Documents
Briefs, oral arguments, agency decisions and the Federal Register.
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Federal Register · Notice · Nov 17, 2017
Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information described in FDA regulations. … These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
82 FR 54387Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 11, 2016
(Response) As required under the Paperwork Reduction Act (PRA), FDA provided 60 days for respondents to submit comment in response to the December 29, 2015, notice. … Any specific estimates submitted by PET drug producers and facilities subsequent to the comment period provided for under the PRA will be reviewed and considered by FDA for future renewals of this information
81 FR 44876Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Aug 16, 2000
The comment period closed on June 12, 2000. … (c) Conveyance means any land or air carrier, or any vessel as defined in paragraph (h) of this section.
65 FR 49906Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 3, 2020
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. … In the Federal Register of December 5, 2019 (84 FR 66673), we published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
85 FR 18985Health and Human Services DepartmentFood and Drug AdministrationAnticaries Drug Products for Over-the-Counter Human Use; Final Monograph
Federal Register · Rule · Oct 6, 1995
Interested persons were invited to submit comments by June 26, 1980. Reply comments in response to comments filed in the initial comment period could be submitted by July 28, 1980. … period.
60 FR 52474Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 8, 2021
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. … Section 801.410(f) requires that the results of impact tests and description of the test method and apparatus be retained for a period of 3 years.
86 FR 56274Health and Human Services DepartmentFood and Drug AdministrationGuidance Documents Related to Coronavirus Disease 2019 (COVID-19); Availability
Federal Register · Notice · May 12, 2020
Therefore, FDA will issue COVID-19-related guidance documents for immediate implementation without prior public comment (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) … a consolidated NOA announcing the availability of COVID-19-related guidance documents FDA issued during the relevant period.
85 FR 28010Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 13, 2021
Section 801.410(f) requires that the results of impact tests and description of the test method and apparatus be retained for a period of 3 years. … We invite comment on our estimates and these assumptions. Dated: July 2, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy.
86 FR 36752Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 12, 2016
Act (21 U.S.C. 371(h)(1)(C)(i)) and § 10.115. … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations.
81 FR 89469Health and Human Services DepartmentFood and Drug AdministrationBaldev Raj Bhutani; Denial of Hearing; Final Debarment Order
Federal Register · Notice · Dec 2, 2004
The act defines the conduct and felony conviction that lead to debarment. The period of debarment is also in section 306(c)(2) of the act, which states that the debarment is permanent. … “Clean Hands” Doctrine Mr.
69 FR 70148Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 20, 2026
FDA-2025-D-7121 for “Compliance Policy Regarding Premarket and Other Requirements for Certain NIOSH Approved Air-Purifying Respirators.” … Paperwork Reduction Act of 1995 While this guidance contains no new collection of information, it does refer to previously approved FDA collections of information.
91 FR 21003Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 26, 2012
provisions of the FD&C Act. … KnowledgePanel® members are accustomed to receiving periodic communication about surveys that they previously participated in and respond well to periodic contact. 3.
77 FR 76046Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 14, 2018
ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk … Two comments were received. One discussed the importance of food safety, and the other comment was unrelated to the information collection.
83 FR 40293Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Mar 25, 2026
The comment period on the proposed order closed on August 29, 2022, and the docket for the Panel meeting also closed on August 29, 2022. … The majority of the comments received by the close of the comment periods were from individual medical professionals.
91 FR 14445Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Dec 5, 2000
(Comment 39) Several comments requested a longer compliance period for the new egg label. … FDA received no comments requesting longer compliance periods for the refrigeration provision. (Comment 41) Some comments requested a 12-month compliance period for the labeling provision.
65 FR 76092Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Aug 28, 1997
DATES: Submit written comments at any time. … Under a mandatory HACCP program, FDA would propose a phase in period for implementation of HACCP plans for juice products.
62 FR 45593Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Apr 17, 1997
The agency invites the public to submit comments with questions and concerns about the draft. DATES: Written comments must be received in the Dockets Management Branch by 4:30 p.m. d.s.t. … (the act).
62 FR 18728Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 13, 2004
Background On October 26, 2002, MDUFMA (Public Law 107-250) amended the Federal Food, Drug, and Cosmetic Act (the act) by adding section 510(o) (21 U.S.C. 360(o)), which provided new regulatory requirements … Since that time, the agency has received comments on various MDUFMA provisions, including several on its implementation of section 510(o) of the act.
69 FR 19433Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 10, 1996
DATES: Written comments by August 8, 1996. … These would include diet, cleaning, and feeding schedules, provisions for periodic veterinary care if applicable, and details of special handling that the animals may require once inoculated.
61 FR 21882Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 15, 2016
validation of cleaning and disinfection of heater-cooler devices in support of labeling claims and technical instructions; (3) appropriate risk mitigations to be implemented by manufacturers of heater-cooler … Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: April 12, 2016.
81 FR 22280Health and Human Services DepartmentFood and Drug Administration
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