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Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease
Federal Register · Proposed Rule · Oct 31, 2017
Blood TC and LDL cholesterol was significantly lower (P <0.05) in soy protein period compared to the cellulose period. … Furthermore, there was no significant difference in blood TC or LDL cholesterol between the animal protein diet period (control) and the soybean diet period or the soy flour diet period.
82 FR 50324Health and Human Services DepartmentFood and Drug AdministrationWilliam Ralph Kincaid; Denial of Hearing; Final Debarment Order
Federal Register · Notice · Jan 18, 2018
Follow the instructions for submitting comments. An application submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. … of a drug product under the FD&C Act.
83 FR 2641Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 3, 1995
Additional changes to the procedures may be useful and comments are requested. DATES: Comments may be submitted at any time. … Under section 736(a)(1)(D) of the Prescription Drug User Fee Act of 1992 (21 U.S.C. 379h(a)(1)(D)), FDA is authorized to retain 25 percent of the total user fee assessed for each NDA that it refuses to
60 FR 34543Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 3, 2006
In 1997, the Food and Drug Administration Modernization Act required the agency to codify its GGPs policy. … Therefore, FDA advises users to periodically check the agency's Information Sheet Web page at http://www.fda.gov/oc/gcp/guidance.html , throughout this time period.
71 FR 5861Health and Human Services DepartmentFood and Drug AdministrationGuidance Documents Related to Coronavirus Disease 2019; Availability
Federal Register · Notice · Oct 6, 2021
Therefore, FDA will issue COVID-19-related guidances for immediate implementation without prior public comment (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)(1) … availability of certain COVID-19-related guidances that FDA issued during the relevant period, as included in table 1.
86 FR 55620Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 18, 2012
Background Section 409 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 348) establishes a premarket approval requirement for “food additives;” section 201(s) of the FD&C Act (21 … In the Federal Register of December 28, 2010 (75 FR 81536) (the GRAS reopener), FDA announced the reopening of the comment period for the 1997 proposed rule.
77 FR 2552Health and Human Services DepartmentFood and Drug AdministrationHarpreet Singh: Final Debarment Order
Federal Register · Notice · Mar 13, 2025
SUMMARY: The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Harpreet Singh for a period of 10 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.
90 FR 11986Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Sep 12, 2018
Paperwork Reduction Act of 1995 I. … When FDA conducts rulemaking, it normally does so using notice-and-comment procedures established under the Administrative Procedure Act (APA) and FDA regulations.
83 FR 46104Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Sep 18, 2025
Comments on the Proposed Order and FDA Responses A. Introduction FDA received more than 25 comments on the proposed order. The comment period on the proposed order closed on November 25, 2024. … The majority of the comments received by the close of the comment period came from research, disease and patient advocacy groups, individual medical professionals and an association of health care organizations
90 FR 44969Health and Human Services DepartmentFood and Drug AdministrationRevising the Announcement Procedures for Approvals and Denials of Premarket Approval Applications
Federal Register · Rule · Jan 30, 1998
Interested persons were given until September 25, 1997, to comment on the proposed regulation. … Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period.
63 FR 4571Health and Human Services DepartmentFood and Drug AdministrationPatient-Focused Drug Development Public Meeting and Scientific Workshop on Female Sexual Dysfunction
Federal Register · Notice · Sep 26, 2014
• Do the changes in your symptoms typically happen over a period of minutes, hours, days, weeks, or months? … FDA will hold an open public comment period during the October 27 meeting and the October 28 workshop to give the public an opportunity to comment.
79 FR 57942Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 20, 2016
of the Animal Drug User Fee Act (ADUFA). … The meeting and written comments submitted to the docket will provide critical input as the Agency prepares for reauthorization discussions.
81 FR 23305Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · May 14, 2002
The period for requesting a change in the classification of the device closed on December 22, 1989. The period for commenting on the proposed rule closed on February 5, 1990. … These may be loaded after a period of healing or, in some patients for some indications, they may be loaded immediately.
67 FR 34416Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 14, 2014
We extended the comment period for an additional 90 days on November 18, 2013. We received five comments in response to the notice, each addressing one or more topics. … (Response) Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires us to provide notice and a 60-day comment period before submitting the information collection to OMB.
79 FR 47642Health and Human Services DepartmentFood and Drug AdministrationLabeling of Drugs for Use in Milk-Producing Animals
Federal Register · Rule · Jun 17, 1998
No comments were received on the proposed rule. … Paperwork Reduction Act of 1995 FDA has determined that this rule contains no collections of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501- 3520).
63 FR 32978Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 11, 2015
In the Federal Register of August 4, 2014 (79 FR 45197), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. … Recall Status Reports Request that recalling firms provide periodic status reports so FDA can ascertain the progress of the recall.
80 FR 7609Health and Human Services DepartmentFood and Drug AdministrationTemporary Deferment of Activities Relating to Medical Device Submissions
Federal Register · Notice · May 21, 2009
513 of the act, premarket approval applications (PMA's) and product development protocols (PDP's) under section 515 of the act, and clinical investigations under section 520 of the act; 2. … Comments Persons who may be affected by this temporary deferment should contact FDA with any questions they may have regarding CDRH's move to the White Oak, Maryland.
74 FR 23874Health and Human Services DepartmentFood and Drug AdministrationMicrobiology Devices; Classification of In Vitro Diagnostic Device for Bacillus Species Detection
Federal Register · Proposed Rule · May 18, 2011
ADDRESSES: You may submit comments, identified by Docket No. … It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments.
76 FR 28689Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 28, 2011
It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011-30474 Filed 11-25-11; 8:45 am] BILLING CODE 4160-01-P
76 FR 72952Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Dec 11, 2003
(Response) It is true that FDA reviews a version of the Circular that a consortium of blood establishments submits periodically. … advertising material, and labeling that might be submitted with periodic adverse drug experience reports.
68 FR 69009Health and Human Services DepartmentFood and Drug Administration
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