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Briefs, oral arguments, agency decisions and the Federal Register.
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Federal Register · Notice · Oct 1, 2018
The report must cover the period of the preceding calendar year and include separate information for each month of the calendar year. … Animal drug manufacturers are already required to maintain distribution records for their animal drug products to comply with FDA's current good manufacturing regulations for periodic drug reports under
83 FR 49395Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Aug 25, 2004
The 90-day comment period closed on January 16, 2001. The agency received comments from two tampon manufacturers. III. … Act of 1995 (44 U.S.C. 3501-3520).
69 FR 52170Health and Human Services DepartmentFood and Drug AdministrationMichael Terry Little: Final Debarment Order
Federal Register · Notice · Jun 3, 2024
SUMMARY: The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Michael Terry Little 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 47576Health and Human Services DepartmentFood and Drug AdministrationEffective Date of Requirement for Premarket Approval for Four Class III Preamendments Devices
Federal Register · Proposed Rule · Aug 25, 2010
Section 515(b)(3) of the act provides that FDA shall, after the close of the comment period on the proposed rule and consideration of any comments received, issue a final rule to require premarket approval … The act does not permit an extension of the 90-day period after issuance of a final rule within which an application or a notice is required to be filed.
75 FR 52294Health and Human Services DepartmentFood and Drug AdministrationCarlton Reico Mallard Jr.: Final Debarment Order
Federal Register · Notice · May 29, 2025
SUMMARY: The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Carlton Reico Mallard Jr. for a period of 10 years from importing … FDA finds that the offenses should be accorded a debarment period of 10 years, with the maximum possible period of debarment as provided by section 306(c)(2)(A)(iii) of the FD&C Act for each felony count
90 FR 22736Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 23, 2003
DATES: Fax written comments on the collection of information by November 24, 2003. … 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: Fumie Yokota, Desk Officer
68 FR 60697Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 21, 2020
Requests for Open Public Comment Period Speakers: FDA will hold an open public comment period to give the public an opportunity to comment on the meeting topics. … The open public comment period is for in-person attendees only. Open public comment period speakers will be notified of their selection approximately 7 days before the public meeting.
85 FR 3384Health and Human Services DepartmentFood and Drug AdministrationEvan Asher Field: Final Debarment Order
Federal Register · Notice · May 30, 2025
SUMMARY: The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Evan Asher Field 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.
90 FR 23057Health and Human Services DepartmentFood and Drug AdministrationMichael Dominic Diaz: Final Debarment Order
Federal Register · Notice · May 29, 2025
SUMMARY: The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Michael Dominic Diaz 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.
90 FR 22732Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 4, 2008
Application for FDA Approval to Market a New Drug—(OMB Control Number 0910-0001)—Extension Under section 505(a) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(a)), a new drug may … Other interested persons may also submit comments on the notice.
73 FR 865Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 27, 2016
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 … FDA received one comment from the public.
81 FR 4628Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 3, 2017
The final guidance addresses new provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) added by the Drug Quality and Security Act (DQSA) and updates reporting instructions for drug compounders … The comment period for the revised draft guidance ended on January 23, 2015. FDA received three comments on the draft.
82 FR 129Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Aug 22, 2014
Follow the instructions for submitting comments. … , Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 321 et seq. ).
79 FR 49727Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 28, 2013
The draft guidance was announced in the Federal Register of January 5, 2011 (76 FR 570), and the comment period closed on April 5, 2011. No comments were received during the comment period. II. … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations.
78 FR 18988Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Sep 11, 1998
SUPPLEMENTARY INFORMATION: FDA solicited comments concerning the direct final rule for a 75-day period ending July 27, 1998. … the comment period.
63 FR 48576Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Sep 13, 2022
Act) and the FOIA Improvement Act of 2016 (FOIA Improvement Act). … The comment asserted that newly promulgated regulations under the FDA Food Safety Modernization Act (Pub.
87 FR 55907Health and Human Services DepartmentFood and Drug AdministrationVeterinary Feed Directive; Draft Text for Proposed Regulation
Federal Register · Proposed Rule · Apr 13, 2012
In the Federal Register of March 29, 2010 (75 FR 15387), FDA published an advance notice of proposed rulemaking (ANPRM) with a 90-day comment period requesting comments on all aspects of the VFD regulations … FDA published a subsequent document in the Federal Register of June 28, 2010 (75 FR 36588), extending the ANPRM comment period for an additional 60 days.
77 FR 22247Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 20, 2013
The regulations were issued under FDA's statutory authority to regulate food safety, including section 402(a)(1) and (a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 342(a)(1) and … No comments were received in response to the notice.
78 FR 69687Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 8, 2008
Background On October 26, 2002, MDUFMA (Public Law 107-250), amended the Federal Food, Drug, and Cosmetic Act (the act). … The comment period for the draft guidance document closed on September 18, 2006. During the comment period, we received several comments and recommendations.
73 FR 1358Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 19, 2016
The statutory basis for FDA conducting this study is derived from the Public Health Service Act (PHS Act) (42 U.S.C. 243, section 311(a)). … The sample for each data collection period is evenly distributed among Specialists.
81 FR 64168Health and Human Services DepartmentFood and Drug Administration
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