Documents
Briefs, oral arguments, agency decisions and the Federal Register.
5,436 results
0.13s
Federal Register · Proposed Rule · Jul 13, 2026
Submit comments (including recommendations) on the collection of information under the Paperwork Reduction Act of 1995 by September 11, 2026. ADDRESSES: You may submit comments as follows. … Subsequent reviews and updates must occur annually, during the period beginning on October 1 and ending December 31 of each calendar year.
91 FR 42888Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Sep 8, 2010
FDA believes that periodic assessment of adverse event reports through medical device reporting submitted to the agency is sufficient to address adverse effects caused by these devices and is the least … FDA did not receive any comments regarding the Panel's recommendation.
75 FR 54493Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 30, 2026
As required by section 743(b)(2)(B)(iii) of the FD&C Act, FDA published guidelines in consideration of the burden of the VQIP fee on small businesses and provided for a period of public comment on the … Consistent with section 743(b)(2)(B)(iii) of the FD&C Act, if we determine to provide for a small business fee reduction, we will adjust the fee schedule for small businesses only through notice and comment
91 FR 48125Health and Human Services DepartmentFood and Drug AdministrationAdvisory Committees; Notice of Meetings
Federal Register · Notice · Mar 17, 1995
emphasized, however, that the 1 hour time limit for an open public hearing represents a minimum rather than a maximum time for public participation, and an open public hearing may last for whatever longer period … Joseph, Acting Deputy Commissioner for Operations. [FR Doc. 95-6692 Filed 3-16-95; 8:45 am] BILLING CODE 4160-01-F
60 FR 14436Health and Human Services DepartmentFood and Drug AdministrationDevices: General Hospital and Personal Use Devices; Reclassification of Medical Device Data System
Federal Register · Proposed Rule · Feb 8, 2008
To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail. … FDAMA added section 510(l) to the act.
73 FR 7498Health and Human Services DepartmentFood and Drug AdministrationAdvisory Committees; Notice of Meetings
Federal Register · Uncategorized Document · Jun 27, 1994
emphasized, however, that the 1 hour time limit for an open public hearing represents a minimum rather than a maximum time for public participation, and an open public hearing may last for whatever longer period … The Federal Advisory Committee Act (FACA) (5 U.S.C. app. 2, 10(d)), permits such closed advisory committee meetings in certain circumstances.
Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Mar 10, 2004
FDA, therefore, for good cause, finds under 5 U.S.C. 553(b)(3)(B) and (d)(3) that notice and public comment are unnecessary. … If the change is required to be reported to FDA in a periodic report, the change may be made before it is reported to FDA.
69 FR 11310Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 22, 2026
Incidence measures new cases that are diagnosed in a population in a given time period. … of the comment.”
91 FR 30312Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 3, 2004
Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act … To ensure that comments on the information collection are received, OMB recommends that comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer for
69 FR 31395Health and Human Services DepartmentFood and Drug AdministrationAdministrative Detention; Corrections
Federal Register · Rule · Feb 19, 2014
FDA therefore, for good cause, finds under 5 U.S.C. 553(b)(3)(B) that notice and public comment are unnecessary, and under 5 U.S.C. 553(d)(3) that the rule can become effective upon publication. … , or establish, and maintain adequate records relating to how the detained devices may have become adulterated or misbranded, records on any distribution of the devices before and after the detention period
79 FR 9412Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Health Claims; Soy Protein and Coronary Heart Disease
Federal Register · Proposed Rule · Aug 23, 1999
Act of 1995. … Therefore, the [[Page 45937]] requirement for a 75-day comment period for a proposed technical regulation found in Executive Order 12889, ``Implementation of the North American Free Trade Agreement,'
64 FR 45932Health and Human Services DepartmentFood and Drug AdministrationAdvisory Committees; Notice of Meetings
Federal Register · Uncategorized Document · Aug 22, 1994
emphasized, however, that the 1 hour time limit for an open public hearing represents a minimum rather than a maximum time for public participation, and an open public hearing may last for whatever longer period … This notice is issued under section 10(a)(1) and (2) of the Federal Advisory Committee Act (5 U.S.C. app. 2), and FDA's regulations (21 CFR part 14) on advisory committees.
Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Dec 22, 2005
Request for Comments Three copies of all written comments are to be submitted. Individuals submitting written comments or anyone submitting electronic comments may submit one copy. … period and the time for submission of new data is 90 days.
70 FR 75988Health and Human Services DepartmentFood and Drug AdministrationFood Additives Permitted in Feed and Drinking Water of Animals; Selenium Yeast
Federal Register · Rule · Sep 3, 2003
The notice of filing provided for a 60-day comment period on the petitioner's environmental assessment. No substantive comments have been received. … Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 573 is amended
68 FR 52339Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 22, 2022
Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360d). … Such standards are those that FDA has recognized by notice published in the Federal Register or that FDA has decided to recognize but for which recognition is pending (because a periodic notice has
87 FR 24175Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 15, 2017
Infant Formula Requirements—21 CFR parts 106 and 107 OMB Control Number 0910-0256—Extension Statutory requirements for infant formula under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) are … We estimate that there will be 10 rats in the control and test groups (20 rats total) and that food consumption and body weight will be measured at day 0 and at 7-day intervals during the 28-day study period
82 FR 52927Health and Human Services DepartmentFood and Drug AdministrationProduct-Specific Guidances; Revised Draft Guidances for Industry; Availability
Federal Register · Notice · Oct 31, 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 86811Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 28, 2014
DATES: Fax written comments on the collection of information by June 27, 2014. … Enrolled jurisdictions must conduct the work described in tables 1, 2, and 3 over a 5-year period.
79 FR 30616Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Reclassification of Polymethylmethacrylate (PMMA) Bone Cement
Federal Register · Rule · Jul 17, 2002
Subsequently, as permitted by section 520(l)(5)(C) of the act, in the Federal Register of November 30, 1992 (57 FR 56586), the agency published a notice extending the period for issuing such regulations … Thus, continued, periodic followup is advised for all patients. d.
67 FR 46852Health and Human Services DepartmentFood and Drug AdministrationClinical Studies of Safety and Effectiveness of Orphan Products
Federal Register · Notice · Dec 18, 2008
Oversight Activities The program project officer will monitor grantees periodically. … Periodic site visits with officials of the grantee organization may also occur.
73 FR 77029Health and Human Services DepartmentFood and Drug Administration
Ask Donna what matters in the record.
She can read the source against your case and show you exactly where the answer came from.