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Briefs, oral arguments, agency decisions and the Federal Register.
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Federal 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 · Nov 27, 2017
(the FD&C Act). … The DSCSA phases in its requirements over a period of 10 years.
82 FR 56033Health 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 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 AdministrationFood and Drug Administration Report and Plan on Best Practices for Guidance; Availability
Federal Register · Notice · Dec 3, 2024
device developers; clinical research organizations; clinical laboratories; healthcare providers; food manufacturers; and patient and consumer groups. 3 The 60-day public comment period closed … A few comments proposed specific topic areas for consideration of future guidance development.
89 FR 95799Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 21, 2014
Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the 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.
79 FR 42333Health 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 AdministrationFood Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis
Federal Register · Rule · Sep 29, 2008
Summary of Comments and the Agency's Response FDA solicited comments on the calcium and vitamin D proposed rule. The comment period closed on March 21, 2007. … per product if the compliance period is 24 months.
73 FR 56477Health 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 · Jun 12, 2014
Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed … Records are maintained on file at each testing facility and examined there periodically by FDA inspectors.
79 FR 33755Health and Human Services DepartmentFood and Drug AdministrationBare-Hand Contact of Ready-to-Eat Foods
Federal Register · Notice · Aug 13, 1999
Oral comments may be made during the open public comment period, Tuesday, September 21, 1999, between 4 p.m. and 5 p.m. … Dotzel, Acting Associate Commissioner for Policy. [FR Doc. 99-20992 Filed 8-12-99; 8:45 am] BILLING CODE 4160-01-F
64 FR 44225Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 6, 2024
L. 105-115), adding section 506 to the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 356). … specified time period after the date of accelerated approval.
89 FR 97011Health and Human Services DepartmentFood and Drug Administration180-Day Exclusivity: Questions and Answers; Draft Guidance for Industry; Availability
Federal Register · Notice · Jan 13, 2017
This draft guidance is intended to address questions that have been raised about the provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that relate to generic drug exclusivity, which commonly … (see section 505(j)(2) and (j)(5) of the FD&C Act).
82 FR 4361Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 29, 2024
FDA has the statutory authority under section 304(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 334(g)) to detain during established inspections devices that are believed to be adulterated … These recordkeeping requirements for administrative detentions permit FDA to trace devices for which the detention period expired before a seizure is accomplished or injunctive relief is obtained.
89 FR 94734Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 7, 2001
Use of Impact-Resistant Lenses in Eyeglasses and Sunglasses (OMB Control Number 0910-0182)—Extension Under section 519 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360(i)), every manufacturer … In the Federal Register of November 28, 2000 (65 FR 70916), the agency requested comments on the proposed collection of information. One comment was received.
66 FR 13769Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 18, 1998
Form FDA 2301 is used for the required transmittal of periodic reports and promotional material for new animal drugs. … In response, FDA received one comment to the docket.
63 FR 64090Health and Human Services DepartmentFood and Drug Administration
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