Department of Health and Human Services September 11, 2013 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the reporting requirements for the collection ``Recommended Glossary and Educational Outreach to Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use.''

The Bureau of Health Professions (BHPr) is announcing a change to its Health Workforce Research Center cooperative agreement program. Funding Opportunity Announcement (FOA) HRSA-13-185, issued on November 26, 2012, announced HRSA's intent to fund Health Workforce Research Centers (HWRCs) focusing on research and technical assistance (TA). The FOA identified five broad areas of focus for research in HWRCs: Allied health, long-term care, behavioral health, oral health, and flexible use of workers to improve care delivery and efficiency. The concentration area, ``flexible use of workers to improve care delivery and efficiency,'' was further defined via published ``frequently asked questions'' as an area intended to address questions related to leveraging the existing health workforce to improve access to care, efficiency, and effectiveness in care delivery. Suggested topics for study included novel health care roles, team-based care (including the composition of teams and division of responsibilities across a team), professionals working at the top of their skills and training, and delegation. These proposed concentration areas were selected as areas of critical importance to health workforce policies and programs, as well as areas in which substantial expertise exists outside the government, indicating strong potential for public benefit. Applicants were asked to design a portfolio consisting of six research or TA projects, of which a subset would be selected for completion in the first budget period. Applicants were instructed to use their own judgment and expertise in designing a portfolio that would address timely, relevant, and important health workforce policy and planning questions. Though the FOA indicated the intent to fund only one cooperative agreement in each research focus area, the latitude given to applicants in designing their portfolios resulted in diverse interpretations of the concentration areas, particularly in the ``flexible use of workers'' category. For example, the top two ranked ``flexible use of workers'' HWRC (ranked at second and third in the research category) have distinct areas of focus. One focuses its portfolio on use of workers in community health centers, health IT, and telehealth. The other focuses primarily on primary care, including competencies for primary care teams, temporal shifts between primary and specialty practice over time, and flexibility in primary vs. specialty care service offerings. After further consideration, and in light of growing interest in promoting full and effective use of health workers, HRSA has concluded it is appropriate and consistent with the intent of the FOA to fund more than one cooperative agreement in a single area of concentration if the proposals cover research on distinct issues of importance. With this in mind, BHPr intends to fund two HWRCs in the concentration area ``flexible use of workers.'' This decision was made in light of the critical importance of defining new and emerging roles and models of the health workforce to meet the nation's changing health care needs. In addition, this allows BHPr to fund directly down the rank order list of applicants produced in the independent review process.

This Notice advises the public that the Indian Health Service (IHS) proposes the geographic boundaries of the Service Delivery Area (SDA) for the Tejon Indian Tribe. The Tribe's federal recognition was reaffirmed by the Assistant Secretary of Indian Affairs on December 30, 2011. The Tejon Indian Tribe's SDA is to be comprised of Kern County in the State of California. The county listed is designated administratively as the SDA, to function as a Contract Health Service Delivery Area (CHSDA), for the purpose of operating a Contract Health Service (CHS) program pursuant to the Indian Self-Determination and Education Assistant Act (ISDEAA), Public Law 93-638.

The Food and Drug Administration (FDA) is extending the comment period for the advance notice of proposed rulemaking (ANPRM) that appeared in the Federal Register of July 24, 2013 (78 FR 44484). In the ANPRM, FDA requested comments, including comments on FDA's preliminary evaluation, and data, research, or other information that may inform regulatory actions that FDA might take with respect to menthol in cigarettes. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

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.