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Briefs, oral arguments, agency decisions and the Federal Register.
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Federal Register · Rule · Aug 24, 2007
, Drug, and Cosmetic Act (the act), which apply to drugs (section 201 of the act et seq … Because the current regulation requires a 5-year record retention period, the 10-year record retention period is a “rolling” 10 years, as previously discussed in comment 3 of this document.
72 FR 48766Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 23, 1999
Period AGENCY: Food and Drug Administration, HHS. … In response to this request, FDA has decided to extend the comment period on the draft standard MOU to June 1, 1999.
64 FR 13997Health 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 · Apr 26, 2024
ACTION: Proposed rule; reopening of the comment period. … We are reopening the comment period for 30 days specifically to invite public comments on the new information being added to the administrative record.
89 FR 32384Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Mar 23, 2021
For example, at the Public Hearing, almost all commenters agreed that HHS should have lengthened the comment period, and offered several reasons in support of a longer comment period, all of which were … In addition, the Department previously took the view that a 30-day comment period was adequate.
86 FR 15404Health and Human Services DepartmentFood and Drug AdministrationRevision of the Requirements for Live Vaccine Processing; Confirmation of Effective Date
Federal Register · Rule · Mar 7, 2008
FDA stated that the effective date of the direct final rule would be on March 18, 2008, 75 days after the end of the comment period, unless any significant adverse comment was submitted to FDA during the … comment period.
73 FR 12262Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Warning and Notice Statements; Labeling of Juice Products
Federal Register · Proposed Rule · Apr 24, 1998
The agency notes that the comment period in this document is shorter than the 75-day period that is customarily provided by FDA for proposed rules. … As discussed below, FDA believes that a 30-day comment period is appropriate in these circumstances.
63 FR 20486Health 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 · Proposed Rule · May 4, 2004
ACTION: Proposed rule; reopening of the comment period. … the comment period for the 1995 proposal.
69 FR 24541Health 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 · Proposed Rule · Nov 9, 2020
ACTION: Notification; extension of comment period. … Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020-24806 Filed 11-6-20; 8:45 am] BILLING CODE 4164-01-P
85 FR 71294Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Nov 18, 2004
ACTION: Proposed rule; reopening of the comment period. … the comment period.
69 FR 67513Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 20, 2023
(FD&C Act). … How are you using the stabilization period to: a.
88 FR 80726Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 7, 2011
ACTION: Notice; extension of comment period. … The Agency received a comment that the 60-day comment period in the notice was inconsistent with the 90-day comment period in the draft guidance document.
76 FR 68767Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; AceonSUPTM
Federal Register · Uncategorized Document · Jul 21, 1994
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act became effective: October 1, 1987.
Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; DIFFERIN Topical Gel
Federal Register · Notice · Jan 28, 1997
SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
62 FR 4064Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; IVY BLOCKSUPTM
Federal Register · Notice · Mar 17, 1997
SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
62 FR 12652Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; PREVACIDRegister
Federal Register · Notice · Jan 2, 1996
SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
61 FR 72Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Tisseel VH Kit
Federal Register · Notice · Nov 25, 1998
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … These periods of time were derived from the following dates: 1. The date an exemption under section 351 of the Public Health Service Act became effective: June 20, 1984.
63 FR 65211Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ZAGAMRegister
Federal Register · Notice · Apr 15, 1998
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … These periods of time were derived from the following dates: 1. The date an exemption under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) became effective: June 1, 1991.
63 FR 18431Health and Human Services DepartmentFood and Drug Administration
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