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Federal Register · Notice · Sep 25, 2000
ADDRESSES: Submit electronic comments on the collection of information via the Internet at: http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm. … In FY 99, there were an estimated 3,662 15-day alert reports, 13,238 periodic reports, and 502 distribution reports submitted to FDA.
65 FR 57612Health and Human Services DepartmentFood and Drug AdministrationCharging for Investigational Drugs Under an Investigational New Drug Application
Federal Register · Rule · Aug 13, 2009
(Comment 43) One comment stated that the 1-year authorization period was unnecessary because FDA can always withdraw authorization if the criteria are no longer being met. … Section 701(a) of the act gives FDA the authority to issue regulations for the efficient enforcement of the act.
74 FR 40872Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Mammography Quality Standards Act of 1992; Inspection Fees
Federal Register · Notice · Jan 14, 1998
Submit written comments by March 16, 1998. … Request for Comments Although the MQSA does not require FDA to solicit comments on fee exemption, assessment and collection, FDA is inviting comments from interested persons in order to have the benefit
63 FR 2245Food and Drug AdministrationEffective Date of Requirement for Premarket Approval for Three Class III Preamendments Devices
Federal Register · Rule · Aug 16, 2011
Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed rule and consideration of any comments received, issue a final rule to require premarket … The comment period closed November 23, 2010. FDA received no comments on the proposed rule.
76 FR 50663Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 12, 2017
Application for FDA Approval To Market a New Drug OMB Control Number 0910-0001—Extension Under section 505(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(a)), a new drug … Other interested persons may also submit comments on the notice.
82 FR 58403Health and Human Services DepartmentFood and Drug AdministrationGuidance for Industry on Bioequivalence Recommendations for Specific Products; Availability
Federal Register · Notice · Jun 11, 2010
For draft BE recommendations, the Federal Register notice will identify a comment period. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010-14036 Filed 6-10-10; 8:45 am] BILLING CODE 4160-01-S
75 FR 33311Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Sep 2, 1997
Comment Period and Effective Date Under 5 U.S.C. 553(d) and Sec. 10.40(c)(4) (21 CFR 10.40(c)(4)), the effective date of a final rule may not be less than 30 days after the date of its publication … FDA therefore finds that there is good cause for a 30-day comment period and an immediate effective date. VIII.
62 FR 46223Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 25, 2017
Background In accordance with section 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e(d)(4) and (e)(2)), notification of an order approving, denying, or … Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period.
82 FR 44626Health and Human Services DepartmentFood and Drug AdministrationClosure Medical Corp.; Withdrawal of Color Additive Petition
Federal Register · Notice · Nov 20, 1998
(ACTS) commented that D&C Violet No. 2 could possibly be a carcinogen, based on studies of other anthraquinone dyes and structurally related compounds that concluded those substances were reasonably anticipated … In response to ACTS'' comment, Flamm Associates commented that in addition to a consideration of the general chemical class of a substance, other structural features need to be evaluated in determining
63 FR 64512Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 12, 2018
Act; this requirement is subject to certain exceptions during a 10-year transition period ending on March 23, 2020 (see section 7002(e)(1) to (3) and (e)(5) of the BPCI Act). … In particular, we invite comment on the compliance policy for the labeling of biological products that are the subject of deemed BLAs and the length of the compliance period.
83 FR 63894Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 1, 2026
FDA will review any comments submitted within the 60-day comment period and will further consider whether the exemption described in this notice should be modified prior to publication of its final determination … FDA must publish in the Federal Register a notice of its intent to exempt the device, or of the petition, and provide a 60-calendar-day period for public comment.
91 FR 23427Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 22, 2021
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 (FD&C Act … This written appeal could include a request for an informal hearing as defined in section 201(y) of the FD&C Act (21 U.S.C. 321(y)).
86 FR 66315Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 10, 2011
ACTION: Notice; request for comments. … It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments.
76 FR 27062Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 17, 2009
The draft guidance is applicable to BE studies conducted for ANDAs during both preapproval and postapproval periods. … Paperwork Reduction Act of 1995 The draft guidance refers to information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act
74 FR 17872Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Dec 17, 2019
for the efficient enforcement of the FD&C Act. … Mandates Reform Act of 1995 (Pub.
84 FR 68829Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jul 22, 1999
Paperwork Reduction Act of 1995 X. Request for Comments XI. References I. … The Secretary seeks comments on a shorter period, perhaps 2 days, as a waiting period between detoxification admissions. F.
64 FR 39810Narcotic Drugs in Maintenance and Detoxification Treatment of NarcoticHealth and Human Services DepartmentFederal Register · Notice · Jul 8, 2016
Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each … These collections of information are subject to review by the OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
81 FR 44611Health and Human Services DepartmentFood and Drug AdministrationCompetitive Generic Therapies; Guidance for Industry; Availability
Federal Register · Notice · Mar 16, 2020
On August 18, 2017, the FDA Reauthorization Act of 2017 (FDARA) (Pub. L. 115-52) was signed into law. … Act of 1995 (44 U.S.C. 3501-3521).
85 FR 14948Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Aug 24, 2016
(See Comment 25, 80 FR 55908 at 55927 to 55928.) … (See Comment 524, 80 FR 55908 at 56062.)
81 FR 57784Health and Human Services DepartmentFood and Drug AdministrationJames Funaro: Final Debarment Order
Federal Register · Notice · Dec 19, 2023
SUMMARY: The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring James Funaro for a period of 5 years from importing or offering … In proposing a debarment period, FDA weighed the considerations set forth in section 306(c)(3) of the FD&C Act that it considered applicable to Mr.
88 FR 87784Health and Human Services DepartmentFood and Drug Administration
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