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Briefs, oral arguments, agency decisions and the Federal Register.
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Agency Information Collection Activities; Submission for OMB Review; Comment Request
Federal Register · Notice · Nov 26, 1997
(the act) that could present a risk to health. … [[Page 63183]] In the final rule (62 FR 27183), the agency requested comments on the information collection provision of the new regulation. The 60-day comment period closed July 18, 1997.
62 FR 63182Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 4, 1999
in the donor's blood (a so-called ``window'' period). … In the Federal Register of August 3, 1999 (64 FR 42132), the agency requested comments on the proposed collections of information. No significant comments were received.
64 FR 60212Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 16, 2011
The Food and Drug Administration Amendments Act of 2007 amended section 522 of the FD&C Act to expand the situations in which FDA may order postmarket surveillance and allow longer surveillance periods … It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments.
76 FR 50740Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 11, 2026
The meeting and written comments submitted to the docket will provide critical input as the Agency prepares for reauthorization discussions. … Notification of Intent to Participate in Periodic Stakeholder Consultation Meetings If you intend to participate in continued periodic stakeholder consultation meetings regarding ADUFA reauthorization
91 FR 25576Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 6, 2015
These waivers are intended to apply to: (1) Subsequent in vivo BA or BE studies of formulations after the initial establishment of the in vivo BA of IR dosage forms during the IND period and (2) in vivo … Act of 1995 (44 U.S.C. 3501-3520).
80 FR 26058Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Exemptions From Premarket Notification; Class II Devices
Federal Register · Notice · Jun 18, 2001
FDA is publishing this notice in order to obtain comments on this petition in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA). … This section requires FDA to publish in the Federal Register a notice of intent to exempt a device, or of the petition, and to provide a 30-day comment period.
66 FR 32828Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 4, 2014
(21 U.S.C. 379g and 21 U.S.C. 379h) (the FD&C Act). … Because FDA may request additional information from the applicant during the review period, we have also included in this estimate time to prepare any additional information.
79 FR 12201Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Mammography Quality Standards Act of 1992; Inspection Fees
Federal Register · Notice · Mar 17, 1995
Written comments by June 15, 1995. ADDRESSES: Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, rm.1-23, 12420 Parklawn Dr., Rockville, MD 20857. … Request for Comments Although MQSA does not require FDA to solicit comments on fee exemption, assessment and collection, FDA is inviting comments from interested persons in order to have the benefit
60 FR 14584Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 1, 1998
DATES: Submit written comments on the collection of information by October 1, 1998. … Color Additive Certification Requests and Recordkeeping--(21 CFR Part 80)--(OMB Control Number 0910-0216)--Extension Section 721(a) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
63 FR 46461Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 10, 2010
(the act) (21 U.S.C. 387d(e)) as amended by the Tobacco Control Act. … Section 904(e) of the act, as added by the Tobacco Control Act, requires FDA to establish, and periodically revise as appropriate, “a list of harmful and potentially harmful constituents, including smoke
75 FR 32952Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 19, 2003
It represents FDA's current thinking on this aspect of the final regulations implementing the Mammography Quality Standards Act. … Before the public comment period closed on May 20, 2003, 2 respondents submitted a total of 14 comments.
68 FR 49781Health and Human Services DepartmentFood and Drug AdministrationAnimal Drug User Fee Act; Public Meeting; Request for Comments
Federal Register · Notice · Apr 12, 2021
FDA-2011-N-0656] Animal Drug User Fee Act; Public Meeting; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public meeting; request for comments. … ; (3) provide a period of 30 days after the public meeting to obtain written comments from the public suggesting changes; and (4) publish the comments on FDA's website.
86 FR 18989Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 30, 2009
Seven comments were received in response to the 60-day notice. Of the seven comments received, six related to the guidance and the information collection requests. … FDA based these estimates on the number of original HDE applications that the Center for Devices and Radiological Health (CDRH) received in the period between October 1, 2004, and September 30, 2007.
74 FR 50214Health and Human Services DepartmentFood and Drug AdministrationGuidance for Industry on Expedited Programs for Serious Conditions-Drugs and Biologics; Availability
Federal Register · Notice · May 30, 2014
Section 901(c)(2) of FDASIA requires FDA to issue a final guidance document to implement amendments to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) made by section 901 of FDASIA (Enhancement … Section 902(b)(1)(A) of FDASIA requires FDA to issue a guidance document to implement requirements of section 902 (Breakthrough Therapies) within 1 year of the date the comment period closes for the draft
79 FR 31117Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 19, 2005
by the Center for Veterinary Medicine” has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. … FDA periodically will review the comments in the docket, and where appropriate, will amend the guidance.
70 FR 41406Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 8, 2008
The comment period for the draft guidance closed on September 18, 2006. During this time, FDA received one set of comments from a device manufacturer concerning the draft guidance. … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations.
73 FR 1359Health and Human Services DepartmentFood and Drug AdministrationHassan Tahsildar; Denial of Hearing; Final Debarment Order
Federal Register · Notice · Feb 8, 2023
and period of his debarment, as discussed below. … Tahsildar during his period of debarment (section 306(c)(1)(B) of the FD&C Act). Dated: February 2, 2023. Namandjé N. Bumpus, Chief Scientist.
88 FR 8292Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 1, 2009
for an additional 1-year period (i.e., for dietary supplements labeled before January 1, 2010) because the agency was still in the process of reviewing the comments and finalizing the guidance. … Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy.
74 FR 45221Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 23, 2011
Background The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. … FDA may amend the guidance document periodically as a result of comments received. II.
76 FR 16424Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 24, 2014
Security Act (DQSA). … The public comment period closed on June 2, 2014. One comment was received from the public, and FDA carefully considered that comment as it finalized the guidance.
79 FR 69856Health and Human Services DepartmentFood and Drug Administration
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