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Federal Register · Notice · Aug 4, 2021
FDA issued part 810 to implement the provisions of section 518 of the FD&C Act. … Section 810.16(a) and (b)—Periodic Status Reports—(Reporting)—The person named in a cease distribution and notification order or a mandatory recall order must submit periodic status reports to FDA to enable
86 FR 41973Health and Human Services DepartmentFood and Drug AdministrationRevocation of Food Standards for 11 Products Not Currently Sold
Federal Register · Rule · Jul 17, 2025
The comment period for the direct final rule runs concurrently with the companion proposed rule. … Review Act/Small Business Regulatory Enforcement Fairness Act (5 U.S.C. 801, Pub.
90 FR 33268Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jul 20, 2004
(Comment 1) One comment stated that the adjusted penalties were not severe enough to “keep crooked manufacturers from stopping their criminal acts which injure the American people.” … (1) 333(b)(2)(A) Violation of certain requirements of the Prescription Drug Marketing Act (PDMA) 50,000 For each of the first two violations in any 10-year period 2004 55,000 (2)
69 FR 43299Health and Human Services DepartmentFood and Drug AdministrationApproved Tobacco Retailer Training Program; Request for Comments
Federal Register · Notice · Dec 9, 2009
(the Tobacco Control Act). … Under each schedule, violators are subject to increasing penalties for repeated violations within prescribed time periods.
74 FR 65129Health 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 · Notice · Jul 9, 2013
FDA-2013-N-0795] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Third-Party Review Under the Food and Drug Administration Modernization Act AGENCY … Third-party reviewers should maintain records of their 510(k) reviews and a copy of the 510(k) for a reasonable period of time, usually a period of 3 years.
78 FR 41065Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 19, 2010
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 … 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
75 FR 2866Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 5, 2005
Act (the act) (21 U.S.C. 360m), directing FDA to accredit persons in the private sector to review certain premarket applications and notifications. … Third-party reviews should maintain records of their 510(k) reviews and a copy of the 510(k) for a reasonable period of time, usually a period of 3 years.
70 FR 821Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 10, 2004
This notice solicits comments on information collection requirements for medical devices; third-party review under the Food and Drug Modernization Act of 1997 (FDAMA). … Third-party reviews should maintain records of their 510(k) reviews and a copy of the 510(k) for a reasonable period of time, usually a period of 3 years.
69 FR 48508Health 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 · Mar 4, 2020
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 (FD&C Act) ( … as to safety, and also that they meet their claimed identity, strength, quality, and purity, as required by section 501(a)(2)(B) of the FD&C Act.
85 FR 12790Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Oct 15, 2004
FDA would like comments regarding labeling, such as the following: • How often to apply the product, • The effect of bathing or showering before the duration of effect period ends, and • Whether any … Comment No. PRC1. 2. Comment No. PRC2. 3. Comment No. SUP4. 4. Comment No. C54. X.
69 FR 61148Health and Human Services DepartmentFood and Drug AdministrationForeign Supplier Verification Programs for Importers of Food for Humans and Animals
Federal Register · Rule · Nov 27, 2015
(Comment 335) Some comments assert that there should be an informed compliance or transition period after the end of the pre-compliance period during which importers would be expected to comply gradually … Some comments specify 12 months as the appropriate time for such an informed compliance or transition period. Some comments ask that we give developing countries longer transition periods.
80 FR 74226Health and Human Services DepartmentFood and Drug AdministrationJason Oppenheimer: Final Debarment Order
Federal Register · Notice · Oct 1, 2025
SUMMARY: The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Jason Oppenheimer 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.
90 FR 47310Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Apr 10, 2001
FDA invited interested persons to comment on the proposed rule by June 14, 1999. FDA received one request to reopen the comment period for six cardiovascular devices. … The requestor asked that FDA extend the comment period until at least 90 days after the guidance documents were publicly available.
66 FR 18540Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jan 10, 2001
If no timely significant comments were submitted to FDA during the comment period, FDA intended to publish a document in the Federal Register within 30 days after the comment period ended, confirming … notice and comment procedures.
66 FR 1834Health 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 AdministrationFederal 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 AdministrationFederal Register · Notice · Jan 3, 2017
The final guidance addresses new provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) added by the Drug Quality and Security Act (DQSA) and updates reporting instructions for drug compounders … The comment period for the revised draft guidance ended on January 23, 2015. FDA received three comments on the draft.
82 FR 129Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 2, 2019
FDA is also reopening the comment period on this draft guidance for comments to be submitted for consideration before we finish work on the final version of the guidance. … FDA is also reopening the comment period on this draft guidance for comments to be submitted for consideration before it finishes work on the final version of the guidance.
84 FR 12621Health and Human Services DepartmentFood and Drug Administration
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