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Federal Register · Notice · Nov 24, 2015
According to information in the NADA, AquAdvantage Salmon is genetically engineered to reach market size in a shorter period than non-GE farm-raised Atlantic salmon. … 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
80 FR 73193Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 21, 2016
period closed on August 4, 2015. … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations.
81 FR 40317Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Mar 21, 2001
This section requires FDA to publish in the Federal Register a notice of intent to exempt a device, or of the petition, and to provide a 30-day comment period. … Both comments objected that the petitioner did not establish that the device met FDA criteria for exemption from premarket notification. FDA disagrees with these comments.
66 FR 15796Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jan 9, 2017
Two comments requested that the comment period be extended due to the complexity of the legal issues involved. One of these comments related to the original 60-day comment period. … The second comment appears to relate to the additional 30-day comment period announced in 80 FR 74737.
82 FR 2193Health and Human Services DepartmentFood and Drug AdministrationJohn Warrington Kosolcharoen: Final Debarment Order
Federal Register · Notice · Mar 13, 2025
Follow the instructions for submitting comments. An application submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. … Kosolcharoen during his period of debarment, other than in connection with an audit under section 306 of the FD&C Act (section 306(c)(1)(B) of the FD&C Act (21 U.S.C. 335a(c)(1)(B))).
90 FR 11988Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 6, 2026
In the Consolidated Appropriations Act, 2023 (CAA), Congress amended section 506(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 356(c)), to provide FDA additional authorities and … completion of confirmatory trials of accelerated approval products, including that FDA may require as appropriate, a confirmatory study or studies to be underway prior to approval or within a specified time period
91 FR 5491Health and Human Services DepartmentFood and Drug AdministrationFood Additives Permitted in Feed and Drinking Water of Animals; Formic Acid
Federal Register · Rule · Feb 9, 2011
Follow the instructions for submitting comments. Written Submissions Submit written objections in the following ways: Fax: 301-827-6870. … The notice of filing provided for a 30-day comment period on the petitioner's environmental assessment. One comment was received that was not substantive. II.
76 FR 7106Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jul 27, 2015
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by August 26, 2015, (see the “Paperwork Reduction Act of 1995” section of this document). … In the Federal Register of May 27, 2014 (79 FR 30055), we extended the comment period until August 1, 2014.
80 FR 44303Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · May 24, 2022
in effect even after the HHS Secretary declares that this PHE no longer exists or the expiration of the 90-day period beginning on the date the HHS Secretary issues a renewal of the determination that … Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection
87 FR 31440Health and Human Services DepartmentFood and Drug AdministrationKalpen D. Patel: Final Debarment Order
Federal Register · Notice · Feb 14, 2024
the FD&C Act). … Patel during his period of debarment, other than in connection with an audit under section 306(c)(1)(B) of the FD&C Act.
89 FR 11296Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Nov 28, 1997
The proposal gave the public 30 days to submit written comments. The comment period later was reopened for an additional 2 weeks (see 61 FR 11349, March 20, 1996). … Comments relied on the recent Ninth Circuit decision, Papike, to support their interpretation of Medtronic and the scope of preemption under 521(a) of the act.
62 FR 63271Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 15, 2007
Request; Mammography Quality Standards Act Requirements AGENCY: Food and Drug Administration, HHS. … The Mammography Quality Standards Act Requirements—21 CFR Part 900 (OMB Control Number 0910-0309)—Extension Mammography Quality Standards Act requires the establishment of a Federal certification and
72 FR 7438Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 15, 2023
This notice solicits comments on the information collection pertaining to the registration of human drug compounding outsourcing facilities under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and … Registered outsourcing facilities must submit a drug product report upon initial registration under section 503B and twice each year in June and December for drug products produced during the previous 6-month period
88 FR 55464Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · May 3, 2000
The final rule implements the Prescription Drug Marketing Act of 1987 (PDMA), as modified by the Prescription Drug Amendments of 1992 (PDA) and the FDA Modernization Act of 1997 (the Modernization Act) … 203.3(u) to mean an association that exists when a manufacturer and a distributor enter into a written agreement under which the distributor is authorized to distribute the manufacturer's products for a period
65 FR 25639Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 6, 2022
the draft guidance was issued; and adding a transition period to facilitate the implementation of the guidance. … Paperwork Reduction Act of 1995 While this guidance contains no new collection of information, it does refer to previously approved FDA collections of information.
87 FR 34275Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 16, 2023
content/pkg/FR-2018-01-22/pdf/2018-00997.pdf ) and a final rule that delayed the general compliance date, while allowing use of three burden-reducing provisions for certain research during the delay period … Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information.
88 FR 55703Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Dec 30, 1997
DATES: Submit written comments by March 16, 1998. Submit written comments on the information collection provisions by January 29, 1998. … Act of 1995 (the PRA) (44 U.S.C. 3501- 3520).
62 FR 67775Health and Human Services DepartmentFood and Drug AdministrationRevocation of Methods of Analysis Regulation
Federal Register · Proposed Rule · Jul 15, 2022
Legal Authority FDA is taking this action under the general administrative provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act). D. … Reform Act of 1995 (Pub.
87 FR 42398Health and Human Services DepartmentFood and Drug AdministrationOphthalmic Drug Products for Over-the-Counter Human Use; Final Monograph; Technical Amendment
Federal Register · Rule · Feb 19, 2003
Comment Dates : Submit written or electronic comments by April 21, 2003. … Also, some manufacturers might be able to make these changes during the implementation period as part of routinely scheduled label revisions.
68 FR 7919Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 5, 2001
EU CABs must maintain records of their third-party evaluations of quality systems and premarket submissions for certain products manufactured for export to the United States for a period of no less than … The agency further estimates based on dialogue with EC officials, that 11 firms will be designated to act as EC CABs. C.
66 FR 51050Health and Human Services DepartmentFood and Drug Administration
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