21 CFR Part 56 - INSTITUTIONAL REVIEW BOARDS
- SUBPART A — General Provisions (§§ 56.101 - 56.105)
- SUBPART B — Organization and Personnel (§§ 56.106 - 56.107)
- SUBPART C — IRB Functions and Operations (§§ 56.108 - 56.114)
- SUBPART D — Records and Reports (§§ 56.115 - 56.115)
- SUBPART E — Administrative Actions for Noncompliance (§§ 56.120 - 56.124)
Title 21 published on 2012-04-01
The following are only the Rules published in the Federal Register after the published date of Title 21.
For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.
GPO FDSys XML | Text type regulations.gov FR Doc. 2013-04387 RIN 0910-AG71 Docket No. FDA-2000-N-0009 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective March 28, 2013. 21 CFR Parts 50 and 56 The Food and Drug Administration (FDA) is amending its regulations to provide additional safeguards for children enrolled in clinical investigations of FDA-regulated products. This rule finalizes the interim rule published in 2001 to bring FDA regulations into compliance with provisions of the Children's Health Act of 2000 (the Children's Health Act). The Children's Health Act requires that all research involving children that is conducted, supported, or regulated by the Department of Health and Human Services (HHS) be in compliance with HHS regulations providing additional protections for children involved as subjects in research. FDA is taking this action both to comply with the congressional mandate and because of increases in the enrollment of children in clinical investigations as a result of ongoing pediatric initiatives.
This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.
This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].
It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.
§ 321 - Definitions; generally
§ 343 - Misbranded food
§ 346a - Tolerances and exemptions for pesticide chemical residues
§ 346 - Tolerances for poisonous or deleterious substances in food; regulations
§ 348 - Food additives
§ 350b - New dietary ingredients
§ 350a - Infant formulas
§ 351 - Adulterated drugs and devices
§ 352 - Misbranded drugs and devices
§ 353 - Exemptions and consideration for certain drugs, devices, and biological products
§ 355 - New drugs
§ 360 - Registration of producers of drugs or devices
§ 360j - General provisions respecting control of devices intended for human use
§ 360i - Records and reports on devices
§ 360h - Notification and other remedies
§ 360f - Banned devices
21 USC § 360e–1 - Pediatric uses of devices
§ 360e - Premarket approval
§ 360d - Performance standards
§ 360c - Classification of devices intended for human use
§ 371 - Regulations and hearings
§ 379e - Listing and certification of color additives for foods, drugs, devices, and cosmetics
§ 381 - Imports and exports
§ 216 - Regulations
§ 241 - Research and investigations generally
§ 263b - Certification of mammography facilities
42 USC § 259 to 261a - Repealed.
Title 21 published on 2012-04-01
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 56 after this date.
GPO FDSys XML | Text type regulations.gov FR Doc. 2013-06030 RIN Docket No. FDA-2013-N-0003 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; correcting amendments. This final rule is effective March 15, 2013. 21 CFR Part 56 The Food and Drug Administration (FDA) is amending its regulations regarding institutional review boards to address a minor correction to the regulatory text and to update contact information. This action is editorial in nature and is intended to provide accuracy and clarity to the Agency's regulations.
GPO FDSys XML | Text type regulations.gov FR Doc. 2013-04387 RIN 0910-AG71 Docket No. FDA-2000-N-0009 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective March 28, 2013. 21 CFR Parts 50 and 56 The Food and Drug Administration (FDA) is amending its regulations to provide additional safeguards for children enrolled in clinical investigations of FDA-regulated products. This rule finalizes the interim rule published in 2001 to bring FDA regulations into compliance with provisions of the Children's Health Act of 2000 (the Children's Health Act). The Children's Health Act requires that all research involving children that is conducted, supported, or regulated by the Department of Health and Human Services (HHS) be in compliance with HHS regulations providing additional protections for children involved as subjects in research. FDA is taking this action both to comply with the congressional mandate and because of increases in the enrollment of children in clinical investigations as a result of ongoing pediatric initiatives.