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 42 - THE PUBLIC HEALTH AND WELFARE
Title 21 published on 20-Sep-2017 03:51
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 1271 after this date.
2016-12-13; vol. 81 # 239 - Tuesday, December 13, 2016 81 FR 89848 - Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs; Correction
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; correction. Effective December 13, 2016. 21 CFR Parts 20, 201, 207, 314, 514, 515, 601, 607, and 1271 Summary The Food and Drug Administration (FDA) is correcting a final rule entitled “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs” that appeared in the Federal Register of August 31, 2016 (81 FR 60169). That final rule amended current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs. The final rule was published with an incorrect statement in the preamble about the rule's effect on establishments at which investigational drugs are manufactured. This document corrects that error.
2016-11-29; vol. 81 # 229 - Tuesday, November 29, 2016 81 FR 85854 - Submission of Food and Drug Administration Import Data in the Automated Commercial Environment
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective December 29, 2016. 21 CFR Parts 1, 1005, and 1271 Summary The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule/regulation to establish requirements for the electronic filing of entries of FDA-regulated products in the Automated Commercial Environment (ACE) or any other electronic data interchange (EDI) system authorized by the U.S. Customs and Border Protection Agency (CBP), in order for the filing to be processed by CBP and to help FDA in determining admissibility of that product. ACE is a commercial trade processing system operated by CBP that is designed to implement the International Trade Data System (ITDS), automate import and export processing, enhance border security, and foster U.S. economic security through lawful international trade and policy. FDA is a Partner Government Agency (PGA) for purposes of submission of import data in ACE. As of July 23, 2016, ACE became the sole EDI system authorized by CBP for entry of FDA-regulated articles into the United States. We also updated certain sections of FDA regulations related to imports. This rule will facilitate effective and efficient admissibility review by the Agency and protect public health by allowing FDA to focus its limited resources on those FDA-regulated products being imported or offered for import that may be associated with a greater public health risk.
2016-08-31; vol. 81 # 169 - Wednesday, August 31, 2016 81 FR 60170 - Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective on November 29, 2016. See section IV for compliance dates. 21 CFR Parts 20, 201, 207, 314, 514, 515, 601, 607, and 1271 Summary The Food and Drug Administration (FDA) is amending its regulations governing drug establishment registration and drug listing. These amendments reorganize, modify, and clarify current regulations concerning who must register establishments and list human drugs, human drugs that are also biological products, and animal drugs. The final rule requires electronic submission, unless waived in certain circumstances, of registration and listing information. This rulemaking pertains to finished drug products and to active pharmaceutical ingredients (APIs) alone or together with one or more other ingredients. The final rule describes how and when owners or operators of establishments at which drugs are manufactured or processed must register their establishments with FDA and list the drugs they manufacture or process. In addition, the rule makes certain changes to the National Drug Code (NDC) system. We are taking this action to improve management of drug establishment registration and drug listing requirements and make these processes more efficient and effective for industry and for us. This action also supports implementation of the electronic prescribing provisions of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and the availability of current drug labeling information through DailyMed, a computerized repository of drug information maintained by the National Library of Medicine.
2016-07-01; vol. 81 # 127 - Friday, July 1, 2016 81 FR 43155 - Submission of Food and Drug Administration Import Data in the Automated Commercial Environment
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule. Submit either electronic or written comments on the proposed rule by August 30, 2016. 21 CFR Parts 1, 1005, and 1271 Summary The Food and Drug Administration (FDA, the Agency, or we) is proposing to establish requirements for the electronic filing of entries of FDA-regulated products in the Automated Commercial Environment (ACE) or any other electronic data interchange (EDI) system authorized by the U.S. Customs and Border Protection Agency (CBP), in order for the filing to be processed by CBP and to help FDA in determining admissibility of that product. ACE is a commercial trade processing system operated by CBP that is designed to implement the International Trade Data System (ITDS), automate import and export processing, enhance border security, foster U.S. economic security through lawful international trade and policy, and to replace the Automated Commercial System (ACS). FDA is a Partner Government Agency (PGA) in the initiative to establish ITDS, the “single window” for the submission of import and export data to the United States Government. The proposed rule would also update certain sections of FDA regulations related to imports. This rule, as proposed, does not affect the ability of filers to continue to submit their import entries and entry summaries by paper for FDA-regulated products that are being imported or offered for import. Once finalized, this action will facilitate effective and efficient admissibility review by the Agency and protect public health by allowing FDA to focus its limited resources on those FDA-regulated products being imported or offered for import that may be associated with a greater public health risk.
