Department of Health and Human Services January 21, 2020 – Federal Register Recent Federal Regulation Documents
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Meeting of the National Vaccine Advisory Committee
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a two-day meeting in-person meeting. The meeting will be open to the public and public comment sessions will be held during the meeting.
Findings of Research Misconduct
Findings of research misconduct have been made against Ozgur Tataroglu, Ph.D. (Respondent), former postdoctoral fellow, Department of Neurobiology, University of Massachusetts Medical School (UMMS). Dr. Tataroglu engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically National Institute of General Medical Sciences (NIGMS), National Institutes of Health (NIH), grants R01 GM066777 and R01 GM079182. The administrative actions, including supervision for a period of three (3) years, were implemented beginning on December 30, 2019, and are detailed below.
Agency Information Collection Activities; Proposed Collection; Comment Request; Radioactive Drug Research Committees
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection requirements contained in regulations governing the use of radioactive drugs for basic informational research.
Request for Nominations for Individuals and Consumer Organizations for Advisory Committees
The Food and Drug Administration (FDA) is requesting that any consumer organizations interested in participating in the selection of voting and/or nonvoting consumer representatives to serve on its advisory committees or panels notify FDA in writing. FDA is also requesting nominations for voting and/or nonvoting consumer representatives to serve on advisory committees and/or panels for which vacancies currently exist or are expected to occur in the near future. Nominees recommended to serve as a voting or nonvoting consumer representative may be self-nominated or may be nominated by a consumer organization. FDA seeks to include the views of women and men, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
Food and Drug Administration Rare Disease Day 2020: Supporting the Future of Rare Disease Product Development; Public Meeting; Request for Comments
The Food and Drug Administration (FDA or the Agency) is announcing a public meeting and an opportunity for public comment on ``FDA Rare Disease Day 2020: Supporting the Future of Rare Disease Product Development.'' Developing a treatment for a rare disease can present unique challenges. The goal of this meeting is to obtain stakeholders' perspectives on challenges and solutions in rare disease product development and identify commonalities that can support product development across a variety of rare diseases.
Agency Information Collection Activities; Proposed Collection; Comment Request; Empirical Study of Promotional Implications of Proprietary Prescription Drug Names
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on a proposed study entitled ``Empirical Study of Promotional Implications of Proprietary Prescription Drug Names.''
Agency Information Collection Activities; Proposed Collection; Comment Request; Customer/Partner Service Surveys
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on voluntary customer satisfaction service surveys.
Achieving Health Equity in the Advancement of Tobacco Control Practices To Prevent Initiation of Tobacco Use Among Youth and Young Adults, Eliminate Exposure to Secondhand Tobacco Product Emissions, and Identify and Eliminate Disparities in Tobacco Use and Secondhand Exposure Among Population Groups; Request for Information
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) leads comprehensive efforts to prevent the initiation of tobacco use among youth and young adults; eliminate exposure to secondhand tobacco product emissions (e.g., secondhand smoke and aerosol); help current smokers quit; and identify and eliminate tobacco-related disparities. From 2017 to late 2018, CDC solicited input from the public through a Federal Register Notice (FRN Docket Number: CDC-2017-0103); regarding these comprehensive prevention efforts. CDC has reviewed these comments, posted to www.regulations.gov, and received helpful feedback. Now, CDC is seeking additional information to inform future activities that assist in achieving health equity in tobacco prevention and control by eliminating differences in tobacco use and dependency and exposure to secondhand tobacco product emissions (e.g., secondhand smoke and aerosol) among certain population groups.
Coordinating Care From Out-of-State Providers for Medicaid-Eligible Children With Medically Complex Conditions
This document is a request for information (RFI) to seek public comments regarding the coordination of care from out-of-state providers for Medicaid-eligible children with medically complex conditions. We wish to identify best practices for using out-of-state providers to provide care to children with medically complex conditions; determine how care is coordinated for such children when that care is provided by out-of-state providers, including when care is provided in emergency and non-emergency situations; reduce barriers that prevent such children from receiving care from out-of-state providers in a timely fashion; and identify processes for screening and enrolling out-of-state providers in Medicaid, including efforts to streamline such processes for out-of-state providers or to reduce the burden of such processes on them. We intend to use the information received in response to this RFI to issue guidance to state Medicaid directors on the coordination of care from out-of-state providers for children with medically complex conditions.
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