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Federal Register · Notice · Mar 16, 2015
Medical Device Recall Authority—21 CFR 810 (OMB Control Number 0910-0432)—Extension This collection of information implements section 518(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 … Request for Regulatory Hearing—810.11(a) 1 1 1 8 8 Written Request for Review—810.12(a-b) 1 1 1 8 8 Mandatory Recall Strategy—810.14 2 1 2 16 32 Periodic
80 FR 13586Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 19, 2015
(the FD&C Act) (21 U.S.C. 334(g)) to detain during established inspections devices that are believed to be adulterated or misbranded. … 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.
80 FR 63232Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Sep 13, 2018
Act of 1995 (Pub. … Act of 1995.
83 FR 46444Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 20, 2009
comment in response to the notice. … Periodic drug experience reports and special drug experience reports must be accompanied by a completed Form FDA 2301, “Transmittal of Periodic Reports and Promotional Material for New Animal Drugs” (see
74 FR 60265Health and Human Services DepartmentFood and Drug AdministrationBio-Components, Inc.; Revocation of U.S. License No. 1160
Federal Register · Notice · Aug 5, 1997
BCI did not submit, within the 30-day time period, a written request for a hearing on the proposed revocation of its license. … The 30-day time period, prescribed in the notice of opportunity for a hearing and in the regulations, may not be extended.
62 FR 42133Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 29, 2016
DATES: Fax written comments on the collection of information by March 30, 2016. … Periodic drug experience reports and special drug experience reports must be accompanied by a completed Form FDA 2301, “Transmittal of Periodic Reports and Promotional Material for New Animal Drugs” (see
81 FR 10252Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 3, 2019
&C Act. 4 Section 503B(d)(4)(C) of the FD&C Act. … rationale for such proposal; (2) providing a period of not less than 60 calendar days for comment on the notice; and (3) publishing a notice in the Federal Register designating bulk drug substances
84 FR 46014Health and Human Services DepartmentFood and Drug AdministrationFederal 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 · Aug 15, 2018
(FD&C Act) (21 U.S.C. 352(b)(1)). … Section 760(e) of the FD&C Act (21 U.S.C. 379aa(e)) also requires that responsible persons maintain records of nonprescription adverse event reports, whether or not the event is serious, for a period of
83 FR 40520Health 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 · Jun 17, 2015
DATES: Fax written comments on the collection of information by July 17, 2015. … (the FD&C Act) (21 U.S.C. 360) clearance.
80 FR 34682Health 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 Administration
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