Department of Health and Human Services June 2009 – Federal Register Recent Federal Regulation Documents

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Center for Complementary and Alternative Medicine (NCCAM), at the National Institutes of Health (NIH), will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.

The Food and Drug Administration (FDA) is announcing an amendment to the Emergency Use Authorization (EUA) (the Authorization) for doxycycline hyclate tablet emergency kits for eligible U.S. Postal Service (USPS) participants in the Cities Readiness Initiative (CRI) and their household members issued on October 3, 2008, under the Federal Food, Drug, and Cosmetic Act (the act), as requested by the Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response (ASPR), Health and Human Services (HHS). Following issuance of FDA's October 3, 2008, Authorization letter, on February 19, 2009, BARDA submitted a request on behalf of ASPR, to amend the Authorization. In response to BARDA's request, FDA amended the Authorization letter and reissued the Authorization letter in its entirety on February 25, 2009. The Authorization, as amended and reissued in its entirety, is reprinted in this document.

This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January 2009 through March 2009, 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 and a list of Medicare-approved carotid stent facilities. Included in this notice is a list of the American College of Cardiology's National Cardiovascular Data registry sites, active CMS coverage-related guidance documents, and special one-time notices regarding national coverage provisions. Also included in this notice is a list of National Oncologic Positron Emissions Tomography Registry sites, a list of Medicare-approved ventricular assist device (destination therapy) facilities, a list of Medicare-approved lung volume reduction surgery facilities, a list of Medicare-approved clinical trials for fluorodeoxyglucose positron emissions tomography for dementia, and a list of Medicare-approved bariatric surgery facilities.

The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of Friday, May 29, 2009 (74 FR 25651). The final rule was published with an inadvertent error in the ``Analysis of Impacts'' section. This document corrects that error.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request information from (1) small- and medium-sized practices about how they study or redesign their workflow, including information on the use of tools and methods for studying workflow, and (2) others (e.g., experts, vendors, professional associations) that have developed, implemented and used tools and methods for studying workflow in the context of health IT implementation and use. Workflow is defined as the way work is performed and patient-related information is communicated within small- and medium-sized practices and between those practices and external organizations such as community pharmacies and local hospitals. It is our understanding that there is currently no standard description of workflows for care processes that can be used to guide decisions of where and how to incorporate health information technology. This Request for Information is part of a three-pronged effort to scan the environment, the literature and knowledgeable and interested parties to produce a useful list of resources that may assist small- and medium- sized medical practices and clinics to consider the utility and potential effectiveness of incorporating health IT into the way they practice and communicate patient information. The responses to this request for information will be considered for reference and possible incorporation into an electronic toolkit to be made available on the Internet to assist small- and medium-sized practices in analyzing or redesigning workflow either before or after implementation of one or more health IT applications. All responses to this request for information are voluntary.

The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of a neutral, independent institution and/or organization that proposes appropriate methods and processes for convening a broad range of stakeholders with relevant expertise to manage and support conferences and meetings. The focus of

Notice is hereby given that the Office of Research Integrity (ORI) and the Assistant Secretary for Health have taken final action in the following case:

This notice announces an administrative hearing to be held on August 4, 2009, at the CMS Seattle Regional Office, 2201 Sixth Avenue, MS/RX-43, Seattle, Washington 98121, to reconsider CMS' decision to disapprove Washington SPA 08-019.

The Health Resources and Services Administration (HRSA) announces that the listing of entities, and their Health Professional Shortage Area (HPSA) scores, that will receive priority for the assignment of National Health Service Corps (NHSC) scholarship recipients (Corps Personnel, Corps members) during the period July 1, 2009, through June 30, 2010, is posted on the NHSC Web site at https:// nhscjobs.hrsa.gov/. This list specifies which entities are eligible to receive assignment of Corps members who are participating in the NHSC Scholarship Program. A separate Federal Register Notice pertaining to sites eligible to receive NHSC Loan Repayment Program participants and non-obligated individuals was published on May 28, 2009 (74 FR 25568). Please note that not all vacancies associated with sites on the list described below will be for Corps members, but could be for NHSC Scholarship Program participants serving their obligation through the Private Practice Option.

The Substance Abuse and Mental Health Services Administration (SAMHSA) is committed to preventing the onset and reducing the progression of mental illness, substance abuse, and substance-related problems among all individuals. As part of this effort, SAMHSA has expanded and refined the agency's National Registry of Evidence-based Programs and Practices (NREPP). Two previous notices announcing these changes have been published in the Federal Register (70 FR 50381, Aug. 26, 2005; 71 FR 13133, Mar. 14, 2006). Since 2006, SAMHSA has held two open submission periods during which interventions could be submitted for potential review and inclusion on the NREPP Web site (71 FR 37590, June 30, 2006; 72 FR 30814, June 4, 2007). This notice announces the open submission period for fiscal year 2010, explains how submissions will be screened and selected, and provides guidance on the submission process for individuals and organizations seeking to have an intervention reviewed and listed on the NREPP Web site. Potential applicants should be aware that this notice includes new information relating to the eligibility of interventions and the review process that supersedes guidance provided in earlier Federal Register notices.

This advance notice of proposed rulemaking announces the intention of CMS to publish proposed amendments to the regulations implementing Medicaid home and community-based services waivers under section 1915(c) of the Social Security Act and solicits advance public comments on the merits of providing States the option to combine or eliminate the existing three permitted waiver targeting groups, and on the most effective means to define home and community.