Documents

Food Labeling: Calorie Labeling of Articles of Food Sold From Certain Vending Machines; Front of Package Type Size

Federal Register · Rule · Oct 28, 2019

Summary of Comments to the Proposed Rule The proposed rule provided a 90-day comment period. We received more than 120 comments. … of the FD&C Act.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Utilization of Adequate Provision Among Low to Non-Internet Users

Federal Register · Notice · Mar 13, 2018

Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to conduct research relating to drugs and other FDA regulated products in carrying out … the provisions of the FD&C Act.

Food and Drug Administration Patient Network Annual Meeting; Demystifying Food and Drug Administration: An Exploration of Drug Development Hosted by the Food and Drug Administration Office of Health and Constituent Affairs, Formerly the Office of Special Health Issues

Federal Register · Notice · Aug 9, 2013

information on a variety of topics, including new product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings, proposed regulatory guidances and opportunity to comment … , and other information of interest to patients and patient advocates; and • Hosting of periodic meetings, briefings, and listening sessions between patient advocates and FDA staff.

Food Additives Permitted for Direct Addition to Food for Human Consumption; Vitamin D2 and Vitamin D3

Federal Register · Rule · Jul 18, 2016

We have not received any new information or comments that would affect our previous determination. VII. Paperwork Reduction Act of 1995 This final rule contains no collection of information. … Section 301( ll ) of the Federal Food, Drug, and Cosmetic Act Our review of this petition was limited to section 409 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 348).

Advisory Committees: Notice of Meetings

Federal Register · Notice · Dec 29, 1995

emphasized, however, that the 1 hour time limit for an open public hearing represents a minimum rather than a maximum time for public participation, and an open public hearing may last for whatever longer period … The Federal Advisory Committee Act (FACA) (5 U.S.C. app. 2, 10(d)), permits such closed advisory committee meetings in certain circumstances.

Food Labeling: Nutrient Content Claims, General Principles; Health Claims, General Requirements and Other Specific Requirements for Individual Health Claims

Federal Register · Proposed Rule · Dec 21, 1995

This new law amended the Federal Food, Drug, and Cosmetic Act (the act) in a number of important ways. … In the Federal Register of January 6, 1993 (58 FR 2066), FDA also issued ``Food Labeling Regulations Implementing the Nutrition Labeling and Education Act of 1990; Opportunity for Comments,'' (the implementation

Potential New Indication for Testosterone Replacement Therapy

Federal Register · Notice · Apr 20, 2026

FDA is in the process of reviewing the comments received. … Patent and Trademark Office and/or by periods of exclusivity.

Food Labeling: Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids

Federal Register · Proposed Rule · Nov 27, 2007

To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail. … Table 4 of this document presents the proportion of branded SKUs that are typically redesigned within a given period of time.

Advisory Committees; Notice of Meetings

Federal Register · Notice · Oct 2, 1995

emphasized, however, that the 1 hour time limit for an open public hearing represents a minimum rather than a maximum time for public participation, and an open public hearing may last for whatever longer period … The Federal Advisory Committee Act (FACA) (5 U.S.C. app. 2, 10(d)), permits such closed advisory committee meetings in certain circumstances.

Advisory Committees; Notice of Meetings

Federal Register · Notice · Dec 27, 1995

emphasized, however, that the 1 hour time limit for an open public hearing represents a minimum rather than a maximum time for public participation, and an open public hearing may last for whatever longer period … The Federal Advisory Committee Act (FACA) (5 U.S.C. app. 2, 10(d)), permits such closed advisory committee meetings in certain circumstances.

Current Good Manufacturing Practice Requirements for Combination Products

Federal Register · Proposed Rule · Sep 23, 2009

under the PHS Act and/or the act. … FDA requests comment on this issue.

Revised Effectiveness Determination; Sunscreen Drug Products for Over-the-Counter Human Use

Federal Register · Proposed Rule · Jun 17, 2011

Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (the PRA) by July 18, 2011, (see the “Paperwork Reduction Act of 1995” section of this document). … Reform Act of 1995 (Pub.

List of Bulk Drug Substances That May Be Used in Pharmacy Compounding

Federal Register · Proposed Rule · Jan 7, 1999

DATES: Submit written comments on or before March 23, 1999. … Request for Comments Interested persons may, on or before March 23, 1999, submit to the Dockets Management Branch (address above) written comments regarding this proposal.

Food Labeling; Calorie Labeling of Articles of Food in Vending Machines

Federal Register · Proposed Rule · Apr 6, 2011

Submit comments on the information collection issues under the Paperwork Reduction Act of 1995 by May 6, 2011, (see the “Paperwork Reduction Act of 1995” section of this document). … Many of these comments were general comments on the law itself and either supported or opposed the requirement in section 403(q)(5)(H)(viii) of the FD&C Act that calorie information be provided for foods

Advisory Committee; Notice of Meeting

Federal Register · Uncategorized Document · May 31, 1994

brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time required to make their comments … This notice is issued under section 10(a)(1) and (2) of the Federal Advisory Committee Act (5 U.S.C. app. 2), and FDA's regulations (21 CFR part 14) on advisory committees. Dated: May 23, 1994.

Hoechst Marion Roussel, Inc., and Baker Norton Pharmaceuticals, Inc.; Terfenadine; Proposal To Withdraw Approval of Two New Drug Applications and One Abbreviated New Drug Application; Opportunity for a Hearing

Federal Register · Notice · Jan 14, 1997

The Director is proposing to withdraw approval of NDA 18-949 and NDA 19-664 in accordance with section 505(e)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(e)(2)). … Any other interested person may also submit comments on this notice.

Advisory Committee; Notice of Meeting

Federal Register · Uncategorized Document · Feb 2, 1994

brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time required to make their comments … This notice is issued under section 10(a)(1) and (2) of the Federal Advisory Committee Act (5 U.S.C. app. 2), and FDA's regulations (21 CFR part 14) on advisory committees.

Advisory Committee; Notice of Meeting

Federal Register · Uncategorized Document · Mar 23, 1994

brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time required to make their comments … This notice is issued under section 10(a)(1) and (2) of the Federal Advisory Committee Act (5 U.S.C. app. 2), and FDA's regulations (21 CFR part 14) on advisory committees.

Advisory Committee; Notice of Meeting

Federal Register · Uncategorized Document · Jun 3, 1994

brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time required to make their comments … This notice is issued under section 10(a)(1) and (2) of the Federal Advisory Committee Act (5 U.S.C. app. 2), and FDA's regulations (21 CFR part 14) on advisory committees. Dated: May 27, 1994.

Advisory Committee; Notice of Meeting

Federal Register · Uncategorized Document · Oct 3, 1994

brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time required to make their comments … This notice is issued under section 10(a)(1) and (2) of the Federal Advisory Committee Act (5 U.S.C. app. 2), and FDA's regulations (21 CFR part 14) on advisory committees.