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Federal 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 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 · Mar 18, 1998
This notice requesting information is required by the Controlled Substances Act (CSA). DATES: Submit written comments by April 17, 1998. … This abbreviated acceptance period is necessary to allow sufficient time to prepare and submit the domestic information package by the deadline imposed by WHO.
63 FR 13258Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis
Federal Register · Proposed Rule · Jan 5, 2007
Paperwork Reduction Act IX. Federalism X. Comments XI. References I. … The most recent reopening of the comment period was announced in the Federal Register on May 4, 2004 (69 FR 24541), and the comment period was open until July 6, 2004.
72 FR 497Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 8, 2002
Background On November 21, 1997, the Food and Drug Administration Modernization Act (FDAMA) (Public Law 105-115) was signed into law. … FDA will periodically review the comments in the docket and, where appropriate, will amend the guidance.
67 FR 68142Health 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 AdministrationFederal Register · Proposed Rule · Jun 23, 1997
The agency is seeking comments and suggestions to assist its Center for Veterinary Medicine (CVM) in fulfilling its responsibility under the Animal Drug Availability Act of 1996 (the ADAA) to issue a report … Creating Incentives Would economic incentives, such as tax breaks, grants, and periods of market or label exclusivity, encourage the pursuit of approvals or supplemental approvals for labeling modifications
62 FR 33781Health 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 · 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 · 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 · 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 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 · Proposed Rule · Dec 30, 1997
DATES: Submit written comments by March 16, 1998. Submit written comments on the information collection provisions by January 29, 1998. … Act of 1995 (the PRA) (44 U.S.C. 3501- 3520).
62 FR 67775Health and Human Services DepartmentFood and Drug AdministrationProduct-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Federal Register · Notice · Feb 18, 2022
Under that process, draft guidances are posted on FDA's website and announced periodically in the Federal Register . … Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. V.
87 FR 9366Health and Human Services DepartmentFood and Drug AdministrationProduct-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Federal Register · Notice · Nov 17, 2023
Under that process, draft guidances are posted on FDA's website and announced periodically in the Federal Register . … Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. V.
88 FR 80315Health and Human Services DepartmentFood and Drug AdministrationProduct-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Federal Register · Notice · May 19, 2023
Under that process, draft guidances are posted on FDA's website and announced periodically in the Federal Register . … Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. V.
88 FR 32231Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 15, 2023
This notice solicits comments on the information collection pertaining to the registration of human drug compounding outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and … Registered outsourcing facilities must submit a drug product report upon initial registration under section 503B and twice each year in June and December for drug products produced during the previous 6-month period
88 FR 55464Health 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 · Oct 17, 2016
Current Good Manufacturing Practice Regulations for Medicated Feeds—21 CFR Part 225 OMB Control Number 0910-0152—Extension Under section 501 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act … A license is required when the manufacturer 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
81 FR 71508Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 28, 1998
The sponsors have not submitted the required periodic reports for their NADA's and have not responded to CVM requests for submission of those reports. … Procedures and requirements governing this notice of opportunity for hearing, notice of appearance and request for hearing, submission of information and analysis to justify a hearing, other comments,
63 FR 29233Health and Human Services DepartmentFood and Drug Administration
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