Department of Health and Human Services September 2007 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management.

This notice announces the ninth meeting of the American Health Information Community Personalized Healthcare Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.)

This notice announces the 20th meeting of the American Health Information Community Consumer Empowerment Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.)

This notice announces the 12th meeting of the American Health Information Community Quality Workgroup in accordance with the Federal Advisory Committee Act (Pub. L. No. 92-463, 5 U.S.C., App.)

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.

The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 018'' (Recognition List Number: 018), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

The Murine Local Lymph Node Assay (LLNA) is the first alternative test method evaluated and recommended by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). It was subsequently accepted by regulatory authorities to determine the allergic contact dermatitis potential of chemicals and products. In January 2007, the U.S. Consumer Product Safety Commission (CSPC) submitted a nomination requesting that NICEATM and ICCVAM assess the validation status of (1) The LLNA as a stand-alone assay for potency determination for hazard classification purposes; (2) modified LLNA protocols; (3) the LLNA limit test; (4) the use of LLNA to test mixtures, aqueous solutions, and metals; and (5) the applicability domain for LLNA. In order to facilitate the review of the modified LLNA protocols, ICCVAM proposed developing performance standards for the LLNA. In May 2007, a Federal Register notice was published (Vol. 72, No. 95, pages 27815-27817, May 17, 2007) requesting comments and data relevant to these nominated activities. In June 2007, the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) endorsed the nominated activities as high priorities for ICCVAM. In response to SACATM comments, along with those provided by the public in response to the previous Federal Register notice, ICCVAM also endorsed these activities as high priorities. ICCVAM subsequently prepared draft performance standards for the LLNA and now requests public comments on this draft document, which is available on the NICEATM/ICCVAM Web site at: (https://iccvam.niehs.nih.gov/methods/immunotox/immunotox.htm) or by contacting NICEATM (see FOR FURTHER INFORMATION CONTACT below).

Under the provisions of section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the Federal Register on July 11, 2007, pages 37789-37790, and allowed 60-days for public comment. No 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, 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: Hispanic Community Health Study (HCHS)/ Study of Latinos (SOL). Type of Information Collection Request: New Collection. Need and Use of Information Collection: The Hispanic Community Health Study (HCHS)/ Study of Latinos (SOL) will identify risk factors for cardiovascular and lung disease in Hispanic populations and determine the role of acculturation in the prevalence and development of these diseases. Hispanics, now the largest minority population in the US, are influenced by factors associated with immigration from different cultural settings and environments, including changes in diet, activity, community support, working conditions, and health care access. This project is a multicenter, six-and-a-half year epidemiologic study and will recruit 16,000 Hispanic men and women aged 18-74 in four community-based cohorts in Chicago, Miami, San Diego, and the Bronx. The study will also examine measures of obesity, physical activity, nutritional habits, diabetes, lung and sleep function, cognitive function, hearing, and dental conditions. Closely integrated with the research component will be a community and professional education component, with the goals of bringing the research results back to the community, improving recognition and control of risk factors, and attracting and training Hispanic researchers in epidemiology and population-based research. Frequency of Response: The participants will be contacted annually. Affected Public: Individuals or households; Businesses or other for profit; Small businesses or organizations. Type of Respondents: Individuals or households; physicians. The annual reporting burden is as follows: Estimated Number of Respondents: 39,844; Estimated Number of Responses per Respondent: 1.0; Average Burden Hours Per Response: 1.1; and Estimated Total Annual Burden Hours Requested: 44,688. The annualized cost to respondents is estimated at $149,415, assuming respondents time at the rate of $15 per hour and physician time at the rate of $55 per hour. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report.

In accordance with the requirements of the Privacy Act of 1974, CMS is proposing to establish a new system of records (SOR) titled, ``Performance Measurement and Reporting System (PMRS),'' System No. 09-70-0584. PMRS will serve as a master system of records to assist in projects that provide transparency in health care on a broad-scale enabling consumers to compare the quality and price of health care services so that they can make informed choices among individual physicians, practitioners and providers of services. In cooperation with local or regional public-private collaborative stakeholders; individuals assigned to provider groups; insurance and provider associations; government agencies; employers; accrediting and quality organizations; Chartered Value Exchanges (CVE), data aggregators, and other community leaders who are committed to improving the quality of services, CMS is laying the foundation for pooling and analyzing information about the quality of medical services and performance provided by physicians and health care providers. PMRS will further assist in developing existing strategies to improve health care quality including transparency of cost and/or price information, quality and utilization information; and patient safety for Medicare beneficiaries by collecting and aggregating data, by measuring performance at the individual physician level, and by reporting meaningful information to Medicare beneficiaries in order to make informed choices and improve outcomes. Pursuant to the ``routine use'' promulgated under this system of records notice, CMS or a non-Quality Improvement Organization (non-QIO) contractor would make the individual physician-level performance measurement results available to Medicare beneficiaries by posting it on a public Web site and by various other methods of data dissemination. If local Web sites are used by a local or regional collaborative, CMS would have links to these Web sites on its main Web site. This information would be made available for the purpose of, and in a manner that would promote more informed choices by Medicare beneficiaries among their Medicare coverage options (i.e., the Medicare Advantage, local or regional plans offered in their area, and original fee-for-service Medicare). The routine uses established with this system contain a proper explanation as to the need for the disclosure provisions and provide clarity to CMS's intention to disclose individual-specific information contained in this system. The primary purpose of this system is to support the collection, maintenance, and processing of information promoting the effective, efficient, and economical delivery of health care services, and promoting the quality of services of the type for which payment may be made under title XVIII by allowing for the establishment and implementation of performance measures, and the provision of feedback to physicians. Information in this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed for the Agency or by a contractor, consultant, or a CMS grantee; (2) assist another Federal and/or state agency, agency of a state government, or an agency established by state law; (3) promote more informed choices by Medicare beneficiaries among their Medicare group options by making physician performance measurement information available to Medicare beneficiaries through a Web site and other forms of data dissemination; (4) provide CVEs and data aggregators with information that will assist in generating single or multi-payer performance measurement results to promote transparency in health care to members of their community; (5) assist individual physicians, practitioners, providers of services, suppliers, laboratories, and others health care professionals who are participating in health care transparency projects; (6) assist individuals or organizations with projects that provide transparency in health care on a broad-scale enabling consumers to compare the quality and price of health care services; or for research, evaluation, and epidemiological projects related to the prevention of disease or disability; restoration or maintenance of health or for payment purposes; (7) assist Quality Improvement Organizations; (8) support litigation involving the agency; and (9) combat fraud, waste, and abuse in certain health benefits programs. We have provided background information about this new system in the ``Supplementary Information'' section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See ``Effective Dates'' section for comment period.

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, is contemplating the grant of an exclusive license worldwide to practice the invention embodied in United States Patent Number 6,635,614 titled ``Use of Lecithin- Cholesterol Acyltransferase (LCAT) to Reduce Accumulation of Cholesterol,'' referenced at DHHS as E-007-1996/0-US-03, and corresponding foreign patent application(s) and issued patent(s), to AlphaCore Pharma, Inc. having a place of business in the state of Michigan. The field of use may be limited to the following: FDA or similar foreign body approved cardiovascular and nephropathy therapeutic. The United States of America is the assignee of the patent rights in this invention. The territory may be worldwide. This announcement is the first notice to grant an exclusive license to this technology.