Department of Health and Human Services September 24, 2013 – Federal Register Recent Federal Regulation Documents
Results 1 - 11 of 11
Request for Information: The National Toxicology Program Requests Information on Use, Human Exposure, and Toxicity of Vinpocetine
To facilitate the design of toxicological studies for vinpocetine (CAS RN: 42971-09-5), the National Toxicology Program (NTP) at the National Institute of Environmental Health Sciences (NIEHS) requests the submission of available information regarding (1) exposure, pharmacokinetics, toxicity, safety, or efficacy in humans; (2) production, use, and consumption patterns in the United States; (3) genotoxicity, repeated dose toxicity, prenatal developmental toxicity, reproductive toxicity, chronic toxicity, and carcinogenicity studies in experimental animals; and (4) any other information relative to the safety or toxicity of vinpocetine not listed above.
Agency Information Collection Activities; Proposed Collection; Public Comment Request
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a new Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
National Standards for Culturally and Linguistically Appropriate Services (CLAS) in Health and Health Care
The Department of Health and Human Service (HHS), Office of the Secretary, Office of Minority Health (OMH) announces the publication of the final enhanced National Standards for Culturally and Linguistically Appropriate Services (CLAS) in Health and Health Care, known as the enhanced National CLAS Standards. In developing the enhanced National CLAS Standards, OMH undertook the National CLAS Standards Enhancement Initiative. From 2010-2012, this initiative included input from a National Project Advisory Committee composed of subject matter experts representing public, private and government sectors, regional public meetings, public comment period, and a systematic literature review. The enhanced National CLAS Standards, including a brief background summary of the development process and public comment period, are printed below.
State System Development Initiative (SSDI) Grant Program; Single-Case Deviation From Competition Requirements
HRSA will be issuing a non-competitive program expansion supplement for one State SSDI Grant. Approximately $82,332 in supplemental funding will be made available in the form of a grant to the Department of Health Care Services, Sacramento, California, Grant Number H18MC24474, during the budget period of December 1, 2012, through November 30, 2013. The SSDI Grant program, CFDA No. 93.110, is authorized by Title V, Social Security Act, Section 501(a)(2); as amended (42 U.S.C. 701(a)(2)). The SSDI Grant program was developed to complement the Title V MCH Services Block Grant program by assisting state MCH and Children with Special Health Care Needs (CSHCN) programs in the building of state data capacity and infrastructure that support comprehensive, community- based systems of care for all children and their families. SSDI grants to states are intended to not only advance and strengthen data capacity by directing grant resources towards Title V MCH Block Grant program's Health Systems Capacity Indicator (HSCI) 09A (i.e., the ability of states to assure that the MCH programs and Title V agency have access to policy and program relevant information and data), but also to move states forward in developing improved capacity for reporting standardized and quality data that is timely.
Unique Device Identification System
The Food and Drug Administration (FDA) is issuing a final rule to establish a system to adequately identify devices through distribution and use. This rule requires the label of medical devices to include a unique device identifier (UDI), except where the rule provides for an exception or alternative placement. The labeler must submit product information concerning devices to FDA's Global Unique Device Identification Database (GUDID), unless subject to an exception or alternative. The system established by this rule requires the label and device package of each medical device to include a UDI and requires that each UDI be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI will be required to be directly marked on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.
Global Unique Device Identification Database; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Global Unique Device Identification Database (GUDID).'' FDA is issuing this draft guidance to communicate our current thinking of how the GUDID will operate. The guidance includes both information about how device labelers (in most instances, the device manufacturer) will interface with the GUDID, as well as information on the database elements that must be submitted to the GUDID and their definitions. We intend to publish a final guidance after the close of the comment period and our implementation of the GUDID.
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