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Federal Register · Proposed Rule · Apr 22, 1996
It is anticipated that most antacid drug products would undergo a label printing within a 12-month period. … A period of 90 days from the date of publication of this proposed rulemaking in the Federal Register will be provided for comments on this subject to be developed and submitted.
61 FR 17807Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 16, 2005
Section 702 of the act (21 U.S.C. 372) authorizes investigational powers to FDA for enforcement of the act. … During this transition period FDA will accept both the newly effective Form FDA 3500A and the prior version of the form.
70 FR 48157Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 16, 2014
(21 U.S.C. 379g and 21 U.S.C. 379h) (the FD&C Act). … Because FDA may request additional information from the applicant during the review period, we have also included in this estimate time to prepare any additional information.
79 FR 41579Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 22, 1998
comment and publication of a final regulation'' if the agency ``determines that such action is necessary * * * to enable [FDA] to act promptly to ban or modify a claim'' under section 403(r) of the act … FDA invites public comment on this interim final rule. The agency will consider modifications to this interim final rule based on comments made during the comment period.
63 FR 34097Health and Human Services DepartmentFood and Drug AdministrationSkin Bleaching Drug Products For Over-the-Counter Human Use; Proposed Rule
Federal Register · Proposed Rule · Aug 29, 2006
Paperwork Reduction Act of 1995 VI. Environmental Impact VII. Federalism VIII. Request for Comments IX. Proposed Effective Date X. References I. … Comment No. LET2. 11. Comment No. MM1. 12. Comment No. RPT3. 13. Comment No. RPT5. 14. Comment No. MM2. 15. Comment No. MM3. 16. Comment No. LET16. 17. Comment No. C24. 18. Cullison D., D.
71 FR 51146Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 24, 2010
Several provisions of this act affect the PMA process, such as section 515(d)(6) of the act. … Thus, FDA estimates that the periodic reporting burden required by this section will take 6,480 hours.
75 FR 58396Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 2, 2006
The agency believes that, at the present time, it is reasonable to maintain all responses to questions concerning food allergens and FALCPA in a single document that is periodically updated as the agency … Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy.
71 FR 64542Health and Human Services DepartmentFood and Drug AdministrationGuidance Documents Related to Coronavirus Disease 2019; Availability
Federal Register · Notice · Sep 9, 2020
Therefore, FDA will issue COVID-19-related guidance documents for immediate implementation without prior public comment (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) … the availability of certain COVID-19-related guidances FDA issued during the relevant period, as included in table 1.
85 FR 55678Health and Human Services DepartmentFood and Drug AdministrationGuidance Documents Related to Coronavirus Disease 2019 (COVID-19); Availability
Federal Register · Notice · Oct 16, 2020
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 (FD&C Act) (21 U.S.C … availability of certain COVID-19-related guidances that FDA issued during the relevant period, as included in table 1.
85 FR 65820Health and Human Services DepartmentFood and Drug AdministrationJeremy Spencer Brown: Final Debarment Order
Federal Register · Notice · Feb 12, 2026
SUMMARY: The Food and Drug Administration (FDA or the Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Jeremy Spencer Brown for a period of 5 years from … In proposing a debarment period, FDA weighed the considerations set forth in section 306(c)(3) of the FD&C Act that the Agency considered applicable to Mr.
91 FR 6643Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 6, 2000
In response to a request from several of the Pearson plaintiffs, the agency agreed to reopen the comment period for scientific data on the four claims after the agency issued its guidance on the significant … Accordingly, in the Federal Register of January 26, 2000 (65 FR 4252), FDA reopened the comment period for an additional 75 days, until April 3, 2000.
65 FR 59855Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Health Claims; Soluble Fiber From Certain Foods and Coronary Heart Disease
Federal Register · Rule · Feb 18, 1998
This new law amended the Federal Food, Drug, and Cosmetic Act (the act) in a number of important ways. … In this study, diets were varied in four 7-day treatment periods with no time between treatment periods.
63 FR 8103Health and Human Services DepartmentFood and Drug AdministrationFood 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 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 · Proposed Rule · Jan 3, 2012
Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by February 2, 2012, (see section “VI. Paperwork Reduction Act of 1995” of this document). … The 180-day period is not to be extended for any reason, including any determination made under section 505(q)(1)(A) of the FD&C Act regarding delay of approval of an application, the submission of comments
77 FR 25Health and Human Services DepartmentFood and Drug AdministrationMeunerie Sawyerville, Inc.; Denial of Hearing; Final Debarment Order
Federal Register · Notice · Mar 1, 2018
In determining the appropriateness and period of Meunerie Sawyerville's debarment, FDA has considered the relevant factors listed in the FD&C Act. … Considering all applicable factors under 306(c)(3) of the FD&C Act, OSI concurs with ORA's proposal that a 5-year period of debarment for each offense is warranted.
83 FR 8877Health 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 · Rule · Jan 12, 2004
The guidance responds to various questions raised about section 305 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) and the agency's implementing … As noted, the Bioterrorism Act requires covered facilities to be registered with FDA by December 12, 2003.
69 FR 1675Health 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 Administration
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