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 U.S. Code: Title 21 - FOOD AND DRUGS U.S. Code: Title 42 - THE PUBLIC HEALTH AND WELFARE
Title 21 published on 09-Jun-2018 03:51
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 312 after this date.
2017-06-21; vol. 82 # 118 - Wednesday, June 21, 2017 82 FR 28277 - Use of Electronic Records and Electronic Signatures in Clinical Investigations Under Part 11—Questions and Answers; Draft Guidance for Industry; Availability
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule; notification of availability. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by August 21, 2017. 21 CFR Parts 11, 312, and 812 Summary The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Use of Electronic Records and Electronic Signatures in Clinical Investigations under our regulations—Questions and Answers.” The draft guidance provides guidance to sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other interested parties on the use of electronic records and electronic signatures under our regulations in clinical investigations of medical products. The draft guidance expands upon recommendations in the guidance for industry entitled “Part 11, Electronic Records; Electronic Signatures—Scope and Application” issued in August 2003 (referred to as the 2003 part 11 guidance) for recommendations that pertain to FDA-regulated clinical investigations conducted under our regulations.
2016-03-28; vol. 81 # 59 - Monday, March 28, 2016 81 FR 17065 - Investigational New Drug Applications for Biological Products; Bioequivalence Regulations; Technical Amendment
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendment. This rule is effective March 28, 2016. 21 CFR Parts 312 and 320 Summary The Food and Drug Administration (FDA or Agency) is amending its regulations to update the address for applicants to submit investigational new drug applications (INDs) for biological products regulated by the Center for Drug Evaluation and Research (CDER). FDA is also amending its regulations on the criteria and evidence to assess actual and potential bioequivalence problems (bioequivalence regulations) to correct a typographical error. FDA is taking this action to ensure accuracy and clarity in the Agency's regulations.
2015-04-03; vol. 80 # 64 - Friday, April 3, 2015 80 FR 18087 - Food and Drug Administration Regulations; Change of Addresses; Technical Amendment
GPO FDSys XML | Text Additional Documents 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 Summary The Food and Drug Administration (FDA) is amending its regulations to update address information for the Center for Biologics Evaluation and Research (CBER) as a result of the recent relocation of CBER offices and laboratories to the FDA White Oak campus in Silver Spring, MD, as well as make other related technical revisions. These changes are being made to ensure the accuracy of the Agency's regulations.
2015-02-10; vol. 80 # 27 - Tuesday, February 10, 2015 80 FR 7318 - Individual Patient Expanded Access Applications: Form FDA 3926; Draft Guidance for Industry; Availability
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notice of draft guidance. February 10, 2015. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 13, 2015. Submit either electronic or written comments concerning the collection of information proposed in the draft guidance by April 13, 2015. 21 CFR Part 312 Summary The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled “Individual Patient Expanded Access Applications: Form FDA 3926.” The draft guidance provides for public comment and describes draft Form FDA 3926 (Individual Patient Expanded Access—Investigational New Drug Application (IND)), which, when finalized, FDA intends to make available for licensed physicians to use for expanded access requests for individual patient INDs. Individual patient expanded access allows for the use of an investigational drug outside of a clinical trial for an individual patient who has a serious or immediately life-threatening disease or condition and there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition. When finalized, draft Form FDA 3926 is intended to provide a streamlined alternative for submitting an Investigational New Drug Application (IND) for use in cases of individual patient expanded access.
2013-05-09; vol. 78 # 90 - Thursday, May 9, 2013 78 FR 27115 - Draft Guidance for Industry on Expanded Access to Investigational Drugs for Treatment Use—Questions and Answers; Availability
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notice of availability. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 8, 2013. 21 CFR Part 312 Summary The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Expanded Access to Investigational Drugs for Treatment Use—Qs & As.” This guidance is intended to provide information for industry, researchers, physicians, and patients about certain aspects of FDA's implementation of its regulations on expanded access to investigational drugs for treatment use. FDA has received a number of questions about implementation of its expanded access regulations. Therefore, FDA is providing this draft guidance in a question and answer format, addressing the most frequently asked questions.
78 FR 27116 - Draft Guidance for Industry on Charging for Investigational Drugs Under an Investigational New Drug Application—Questions and Answers; Availability
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notice of availability. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 8, 2013. 21 CFR Part 312 Summary The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Charging for Investigational Drugs Under an IND—Qs & As.” This guidance is intended to provide information for industry, researchers, and physicians on how FDA is implementing its regulation on charging for an investigational drug under an investigational new drug (IND) application. FDA has received a number of questions about how it is implementing the charging regulation. Therefore, FDA is providing this draft guidance in a question and answer format, addressing the most frequently asked questions and answers, including questions about charging for investigational drugs made available under expanded access programs.
2012-04-30; vol. 77 # 83 - Monday, April 30, 2012 77 FR 25353 - Disqualification of a Clinical Investigator
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective May 30, 2012. 21 CFR Parts 16, 312, 511, and 812 Summary The Food and Drug Administration (FDA) is amending the regulations to expand the scope of clinical investigator disqualification. Under this rulemaking, when the Commissioner of Food and Drugs (the Commissioner) determines that an investigator is ineligible to receive one kind of test article (drugs, devices or new animal drugs), the investigator also will be ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for other kinds of products regulated by FDA. This final rule is based in part upon recommendations from the Government Accountability Office (GAO), and is intended to help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA. FDA also is amending the list of regulatory provisions under which an informal regulatory hearing is available by changing the scope of certain provisions and adding regulatory provisions that were inadvertently omitted.
2012-02-06; vol. 77 # 24 - Monday, February 6, 2012 77 FR 5696 - Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic National Stockpile
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective February 6, 2012. 21 CFR Parts 201, 312, 314, 601, 610, 801, 807, 809, 812, and 814 Summary The Food and Drug Administration (FDA) is adopting as a final rule, without change, the interim final rule that issued regulations permitting FDA Center Directors to grant exceptions or alternatives to certain regulatory labeling requirements applicable to human drugs, biological products, or medical devices that are or will be included in the Strategic National Stockpile (SNS). FDA is taking this action to complete the rulemaking initiated with the interim final rule.
