Documents
Briefs, oral arguments, agency decisions and the Federal Register.
5,436 results
0.18s
Federal Register · Proposed Rule · May 11, 2000
The comment period for this companion proposed rule runs concurrently with the direct final rule's comment period. … This comment period runs concurrently with the comment period for the direct final rule. Two copies of any comment are to be submitted, except that individuals may submit one copy.
65 FR 30366Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · May 5, 2009
The comment period for this companion proposed rule runs concurrently with the comment period for the direct final rule. … If FDA receives no significant adverse comments during the specified comment period, FDA intends to publish a document confirming the effective date within 30 days after the comment period ends.
74 FR 20663Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ANTISEDANRegister
Federal Register · Notice · Jul 18, 1997
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 512(j) of the Federal Food, Drug, and Cosmetic Act became effective: April 24, 1989.
62 FR 38563Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jul 19, 2022
The comment period for the 2021 agricultural water proposed rule closed on April 5, 2022. … As the comment period for the 2021 agricultural water proposed rule closed on April 5, 2022, we are reopening the comment period solely to request comments on the proposed compliance dates for the proposed
87 FR 42973Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 5, 2012
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 … (FD&C Act).
77 FR 72353Health and Human Services DepartmentFood and Drug AdministrationRegulation of Medical Foods; Extension of Comment Period
Federal Register · Proposed Rule · Feb 19, 1997
I [Docket No. 96N-0364] RIN 0910-AA20 Regulation of Medical Foods; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. … This action is being taken in response to several requests from interested persons for an extension of the comment period on this document. DATES: Written comments by April 28, 1997.
62 FR 7390Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 10, 2024
DATES: Electronic or written comments on the application may be submitted beginning May 10, 2024. FDA will establish a closing date for the comment period as described in section I. … FDA believes that this comment period is appropriate given the volume and complexity of information in the MRTPA that has not been available for public comment as part of the previously authorized MRTPA
89 FR 40487Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 26, 2019
ACTION: Notice of availability; reopening of comment period. … Schiller, Acting Associate Commissioner for Policy. [FR Doc. 2019-03241 Filed 2-25-19; 8:45 am] BILLING CODE 4164-01-P
84 FR 6150Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Dec 6, 2011
ACTION: Advance notice of proposed rulemaking; extension of comment period. … FDA provided a 90-day comment period ( i.e., until December 8, 2011) for the ANPRM. FDA has received a request to extend the comment period.
76 FR 76096Health and Human Services DepartmentFood and Drug AdministrationOver-the-Counter Human Drugs; Labeling Requirements; Partial Delay of Compliance Dates
Federal Register · Rule · Apr 5, 2002
Within the period specified in the final monograph. … Act of 1995 (2 U.S.C. 1501 et seq .).
67 FR 16304Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; BetaseronRegister
Federal Register · Notice · Jan 4, 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: May 19, 1983.
59 FR 305Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Maxalt®
Federal Register · Notice · Jan 27, 2000
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective: October 1, 1992.
65 FR 4428Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Arava®
Federal Register · Notice · Jan 27, 2000
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective: February 18, 1993.
65 FR 4429Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Plavix®
Federal Register · Notice · Jan 27, 2000
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective: May 5, 1990.
65 FR 4430Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; VitraveneTM
Federal Register · Notice · Jan 27, 2000
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective: November 24, 1993.
65 FR 4434Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; AzoptTM
Federal Register · Notice · Jan 27, 2000
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective: August 23, 1992.
65 FR 4435Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Synercid
Federal Register · Notice · Sep 21, 2001
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective : June 22, 1994.
66 FR 48688Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 3, 1997
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … period.
62 FR 46501Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ARICEPTSUPTM/SUP
Federal Register · Notice · Jul 18, 1997
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … period.
62 FR 38564Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; FlowmaxSUPTM/SUP
Federal Register · Notice · Jul 21, 1998
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective: August 19, 1987.
63 FR 39097Health and Human Services DepartmentFood and Drug Administration
Ask Donna what matters in the record.
She can read the source against your case and show you exactly where the answer came from.