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Briefs, oral arguments, agency decisions and the Federal Register.
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Federal Register · Notice · May 19, 2015
After the comment period is closed, nominations to add or remove bulk drug substances from the list may be submitted to FDA by citizen petition under § 10.30 (21 CFR 10.30). … Follow the instructions for submitting comments.
80 FR 28622Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 9, 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. … In the Federal Register of August 7, 2025 (90 FR 38151) FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
90 FR 57067Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 27, 2014
The comment stated that the Food Safety Modernization Act (FSMA) gave FDA authority “to require producers to implement prevention based food safety standards.” … The comment also noted the periodic scheduling of audits and inspections of hospitals by the regulator.
79 FR 4350Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 5, 2020
Now that the comment period has closed, FDA plans to hold an advisory committee meeting to review the information submitted and discuss its key points. … Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: January 31, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy.
85 FR 6565Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 19, 2002
DATES: Submit written comments on the collection of information by September 3, 2002. … All comments should be identified with the docket number found in brackets in the heading of this document.
67 FR 53805Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jul 18, 2000
The comment period for the 1999 proposed rule was reopened on April 18, 2000 (65 FR 20774), and will close on July 17, 2000. … proposed rule for establishment registration and listing also proposed criteria that human cellular and tissue-based products must meet for regulation solely under section 361 of the Public Health Service Act
65 FR 44485Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Sep 23, 1997
The comment noted that the period to use labels that state ``manufactured for'' and ``distributed by'' could be easily as long. … FDA is persuaded by the majority of the comments that it is appropriate to have the effective date of this final rule be 18 months from the date of its publication, consistent with the time period allowed
62 FR 49859Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Nov 28, 2012
FDA seeks comment on the following issues related to section 918(a)(2) of the FD&C Act: 2.1. … FDA seeks comment on the following issues related to section 918(a)(3) of the FD&C Act: 3.1.
77 FR 70955Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 16, 2004
Therefore, the physician who elects to use isocarboxazid for extended periods should periodically evaluate the long-term usefulness of the drug for the individual patient. 3. … Any other interested person may also submit comments on this proposal to withdraw approval.
69 FR 20632Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 12, 2023
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 … Therefore, designated countries may respond to our periodic requests by submitting information to confirm their designations remain appropriate.
88 FR 70676Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 14, 2018
Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to conduct research relating to drugs and other FDA regulated products in carrying … out the provisions of the FD&C Act.
83 FR 56845Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Dec 4, 2013
Follow the instructions for submitting comments. … FDA cannot guarantee that all drugs nominated during the nomination period will be considered for inclusion on the next published bulk drugs list.
78 FR 72838Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 11, 2013
Evaluation of FDA's General Market Youth Tobacco Prevention Campaigns—(OMB Control Number 0910-New) The 2009 Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. … As the cohort will be aging over this time period, the data collected throughout the study will reflect information from youth aged 11 to 18.
78 FR 55725Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 23, 2017
(Appendix A to Subpart C of 41 CFR 102-3, the Federal Advisory Committee Management Final Rule notes that the Federal Advisory Committee Act (FACA, 5 U.S.C. … Vacancies are updated periodically; therefore, one or more vacancies listed may be in the nomination process or a final appointment may have been made.
82 FR 23583Health 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
The topic to be discussed is 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 21, 1998, to the Dockets Management Branch
63 FR 44627Health and Human Services DepartmentFood and Drug AdministrationCriteria Used To Order Administrative Detention of Food for Human or Animal Consumption
Federal Register · Rule · May 5, 2011
FDA invites public comment on this interim final rule and will consider modifications to it based on comments made during the comment period. … It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments.
76 FR 25538Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Aug 19, 1999
In response to requests for additional time, FDA twice extended the comment period, as announced in the Federal Register of August 17, 1994 (59 FR 42193), and November 14, 1994 (59 FR 56448). … Specifically, FDA seeks comments on whether the proposed rule, when finalized, should be revised to permit testing proposed in Sec. 610.40(a) to be completed only once at the beginning of a 30-day period
64 FR 45340Requirements for Testing Human Blood Donors for Evidence of InfectionDue to Communicable Disease Agents and Requirements for Blood, BloodMedical Devices; Device Tracking
Federal Register · Proposed Rule · Apr 25, 2000
Submission of Comments Interested persons may, on or before July 24, 2000, submit to the Dockets Management Branch (address above) written comments regarding this proposal. … Received comments may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday. VIII. Paperwork Reduction Act of 1995 A.
65 FR 24144Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 17, 2010
The deadline for submitting comments related to the agenda is 5 p.m. EDT on June 25, 2010. The comment period for this public meeting closes on August 16, 2010. … David Dorsey, Acting Deputy Commissioner for Policy, Planning and Budget. [FR Doc. 2010-14687 Filed 6-14-10; 4:15 pm] BILLING CODE 4160-01-S
75 FR 34459Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jul 19, 1996
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(m)), and whether Sec. 211.122(g) expanded the proposed scope of the provision from immediate container labels to all drug product labeling. … received during the extended comment period.
61 FR 37679Health and Human Services DepartmentFood and Drug Administration
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