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Federal Register · Notice · May 2, 2025
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 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
90 FR 18859Health and Human Services DepartmentFood and Drug AdministrationBeverages: Bottled Water; Technical Amendment; Confirmation of Effective Date
Federal Register · Rule · Jul 5, 2001
FDA received no significant adverse comments within the comment period. Therefore, FDA is confirming that the effective date of the regulation is January 1, 2002. … Publication of this document constitutes final action of this change under the Administrative Procedure Act (5 U.S.C. 553).
66 FR 35373Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 2, 2015
New Animal Drugs for Investigational Uses—21 CFR Part 511 (OMB Control Number 0910-0117)—(Extension) FDA has the authority under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to approve new … maintain records showing the name and post office address of the expert or expert organization to whom it is shipped and the date, quantity, and batch or code mark of each shipment and delivery for a period
80 FR 17758Health and Human Services DepartmentFood and Drug AdministrationSeafood HACCP Transition Guidance; Availability
Federal Register · Notice · Feb 2, 2000
(the act). … As noted by the comment, the 180-day period is the maximum permitted tentative response time.
65 FR 4984Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 13, 2020
Draft guidance is required to be issued by February 14, 2020, with final guidance issuing not later than 1 year after the close of the comment period on the draft guidance. II. … Paperwork Reduction Act of 1995 This draft guidance refers to previously approved FDA collections of information.
85 FR 8297Health and Human Services DepartmentFood and Drug AdministrationBioavailability and Bioequivalence Requirements; Abbreviated Applications; Proposed Revisions
Federal Register · Proposed Rule · Nov 19, 1998
FDA is proposing these revisions because the drug elimination period (wash-out period) of three times the half-life of the active drug ingredient or therapeutic moiety, or its active metabolite(s), is … Title II of the Unfunded Mandates Reform Act (Pub.
63 FR 64222Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 19, 2015
Specific Topics for Comment In addition to comments on the draft guidance as written, we are specifically requesting comments on the following issues: • Should the final guidance address the issue … It is only necessary to send one set of comments. Identify comments with Docket No. FDA-2015-D-1176.
80 FR 28624Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 13, 2012
(the FD&C Act) (21 U.S.C. 360) clearance. … an annual report for 3 consecutive years, this would be less burdensome than the current postapproval requirements under part 814, subpart E (21 CFR part 814, subpart E), including the submission of periodic
77 FR 41410Health and Human Services DepartmentFood and Drug AdministrationFederal 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 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 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 AdministrationPublic Meeting on Section 406(b) of the FDA Modernization Act of 1997
Federal Register · Notice · Aug 20, 1998
of 1997 (FDAMA) to discuss how FDA can best meet its statutory obligations under the Federal Food, Drug, and Cosmetic Act (the act). … Comments Written comments should be identified with the docket number found in brackets in the heading of this document and should be submitted by September 11, 1998, to the Dockets Management Branch
63 FR 44628Health 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 Administration
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