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Federal Register · Notice · Oct 18, 2016
Comments Submitted by Other Interested Parties: For all comments submitted by other interested parties you may submit comments as follows: Electronic Submissions Submit electronic comments in the … under fasting conditions and 8- to 12-hour post-dosing time period under fed conditions.
81 FR 71741Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 5, 1998
during that time period. … FDA believes that the 18- to 30-month time period is a reasonable period for gathering safety and effectiveness data and obtaining FDA approval or clearance.
63 FR 235Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Health Claims; Soy Protein and Coronary Heart Disease
Federal Register · Proposed Rule · Aug 4, 1999
Section 302 of FDAMA amended section 403(r)(4)(A)(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 343(r)(4)(A)(i)) to provide, in part, that FDA must publish a final rule on a health … However, because of the need to provide for public notice and comment on the reproposal, FDA hereby gives notice that there is cause to extend the period for publication of the final rule for a period
64 FR 42315Health and Human Services DepartmentFood and Drug AdministrationElectronic Product Reporting for Human Drug Compounding Outsourcing Facilities; Draft Guidance
Federal Register · Notice · Nov 24, 2014
The revised draft guidance addresses provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) added by the Drug Quality and Security Act (DQSA) and updates reporting instructions for drug … The comment period on the initial draft guidance ended on February 3, 2014. FDA received six comments on the draft.
79 FR 69857Health and Human Services DepartmentFood and Drug AdministrationExtralabel Drug Use in Animals
Federal Register · Proposed Rule · May 17, 1996
Such order would specify the nature and extent of the order of prohibition and the reasons for the prohibition, and provide a period of not less than 60 days for comments. … Paperwork Reduction Act of 1995 -This proposed rule contains reporting requirements that are subject to public comment and to review by OMB under the Paperwork Reduction Act of 1995 (Pub.
61 FR 25106Health and Human Services DepartmentFood and Drug AdministrationBiosimilar User Fee Act; Public Meeting
Federal Register · Notice · Sep 19, 2016
BsUFA was originally enacted in 2012 as the Biosimilar User Fee Act (Pub. L. 112-144) for a period of 5 years. … FDA will also hold an open public comment period at the meeting to give the public an opportunity to present their comments.
81 FR 64171Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 16, 2021
The statutory basis for FDA conducting this study is derived from the Public Health Service Act (PHS Act) (42 U.S.C. 243, section 311(a)). … The sample for each data collection period is evenly distributed among Specialists.
86 FR 14433Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Hearing Aids; Technical Data Amendments; Confirmation of Effective Date
Federal Register · Rule · Oct 8, 2008
FDA stated that the effective date of the direct final rule would be on October 15, 2008, 60 days after the end of the comment period, unless any significant adverse comment was submitted to FDA during … the comment period.
73 FR 58874Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities: Proposed Collection; Comment Request
Federal Register · Notice · Oct 6, 1997
DATES: Submit written comments on the collection of information by December 5, 1997. … (the act) (21 U.S.C. 351, 352, and 371(a)) to regulate medical devices.
62 FR 52133Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 20, 2016
Background In accordance with sections 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e(d)(4) and (e)(2)), notification of an order approving, denying, or … Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period.
81 FR 31944Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Mar 18, 2026
Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed order, 1 consideration of comments received, and a meeting of a device classification … because that will be the later of the two time periods.
91 FR 12966Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jun 3, 1998
FDA is also reopening the comment period for this proposal until July 6, 1998, for the sole purpose of providing an opportunity for public comment on these documents. … FDA is reopening the comment period for 30 days to allow interested persons the opportunity to comment specifically on issues raised by the documents being added to the record.
63 FR 30160Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 13, 2026
FDA's Center for Tobacco Products (CTP) was created to carry out the authorities granted under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. … We will replenish the sample up to 4 times during the study period.
91 FR 27062Health and Human Services DepartmentFood and Drug AdministrationGeneric Drug User Fee; Notice of Public Meeting; Extension of Comment Period
Federal Register · Notice · Jun 8, 2011
FDA-2010-N-0381] Generic Drug User Fee; Notice of Public Meeting; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of comment period. … Consequently, FDA is extending the comment period for the notice until August 1, 2011.
76 FR 33307Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 5, 2017
” (VICH GL56) should be made available for public comment. … Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations.
82 FR 1342Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Feb 18, 2016
Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed order, consideration of any comments received, and a meeting of a device classification … For MoM hips, the later of these two time periods is the 90-day period.
81 FR 8146Health and Human Services DepartmentFood and Drug AdministrationIldiko M. Knoll: Final Debarment Order
Federal Register · Notice · Aug 15, 2023
In proposing a debarment period, FDA weighed the considerations set forth in section 306(c)(3) of the FD&C Act that it considered applicable to Ms. … FDA finds that this pattern of conduct should be accorded a debarment period of 5 years as provided by section 306(c)(2)(A)(iii) of the FD&C Act. As a result of the foregoing finding, Ms.
88 FR 55461Health and Human Services DepartmentFood and Drug AdministrationUniform Compliance Date for Food Labeling Regulations
Federal Register · Rule · Dec 21, 2006
SUPPLEMENTARY INFORMATION: FDA periodically issues regulations requiring changes in the labeling of food. … FDA has examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).
71 FR 76599Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jul 20, 2004
Section 505(c)(1) of the act directs FDA, within 180 days after the filing of an application under section 505(b) of the act or an additional period agreed upon by the applicant and the agency, to either … (2) For applications that are human drug applications, as defined in section 735(1)(A) and (B) of the act, or supplements to such applications, as defined in section 735(2) of the act, the 180-day period
69 FR 43351Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 11, 2001
Several comments suggest that under a recent Supreme Court decision it may be a violation of the American with Disabilities Act (“ADA”) to deny HIV-infected patients the right to use their own blood. … Description: FDA is revising the test requirements in part 610 subpart E issued under the authorities of the act and the PHS Act.
66 FR 31146Health and Human Services DepartmentFood and Drug Administration
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