21 CFR 56 - INSTITUTIONAL REVIEW BOARDS | LII / Legal Information Institute

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Authority: 21 U.S.C. 321, 343, 346, 346a, 348, 350a, 350b, 351, 352, 353, 355, 360, 360c-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 241, 262, 263b-263n.

Source: 46 FR 8975, Jan. 27, 1981, unless otherwise noted.

Title 21 published on 2011-04-01

no entries appear in the Federal Register after this date.

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

21 USC 321 - Definitions; generally

21 USC 343 - Misbranded food

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

21 USC 346a - Tolerances and exemptions for pesticide chemical residues

21 USC 348 - Food additives

21 USC 350a - Infant formulas

21 USC 350b - New dietary ingredients

21 USC 351 - Adulterated drugs and devices

21 USC 352 - Misbranded drugs and devices

21 USC 353 - Exemptions and consideration for certain drugs, devices, and biological products

21 USC 355 - New drugs

21 USC 360 - Registration of producers of drugs or devices

21 USC 360c - Classification of devices intended for human use

21 USC 360d - Performance standards

21 USC 360e - Premarket approval

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

21 USC 360f - Banned devices

21 USC 360h - Notification and other remedies

21 USC 360i - Records and reports on devices

21 USC 360j - General provisions respecting control of devices intended for human use

21 USC 371 - Regulations and hearings

21 USC 379e - Listing and certification of color additives for foods, drugs, devices, and cosmetics

21 USC 381 - Imports and exports

42 USC 216 - Regulations

42 USC 241 - Research and investigations generally

42 USC 263b - Certification of mammography facilities

42 USC § 259 to 261a - Repealed.

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 56

2011-09-01; vol. 76 # 170 - Thursday, September 1, 2011

76 FR 54408 - Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators; Extension of Comment Period

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2011-22341
RIN

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary, Food and Drug Administration

Advance notice of proposed rulemaking; extension of comment period.

The comment period for the proposed rule published July 26, 2011, at 76 FR 44512 is extended. Comments will be received through October 26, 2011.

45 CFR Parts 46, 160, and 164

Summary

The Office of the Secretary of the Department of Health and Human Services (HHS) in coordination with the Office of Science and Technology Policy (OSTP) is extending the comment period for an advance notice of proposed rulemaking (ANPRM) requesting comment on how current regulations for protecting human subjects who participate in research might be modernized and revised to be more effective. That ANPRM was published in the Federal Register on July 26, 2011.

2011-07-26; vol. 76 # 143 - Tuesday, July 26, 2011

76 FR 44512 - Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators

GPO FDSys XML | Text

Additional Documents

type	regulations.gov
FR Doc.	2011-18792
RIN

DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary, Food and Drug Administration

Advance notice of proposed rulemaking.

To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on September 26, 2011.

45 CFR Parts 46, 160, and 164

Summary

The Office of the Secretary of the Department of Health and Human Services (HHS) in coordination with the Office of Science and Technology Policy (OSTP) is issuing this advance notice of proposed rulemaking (ANPRM) to request comment on how current regulations for protecting human subjects who participate in research might be modernized and revised to be more effective. This ANPRM seeks comment on how to better protect human subjects who are involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. The current regulations governing human subjects research were developed years ago when research was predominantly conducted at universities, colleges, and medical institutions, and each study generally took place at only a single site. Although the regulations have been amended over the years, they have not kept pace with the evolving human research enterprise, the proliferation of multi-site clinical trials and observational studies, the expansion of health services research, research in the social and behavioral sciences, and research involving databases, the Internet, and biological specimen repositories, and the use of advanced technologies, such as genomics. Revisions to the current human subjects regulations are being considered because OSTP and HHS believe these changes would strengthen protections for research subjects.

21 CFR 56 - INSTITUTIONAL REVIEW BOARDS

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