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Briefs, oral arguments, agency decisions and the Federal Register.
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Federal 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 AdministrationOver-the-Counter Sunscreen Drug Products-Regulatory Status of Enzacamene
Federal Register · Proposed Rule · Feb 25, 2015
Publication of a proposed sunscreen order triggers several timelines under the SIA, including a 45-day public comment period, and a 30-day period in which a sponsor may request a meeting with FDA to discuss … Comments Similarly, section 586C(b)(6) of the FD&C Act, as amended by the SIA, establishes that a proposed sunscreen order shall provide 45 days for public comment.
80 FR 10026Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 10, 2008
(Comment 1) The commenter recommended that once a firm has qualified for small business status, this should be good enough for 3 to 5 years. … Because both requirements specify that the information must be for the “most recent” year, FDA cannot determine whether an applicant's status as a small business will persist for a period of more than
73 FR 19508Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 30, 1997
These regulatory definitions and requirements reflect requirements in the Federal Food, Drug, and Cosmetic Act and other agency regulations. … bioequivalence approach be used by sponsors of ANDA's and AADA's to assess bioequivalence between a generic and reference listed drug, or by sponsors of NDA's, ANDA's, and AADA's who, during the postapproval period
62 FR 67880Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 25, 2020
This estimate reflects the average number of petitions we have received annually over a period of 10 years. … and other specific labeling acts administered by FDA.
85 FR 52353Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 12, 2001
Comments Interested persons may submit to the Dockets Management Branch (address above) written comments on the draft guidance. … Paperwork Reduction Act of 1995 This notice contains no new collections of information.
66 FR 14391Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 6, 2002
DATES: Submit written comments on the collection of information by July 8, 2002. … Manufacturers keep infant formula distribution records for the prescribed period as a matter of routine business practice.
67 FR 39011Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 29, 2005
successive stages of a product's lifecycle, specifically the following topics: (1) During medical product development, (2) during product application review and approval, and (3) during the postmarketing period … Paperwork Reduction Act of 1995 These guidances contain information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995
70 FR 15866Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 29, 2024
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. … Planning for the local, territorial, and tribal information collections will commence during this period of renewal.
89 FR 60899Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 13, 2015
A draft of this guidance was made available in the Federal Register on April 23, 2014, and the comment period closed July 22, 2014. … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations.
80 FR 19669Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 9, 2019
(FD&C Act) (21 U.S.C. 360c(f)(1)). … FDA anticipates that the Agency and industry may need a period of time to operationalize the policies within this guidance.
84 FR 47310Health 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 · Sep 15, 2011
It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011-23492 Filed 9-14-11; 8:45 am] BILLING CODE 4160-01-P
76 FR 57058Health 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 AdministrationFederal Register · Notice · Jul 28, 2014
Since the program's inception in 1976, FDA has periodically published documents, including guidance documents, which describe FDA's approach and any changes therein to the 510(k) program. … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations.
79 FR 43753Health 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 · May 23, 2017
(21 U.S.C. 379g and 21 U.S.C. 379h) (the FD&C Act). … Because FDA may request additional information from the applicant during the review period, we have also included in this estimate time to prepare any additional information.
82 FR 23581Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 23, 2020
FDA believes that dispensers can use the 3-year period to ensure the systems and processes that are put into place to meet the enhanced system requirements by November 27, 2023, will also fulfill all dispenser … verification requirements under section 582(d)(4) of the FD&C Act.
85 FR 67550Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Exemptions from Premarket Notification; Class II Devices
Federal Register · Notice · Dec 26, 2006
Section 206 of FDAMA, in part, added section 510(m) to the act. … 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.
71 FR 77400Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 3, 2004
DATES: Fax written comments on the collection of information by December 2, 2004. … 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: Fumie Yokota, Desk Officer
69 FR 64073Health and Human Services DepartmentFood and Drug Administration
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