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Federal Register · Proposed Rule · Oct 26, 2011
We will not consider comments received during the reply comment period that do not identify the specific issue(s) raised during the initial comment period on which the reply comment is based. … It is the Agency's intent to comply with Executive Order 13563 as quickly as possible, so we will not look favorably on requests for extensions of the comment period.
76 FR 66235Health and Human Services DepartmentFood and Drug AdministrationUniform Compliance Date for Food Labeling Regulations
Federal Register · Rule · Nov 25, 2016
SUPPLEMENTARY INFORMATION: We periodically issue regulations requiring changes in the labeling of food. … We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub.
81 FR 85156Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 26, 2016
Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed … The regulations were issued under FDA's statutory authority to regulate food safety, including section 402(a)(1) and (4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 342(a)(1) and (4)).
81 FR 48816Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 20, 2025
Under section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360) and part 807, subparts A through D (21 CFR part 807, subparts A through D), medical device establishment owners … We attribute this adjustment to a decrease in the number of submissions we received over the last approval period. Dated: June 13, 2025. Grace R.
90 FR 26304Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 17, 2016
Because the cohort aged over the study period, data have been collected from youth aged 11 to 18. … Media Tracking Survey The media tracking survey consists of assessments of youth aged 13 to 18 conducted periodically during the campaign period.
81 FR 39675Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 22, 2018
Background In accordance with section 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360e(d)(4) and (e)(2)), notification of an order approving, denying, or withdrawing … Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period.
83 FR 23686Health and Human Services DepartmentFood and Drug AdministrationEffective Date of Requirement for Premarket Approval for Two Class III Preamendments Devices
Federal Register · Proposed Rule · Jan 18, 2013
Paperwork Reduction Act of 1995 X. Proposed Effective Date XI. Comments XII. References I. … Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed order, consideration of any comments received, and a meeting of a device classification
78 FR 4094Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jan 22, 2016
Section 515(b)(3) of the FD&C Act provides that FDA shall, after the close of the comment period on the proposed order, consideration of any comments received, and a meeting of a device classification … The comment period for the proposed rule closed on November 7, 2011.
81 FR 3751Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 19, 2016
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)). … The sample for each data collection period is evenly distributed among Specialists.
81 FR 64168Health and Human Services DepartmentFood and Drug AdministrationDrug Development for Chronic Fatigue Syndrome and Myalgic Encephalomyelitis; Public Workshop
Federal Register · Notice · Mar 11, 2013
Workshop participants should register to participate in the open public comment period by April 8, 2013, and will be asked to provide a brief summary of their comments. … and Innovation Act (FDASIA) (Pub.
78 FR 15371Health and Human Services DepartmentFood and Drug AdministrationDraft Prescription Drug User Fee Act IV Drug Safety Five-Year Plan; Availability for Comment
Federal Register · Notice · May 5, 2008
FDA-2008-N-0257] Draft Prescription Drug User Fee Act IV Drug Safety Five-Year Plan; Availability for Comment AGENCY: Food and Drug Administration, HHS. ACTION: Notice. … At the end of the comment period, FDA will review the comments, update the “PDUFA IV Drug Safety Five-Year Plan,” and publish the final version. II.
73 FR 24599Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Feb 18, 2015
ACTION: Notice of public meeting; request for comments; reopening of the comment period. … Comments. The comment period for the proposed rule publilshed November 13, 2013 (78 FR 67985), is reopened.
80 FR 8577Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 23, 2026
FDA is adding 18 new constituents to the established list consistent with the requirement in section 904(e) of the FD&C Act to periodically revise, as appropriate, the established HPHC list (Table 1). … This determination may be revised, consistent with the directive in section 904(e) of the FD&C Act that FDA periodically revise the established list as appropriate.
91 FR 21824Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 23, 2003
DATES: Fax written comments on the collection of information by November 24, 2003. … To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk Officer
68 FR 60697Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Oct 26, 2009
DATES: Submit written or electronic comments on the collection of information by December 28, 2009. … The report must cover the period of the preceding calendar year and include separate information for each month of the calendar year.
74 FR 55046Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Nov 21, 2023
Summary of Comments to the Proposed Rule There were three public comment periods for the proposed rule. … Review Act/Small Business Regulatory Enforcement Fairness Act (5 U.S.C. 801, Pub.
88 FR 80958Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 4, 2009
The comment period on the proposed rule closed on May 21, 2002. … The comment period closed on July 28, 2008. FDA received more than 1,400 comments on the proposed rule and the draft special controls guidance document.
74 FR 38661Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 5, 2014
Section 351(k)(7) of the PHS Act, entitled “Exclusivity for Reference Product,” describes reference product exclusivity, the period of time in which a 351(k) sponsor is not permitted to submit and FDA … Determining the date of first licensure for a reference product, in turn, determines whether a particular biological product qualifies for a period of exclusivity under 351(k)(7) of the PHS Act and the
79 FR 45448Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 25, 2014
Section 417(g) of the FD&C Act requires that responsible persons maintain records related to reportable foods for a period of 2 years. … Act for a period of 2 years.
79 FR 50656Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 15, 1998
After the comment period, comments may be submitted to one of the centers at the addresses below. FOR FURTHER INFORMATION CONTACT: Joseph P. … However, the agency wishes to solicit comment from the public and is providing a 90- day comment period and establishing a docket for the receipt of comments.
63 FR 27092Health and Human Services DepartmentFood and Drug Administration
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