Department of Health and Human Services August 24, 2007 – Federal Register Recent Federal Regulation Documents
Results 1 - 19 of 19
Notice To Award a Grant
The Office of Refugee Resettlement, Anti-Trafficking in Persons Office, will award a non-competitive grant to Polaris Project, P.O. Box 77892, Washington DC, 20013, in the amount of $394,452 in Fiscal Year 2007 due to urgent and compelling circumstances. The award will be used to improve the systemic response to protect victims of human trafficking in the United States through the Training, Technical Assistance, and Strategic Planning (TTASP) Program. The specific goal of the TTASP program is to raise the standards of the anti-trafficking field through the development of new and cutting edge strategies, best practices, improved national levels of coordination and strategic planning, and capacity building for the field through practitioner-based training and technical assistance. The services obtained are intended to increase levels of victim identification through the creation of improved direct outreach strategies, enable localized best practice strategies to be shared on a national scale, provide around the clock technical assistance from leading human trafficking experts, and be a resource for strategic planning assistance at the local, State and Federal levels. Services will be provided via a centralized online clearinghouse of training and technical assistance resources, a dedicated technical assistance telephone hotline, on-site training and consulting services, and a peer-to-peer training and strategic planning event. Grant and Cooperative Agreement Program Authority for this activity is contained in section 106(b) and section 107(b)(1)(B) of the Trafficking Victims Protection Act of 2000 (TVPA), Public Law 106-386, Division A, 114 Stat. 1464 (2000) and in section 412(c)(1)(A) of the Immigration and Nationality Act (INA), (8 U.S.C. 1522(c)(1)(A)). The Recipient will: 1. Develop anti-trafficking materials covering topics not currently in circulation; 2. Create an online clearing house of training and technical assistance resources, including all TTASP training manuals, briefing materials, model strategic plans, sample outreach materials, user- driven worksheets, and summaries of best practices and model programs; 3. Provide targeted training and technical assistance on effective anti-trafficking strategies to anti-trafficking coalitions, task forces, direct outreach organizations, service providers, and others as needed; 4. Provide around the clock technical assistance via telephone on an emergency or on-demand basis for service providers or law enforcement officials that encounter trafficking victims; 5. Create a comprehensive strategic planning document for use by new and existing anti-trafficking coalitions that consolidates national best practices for implementing anti-trafficking activities at the local level; 6. Provide technical review of third-party materials, including, but not limited to client service protocols and forms, outreach protocols and materials, and organizational training documents; and 7. Provide consulting services to ORR in areas of strategic planning, staying abreast of the latest trends in the field, and any other technical assistance requested. After the appropriate reviews, it has been determined that the need to improve the systemic response to protect victims of human trafficking in the United States through the training, technical assistance, and strategic planning is urgent and compelling. The project period is September 30, 2007 to September 29, 2010.
Medicare Program; Meeting of the Medicare Evidence Development and Coverage Advisory Committee (MedCAC)-October 22, 2007
This notice announces a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MedCAC) (``Committee'') entitled CMS Evidentiary Priorities for Medicare. The Committee generally provides advice and recommendations about whether scientific evidence is adequate to determine if certain medical items and services are reasonable and necessary under the Medicare statute. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).
Agency Information Collection Activities: Proposed Collection; Comment Request; Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. 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 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 requirements governing the registration of producers of drugs and listing of drugs in commercial distribution.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Manufactured Food Regulatory Program Standards
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Manufactured Food Regulatory Program Standards'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Summaries of Safety and Effectiveness Data for Premarket Approval Applications
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved by the Center for Biologics Evaluation and Research (CBER). This list is intended to inform the public of the availability through the Internet and FDA's Division of Dockets Management of summaries of safety and effectiveness data of approved PMAs.
