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Federal Register · Notice · Mar 16, 2009
Background The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Public Law 107-250) amends the Federal Food, Drug, and Cosmetic Act (the act) to provide FDA new responsibilities and resources … The primary difference between this draft guidance and the November 24, 2003, version now in effect is the addition of user fee and user fee refund information for 30-day notices and periodic reports.
74 FR 11117Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 10, 2018
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 … 80 8,800 Notification of withdrawal of an HDE—814.116(e)(3) 1 1 1 1 1 Notification of withdrawal of Institutional Review Board approval—814.124(b) 1 1 1 2 2 Periodic
83 FR 1263Health and Human Services DepartmentFood and Drug AdministrationVithal K. Patel; Denial of Hearing; Final Debarment Order
Federal Register · Notice · Aug 2, 2021
In determining the appropriateness and period of Mr. Patel's debarment, FDA considered the relevant factors listed in the FD&C Act. Mr. … Patel during his period of debarment (section 306(c)(1)(B) of the FD&C Act). Dated: July 27, 2021. Denise Hinton, Chief Scientist.
86 FR 41483Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 13, 2012
The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. … The commenter also provided comments that were not PRA-related and are beyond the scope of this document.
77 FR 74194Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 24, 2008
Infant Formula Recall Regulations—(OMB Control Number 0910-0188)—Extension Section 412(e) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 350a(e)) provides that if the manufacturer … Manufacturers keep infant formula distribution records for the prescribed period as a matter of routine business practice.
73 FR 35699Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 23, 2011
New Animal Drugs for Investigational Uses—21 CFR Part 511 (OMB Control Number 0910-0117)—Extension FDA has the authority under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to approve new animal … maintain records showing the name and post office address of the expert or expert organization to whom it is shipped and the date, quantity, and batch or code mark of each shipment and delivery for a period
76 FR 59139Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jan 5, 2016
within which such labeling or change in labeling was to be done, such labeling or change in labeling was not done within such period. … One author in that report switched to the mesh-augmented technique part way through the period covered by the study due to dissatisfaction with native tissue repair.
81 FR 354Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jun 17, 2011
for public comment in response to the notice. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011-14771 Filed 6-14-11; 8:45 am] BILLING CODE 4160-01-P
76 FR 35678Health and Human Services DepartmentFood and Drug AdministrationGeneral and Plastic Surgery Devices; Reclassification of the Absorbable Hemostatic Device
Federal Register · Proposed Rule · Oct 31, 2006
Consequently, in the Federal Register of March 10, 1992 (57 FR 8462), FDA extended the reporting period to March 31, 1992. … Subsequently, as permitted by section 520(l)(5)(C) of the act, in the Federal Register of November 30, 1992 (57 FR 56586), the agency published a notice extending the period for issuing such regulations
71 FR 63728Health and Human Services DepartmentFood and Drug AdministrationPrescription Drug User Fee Act IV Information Technology Plan
Federal Register · Notice · Jun 30, 2008
FDA-2008-N-0352] Prescription Drug User Fee Act IV Information Technology Plan AGENCY: Food and Drug Administration, HHS. ACTION: Notice. … As part of this process, FDA has developed and will periodically update the 5-year IT plan. II.
73 FR 36880Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 31, 2000
Title: Food-Contact Substances Notification System Description: Section 409(h) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 348(h)) establishes a premarket notification (PMN) process … FDA expects to accomplish this through the periodic reauthorization of the form required by OMB.
65 FR 34713Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 7, 2017
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. … No comments were received.
82 FR 36795Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 15, 2012
of 2009 (BPCI Act). … , the comment period, and the publication date of final guidance Q&As.
77 FR 8885Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 2, 2016
(PHS Act) to bear a nonproprietary name that includes an FDA-designated suffix. … This estimate is an annualized figure based on the average number of responses per respondent and the average burden per response over a 3-year period.
81 FR 35367Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Sep 18, 2025
Comments on the Proposed Order and FDA Responses A. Introduction FDA received more than 25 comments on the proposed order. The comment period on the proposed order closed on November 25, 2024. … The majority of the comments received by the close of the comment period came from research, disease and patient advocacy groups, individual medical professionals and an association of health care organizations
90 FR 44969Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 8, 2010
This meeting and written comments submitted to the docket have provided critical input as the Agency prepares for reauthorization discussions. … Notification of Intent to Participate in Periodic Consultation Meetings If you intend to participate in continued periodic stakeholder consultation meetings regarding PDUFA Reauthorization, please provide
75 FR 32483Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 27, 2014
your comments by November 25, 2014. … FDA believes a 180-day comment period is appropriate because of the volume and complexity of the material being posted in the applications.
79 FR 51183Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Revision of the Nutrition and Supplement Facts Labels
Federal Register · Rule · May 27, 2016
Air Regulatory Group v. EPA, 134 S. Ct. 2427 (2014)). … Thus, the comment's reference to Util. Air Regulatory Group v.
81 FR 33742Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 30, 2001
Background The Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 301 et . … FDA invited interested persons to comment by October 6, 2000. In response to a request, FDA later extended the comment period to November 4, 2000. V.
66 FR 21401Health 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 Administration
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