Documents
Briefs, oral arguments, agency decisions and the Federal Register.
5,436 results
1.41s
Federal Register · Rule · May 27, 2016
We provided an opportunity to comment on the serving size proposed rule until June 2, 2014. On May 27, 2014, we extended the comment period until August 1, 2014 (79 FR 30056). … We believe the comment period on the proposed rule provided a sufficient opportunity to comment on this and other related issues. As discussed in section III.
81 FR 34000Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 21, 2009
ACTION: Notice of public hearing; request for comments. … As a result, information may be available to a much broader audience than originally engaged in the communication or program if the comments/entries are posted for an indefinite period of time (“archived
74 FR 48083Health and Human Services DepartmentFood and Drug AdministrationCardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices
Federal Register · Proposed Rule · Oct 17, 2011
For additional information on submitting comments, see the “Comments” heading of the SUPPLEMENTARY INFORMATION section of this document. … It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments.
76 FR 64224Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 9, 2022
(FD&C Act) (21 U.S.C. 355) or section 351 of the Public Health Service Act; legally marketed pursuant to section 505G of the FD&C Act (21 U.S.C. 355h) (nonprescription drugs marketed without an approved … • LAR: A measure of the proportion of lots that were accepted in a given time period.
87 FR 13295Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 27, 2003
According to the Paperwork Reduction Act of 1995, a collection of information should display a valid OMB control number. … FDA periodically will review the comments in the docket and, where appropriate, will amend the guidance.
68 FR 61221Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 21, 2024
In response to a request for an extension, we extended the comment period for the draft guidance to October 16, 2023 (August 16, 2023, 88 FR 55702). … FDA received two comment submissions on the draft guidance and those comments were considered as the guidance was finalized.
89 FR 52058Health and Human Services DepartmentFood and Drug AdministrationCurrent Good Manufacturing Practice for Finished Pharmaceuticals; Positron Emission Tomography
Federal Register · Rule · Apr 22, 1997
The agency will periodically provide guidance to industry on the application of the CGMP regulations to PET radiopharmaceutical drug products. … FDA disagrees with these comments.
62 FR 19493Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 17, 2007
§ 814.82(a)(9)—Postapproval Requirements Postapproval requirements concern approved PMAs that were not reclassified and require a periodic report. … Thus, FDA estimates that the periodic reporting burden required by this section will take 340 hours.
72 FR 52882Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jul 30, 2003
Act of 1995 (44 U.S.C. 3501-3520). … (c) * * * A Product B Manufacturer's storage period 1 to 5 °C (unless otherwise stated) C Manufacturer's storage period 0 °C or colder (unless otherwise stated) D Dating period after
68 FR 44678Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 22, 1998
The Annual Review of Medicine is published periodically by Annual Reviews, Inc., in Palo Alto, CA. … FDA invites public comment on this interim final rule. The agency will consider modifications to this interim final rule based on comments made during the comment period.
63 FR 34084Health and Human Services DepartmentFood and Drug AdministrationAnimal Drug Availability Act; Medicated Feed Mill Licenses
Federal Register · Rule · Nov 19, 1999
Ninety-Day Approval Period 6. One comment noted that proposed Sec. 515.20 provides the agency 90 days to act upon a medicated feed mill license application. … The comment stated that this burden applies to sponsors under section 512(a)(1)(B) of the act and to licensed feed mills under proposed Sec. 510.305.
64 FR 63195Health and Human Services DepartmentFood and Drug AdministrationGeneric Drug Issues; Request for Comments
Federal Register · Proposed Rule · Mar 3, 2004
Title XI of MMA made changes to section 505(a), (b), and (j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 505(a), (b), and (j). … The specific portions of the statute for which FDA seeks comment are Title XI of MMA's provisions concerning the 30-month stay of effectiveness period, 180-day exclusivity, and bioavailability and bioequivalence
69 FR 9982Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 19, 2007
of 2002 (the Bioterrorism Act) added section 414 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 350c), which requires that persons who manufacture, process, pack, hold, receive, distribute … Existing records may be used if they contain all of the required information and are retained for the required time period.
72 FR 65033Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 2, 2023
In the Federal Register of September 9, 2011 (76 FR 55927), we extended the comment period to December 2, 2011. We received numerous comments on the 2011 draft guidance. … In the Federal Register of October 4, 2016 (81 FR 68434), we extended the comment period to December 12, 2016.
88 FR 50876Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Feb 21, 2002
Request for Comments and Proposed Dates Interested persons may submit to the Dockets Management Branch (address above) written or electronic comments regarding this proposed rule by April 22, 2002. … Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document.
67 FR 7982Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 29, 2019
DATES: Fax written comments on the collection of information by May 29, 2019. … These recordkeeping requirements for administrative detentions permit FDA to trace devices for which the detention period expired before a seizure is accomplished or injunctive relief is obtained.
84 FR 18057Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 6, 2013
Act) (21 U.S.C. 334(g)) to detain during established inspections devices that are believed to be adulterated or misbranded. … These recordkeeping requirements for administrative detentions permit FDA to trace devices for which the detention period expired before a seizure is accomplished or injunctive relief is obtained.
78 FR 8542Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 23, 1998
It is being implemented immediately without prior public comment because the guidance document is needed to explain to industry the agency's current policy on enforcement of section 503A of the act, which … However, the agency wishes to solicit comment from the public and is providing a 90-day comment period and establishing a docket for the receipt of comments.
63 FR 64723Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 30, 2004
Paperwork Reduction Act of 1995 FDA concludes that this guidance contains no collections of information. … FDA periodically will review the comments in the docket and, where appropriate, will amend the guidance.
69 FR 58448Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 20, 2003
The guidance applies to human drugs (as defined in the Federal Food, Drug, and Cosmetic Act). … All comments received during the comment period have been carefully reviewed and, where appropriate, incorporated in the guidance.
68 FR 27567Health 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.