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Action Level for Inorganic Arsenic in Apple Juice: Guidance for Industry; Availability
Federal Register · Notice · Jun 2, 2023
We also considered all comments received during the comment period in finalizing the document. … Paperwork Reduction Act of 1995 This final guidance contains no collection of information.
88 FR 36319Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 2, 2009
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 … States that are awarded this option will receive up to $25,000 over a period of 5 years to fully implement the program standards.
74 FR 63154Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 12, 2003
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, and to allow 60 days … for public comment in response to the notice.
68 FR 7124Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 1, 2011
(Response) The questionnaire, which has information about how questions will be asked and how behavioral intention will be assessed, was available upon request during the first comment period and will … continue to be available during the second comment period.
76 FR 38658Health and Human Services DepartmentFood and Drug AdministrationNatural Rubber-Containing Medical Devices; User Labeling
Federal Register · Rule · Sep 30, 1997
Other comments complained that a 180- day implementation period is not sufficient to change the labeling on the numerous devices affected by this rule. … These comments requested at least a 12-month implementation period.
62 FR 51021Health and Human Services DepartmentFood and Drug AdministrationProduct-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Federal Register · Notice · Aug 3, 2022
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.
87 FR 47425Health and Human Services DepartmentFood and Drug AdministrationProduct-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Federal Register · Notice · Nov 18, 2022
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.
87 FR 69278Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Apr 23, 2001
The comment period closed March 26, 2001. FDA is withdrawing the direct final rule because the agency received significant adverse comment. … Witt, Acting Associate Commissioner for Policy. [FR Doc. 01-9950 Filed 4-20-01; 8:45 am] BILLING CODE 4160-01-S
66 FR 20401Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Sep 13, 2024
The final rule implements a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. … These time periods are consistent with section 201(b) of the Tobacco Control Act and the effective date of the final rule upon its publication.
89 FR 74831Health and Human Services DepartmentFood and Drug AdministrationMedical Device Warning Letter Pilot
Federal Register · Notice · Mar 8, 1999
This pilot will be evaluated by FDA at the end of the 18-month period. … Hubbard, Acting Deputy Commissioner for Policy. [FR Doc. 99-5523 Filed 3-5-99; 8:45 am] BILLING CODE 4160-01-F
64 FR 11018Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 7, 2014
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 … of 2007 (FDAAA) includes a requirement that FDA identify and periodically update susceptibility test interpretive criteria for antibacterial drug products and make those findings publicly available.
79 FR 19099Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 22, 2012
Under that process, recommendations are posted on FDA's Web site and announced periodically in the Federal Register. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2012-4037 Filed 2-21-12; 8:45 am] BILLING CODE 4160-01-P
77 FR 10535Health 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 AdministrationFederal Register · Notice · Jul 23, 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 … 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
89 FR 59742Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 19, 2022
The final rule implements a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. … This subsection requires that the FDA-approved plan must be retained while in effect and for a period of not less than 4 years from the date it was last in effect.
87 FR 57206Health and Human Services DepartmentFood and Drug AdministrationProduct Development Under the Animal Rule; Guidance for Industry; Availability
Federal Register · Notice · Oct 28, 2015
The comment period for the revised draft guidance closed on August 4, 2014. We reviewed all comments received and considered them in finalizing the revised draft guidance. … Paperwork Reduction Act This guidance refers to previously approved collections of information that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act
80 FR 66011Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 11, 2010
FDA-2010-N-0121] Agency Information Collection Activities; Proposed Collection; Comment Request; Mammography Quality Standards Act Requirements AGENCY: Food and Drug Administration, HHS. … This notice solicits comments on the estimated reporting and recordkeeping burden associated with the Mammography Quality Standards Act requirements.
75 FR 11542Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 18, 2026
ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. … A medicated feed mill license is required when the manufacturing process involves the use of a drug or drugs that FDA has determined requires more control because of the need for a withdrawal period before
91 FR 36863Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 25, 2019
(FD&C Act), when determining the sufficiency of the reports under the FD&C Act and the active postmarket risk identification and analysis (ARIA) system available under the FD&C Act to meet these purposes … (b), subpart I have been approved under OMB control number 0910-0001: (1) Preparing and submitting reports pertaining to safety, postmarketing commitments and preparing and submitting spontaneous and periodic
84 FR 57452Health and Human Services DepartmentFood and Drug AdministrationProduct-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Federal Register · Notice · Oct 24, 2022
Under that process, draft guidances are posted on FDA's website and announced periodically in the Federal Register . … Paperwork Reduction Act of 1995 FDA tentatively concludes that these draft guidances contain no collection of information.
87 FR 64236Health and Human Services DepartmentFood and Drug Administration
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