Documents
Briefs, oral arguments, agency decisions and the Federal Register.
5,436 results
0.36s
Robert Lance Shuffert: Final Debarment Order
Federal Register · Notice · Apr 5, 2024
SUMMARY: The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Robert Lance Shuffert for a period of 5 years from importing or … 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 24013Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 11, 2024
For draft guidance documents issued after October 1, 2014, CDRH committed to finalize, withdraw, reopen the comment period, or issue new draft guidance on the topic for 80 percent of the documents within … 3 years of the close of the comment period and for the remaining 20 percent, within 5 years.
89 FR 82612Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 6, 2015
The comment period on the revised draft guidance ended on September 23, 2014. We reviewed all comments received on the draft guidance and revised several sections of the guidance. … These requirements will be phased in over 2- and 3-year periods after the issuance of this guidance.
80 FR 26057Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 29, 2011
SUMMARY: The Food and Drug Administration (FDA) is opening a comment period for the notice of public workshop published in the Federal Register of July 28, 2011 (76 FR 45268). … FDA is opening a comment period in light of public interest in this topic and in order to gain additional insight about the causes and impact of drug shortages, and possible strategies for preventing or
76 FR 60505Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 14, 2013
The draft guidance document and comment period were announced in the Federal Register on January 3, 2007 (72 FR 137). The comment period closed on April 2, 2007. … Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations.
78 FR 49529Health and Human Services DepartmentFood and Drug AdministrationBrendon Gagne: Final Debarment Order
Federal Register · Notice · Feb 9, 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 Brendon Gagne for a period of 5 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 9158Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Patient Examination and Surgeons' Gloves; Test Procedures and Acceptance Criteria
Federal Register · Proposed Rule · Mar 31, 2003
the entire 10-year evaluation period. … Submit a single copy of electronic comments to http://www.fda.gov/dockets/ecomments or two copies of any mailed comments, except that individuals may submit one hard copy.
68 FR 15404Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 1, 2014
Under section 701(a) of the FD&C Act, the FDA is authorized to issue regulations for the FD&C Act's efficient enforcement. … Existing records may be used if they contain all of the required information and are retained for the required time period.
79 FR 44785Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 1, 2020
Paperwork Reduction Act of 1995 The guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 … The period of this waiver will not exceed the period of time for the public health emergency related to COVID-19, including any immediate post-response review.
85 FR 18247Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 17, 2026
Section 417(g) of the FD&C Act requires that responsible persons maintain records related to reportable foods for a period of 2 years. … Recordkeeping: As noted previously, section 417(g) of the FD&C Act requires that responsible persons maintain records related to reportable foods reports and notifications for a period of 2 years.
91 FR 53269Health and Human Services DepartmentFood and Drug AdministrationRichard M. Fleming; Denial of Hearing; Final Debarment Order
Federal Register · Notice · Sep 28, 2018
In determining the appropriateness and period of Fleming's debarment, FDA considered the relevant factors listed in the FD&C Act. … The proposal outlined findings concerning the four relevant factors that ORA considered in determining the appropriateness and period of debarment, as provided in section 306(c)(3) of the FD&C Act: (1)
83 FR 49095Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 26, 2000
DATES: Submit written comments on the collection of information by January 25, 2001. … In the Federal Register of September 25, 2000 (65 FR 57612), the agency requested comments on the proposed collection of information. No significant comments were received.
65 FR 81528Health and Human Services DepartmentFood and Drug AdministrationSecure Supply Chain Pilot Program; Notice of Pilot Program
Federal Register · Notice · Jan 15, 2009
Because FDA intends to continue the SSC pilot program for 2 years, these burden estimates are for a one-time burden over a 2-year period. … Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy.
74 FR 2605Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 28, 2023
Under the Public Health Service Act (PHS Act) (42 U.S.C. 262), FDA may only approve a biologics license application for a biological product that is safe, pure, and potent. … New information generated during the postmarketing period offers further insight into the benefits and risks of the product, and evaluation of this information is important to ensure its safe use.
88 FR 66856Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 24, 2022
DATES: Fax written comments on the collection of information by July 25, 2022. … In the Federal Register of February 8, 2022 (87 FR 7187), we published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
87 FR 37859Health and Human Services DepartmentFood and Drug AdministrationTopical Drug Products Containing Benzoyl Peroxide; Required Labeling
Federal Register · Proposed Rule · Feb 17, 1995
Manufacturers of both benzoyl peroxide and sunscreen products are invited to comment on the appropriateness of a waiting period between application of the two products and to submit any information available … A period of 90 days from the date of pubication of this proposed rulemaking in the Federal Register will be provided for comments on this subject to be developed and submitted.
60 FR 9554Health and Human Services DepartmentFood and Drug AdministrationAnimal Drug Availability Act; Veterinary Feed Directive
Federal Register · Rule · Dec 8, 2000
Fairness Act of 1996 (Public Law 104-121)), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). … with a zero tolerance because of a carcinogenic concern regardless of whether a withdrawal period is required, or are a veterinary feed directive drug
65 FR 76924Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · May 16, 2022
The comment period on the proposed order closed on April 21, 2020. II. … of the comment period, each containing one or more comments on one or more issues.
87 FR 29661Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 28, 2012
The regulations that are codified at 21 CFR Part 1140 (previously codified at 21 CFR Part 897) are authorized by section 102 of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act … For the recordkeeping and disclosure requirements, 1140.32 (previously 897.32) requires competent and reliable survey evidence to establish whether a newspaper, magazine, periodical, or other publication
77 FR 59622Health and Human Services DepartmentFood and Drug AdministrationAdam Michael Nagy: Final Debarment Order
Federal Register · Notice · Dec 15, 2023
SUMMARY: The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Adam Michael Nagy for a period of 15 years from importing or … 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.
88 FR 86906Health and Human Services DepartmentFood and Drug Administration
Ask Donna what matters in the record.
She can read the source against your case and show you exactly where the answer came from.