Department of Health and Human Services September 27, 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.