Department of Health and Human Services February 12, 2015 – Federal Register Recent Federal Regulation Documents
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Advisory Committee Renewals
The Food and Drug Administration (FDA) is announcing the renewal of certain FDA advisory committees by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the charters of the committees listed in the following table for an additional 2 years beyond charter expiration date. The new charters will be in effect until the dates of expiration listed in the following table. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app.).
Alcoholism: Developing Drugs for Treatment; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Alcoholism: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in the development of drugs for the treatment of alcoholism.
Meeting of the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health
In accordance with Section 10(a) of the Federal Advisory Committee Act, Public Law 92-463, as amended (5 U.S.C. App.), notice is hereby given that a meeting is scheduled to be held for the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health (the ``Advisory Group''). The meeting will be open to the public. Information about the Advisory Group and the agenda for this meeting can be obtained by accessing the following Web site: https:// www.surgeongeneral.gov/initiatives/prevention/advisorygrp/ind ex.html.
Health IT Standards Committee; Call for Nominations
The Office of the National Coordinator for Health Information Technology (ONC) is seeking nominations to the Health Information Technology Standards Committee (HITSC) to fill expiring terms of ten (10) current members. Name of Committee: Health IT Standards Committee. General Function of the Committee: The HITSC is charged with making recommendations to the National Coordinator on standards, implementation specifications, and certification criteria for the electronic exchange and use of health information for purposes of adoption, consistent with the implementation of the Federal Health IT Strategic Plan, and in accordance with policies developed by the Health IT Policy Committee. Date and Time: Nominations must be received by 12:00 p.m. on Friday, March 6, 2015. Contact Person: Michelle Consolazio, phone: 781-710-0786, email: michelle.consolazio@hhs.gov. Background: The Health IT Standards Committee was established under the American Recovery and Reinvestment Act 2009 (ARRA) (Pub. L. 111-5), section 13101, new Section 3003. Members of the Health IT Standards Committee are appointed by the Secretary, HHS and shall at least reflect providers, ancillary healthcare workers, consumers, purchasers, health plans, technology vendors, researchers, relevant Federal agencies, and individuals with technical expertise on health care quality, privacy and security, and on the electronic exchange and use of health information. Nominees of the HITSC should have experience promoting the meaningful use of health information technology and be knowledgeable in areas such as: small innovative health care providers, providers participating in payment reform initiatives, accountable care organizations, pharmacists, behavioral health professionals, home health care, purchaser or employer representatives, patient safety, health information technology security, big data, consumer e-health, personal health records, and mobile health. Members will be selected to achieve a balanced representation of viewpoints, areas of experience, subject matter expertise, and representation across the health care system. Terms will be three (3) years from the appointment date. Members of the Committee serve without pay; however, members will be provided per diem and travel costs for Committee services. The HITSC is seeking applicants with the following areas of expertise:
Medicare Program; Contract Year 2016 Policy and Technical Changes to the Medicare Advantage and the Medicare Prescription Drug Benefit Programs
This final rule amends the Medicare Advantage (MA) program (Part C) regulations and Medicare Prescription Drug Benefit Program (Part D) regulations to implement statutory requirements; improve program efficiencies; strengthen beneficiary protections; clarify program requirements; improve payment accuracy; and make various technical changes. Additionally, this rule finalizes two technical changes that reinstate previously approved but erroneously removed regulation text sections.
Agency for Toxic Substances and Disease Registry; Notice of Intent To Develop Set 28 Toxicological Profiles
This notice announces the development of Set 28 Toxicological Profiles. Set 28 Toxicological Profiles consists of one updated profile and three new profiles. These profiles will be available to the public on or about October 17, 2015. Electronic access to these documents will be available at the ATSDR Web site: https://www.atsdr.cdc.gov/ toxprofiles/index.asp.
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