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Federal Register · Notice · Aug 1, 2012
FDA is accepting comments to this document and intends to consider such comments in its continued implementation of these fees. Submit either electronic or written comments by October 31, 2012. … The comment period for this request ended November 30, 2011.
77 FR 45636Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Oct 19, 2011
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by November 18, 2011 (see the “Paperwork Reduction Act of 1995” section of this document). … Paperwork Reduction Act of 1995 VIII. Analysis of Impacts A. Background B. Benefits and Costs of the Proposed Rule C. Small Business Analysis IX. Request for Comments I.
76 FR 64868Health and Human Services DepartmentFood and Drug AdministrationAdministrative Destruction of Certain Drugs Refused Admission to the United States
Federal Register · Rule · Sep 15, 2015
Comments on the Proposed Rule FDA received 22 comments in the public docket for the May 6, 2014, proposed rule by the close of the comment period, July 7, 2014, each containing one or more comments. … The notice shall specify a place and a period of time during which the owner or consignee shall have an opportunity to introduce testimony.
80 FR 55237Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 4, 2014
The comment also expressed support for the provisions in the Antibiotic Development to Advance Patient Treatment (ADAPT) Act, H.R. 3742. … The comment said that the ADAPT Act would direct FDA to publish quarterly on its Web site new or updated breakpoints set by an appropriate standard setting organization and recognized by the Agency.
79 FR 65403Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 29, 1999
DATES: Submit written comments on the collection of information by January 28, 2000. … In the Federal Register of September 28, 1999 (64 FR 52330), the agency requested comments on the proposed collections of information. No significant comments were received.
64 FR 73056Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 26, 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 … Planning for the local, territorial, and tribal information collections will commence during this period of renewal.
89 FR 20980Health and Human Services DepartmentFood and Drug AdministrationAngela Anatilde Baquero: Final Debarment Order
Federal Register · Notice · Aug 3, 2026
) of the FD&C Act. … Baquero 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.
91 FR 48875Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 5, 2012
The Tobacco Control Act (Pub. … The study and copies of the instrument were made available to the public during the original information collection period.
77 FR 72355Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 30, 2015
FDA-2015-N-0007] Biosimilar User Fee Act; Stakeholder Meetings on Biosimilar User Fee Act of 2012 Reauthorization; Request for Notification of Regulated Industry Organization Intention To Participate … The FD&C Act further requires that after negotiations with the regulated industry are concluded, FDA shall present those recommendations for public review and comment, and finally transmit recommendations
80 FR 58738Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 22, 2016
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 … In the Federal Registe r of October 19, 2015 (80 FR 63228) FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
81 FR 8723Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 4, 2023
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. … FDA marketing approval for that drug for the orphan indication for a period of 7 years; and, finally, section 528 is intended to encourage sponsors to make investigational orphan drugs available for treatment
88 FR 84148Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 9, 2013
Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act … Eleven public comments were received during the comment period and in nine of the letters the following two issues were raised.
78 FR 41064Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 21, 2016
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 … Under the statute, the records must be retained for a period of 6 years.
81 FR 3438Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 9, 2006
The notice of availability for the February 27, 2003, draft guidance was published in the Federal Register of April 21, 2003 (68 FR 19549) and the comment period closed on July 21, 2003. … Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations.
71 FR 6779Health and Human Services DepartmentFood and Drug AdministrationScience of Abuse Liability Assessment; Public Workshop
Federal Register · Notice · Oct 7, 2011
The comment period has closed and FDA is gathering current information that may relate to some of the comments received. … David Dorsey, Acting Associate Commissioner for Policy and Planning. [FR Doc. 2011-25918 Filed 10-6-11; 8:45 am] BILLING CODE 4160-01-P
76 FR 62419Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 17, 2018
(Tobacco Control Act) (Pub. … When these compliance periods end, FDA expects a drop in the number of grandfathered submissions.
83 FR 52488Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 10, 2021
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.
86 FR 30941Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 7, 2022
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. … (FD&C Act) (21 U.S.C. 360j(g)), which governs exemption for devices for investigational use.
87 FR 61032Health and Human Services DepartmentFood and Drug AdministrationProduct-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Federal Register · Notice · Dec 5, 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 56161Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 29, 2017
The Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. … These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
82 FR 45594Health and Human Services DepartmentFood and Drug Administration
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