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Federal Register · Notice · Dec 30, 2011
Once the comment period has closed, the Agency reviews the comments and considers them as it prepares the final guidance document. … Importantly, the additional administrative steps required for standard Level 1 guidance documents ( i.e. , issuing a draft guidance document, providing a comment period, and issuing a final guidance
76 FR 82311Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 30, 2009
comment in response to the notice. … Were there any other foods or products given to the animal during this period of time?
74 FR 69106Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Apr 12, 2000
The comment period initially closed on June 28, 1993. … In the Federal Register of July 1, 1993 (58 FR 35416), FDA extended the comment period for 60 days to August 27, 1993, to ensure that there was adequate time for preparation and submission of comments
65 FR 19650Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 29, 2015
Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act … We received 12 NPCs during the 5-year period from 2005 through 2009, for an average of 2.4 NPCs per year.
80 FR 58487Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 1, 2023
The impetus for this standardization effort was the provisions from the 2012 Food and Drug Administration Safety and Innovation Act (Pub. … FDA will aim to provide a new Chapter of the PQ/CMC Data Elements and Terminologies periodically.
88 FR 26567Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 14, 2019
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). … Medical device software—Software life cycle processes Title change and transition period.
84 FR 9354Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 15, 2009
On January 31, 2005 (70 FR 4857), FDA announced the availability of the draft revision for public comment. The comment period closed on May 2, 2005. … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations.
74 FR 34359Health 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 · 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 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 · Jul 30, 2012
comments specific to FDA's eSubmitter tool and paper forms); • Cost associated with the collection of information to comply with section 904(a)(3) of the FD&C Act, particularly for small tobacco product … To avoid overcounting the one-time reporting burden, FDA has annualized the one-time burden over the 3-year expected OMB period of approval.
77 FR 44636Health 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 AdministrationFederal Register · Notice · Nov 10, 2003
To ensure that comments on the information collection are received, OMB recommends that comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer for … This is likely to inhibit some companies from submitting petitions during the interim period. FDA prefers that this interim period be as short as possible.
68 FR 63802Health 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 AdministrationFederal Register · Notice · Nov 7, 2013
The collections of information in 21 CFR parts 202.1, 314, and 601, and sections 505(a), 506(a)(1), 735, and 736 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(a), 356(a)(1), 379 … materials including promotional labeling as well as advertisements intended for dissemination or publication within 120 days following marketing approval must be submitted to FDA during the preapproval period
78 FR 66939Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 22, 2001
This guidance implements provisions of the Government Paperwork Elimination Act (GPEA). DATES: Submit written comments at any time. … FDA will periodically review the comments in the docket and, where appropriate, will amend the guidance.
66 FR 11173Health 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 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 AdministrationThe Food and Drug Administration's Development, Issuance, and Use of Guidance Documents
Federal Register · Notice · Feb 27, 1997
The comment period for the March 7 Notice closed on June 5, 1996. … Under the Administrative Procedure Act (Sec. l0.40(d)), in order to bind the public, FDA must (with limited exceptions) follow the notice and comment rulemaking process.
62 FR 8961Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 18, 2016
Substances Generally Recognized as Safe: Notification Procedure—21 CFR 170.36 and 570.36 (OMB Control Number 0910-0342)—Extension Section 409 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) ( … Under an interim policy announced in the proposed rule, we invited manufacturers to submit notices of their independent determinations for review under the framework of the proposed rule during the period
81 FR 8206Health and Human Services DepartmentFood and Drug Administration
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