Documents
Briefs, oral arguments, agency decisions and the Federal Register.
5,436 results
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Focused Mitigation Strategies To Protect Food Against Intentional Adulteration
Federal Register · Proposed Rule · Dec 24, 2013
Comments X. … We also request comment on whether we should require training to be repeated periodically, including when significant changes are made to food defense plans.
78 FR 78014Health and Human Services DepartmentFood and Drug AdministrationQuality Mammography Standards; Correcting Amendment
Federal Register · Rule · Oct 22, 1998
Fairness Act of 1996 (Pub. … * * * * * (d) Air kerma means kerma in a given mass of air. The unit used to measure the quantity of air kerma is the Gray (Gy).
63 FR 56555Health and Human Services DepartmentFood and Drug AdministrationElectronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components
Federal Register · Rule · Jun 10, 2005
Act (PHS Act) (42 U.S.C. 201 et seq. ) to chapter V of the act (21 U.S.C. 301 et seq. ). … No additional information was received on this topic during the comment period.
70 FR 33998Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 11, 2016
This document describes certain design features and capacity for cleaning and disinfection to prevent the spread of bloodborne pathogens. … In the Federal Register of April 9, 2014 (79 FR 19622), the Agency announced that the deadline for the comment period would be extended until May 7, 2014, to allow for more public comments on this
81 FR 70122Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 17, 2015
out the provisions of the FD&C Act. … the same ad airs three to six times.
80 FR 34672Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 19, 2013
DSHEA, among other things, amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by adding section 402(g) of the FD&C Act (21 U.S.C. 342(g)). … Under section 701(a) of the FD&C Act (21 U.S.C. 371), FDA may issue regulations necessary for the efficient enforcement of the FD&C Act.
78 FR 76836Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 5, 2024
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. … Over the course of the study period, we intend to survey approximately 2,000 teens ages 12-20 per month for 24 months.
89 FR 15875Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Nov 12, 2014
Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed order, consideration of any comments received, and a meeting of a device classification … We request comment on whether it is appropriate to allow continued distribution and, if so, whether the 30 month period proposed is reasonable.
79 FR 67105Health and Human Services DepartmentFood and Drug AdministrationExtreme Weather Effects on Medical Device Safety and Quality
Federal Register · Notice · Feb 21, 2013
ACTION: Notice; request for comments. … How did you respond to extended periods of electrical or network outages or other events related to EW? 3.
78 FR 12067Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids
Federal Register · Proposed Rule · Oct 20, 2021
A hearing aid is “used” if a user has worn it for any period of time. … A hearing aid is “used” if a user has worn it for any period of time.
86 FR 58150Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 20, 2017
DSHEA, among other things, amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by adding section 402(g) of the FD&C Act (21 U.S.C. 342(g)). … FDA received comments from two commenters.
82 FR 18652Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Dec 2, 1997
Two responses were received before and two after the close of the comment period. The two late comments discussed data and reiterated arguments contained in other comments. A. … over a longer time period.
62 FR 63647Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 27, 2023
Before the migration of campaign ads to digital channels, ads from “The Real Cost” were primarily aired on broadcast TV. … Over the course of the study period, we intend to survey approximately 2,000 youth and young adults ages 12 to 20 per month for 24 months.
88 FR 25660Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Uncategorized Document · Nov 15, 1994
) is extending to June 19, 1995, the period for comments; to December 15, 1995, the period for new data; and to February 13, 1996, the period for comments on the new data for the notice of proposed rulemaking … Thus, the agency finds an extension of the periods for comments, new data, and comments on the new data to be appropriate.
Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Sep 15, 2014
Follow the instructions for submitting comments. … The proposed rule provided for a comment period that was open until January 17, 2012. FDA received three sets of comments.
79 FR 54927Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 8, 2007
One of the respondents' comments was received after the 60-day comment period closed and is not addressed. … (Comment 1) One industry respondent wanted assurances from FDA that individual company information was not subject to release under the Freedom of Information Act (FOIA).
72 FR 26132Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 2, 2023
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). … products—Requirements for development and validation of a cleaning process for medical devices.
88 FR 50870Health and Human Services DepartmentFood and Drug AdministrationElectronic Products; Performance Standard for Diagnostic X-Ray Systems and Their Major Components
Federal Register · Proposed Rule · Dec 10, 2002
Act (PHS Act) (42 U.S.C. 201 et seq .) to chapter V of the act (21 U.S.C. 301 et seq .). … The 1994 change in the regulations underwent an extensive review and comment period.
67 FR 76056Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 3, 2025
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. … In the Federal Register of April 27, 2023 (88 FR 25660), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
90 FR 29557Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Sep 10, 2026
(FD&C Act). … (2) Biocompatibility testing must demonstrate safe residual levels of chemicals on medical devices surfaces and/or gaseous byproducts in air.
91 FR 57507Health and Human Services DepartmentFood and Drug Administration
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