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Federal Register · Notice · Jun 23, 2003
Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding the draft guidance. … Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy.
68 FR 37161Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 14, 2019
The Family Smoking Prevention and Tobacco Control Act (Pub. … Drug, and Cosmetic Act (FD&C Act).
84 FR 9345Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 25, 2015
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 FD&C Act) (21 U.S.C. 350b(a)) … The purpose of the current PRA proceeding is to seek comment on and obtain OMB approval for the NDIN collections of information in effect during this interim period, which are those found in the FDA's
80 FR 10121Health and Human Services DepartmentFood and Drug AdministrationMarwan Massouh; Denial of Hearing; Final Debarment Order
Federal Register · Notice · May 11, 2022
In determining the appropriateness and period of Dr. Massouh's debarment, FDA considered the relevant factors listed in the FD&C Act. Dr. … Massouh during his period of debarment (section 306(c)(1)(B) of the FD&C Act). Dated: April 21, 2022. Jacqueline A. O'Shaughnessy, Acting Chief Scientist.
87 FR 28834Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 1, 1999
In response to a request from several of the Pearson plaintiffs, the agency has agreed to extend or reopen the comment period on the September 8, 1999, notice for 75 days after the agency issues its guidance … The agency will give careful consideration to any additional data it receives during the second 75-day comment period. IV.
64 FR 67289Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 17, 2022
Given that FDA must comply with a court order and that the public can comment both by submitting comments to the docket and by participating in the public meeting, FDA believes that a 60-day comment period … is appropriate and does not intend to grant requests for extension of the comment period.
87 FR 69030Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 18, 2010
DATES: Fax written comments on the collection of information by July 19, 2010. … In the Federal Register of April 9, 2010 (75 FR 18211), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
75 FR 34746Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 4, 2017
Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. … The collections of information in sections 512(b) and (n) of the Federal Food, Drug, and Cosmetic Act have been approved under OMB control number 0910-0669. IV.
82 FR 851Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Ingredient Labeling of Dietary Supplements That Contain Botanicals
Federal Register · Proposed Rule · Aug 28, 2003
During the comment period prior to the issuance of the 1997 final rule, and after the publication of the final rule, the agency received no comments, correspondence, or other communications from any State … This comment period runs concurrently with that for the direct final rule.
68 FR 51738Health and Human Services DepartmentFood and Drug AdministrationAgency Information Collection Activities: Proposed Collection; Comment Request
Federal Register · Notice · Dec 11, 1997
(the act), designed to assure the adequate labeling of prescription (Rx) drugs. … Under section 502(a) of the act (21 U.S.C. 352(a)), a drug product is misbranded if its labeling is false or misleading in any particular, and under section 201(n) of the act (21 U.S.C. 321(n)), a drug's
62 FR 65273Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 16, 2018
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 … New Animal Drugs for Investigational Use OMB Control Number 0910-0117—Extension FDA has the authority under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to approve new animal drugs.
83 FR 32877Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 28, 2020
FDA-2020-N-2252 for “Interim Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act (BsUFA); Public Meeting; Request for Comments.” … Background The BsUFA was originally enacted in 2012 as the Biosimilar User Fee Act under the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) for a period of 5 years.
85 FR 84345Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 23, 2015
DATES: Fax written comments on the collection of information by July 22, 2015. … Under § 314.80(c)(2), applicants must provide periodic reports of adverse drug experiences.
80 FR 35957Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 13, 2018
A draft guidance was announced in the Federal Register on July 8, 2016 (81 FR 44611) and made available for public comment. The comment period closed on October 6, 2016. … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information.
83 FR 16110Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Oct 24, 2002
Therefore, we invite comment on ways to ensure that only appropriate product by process patents are listed, while maintaining the act's restriction against listing process patents. 2. … a second notice to the patent owner and NDA holder, and the 45-day period for filing a patent infringement suit, as described in section 505(j)(5)(B)(iii) of the act, will not have run.
67 FR 65448Health and Human Services DepartmentFood and Drug AdministrationRyan Stabile: Final Debarment Order
Federal Register · Notice · Aug 15, 2024
SUMMARY: The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Ryan Stabile for a period of 15 years from importing or offering … In proposing a debarment period, FDA weighed the considerations set forth in section 306(c)(3) of the FD&C Act that it considered applicable to Mr.
89 FR 66413Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 1, 2019
DATES: Fax written comments on the collection of information by May 31, 2019. … 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
84 FR 18551Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 9, 2011
Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) either electronic or written comments regarding this document. … It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments.
76 FR 55923Health and Human Services DepartmentFood and Drug AdministrationComprehensive Assessment of the Process for the Review of Device Submissions; Request for Comments
Federal Register · Notice · Dec 19, 2012
FDA is providing a period of 30 days for public comment on the statement of work before requesting proposals for the assessment. 1 http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences … Background On July 9, 2012, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (Pub.
77 FR 75173Health and Human Services DepartmentFood and Drug AdministrationMedical Device User Fee Amendments; Public Meeting; Request for Comments
Federal Register · Notice · Jun 17, 2015
public input on the reauthorization, hold a public meeting at which the public may present its views on the reauthorization, provide a period of 30 days after the public meeting to obtain written comments … This notice, the public meeting, the 30-day comment period after the meeting, and the posting of the comments on FDA's Web site will satisfy these requirements.
80 FR 34679Health and Human Services DepartmentFood and Drug Administration
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