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Federal Register · Notice · Feb 7, 2011
DATES: Fax written comments on the collection of information by March 9, 2011. … A license is required when the manufacture of a medicated feed involves the use of a drug or drugs that FDA has determined requires more control because of the need for a withdrawal period before slaughter
76 FR 6620Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 21, 2026
FDA marketing approval for that drug for the orphan indication for a period of 7 years; and, finally, section 528 is intended to encourage sponsors to make investigational orphan drugs available for treatment … One comment was received encouraging FDA to offer more incentives toward the development of drug products to treat specific conditions and we appreciate this comment.
91 FR 59780Health and Human Services DepartmentFood and Drug AdministrationRegulation Requiring an Approved New Drug Application for Drugs Sterilized by Irradiation
Federal Register · Rule · Dec 16, 2019
Comments on the Proposed Rule V. Effective Date VI. Economic Analysis of Impacts VII. Analysis of Environmental Impact VIII. Paperwork Reduction Act of 1995 IX. Federalism X. … Comments on the Proposed Rule We received five comment letters on the proposed rule by the close of the comment period, all from individuals.
84 FR 68331Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 9, 2017
forms repackaged in unit-dose containers from 12 months to 6 months or 25 percent of the time remaining until the expiration date on the container of the original manufacturer's product, whichever time period … Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
82 FR 37229Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 25, 2019
Act of 1995 (44 U.S.C. 3501-3520). … Schiller, Acting Associate Commissioner for Policy. [FR Doc. 2019-05655 Filed 3-22-19; 8:45 am] BILLING CODE 4164-01-P
84 FR 11110Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 22, 2011
Estimate of survey respondents was based on an estimate of the ideal number of usability surveys that FDA would conduct over a 3-year period. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011-21379 Filed 8-19-11; 8:45 am] BILLING CODE 4160-01-P
76 FR 52332Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 22, 1998
comment and publication of a final regulation'' if the agency ``determines that such action is necessary * * * to enable [FDA] to act promptly to ban or modify a claim'' under section 403(r) of the act … FDA invites public comment on this interim final rule. The agency will consider modifications to this interim final rule based on comments made during the comment period.
63 FR 34092Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 26, 2010
The public comment period closed on October 6, 2008. A number of comments were received, which the agency considered carefully as it finalized the guidance and made appropriate changes. … Paperwork Reduction Act of 1995 This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995
75 FR 8970Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 10, 2011
of 2007 (FDAAA) includes a requirement that FDA identify and periodically update susceptibility test interpretive criteria for antibacterial drug products and make those findings publicly available. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011-11359 Filed 5-9-11; 8:45 am] BILLING CODE 4160-01-P
76 FR 27061Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 28, 2023
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 … 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.
88 FR 41964Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 15, 2012
The FDA Food Safety Modernization Act (FSMA), enacted on January 4, 2011, amended section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350d). … intends to issue a final guidance that identifies the additional food categories that will be included as mandatory fields in food facility registration forms before the first biennial registration renewal period
77 FR 48990Health and Human Services DepartmentFood and Drug AdministrationDelegations of Authority and Organization; Center for Food Safety and Applied Nutrition
Federal Register · Uncategorized Document · Aug 18, 1994
the issuance of notices of filing (including notices of extension of, or reopening of, the comment period), and of voluntary withdrawal, of petitions on food additives, generally recognized as safe (GRAS … regarding the issuance of proposed rulemaking (including notices of extension of, or reopening of, the comment period) pertaining to food standards.
Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 21, 2009
That notification alerts NIH to the fact that the responsible party must submit the results of the trials within a certain period of time, thereby enabling NIH to exercise its responsibilities under Title … We also received a number of comments on this issue during the process for obtaining clearance under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) for the certification form itself.
74 FR 3614Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Dec 26, 2017
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by February 26, 2018. See section IV of this document, the “Paperwork Reduction Act of 1995.” … The Food and Drug Administration Amendments Act of 2007 (FDAAA) (Pub. L. 110-85) amended section 519(a) of the FD&C Act related to the reporting of device malfunctions.
82 FR 60922Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 25, 2008
FDA gave interested persons 60 days to comment on the draft guidance. The comment period closed on May 5, 2006. The draft guidance was revised based on public comments. … Paperwork Reduction Act of 1995 This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995
73 FR 10037Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 7, 2008
The draft of this guidance was issued August 14, 2000, and the comment period closed on November 13, 2000. … Paperwork Reduction Act of 1995) and are now issuing the final guidance.
73 FR 25752Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 3, 2010
States that are awarded this option will receive up to $25,000 over a period of 5 years to fully implement the program standards. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010-4340 Filed 3-2-10; 8:45 am] BILLING CODE 4160-01-S
75 FR 9605Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities; Submission for OMB Review; Comment Request
Federal Register · Notice · Nov 26, 1997
(the act) that could present a risk to health. … [[Page 63183]] In the final rule (62 FR 27183), the agency requested comments on the information collection provision of the new regulation. The 60-day comment period closed July 18, 1997.
62 FR 63182Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 6, 2015
These waivers are intended to apply to: (1) Subsequent in vivo BA or BE studies of formulations after the initial establishment of the in vivo BA of IR dosage forms during the IND period and (2) in vivo … Act of 1995 (44 U.S.C. 3501-3520).
80 FR 26058Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 7, 2020
of 2002 added section 414 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350c), which requires that persons who manufacture, process, pack, hold, receive, distribute, transport, or … Existing records may be used if they contain all the required information and are retained for the required time period. Section 101 of the FDA Food Safety Modernization Act (FSMA) (Pub.
85 FR 19489Health and Human Services DepartmentFood and Drug Administration
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