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Federal Register · Notice · Mar 5, 2021
Table 1 provides examples of the types of activities that may be administered and estimated burden levels during the 3-year period. … Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021-04606 Filed 3-4-21; 8:45 am] BILLING CODE 4164-01-P
86 FR 12952Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 27, 2003
(the act) (21 U.S.C. 357) … ”) • 32-92 “Reaffirmation of Expiration Dating Period for Abbreviated Applications” (This is addressed by MaPP 5226.1.
68 FR 61222Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · May 30, 2014
Follow the instructions for submitting comments. … The comment period closed August 19, 2013, and FDA did not receive any comments. We revise the analysis of impact presented in the proposed rule with more current data, and adjust for inflation.
79 FR 31023Health and Human Services DepartmentFood and Drug AdministrationState Certification of Mammography Facilities
Federal Register · Proposed Rule · Mar 30, 2000
DATES: Submit written comments on the proposed rule by June 28, 2000. Written comments on the information collection requirements should be submitted by May 1, 2000. … Act.
65 FR 16847Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 19, 2019
FDA does not intend to accept requests for inclusion in STeP within this time period. II. … Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information.
84 FR 49306Health and Human Services DepartmentFood and Drug AdministrationProduct-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Federal Register · Notice · Nov 21, 2025
Under that process, draft guidances are posted on FDA's website and announced periodically in the Federal Register . … The previously approved collections of information are subject to review by OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).
90 FR 52681Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 9, 2009
FDA requested that comments on this draft guidance be submitted within 90 days of publication. The 90-day comment period ended on July 28, 2008. … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations.
74 FR 57685Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 2, 2014
The comment period closed on June 10, 2013. A number of comments were received from the public, all of which the Agency considered carefully as it finalized the guidance and made appropriate changes. … Paperwork Reduction Act of 1995 This guidance refers to currently approved collections of information found in FDA regulations.
79 FR 71436Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 8, 2001
DATES: Submit written comments on the collection of information by June 7, 2001. … In the same time period 134 sponsors submitted 4,243 postmarketing reports via Forms FDA 2253 and 2567 to CBER.
66 FR 23264Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 28, 2009
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 … A source previously found to contain E. coli will be considered negative for E. coli after five samples collected over a 24-hour period from the same sampling site are tested and found to be
74 FR 55557Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 19, 2016
The public comment period closed on April 10, 2012. FDA carefully considered all comments received in developing the guidance. … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations.
81 FR 8509Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 22, 1997
(3) PET radiopharmaceuticals must be administered to patients within a short period of time after manufacturing because of the short half-lives of the products. … A regulated entity may adopt an alternative approach to CGMP's for PET drugs if such approach satisfies the requirements of the Federal Food, Drug, and Cosmetic Act and FDA regulations.
62 FR 19580Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 22, 2024
The September 2020 guidance was published to support public health efforts following a declaration, under section 319 of the Public Health Service Act (PHS Act) (42 U.S.C. 247d), by the Secretary of Health … Specifically, we are not seeking prior comment because although the COVID-19 public health emergency under section 319 of the PHS Act has expired, COVID-19 remains a serious health risk for some individuals
89 FR 13351Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 22, 2018
As amended by the FDA Food Safety Modernization Act (FSMA) (Pub. … L. 111-353), the Federal Food, Drug, and Cosmetic Act (FD&C Act) enables the Agency to better protect the public health by helping to ensure the safety and security of the food supply.
83 FR 53271Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 14, 2014
This draft guidance has been revised and is being reissued for comment because the Food and Drug Administration Safety and Innovation Act (FDASIA), which became law on July 9, 2012, amended the FD&C Act … The comment period closed on December 2, 2011.
79 FR 47651Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 6, 2017
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 and to allow 60 days for … Vacancies are updated periodically; therefore, one or more vacancies listed may be in the nomination process or a final appointment may have been made.
82 FR 9383Health and Human Services DepartmentFood and Drug AdministrationIvette Maria Portela Martinez: Final Debarment Order
Federal Register · Notice · Nov 19, 2024
307(a)(7) of the FD&C Act). … Portela Martinez during her 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).
89 FR 91406Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 25, 2026
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. … A license is required when the manufacturer 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
91 FR 9285Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 7, 2016
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 each proposed … cruzi and positive on a licensed supplemental test, we recommend that the establishment notify consignees of all previously distributed blood and blood components collected during the lookback period
81 FR 78170Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 29, 2009
for public comment in response to the notice. … A source previously found to contain E. coli will be considered negative for E. coli after five samples collected over a 24-hour period from the same sampling site are tested and found to be
74 FR 25752Health and Human Services DepartmentFood and Drug Administration
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