21 CFR 56.120 · Lesser administrative actions.
- 21 CFR 56.121 · Disqualification of an IRB or an institution.
- 21 CFR 56.122 · Public disclosure of information regarding revocation.
- 21 CFR 56.123 · Reinstatement of an IRB or an institution.
- 21 CFR 56.124 · Actions alternative or additional to disqualification.
- 21 CFR 58.1 · Scope.
- 21 CFR 58.3 · Definitions.
- 21 CFR 58.10 · Applicability to studies performed under grants and contracts.
- 21 CFR 58.15 · Inspection of a testing facility.
- 21 CFR 58.29 · Personnel.
- 21 CFR 58.31 · Testing facility management.
- 21 CFR 58.33 · Study director.
- 21 CFR 58.35 · Quality assurance unit.
- 21 CFR 58.41 · General.
- 21 CFR 58.43 · Animal care facilities.