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Federal Register · Notice · Nov 15, 2019
Background The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-31) does not require retailers to implement retailer training programs. … One comment was received that was PRA related.
84 FR 62539Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 26, 2013
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 … Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES
78 FR 38349Health and Human Services DepartmentFood and Drug AdministrationOver the Counter Cough and Cold Medications for Pediatric Use; Notice of Public Hearing
Federal Register · Notice · Aug 25, 2008
ACTION: Notice of public hearing; request for comments. … This program was reauthorized and expanded first in the Best Pharmaceuticals for Children Act of 2002 (Public Law 107-109) (January 4, 2002), and then again in Title V of the FDA Amendments Act of 2007
73 FR 50033Health and Human Services DepartmentFood and Drug AdministrationFood Standards of Identity Modernization; Pasteurized Orange Juice
Federal Register · Proposed Rule · Aug 6, 2025
Legal Authority We are issuing this proposed rule consistent with our authority in sections 401 and 701 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 341, 371). C. … U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub.
90 FR 37817Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Aug 18, 2004
General Comments (Comment 1) Two comments assert that presubmission conferences under section 512(b)(3) of the act represent a fundamental change in the manner the agency is to operate and a new way for … One comment acknowledges that scientific knowledge on which agreements are based may change over long periods of time, but expresses concern that no guidance on the duration of those timeframes was given
69 FR 51162Health and Human Services DepartmentFood and Drug AdministrationFood and Drug Administration Review and Action on Over-the-Counter Time and Extent Applications
Federal Register · Rule · Nov 23, 2016
The Agency requested public comments on the Proposed Rule, and the comment period closed June 3, 2016. B. … Furthermore, as with comments submitted after the comment period, any data submitted after the comment period for the NPRM may not be considered before issuance of the final rule.
81 FR 84465Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 21, 2005
The regulations also state that FDA will periodically issue guidance on how to provide the electronic submission. II. … Paperwork Reduction Act of 1995 This guidance contains 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 20759Health and Human Services DepartmentFood and Drug AdministrationRefuse To Accept Procedures for Premarket Tobacco Product Submissions; Withdrawal
Federal Register · Rule · Nov 16, 2016
The comment period closed October 24, 2016. FDA is withdrawing the direct final rule because the Agency received significant adverse comment. … FDA will consider the comments we received on the direct final rule to be comments on the companion proposed rule published at 81 FR 52371 (August 8, 2016).
81 FR 80567Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 16, 2025
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 … 822.28; Changes to PS plan for a device that is no longer marketed 1 1 1 8 8 § 822.29; Waiver 1 1 1 40 40 § 822.30; Exemption request 1 1 1 40 40 § 822.38; Periodic
90 FR 25318Health 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 · Feb 1, 2005
Infant Formula Recall Regulations—21 CFR 107.230, 107.240, 107.250, 107.260, 107.280 (OMB Control Number 0910-0188)—Extension Section 412(e) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C … Manufacturers keep infant formula distribution records for the prescribed period as a matter of routine business practice.
70 FR 5188Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 5, 2020
FDA-2018-N-4337] Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. … Request for Oral Presentations: During the request for comment period, you may indicate if you wish to present at the public meeting and which topic(s) you would like to address.
85 FR 6547Health 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 · Jul 9, 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. … FDA has the authority under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to approve new animal drugs.
89 FR 56385Health 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 · Apr 9, 2021
Similarly, during the same period, 6,287 recalls were terminated, for an average of 2,095 recall terminations annually, and we assume an average of 10 hours is needed for the corresponding information … Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021-07287 Filed 4-8-21; 8:45 am] BILLING CODE 4164-01-P
86 FR 18543Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 9, 2004
FDA has prepared this guidance in accordance with the Small Business Regulatory Enforcement Fairness Act. … FDA has prepared this guidance in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act.
69 FR 71420Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Feb 9, 1996
Finally [[Page 4872]] FDA acknowledges that under the Federal Food, Drug, and Cosmetic Act (the act), a food manufacturer may market a substance for use in food on the basis of the manufacturer's independent … FDA received no comments in response to that notice. The agency has carefully considered the potential environmental effects of this action.
61 FR 4871Health 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 AdministrationFederal Register · Notice · Mar 5, 2014
diagnostic testing of the donor indicating T. cruzi infection, we recommend that the establishment notify consignees of all previously distributed blood and blood components collected during the “lookback” period … Peter Lurie, Acting Associate Commissioner for Policy and Planning. [FR Doc. 2014-04776 Filed 3-4-14; 8:45 am] BILLING CODE 4160-01-P
79 FR 12506Health and Human Services DepartmentFood and Drug Administration
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