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Briefs, oral arguments, agency decisions and the Federal Register.
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Federal 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 AdministrationRepeal of Regulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation
Federal Register · Proposed Rule · Sep 12, 2018
Act of 1995 (Pub. … Reduction Act of 1995 (44 U.S.C. 3501-3520).
83 FR 46121Health and Human Services DepartmentFood and Drug AdministrationAntimicrobial Animal Drug Sales and Distribution Reporting
Federal Register · Proposed Rule · Jul 27, 2012
Background Section 512( l ) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b( l )) requires sponsors of approved or conditionally approved new animal drug applications … FDA is soliciting public comment on whether, consistent with its authority under section 512( l ) of the FD&C Act to collect information relating to approved new animal drugs, it should amend its regulations
77 FR 44177Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 22, 2017
of 2002 (the Bioterrorism Act) added section 414 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 350c), which requires that persons who manufacture, process, pack, hold, receive, … Existing records may be used if they contain all of the required information and are retained for the required time period. Section 101 of the FDA Food Safety Modernization Act (FSMA) (Pub.
82 FR 44427Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 3, 2010
States that are awarded this option will receive up to $25,000 over a period of 5 years to fully implement the program standards. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010-4340 Filed 3-2-10; 8:45 am] BILLING CODE 4160-01-S
75 FR 9605Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 7, 2016
The comment period closed on June 6, 2016. FDA reviewed and considered all public comments received and revised the guidance as appropriate. II. … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations.
81 FR 78167Health and Human Services DepartmentFood and Drug AdministrationBlood Vessels Recovered With Organs and Intended for Use in Organ Transplantation; Withdrawal
Federal Register · Rule · Sep 14, 2006
The comment period closed July 26, 2006. HRSA and FDA are withdrawing the direct final rule because FDA received significant adverse comment. … Authority: Therefore, under the Public Health Service Act and under authority delegated to the Commissioner of Food and Drugs and to the Administrator, Health Resources and Services Administration, the
71 FR 54198Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Apr 1, 2019
Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before July 1, 2019. … (section 534(a)-(b) of the FD&C Act).
84 FR 12147Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Health Claims; Dietary Noncariogenic Carbohydrate Sweeteners and Dental Caries
Federal Register · Rule · May 27, 2008
Summary of Comments and the Agency's Response FDA solicited comments on the interim final rule. The comment period closed on December 3, 2007. … FDA received no comments relevant to economic impact.
73 FR 30299Health and Human Services DepartmentFood and Drug AdministrationChallenges and Solutions in Lot-Level Food Traceability; Public Meeting and Request for Comments
Federal Register · Notice · May 28, 2026
Subsequently, the Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act of 2026 (Pub. … Individuals who want to speak during the public comment period must register by June 5, 2026. Same-day registration is not allowed.
91 FR 31723Health 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 AdministrationFederal Register · Notice · Mar 2, 2009
(the act) (21 U.S.C. 360) clearance. … with FDA an annual report for 3 consecutive years, this would be less burdensome than the current postapproval under part 814, subpart E (21 CFR part 814, subpart E), including the submission of periodic
74 FR 9097Health and Human Services DepartmentFood and Drug AdministrationGuidance for Industry on Providing Regulatory Submissions in Electronic Format-ANDAs; Availability
Federal Register · Notice · Jun 27, 2002
In the Prescription Drug User Fee Act as amended by the Food and Drug Administration Modernization Act of 1997 (Public Law 105-115), the agency stated its plans to develop and update its information management … The comment period closed on January 15, 2002, and the agency considered the received comments as it finalized this guidance.
67 FR 43331Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 15, 2016
Annualized over a 20-year period, we estimate these costs to range from $1.1 million to $3.2 million. … The Agency requested public comments on the proposed rule, and the comment period closed on June 18, 2013.
81 FR 38911Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 18, 2017
We review the records during the conduct of periodic plant inspections. This information is needed so that we can monitor drug usage and possible misformulation of Type A medicated articles. … In the Federal Register of October 17, 2016 (81 FR 71513), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received no comment.
82 FR 32834Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 24, 2022
Section 506(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 356(a)) provides for the granting of BTD “if the drug is intended, alone or in combination with 1 or more other drugs, to … Accordingly, in keeping with the Agency's authority to grant BTD only to drugs that meet the legal criteria, FDA periodically assesses whether the criteria for BTD continue to be met for designated products
87 FR 37865Health and Human Services DepartmentFood and Drug AdministrationTin-Coated Lead Foil Capsules for Wine Bottles
Federal Register · Rule · Feb 8, 1996
These comments apparently derive in large measure from the fact that the State of California has acted to prohibit the use of capsules that contain more than 0.3 percent lead. … The USDA food consumption survey (1977-1978) reported average wine intake per day for individuals who drank wine on 1, 2, and 3 days over a 3-day period.
61 FR 4816Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 25, 2016
(the FD&C Act) 505(j)(2)(A) and (j)(4) (21 U.S.C. 355(j)(2)(A) and (j)(4))). … FDA intends to hold a public meeting following the close of the comment period to discuss further the evaluation of the abuse deterrence of generic opioid drug products and related issues, as appropriate
81 FR 16186Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 11, 2006
act) (21 U.S.C. 343(q)) establishes the requirements for nutrition labeling of foods. … Based on the labeling cost model, FDA expected that, with a compliance period of over 2 years, 75 percent of firms will coordinate labeling revisions required by the trans fat final rule with other planned
71 FR 18338Health and Human Services DepartmentFood and Drug AdministrationAdministrative Practices and Procedures; Good Guidance Practices
Federal Register · Rule · Sep 19, 2000
(Comment 26) One comment suggested that we adopt a 30-day grace period for Level 1 guidance documents issued without prior public participation. … A grace period would not be needed for a guidance document because guidance is not binding on us or you.
65 FR 56468Health and Human Services DepartmentFood and Drug Administration
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