Department of Health and Human Services September 2005 – Federal Register Recent Federal Regulation Documents

The Department of Health and Human Services (HHS) gives notice of a decision to designate a class of employees at the Iowa Army Ammunition Plant, in Burlington, Iowa as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On August 25, 2005, the Secretary of HHS designated the following class of employees as an addition to the SEC: Department of Energy (DOE) employees or DOE contractor or subcontractor employees who worked as radiographers from May 1948 to March 1949 in support of Line 1 operations at the Iowa Army Ammunition Plant and who were employed for a number of work days aggregating at least 250 work days, occurring under this employment in combination with work days of employment occurring within the parameters (excluding aggregate work day requirements) established for other classes of employees included in the SEC. This designation will become effective on September 24, 2005, unless Congress provides otherwise prior to the effective date. After this effective date, HHS will publish a notice in the Federal Register reporting the addition of this class to the SEC or the result of any provision by Congress regarding the decision by HHS to add the class to the SEC.

The Food and Drug Administration (FDA) is announcing a public workshop entitled ``ICH Workshop on Oncolytic Viruses.'' The workshop will be held in conjunction with the International Conference on Harmonisation (ICH) expert working group and steering committee meetings in Chicago, IL. The objective of the workshop is to identify and discuss issues relevant to clinical development of oncolytic viruses including safety. The following viruses will be covered: Adenovirus, herpes simplex virus, reovirus, Newcastle disease virus, measles virus, and Sendai virus. Speakers will address selectivity, attenuation modes, shedding, clinical and viral safety, and proof of concept in support of the approach in animal and human setting. Date and Time: The workshop will be held on November 7, 2005, from 8 a.m. to 5 p.m. Location: The public workshop will be held at the Westin Michigan Avenue, 909 North Michigan Ave., Chicago, IL 60611. Contact Person: Daniel Takefman, Center for Biologics Evaluation and Research (HFM-720), Food and Drug Administration, Rockville, MD 20852, 301-827-5102, e-mail: daniel.takefman@fda.hhs.gov. Registration: Registrations are being collected by the Pharmaceutical Research and Manufacturers of America (PhRMA). Send registration information (including name, title, firm name, address, telephone, and fax number) to Liz Cross at PhRMA by FAX: 202-572-7797, or e-mail: lcross@phrma.org, no later than Friday, October 14, 2005. The registration fee for this workshop is $450 for industry; $175 for academia and government participants. To register via the Internet go to https:// www.ich.org/cache/html/2238-272-1.html. The registration fee will be used to offset some expenses of hosting the workshop including speakers, meeting rooms, coffee breaks, and materials. If you need special accommodations due to a disability, please contact Liz Cross at least 7 days in advance of the workshop.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Environmental Health Sciences (NIEHS), the National Institute of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on February 14, 2005 (Volume 70, Number 29, Pages 7508-7509, and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to the collection of information unless it displays a currently valid OMB control number. Proposed Collection: Title: Active Living by Design Program Evaluation. Type of Information Collection Request: NEW. Need and Use of Information Collection: The purpose of this study is to provide NIEHS with an overall evaluation of the Active Living by Design (ALbD) program to determine the extent to which program strategies to increase physical activity influence change, as measured by increased physical activity and reduction of Body Mass Index (BMI), in residents of participating communities. The objective of this study is to determine the degree to which the changes in the built environment, communication strategies and policy as a result of ALbD's program has impacted physical activity and BMI in residents within the twenty-five (25) participating communities relative to a set of ten (10) control communities. Two types of data collection will occur throughout the study. A telephone survey, which relies on self-reports, and a clinical survey, which will collect physical activity data using measures of physical activity such as, accelerometers; measures of BMI and an interview on respondents' perceptions of their neighborhood. The findings of this study will provide valuable information concerning (1) The Impact ALbD strategies have on increasing physical activity and bringing about positive changes in health associated with exercise, such as weight loss; and (2) possible reduction of health risks and diseases related to physical inactivity through implementation of ALbd strategies. Frequency of Response: Three times over a period of five (5) years, during three rounds of data collection. Affected Public: Individuals or households. Type of Respondents: Respondents includes adults and children ages 13 through 17 years and their parents. The clinical procedures require respondents under 18 years of age to be accompanied by their parent/guardian, therefore the burden has been doubled for these respondents. The annual reporting burden is respected in the following table:

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.

In accordance with section 10(a) of the Federal Advisory Committee Act, this notice announces meetings of the Citizens' Health Care Working Group (the Working Group) mandated by section 1014 of the Medicare Modernization Act.

The Administration on Aging (AoA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Office of Rural Health Policy (ORHP), in cooperation with the Office of Global Health Affairs (OGHA), Office of Minority Health (OMH), Office on Women's Health (OWH), and Centers for Disease Control and Prevention (CDC) will award a one year single source award to the U.S.-Mexico Border Health Association (USMBHA) to identify and promote best practices in border communities. As defined in the La Paz Agreement, the border region is 100 km north and south of the international boundary line between the United States and Mexico. Funds will be used on both sides of the U.S.-Mexico border for the development of activities under the second annual Border Binational Health Week (October 10-16, 2005).

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the Food and Drug Administration Alumni Association, Inc. The purpose of this MOU is to establish a greater collaboration between FDA and the Food and Drug Administration Alumni Association, Inc., regarding FDAs 2006 Centennial Observance.

This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from April 2005 through June 2005, relating to the Medicare and Medicaid programs. This notice provides information on national coverage determinations (NCDs) affecting specific medical and health care services under Medicare. Additionally, this notice identifies certain devices with investigational device exemption (IDE) numbers approved by the Food and Drug Administration (FDA) that potentially may be covered under Medicare. This notice also includes listings of all approval numbers from the Office of Management and Budget for collections of information in CMS regulations. Finally, this notice includes a list of Medicare-approved carotid stent facilities. Section 1871(c) of the Social Security Act requires that we publish a list of Medicare issuances in the Federal Register at least every 3 months. Although we are not mandated to do so by statute, for the sake of completeness of the listing, and to foster more open and transparent collaboration efforts, we are also including all Medicaid issuances and Medicare and Medicaid substantive and interpretive regulations (proposed and final) published during this 3-month time frame.

This notice announces a public meeting of the Medicare Coverage Advisory Committee (MCAC). The Committee provides advice and recommendations about whether scientific evidence is adequate to determine whether certain medical items and services are reasonable and necessary under the Medicare statute. This meeting concerns the treatments for age-related macular degeneration. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)).

This proposed notice acknowledges the receipt of an application from the Accreditation Commission for Healthcare for recognition as a national accreditation program for home health agencies that wish to participate in the Medicare or Medicaid programs. Section 1865(b)(3)(A) of the Social Security Act requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.

This notice announces the inpatient hospital deductible and the hospital and extended care services coinsurance amounts for services furnished in calendar year (CY) 2006 under Medicare's Hospital Insurance program (Medicare Part A). The Medicare statute specifies the formulae used to determine these amounts. For CY 2006, the inpatient hospital deductible will be $952. The daily coinsurance amounts for CY 2006 will be: (a) $238 for the 61st through 90th day of hospitalization in a benefit period; (b) $476 for lifetime reserve days; and (c) $119.00 for the 21st through 100th day of extended care services in a skilled nursing facility in a benefit period.