Documents
Briefs, oral arguments, agency decisions and the Federal Register.
5,436 results
0.45s
Federal Register · Notice · Feb 8, 2002
The comment also said that companies report difficulties locating investigators who have already left the study prior to completion and also during the 1-year period following completion of the study. … completion of the study period.
67 FR 6039Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 29, 2001
In the Federal Register of April 13, 2001 (66 FR 19174), the agency requested comments on the proposed collection of information. No comments were received. … Approximately 41 different respondents submitted requests for certification each year over the period FY 1998 to 2000.
66 FR 34685Health and Human Services DepartmentFood and Drug AdministrationDefinition of the Term “Biological Product”
Federal Register · Proposed Rule · Dec 12, 2018
Act, subject to certain exceptions during a 10-year transition period ending on March 23, 2020 (see sections 7002(e)(1) through (3) and (e)(5) of the BPCI Act). … History of the Rulemaking On October 5, 2010, the Agency published a notice of public hearing and request for comments concerning implementation of the BPCI Act (75 FR 61497).
83 FR 63817Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 13, 2001
FDA will periodically review the comments in the docket and, where appropriate, will amend this final guidance. … Witt, Acting Associate Commissioner for Policy. [FR Doc. 01-9259 Filed 4-12-01; 8:45 am] BILLING CODE 4160-01-S
66 FR 19177Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 24, 2020
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. … Specifically, we are including Form FDA 766 “Application for Authorization to Relabel or to Perform Other Action of the Federal Food, Drug, and Cosmetic Act and Other Related Acts” (currently approved
85 FR 23048Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Feb 5, 2018
DATES: Fax written comments on the collection of information by March 7, 2018. … (l) of the FD&C Act.
83 FR 5107Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Jun 23, 2015
What issues did the comments raise? What are FDA's responses to the comments? We invited public comment on the proposed rule. The comment period closed on July 1, 2013. … This will allow the industry to make any needed reformulations and label changes to their infant formula products in the 12-month period that the comment identified as cost effective and timely for needed
80 FR 35834Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 9, 2021
SUPPLEMENTARY INFORMATION: Section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353a) describes the conditions that must be satisfied for drug products compounded by a licensed … Based on comments from stakeholders, it was FDA's understanding that this timeframe corresponds to a full legislative cycle for most States and would, therefore, afford sufficient time for States to modify
86 FR 43550Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Nov 30, 2023
Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed order, 1 consideration of any comments received, and a meeting of a device classification … will be the later of the two time periods.
88 FR 83802Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 23, 2018
A risk modification order issued under section 911(g)(1) will be effective for the period of time specified in the order issued by FDA (section 911(h)(4) of the FD&C Act). … Because the dates on which orders are issued and the length of the period for which the order is valid will vary, FDA expects one request for renewal annually.
83 FR 3158Health and Human Services DepartmentFood and Drug AdministrationFrench Dressing; Proposed Revocation of a Standard of Identity
Federal Register · Proposed Rule · Dec 21, 2020
Legal Authority We are issuing this proposed rule to revoke the standard of identity for French dressing consistent with our authority under of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which … U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub.
85 FR 82980Health 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 rule based on comments made during the comment period.
63 FR 34101Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 15, 2016
The draft guidance also provides recommendations for the use of secondary testing of platelets as the basis to extend the dating period of platelets, when appropriately labeled bacterial detection devices … Paperwork Reduction Act of 1995 Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct
81 FR 13798Health and Human Services DepartmentFood and Drug AdministrationJohn D. McCoy; Denial of Hearing; Final Debarment Order
Federal Register · Notice · Sep 28, 2018
In determining the appropriateness and period of McCoy's debarment, FDA has considered the relevant factors listed in the FD&C Act. … The proposal outlined findings concerning three relevant factors ORA considered in determining the appropriateness and period of debarment, as provided in section 306(c)(3) of the FD&C Act.
83 FR 49099Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 29, 2001
DATES: Submit written comments by August 13, 2001. … The period from 1986 to 1996 showed that a 0.03 percent of donations were associated with some type of event which were reported to Baxter.
66 FR 29149Health and Human Services DepartmentFood and Drug AdministrationDilip Patel; Denial of Hearing; Final Debarment Order
Federal Register · Notice · Sep 27, 2018
In determining the appropriateness and period of Patel's debarment, FDA considered the relevant factors listed in the FD&C Act. … In addition, FDA will not accept or review any abbreviated new drug applications submitted by or with the assistance of Patel during his period of debarment (section 306(c)(1)(B) of the FD&C Act).
83 FR 48829Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 8, 2010
It also amends section 520(m) of the act to exempt some HUDs from the prohibition on profit (new section 520(m)(6) of the act). … In the Federal Register of August 5, 2008 (73 FR 45460), FDA published a 60-day notice requesting public comment. The comment period closed on November 3, 2008.
75 FR 39263Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 18, 2011
Manufacturers keep infant formula distribution records for the prescribed period as a matter of routine business practice. … Manufacturers keep infant formula distribution records for the prescribed period as a matter of routine business practice.
76 FR 51371Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 14, 2018
This draft guidance provides a comprehensive look into FDA's current thinking regarding the 510(k) Third-Party (3P) Review Program authorized under the Federal Food, Drug, and Cosmetic Act (FD&C Act). … Third-party reviewers should maintain records of their 510(k) reviews and a copy of the 510(k) for a reasonable period of time, usually a period of 3 years.
83 FR 46742Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Aug 1, 2000
Both a shorter and a longer time period for this rule may cost more if firms would have to undertake two successive labeling revisions. … In addition, a longer time period would unnecessarily delay the benefit of the new labeling to consumers who self-medicate with these products.
65 FR 46864Health 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.