Department of Health and Human Services July 3, 2008 – Federal Register Recent Federal Regulation Documents

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.

This project will support the Gorgas Memorial Institute (GMI) to: (a) Develop a regional training center in Panama and (b) train community health workers, clinicians (physicians, nurses, and auxiliary medical workers) and select public-health professionals from Central and South America (i.e., Latin America), (c) facilitate partnerships between U.S. universities and their Latin American counterparts to develop human resources for health in Latin America, and (d) harness the energies of U.S. and other non-governmental organizations by partnering with them to advance community health-training and program efforts in Latin America. These efforts will help engage significantly more areas of these countries to prepare for and respond to public-health emergencies, such as pandemic influenza, and they will contribute to the improved and expanded provision of prevention and primary health care. This training of nurses, community health workers and physicians will focus on improving and expanding coverage and access to both public-health emergency care and preventive and primary health care in underserved parts of Latin America (i.e., both underserved rural and poor urban communities). A result of this project, the health-care work force in Central America should be better prepared to respond to public-health emergencies, including pandemic influenza. Key to the selection of recipients for this training will be their availability and willingness to provide their health and medical care skills in underserved areas within the region, especially rural and indigenous communities and those visited by U.S. Government humanitarian missions in the past year. In addition to all appropriate subjects in the fields of medical care and health education or communication, training supported by this project will emphasize infectious diseases, epidemiology, disease surveillance and outbreak response, so graduates of training programs will be prepared to play contributing roles in any pandemic preparation and response.

The Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644). A notice listing all currently certified laboratories is published in the Federal Register during the first week of each month. If any laboratory's certification is suspended or revoked, the laboratory will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any laboratory has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end, and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes 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 April 30, 2008 (Vol. 73, No. 84, p. 23473), and allowed 60 days for public comment. No public comments or questions 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, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: The Agricultural Health Study: A Prospective Cohort Study of Cancer and Other Disease Among Men and Women in Agriculture (NCI) (OMB: 0925-0406). Type of Information Collection Request: Renewal. Need and Use of Information Collection: The purpose of this information collection is to continue and complete updating the occupational and environmental exposure information as well as medical history information for respondents enrolled in the Agriculture Health Study. This represents a request to continue and complete phase III (2005-2008) of the study. Due to reduced annual budgets for research, a delay in data collection has resulted and there has not been enough time to complete the data collection on the number of respondents that had been originally requested in the 2005 OMB submission. The primary objectives of the study are to determine the health effects resulting from occupational and environmental exposures in the agricultural environment. The data will be collected by using a computer assisted telephone interview (CATI) system. A small percentage of the respondents will also be asked to participate in a buccal cell collection which is a sample of loose cells from the respondent's mouth. The findings will provide valuable information concerning the potential link between agricultural exposures and cancer and other chronic diseases among agricultural Health Study cohort members, and this information may be generalized to the entire agricultural community. Frequency of Response: Once. Affected Public: Private sector, farms. Type of Respondents: Licensed pesticide applicators and their spouses. The annual reporting burden is as follows:

The Food and Drug Administration (FDA) is issuing an order prohibiting the extralabel use of cephalosporin antimicrobial drugs in food-producing animals. We are issuing this order based on evidence that extralabel use of these drugs in food-producing animals will likely cause an adverse event in humans and, as such, presents a risk to the public health.