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Briefs, oral arguments, agency decisions and the Federal Register.
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Required Warnings for Cigarette Packages and Advertisements; Research Report
Federal Register · Proposed Rule · Dec 7, 2010
Background The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) was enacted on June 22, 2009, amending the Federal Food, Drug, and Cosmetic Act and the Federal Cigarette Labeling … On November 12, 2010, FDA published a proposed rule seeking comment on these new requirements (75 FR 69524). The proposed rule provides a 60-day comment period, which ends January 11, 2011.
75 FR 75936Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Needle-Bearing Devices; Request for Comments and Information
Federal Register · Proposed Rule · Jun 20, 2002
FDA regulates medical devices, including those containing sharps under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) (the act). … The CDC reported that, for the period from June 1995 to July 1999, there were 4,951 sharp object injuries reported to its surveillance system.
67 FR 41890Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 11, 2026
The meeting and written comments submitted to the docket will provide critical input as the Agency prepares for reauthorization discussions. … Notification of Intent to Participate in Periodic Stakeholder Consultation Meetings If you intend to participate in continued periodic stakeholder consultation meetings regarding ADUFA reauthorization
91 FR 25576Health and Human Services DepartmentFood and Drug AdministrationListing of Color Additives Exempt From Certification; Galdieria Extract Blue
Federal Register · Rule · May 12, 2025
All control animals and treated animals survived during the treatment period of 90 days and during the 28-day recovery period. No gross treatment-related changes were observed at necropsy. … We did not receive any new information or comments regarding this claim of categorical exclusion.
90 FR 20104Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 24, 2021
Background In accordance with section 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360e(d)(4) and (e)(2)), notification of an order approving, denying, or withdrawing … Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period.
86 FR 15686Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Dec 29, 2015
Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed order, consideration of any comments received, and a meeting of a device classification … For ECT devices, the preamendments class III devices that are the subject of this proposal, the later of these two time periods is the 90-day period.
80 FR 81223Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 12, 2015
The comment period on the draft guidance ended on May 20, 2015. FDA received eleven comments on the draft guidance. … Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES
80 FR 48324Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Nov 30, 2023
DATES: Either electronic or written comments on the proposed rule must be submit by February 28, 2024. ADDRESSES: You may submit comments as follows. … after opening and using for a defined period.
88 FR 83774Health and Human Services DepartmentFood and Drug AdministrationRevocation of Authorization for Use of Brominated Vegetable Oil in Food
Federal Register · Proposed Rule · Nov 3, 2023
DATES: Either electronic or written comments on the proposed rule must be submitted by January 17, 2024. ADDRESSES: You may submit comments as follows. … Section 701(a) of the FD&C Act (21 U.S.C. 371(a)) provides the authority to issue regulations for the efficient enforcement of the FD&C Act. VI.
88 FR 75523Health and Human Services DepartmentFood and Drug AdministrationGuidance Documents Related to Coronavirus Disease 2019; Availability
Federal Register · Notice · Feb 19, 2021
availability of certain COVID-19-related guidances that FDA issued during the relevant period, as included in table 1. … Paperwork Reduction Act of 1995 A.
86 FR 10285Health and Human Services DepartmentFood and Drug AdministrationPediatric Ethics Subcommittee of the Pediatric Advisory Committee; Notice of Meeting
Federal Register · Notice · Aug 4, 2004
Also elsewhere in this issue of the Federal Register is a document announcing a public comment period concerning whether the proposed clinical investigation should proceed. … Information regarding submitting comments during that period is contained in that document.
69 FR 47157Health and Human Services DepartmentFood and Drug AdministrationFood Additives Permitted for Direct Addition to Food for Human Consumption; Neotame
Federal Register · Rule · Jul 9, 2002
Comments IV. Conclusion V. Environmental Effects VI. Paperwork Reduction Act of 1995 VII. References VIII. Objections I. … Paperwork Reduction Act of 1995 This final rule contains no collection of information.
67 FR 45300Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · May 29, 2001
Comment No. CP1, Docket No. 96P-0460, Dockets Management Branch. 2. Comment No. SUP1, Docket No. 96P-0460, Dockets Management Branch. 3. Comment No. … and Regulatory Fairness Act of 1996 (Public Law 104-121)), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4) (2 U.S.C. 1501 et seq .).
66 FR 29059Health and Human Services DepartmentFood and Drug AdministrationPrescription Drug User Fee Act, ``PDUFA II Five-Year Plan;'' Availability
Federal Register · Notice · Jul 10, 1998
This plan is intended to show FDA's anticipated prescription drug user fee revenues and planned expenditures of the fee revenues over the 5-year period from 1998 through 2002. … Food and Drug Administration Modernization Act of 1997 (FDAMA).
63 FR 37401Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · May 27, 2016
We provided an opportunity to comment on the serving size proposed rule until June 2, 2014. On May 27, 2014, we extended the comment period until August 1, 2014 (79 FR 30056). … We believe the comment period on the proposed rule provided a sufficient opportunity to comment on this and other related issues. As discussed in section III.
81 FR 34000Health and Human Services DepartmentFood and Drug AdministrationGeneral Requirements for Blood, Blood Components, and Blood Derivatives; Donor Notification
Federal Register · Rule · Jun 11, 2001
(the act). … (c) Time period for notification .
66 FR 31165Health and Human Services DepartmentFood and Drug AdministrationGuidance for Industry on Use of Material From Deer and Elk in Animal Feed; Availability
Federal Register · Notice · Sep 16, 2003
FDA considered all comments received. II. Paperwork Reduction Act of 1995 FDA concludes that this guidance contains no collections of information. … FDA periodically will review the comments in the docket and, where appropriate, will amend the guidance.
68 FR 54233Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Class I Surgeon's and Patient Examination Gloves
Federal Register · Notice · Apr 16, 2021
FDA invited comments on the February 2, 1998, Notice, and received no comments regarding gloves. … started to be used after the March 30, 2020, guidance until November 30, 2020, which was the end of the adverse event review period.
86 FR 20167Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Apr 22, 1996
It is anticipated that most antacid drug products would undergo a label printing within a 12-month period. … A period of 90 days from the date of publication of this proposed rulemaking in the Federal Register will be provided for comments on this subject to be developed and submitted.
61 FR 17807Health and Human Services DepartmentFood and Drug AdministrationRevisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma
Federal Register · Rule · Jan 3, 2012
Reform Act of 1995 (Pub. … Service Act.
77 FR 7Health and Human Services DepartmentFood and Drug Administration
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