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CFR › Title 21 › Chapter I › Subchapter A › Part 56 › Subpart A › Section 56.101

21 CFR 56.101 - Scope.

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§ 56.101
Scope.
(a) This part contains the general standards for the composition, operation, and responsibility of an Institutional Review Board (IRB) that reviews clinical investigations regulated by the Food and Drug Administration under sections 505(i) and 520(g) of the act, as well as clinical investigations that support applications for research or marketing permits for products regulated by the Food and Drug Administration, including foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products. Compliance with this part is intended to protect the rights and welfare of human subjects involved in such investigations.
(b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.
[46 FR 8975, Jan. 27, 1981, as amended at 64 FR 399, Jan. 5, 1999; 66 FR 20599, Apr. 24, 2001]

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.

  • 2013-03-15; vol. 78 # 51 - Friday, March 15, 2013
    1. 78 FR 16401 - Institutional Review Boards; Correcting Amendments
      GPO FDSys XML | Text
      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

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.

United States Code
USC : Title 21 - FOOD AND DRUGS

§ 321 - Definitions; generally

§ 343 - Misbranded food

§ 346 - Tolerances for poisonous or deleterious substances in food; regulations

§ 346a - Tolerances and exemptions for pesticide chemical residues

§ 348 - Food additives

§ 350a - Infant formulas

§ 350b - New dietary ingredients

§ 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

§ 360c - Classification of devices intended for human use

§ 360d - Performance standards

§ 360e - Premarket approval

21 USC § 360e–1 - Pediatric uses of devices

§ 360f - Banned devices

§ 360h - Notification and other remedies

§ 360i - Records and reports on devices

§ 360j - General provisions respecting control 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

U.S.C. : Title 42 - THE PUBLIC HEALTH AND WELFARE

§ 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.

  • 2013-03-15; vol. 78 # 51 - Friday, March 15, 2013
    1. 78 FR 16401 - Institutional Review Boards; Correcting Amendments
      GPO FDSys XML | Text
      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