Medicare Program; Changes for Long-Term Care Hospitals Required by Certain Provisions of the Medicare, Medicaid, SCHIP Extension Act of 2007: 3-Year Moratorium on the Establishment of New Long-Term Care Hospitals and Long-Term Care Hospital Satellite Facilities and Increases in Beds in Existing Long-Term Care Hospitals and Long-Term Care Hospital Satellite Facilities; and 3-Year Delay in the Application of Certain Payment Adjustments
This interim final rule with comment period implements certain provisions of section 114 of the Medicare, Medicaid, and SCHIP Extension Act of 2007 relating to long-term care hospitals (LTCHs) and LTCH satellite facilities. It implements a 3-year moratorium on the establishment of new LTCHs and LTCH satellite facilities; and on increases in beds in existing LTCHs and LTCH satellite facilities. This interim final rule with comment period also implements a 3-year delay in the application of certain payment policies which apply payment adjustments for discharges from LTCHs and LTCH satellites that were admitted from certain referring hospitals in excess of various percentage thresholds.
Draft Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti-HBc); Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Requalification Method for Reentry of Blood Donors Deferred Because of Reactive Test Results for Antibody to Hepatitis B Core Antigen (Anti- HBc)'' dated May 2008. The draft guidance document provides recommendations to establishments that collect human blood or blood components for a requalification method or process to reenter deferred donors into a donor pool based on a determination that the previous tests that were repeatedly reactive for anti-HBc were falsely positive and that there is no evidence of infection with Hepatitis B virus (HBV).
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Lubrizol Advanced Materials, Inc.; Filing of Food Additive Petition
The Food and Drug Administration (FDA) is announcing that Lubrizol Advanced Materials, Inc., has filed a petition proposing that the food additive regulations be amended to provide for the safe use of cassia gum as a stabilizer in frozen dairy desserts, and to improve texture and water retention in cheeses, meat products, and poultry products.
Solicitation for Nominations for Members of the U.S. Preventive Services Task Force
The Agency for Healthcare Research and Quality (AHRQ) invites nominations of individuals qualified to serve as members of the U.S. Preventive Services Task Force (USPSTF). The USPSTF, a standing, independent panel of outside experts that makes evidence-based recommendations regarding the provision of clinical preventive services, is composed of members appointed to serve for four year terms with an option for reappointment. New members are selected each year to replace approximately one fourth of the USPSTF members, i.e., those who are completing their appointments. Individuals nominated but not appointed in previous years, as well as those newly nominated, are considered in the annual selection process. USPSTF members meet three times a year for two days in the Washington, DC area. Between meetings, member duties include reviewing and preparing comments (off site) on systematic evidence reviews prior to discussing and making recommendations on preventive services, drafting final recommendation documents, and participating in workgroups on specific topics or methods. AHRQ particularly encourages nominations of women, members of minority populations, and persons with disabilities. Interested individuals can self nominate. Organizations and individuals may nominate one or more persons qualified for membership on the USPSTF. Qualification Requirements: The mission of the USPSTF is to produce evidence-based recommendations on the appropriate screening, counseling, and provision of preventive medication for asymptomatic patients seen in the primary care setting. Therefore, in order to qualify for the USPSTF, an applicant or nominee must demonstrate the following: 1. Knowledge and experience in the critical evaluation of research published in peer reviewed literature and in the methods of evidence review; 2. Understanding and experience in the application of synthesized evidence to clinical decision-making and/or policy; 3. Expertise in disease prevention and health promotion; 4. Ability to work collaboratively with peers; and, 5. Clinical expertise in the primary health care of children and/or adults, and/or expertise in counseling and behavioral interventions for primary care patients. Some USPSTF members without primary health care clinical experience may be selected based on their expertise in methodological issues such as medical decision making, clinical epidemiology, behavioral medicine, and health economics. Consideration will be given to individuals who are recognized nationally for scientific leadership within their field of expertise. Applicants must have no substantial conflicts of interest that would impair the scientific integrity of the work of the USPSTF including financial, intellectual, or other conflicts.
