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Product-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 AdministrationFood and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications
Federal Register · Proposed Rule · Apr 4, 2016
FDA is proposing to issue a final rule within 912 days (generally 30 months) of the closing of the comment period for the proposed rule. … During this 912-day time period, FDA will review and consider any new data, information, and public comments submitted to the docket and draft and publish a final regulation.
81 FR 19069Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 20, 2017
FDA received one comment, which was outside the scope of the comment requests in the notice. … We based our estimates in tables 1 and 2 on our experience with the MUMS indexing program and the requests for eligibility for indexing and for addition to the index, as well as the periodic drug experience
82 FR 33507Health and Human Services DepartmentFood and Drug AdministrationExport Requirements for Medical Devices; Withdrawal of Proposed Rule
Federal Register · Proposed Rule · Jun 6, 1997
The agency received 7 comments on the proposed rule. … period for the proposed rule and to solicit public comment on whether the proposed rule was still necessary.
62 FR 31023Health and Human Services DepartmentFood and Drug AdministrationProduct-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Federal Register · Notice · Aug 23, 2021
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.
86 FR 47112Health and Human Services DepartmentFood and Drug AdministrationProduct-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Federal Register · Notice · Mar 25, 2021
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.
86 FR 15948Health and Human Services DepartmentFood and Drug AdministrationInorganic Arsenic in Rice Cereals for Infants: Action Level; Guidance for Industry; Availability
Federal Register · Notice · Aug 6, 2020
We gave interested parties an opportunity to submit comments by July 5, 2016, and later extended the comment period to July 19, 2016 (see 81 FR 42714 (June 30, 2016)). … Paperwork Reduction Act of 1995 This guidance contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act is not required.
85 FR 47797Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 20, 2022
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. … of certain agricultural water for covered produce other than sprouts to be minimal for the period of time that FDA intends to exercise enforcement discretion with regard to those requirements.
87 FR 43273Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 22, 2018
(FD&C Act) (21 U.S.C. 360(k)) clearance. … devices file with FDA an annual report for 3 consecutive years, this would be less burdensome than the current postapproval requirements under 21 CFR part 814, subpart E, including the submission of periodic
83 FR 7745Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 21, 2020
We review the records during the conduct of periodic plant inspections. This information is needed so that we can monitor drug usage and possible misformulation of Type A medicated articles. … as to safety and also meet the article's claimed identity, strength, quality, and purity, as required by section 501(a)(2)(B) of the FD&C Act.
85 FR 10170Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 6, 2024
On October 4, 2016, we extended the comment period for the revised draft guidance to December 12, 2016 (81 FR 68434). … 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
89 FR 16003Health and Human Services DepartmentFood and Drug AdministrationMenu Labeling: Supplemental Guidance for Industry; Availability
Federal Register · Proposed Rule · Nov 9, 2017
As previously stated, although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), we do not intend to extend the comment period for the guidance, as we intend to finalize this guidance … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations.
82 FR 52036Health and Human Services DepartmentFood and Drug AdministrationDrug-Induced Liver Injury: Are We Ready to Look?; Public Conference; Request for Comments
Federal Register · Notice · Jan 27, 2011
It discusses methods of detecting DILI by periodic tests of serum enzyme activities and bilirubin concentration elevations, and how those laboratory tests might change over time, along with symptoms and … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011-1759 Filed 1-26-11; 8:45 am] BILLING CODE 4160-01-P
76 FR 4918Health and Human Services DepartmentFood and Drug AdministrationProduct-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Federal Register · Notice · Aug 24, 2026
Under that process, draft guidances are posted on FDA's website and announced periodically in the Federal Register . … Paperwork Reduction Act of 1995 While these guidances contain no collection of information, they do refer to previously approved FDA collections of information.
91 FR 54722Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 29, 2016
DATES: Fax written comments on the collection of information by March 30, 2016. … Periodic drug experience reports and special drug experience reports must be accompanied by a completed Form FDA 2301, “Transmittal of Periodic Reports and Promotional Material for New Animal Drugs” (see
81 FR 10252Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 19, 2022
The final rule implements a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. … This subsection requires that the FDA-approved plan must be retained while in effect and for a period of not less than 4 years from the date it was last in effect.
87 FR 57206Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 4, 1999
Paperwork Reduction Act of 1995 VI. References VII. Objections I. … Paperwork Reduction Act of 1995 This final rule contains no collection of information.
64 FR 29949Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 3, 2019
&C Act. 4 Section 503B(d)(4)(C) of the FD&C Act. … rationale for such proposal; (2) providing a period of not less than 60 calendar days for comment on the notice; and (3) publishing a notice in the Federal Register designating bulk drug substances
84 FR 46014Health and Human Services DepartmentFood and Drug AdministrationMultiple Endpoints in Clinical Trials; Draft Guidance for Industry; Availability
Federal Register · Notice · Jan 13, 2017
(Title I of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85)). … Trials,” and to complete the final guidance within one year of the close of the public comment period of the PDUFA Performance Goals (see http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee
82 FR 4353Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jul 25, 2001
the requirements of 510(k) of the act. … Fairness Act of 1996 (Public Law 104-121)), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).
66 FR 38786Health and Human Services DepartmentFood and Drug Administration
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