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Federal Register · Notice · Jan 20, 1995
This notice is issued pursuant to the Controlled Substances Act (CSA). … The short time period for the submission of comments and requests for a public meeting is needed to assure that HHS may, in a timely fashion, carry out the required action and be responsive to the United
60 FR 4169Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 3, 2023
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. … L. 103-417) added section 402(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 342(g)), which provides, in part, that the Secretary of Health and Human Services may, by regulation,
88 FR 27898Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 3, 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. … L. 103-417) added section 402(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 342(g)), which provides, in part, that the Secretary of Health and Human Services may, by regulation,
85 FR 18998Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jun 18, 2026
L. 103-417) added section 402(g) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 342(g)), which provides, in part, that the Secretary of Health and Human Services may, by regulation, … One stakeholder provided multiple comments.
91 FR 36861Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 15, 2011
The labeling available in the repository might cover specific highlighted areas, such as indications for use, operational instructions, warning and precautions, and basic maintenance and cleaning. … Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011-5950 Filed 3-14-11; 8:45 am] BILLING CODE 4160-01-P
76 FR 14028Health and Human Services DepartmentFood and Drug AdministrationGeneral and Plastic Surgery Devices; Reclassification of Certain Surgical Staplers
Federal Register · Rule · Oct 8, 2021
The period for public comment on the proposed order closed on June 24, 2019. FDA received and has considered comments on the proposed order, as discussed in section III. … (vii) Validation of cleaning and sterilization instructions must demonstrate that any reusable device components can be safely and effectively reprocessed per the recommended cleaning and sterilization
86 FR 56195Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jul 8, 2003
Submission of Validation Data for Reprocessed Single Use Devices Section 302(b) of MDUFMA adds new requirements for reprocessed SUDs to section 510 of the Food Drug and Cosmetic Act (the act) (21 U.S.C … The types of validation data include cleaning and sterilization data and functional performance data.
68 FR 40676Health and Human Services DepartmentFood and Drug AdministrationUse of Salt Substitutes To Reduce the Sodium Content in Standardized Foods
Federal Register · Proposed Rule · Apr 10, 2023
DATES: Either electronic or written comments on the proposed rule must be submitted by August 8, 2023. ADDRESSES: You may submit comments as follows. … the Unfunded Mandates Reform Act of 1995 (Pub.
88 FR 21148Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Warning and Notice Statement; Labeling of Juice Products
Federal Register · Rule · Jul 8, 1998
of that comment period to August 7, 1998. … The agency believes that this comment period is consistent with customary practice and agency regulations.
63 FR 37030Health and Human Services DepartmentFood and Drug AdministrationPhysical Medicine Devices; Reclassification of Non-Invasive Bone Growth Stimulators
Federal Register · Proposed Rule · Aug 17, 2020
ACTION: Proposed amendment; proposed order; request for comments. … ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before October 16, 2020.
85 FR 49986Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 6, 2016
It is found in water, air ( e.g., in dust or particulates), soil, and foods. In foods, arsenic may be present as inorganic arsenic (the primary toxic form of arsenic) or organic arsenic. … We qualitatively address certain non-cancer health risks of exposure to inorganic arsenic in rice and rice products during pregnancy, infancy, and early childhood, periods of high susceptibility to those
81 FR 19976Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · May 9, 2003
FDA believes that a 60-day comment period is appropriate in this instance. … FDA will not consider any comments submitted after the 60-day comment period closes.
68 FR 25242Health and Human Services DepartmentFood and Drug AdministrationLabeling of Drug Products for Over-The-Counter Human Use
Federal Register · Uncategorized Document · Aug 3, 1994
published in the Federal Register of January 28, 1994 (59 FR 3998), the agency allowed the following terms to be used interchangeably: (1) ``Ask'' or ``consult,'' (2) ``assistance'' or ``help,''(3) ``clean … Therefore, under the Regulatory Flexibility Act, no further analysis is required.
Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Apr 7, 2015
full description of the changes to the REMS and/or appended materials, the date the changes will be implemented, and a REMS history that outlines all changes made to the REMS since its approval; (2) a clean … Comments Interested persons may submit either electronic comments regarding this document to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES
80 FR 18629Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Apr 4, 2013
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 … For the preamendments class III devices that are the subject of this proposal, the later of these two time periods is the 90-day period.
78 FR 20268Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 18, 2010
for public comment in response to the notice. … Section 510(j)(1)(B)(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360(j)(1)(B)(i)), requires persons who register and list a restricted device to provide, among other things, a copy
75 FR 27791Health and Human Services DepartmentFood and Drug AdministrationMedical Gases-Current Good Manufacturing Practice; Draft Guidance for Industry; Availability
Federal Register · Notice · Dec 1, 2025
“Medical gas” is defined in section 575(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360ddd(2)) as a drug that is manufactured or stored in a liquefied, nonliquefied, or cryogenic … part 213, and includes among its recommendations clarification on the following: • Ensuring the reliability of a supplier's capabilities • Protecting against container closure leaks • Appropriate cleaning
90 FR 55131Health and Human Services DepartmentFood and Drug AdministrationSubstances Prohibited From Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed
Federal Register · Proposed Rule · Nov 6, 2002
In this regulation we determined that protein derived from mammalian tissues for use in ruminant feed is a food additive under the Federal Food, Drug, and Cosmetic Act (the act), and that use of certain … mammalian proteins in ruminant feed causes the feed to be adulterated under the act.
67 FR 67572Health and Human Services DepartmentFood and Drug AdministrationBeverages: Bottled Water; Companion Document to Direct Final Rule
Federal Register · Proposed Rule · Mar 3, 2003
The comment period for the companion proposed rule runs concurrently with the comment period of the direct final rule. … Instead, FDA will publish a confirmation notice, after the comment period ends, to confirm the effective date of the direct final rule.
68 FR 9955Health and Human Services DepartmentFood and Drug AdministrationIrradiation in the Production, Processing, and Handling of Food
Federal Register · Rule · Jun 11, 2012
Follow the instructions for submitting comments. Written Submissions Submit written objections in the following ways: • FAX: 301-827-6870. … For example, the Food and Drug Administration Amendments Act of 2007, which was signed into law on September 27, 2007, amended the FD&C Act to, among other things, add section 301(ll) of the FD&C Act (
77 FR 34212Health and Human Services DepartmentFood and Drug Administration
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