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Federal Register · Notice · Aug 14, 2020
Under section 701(a) of the FD&C Act, we are authorized to issue regulations for the FD&C Act's efficient enforcement. … Existing records may be used if they contain all of the required information and are retained for the required time period.
85 FR 49657Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 10, 2018
Paperwork Reduction Act of 1995 This revised draft guidance refers to previously approved collections of information found in FDA regulations.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).
83 FR 50942Health and Human Services DepartmentFood and Drug AdministrationAnimal Generic Drug User Fee Act; Public Meeting; Request for Comments
Federal Register · Notice · Dec 5, 2012
FDA-2011-N-0655] Animal Generic Drug User Fee Act; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of meeting; request for comments. … AGDUFA Achievements AGDUFA I established increasingly stringent review performance goals over a 5-year period from FY 2009 through FY 2013.
77 FR 72359Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 14, 2013
Drug, and Cosmetic Act (the FD&C Act) to specify certain situations in which FDA cannot disapprove an IDE. … The Agency has considered the comments received during the comment period and incorporated modifications, as appropriate.
78 FR 35937Health and Human Services DepartmentFood and Drug AdministrationOver-the-Counter Drug Products Containing Phenylpropanolamine; Required Labeling
Federal Register · Proposed Rule · Feb 14, 1996
Therefore, under the Regulatory Flexibility Act, no further analysis is required. … A period of 90 days from the date of publication of this proposed rulemaking in the Federal Register will be provided for comments on this subject to be developed and submitted.
61 FR 5912Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 18, 1998
The agency is seeking comments on the draft guidance. DATES: Written comments may be submitted on the draft guidance by August 17, 1998. … These regulatory definitions and requirements reflect requirements in the Federal Food, Drug, and Cosmetic Act and other agency regulations.
63 FR 33375Health and Human Services DepartmentFood and Drug AdministrationSubstances Affirmed as Generally Recognized as Safe: Menhaden Oil
Federal Register · Proposed Rule · Jan 15, 2004
FDA will review any comments that are relevant to this condition of use and that are received within the 75-day comment period and will respond accordingly to these comments in the Federal Register … At the close of the comment period, the agency had received two comments that expressed concern regarding the environmental impact of the proposed rule.
69 FR 2313Health and Human Services DepartmentFood and Drug AdministrationRobert Lance Shuffert: Final Debarment Order
Federal Register · Notice · Apr 5, 2024
SUMMARY: The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Robert Lance Shuffert for a period of 5 years from importing or … In proposing a debarment period, FDA weighed the considerations set forth in section 306(c)(3) of the FD&C Act that it considered applicable to Mr.
89 FR 24013Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 7, 2007
DATES: Fax written comments on the collection of information by April 6, 2007. … 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 Officer
72 FR 10222Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 20, 2026
With regard to adverse events and product/manufacturing defects associated with approved new animal drugs, section 512(l) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(l)) requires … The information collection also includes Form FDA 2301; Transmittal of Periodic Reports and Promotional Material for New Animal Drugs.
91 FR 8245Health and Human Services DepartmentFood and Drug AdministrationBrendon Gagne: Final Debarment Order
Federal Register · Notice · Feb 9, 2024
SUMMARY: The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Brendon Gagne for a period of 5 years from importing or offering … In proposing a debarment period, FDA weighed the considerations set forth in section 306(c)(3) of the FD&C Act that it considered applicable to Mr.
89 FR 9158Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Dec 21, 2023
Comments on the Proposed Rule and FDA Response A. Introduction We received fewer than 50 comment letters on the proposed rule by the close of the comment period. … Review Act/Small Business Regulatory Enforcement Fairness Act (5 U.S.C. 801, Pub.
88 FR 88228Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities: Proposed Collection; Comment Request
Federal Register · Notice · Dec 30, 1997
public comment in response to the notice. … The media campaign would be conducted over a 12-month period in each State that receives it.
62 FR 67876Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 4, 2003
DATES: Effective October 1, 2003, for all inspections conducted under section 354(g) of the Public Health Service Act (PHS Act) (42 U.S.C. 263b(g)). Submit written comments by October 1, 2003. … Request for Comments Although the MQSA does not require FDA to solicit comments on fee exemption, assessment and collection, FDA is inviting comments from interested persons in order to have the benefit
68 FR 52589Health and Human Services DepartmentFood and Drug AdministrationRichard M. Fleming; Denial of Hearing; Final Debarment Order
Federal Register · Notice · Sep 28, 2018
In determining the appropriateness and period of Fleming's debarment, FDA considered the relevant factors listed in the FD&C Act. … The proposal outlined findings concerning the four relevant factors that ORA considered in determining the appropriateness and period of debarment, as provided in section 306(c)(3) of the FD&C Act: (1)
83 FR 49095Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities; Submission for OMB Review; Comment Request
Federal Register · Notice · Jan 5, 1998
DATES: Submit written comments on the collection of information by February 4, 1998. … ADDRESSES: Submit written comments on the collection of information to Office of Information and Regulatory Affairs, OMB, New Executive Office Bldg., 725 17th St.
63 FR 231Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 24, 2005
Recall Status Reports Requests that recalling firms provide periodic status reports so FDA can ascertain the progress of the recall. … In the Federal Register of October 12, 2004 (69 FR 60630), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received.
70 FR 49654Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 8, 2022
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. … Although FDA receives fewer than one application submission under section 571 of the FD&C Act annually when averaged over a 3-year period, we use a placeholder of one response and 1 hour annually to account
87 FR 34880Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 13, 2001
Color Additive Certification Requests and Recordkeeping—(21 CFR Part 80)—(OMB Control Number 0910-0216)—Extension Section 721(a) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 379e(a … Approximately 41 different respondents submitted requests for certification each year over the period FY 1998 to 2000.
66 FR 19174Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 19, 2005
(Comment 43) Some comments questioned why FDA did not reconvene an advisory review panel when it reopened the comment period in response to the Court order of October 27, 2004. … (Response) FDA is charged with implementing the Federal Food, Drug, and Cosmetic Act, as well as certain provisions of the Public Health Service Act.
70 FR 75180Health and Human Services DepartmentFood and Drug Administration
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