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Briefs, oral arguments, agency decisions and the Federal Register.
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Federal Register · Notice · Feb 25, 2008
Paperwork Reduction Act of 1995 This 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).
73 FR 10035Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 18, 2014
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 … These procedures may include, but are not limited to, review of records and manufacturing deviations and defects, and periodic audits.
79 FR 75569Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 27, 2023
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. … Records are maintained on file at each testing facility and examined there periodically by FDA inspectors.
88 FR 82906Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 20, 2016
The public comment period closed on June 25, 2003. A number of comments were received, which the Agency considered carefully as it prepared this revised draft guidance. … Paperwork Reduction Act of 1995 This draft guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act
81 FR 23303Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 11, 2016
In the Federal Register of April 9, 2014 (79 FR 19622), the Agency announced that the deadline for the comment period would be extended until May 7, 2014, to allow for more public comments on this … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations and guidance.
81 FR 70120Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 27, 2024
Therefore, designated countries may respond to our periodic requests by submitting information to confirm their designations remain appropriate. … Although three comments were received, the comments were not responsive to the four collection of information topics solicited.
89 FR 21257Health and Human Services DepartmentFood and Drug AdministrationFDA Plan for Statutory Compliance
Federal Register · Notice · Nov 24, 1998
Submit e-mail comments to ``FDAD[email protected]''. E-mail comments should be labeled as comments and identified with the docket number found in brackets in the heading of this document. … scientific and technical expertise needed by the Secretary to meet the obligations of the Secretary under the act; (5) establishing mechanisms, by July 1, 1999, for meeting the time periods specified in
63 FR 65000Health and Human Services DepartmentFood and Drug AdministrationInvestigational New Drug Applications; Clinical Holds
Federal Register · Rule · Dec 14, 1998
The comment period for the direct final rule runs concurrently with that of the companion proposed rule. … adverse comment.
63 FR 68676Health and Human Services DepartmentFood and Drug AdministrationElectronic Cigarettes and the Public Health; Public Workshop
Federal Register · Notice · Dec 30, 2014
For those requesters with Internet access, Caryn Cohen (see Contact Person ) will email you regarding your request to speak during the public comment period by February 23, 2015. … Comments submitted to the docket will not be added to other dockets, such as the docket for the proposed rule deeming additional tobacco products subject to the FD&C Act. II.
79 FR 78450Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 8, 1997
(the [[Page 36559]] PHS Act) and the Federal Food, Drug, and Cosmetic Act (the act). … In the interim period the old Form FDA 356h, interim Form FDA 3439, and the new Form FDA 356h are all acceptable alternatives for NDA's, ANDA's, and AADA's.
62 FR 36558Health and Human Services DepartmentFood and Drug AdministrationPublic Information Regulations; Withdrawal
Federal Register · Rule · Jan 18, 2005
: The Food and Drug Administration (FDA) published in the Federal Register of September 2, 2004, a direct final rule to incorporate exemptions one, two, and three of the Freedom of Information Act … The comment period closed November 16, 2004. FDA is withdrawing the direct final rule because the agency received significant adverse comment.
70 FR 2799Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 19, 2009
The abbreviated comment period is necessary because pandemic (H1N1) 2009 virus has the potential to cause disruptions in the blood supply and given this possibility, the agency needs to finalize the guidance … Paperwork Reduction Act of 1995 The draft guidance refers to previously approved collections of information found in FDA regulations.
74 FR 59982Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 14, 2015
The comment period closed on September 30, 2014. FDA received 55 sets of comments on the draft guidance. FDA published a final guidance on July 1, 2015 (80 FR 37633). … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations.
80 FR 48868Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 26, 2019
As amended by the FDA Food Safety Modernization Act (FSMA) (Pub. … L. 111-353), the Federal Food, Drug, and Cosmetic Act (FD&C Act) enables the Agency to better protect the public health by helping to ensure the safety and security of the food supply.
84 FR 6152Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jul 20, 2010
The comment period closed on June 15, 2010. FDA is withdrawing the direct final rule because the agency received significant adverse comment. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010-17617 Filed 7-19-10; 8:45 am] BILLING CODE 4160-01-S
75 FR 41986Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 29, 2021
Section 301 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 331) prohibits the misbranding of FDA-regulated products, including prescription drugs. … 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
86 FR 22686Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 17, 1999
In the Federal Register of February 23, 1999 (64 FR 8832), the agency requested comments on the proposed collections of information. No comments were received. … Manufacturers keep infant formula distribution records for the prescribed period as a matter of routine business practice.
64 FR 26765Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 9, 2021
Such a prolonged assessment period (in which patients may receive multiple therapies) with low death rates may make the use of overall survival impractical as a primary endpoint to support approval of … Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021-16929 Filed 8-6-21; 8:45 am] BILLING CODE 4164-01-P
86 FR 43551Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 25, 2017
Administration (FDA or we) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act … diagnostic testing of the donor indicating T. cruzi infection, we recommend that the establishment notify consignees of all previously distributed blood and blood components collected during the lookback period
82 FR 19062Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 19, 2003
Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act … During that 4-year period, an average of five antimicrobial NADAs (including original and major supplements) was approved in food-producing animals per year.
68 FR 54906Health and Human Services DepartmentFood and Drug Administration
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