Department of Health and Human Services October 1, 2012 – Federal Register Recent Federal Regulation Documents

The Health Resources and Services Administration (HRSA)'s Bureau of Health Professions is issuing a non-competitive single source award to the Texas AHEC EastUniversity of Texas Medical Branch, an AHEC program grantee, to add a Behavioral Health component to a Community Health Worker (CHW) curriculum, pilot and evaluate it in primary care settings, and disseminate the curriculum. This project shall be titled: Community Health Worker (CHW) Behavioral Health Primary Care Integration Project. In fiscal year (FY) 2012, $486,394 will be available to fully fund this cooperative agreement with a single project/budget period of four years. The Texas AHEC East is uniquely qualified and has the capacity, capability, expertise, experience, and infrastructure to expeditiously, effectively, and efficiently implement the CHW Behavioral Health Primary Care Integration Project within their existing educational programming, and disseminate the tested model nationally. CHWs play an important role in increasing access to services for vulnerable populations, and increasing support for direct service workers, including community health workers, which is a priority for the Department of Health and Human Services as well as the Health Resources and Services Administration.

The Health Resources and Services Administration (HRSA)'s Bureau of Health Professions is issuing a non-competitive single source program expansion supplement award to the NEPQR Program grantee TAMUCC- CONHS to build upon their feasibility study, Transitioning Enlisted Health Care Training into Academic Credit for Nursing Education Programs, and undertake a dissemination program to advance the goal of aligning enlisted health care training with civilian nursing program requirements. In fiscal year (FY) 2012, $178,374 will be available to fund this award. TAMUCC-CONHS is uniquely qualified and has the capacity, capability, expertise, experience, and infrastructure to expeditiously, effectively, and efficiently implement the project within their existing educational programming. During the previous year, TAMUCC-CONHS has gained in-depth insight into the full range academic, financial, and socio-economic barriers that interfere with successful transition from military to civilian careers, and how these barriers are compounded by the burden of navigating the military- academic labyrinth. Thus they are well-positioned to bridge the gap between health care training command programs and academic programs in schools of nursing work.

The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), is announcing a scientific public workshop to solicit information on a variety of issues related to the clinical development of disease-modifying agents for the treatment of peripheral neuropathy. Discussion will focus on possible therapeutic targets for these agents, the types of painful peripheral neuropathies amenable to treatment with disease-modifying agents, and clinical trial design. FDA intends to take this information into account in developing FDA guidance on clinical development programs for disease-modifying products for the management of peripheral neuropathy. Date and Time: The public workshop will be held on February 11, 2013, from 8:30 a.m. to 5 p.m. and February 12, 2013, from 8:30 a.m. to 2 p.m. Location: The public workshop will be held at FDA White Oak Campus, Building 31, The Great Room (Rm. 1503),White Oak Conference Center, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002. Entrance for the consultation meeting's participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to https:// www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ucm241740.htm Contacts:

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Acute Bacterial Exacerbations of Chronic Bronchitis in Patients With Chronic Obstructive Pulmonary Disease: Developing Antimicrobial Drugs for Treatment.'' This guidance addresses FDA's current thinking regarding the overall development program and clinical trial designs for drugs to support an indication for treatment of acute bacterial exacerbations of chronic bronchitis in patients with chronic obstructive pulmonary disease (ABECB-COPD), and finalizes the revised draft guidance issued on August 22, 2008.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services (HHS), is contemplating the grant of a worldwide exclusive evaluation option license, to practice the inventions embodied in: