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Revising the National Drug Code Format and Drug Label Barcode Requirements
Federal Register · Rule · Mar 5, 2026
provisions of the Public Health Service Act (PHS Act) (42 U.S.C. 262, et seq. ). … A third commenter asserts that the transition period should end at least 10 years from the close of the comment period on the proposed rule ( i.e., November 2032).
91 FR 10749Health and Human Services DepartmentFood and Drug AdministrationNew Animal Drugs for Use in Animal Feed; Category Definitions
Federal Register · Rule · Aug 24, 2016
The comment period for this direct final rule runs concurrently with the comment period of the companion proposed rule. … response in a notice-and-comment process in accordance with section 553 of the Administrative Procedure Act (APA) (5 U.S.C. 553).
81 FR 57796Health and Human Services DepartmentFood and Drug AdministrationAbbreviated New Drug Applications and 505(b)(2) Applications; Extension of Comment Period
Federal Register · Proposed Rule · Apr 24, 2015
ACTION: Proposed rule; extension of comment period. … of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that govern the approval of 505(b)(2) applications and abbreviated new drug applications (ANDAs).
80 FR 22953Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 14, 2002
Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d … Submission of Comments and Effective Date Interested persons may, at any time, submit to the contact person (address above) written comments regarding this document.
67 FR 1774Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Feb 19, 2013
Act of 1995. … period on the provisions of the proposed rule and a 30-day comment period on the information collection provisions that are subject to review by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C
78 FR 11611Health and Human Services DepartmentFood and Drug AdministrationLead in Food and Color Additives and GRAS Ingredients; Request for Data
Federal Register · Uncategorized Document · Feb 4, 1994
Lead exposure occurs through pathways such as food, air, dust, soil, and water. … Under the National Environmental Policy Act, FDA must consider the environmental impact of its actions.
Health and Human Services DepartmentFood and Drug AdministrationMaximum Civil Money Penalty Amounts; Civil Money Penalty Complaints
Federal Register · Rule · Feb 3, 2014
Act of 1995 (Pub. … Service Act.
79 FR 6088Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Nov 20, 2013
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (the PRA) by January 27, 2014 (see the “Paperwork Reduction Act of 1995” section of this document). … We also are extending the comment period for the information collection provisions for 60 days to make the comment period for the information collection provisions the same as the comment period for the
78 FR 69602Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Mar 8, 1996
DATES: Written comments by June 6, 1996. … Request for Comments Interested persons may, on or before June 6, 1996, submit to the Dockets Management Branch (address above) written comments regarding this proposal.
61 FR 9373Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 29, 2018
.; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; reopening of the comment period. … The comment period closed on August 31, 2015.
83 FR 54362Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jan 28, 1997
First, a longer comment period on the revocation is impracticable. … Second, a longer comment period would be contrary to the public interest.
62 FR 4023Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Nov 20, 2013
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 (the PRA) by January 27, 2014 (see the “Paperwork Reduction Act of 1995” section of this document). … We also are extending the comment period for the information collection provisions for 60 days to make the comment period for the information collection provisions the same as the comment period for the
78 FR 69603Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Feb 19, 2013
Act of 1995. … period on the provisions of the proposed rule and a 30-day comment period on the information collection provisions that are subject to review by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C
78 FR 11611Health and Human Services DepartmentFood and Drug AdministrationAnnual Summary Reporting Requirements Under the Right to Try Act
Federal Register · Rule · Sep 14, 2022
use from a prior reporting period. … The first report will cover the time period between enactment of the Right to Try Act (March 30, 2018) and December 31, 2022.
87 FR 56269Health and Human Services DepartmentFood and Drug AdministrationAmendments to General Regulations of the Food and Drug Administration
Federal Register · Proposed Rule · Nov 30, 2010
If we receive any significant adverse comment regarding the direct final rule, we will withdraw the direct final rule within 30 days after the comment period ends and proceed to respond to all of the comments … The comment period for this companion proposed rule runs concurrently with the direct final rule's comment period.
75 FR 73984Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Apr 26, 2013
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by September 16, 2013 (see the “Paperwork Reduction Act of 1995” section of this document). … period on the provisions of the proposed rule and a 30-day comment period on the information collection provisions that are subject to review by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C
78 FR 24692Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Apr 26, 2013
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by September 16, 2013 (see the “Paperwork Reduction Act of 1995” section of this document). … period on the provisions of the proposed rule and a 30-day comment period on the information collection provisions that are subject to review by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C
78 FR 24691Health and Human Services DepartmentFood and Drug AdministrationAmendments to General Regulations of the Food and Drug Administration
Federal Register · Rule · Nov 30, 2010
days after the comment period on this direct final rule ends. … The comment period for this direct final rule runs concurrently with the comment period of the companion proposed rule.
75 FR 73951Health and Human Services DepartmentFood and Drug AdministrationDietary Supplements; Establishment of Date of Application
Federal Register · Rule · Jan 4, 1994
The comments reported many examples of the difficulties in meeting a 6-month compliance period. … period.
59 FR 350Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Mar 10, 2023
Legal Authority This final rule is issued under section 512(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(i)), which requires Federal Register publication of “notice[ … For the treatment of air sacculitis (air-sac disease, chronic respiratory disease) caused by Mycoplasma gallisepticum and Escherichia coli; fowl cholera caused by Pasteurella multocida; infectious
88 FR 14893Health and Human Services DepartmentFood and Drug Administration
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