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Briefs, oral arguments, agency decisions and the Federal Register.
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Federal Register · Notice · May 16, 2018
FDA received one comment by a private citizen that was PRA-related. (Comment) The commenter stated that FDA should use the data we have collected in the past instead of collecting new information. … Table 1 provides examples of the types of studies that may be administered and estimated burden levels during a 3-year period.
83 FR 22690Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 23, 1999
Significant changes made to the August 1999 draft guidance document since the 60- day comment period closed are as follows: (1) A new recommended deferral for donors who have injected bovine insulin … , and are safe, pure and potent within the meaning of the Public Health Service Act.
64 FR 65715Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 18, 2015
The Biologics Price Competition and Innovation Act of 2009 amended the Public Health Service Act (PHS Act) and other statutes to create an abbreviated licensure pathway in section 351(k) of the PHS Act … All comments received during the comment period for the draft guidance have been reviewed and, where appropriate, incorporated into this guidance.
80 FR 72069Health and Human Services DepartmentFood and Drug AdministrationFederal 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(Comment) Some of the comments related to the placement of information in the draft guidance.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 AdministrationStatus of Certain Additional Over-the-Counter Drug Category II and III Active Ingredients
Federal Register · Rule · Aug 24, 1998
The periods for submission of comments and new data following the publication of a notice of proposed rulemaking (NPRM) had closed and no significant comments or new data had been submitted to upgrade … (the act) (21 U.S.C. 352) and a new drug under section 201(p) of the act (21 U.S.C. 321(p)) for which an approved application under section 505 of the act (21 U.S.C. 355) and part 314 of the regulations
63 FR 44996Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 4, 2016
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.
81 FR 26802Health and Human Services DepartmentFood and Drug AdministrationGuidance for Industry on Drug-Induced Liver Injury: Premarketing Clinical Evaluation; Availability
Federal Register · Notice · Jul 30, 2009
FDA organized a public meeting in March 2008 for discussion of issues raised by the draft guidance and reopened the public comment period from March 6, 2008, to June 30, 2008, with Docket No. … Act of 1995 (44 U.S.C. 3501-3520).
74 FR 38035Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 1, 2005
To ensure that comments on the information collection are received, OMB recommends that comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer for … FDA estimates a 2-year time period during which these requests will be made following the issuance of this guidance.
70 FR 52108Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 7, 2022
ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. … 822.28; Changes to PS plan for a device that is no longer marketed 1 1 1 8 8 § 822.29; Waiver 0 0 0 40 0 § 822.30; Exemption request 0 0 0 40 0 § 822.38; Periodic
87 FR 67045Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 24, 2019
In the Federal Register of June 19, 2019 (84 FR 28554), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. … Changes to PS plan for a device that is no longer marketed (822.28) 6 1 6 8 48 Waiver (822.29) 1 1 1 40 40 Exemption request (822.30) 16 1 16 40 640 Periodic
84 FR 57029Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 6, 2010
diagnostic testing of the donor indicating T. cruzi infection, we recommend that the establishment notify consignees of all previously distributed blood and blood components collected during the lookback period … No comments were received on the information collection. Dated: November 30, 2010. Leslie Kux, Acting Assistant Commissioner for Policy.
75 FR 75811Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 3, 2013
(the FD&C Act) to require that certain submissions under the FD&C Act and Public Health Service Act (PHS Act) be submitted in electronic format, beginning no earlier than 2 years after publication of … These requirements will be phased in over 2 and 3 year periods after the issuance of the final guidance.
78 FR 310Health 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 AdministrationAction Level for Inorganic Arsenic in Apple Juice: Guidance for Industry; Availability
Federal Register · Notice · Jun 2, 2023
We also considered all comments received during the comment period in finalizing the document. … Paperwork Reduction Act of 1995 This final guidance contains no collection of information.
88 FR 36319Health 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 AdministrationFederal Register · Notice · Mar 27, 2002
To obtain this estimate, FDA averaged the number of requests for fast track designation received by CBER and CDER in the 3-year period of 1998 to 2000. … FDA disagrees with the comment.
67 FR 14719Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 1, 2016
documenting that all individual employees have been trained and that retailers retain these records for 4 years in order to be able to provide evidence of a training program during the 48-month time period … ) (section 901(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
81 FR 50522Health 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 AdministrationProduct-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Federal Register · Notice · May 20, 2021
Under that process, draft guidances are posted on FDA's website and announced periodically in the Federal Register . … Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. V.
86 FR 27447Health 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 Administration
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