Medicare and Medicaid Programs; Hospital Conditions of Participation: Laboratory Services
This interim final rule with comment period requires hospitals that transfuse blood and blood components to: Prepare and follow written procedures for appropriate action when it is determined that blood and blood components the hospitals received and transfused are at increased risk for transmitting hepatitis C virus (HCV); quarantine prior collections from a donor who is at increased risk for transmitting HCV infection; notify transfusion recipients, as appropriate, of the need for HCV testing and counseling; and extend the records retention period for transfusion-related data to 10 years. These changes are based on recommendations by the Secretary's Advisory Committee on Blood Safety and Availability and are being published in conjunction with the Food and Drug Administration's (FDA) Final Rule, ``Current Good Manufacturing Practice for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV Infection'' (``lookback'') found elsewhere in this issue of the Federal Register. The intent is to aid in the prevention of HCV infection and to create opportunities for disease prevention that, in most cases, can occur many years after recipient exposure to a donor.
Current Good Manufacturing Practice for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting Hepatitis C Virus Infection (“Lookback”)
The Food and Drug Administration (FDA) is requiring establishments collecting Whole Blood or blood components, including Source Plasma and Source Leukocytes, to establish, maintain, and follow an appropriate system for identifying blood and blood components previously donated by a donor who tests reactive for evidence of hepatitis C virus (HCV) infection on a subsequent donation identified either by current testing or after a review of historical testing records, or when the collecting establishment is made aware of other reliable test results or information indicating evidence of HCV infection. Such collections may be at increased risk of transmitting HCV infection. FDA is requiring collecting establishments to quarantine prior in-date blood and blood components from such a donor, to notify consignees of prior in-date blood and blood components from such a donor for quarantine purposes, and to perform further testing on the donor. FDA is also requiring consignees to notify transfusion recipients of blood and blood components from such a donor, as appropriate. In addition, FDA is revising the human immunodeficiency virus (HIV) ``lookback'' requirements for greater consistency with the HCV ``lookback'' requirements, and extending the record retention period to 10 years. FDA is taking this action to help ensure the continued safety of the blood supply and to help ensure that information is provided to recipients of blood and blood components that may have been at increased risk of transmitting HIV or HCV infection. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled ``Guidance for Industry: `Lookback' for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV'' (the ``lookback'' guidance). We are also issuing this final rule in conjunction with a companion interim final rule published by the Centers for Medicare and Medicaid Services (CMS) elsewhere in this issue of the Federal Register.
Medicare Program; Medicare Integrity Program, Fiscal Intermediary and Carrier Functions, and Conflict of Interest Requirements
This final rule establishes the Medicare Integrity Program (MIP) and implements program integrity activities that are funded from the Federal Hospital Insurance Trust Fund. This final rule sets forth the definitions related to eligible entities; services to be procured; competitive requirements based on Federal acquisition regulations and exceptions (guidelines for automatic renewal); procedures for identification, evaluation, and resolution of conflicts of interest; and limitations on contractor liability. This final rule brings certain sections of the Medicare regulations concerning fiscal intermediaries (FIs) and carriers into conformity with the Social Security Act (the Act). The rule distinguishes between those functions that the statute requires to be included in agreements with FIs and those that may be included in the agreements. It also provides that some or all of the functions may be included in carrier contracts.
``Guidance for Industry: `Lookback' for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV;'' Availability
The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: `Lookback' for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV,'' dated August 2007. The guidance document provides recommendations for complying with the HCV ``Lookback'' requirements. This guidance document finalizes the guidance entitled, ``Draft Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis C Virus (HCV); (2) Supplemental Testing, and the Notification of Consignees and Transfusion Recipients of Donor Test Results for Antibody to HCV (Anti-HCV)'' dated June 1999. Additionally, this guidance document supersedes the HCV sections of the FDA memorandum entitled, ``Recommendations for the Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and Human T-Lymphotropic Virus Type I (HTLV-I),'' dated July 19, 1996; and also supersedes the document entitled, ``Guidance for Industry: Current Good Manufacturing Practice for Blood and Blood Components: (1) Quarantine and Disposition of Units from Prior Collections from Donors with Repeatedly Reactive Screening Tests for Antibody to Hepatitis C Virus (Anti-HCV); (2) Supplemental Testing, and the Notification of Consignees and Blood Recipients of Donor Test Results for Anti-HCV'' dated September 1998. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule entitled ``Current Good Manufacturing Practice for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting Hepatitis C Virus Infection (`Lookback').''
