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Federal Register · Proposed Rule · Sep 27, 2005
FDA is publishing this document in accordance with section 701(e)(1) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 371(e)(1)), which directs the Secretary of Health and Human Services … FDA is publishing this document in accordance with section 701(e)(1) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C 371(e)(1)), which directs the Secretary of Health and Human Services
70 FR 56409Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 19, 2017
Records are maintained on file at each testing facility and examined there periodically by FDA inspectors. … In response to requests, the comment period was extended to January 21, 2017 (81 FR 75351, October 31, 2016).
82 FR 60203Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 12, 2004
Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed … Recall Status Reports Requests that recalling firms provide periodic status reports so FDA can ascertain the progress of the recall.
69 FR 60630Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 11, 2014
Additionally, the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq) and the Economy Act (31 U.S.C. 1535) require FDA to provide assistance to other Federal, state, and local government bodies … The sample for each data collection period will be evenly distributed among Specialists.
79 FR 73596Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 13, 2023
Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. … Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required for this guidance.
88 FR 9296Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 6, 2007
Request for Comments Although the MQSA does not require FDA to solicit comments on fee exemption, assessment, and collection, FDA is inviting comments from interested persons in order to have the benefit … Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy.
72 FR 37027Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Health Claims; D-tagatose and Dental Caries
Federal Register · Rule · Dec 2, 2002
Section 403(r)(7) of the act authorizes us to make proposed regulations issued under section 403(r) of the act effective upon publication pending consideration of public comment and publication of a final … 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.
67 FR 71461Health and Human Services DepartmentFood and Drug AdministrationRichard B. Smith III: Final Debarment Order
Federal Register · Notice · Jun 13, 2024
In proposing a debarment period, FDA weighed the considerations set forth in section 306(c)(3) of the FD&C Act that it considered applicable to Mr. … FDA finds that the offense should be accorded a debarment period of 5 years as provided by section 306(c)(2)(A)(iii) of the FD&C Act. As a result of the foregoing finding, Mr.
89 FR 50344Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 12, 2015
Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed … Under § 314.80(c)(2), applicants must provide periodic reports of adverse drug experiences.
80 FR 13009Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 19, 2011
We are requesting that OMB extend approval for the information in this collection, as described below, which will continue to be submitted to FDA during this multi-year period. … David Dorsey, Acting Associate Commissioner for Policy and Planning. [FR Doc. 2011-32397 Filed 12-16-11; 8:45 am] BILLING CODE 4160-01-P
76 FR 78668Health and Human Services DepartmentFood and Drug AdministrationFood Labeling; Health Claims; Dietary Noncariogenic Carbohydrate Sweeteners and Dental Caries
Federal Register · Rule · Sep 17, 2007
Baseline plaque pH was measured over a 15 minute period following a 3 minute period of chewing paraffin. … 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.
72 FR 52783Health and Human Services DepartmentFood and Drug AdministrationPlasma Derivatives and Other Blood-Derived Products; Requirements for Tracking and Notification
Federal Register · Proposed Rule · Aug 19, 1999
provisions of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 351-353, 355-360, and 371-374)), FDA has the authority to issue regulations designed to protect the public from unsafe or ineffective … For example, the patient may have moved or may be away from his or her home for an extended period of time.
64 FR 45383Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 29, 2023
of the FD&C Act. … No comments were received.
88 FR 42080Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 9, 2017
Manufacturers keep infant formula distribution records for the prescribed period as a matter of routine business practice. … Manufacturers keep infant formula distribution records for the prescribed period as a matter of routine business practice.
82 FR 52055Health and Human Services DepartmentFood and Drug AdministrationFood Additives Permitted for Direct Addition to Food for Human Consumption; Advantame
Federal Register · Rule · May 21, 2014
Comments IV. Conclusion V. Public Disclosure VI. Environmental Impact VII. Paperwork Reduction Act of 1995 VIII. Section 301( ll ) of the FD&C Act IX. Objections X. References I. … Comments We received two comments in response to the advantame food additive petition.
79 FR 29078Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 15, 2022
The guidance provides recommendations on conducting relative BA studies during the investigational period for an NDA and bioequivalence (BE) studies during the postapproval period for certain changes to … Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information.
87 FR 22537Health and Human Services DepartmentFood and Drug AdministrationEligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products
Federal Register · Rule · May 25, 2004
The comment period for that proposed rule closed on December 29, 1999. On April 18, 2000, we reopened the comment period for an additional 90 days. … We received two requests for an extension of the comment period.
69 FR 29786Health and Human Services DepartmentFood and Drug AdministrationRevision of the Requirements for Live Vaccine Processing; Companion to Direct Final Rule
Federal Register · Proposed Rule · Oct 18, 2007
The comment period for this companion proposed rule runs concurrently with the comment period for the direct final rule. … response in a notice-and-comment process in accordance with section 553 of the Administrative Procedure Act (5 U.S.C. 553).
72 FR 59041Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Patient Examination and Surgeons' Gloves; Test Procedures and Acceptance Criteria
Federal Register · Proposed Rule · Mar 31, 2003
the entire 10-year evaluation period. … Submit a single copy of electronic comments to http://www.fda.gov/dockets/ecomments or two copies of any mailed comments, except that individuals may submit one hard copy.
68 FR 15404Health and Human Services DepartmentFood and Drug AdministrationRequirements for Submission of In Vivo Bioequivalence Data; Proposed Rule
Federal Register · Proposed Rule · Oct 29, 2003
Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. … Regulatory Fairness Act of 1996 (Public Law 104-121))), and the Unfunded Mandates Reform Act (Public Law 104-4).
68 FR 61640Health and Human Services DepartmentFood and Drug Administration
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