Documents
Briefs, oral arguments, agency decisions and the Federal Register.
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Veterinary Feed Directive; Extension of Comment Period
Federal Register · Proposed Rule · Jun 28, 2010
ACTION: Advance notice of proposed rulemaking; extension of comment period. … The agency has received requests for a 60-day extension of the comment period for the ANPRM.
75 FR 36588Health and Human Services DepartmentFood and Drug AdministrationElectronic Cigarettes and the Public Health; Public Workshop
Federal Register · Notice · Mar 20, 2015
ACTION: Notice of public workshop; extension of comment period. … Extension of Comment Period Extension.
80 FR 15018Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jan 26, 2000
The agency disagrees with this comment. … (c) * * * Manufacturers and importers shall retain an MDR event file relating to an adverse event for a period of 2 years from the date of the event or a period of time equivalent to the expected life
65 FR 4112Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Apr 3, 1996
State lacks such a requirement, for a period of 7 years, which is the time period specified by California. … The comment period on the interim regulations ended on December 29, 1994. No comments were received on the alternative requirements or, for that matter, on any of the amendments.
61 FR 14870Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Dec 20, 1999
Three comments recommended that the agency establish a 90-day time period for the review of eligibility data. Two comments requested that this time period be 120 days. … The agency is providing a 90-day comment period, rather than the 60 days as suggested by the comment, because it anticipates that most interested parties will want a longer period of time to respond to
64 FR 71062Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 9, 2014
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Act … In January 2012, the ICH Steering Committee agreed that the “E2C(R2) Periodic Benefit-Risk Evaluation Report” draft guidance (the draft PBRER guidance) should be made available for public comment.
79 FR 26766Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · May 14, 1999
30 days after the comment period on this direct final rule ends. … If FDA receives no significant adverse comments during the specified comment period, FDA intends to publish a confirmation document within 30 days after the comment period ends, confirming the effective
64 FR 26282Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Feb 16, 2000
ACTION: Proposed rule; reopening of comment period. … The agency has received requests to reopen the comment period for the November 17, 1999, proposal to allow additional time for interested persons to comment.
65 FR 7806Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 25, 2011
ACTION: Notice; request for comments; extension of comment period. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011-7068 Filed 3-24-11; 8:45 am] BILLING CODE 4160-01-P
76 FR 16795Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 26, 2014
ACTION: Notice; extension of comment period. … FDA has received requests for extension of the comment period for the notice.
79 FR 16800Health and Human Services DepartmentFood and Drug AdministrationPublic Information Regulations
Federal Register · Rule · Sep 2, 2004
If FDA receives no significant adverse comments by the specified comment period, the agency will publish a document in the Federal Register confirming the effective date of this direct final rule. … The comment period for the direct final rule runs concurrently with that of the companion proposed rule.
69 FR 53615Health and Human Services DepartmentFood and Drug AdministrationBar Code Label Requirement for Human Drug Products and Biological Products
Federal Register · Rule · Feb 26, 2004
One comment requested that we shorten the implementation period without specifying a different implementation period. … Only one comment advocated a longer implementation period. The comment said the implementation period should be 5 years if we refuse to create a general exemptions provision.
69 FR 9120Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 25, 2023
ACTION: Notice; reopening of the comment period. … Therefore, we are reopening the comment period to allow interested parties additional time to submit comments.
88 FR 47886Health and Human Services DepartmentFood and Drug AdministrationPreventive Controls for Fresh Produce; Request for Comments; Extension of the Comment Period
Federal Register · Notice · May 20, 2010
ACTION: Notice; extension of the comment period. … FDA is extending the comment period until July 23, 2010.
75 FR 28263Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 6, 2002
We provided a period of 90 days for comments from interested parties. We received comments from four entities. … (Comment 20) One comment stated that the reporting requirements are not authorized by the PS provisions in the act and that they are unduly burdensome, in contravention of section 519(a)(4) of the act
67 FR 38878Health and Human Services DepartmentFood and Drug AdministrationDraft Civil Money Penalty Reduction Policy for Small Entities
Federal Register · Notice · May 18, 1999
Whether the small entity corrected the violations within a reasonable time period; 8. … As a general statement of policy, the Administrative Procedure Act does not require that FDA publish this draft policy for notice and comment.
64 FR 26984Health and Human Services DepartmentFood and Drug AdministrationExpedited Safety Reporting Requirements for Human Drug and Biological Products
Federal Register · Rule · Oct 7, 1997
Although the October 1994 proposal provided a 90-day comment period under the Paperwork Reduction Act of 1980, FDA is providing an additional opportunity for public comment under the Paperwork Reduction … Act of 1995, which was enacted after the expiration of the comment period and applies to this final rule.
62 FR 52237Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 29, 2012
There were five comments received: (Comment 1) Jane Public commented that she does not see the usefulness of the study. … (Comment 4) FMI believes the proposed study fails to meet FDA's Information Quality Guidelines and the requirements of the Data Quality Act because its structure will not provide information of utility
77 FR 65555Health and Human Services DepartmentFood and Drug AdministrationAnimal Drug User Fee Act; Public Meeting; Request for Comments
Federal Register · Notice · Oct 5, 2017
FDA-2011-N-0656 for “Animal Drug User Fee Act; Public Meeting; Request for Comments.” … Section 740A(d)(4) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 379j-13(d)(4)) requires that, after holding negotiations with regulated industry and periodic consultations with
82 FR 46503Health and Human Services DepartmentFood and Drug AdministrationRevocation of Uses of Partially Hydrogenated Oils in Foods; Companion Document to Direct Final Rule
Federal Register · Proposed Rule · Aug 9, 2023
The comment period for this companion proposed rule runs concurrently with the comment period for the direct final rule. … If any significant adverse comments to the direct final rule are received during the comment period, FDA will publish, within 30 days after the comment period ends, a notice of significant adverse
88 FR 53827Health and Human Services DepartmentFood and Drug Administration
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