Request for Public Comment: 60-Day Proposed Information Collection: Indian Health Service Loan Repayment Program
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, which requires 60 days for public comment on proposed information collection projects, the Indian Health Service (IHS) is publishing for comment a summary of a proposed information collection to be submitted to the Office of Management and Budget (OMB) for review. Proposed Collection: Title: 0917-0014, ``Indian Health Service Loan Repayment Program.'' Type of Information Collection Request: Extension, without revision, of currently approved information collection, 0917- 0014, ``Indian Health Service Loan Repayment Program.'' Form(s): The IHS Loan Repayment Program Information Booklet contains the instructions and the application formats. Need and Use of Information Collection: The IHS Loan Repayment Program (LRP) identifies health professionals with pre-existing financial obligations for education expenses that meet program criteria and who are qualified and willing to serve at, often remote, IHS health care facilities. Under the program, eligible health professionals sign a contract under which the IHS agrees to repay part or all of their indebtedness for professional training time in IHS health care facilities. This program is necessary to augment the critically low health professional staff at IHS health care facilities. Any health professional wishing to have their health education loans repaid may apply to the IHS Loan Repayment Program. A two-year contract obligation is signed by both parties, and the individual agrees to work at an IHS location and provide health services to Native American and Alaska Native individuals. The information collected from individuals is analyzed and a score is given to each applicant. This score will determine which applicants will be awarded each fiscal year. The administrative scoring system assigns a score to the geographic location according to vacancy rates for that fiscal year and also considers whether the location is in an isolated area. When an applicant takes employment at a location, they in turn ``pick-up'' the score of that location. Affected Public: Individuals and households. Type of Respondents: Individuals. The table below provides: Types of data collection instruments, Estimated number of respondents, Number of responses per respondent, Annual number of responses, Average burden hour per response, and Total annual burden hour(s).
Notice of Public Process for the Expansion of the ClinicalTrials.gov Registry and Availability for Public Comment of Preliminary Information Related to the Establishment of a Basic Results Database
Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA; Pub. L. 110-85) mandates the expansion of the existing ClinicalTrials.gov registry and the establishment of a clinical trial results database. This notice announces our intent to implement the expanded registry and the basic results database via rulemaking and to post for public comment on the website identified below preliminary materials related to the basic results database. Comments received on the preliminary basic results materials will be considered in the development of an operational version of the basic results database and in the drafting of the associated regulation and any necessary guidance documents. The regulation will be subject to a separate public comment process.
Medical Devices; Immunology and Microbiology Devices; Classification of Plasmodium Species Antigen Detection Assays
The Food and Drug Administration (FDA) is classifying Plasmodium species antigen detection assays into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Class II Special Controls Guidance Document: Plasmodium Species Antigen Detection Assays.'' The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for this device.
Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Plasmodium Species Antigen Detection Assays; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Class II Special Controls Guidance Document: Plasmodium Species Antigen Detection Assays.'' This guidance document describes a means by which antigen detection assays for Plasmodium species may comply with the requirement of special controls for class II devices. It includes recommendations for validation of performance characteristics and recommendations for product labeling. Elsewhere in this issue of the Federal Register, FDA is publishing a final rule to classify these device types into class II (special controls). This guidance document is immediately in effect as the special control for antigen detection assays for Plasmodium species, but it remains subject to comment in accordance with the agency's good guidance practices.
National Toxicology Program (NTP); Report on Carcinogens (RoC); Availability of the Draft Background Document for Styrene; Request for Comments on the Draft Background Document for Styrene; Announcement of the Styrene Expert Panel Meeting
The NTP announces the availability of the draft background document for styrene on May 22, 2008, on the RoC Web site (http:// ntp.niehs.nih.gov/go/29679) or in printed text from the RoC (see ADDRESSES below). The NTP invites the submission of public comments on the draft background document for styrene. The expert panel will meet on July 21-22, 2008, at the Radisson Hotel Research Triangle Park, 150 Park Drive, Research Triangle Park, NC 27709 to peer review the draft background document for styrene and, once completed, make a recommendation regarding the listing status for styrene (i.e., known to be a human carcinogen, reasonably anticipated to be a human carcinogen, or not to list) in the 12th Edition of the RoC (12th RoC). The RoC expert panel meeting is open to the public with time scheduled for oral public comments. Attendance is limited only by the available meeting room space. Following the expert panel meeting and completion of the expert panel report, the NTP will post the final version of the background document and the expert-panel peer review report on the RoC Web site.
