Documents

New Animal Drugs; Approval of New Animal Drug Applications; Change of Sponsor

Federal Register · Rule · Mar 8, 2021

This rule is issued under section 512(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(i)), which requires Federal Register publication of the conditions of use of an approved … A notice published pursuant to section 512(i) is not subject to the notice-and-comment rulemaking requirements of the Administrative Procedure Act, 5 U.S.C. 551 et seq.

Medical Devices; Classification/Reclassification of Immunohistochemistry Reagents and Kits

Federal Register · Rule · Jun 3, 1998

One comment asked FDA to discuss with the Health Care Financing Administration (HCFA) and announce the Medicare reimbursement status of: (1) IHC reagents in the interim period while manufacturers prepared … Regulatory Enforcement Fairness Act of 1966 (Pub.

Amendments to Sterility Test Requirements for Biological Products

Federal Register · Proposed Rule · Jun 21, 2011

This verification activity may be necessary periodically or each time a sample is tested, depending upon the test method used. … Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520).

Advisory Committee; Notice of Meeting

Federal Register · Notice · May 25, 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.

Advisory Committee; Notice of Meeting

Federal Register · Notice · Jan 17, 1996

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 · Nov 28, 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.

Permanent Listing of Color Additive Lakes

Federal Register · Proposed Rule · Mar 4, 1996

Paperwork Reduction Act XII. Comments XIII. References I. … until the period for filing objections is over.

Advisory Committee; Notice of Meeting

Federal Register · Notice · May 7, 1996

that the 1 hour time limit for an open public hearing represents a minimum rather than a maximum time [[Page 20528]] 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 Committee; Notice of Meeting

Federal Register · Notice · Apr 18, 1997

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 … The Federal Advisory Committee Act (FACA) (5 U.S.C. app. 2, 10(d)), permits such closed advisory committee meetings in certain circumstances.

Advisory Committee; Notice of Meeting

Federal Register · Notice · May 15, 1997

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 … 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; Statement of Identity, Nutrition Labeling and Ingredient Labeling of Dietary Supplements; Compliance Policy Guide, Revocation

Federal Register · Rule · Sep 23, 1997

The 1990 amendments amended the Federal Food, Drug, and Cosmetic Act (the act) in a number of important ways. … The agency has carefully reviewed these comments but concludes that the best reading of the act, as well as the agency's longstanding regulations that implement the act, require that the term ``dietary

Medical Devices; Patient Examination and Surgeons' Gloves; Test Procedures and Acceptance Criteria; Correction

Federal Register · Rule · Jan 19, 2007

Introduction FDA has examined the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). … FDA acknowledged these differences in the proposed rule and solicited comment on other appropriate measures for estimating the societal value of avoiding blood-borne pathogens.

Indirect Food Additives: Adhesives and Components of Coatings; Paper and Paperboard Components; Polymers; Adjuvants, Production Aids, and Sanitizers

Federal Register · Rule · May 20, 2022

Evaluation of Abandonment Section 409(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 348(i)) states that we must, by regulation, establish the procedure for amending or repealing … However, this delay did not affect the length of the 60-day comment period for the petition or the outcome of FDA's review of the petition.

Regulations Regarding “Intended Uses”

Federal Register · Proposed Rule · Sep 23, 2020

Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before October 23, 2020. … Benefits, Costs, and Distributional Effects of Proposed Rule Category Primary estimate Low estimate High estimate Units Year dollars Discount rate (percent) Period

Draft Compliance Policy Guide Sec. 555.320 Listeria monocytogenes; Notice of Public Meeting

Federal Register · Notice · Feb 7, 2008

Stakeholders will have an opportunity to ask questions about the draft CPG and provide oral comments on the draft CPG. … Under section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 342(a)(1)), a food shall be deemed to be adulterated if it bears or contains any poisonous or deleterious substance

Advisory Committee; Notice of Meeting

Federal Register · Notice · Jul 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 … 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: July 19, 1995.

Advisory Committee; Notice of Meeting

Federal Register · Notice · Jan 21, 1997

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 (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.

Advisory Committee; Notice of Meeting

Federal Register · Notice · Apr 30, 1996

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 · May 8, 1996

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.

Medical Devices; Investigational Device Exemptions

Federal Register · Proposed Rule · Jul 15, 1998

The proposed regulatory changes are intended to reflect amendments to the Federal Food, Drug, and Cosmetic Act (the act) by the FDA Modernization Act of 1997 (FDAMA). … Increasing the frequency at which data or information is gathered or lengthening the subject follow-up period.