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Briefs, oral arguments, agency decisions and the Federal Register.
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Federal Register · Notice · Jul 15, 2020
(FD&C Act). … period to September 16, 2019 (84 FR 40071).
85 FR 42867Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 26, 2024
FDA has revised and is reissuing the draft guidance in response to public comments and recent amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act). … The comment period for the original draft guidance ended on September 23, 2022.
89 FR 5244Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 26, 2000
(the act). … During the period when an innovator drug is being marketed, it may undergo a number of changes that are approved through supplements to new drug applications (NDA's).
65 FR 64225Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 5, 2013
The guidance will be especially useful when planning BE studies intended to be conducted during the postapproval period for certain changes in an ANDA. … Act of 1995 (44 U.S.C. 3501-3520).
78 FR 73199Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 20, 2014
DATES: Fax written comments on the collection of information by July 21, 2014. … Current Good Manufacturing Practice Regulations for Medicated Feeds—21 CFR Part 225 (OMB Control Number 0910-0152)—Extension Under section 501 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act
79 FR 35358Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 27, 2022
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. … Third-party reviewers should maintain records of their 510(k) reviews and a copy of the 510(k) for a reasonable period of time, usually 3 years.
87 FR 65088Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Aug 29, 2006
We invite comment on whether a shorter implementation period would be preferable. … Therefore, we selected the proposed implementation periods as a reasonable balance. We solicit public comment on the proposed implementation period and the effect on expected costs and benefits.
71 FR 51276Health and Human Services DepartmentFood and Drug AdministrationAgency Emergency Processing Under OMB Review; Emergency Medical Device Shortage Program Survey
Federal Register · Notice · Mar 26, 2002
DATES: Submit written comments on the collection of information by April 25, 2002. … FDA estimates that approximately 10 percent of these manufacturers would be contacted in a 1-year period, due to limitations on FDA staff.
67 FR 13788Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 17, 2003
mail comments to sshapiro@omb.eop.gov . … Therefore, FDA estimates that approximately 150 manufacturers would be contacted in a 1-year period.
68 FR 12705Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 29, 2026
In addition, this guidance describes how to meet the BE requirements set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations. … This guidance will also be useful to applicants planning BE studies intended to be conducted during the postapproval period for changes to a drug product approved under an ANDA.
91 FR 32057Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 27, 2003
See section 738(d)(2)(A)(i) and (e)(2)(A) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 379j(d)(2)(A)(i) and (e)(2)(A)). … FDA periodically updates this site to provide you the most current information and guidance concerning the MDUFMA program. IV.
68 FR 14992Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Sep 17, 2015
We extended the comment period on February 3, 2014 (79 FR 6116), to March 31, 2014. We received 11 comments on the draft RA and have revised it where appropriate (Ref. 2). … addressed by the RA, and our request for comments.
80 FR 56360Health and Human Services DepartmentFood and Drug AdministrationRevocation of Authorization for Use of Brominated Vegetable Oil in Food
Federal Register · Rule · Jul 3, 2024
We discuss the comments later in this final rule. IV. Legal Authority We are issuing this final rule under sections 409(i) and 701(a) of the FD&C Act. … The time between the publication of our final rule and the rule's compliance period should minimize costly disruptions to manufacturers still using BVO.
89 FR 55040Health and Human Services DepartmentFood and Drug AdministrationOver-the-Counter Drug Products Containing Colloidal Silver Ingredients or Silver Salts
Federal Register · Rule · Aug 17, 1999
(the act) (21 U.S.C. 321(p)). … The physician also commented on some other observations from about 50 men who had taken colloidal silver (most for symptoms of prostatism) under his direction before, during, and after the study (a period
64 FR 44653Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 10, 2011
Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011-29118 Filed 11-9-11; 8:45 am] BILLING CODE 4160-01-P
76 FR 70151Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 7, 2011
It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011-8360 Filed 4-6-11; 8:45 am] BILLING CODE 4160-01-P
76 FR 19311Agriculture DepartmentFood Safety and Inspection ServiceFederal Register · Rule · Sep 5, 1996
(the act) with respect to this nutrient until after January 1, 1998. … Furthermore, the agency pointed out that a 2-year period is consistent with the amount of time given for implementation of the requirements of the Nutrition Labeling and Education Act of 1990 (the 1990
61 FR 46714Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Oct 18, 2022
Summary of Comments to the Proposed Rule We received four comments on the proposed rule by the close of the comment period, all from individuals. One comment is unintelligible. … Comments on the Proposed Rule and FDA Response We received four comments on the proposed rule by the close of the comment period, all from individuals. One comment is unintelligible.
87 FR 62977Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 4, 2011
All comments received during the comment period, questions received by Agency staff related to implementation of the regulations, and information presented at the public hearing have been carefully reviewed … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011-7846 Filed 4-1-11; 8:45 am] BILLING CODE 4160-01-P
76 FR 18558Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 17, 2021
(Comment) The comment suggested specific types of messages that FDA should test and then implement in public health campaigns. (Response) FDA appreciates the comment. … Table 1 provides examples of the types of activities that may be administered and estimated burden levels during the 3-year period.
86 FR 51897Health and Human Services DepartmentFood and Drug Administration
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