Documents
Briefs, oral arguments, agency decisions and the Federal Register.
5,436 results
1.45s
Federal Register · Notice · Oct 19, 2016
§ 814.84(b)—Periodic Reports. Postapproval requirements described in § 814.82(a)(7) require submission of an annual report for each approved PMA. … Meeting (513(1)(3)(D) of the FD&C Act) 1 1 1 50 50 Panel meeting (515(c)(3) of the FD&C Act) 9 1 9 30 270 Day 100 meeting (515(d)(3) of the FD&C Act) 19 1 19 10
81 FR 72063Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Dec 30, 1997
Period AGENCY: Food and Drug Administration, HHS. … ACTION: Proposed rule; reopening of comment period on specific data. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is reopening
62 FR 67770Health and Human Services DepartmentFood and Drug AdministrationNonclinical Testing Terminology
Federal Register · Rule · Sep 22, 2026
The comment period for the direct final rule runs concurrently with the comment period for the companion proposed rule. … The comment period for the direct final rule runs concurrently with the comment period for the companion proposed rule.
91 FR 59988Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Health Claims; Plant Sterol/Stanol Esters and Coronary Heart Disease
Federal Register · Rule · Jun 6, 2001
ACTION: Interim final rule; notice of extension of period for issuance of final rule. … The act, as amended by FDAMA, authorizes FDA to make proposed health claim regulations effective upon publication pending consideration of public comment and publication of a final regulation, if the agency
66 FR 30311Health and Human Services DepartmentFood and Drug AdministrationUniform Compliance Date for Food Labeling Regulations
Federal Register · Rule · Dec 15, 2010
SUPPLEMENTARY INFORMATION: FDA periodically issues regulations requiring changes in the labeling of food. … FDA has examined the impacts of the final rule under Executive Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).
75 FR 78155Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 23, 2013
This notice solicits comments on requirements for premarket approval of medical devices. … Thus, FDA estimates that the periodic reporting burden required by this section will take 6,000 hours.
78 FR 44128Health and Human Services DepartmentFood and Drug AdministrationProtection of Human Subjects; Informed Consent
Federal Register · Rule · Oct 2, 1996
Comment Period and Effective Date Several comments opposed to the regulation objected to the 45-day comment period and the agency's proposal that the final rule will be effective upon publication. … act).
61 FR 51498Health and Human Services DepartmentFood and Drug AdministrationGastroenterology-Urology Devices: Reclassification of the Penile Rigidity Implant
Federal Register · Proposed Rule · Dec 16, 1997
In the Federal Register of April 7, 1981 (46 FR 20687), FDA reopened the comment period for the proposed regulation classifying this device for an additional 60 days. … No other comments were received during the remainder of the comment period.
62 FR 65770Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 5, 2021
The statutory basis for FDA conducting this study is derived from the Public Health Service Act (PHS Act) (42 U.S.C. 243, section 311(a)). … (Comment) An interested citizen submitted the following comment: a.
86 FR 42845Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 28, 2020
For example, a recognized accreditation body agrees to attend training, regularly communicate with FDA, and support periodic FDA audits. … For example, an ASCA-accredited testing laboratory agrees to attend training, regularly communicate with FDA, and support periodic FDA audits.
85 FR 23521Health and Human Services DepartmentFood and Drug AdministrationMedical Device User Fee Amendments; Public Meeting; Request for Comments
Federal Register · Notice · Oct 7, 2016
Following discussions with the device industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) directs FDA to publish the recommendations for … As required by section 738A(b)(2), (3), and (6) of the FD&C Act (21 U.S.C. 379j-1(b)(2), (3), and (6)), FDA obtained prior public input and negotiated an agreement with regulated industry while periodically
81 FR 69829Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 26, 2022
We will need to screen approximately 54,000 potential participants (27,000 youth and 27,000 young adults) over the study period. … The survey will be repeated with a new cross-sectional sample approximately every month or every other month over a period of 18 months.
87 FR 44405Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 11, 2008
The comment period closed on November 13, 2000. We received a small number of comments, and FDA has made some changes to the final guidance document based on these comments. … One comment indicated that the risk of detention is greater for high-volume manufacturers because they have many shipments and many FDA analyses in a 24-month period and, therefore, a greater cumulative
73 FR 39969Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 23, 2018
Submissions under 904(c) of the FD&C Act are for any new product that is not yet on the market ( e.g., if on the market due to deeming compliance period), newly deemed product manufacturers should have … This includes any statutorily regulated product that would receive a marketing authorization and any new deemed product not subject to the deeming compliance period.
83 FR 53478Health and Human Services DepartmentFood and Drug AdministrationForeign Supplier Verification Programs for Importers of Food for Humans and Animals
Federal Register · Rule · Nov 27, 2015
(Comment 335) Some comments assert that there should be an informed compliance or transition period after the end of the pre-compliance period during which importers would be expected to comply gradually … Some comments specify 12 months as the appropriate time for such an informed compliance or transition period. Some comments ask that we give developing countries longer transition periods.
80 FR 74226Health and Human Services DepartmentFood and Drug AdministrationState Certification of Mammography Facilities
Federal Register · Rule · Feb 6, 2002
The proposed rule’s 90-day comment period ended on June 28, 2000. FDA analyzed the comments received and responds to them in sections III, V, and VI of this document. … A few of the comments dealt with paperwork issues and will be discussed in section VIII of this document (Paperwork Reduction Act of 1995).
67 FR 5446Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 4, 2013
Modernization Act AGENCY: Food and Drug Administration, HHS. … 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.
78 FR 72894Health and Human Services DepartmentFood and Drug AdministrationRemoval of Designated Journals; Confirmation of Effective Date
Federal Register · Rule · Mar 31, 2000
FDA stated that the effective date of the direct final rule would be on April 24, 2000, 60 days after the end of the comment period, unless any significant adverse comment was submitted to FDA during the … comment period.
65 FR 17134Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 29, 2025
The statutory authority to collect this information is provided under sections 351 and 361 of the Public Health Service Act (PHS Act) (42 U.S.C. 262 and 264) and the provisions of the Federal Food, Drug … , and Cosmetic Act (FD&C Act) that apply to drugs (21 U.S.C. 321 et seq. ).
90 FR 35689Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 20, 2009
L. 109-462; Section 761(b)(1) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 379aa-1(b)(1)) M CFSAN/Center for Veterinary Medicine (CVM) 1 None This notice solicits comments … (Comment 17) Another comment suggested that questions on the rational questionnaire should be prioritized to capture the most important questions and information first in a shorter period of time.
74 FR 23721Health 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.