2016-06-22; vol. 81 # 120 - Wednesday, June 22, 2016 81 FR 40512 - Revisions to Exceptions Applicable to Certain Human Cells, Tissues, and Cellular and Tissue-Based Products
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective August 22, 2016. 21 CFR Part 1271 Summary The Food and Drug Administration (FDA or Agency or we) is issuing this final rule to amend certain regulations regarding donor eligibility, including the screening and testing of donors of particular human cells, tissues, and cellular and tissue-based products (HCT/Ps), and related labeling. This final rule is in response to our enhanced understanding in this area and in response to comments from stakeholders regarding the importance of embryos to individuals and couples seeking access to donated embryos.
2016-04-22; vol. 81 # 78 - Friday, April 22, 2016 81 FR 23661 - Draft Guidances Relating to the Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Rescheduling of Public Hearing; Request for Comments
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification of rescheduling of public hearing; request for comments. The public hearing will be held on September 12 and 13, 2016, from 9 a.m. to 5 p.m. The hearing on September 13 may be extended or end early depending on the number of speakers scheduled. Persons (including FDA employees) seeking to view the hearing via a live Webcast are not required to register. Persons (including FDA employees) seeking to attend in person or to attend and speak at the public hearing must register by June 1, 2016. FDA will notify registered speakers of their scheduled times, and make available an agenda at http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetingsConferences/ucm462125.htm on or before July 1, 2016. Once FDA notifies registered speakers of their scheduled times, speakers should submit an electronic copy of their presentation to CBERPublicEvents@fda.hhs.gov by August 1, 2016. Section IV of this document provides attendance and registration information. Electronic or written comments will be accepted after the public hearing until September 27, 2016. 21 CFR Part 1271 Summary The Food and Drug Administration (FDA or Agency) is announcing a 2-day public hearing to obtain input on four draft guidance documents relating to the regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps). FDA had announced a 1-day public hearing for April 13, 2016, to obtain input on the guidances, but on February 29, 2016, announced that due to considerable interest in the public hearing and to give stakeholders additional time to provide comments to the Agency, the hearing was postponed. FDA also stated its intent to extend the comment period for the four draft guidance documents and to schedule a scientific workshop to identify and discuss the scientific considerations and challenges to help inform the development of HCT/Ps subject to premarket approval, including stem cell-based products. FDA will consider information it obtains from the public hearing in the finalization of the four draft guidance documents.
81 FR 23664 - Draft Guidances Relating to the Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Extension of Comment Periods
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification; extension of comment periods. FDA is extending the comment period on the four draft guidances announced in the Federal Register (see SUPPLEMENTARY INFORMATION ). Submit either electronic or written comments by September 27, 2016. 21 CFR Part 1271 Summary The Food and Drug Administration (FDA or the Agency) is extending the comment period for the draft guidance documents entitled “Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry”; “Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff”; “Human Cells, Tissues, and Cellular and Tissue-Based Products from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry”; and ”Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and FDA Staff.” The Agency is taking this action to allow interested persons additional time to submit comments and any new information.
2015-12-29; vol. 80 # 249 - Tuesday, December 29, 2015 80 FR 81233 - Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public Hearing; Request for Comments; Correction
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification of public hearing; request for comments; correction. 21 CFR Part 1271 Summary The Food and Drug Administration (FDA or Agency) is correcting a notification of a public hearing entitled “Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public Hearing; Request for Comments” that appeared in the Federal Register of October 30, 2015 (80 FR 66845). The document announced a public hearing to obtain input on four recently issued draft guidances relating to the regulation of human cells, tissues, or cellular or tissue-based products (HCT/Ps). The document published with conflicting information about who must register for the public hearing. This document corrects that error.
2015-10-30; vol. 80 # 210 - Friday, October 30, 2015 80 FR 66844 - Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff; Reopening of the Comment Period
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification; reopening of the comment period. Submit either electronic or written comments on the draft guidance by April 29, 2016. 21 CFR Part 1271 Summary The Food and Drug Administration (FDA) is reopening the comment period for the draft document entitled “Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff,” published in the Federal Register of December 23, 2014. FDA is reopening the comment period to allow interested persons additional time to submit comments and any new information.
