21 CFR 312.81 - Scope.

Status message

There are 2 Updates appearing in the Federal Register for 21 CFR Part 312. View below or at eCFR (GPOAccess)
§ 312.81 Scope.
This section applies to new drug and biological products that are being studied for their safety and effectiveness in treating life-threatening or severely-debilitating diseases.
(a) For purposes of this section, the term “life-threatening” means:
(1) Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted; and
(2) Diseases or conditions with potentially fatal outcomes, where the end point of clinical trial analysis is survival.
(b) For purposes of this section, the term “severely debilitating” means diseases or conditions that cause major irreversible morbidity.
(c) Sponsors are encouraged to consult with FDA on the applicability of these procedures to specific products.
[53 FR 41523, Oct. 21, 1988, as amended at 64 FR 401, Jan. 5, 1999]

Title 21 published on 2014-04-01.

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.

  • 2015-04-03; vol. 80 # 64 - Friday, April 3, 2015
    1. 80 FR 18087 - Food and Drug Administration Regulations; Change of Addresses; Technical Amendment
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective April 3, 2015.
      21 CFR Parts 1, 26, 99, 201, 203, 206, 207, 310, 312, 314, 600, 601, 606, 607, 610, 660, 680, 801, 807, 812, 814, 822, and 1271

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

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 312 after this date.

  • 2015-04-03; vol. 80 # 64 - Friday, April 3, 2015
    1. 80 FR 18087 - Food and Drug Administration Regulations; Change of Addresses; Technical Amendment
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective April 3, 2015.
      21 CFR Parts 1, 26, 99, 201, 203, 206, 207, 310, 312, 314, 600, 601, 606, 607, 610, 660, 680, 801, 807, 812, 814, 822, and 1271