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Briefs, oral arguments, agency decisions and the Federal Register.
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Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Federal Register · Notice · May 17, 2024
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.
89 FR 43413Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 15, 2008
Drug Consumer Protection Act.” … Under the statute, the records must be retained for a period of 6 years.
73 FR 53252Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 28, 2016
Background Section 412(h)(1) (21 U.S.C. 350a(h)(1)) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) exempts an infant formula which is represented and labeled for use by an infant with an … The total hours column reflects the total number of hours averaged over the four-year period. III.
81 FR 4917Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Dec 4, 2013
Follow the instructions for submitting “comments.” … FDA cannot guarantee that all drugs nominated during the nomination period will be considered for inclusion on the next published bulk drugs list.
78 FR 72841Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jan 31, 2013
FSMA amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish the foundation of a modernized, prevention-based food safety system. … The Washington, DC public meeting is the first of three that the Agency will hold during the proposed rules' comment period.
78 FR 6762Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jan 8, 2001
The comment period for the direct final rule runs concurrently with that of the companion proposed rule. … Act of 1995.
66 FR 1257Health and Human Services DepartmentFood and Drug AdministrationProduct-Specific Guidances; Revised Draft Guidances for Industry; Availability
Federal Register · Notice · Jul 29, 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 47834Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Mar 4, 2016
(the FD&C Act). … Repair: Return the device or component to original specifications including replacing non-working components or parts outside of routine or periodic upkeep for the current owner of the device. 4.
81 FR 11477Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 23, 2010
The number of presentations may be limited based on the number of requests received during the public comment period. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010-20837 Filed 8-20-10; 8:45 am] BILLING CODE 4160-01-S
75 FR 51829Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 28, 2003
The Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act (the PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection … Section 314.81(b)(2) and FDA Form 2252 (Transmittal of Periodic Reports for Drugs for Human Use) specify the information required in the submission of annual reports.
68 FR 51788Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jan 14, 2000
FDA invited comments on the February 2, 1998, notice. … , subject to limitations, under notice and comment rulemaking proceedings under new section 510(l) of the act.
65 FR 2364Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 22, 2006
Act Requirements AGENCY: Food and Drug Administration, HHS. … This notice solicits comments on the estimated reporting and recordkeeping burden associated with the Mammography Quality Standards Act requirements.
71 FR 55488Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 13, 2015
A draft of this guidance was made available in the Federal Register on April 23, 2014, and the comment period closed July 22, 2014. … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations.
80 FR 19669Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 18, 2010
deactivate the Plan and make decisions during the emergency; (2) prioritizing the manufacturer's drug products based on medical necessity; (3) identifying actions that should be taken prior to an anticipated period … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010-26103 Filed 10-15-10; 8:45 am] BILLING CODE 4160-01-P
75 FR 63832Health and Human Services DepartmentFood and Drug AdministrationProduct-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Federal Register · Notice · Nov 20, 2024
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.
89 FR 91763Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 24, 2015
Background The FDA Food Safety Modernization Act (FSMA) (Pub. … However, we will not use any information or data submitted during the public meeting or through the docket to inform any FSMA rulemakings where the comment periods have closed.
80 FR 15612Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 25, 2020
This estimate reflects the average number of petitions we have received annually over a period of 10 years. … and other specific labeling acts administered by FDA.
85 FR 52353Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · May 3, 2002
DATES: Submit written or electronic comments by August 1, 2002. Submit written comments on the information collection requirements by June 3, 2002. … Regulatory Fairness Act of 1996 (Public Law 104-121))), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).
67 FR 22367Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 6, 2017
The comment period was extended on February 23, 2016 (81 FR 8966), to April 28, 2016. FDA has considered all of the public comments received in finalizing this guidance. … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations.
82 FR 42101Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 20, 2018
Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information. … These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
83 FR 47623Health and Human Services DepartmentFood and Drug Administration
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