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Federal Register · Notice · Sep 19, 2022
The Food and Drug Administration Safety and Innovation Act (Pub. … The application review period will take a minimum of 2 months after 11:59 p.m. eastern time on October 19, 2022.
87 FR 57203Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 14, 2023
The Food and Drug Administration Safety and Innovation Act (Pub. … The application review period will take a minimum of 2 months after 11:59 p.m. Eastern Time on August 14, 2023.
88 FR 45223Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 9, 2024
The Food and Drug Administration Safety and Innovation Act (Pub. … The application review period will take a minimum of 2 months after 11:59 p.m. Eastern Time on August 8, 2024.
89 FR 56393Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Oct 30, 2015
, and/or section 351 of the PHS Act (42 U.S.C. 262). … In separate documents published elsewhere in this issue of the Federal Register , FDA is also reopening the comment periods to FDA's public dockets on the previously issued draft guidance documents
80 FR 66850Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Apr 21, 2003
Background The Dietary Supplement Health and Education Act of 1994 (DSHEA) (Public Law 103-417) amended the Federal Food, Drug, and Cosmetic Act to, among other things, provide FDA with express statutory … Comments To submit written comments on the proposed rule that published in the Federal Register of March 13, 2003, please follow the instructions in the “Request for Comment” section of that document
68 FR 19471Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities: Proposed Collection; Comment Request
Federal Register · Notice · Dec 30, 1997
(the act) (21 U.S.C. 321, 352, 355, and 371) require that marketed drugs be safe and effective. … Under Sec. 314.80(c)(2) applicants must provide periodic reports of adverse drug experiences.
62 FR 67874Health and Human Services DepartmentFood and Drug AdministrationBlood Vessels Recovered With Organs and Intended for Use in Organ Transplantation; Withdrawal
Federal Register · Rule · Sep 14, 2006
The comment period closed July 26, 2006. HRSA and FDA are withdrawing the direct final rule because FDA received significant adverse comment. … Authority: Therefore, under the Public Health Service Act and under authority delegated to the Commissioner of Food and Drugs and to the Administrator, Health Resources and Services Administration, the
71 FR 54198Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 25, 2013
The report covered the period of the preceding calendar year and included separate information for each month of the calendar year. … &C Act.
78 FR 5463Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Investigational Device Exemptions
Federal Register · Rule · Nov 23, 1998
Comments suggested various time periods in which FDA should respond to the notices, ranging from 5 days to 30 days. FDA agrees, in part, with the comments. … The statute does not require that FDA conduct its review of the notices within a specific period of time.
63 FR 64617Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 22, 2016
Summary of Comments to the Proposed Rule We received approximately 10 comment letters on the proposed rule by the close of the comment period. … Introduction We received approximately 10 comment letters on the proposed rule by the close of the comment period, each containing one or more comments on one or more issues.
81 FR 40512Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 16, 2017
Under section 520(m) of the FD&C Act, FDA is authorized to exempt an HUD from the effectiveness requirements of sections 514 and 515 of the FD&C Act (21 U.S.C. 360d and 360e) provided that the device … 80 8,800 Notification of withdrawal of an HDE—814.116(e)(3) 1 1 1 1 1 Notification of withdrawal of Institutional Review Board approval—814.124(b) 1 1 1 2 2 Periodic
82 FR 48096Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities: Proposed Collection; Comment Request
Federal Register · Notice · Oct 24, 1997
public comment in response to the notice. … In the same period of time, CBER received 1,034 submissions from 57 manufacturers that could have made use of revised Form FDA 2253.
62 FR 55408Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 5, 2024
FDA issued part 810 to implement the provisions of section 518 of the FD&C Act. … vacated—810.12(a-b) 1 1 1 8 8 Submission of a strategy for compliance with cease distribution and notification or mandatory recall order—810.14 2 1 2 16 32 Submission of periodic
89 FR 48174Health and Human Services DepartmentFood and Drug AdministrationGuidance for Industry on Electronic Source Data in Clinical Investigations; Availability
Federal Register · Notice · Sep 18, 2013
The comment period on the draft guidance ended on March 26, 2013 (see the correction notice of December 26, 2012 (77 FR 76049)). … Paperwork Reduction Act of 1995 This guidance refers to collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (
78 FR 57395Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 29, 2026
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. … The FDA uses this information to allow for determining eligibility for designation and the associated incentives and benefits described in section 573 of the act, including a 7-year period of exclusive
91 FR 39104Health and Human Services DepartmentFood and Drug AdministrationStudy Data Technical Conformance Guide and Data Standards Catalog; Availability
Federal Register · Notice · Jan 12, 2015
Safety and Innovation Act (Pub. … The comment period on the Guide ended on May 7, 2014. We reviewed all comments received and revised it accordingly.
80 FR 1508Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 16, 2012
ACTION: Notice of public hearing; request for comments. … the exclusivity periods provided by sections 505(c)(3)(E)(ii) through (c)(3)(E)(iv) (21 U.S.C. 355(c)(3)(E)(ii) through (c)(3)(E)(iv)), 505(j)(5)(F)(ii) through (j)(5)(F)(iv) (21 U.S.C. 355(j)(5)(F)(ii
77 FR 68789Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 4, 2013
The draft guidance addresses new provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Quality and Security Act (DQSA). … 503B of the FD&C Act.
78 FR 72899Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Nov 15, 2006
Section 503(e)(1)(A) of the Federal Food, Drug, and Cosmetic Act (act) establishes the so-called “pedigree” requirement for prescription drugs. … As part of its June 14, 2006, announcement, FDA also issued and requested comment on draft Compliance Policy Guide 160.900 entitled “Prescription Drug Marketing Act Pedigree Requirements under 21 CFR Part
71 FR 66448Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 1, 2015
(the FD&C Act) (21 U.S.C. 360(l))) from premarket notification requirements. … The comment period closed on September 30, 2014.
80 FR 37633Health and Human Services DepartmentFood and Drug Administration
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