Medicare Program; Emergency Medical Treatment and Labor Act (EMTALA) Technical Advisory Group (TAG) Meeting-September 17-18, 2007
This notice announces the seventh and final meeting of the Emergency Medical Treatment and Labor Act (EMTALA) Technical Advisory Group (TAG). In addition, this notice announces the selection of a new member of the EMTALA TAG. The purpose of the EMTALA TAG is to review regulations affecting hospital and physician responsibilities under EMTALA to individuals who come to a hospital seeking examination or treatment for medical conditions. The primary purpose of the seventh meeting is to enable the EMTALA TAG to hear additional testimony, to further consider written responses from medical societies and other organizations on specific issues considered by the TAG at previous meetings, and to finalize the recommendations for the Secretary. However, the public is permitted to attend this meeting and, to the extent that time permits and at the discretion of the Chairperson, the EMTALA TAG may hear comments from the floor.
Town Hall Meeting Regarding the Effect of Coverage and Payment on Clinical Research Study Participation and Retention, September 20, 2007
This notice announces a Town Hall meeting to allow interested parties to provide individual advice and recommendations to Centers for Medicare and Medicaid Services (CMS) regarding the impacts of health insurance coverage, and payment for items, and services in clinical research studies on the generalizability and validity of study results and findings to guide decision-making.
Medicaid Program; State Option To Establish Non-Emergency Medical Transportation Program
This proposed rule would implement section 6083 of the Deficit Reduction Act of 2005 which provides States with additional State plan flexibility to establish a non-emergency, medical transportation brokerage program, and to receive the Federal medical assistance percentage rate. This authority supplements the current authority that States have to provide non-emergency medical transportation to Medicaid beneficiaries who need access to medical care, but have no other means of transportation.
Medicare Program; Meeting of the Advisory Panel on Medicare Education, September 20, 2007
In accordance with the Federal Advisory Committee Act, 5 U.S.C. Appendix 2, section 10(a) (Pub. L. 92-463), this notice announces a meeting of the Advisory Panel on Medicare Education (the Panel) on September 20, 2007. The Panel advises and makes recommendations to the Secretary of Health and Human Services (the Secretary) and the Administrator of the Centers for Medicare & Medicaid Services on opportunities to enhance the effectiveness of consumer education strategies concerning the Medicare program. This meeting is open to the public.
Medicare Program; Announcement of New Members to the Advisory Panel on Ambulatory Payment Classification (APC) Groups
This notice announces two new members selected to serve on the Advisory Panel on Ambulatory Payment Classification (APC) Groups (the Panel). The purpose of the Panel is to review the APC groups and their associated weights and to advise the Secretary of the Department of Health and Human Services (DHHS), and the Administrator of the Centers for Medicare & Medicaid Services (CMS), concerning the clinical integrity of the APC groups and their associated weights. We will consider the Panel's advice as we prepare the annual updates of the hospital outpatient prospective payment system (OPPS).
Office of the National Coordinator for Health Information Technology; Notice of Public Meeting
On September 5, 2007, the Office of the National Coordinator for Health Information Technology will lead a technical assistance public meeting to share information and answer detailed questions about plans to design and establish a successor to the American Health Information community, including information on the Notice of Funding Availability. The AHIC is a federally chartered advisory committee that provides input and recommendations to the Department of Health and Human Services (HHS) on how to make health records digital and interoperable, and how to assure that the privacy and security of those records are protected. (Please visit https://www.hhs.gov/healthit/community/ background/ for more information on the AHIC.) The AHIC charter specifies that the AHIC will develop and advance recommendations to the Secretary on a private-sector health information community initiative that will succeed the AHIC. The AHIC successor will bring together public and private, not-for-profit and for-profit entities that represent all sectors of the health community. This new public-private partnership will develop a unified approach to realize an effective, secure, interoperable nationwide health information system that improves the quality, safety, and efficiency of health care in the U.S. For the purposes of facilitating the establishment of the AHIC successor and convening a planning board, HHS will award a Cooperative Agreement that allows for substantial involvement by the Federal government. Once a new legal entity is established and after certain conditions are met, HHS will support that entity through additional funding that will enable initial operations and transition of specific AHIC responsibilities by late Fall 2008.
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