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Federal Register · Notice · Aug 1, 2016
documenting that all individual employees have been trained and that retailers retain these records for 4 years in order to be able to provide evidence of a training program during the 48-month time period … ) (section 901(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
81 FR 50522Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 25, 2025
(Field G4) • revise “Periodic” to “Non-expedited (periodic)” under “Type of Report” field (Field G6) • revise “If action reported to FDA under 21 U.S.C. 360i(g), list correction/removal reporting number … ” ○ Change the “Periodic” label to “Non-expedited (Periodic)” and add “For Cosmetic products, use this option for non-serious adverse event.
90 FR 27029Health and Human Services DepartmentFood and Drug AdministrationProduct-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Federal Register · Notice · May 20, 2021
Under that process, draft guidances are posted on FDA's website and announced periodically in the Federal Register . … Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. V.
86 FR 27447Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 5, 2002
Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including renewal of … Form FDA 2301 is available for the required transmittal of periodic reports and promotional material for new animal drugs.
67 FR 56846Health and Human Services DepartmentFood and Drug AdministrationConducting Remote Regulatory Assessments-Questions and Answers; Guidance for Industry; Availability
Federal Register · Notice · Jun 26, 2025
The comment period for the revised draft guidance ended on March 26, 2024. 1 See sections 3611, 3612, and 3613 of the Food and Drug Omnibus Reform Act of 2022 (FDORA), enacted as part of the Consolidated … Appropriations Act, 2023, Public Law 117-328 (2022).
90 FR 27319Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 22, 1998
comment and publication of a final regulation'' if the agency ``determines that such action is necessary * * * to enable [FDA] to act promptly to ban or modify a claim'' under section 403(r) of the act … 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 34115Health and Human Services DepartmentFood and Drug AdministrationGeneral and Plastic Surgery Devices: Reclassification of the Tweezer-Type Epilator
Federal Register · Rule · Oct 26, 1998
This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the … Interested persons were given until September 9, 1997, to comment on the proposed rule. During the comment period, FDA received 10 comments.
63 FR 57059Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 26, 2014
of 2002 (the Bioterrorism Act) (Pub. … Existing records may be used if they contain all of the required information and are retained for the required time period. Section 101 of the FDA Food Safety Modernization Act (FSMA) (Pub.
79 FR 36321Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 26, 2018
included in the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI), part of the FDA Reauthorization Act of 2017 (FDARA). … FDA will also hold an open public comment period at the meeting to give the public an opportunity to present their comments.
83 FR 8281Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 25, 2018
Drug Consumer Protection Act (DSNDCPA). … a period of 6 years.
83 FR 48433Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 27, 2014
The comment period closed on February 7, 2013. Two sets of comments were received and reviewed by FDA. The guidance was updated to address comments where appropriate. II. … Paperwork Reduction Act of 1995 This guidance refers to currently approved collections of information found in FDA regulations.
79 FR 51182Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 14, 2013
The comment period on the draft guidance ended on April 18, 2011. Most of the comments sought clarification and further illustrations of issues discussed in the guidance. … Paperwork Reduction Act of 1995 This guidance provides best practices for reporting pharmacoepidemiologic safety studies using electronic healthcare data.
78 FR 28228Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 7, 2007
FDA received one set of comments on the draft guidance document during the comment period. … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations.
72 FR 31589Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 15, 2021
FDA is publishing this notice to obtain comments in accordance with procedures established by the Federal Food, Drug, and Cosmetic Act (FD&C Act). … To do so, FDA must publish in the Federal Register notice of its intent to exempt the device, or the petition, and provide a 60-calendar day period for public comment.
86 FR 31722Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · May 18, 2018
Introduction In response to the proposed rule (81 FR 10553) to classify BECS and BECS accessories into class II, we received seven comment letters by the close of the comment period, each containing one … Section 3060 of the 21st Century Cures Act (Cures Act), Pub.
83 FR 23212Health and Human Services DepartmentFood and Drug AdministrationProposal To Revoke 18 Standards of Identity for Dairy Products
Federal Register · Proposed Rule · Jul 17, 2025
DATES: Either electronic or written comments on the proposed rule must be submitted by September 15, 2025. FDA does not intend to extend the comment period. … The Unfunded Mandates Reform Act of 1995 (Pub.
90 FR 33334Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 29, 2010
Current Good Manufacturing Practice Regulations for Medicated Feeds—21 CFR Part 225 (OMB Control Number 0910-0152)—Extension Under section 501 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act … A license is required when the manufacture of a medicated feed involves the use of a drug or drugs that FDA has determined requires more control because of the need for a withdrawal period before slaughter
75 FR 73101Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 31, 2003
In addition, section 501 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 351) provides that drugs and devices (including human blood and blood components) are adulterated if they do not … However, we expect the numbers of reports to level off after this adjustment period, and therefore, we estimate that the rate of submission will not significantly increase in the next few years.
68 FR 75572Health and Human Services DepartmentFood and Drug AdministrationColor Additive Certification; Increase in Fees for Certification Services
Federal Register · Rule · Dec 7, 2006
ACTION: Interim final rule; technical amendment; reopening of comment period. … (the act) (21 U.S.C. 379(e)).
71 FR 70873Health and Human Services DepartmentFood and Drug AdministrationGuidance for Industry on NDAs: Impurities in Drug Substances; Availability
Federal Register · Notice · Feb 25, 2000
All comments received during the comment period have been carefully reviewed and the guidance has been revised, where appropriate. … Dotzel, Acting Associate Commissioner for Policy. [FR Doc. 00-4405 Filed 2-24-00; 8:45 am] BILLING CODE 4160-01-F
65 FR 10097Health and Human Services DepartmentFood and Drug Administration
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