Documents
Briefs, oral arguments, agency decisions and the Federal Register.
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Federal Register · Notice · Jul 23, 2007
Public Health Service Act. … These procedures may include, but are not limited to, review of records and manufacturing deviations and defects, and periodic audits.
72 FR 40157Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 23, 2003
Comments on this draft guidance may be submitted at any time. Submit comments on the collection of information by September 22, 2003. … Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy.
68 FR 43535Health and Human Services DepartmentFood and Drug AdministrationWorkshop To Enhance Clinical Study Diversity; Public Workshop; Request for Comments
Federal Register · Notice · Aug 23, 2023
This public workshop will satisfy a mandate of the Food and Drug Omnibus Reform Act of 2022 (FDORA) for FDA to convene one or more public workshops to solicit input from various stakeholders on enhancing … Following the workshop, a public comment period will be established to receive comments related to the topics addressed during the public workshop.
88 FR 57462Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 28, 2016
Specifically, FDA does not intend to enforce the reporting requirements when circumstances outlined in the guidance are met within the predefined periods of time ( e.g., communicate vulnerability to … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations.
81 FR 95617Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 8, 2009
Most information is already required to be submitted under section 510 of the act, section 351 of the Public Health Service Act, and part 207. … In the Federal Register of July 11, 2008 (73 FR 39964), FDA published a notice of availability of the draft guidance document providing a 60-day public comment period on the information collection
74 FR 816Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Oct 30, 2015
or section 351 of the PHS Act (42 U.S.C. 262). … periods on the Same Surgical Procedure Exception, Minimal Manipulation, and Adipose Tissue Draft Guidances.
80 FR 66845Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 9, 2004
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 … FDA has received approximately 65 requests in a 7-month period, and most requests involved requests to move an animal from one location to another.
69 FR 41501Health and Human Services DepartmentFood and Drug AdministrationToll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products
Federal Register · Rule · Oct 28, 2008
(the act). … We also received comments supporting the 1-year compliance period from both pharmacy interests and drug manufacturing interests.
73 FR 63886Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 18, 2026
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. … FDA is reopening the 30-day comment period in order to satisfy PRA requirements. No changes have been made to the information collection. Grace R.
91 FR 7496Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 23, 2013
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 … For many studies, continuing review can be fairly straightforward, and the IRB should be able to complete its deliberations and approve the research within a brief period of time.
78 FR 44126Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 15, 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 … No comments were received in response to the notice.
82 FR 13822Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities: Proposed Collection; Comment Request
Federal Register · Notice · Jun 5, 1998
Statutory authority for the collection of this information is provided by section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262). … In the interim period, the old Form FDA 356h and the new Form FDA 356h were to be acceptable alternatives for NDA's, ANDA's, AADA's, and BLA's.
63 FR 30762Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 22, 2001
Consistent with that advice, the agency is recommending that manufacturers that choose to follow this sampling guidance phase it in over a period of no more than 30 days dating from December 27, 2000. … Witt, Acting Associate Commissioner for Policy. [FR Doc. 01-1609 Filed 1-19-01; 8:45 am] BILLING CODE 4160-01-S
66 FR 6627Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 22, 2023
This guidance addresses requirements set forth in section 3607(a) of the Food and Drug Omnibus Reform Act of 2022 (FDORA) and meets a Prescription Drug User Fee Act (PDUFA) Reauthorization Performance … This provision of FDORA further requires that, not later than 18 months after the end of the public comment period on the draft guidance, FDA must issue a revised draft guidance or final guidance.
88 FR 88629Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 16, 2004
DATES: Fax written comments on the collection of information by April 15, 2004. … The comment recommended the incorporation of risk-based analysis.
69 FR 12331Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 9, 1997
Written comments may be submitted at any time. … The comments in the docket will be periodically reviewed, and, where appropriate, the guideline will be amended.
62 FR 25692Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 3, 2017
extended-release oral tablets, submitted by Intellipharmaceutics Corp., with the proposed indication of management of moderate-to-severe pain when a continuous around-the-clock analgesic is needed for an extended period … Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: June 27, 2017. Anna K.
82 FR 30874Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Uncategorized Document · Mar 14, 1994
Paperwork Reduction Act of 1980 VI. Environmental Impact VII. Request for Comments I. Background On April 22, 1988, the President signed PDMA into law (Pub. L. 100- 293). … Sometimes the period of time is only a few minutes, but often it may be hours, days, or weeks.
Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 2, 2014
The draft guidance was made available on April 1, 2014, and the period to provide comments lasted 60 days, closing on June 2, 2014. … 503A and 503B of the FD&C Act.
79 FR 52012Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Health Claims; D-tagatose and Dental Caries
Federal Register · Rule · Jul 3, 2003
Comments from seven consumers were sent to this docket during the comment period, none of which were relevant to this rulemaking. … No comments from State or local government entities were received.
68 FR 39831Health and Human Services DepartmentFood and Drug Administration
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