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Federal Register · Notice · Feb 18, 2010
(Comment) Some of the comments related to the placement of information in the draft guidance. … FDA based these estimates on the number of original HDE applications that the Center for Devices and Radiological Health (CDRH) received for the period October 1, 2004, through September 30, 2007.
75 FR 7270Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 23, 2005
22, 2004, Blood Products Advisory Committee Meeting indicating that self-reported fever with headache in the past week did not appear to be predictive of WNV infection and did not correlate with peak periods … Paperwork Reduction Act of 1995 This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995
70 FR 29529Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 27, 2001
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360m), directing FDA to accredit persons in the private sector to review certain premarket applications and notifications. … Third-party reviews should maintain records of their 510(k) reviews and a copy of the 510(k) for a reasonable period of time.
66 FR 45047Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 18, 2013
The records of processing information are periodically reviewed during factory inspections by FDA to verify fulfillment of the requirements in parts 113 or 114. … That notice will have a 30-day public comment period.
78 FR 57391Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Exemption From Premarket Notification: Over-the-Counter Denture Repair Kits
Federal Register · Notice · Nov 20, 2017
FDA is publishing this notice to obtain comments in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA). … L. 114-255), requires FDA to publish in the Federal Register a notice of intent to exempt a device, or of the petition, and to provide a 60-day comment period.
82 FR 55105Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 6, 2013
Medical Device User Fee Cover Sheet, Form FDA 3601—(OMB Control Number 0910-0511)—Extension The Federal Food, Drug, and Cosmetic Act, as amended by the Medical Device User Fee and Modernization Act of … It is unclear whether the comment addresses the topics on which the 60-day notice invited comment.
78 FR 8543Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 11, 2008
finalizing the guidance, FDA is issuing this revised draft guidance to notify industry that it intends to exercise enforcement discretion with regard to these labeling requirements for an additional 1-year period … Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy.
73 FR 75436Health and Human Services DepartmentFood and Drug AdministrationThird Annual Animal Drug User Fee Educational Conference; Public Meeting
Federal Register · Notice · Jun 3, 2026
Background The Animal Drug User Fee Act (Pub. L. 108-130) (ADUFA or the Act) was originally signed into law in 2003 and was subsequently reauthorized by Congress in 2008, 2013, 2018, and 2023. … “The Animal Drug User Fee Act Reauthorization Performance Goals and Procedures Fiscal Years 2024 Through 2028” (Performance Goals Letter) sets forth the Agency's performance goals for the period covered
91 FR 33176Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 18, 2001
The regulations further provide that fish and fishery products are adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 342(a)(4)) if their processor fails … The provision in question, § 123.9(b)(3), allows a processor to store records offsite under two circumstances: (1) The facility is closed for prolonged periods between seasonal packs, or (2) the facility
66 FR 37482Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Oct 19, 2011
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by November 18, 2011 (see the “Paperwork Reduction Act of 1995” section of this document). … Paperwork Reduction Act of 1995 VIII. Analysis of Impacts A. Background B. Benefits and Costs of the Proposed Rule C. Small Business Analysis IX. Request for Comments I.
76 FR 64868Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Sep 13, 2018
Act of 1995 (Pub. … Act of 1995.
83 FR 46444Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 27, 2005
The agency believes that, at the present time, it is reasonable to maintain all responses to questions concerning food allergens and FALCPA in a single document that is periodically updated as the agency … Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy.
70 FR 76463Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 23, 2020
On August 15, 2018, we published a notice reopening the comment period to October 15, 2018 (83 FR 40524). … Paperwork Reduction Act of 1995 This guidance contains no collection of information.
85 FR 74736Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 26, 2008
Infant Formula Recall Regulations—21 CFR 107.230, 107.240, 107.250, 107.260, and 107.280 (OMB Control Number 0910-0188)—Extension Section 412(e) of the Federal Food, Drug, and Cosmetic Act (the act) ( … Manufacturers keep infant formula distribution records for the prescribed period as a matter of routine business practice.
73 FR 16018Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 25, 2015
FDA is requesting public comment on estimates of annual submissions from these respondents, as required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Pub. … Section 760(e) (21 U.S.C. 379aa(e) of the FD&C Act also requires that responsible persons maintain records of nonprescription adverse event reports, whether or not the event is serious, for a period of
80 FR 36543Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Exemptions From Premarket Notification; Class II Devices
Federal Register · Notice · Oct 24, 2006
FDA is publishing this notice in order to obtain comments 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.
71 FR 62268Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 7, 2025
under section 319 of the Public Health Service Act (PHS Act) (42 U.S.C. 247d). … FDA expects that the list will evolve over time and FDA intends to periodically reevaluate the list.
90 FR 1152Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 14, 2004
Current Good Manufacturing Practice Regulations for Medicated Feeds—21 CFR Part 225 (OMB Control Number 0910-0152)—Extension Under section 501 of the Federal Food, Drug, and Cosmetic Act (the act) (21 … A license is required when the manufacturer of a medicated feed involves the use of a drug or drugs that FDA has determined requires more control because of the need for a withdrawal period before slaughter
69 FR 33040Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 16, 2007
Current Good Manufacturing Practice Regulations for Medicated Feeds—21 CFR Part 225 (OMB Control Number 0910-0152)—Extension Under section 501 of the Federal Food, Drug, and Cosmetic Act (the act) (21 … A license is required when the manufacturer of a medicated feed involves the use of a drug or drugs that FDA has determined requires more control because of the need for a withdrawal period before slaughter
72 FR 46089Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 31, 2009
(the act) (21 U.S.C. 360) clearance. … In the Federal Register of March 2, 2009 (74 FR 9097), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received.
74 FR 38196Health and Human Services DepartmentFood and Drug Administration
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