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Federal Register · Notice · Mar 6, 2024
Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed … FDA developed reports summarizing the findings for each of the three data collection periods, released in 2000, 2004, and 2009. 1 2 3 Data from all three data collection periods were analyzed to detect
89 FR 15996Health and Human Services DepartmentFood and Drug AdministrationDulal C. Chatterji; Grant of Special Termination; Final Order Terminating Debarment
Federal Register · Notice · Jun 11, 1998
Under section 306(d)(4)(D) of the act, the period of debarment of an individual who qualifies for special termination may be limited to less than permanent but to no less than 1 year. Dr. … Chatterji's period of debarment has lasted more than 1 year.
63 FR 32013Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 9, 2010
Section 130(a) of the Food and Drug Administration Modernization Act (Public Law 105-115) amended the Federal Food, Drug, and Cosmetic Act (the act) by adding a new provision (section 506B of the act ( … No comments were received on this information collection request.
75 FR 32786Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 4, 2010
All comments received during the comment period have been carefully reviewed and, where appropriate, incorporated in the guidance. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010-13420 Filed 6-3-10; 8:45 am] BILLING CODE 4160-01-S
75 FR 31794Health and Human Services DepartmentFood and Drug AdministrationDraft Guidance for Industry: Acidified Foods; Availability
Federal Register · Notice · Sep 27, 2010
Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection … It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments.
75 FR 59268Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 4, 2004
The draft guidance also clarifies the applicability of certain changes made by the MMA regarding the period described by section 505(j)(5)(B)(iv) of the act during which ANDAs with paragraph IV certifications … Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments on the draft guidance.
69 FR 64314Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 20, 2000
DATES: Submit written comments on the collection of information by July 20, 2000. … In the Federal Register of March 7, 2000 (65 FR 12011), the agency requested comments on the proposed collections of information. No significant comments were received.
65 FR 38290Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 14, 2024
period was open until July 3, 2023. … , as amended by the 21st Century Cures Act (Pub.
89 FR 90018Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 31, 2023
Section 502(n) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 352(n)) requires that manufacturers, packers, and distributors (firms) who advertise prescription human and animal drugs … Section 202.1 applies to advertisements published in journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television, and telephone communication
88 FR 19313Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 6, 2012
Medical Device User Fee Cover Sheet—Form FDA 3601 (OMB Control Number 0910-0511)—Extension The Federal Food, Drug, and Cosmetic Act, as amended by the Medical Device User Fee and Modernization Act of … , PDP, PMR, BLA), 1 3,561 premarket notifications, 12 panel track supplements, 180 real-time supplements, 127 180-day supplements, 749 30-day notices, 84 513(g) requests, and 463 annual fees for periodic
77 FR 33469Health and Human Services DepartmentFood and Drug AdministrationRequirements for Decorative Ceramicware To Be Deemed not for Food Use
Federal Register · Uncategorized Document · Jan 12, 1994
FDA responded in a notice published in the Federal Register of September 1, 1989 (54 FR 36324), that reopened and extended the comment period until November 30, 1989. … (the act) (21 U.S.C. 342(a)(2)(C)).
Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 28, 2016
Section 130(a) of the Food and Drug Administration Modernization Act (Pub. … L. 105-115) amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by adding a new provision (section 506B of the FD&C Act (21 U.S.C. 356b)) requiring reports of postmarketing studies for approved
81 FR 75130Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 17, 2020
ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk … L. 105-115) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) by adding a new provision (section 506B of the FD&C Act (21 U.S.C. 356b)) requiring reports of postmarketing studies for approved
85 FR 3053Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 18, 2015
(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
80 FR 72071Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 26, 2018
Because such radiopharmaceuticals are not eligible for exemptions from provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to the production of drugs, FDA is issuing this guidance … The comment period on the draft guidance ended on February 27, 2017. FDA received comments on the draft guidance.
83 FR 48633Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 12, 2006
DATES: Fax written comments on the collection of information by November 13, 2006. … ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer
71 FR 60157Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 18, 2014
The comment period on the draft guidance ended on May 6, 2014. We reviewed all comments received on the draft guidance and revised several sections of the guidance. … Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES
79 FR 75570Health and Human Services DepartmentFood and Drug AdministrationOversight of Laboratory Developed Tests; Public Meeting; Request for Comments
Federal Register · Notice · Jun 17, 2010
The comment period for this public meeting closes on August 15, 2010. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010-14654 Filed 6-16-10; 8:45 am] BILLING CODE 4160-01-S
75 FR 34463Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Revision of the Nutrition and Supplement Facts Labels
Federal Register · Rule · May 27, 2016
Air Regulatory Group v. EPA, 134 S. Ct. 2427 (2014)). … Thus, the comment's reference to Util. Air Regulatory Group v.
81 FR 33742Health and Human Services DepartmentFood and Drug AdministrationGeneral and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device
Federal Register · Proposed Rule · Oct 31, 2006
Consequently, in the Federal Register of March 10, 1992 (57 FR 8462), FDA extended the reporting period to March 31, 1992. … Subsequently, as permitted by section 520(l)(5)(C) of the act, in the Federal Register of November 30, 1992 (57 FR 56586), the agency published a notice extending the period for issuing such regulations
71 FR 63728Health and Human Services DepartmentFood and Drug Administration
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