National Toxicology Program (NTP); Office of Liaison, Policy and Review; Meeting of the NTP Board of Scientific Counselors: Amended Notice
This notice announces the availability of a public telephone call-in line for the June 11-12, 2008 meeting of the NTP Board of Scientific Counselors. The meeting will be held at the Radisson Hotel Research Triangle Park, 150 Park Drive, Research Triangle Park, NC 27709 and videocast through the Internet at http://www.niehs.nih.gov/ news/video/live. Information regarding the meeting was announced in the Federal Register (73FR20289) published on April 15, 2008. The guidelines published in the April 15 Federal Register notice for submitting written public comments or making an oral presentation at the meeting still apply. In response to the public interest in the peer review of the Draft NTP Brief on Bisphenol A, the NTP will provide a telephone call-in line for public comments. The line will be open from 8:30 a.m. until 3 p.m. on June 11, although public comments will be received only during the formal public comment period on the draft brief. The exact time for the presentation of public comments is not set, but will follow the overview presentation on the draft brief and the talk on biomonitoring of bisphenol A exposures (the preliminary agenda is available at (http://ntp.niehs.nih.gov/go/165) or by contacting Dr. Barbara Shane, see FOR FURTHER INFORMATION CONTACT below).
National Toxicology Program (NTP); NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM); Peer Review Panel Report on the Validation Status of New Versions and Applications of the Murine Local Lymph Node Assay (LLNA): A Test Method for Assessing the Allergic Contact Dermatitis Potential of Chemicals and Products: Notice of Availability and Request for Public Comments
NICEATM, in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), convened an independent international scientific peer review panel on March 4-6, 2008 to evaluate new versions and applications of the LLNA for assessing the allergic contact dermatitis potential of chemicals and products. The peer review panel (``the Panel'') report from this meeting is now available. The report contains (1) the Panel's evaluation of the validation status of the methods and (2) the Panel's comments and conclusions on draft ICCVAM test method recommendations. NICEATM invites public comment on the Panel's report. The report is available on the NICEATM-ICCVAM Web site at http:// iccvam.niehs.nih.gov/methods/immunotox/llnaPeerPanel.htm or by contacting NICEATM at the address given below.
Office of Global Health Affairs; Regulation on the Organizational Integrity of Entities Implementing Leadership Act Programs and Activities
This document corrects a technical error that appeared in the Notice of Proposed Rulemaking (NPRM) on April 17, 2008, entitled ``Organizational Integrity of Entities Implementing Leadership Act Programs and Activities.''
Announcement of Third Meeting of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020
The U.S. Department of Health and Human Services (HHS) announces the third meeting of the Secretary's Advisory Committee on National Health Promotion and Disease Prevention Objectives for 2020. All Committee meetings are open to the public. The Committee will review the nation's health promotion and disease prevention objectives and efforts to develop goals and objectives to improve the health status and reduce health risks for Americans by the year 2020. The Committee will provide to the Secretary of Health and Human Services advice and consultation to facilitate the process for developing and implementing the next iteration of national health promotion and disease prevention goals and objectives and provide advice for initiatives to occur during the initial implementation phase of the goals and objectives. HHS will use the advice that is provided to develop recommendations to form the national health promotion and disease prevention objectives for 2020 and the process for implementing the objectives. The intent is to develop and launch objectives designed to improve the health status and reduce health risks for Americans by the year 2020.
Solicitation for Public Comments
The Department of Health and Human Services (DHHS) is hereby giving notice that the National Vaccine Program Office (NVPO) is seeking comments on a draft document that has been prepared for presentation to the National Vaccine Advisory Committee (NVAC).
Meeting of the National Vaccine Advisory Committee
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold a meeting. The meeting is open to the public.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Experience Reporting for Licensed Biological Products; and General Records
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Program Reporting and Accountability Changes to the Hospital Preparedness Program (HPP)
The Department of Health and Human Services (HHS or the Department) is issuing in the third quarter of FY 2008 a Funding Opportunity Announcement (FOA) for the HPP, authorized under section 319C-2 of the Public Health Service (PHS) Act, as amended by the Pandemic and All-Hazards Preparedness Act (PAHPA) (Pub. L. 109-417). The Consolidated Appropriations Act, 2008, provides funding for these awards (Pub. L. 110-161). This Federal Register notice provides information concerning critical aspects of this program including: