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Federal Register · Rule · Jun 22, 2016
Summary of Comments to the Proposed Rule We received approximately 10 comment letters on the proposed rule by the close of the comment period. … Introduction We received approximately 10 comment letters on the proposed rule by the close of the comment period, each containing one or more comments on one or more issues.
81 FR 40512Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Exemptions From Premarket Notification; Class II Devices
Federal Register · Notice · Sep 30, 1998
FDA is publishing this notice in order to obtain comments on these petitions 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, of the petition, and to provide a 30-day comment period.
63 FR 52275Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Oct 4, 2004
The comment period closed June 3, 2004. … FDA received no comments on the proposed rule. II.
69 FR 59132Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 7, 2000
No comments were received. … FDA will periodically review the comments in the docket and, where appropriate, will amend the guidance.
65 FR 66758Health and Human Services DepartmentFood and Drug AdministrationGuidance for Industry on Blue Bird Medicated Feed Labels; Availability
Federal Register · Notice · Apr 10, 2008
amended by the Paperwork Reduction Act of 1995, Pub. … Reduction Act of 1995.
73 FR 19516Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 22, 2001
This guidance implements provisions of the Government Paperwork Elimination Act (GPEA). DATES: Submit written comments at any time. … FDA will periodically review the comments in the docket and, where appropriate, will amend the guidance.
66 FR 11172Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Exemption From Premarket Notification: Wheelchair Elevator
Federal Register · Notice · Jun 1, 2012
FDA is publishing this notice 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.
77 FR 32644Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 17, 2025
The Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353b, 355, 360i, 360l, 379aa, and 393) and the Public Health Service Act (42 U.S.C. 262) authorize FDA to collect adverse event reports and … (field G4), revise “Periodic” to “Non-expedited (periodic)” under “Type of Report” field (field G6), and revise “If action reported to FDA under 21 U.S.C. 360i(g), list correction/removal reporting number
90 FR 5900Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 10, 2002
One comment was received, but it did not pertain to the information collection. … Twenty-three represents 12 more notifications than the agency received as an annual average during the previous 3-year period (i.e.,1996-1998).
67 FR 39728Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities: Proposed Collection; Comment Request
Federal Register · Notice · Jun 10, 1998
DATES: Submit written comments on the collection of information by August 10, 1998. … Form FDA 2301 is available for the required transmittal of periodic reports and promotional material for new animal drugs.
63 FR 31788Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Sep 26, 2006
The guidance responds to various questions raised about the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and the agency's implementing regulation … The agency believes that it is reasonable to maintain all responses to questions concerning establishment and maintenance of records in a single document that is periodically updated as the agency receives
71 FR 56006Health and Human Services DepartmentFood and Drug AdministrationOver-the-Counter Sunscreen Drug Products-Regulatory Status of Ecamsule
Federal Register · Proposed Rule · Feb 25, 2015
Publication of a proposed sunscreen order triggers several timelines under the SIA, including a 45-day public comment period, and a 30-day period in which a sponsor may request a meeting with FDA to discuss … Comments Similarly, section 586C(b)(6) of the FD&C Act, as amended by the SIA, establishes that a proposed sunscreen order shall provide 45 days for public comment.
80 FR 10035Health and Human Services DepartmentFood and Drug AdministrationOver-the-Counter Drug Products Containing Colloidal Silver Ingredients or Silver Salts
Federal Register · Rule · Aug 17, 1999
(the act) (21 U.S.C. 321(p)). … The physician also commented on some other observations from about 50 men who had taken colloidal silver (most for symptoms of prostatism) under his direction before, during, and after the study (a period
64 FR 44653Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Nov 15, 2006
Section 503(e)(1)(A) of the Federal Food, Drug, and Cosmetic Act (act) establishes the so-called “pedigree” requirement for prescription drugs. … As part of its June 14, 2006, announcement, FDA also issued and requested comment on draft Compliance Policy Guide 160.900 entitled “Prescription Drug Marketing Act Pedigree Requirements under 21 CFR Part
71 FR 66448Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 13, 2011
of 2002 (the Bioterrorism Act) added section 414 of the Federal Food, Drug, and Cosmetic Act (the FD & C Act) (21 U.S.C. 350c), which requires that persons who manufacture, process, pack, hold, receive … Existing records may be used if they contain all of the required information and are retained for the required time period.
76 FR 2396Health and Human Services DepartmentFood and Drug AdministrationNeurological Devices; Reclassification of the Totally Implanted Spinal Cord Stimulator
Federal Register · Notice · Sep 6, 2000
DATES: Submit written comments by October 6, 2000. … Class II device manufacturing sites are periodically inspected after FDA clears the device for marketing.
65 FR 54053Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 16, 2015
Medical Device Recall Authority—21 CFR 810 (OMB Control Number 0910-0432)—Extension This collection of information implements section 518(e) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 … Request for Regulatory Hearing—810.11(a) 1 1 1 8 8 Written Request for Review—810.12(a-b) 1 1 1 8 8 Mandatory Recall Strategy—810.14 2 1 2 16 32 Periodic
80 FR 13586Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 7, 2005
Premarket Notification for a New Dietary Ingredient—21 CFR 190.6 (OMB Control Number 0910-0330)—Extension Section 413(a) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 350b(a)) provides … Forty-seven represents 24 more notifications than the agency received as an annual average during the previous 3-year period (i.e., 1999 to 2001).
70 FR 6444Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 20, 2000
DATES: Submit written comments on the collection of information by July 20, 2000. … In the Federal Register of March 7, 2000 (65 FR 12011), the agency requested comments on the proposed collections of information. No significant comments were received.
65 FR 38290Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Apr 21, 2003
Background The Dietary Supplement Health and Education Act of 1994 (DSHEA) (Public Law 103-417) amended the Federal Food, Drug, and Cosmetic Act to, among other things, provide FDA with express statutory … Comments To submit written comments on the proposed rule that published in the Federal Register of March 13, 2003, please follow the instructions in the “Request for Comment” section of that document
68 FR 19471Health and Human Services DepartmentFood and Drug Administration
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