Documents
Briefs, oral arguments, agency decisions and the Federal Register.
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Agency Information Collection Activities: Proposed Collection; Comment Request; Extension
Federal Register · Notice · Nov 4, 1996
DATES: Submit written comments on the collection of information by January 3, 1997. … There are 39 national and international organizations with one report each reporting --------------------------------------------------------------------------- period. Dated: October 29, 1996.
61 FR 56685Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 28, 1999
Advisory Opinions--21 CFR 10.85 (OMB Control Number 0910-0193-- Extension) Section 10.85 (21 CFR 10.85), issued under section 701(a) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C … The burden estimate for this collection of information is based on an average for the period 1996 through 1998 with each advisory opinion requiring an estimated 16 hours of preparation time.
64 FR 52329Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 28, 2011
of 2002 (the Bioterrorism Act) added section 414 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 350c), which requires that persons who manufacture, process, pack, hold, receive, … Existing records may be used if they contain all of the required information and are retained for the required time period.
76 FR 17131Health and Human Services DepartmentFood and Drug AdministrationGuidance for Industry: Food Contact Substance Notification System; Availability
Federal Register · Notice · Apr 11, 2002
Background The FDAMA amended section 409 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 348) to establish the FCN process as the primary method for authorizing new uses of food additives … The comment period for these two draft guidance documents closed on February 14, 2000.
67 FR 17703Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 13, 1998
The agency requested comments on this guidance. DATES: Written comments may be submitted at any time. … The guidance advises that, for a limited period of time, FDA does not intend to object if manufacturers, packers, or distributors of already approved products implement section 126 of FDAMA at the time
63 FR 12473Health and Human Services DepartmentFood and Drug AdministrationNew Animal Drug Applications; Sheep as a Minor Species
Federal Register · Proposed Rule · Jul 26, 1999
A tissue residue depletion study would be conducted in sheep to establish the withdrawal period. … Reform Act (Pub.
64 FR 40321Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 25, 2000
Section 510(h) of the act (21 U.S.C. 360(h)) requires that condom manufacturers as device manufacturers be inspected at least once in a 2-year period. … In the Federal Register of June 23, 2000 (65 FR 39150), the agency requested comments on the proposed collection of information. No comments were received.
65 FR 57617Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 31, 2006
Administrative Detention and Banned Medical Devices—(OMB Control Number 0910-0114)—Extension FDA has the statutory authority under section 304(g) of the Federal Food, Drug, and Cosmetic Act (the act … These recordkeeping requirements for administrative detentions allow FDA to trace devices for which the detention period expired before a seizure is accomplished or injunctive relief is obtained.
71 FR 63764Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 6, 2011
Prevention and Tobacco Control Act (the Tobacco Control Act) (Pub. … FDA intends to determine what constitutes a reasonable period of time on a case-by-case basis.
76 FR 789Health and Human Services DepartmentFood and Drug AdministrationAdministrative Applications and the Phased Review Process; Guidance for Industry; Availability
Federal Register · Notice · May 6, 2015
This guidance defines the “phased review process” for reviewing application-level information during the investigational period of new animal drug development, and an “administrative” new animal drug application … approval under section 571 of the FD&C Act (21 U.S.C. 360ccc), or an index listing under section 572 of the FD&C Act (21 U.S.C. 360ccc-1).
80 FR 26062Health and Human Services DepartmentFood and Drug AdministrationMicrobiology Devices; Reclassification of Human Immunodeficiency Virus Viral Load Monitoring Tests
Federal Register · Rule · Nov 4, 2022
The comment period on the proposed order closed on January 24, 2022. II. … ) by the close of the comment period, each containing one or more comments on one or more issues.
87 FR 66545Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 12, 2015
In the Federal Register of December 10, 2013 (78 FR 74154), FDA published a notice reopening the comment period for the draft guidance giving interested persons until January 9, 2014, to comment on … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations.
80 FR 33528Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Feb 10, 2009
The comment period closed December 15, 2008. FDA is withdrawing the direct final rule because the agency received significant adverse comment. … Comments received by the agency regarding the withdrawn rule will be considered in developing a final rule using the usual Administrative Procedure Act notice-and-comment procedures.
74 FR 6541Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 23, 2001
DATES: Submit written comments at any time. … Background The draft guidance document was issued for public comment in the Federal Register of September 13, 2000 (65 FR 55265). The comment period ended on December 13, 2000.
66 FR 28527Health and Human Services DepartmentFood and Drug AdministrationCompounding Animal Drugs From Bulk Drug Substances; Guidance for Industry; Availability
Federal Register · Notice · Apr 14, 2022
period. … In response to requests from interested parties, we extended the comment period to July 17, 2020, and then to October 15, 2020.
87 FR 22212Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 25, 2013
(the FD&C Act) (21 U.S.C. 393(d)(2)(D)), and to develop stronger health warnings on tobacco packaging as authorized by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), it is … The third commenter indicated that the authorizing statute was incorrectly identified. The correct authorizing statute is section 1003(d)(2)(D) of the FD&C Act.
78 FR 5462Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Dec 1, 2014
One comment noted that the proposed rule did not include a defined time period for revenue. … A few comments maintained that a 2-year compliance period is appropriate because, according to one comment, we used a 2-year uniform compliance period when implementing the NLEA.
79 FR 71156Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 30, 2018
(See section 417(a)(2) of the FD&C Act.) … Periodic drug experience reports and special drug experience reports must be accompanied by a completed Form FDA 2301, “Transmittal of Periodic Reports and Promotional Material for New Animal Drugs” (see
83 FR 61653Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jul 21, 1995
DATES: Written comments by October 4, 1995. … Also, most manufacturers of food products typically redesign labels within a 2- year period.
60 FR 37611Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 7, 2000
extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. … DATES: Submit written comments on the collection of information by May 8, 2000.
65 FR 12011Health and Human Services DepartmentFood and Drug Administration
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