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Federal Register · Notice · Dec 27, 2011
ACTION: Notice; extension of comment period. … Interested persons were invited to submit comments by February 8, 2012. At this time, the Agency is extending the comment period until March 9, 2012, to continue to receive public comments.
76 FR 80947Health and Human Services DepartmentFood and Drug AdministrationAnimal Generic Drug User Fee Act; Public Meeting; Request for Comments
Federal Register · Notice · Sep 30, 2022
FDA-2011-N-0655 for “Animal Generic Drug User Fee Act; Public Meeting; Request for Comments.” … Section 742(d)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 379j-13(d)(4)) requires that, after holding negotiations with regulated industry and periodic consultations with stakeholders
87 FR 59441Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Revised MedWatch Forms; Availability
Federal Register · Notice · Feb 17, 2004
Background Section 303 of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) amended the Federal Food, Drug, and Cosmetic Act (the act) to require FDA to modify Forms 3500 and 3500A, the … A later comment suggested providing a 1-year interim period for industry to modify their reporting systems. FDA partially agrees with the comments.
69 FR 7490Health and Human Services DepartmentFood and Drug AdministrationDietary Supplements Containing Ephedrine Alkaloids; Availability
Federal Register · Notice · May 22, 2000
ACTION: Notice of availability; extension of comment period. … Dotzel, Acting Associate Commissioner for Policy. [FR Doc. 00-12749 Filed 5-19-00; 8:45 am] BILLING CODE 4160-01-F
65 FR 32113Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 12, 2013
(Comment 9) One comment questioned why the preamble to the proposed rule identified change in dosage form as an example of “inappropriate `evergreening' of exclusive approval periods” (76 FR 64868 at 64870 … Congress would not have prescribed a definite period of exclusivity and at the same time provided for means to indefinitely extend that period.
78 FR 35117Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jul 25, 2018
The BPCI Act provides, among other things, exclusivity periods for certain biological products licensed in “stand alone” applications under section 351(a) of the PHS Act. … duration of the exclusivity period for a previously approved reference product.
83 FR 35154Health and Human Services DepartmentFood and Drug AdministrationAnimal Drug User Fee Act; Public Meeting; Request for Comments
Federal Register · Notice · Nov 21, 2022
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 (21 U.S.C. 379j-13(d)(4)) requires that, after holding negotiations with regulated industry and periodic consultations with stakeholder, and
87 FR 70833Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 8, 2011
ACTION: Notice; reopening of comment period. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011-28875 Filed 11-7-11; 8:45 am] BILLING CODE 4160-01-P
76 FR 69274Health and Human Services DepartmentFood and Drug AdministrationEffective Date of Requirement for Premarket Approval for an Implantable Pacemaker Pulse Generator
Federal Register · Proposed Rule · Jul 27, 2011
Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed rule and consideration of any comments received, issue a final rule to require premarket … The FD&C Act does not permit an extension of the 90-day period after issuance of a final rule within which an application or a notice is required to be filed.
76 FR 44872Health and Human Services DepartmentFood and Drug AdministrationPostmarketing Safety Reporting for Combination Products
Federal Register · Proposed Rule · Oct 1, 2009
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by November 2, 2009, (see the “Paperwork Reduction Act of 1995” section of this document). … PHS Act).
74 FR 50744Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jan 12, 1999
SUPPLEMENTARY INFORMATION: FDA solicited comments concerning the direct final rule for a 75-day period ending on December 14, 1998. … the comment period.
64 FR 1762Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 1, 2020
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 … There were an estimated 169,334 15-day Alert reports, 184,265 periodic reports, and 789 lot distribution reports submitted to FDA.
85 FR 54385Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 27, 2023
The guidances in List 1 of this guidance will no longer be in effect after the 180-day transition period ends. … As described in this guidance, a 180-day transition period will begin on the implementation date.
88 FR 18153Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 29, 2014
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 … FDA received one comment; however, this comment did not address the information collection.
79 FR 64392Health and Human Services DepartmentFood and Drug AdministrationPostmarketing Safety Reporting for Combination Products
Federal Register · Rule · Dec 20, 2016
(Comment 15) Some commenters sought clarification of the applicability of section 227 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) concerning the reporting of malfunctions to FDA, … (Comment 16) One commenter sought clarification of whether the periodic reports addressed in proposed § 4.103(c) should be considered “expedited” reports for purposes of this rule.
81 FR 92603Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 19, 2019
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).
84 FR 42927Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Aug 18, 1998
Section 515(b)(3) of the act provides that FDA shall, after the close of the comment period on the proposed rule and consideration of any comments received, issue a final rule to require premarket approval … Interested persons were given until September 16, 1997, to comment on the proposed rule. During the comment period, the agency received no comments on the proposed rule.
63 FR 44177Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 8, 2018
Under § 314.80(c)(2), applicants must provide periodic reports of adverse drug experiences. … Section 760(e) of the FD&C Act (21 U.S.C. 379aa(e)) also requires that responsible persons maintain records of nonprescription adverse event reports, whether or not the event is serious, for a period of
83 FR 55900Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 9, 2001
ACTION: Notice; extension of comment period. … FDA received an e-mail request, dated January 4, 2001, requesting that the agency extend the comment period on the draft guidance by 60 days, allowing 90 days for comments.
66 FR 9711Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 29, 2017
FDA-2017-N-3199] Program for Enhanced Review Transparency and Communication for Original 351(k) Biologics License Applications in Biosimilar User Fee Act II AGENCY: Food and Drug Administration, … DATES: FDA is providing a period of 30 days for public comment on the statement of work before beginning the assessment.
82 FR 29569Health and Human Services DepartmentFood and Drug Administration
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