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Federal Register · Notice · Jun 26, 2013
Paperwork Reduction Act of 1995 Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each … Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES
78 FR 38349Health and Human Services DepartmentFood and Drug AdministrationTobacco Products, Exemptions From Substantial Equivalence Requirements
Federal Register · Proposed Rule · Jan 6, 2011
Although substantial equivalence requirements are not yet in effect, the statutory grace period ends on March 22, 2011. … The statutory deadline for issuing regulations under section 905(j)(3) is July 1, 2011, after the end of the grace period.
76 FR 737Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 1, 2025
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. … In anticipation of the end of the enhanced drug security requirements 12-month stabilization period on November 27, 2024, we received an increased number of waiver and exemption requests and have issued
90 FR 18675Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 7, 2020
(Appendix A to Subpart C of 41 CFR 102-3, the Federal Advisory Committee Management Final Rule notes that the Federal Advisory Committee Act (FACA, 5 U.S.C. … Vacancies are updated periodically; therefore, one or more vacancies listed may be in the nomination process or a final appointment may have been made.
85 FR 718Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 1, 1995
Submit written comments at any time. … The comments in the docket will be periodically reviewed, and, where appropriate, the guideline will be amended.
60 FR 11264Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 8, 2013
This notice is issued under the Controlled Substances Act (the CSA). DATES: Submit either electronic or written comments by February 25, 2013. … The short time period for the submission of comments and requests for a public meeting is needed to ensure that HHS may, in a timely fashion, carry out the required action and be responsive to the United
78 FR 9397Health and Human Services DepartmentFood and Drug AdministrationRetrospective Review of Draft Guidance Documents Issued Before 2010; Withdrawal of Guidances
Federal Register · Notice · Aug 7, 2013
In addition, the GGP regulation explains that FDA will periodically review existing guidance documents to determine whether they need to be changed or withdrawn. … Comments Interested persons may submit either electronic comments regarding Agency guidance documents to http://www.regulations.gov or written comments to the Division of Dockets Management (see
78 FR 48175Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Feb 27, 2014
A withdrawal period has not been established for this product in preruminating calves. … A withdrawal period has not been established for this product in preruminating calves. Do not use in calves to be processed for veal 016592 (2) Chickens.
79 FR 10976Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 12, 2016
DSHEA amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by adding, among other provisions: (1) Section 201(ff) (21 U.S.C. 321(ff)), which defines the term “dietary supplement” and (2) section … We gave interested parties an opportunity to submit comments by October 3, 2011. In the Federal Register of September 9, 2011 (76 FR 55927), we extended the comment period to December 2, 2011.
81 FR 53486Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Aug 10, 2001
Act of 1996 (ADAA). … We plan to hold a public meeting on import tolerances during the comment period for this advance notice of proposed rulemaking (ANPRM) and intend to consider the comments made at the meeting and in response
66 FR 42167Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 9, 2024
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. … FDA has the authority under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to approve new animal drugs.
89 FR 56385Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 24, 2011
Prescription Drug Advertisements—(OMB Control Number 0910)—New 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, and distributors … 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
76 FR 4117Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 29, 2015
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 … 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
80 FR 23803Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 30, 2005
No comments were received on this information collection. … During that period, microbial food safety for approximately 15 antimicrobial NADAs (including original and major supplements) was evaluated.
70 FR 37859Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 29, 2014
Control Act) (Pub. … Four commenters submitted nine comments that were PRA related.
79 FR 64394Health and Human Services DepartmentFood and Drug AdministrationEffective Date of Approval of an Abbreviated New Drug Application
Federal Register · Rule · Nov 5, 1998
Submit written comments by February 3, 1999. … For the foregoing reasons, FDA finds, for good cause, that notice and public procedure would be impracticable, unnecessary, and contrary to the public interest; therefore, a public comment period before
63 FR 59710Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 10, 2001
Quality Protection Act (FQPA) of 1996. … comments of the comments in the preparation of a revised guidance, if warranted.
66 FR 35990Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 22, 2017
Voluntary Cosmetic Registration Program—21 CFR Parts 710 and 720 OMB Control Number 0910-0027—Extension The Federal Food, Drug, and Cosmetic Act (the FD&C Act) provides us with the authority to regulate … Cosmetic products that are adulterated under section 601 of the FD&C Act (21 U.S.C. 361) or misbranded under section 602 of the FD&C Act (21 U.S.C. 362) may not be distributed in interstate commerce.
82 FR 39795Health and Human Services DepartmentFood and Drug AdministrationDaylen Diaz: Final Debarment Order
Federal Register · Notice · Jun 21, 2023
Follow the instructions for submitting comments. An application submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. … Diaz 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 (21 U.S.C. 335a(c)(1)(B))).
88 FR 40275Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 30, 2010
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 … In the Federal Register of June 14, 2010 (75 FR 33624), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
75 FR 52954Health and Human Services DepartmentFood and Drug Administration
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