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Briefs, oral arguments, agency decisions and the Federal Register.
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Federal Register · Notice · Jun 23, 2015
New Animal Drugs for Investigational Uses—21 CFR Part 511 OMB Control Number 0910-0117—Extension FDA has the authority under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to approve new animal … maintain records showing the name and post office address of the expert or expert organization to whom it is shipped and the date, quantity, and batch or code mark of each shipment and delivery for a period
80 FR 35956Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 6, 2000
These recordkeeping requirements for administrative detentions allow FDA to trace devices for which the detention period expired before a seizure is accomplished or injunctive relief is obtained. … In the Federal Register of March 31, 2000 (65 FR 17282), the agency requested comments on the proposed collection of information. No significant comments were received.
65 FR 41679Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 3, 2005
Infant Formula Recall Regulations—21 CFR 107.230, 107.240, 107.250, 107.260, 107.280 (OMB Control Number 0910-0188)—Extension Section 412(e) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C … Manufacturers keep infant formula distribution records for the prescribed period as a matter of routine business practice.
70 FR 22885Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 17, 2026
In the Federal Register of April 9, 2025 (90 FR 15248), FDA extended the comment period of the draft guidance until June 9, 2025. … Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information.
91 FR 53257Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 15, 2012
(the FD&C Act) (21 U.S.C. 360) clearance. … an annual report for 3 consecutive years, this would be less burdensome than the current postapproval requirements under part 814, subpart E (21 CFR part 814, subpart E), including the submission of periodic
77 FR 8879Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 27, 2014
Prescription Drug Advertisements—(OMB Control Number 0910-0686)—Extension Section 502(n) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 352(n)) requires that manufacturers, packers … Section 202.1 applies to advertisements published in journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television, and telephone communication
79 FR 11112Health and Human Services DepartmentFood and Drug AdministrationSecond Annual Animal Drug User Fee Educational Conference; Public Meeting
Federal Register · Notice · May 29, 2025
Background The Animal Drug User Fee Act (Pub. L. 108-130) (ADUFA or the Act) was originally signed into law in 2003 and was subsequently reauthorized by Congress in 2008, 2013, 2018, and 2023. … “The Animal Drug User Fee Act Reauthorization Performance Goals and Procedures Fiscal Years 2024 Through 2028” (Performance Goals Letter) sets forth the Agency's performance goals for the period covered
90 FR 22739Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 11, 2019
901(b) of the FD&C Act (21 U.S.C. 387a(b))). … Among other requirements, section 904(e) of the FD&C Act (21 U.S.C. 387d(e)) requires FDA to establish, and periodically revise as appropriate, a list of HPHCs, including smoke constituents, to health
84 FR 3188Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 16, 2018
(FD&C Act) (21 U.S.C. 360(k)) clearance. … devices file with FDA an annual report for 3 consecutive years, this would be less burdensome than the current postapproval requirements under 21 CFR part 814, subpart E, including the submission of periodic
83 FR 32883Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 24, 2025
ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. … Third-party reviewers should maintain records of their 510(k) reviews and a copy of the 510(k) for a reasonable period of time, usually 3 years.
90 FR 52971Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 6, 2020
FDA-2020-N-0989] Assessing the Resource Needs of the Prescription Drug User Fee Act and Biosimilar User Fee Act; Publication of Report; Request for Comments AGENCY: Food and Drug Administration, … FDA-2020-N-0989 for “Assessing the Resource Needs of the Prescription Drug User Fee Act, Biosimilar User Fee Act, Report Publication; Request for Comments.”
85 FR 19149Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 15, 2020
(FD&C Act). … period to September 16, 2019 (84 FR 40071).
85 FR 42867Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 26, 2024
FDA has revised and is reissuing the draft guidance in response to public comments and recent amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act). … The comment period for the original draft guidance ended on September 23, 2022.
89 FR 5244Health and Human Services DepartmentFood and Drug AdministrationDrug Labeling; Sodium Labeling for Over-the-Counter Drugs; Partial Delay of Effective Date
Federal Register · Rule · Apr 24, 1997
In response to two requests for extension of time to file comments to the final rule, FDA published a notice in the Federal Register of July 22, 1996 (61 FR 38046), extending the comment period until September … (the act).
62 FR 19923Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 26, 2000
(the act). … During the period when an innovator drug is being marketed, it may undergo a number of changes that are approved through supplements to new drug applications (NDA's).
65 FR 64225Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Aug 29, 2006
We invite comment on whether a shorter implementation period would be preferable. … Therefore, we selected the proposed implementation periods as a reasonable balance. We solicit public comment on the proposed implementation period and the effect on expected costs and benefits.
71 FR 51276Health and Human Services DepartmentFood and Drug AdministrationAgency Emergency Processing Under OMB Review; Emergency Medical Device Shortage Program Survey
Federal Register · Notice · Mar 26, 2002
DATES: Submit written comments on the collection of information by April 25, 2002. … FDA estimates that approximately 10 percent of these manufacturers would be contacted in a 1-year period, due to limitations on FDA staff.
67 FR 13788Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 17, 2003
mail comments to sshapiro@omb.eop.gov . … Therefore, FDA estimates that approximately 150 manufacturers would be contacted in a 1-year period.
68 FR 12705Health and Human Services DepartmentFood and Drug AdministrationRevocation of Authorization for Use of Brominated Vegetable Oil in Food
Federal Register · Rule · Jul 3, 2024
We discuss the comments later in this final rule. IV. Legal Authority We are issuing this final rule under sections 409(i) and 701(a) of the FD&C Act. … The time between the publication of our final rule and the rule's compliance period should minimize costly disruptions to manufacturers still using BVO.
89 FR 55040Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 20, 2026
“3PLs”), as directed by the Drug Supply Chain Security Act (DSCSA). … Therefore, to keep its approval, FDA is proposing to require that an AO maintain certain records for a period of at least 5 years and these records must be readily available to FDA upon request.
91 FR 8247Health and Human Services DepartmentFood and Drug Administration
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