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Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Federal Register · Notice · Nov 19, 2020
Under that process, draft guidances are posted on FDA's website and announced periodically in the Federal Register . … Paperwork Reduction Act of 1995 FDA tentatively concludes that this draft guidance contains no collection of information.
85 FR 73725Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Aug 6, 1998
Because of the significant adverse comment received, FDA is unable to promulgate monitoring requirements within the statutory time period, i.e., by August 6, 1998, set forth in section 410(b)(1) of the … Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 349(b)(1)).
63 FR 42198Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities; Submission for OMB Review; Comment Request
Federal Register · Notice · Feb 21, 1997
DATES: Submit written comments on the collection of information by March 24, 1997. … There are 39 national and international organizations with one report each reporting period. Dated: February 12, 1997. William K. Hubbard, Associate Commissioner for Policy Coordination.
62 FR 8024Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 2, 2018
In the Federal Register of January 13, 2017 (82 FR 4225), we extended the comment period to February 13, 2017. … Paperwork Reduction Act of 1995 The guidance refers to previously approved collections of information found in FDA regulations.
83 FR 8997Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 7, 2014
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 FD&C Act … 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
79 FR 19091Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 9, 2001
Current Good Manufacturing Practice Regulations for Medicated Feeds—21 CFR Part 225 (OMB Control No. 0910-0152)—Extension Under section 501 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C … A license is required when the manufacturer of a medicated feed involves the use of a drug or drugs, which FDA has determined requires more control because of the need for a withdrawal period before slaughter
66 FR 9707Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 1, 2014
for public comment in response to the notice. … Table 1 provides examples of the types of studies that may be administered and estimated burden levels during the 3-year period.
79 FR 44779Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 28, 2012
records of compensation agreements with any compensation paid to nonemployee clinical investigators, including information showing any financial interests held by the clinical investigator, for a time period … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2012-7405 Filed 3-27-12; 8:45 am] BILLING CODE 4160-01-P
77 FR 18826Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 29, 2001
Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed … FDA form 2301 is available for the required transmittal of periodic reports and promotional material for new animal drugs.
66 FR 29141Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 3, 2017
) of the FD&C Act. … partners can determine that product was initially introduced by manufacturers in a transaction into commerce during that time period.
82 FR 30868Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 21, 2015
DATES: Submit either electronic or written comments on the collection of information by June 22, 2015. … the past 3 years in the regulation of tobacco products and is based on the actual number of establishment registration and product listings and product ingredient submissions received during this time period
80 FR 22202Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 24, 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. … 80 9,280 Notification of withdrawal of an HDE—814.116(e)(3) 2 1 2 1 2 Notification of withdrawal of institutional review board approval—814.124(b) 1 1 1 2 2 Periodic
87 FR 51993Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Apr 4, 2008
The comment period closed February 19, 2008. FDA is withdrawing the direct final rule because the agency received significant adverse comments. … FDA will consider the comments received under our usual procedures for notice and comment in connection with the notice of proposed rulemaking that was published in the Federal Register of December
73 FR 18440Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 28, 2001
DATES: Submit written comments on the collection of information by July 30, 2001. … In the Federal Register of May 9, 2001 (66 FR 23715), the agency requested comments on the proposed collections of information. No significant comments were received.
66 FR 34455Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Health Claims; Soluble Dietary Fiber From Certain Foods and Coronary Heart Disease
Federal Register · Rule · Oct 2, 2002
The Nutrition Labeling and Education Act of 1990 The Nutrition Labeling and Education Act of 1990 (the 1990 amendments) (Public Law 101-535) amended the Federal Food, Drug, and Cosmetic Act (the act) … Section 403(r)(7) of the act authorizes us to make proposed regulations issued under section 403(r) of the act effective upon publication pending consideration of public comment and publication of
67 FR 61773Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; 30-Day Notices and 135-Day PMA Supplement Review
Federal Register · Rule · Aug 11, 1998
, as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). … The comment period closed on July 13, 1998. FDA is withdrawing the direct final rule because the agency received significant adverse comment.
63 FR 42699Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 15, 2006
Paperwork Reduction Act of 1995 This guidance document refers to previously approved collections of information found in FDA regulations. … FDA will periodically review the comments in the docket and, where appropriate, will amend the guidance.
71 FR 34623Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 23, 2010
of 2007 (FDAAA) includes a requirement that FDA identify and periodically update susceptibility test interpretive criteria for antibacterial drug products and make those findings publicly available. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2010-32276 Filed 12-22-10; 8:45 am] BILLING CODE 4160-01-P
75 FR 80823Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 28, 2011
Since that time, FDA has periodically published guidance that described its approach and any changes therein, to the 510(k) program. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011-33232 Filed 12-27-11; 8:45 am] BILLING CODE 4160-01-P
76 FR 81510Health and Human Services DepartmentFood and Drug AdministrationThe Procter & Gamble Co.; Filing of Food Additive Petition
Federal Register · Notice · Mar 3, 2000
Although section 409 of the act establishes no comment period for food additive petitions, and the agency does not solicit comments in notices announcing the filing of a food additive petition, it is FDA's … Consistent with section 409 of the act, FDA will, as part of the review of P&G's petition, fairly evaluate all the evidence of record, including relevant comments received by the agency that become part
65 FR 11585Health and Human Services DepartmentFood and Drug Administration
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