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.
2014-11-14; vol. 79 # 220 - Friday, November 14, 2014 79 FR 68114 - Division of Freedom of Information; Change of Office Name, and Removal of Address, Telephone Number, and Fax Number; Technical Amendment
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendments. This rule is effective November 14, 2014. 21 CFR Parts 5, 10, 14, 20, 21, 314, 350, 516, and 814 Summary The Food and Drug Administration (FDA) is amending the Agency's regulations to change the Division of Freedom of Information's (FOI's) name, and remove the address, telephone number, fax number, and Public Reading Room fax number and room number and replace them with FOI's address located on the Agency's Web site. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
2014-09-08; vol. 79 # 173 - Monday, September 8, 2014 79 FR 53133 - Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Correction
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; correction. Effective date: September 8, 2014. 21 CFR Parts 310, 314, 329, and 600 Summary The Food and Drug Administration (FDA) is correcting a final rule entitled “Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements” that appeared in the Federal Register of June 10, 2014 (79 FR 33072). The document amended FDA's postmarketing safety reporting regulations for human drug and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. The document was published with an incorrect RIN number. This document corrects the error.
79 FR 53133 - Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Corrections
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; corrections. Effective Date: September 8, 2014. 21 CFR Part 310, 314, 329, and 600 Summary The Food and Drug Administration (FDA) is correcting a document entitled “Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Correction” that appeared in the Federal Register of August 14, 2014 (79 FR 47655). The document published without the required RIN number and in the Notice category. This document corrects those errors.
2014-06-10; vol. 79 # 111 - Tuesday, June 10, 2014 79 FR 33072 - Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective June 10, 2015. 21 CFR Parts 310, 314, 329, and 600 Summary The Food and Drug Administration (FDA or we) is amending its postmarketing safety reporting regulations for human drug and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. FDA is taking this action to improve the Agency's systems for collecting and analyzing postmarketing safety reports. The change will help the Agency to more rapidly review postmarketing safety reports, identify emerging safety problems, and disseminate safety information in support of FDA's public health mission. In addition, the amendments will be a key element in harmonizing FDA's postmarketing safety reporting regulations with international standards for the electronic submission of safety information.
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 15 - COMMERCE AND TRADE U.S. Code: Title 21 - FOOD AND DRUGS
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 314 after this date.
2015-02-18; vol. 80 # 32 - Wednesday, February 18, 2015 80 FR 8577 - Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products; Public Meeting; Request for Comments; Reopening of the Comment Period
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Notice of public meeting; request for comments; reopening of the comment period. Meeting. The public meeting will be held on March 27, 2015, from 8 a.m. to 5 p.m. Registration to attend the meeting must be received by March 20, 2015. See the SUPPLEMENTARY INFORMATION section for information on how to register for the meeting. Comments. The comment period for the proposed rule publilshed November 13, 2013 (78 FR 67985), is reopened. Submit either electronic or written comments regarding proposed alternatives to the proposed rule by April 27, 2015. 21 CFR Parts 314 and 601 Summary The Food and Drug Administration (FDA) is announcing a 1-day public meeting entitled “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products.” The purpose of the meeting is to provide a public forum for FDA to listen to comments on the proposed rule on “changes being effected” supplements that was published in the Federal Register of November 13, 2013, and alternatives offered to this proposed rule. FDA is also reopening the comment period for the proposed rule to receive submissions of additional written comments on the proposed rule as well as alternative proposals presented during the public meeting.
2015-02-06; vol. 80 # 25 - Friday, February 6, 2015 80 FR 6802 - Abbreviated New Drug Applications and 505(b)(2) Applications
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 May 7, 2015. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by March 9, 2015 (see the “Paperwork Reduction Act of 1995” section of this document). See section VII of this document for the proposed effective date of a final rule based on this document. 21 CFR Parts 314 and 320 Summary The Food and Drug Administration (FDA) is proposing regulations to implement Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), which amended provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that govern the approval of 505(b)(2) applications and abbreviated new drug applications (ANDAs). This proposed rule would implement portions of Title XI of the MMA that pertain to provision of notice to each patent owner and the new drug application (NDA) holder of certain patent certifications made by applicants submitting 505(b)(2) applications or ANDAs; the availability of 30-month stays of approval on 505(b)(2) applications and ANDAs that are otherwise ready to be approved; submission of amendments and supplements to 505(b)(2) applications and ANDAs; and the types of bioavailability and bioequivalence data that can be used to support these applications. This proposed rule also would amend certain regulations regarding 505(b)(2) applications and ANDAs to facilitate compliance with and efficient enforcement of the FD&C Act.
2014-11-14; vol. 79 # 220 - Friday, November 14, 2014 79 FR 68114 - Division of Freedom of Information; Change of Office Name, and Removal of Address, Telephone Number, and Fax Number; Technical Amendment
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; technical amendments. This rule is effective November 14, 2014. 21 CFR Parts 5, 10, 14, 20, 21, 314, 350, 516, and 814 Summary The Food and Drug Administration (FDA) is amending the Agency's regulations to change the Division of Freedom of Information's (FOI's) name, and remove the address, telephone number, fax number, and Public Reading Room fax number and room number and replace them with FOI's address located on the Agency's Web site. This action is editorial in nature and is intended to improve the accuracy of the Agency's regulations.
2014-09-08; vol. 79 # 173 - Monday, September 8, 2014 79 FR 53133 - Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Correction
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; correction. Effective date: September 8, 2014. 21 CFR Parts 310, 314, 329, and 600 Summary The Food and Drug Administration (FDA) is correcting a final rule entitled “Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements” that appeared in the Federal Register of June 10, 2014 (79 FR 33072). The document amended FDA's postmarketing safety reporting regulations for human drug and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. The document was published with an incorrect RIN number. This document corrects the error.
79 FR 53133 - Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Corrections
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule; corrections. Effective Date: September 8, 2014. 21 CFR Part 310, 314, 329, and 600 Summary The Food and Drug Administration (FDA) is correcting a document entitled “Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements; Correction” that appeared in the Federal Register of August 14, 2014 (79 FR 47655). The document published without the required RIN number and in the Notice category. This document corrects those errors.
2014-06-10; vol. 79 # 111 - Tuesday, June 10, 2014 79 FR 33072 - Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Requirements
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final rule. This rule is effective June 10, 2015. 21 CFR Parts 310, 314, 329, and 600 Summary The Food and Drug Administration (FDA or we) is amending its postmarketing safety reporting regulations for human drug and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. FDA is taking this action to improve the Agency's systems for collecting and analyzing postmarketing safety reports. The change will help the Agency to more rapidly review postmarketing safety reports, identify emerging safety problems, and disseminate safety information in support of FDA's public health mission. In addition, the amendments will be a key element in harmonizing FDA's postmarketing safety reporting regulations with international standards for the electronic submission of safety information.
