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Conventional Foods Being Marketed as “Functional Foods”; Public Hearing; Request for Comments
Federal Register · Proposed Rule · Oct 25, 2006
ACTION: Notice of public hearing; request for comments. … If you wish to request an opportunity to make an oral presentation during the open public comment period of the hearing, your notice of participation also must include the title of your presentation, the
71 FR 62400Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 3, 2012
A risk modification order issued under section 911(g)(1) will be effective for the period of time specified in the order issued by FDA (section 911(h)(4) of the FD&C Act). … Because the dates on which orders are issued and the length of the period for which the order is valid will vary, FDA expects one request for renewal annually.
77 FR 20026Health and Human Services DepartmentFood and Drug AdministrationProposed Warning Labels for Iron-Containing Products; FDA Report on Consumer Research; Availability
Federal Register · Notice · May 23, 1995
FDA is inviting comments on the findings in this report. DATES: Written comments by July 24, 1995. … After the comment period shown above, copies of the document will be available at cost from the Freedom of Information Staff (HFI-35), Food and Drug Administration, rm. 12A-16, 5600 Fishers Lane, Rockville
60 FR 27321Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 16, 2009
Administrative Detention and Banned Medical Devices (OMB Control Number 0910-0114)—Extension FDA has the statutory authority under section 304(g) of the Federal Food, Drug, and Cosmetic Act (the act … These recordkeeping requirements for administrative detentions pemits FDA to trace devices for which the detention period expired before a seizure is accomplished or injunctive relief is obtained.
74 FR 53257Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 13, 2022
Under section 705 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 375), the Secretary of the Department of Health and Human Services (the Secretary) may require dissemination of information … We have identified 24 DHCP letters that 18 distinct sponsors submitted to FDA during the 3-year period (2019 to 2021).
87 FR 76203Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 1, 2002
The guidance was made available as a draft for comment on December 7, 2001 (66 FR 63546). The comment period closed March 7, 2002. FDA received two comments, both agreeing with FDA's recommendation. … Paperwork Reduction Act of 1995 This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995
67 FR 44218Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 11, 2022
One comment was received that was not PRA related. … Submissions under section 904(c) of the FD&C Act are for any new product that is not yet on the market ( e.g., if on the market due to deeming compliance period, deemed product manufacturers should
87 FR 49593Health and Human Services DepartmentFood and Drug AdministrationCrabmeat; Amendment of Common or Usual Name Regulation
Federal Register · Proposed Rule · Apr 23, 1998
(the act) (21 U.S.C. 343(b)). … Comments Interested persons may on or before July 7, 1998, submit to the Dockets Management Branch (address above) written comments regarding this proposal.
63 FR 20148Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 15, 2008
Section 760(e) of the act also requires that responsible persons maintain records of nonprescription drug adverse event reports, whether or not the event is serious, for a period of 6 years. … No comments were received on the information collection.
73 FR 53251Health and Human Services DepartmentFood and Drug AdministrationRequired 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 AdministrationIngrown Toenail Relief Drug Products for Over-the-Counter Human Use
Federal Register · Proposed Rule · Oct 4, 2002
The agency is providing a period of 60 days from the date of publication of this proposed rulemaking in the Federal Register for comments to be developed and submitted. … section 505(a) of the act.
67 FR 62218Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 24, 2014
The guidance addresses new provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Quality and Security Act (DQSA). … The comment period on the draft guidance ended on February 3, 2014. FDA received nine comments on the draft guidance.
79 FR 69859Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 26, 2010
DATES: Submit written or electronic comments on the collection of information by March 29, 2010. … Section 130(a) of the Food and Drug Administration Modernization Act (Public Law 105-115) amended the Federal Food, Drug, and Cosmetic Act (the act) by adding a new provision (section 506B of the act (
75 FR 4081Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 9, 2002
Background Section 403(r)(4)(A)(iii) of the Federal Food, Drug and Cosmetic Act (the act) (21 U.S.C. 343(r)(4)(A)(iii)), provides that any person may petition the Secretary of Health and Human Services … If FDA fails to notify the petitioner of its decision to grant or deny the petition within the 100-day period, the petition shall be considered to be granted.
67 FR 72963Health and Human Services DepartmentFood and Drug AdministrationRahim Shafa; Denial of Hearing; Final Debarment Order
Federal Register · Notice · Aug 31, 2026
Shafa is subject to mandatory debarment under section 306(a)(2)(B) of the FD&C Act and permissive debarment under section 306(b)(3)(C) of the FD&C Act, FDA then must determine the debarment period for … Shafa during his period of debarment (section 306(c)(1)(B) of the FD&C Act). Additionally, as a result of the foregoing findings, Dr.
91 FR 55886Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 22, 2003
This section requires FDA to publish in the Federal Register a notice of intent to exempt a device, or of the petition, and to provide a 30-day comment period. … Paperwork Reduction Act of 1995 This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995
68 FR 19834Health and Human Services DepartmentFood and Drug AdministrationPublic Meeting on Pre-Market Evaluation of Abuse-Deterrent Properties of Opioid Drug Products
Federal Register · Notice · Oct 6, 2016
See section 505(j)(2)(A) and (j)(4) of the FD&C Act. … Topics for discussion during the open public comment period on Day 1 and by the panel: • Based on any testing you have attempted to perform or performed in accordance with the March 2016 draft guidance
81 FR 69532Health 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 · Notice · Jun 27, 2008
New Animal Drugs for Investigational Use (OMB Control Number 0910-0117)—Extension FDA has authority under the Federal Food, Drug, and Cosmetic Act (the act) to approve new animal drugs. … maintain records showing: (1) The name and post office address of the expert or expert organization to whom the drug is shipped; and (2) the date, quantity, batch or code mark for each shipment for a period
73 FR 36533Health 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 Administration
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