80 FR 66845 - Draft Guidances Relating to the Regulation of Human Cells, Tissues, or Cellular or Tissue-Based Products; Public Hearing; Request for Comments
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification of public hearing; request for comments. The public hearing will be held on April 13, 2016, from 8 a.m. to 5 p.m. The meeting may be extended or end early depending on the level of public participation. Persons seeking to attend or to present at the public hearing must register by January 8, 2016. Section IV provides attendance and registration information. Electronic or written comments will be accepted after the public hearing until April 29, 2016. 21 CFR Part 1271 Summary The Food and Drug Administration (FDA or Agency) is announcing a 1-day public hearing to obtain input on four recently issued draft guidances relating to the regulation of human cells, tissues, or cellular or tissue-based products (HCT/Ps). These draft guidances were issued by FDA in response to stakeholders' requests for guidance on FDA's current views about how manufacturers, establishments, and distributors of HCT/Ps and health care professionals can meet the criteria under the Agency's regulations that apply to HCT/Ps. FDA will consider information it obtains from the public hearing in the finalization of these guidances.
80 FR 66847 - Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry; Reopening of the Comment Period
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification; reopening of the comment period. Submit either electronic or written comments on the draft guidance by April 29, 2016. 21 CFR Part 1271 Summary The Food and Drug Administration (FDA) is reopening the comment period for the draft document entitled “Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry” announced in the Federal Register of October 23, 2014. FDA is reopening the comment period to allow interested persons additional time to submit comments and any new information.
80 FR 66849 - Human Cells, Tissues, and Cellular and Tissue-Based Products From Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry; Reopening of the Comment Period
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notification; reopening of the comment period. Submit either electronic or written comments on the draft guidance by April 29, 2016. 21 CFR Part 1271 Summary The Food and Drug Administration (FDA) is reopening the comment period for the draft document entitled “Human Cells, Tissues, and Cellular and Tissue-Based Products from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry” published in the Federal Register of December 24, 2014. FDA is reopening the comment period to allow interested persons additional time to submit comments and any new information.
80 FR 66850 - Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration 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 April 29, 2016. 21 CFR Part 1271 Summary The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled “Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and FDA Staff.” The draft guidance document provides human cells, tissues, and cellular and tissue-based product (HCT/P) manufacturers, health care providers, and FDA staff, with recommendations for applying the criterion of “homologous use” as it applies to HCT/Ps. The interpretation and application of the homologous use criterion and related definitions have been of considerable interest to industry stakeholders since they were first proposed during the Agency's rulemaking on HCT/Ps.
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.
2014-12-31; vol. 79 # 250 - Wednesday, December 31, 2014 79 FR 78744 - Revisions to Exceptions Applicable to Certain Human Cells, Tissues, and Cellular and Tissue-Based Products
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Proposed rule. Submit either electronic or written comments on the proposed rule by March 31, 2015. 21 CFR Part 1271 Summary The Food and Drug Administration (FDA or Agency) is issuing this proposed rule to amend certain regulations regarding donor eligibility, including the screening and testing of donors of particular human cells, tissues, and cellular and tissue-based products (HCT/Ps), and related labeling. FDA is proposing this action in response to our enhanced understanding in this area and in response to comments from stakeholders regarding the importance of embryos to individuals and couples seeking access to donated embryos.
2014-12-24; vol. 79 # 247 - Wednesday, December 24, 2014 79 FR 77414 - Human Cells, Tissues, and Cellular and Tissue-Based Products From Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry; Availability
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notice of availability; request for comments on draft guidance. 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 February 23, 2015. 21 CFR Part 1271 Summary The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled “Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry” dated December 2014. The draft guidance document provides sponsors, clinicians, and other establishments that manufacture and use adipose tissue, with recommendations for complying with the regulatory framework for HCT/Ps. For purposes of applying the HCT/P regulatory framework, FDA considers connective tissue, including adipose tissue, to be a structural tissue. This draft guidance is not final nor is it in effect at this time.
2014-10-23; vol. 79 # 205 - Thursday, October 23, 2014 79 FR 63348 - Same Surgical Procedure Exception Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry; Availability
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Request for comment on draft guidance. 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 December 22, 2014 21 CFR Part 1271 Summary The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document entitled “Same Surgical Procedure Exception Questions and Answers Regarding the Scope of the Exception” dated October 2014. The draft guidance document is intended for tissue establishments and healthcare professionals and discusses one of the exceptions for establishments from certain regulatory requirements.
