Documents

Tobacco Products, User Fees, Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products

Federal Register · Rule · Jul 10, 2014

These comments relate to tobacco products that are not currently subject to chapter IX of the FD&C Act. … (Comment 7) One comment recommended that FDA “develop a schedule for periodically reevaluating and adjusting user fee percentage allocations” for tobacco product classes as well as manufacturers and importers

Crabmeat; Amendment of Common or Usual Name Regulation

Federal Register · Uncategorized Document · Jul 15, 1994

Comments Interested persons may, on or before September 13, 1994, submit to the Dockets Management Branch (address above) written comments regarding this proposal. … Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document.

Submission of Food and Drug Administration Import Data in the Automated Commercial Environment for Veterinary Devices

Federal Register · Proposed Rule · Aug 3, 2020

Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (PRA) by September 2, 2020. … Costs, Benefits, and Distributional Effects of the Proposed Rule Category Primary estimate Low estimate High estimate Units Year dollars Discount rate (%) Period

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 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).

International Harmonization; Policy on Standards

Federal Register · Notice · Oct 11, 1995

The statutory mandates for safeguarding the public health in these product sectors are prescribed in several statutes, notably in the Federal Food, Drug, and Cosmetic Act; the Public Health Service Act … ; and the Fair Packaging and Labeling 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 D3

Federal Register · Rule · Jun 29, 2005

Follow the instructions for submitting comments. • Agency Web site: http://www.fda.gov/dockets/ecomments . Follow the instructions for submitting comments on the agency Web site. … Paperwork Reduction Act of 1995 This final rule contains no collection of information.

Advisory Committee; Notice of Meeting

Federal Register · Uncategorized Document · Jul 27, 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 · Notice · Feb 2, 1995

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 [[Page 6537]] 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 · Notice · Nov 29, 1995

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.

Premarket Notification; Requirement for Redacted Version of Substantially-Equivalent Premarket Notification

Federal Register · Proposed Rule · Dec 21, 1999

DATES: Submit written comments by March 22, 2000. Submit written comments on the information collection requirements by January 20, 2000. … A second reason is that by the time a FOIA request is filed and predisclosure notification is given, a significant period of time may have passed since the 510(k) was cleared by FDA.

International Dairy Foods Association and Chobani, Inc.: Response to the Objections and Requests for a Public Hearing on the Final Rule To Revoke the Standards for Lowfat Yogurt and Nonfat Yogurt and To Amend the Standard for Yogurt

Federal Register · Rule · Dec 15, 2022

We will review this copy, including the claimed confidential information, in our consideration of comments. … Under section 701(e)(1) of the FD&C Act (21 U.S.C. 371(e)(1)), any action for the amendment or repeal of any definition and standard of identity under section 401 of the FD&C Act for any dairy product

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.

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.

Ruminant Feed Ban Support Project; Availability of Cooperative Agreements: Request for Applications: RFA-FDA-ORA-05-3; Catalog of Federal Domestic Assistance Number: 93.449

Federal Register · Notice · Jul 1, 2005

FDA does not guarantee to accommodate or explain SPOC comments that are received after the 60-day cutoff. 5. … Periodic site visits with officials of the grantee organization may also occur.

Advisory Committees; Notice of Meetings

Federal Register · Notice · Feb 20, 1997

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 … This notice is issued under section 10(a)(1) and (a)(2) of the Federal Advisory Committee Act (5 U.S.C. app. 2), and FDA's regulations (21 CFR part 14) on advisory committees.

Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study of Risk Information Amount and Location in Direct-to-Consumer Print Ads

Federal Register · Notice · Aug 14, 2018

out the provisions of the FD&C Act. … The commenter suggests incorporating a parameter to capture this, for example, including a re-contact option to test recall and interpretation after a period of 2-4 days.

Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Amendment of the Tentative Final Monograph for Combination Drug Products

Federal Register · Proposed Rule · Feb 23, 1995

The agency is providing a short comment period of 75 days and plans to issue a notice of enforcement policy at a later date to state whether marketing may begin prior to the issuance of the final monograph … Therefore, under the Regulatory Flexibility Act, no further analysis is required.

Joint Meeting of the Drug Safety and Risk Management Advisory Committee, Nonprescription Drugs Advisory Committee, and the Anesthetic and Life Support Drugs Advisory Committee; Notice of Meeting

Federal Register · Notice · Apr 24, 2009

Addresses : Electronic comments should be submitted to http://www.regulations.gov . … All comments received will be posted without change, including any personal information provided.