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Briefs, oral arguments, agency decisions and the Federal Register.
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The 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 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 AdministrationFederal Register · Proposed Rule · Jul 18, 2000
The comment period for the 1999 proposed rule was reopened on April 18, 2000 (65 FR 20774), and will close on July 17, 2000. … proposed rule for establishment registration and listing also proposed criteria that human cellular and tissue-based products must meet for regulation solely under section 361 of the Public Health Service Act
65 FR 44485Health and Human Services DepartmentFood and Drug AdministrationGina Acosta: Final Debarment Order
Federal Register · Notice · May 15, 2024
of the FD&C Act). … Acosta during her period of debarment, other than in connection with an audit under section 306 of the FD&C Act (section 306(c)(1)(B) of the FD&C Act).
89 FR 42474Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 5, 2020
Now that the comment period has closed, FDA plans to hold an advisory committee meeting to review the information submitted and discuss its key points. … Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: January 31, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy.
85 FR 6565Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 3, 2012
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 … FDA experience over the past 2 years in the regulation of tobacco products and is based on the actual number of establishment registration and product ingredient submissions received during this time period
77 FR 46441Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 23, 2017
Prescription Drug Advertisements; OMB Control Number 0910-0686—Extension Section 502(n) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 352(n)) requires that manufacturers, packers … Section 202.1 applies to advertisements published in journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television, and telephone communication
82 FR 23574Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 18, 2016
In the Federal Register of May 28, 2015 (80 FR 30466), FDA reopened and extended the comment period on the draft guidance. The Agency has considered the comments, as appropriate. II. … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations.
81 FR 22615Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Aug 16, 2013
FSMA amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to establish the foundation of a modernized, prevention-based food safety system. … The Washington, DC public meeting is the first of three that the Agency plans to hold during the proposed rules' comment period.
78 FR 49988Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 27, 2012
All comments received during the comment period and questions received by Agency staff related to implementation of the regulations have been carefully reviewed and, where appropriate, incorporated into … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2012-4425 Filed 2-24-12; 8:45 am] BILLING CODE 4160-01-P
77 FR 11555Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 17, 2003
The Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act (the PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection … Participation in this pilot program will be voluntary. 1 The burden estimate is for the application period because this is a pilot program and limited in duration.
68 FR 35901Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 27, 1998
The National Environmental Policy Act of 1969 (NEPA) requires all Federal agencies to assess the environmental impacts of their actions and to ensure that the interested and affected public is informed … All comments received during the comment period have been carefully reviewed and incorporated, where appropriate, in this revised guidance.
63 FR 40127Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 1, 2014
DATES: Fax written comments on the collection of information by July 31, 2014. … In the Federal Register of April 16, 2014 (79 FR 21469) FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
79 FR 37330Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 7, 2020
Index of Legally Marketed Unapproved New Animal Drugs for Minor Species—21 CFR Part 516 OMB Control Number 0910-0620—Extension The Minor Use and Minor Species Animal Health Act of 2004 (the MUMS Act) … We based our estimates in tables 1 and 2 on our experience with the MUMS indexing program and the requests for eligibility for indexing and for addition to the index, as well as the periodic drug experience
85 FR 714Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 11, 2018
importance of developing formulations for patients who are unable to swallow solid oral dosage formulations, as well as the importance of generating stability data needed to support a long expiration dating period … Reduction Act of 1995 (44 U.S.C. 3501-3520).
83 FR 32136Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 28, 2014
Since the program's inception in 1976, FDA has periodically published documents, including guidance documents, which describe FDA's approach and any changes therein to the 510(k) program. … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations.
79 FR 43753Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 30, 2024
information collection supports implementation of section 512 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b), which governs new animal drugs. … Although FDA receives fewer than one application submission annually under section 571 of the FD&C Act when averaged over a 3-year period, we use a place holder of one response and 1 hour annually to account
89 FR 106493Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 17, 2019
Background The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-31) does not require retailers to implement retailer training programs. … covered by the civil money penalty schedules in section 103(q)(2)(A) of the Tobacco Control Act.
84 FR 28059Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 19, 2023
The final rule implements a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. … This subsection requires that the FDA-approved plan must be retained while in effect and for a period of not less than 4 years from the date it was last in effect.
88 FR 24191Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 26, 2014
Records are maintained on file at each testing facility and examined there periodically by FDA inspectors. … In the Federal Register of June 12, 2014 (79 FR 33755), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
79 FR 57935Health and Human Services DepartmentFood and Drug Administration
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