Department of Health and Human Services September 2010 – Federal Register Recent Federal Regulation Documents

This notice announces a public workshop hosted by the Federal Trade Commission (FTC), the Centers for Medicare & Medicaid Services (CMS), and the Office of the Inspector General (OIG) of the Department of Health and Human Services (DHHS). This workshop will include panel discussions and a listening session on certain legal issues related to Accountable Care Organizations (ACOs). Physicians, physician associations, hospitals, health systems, consumers, and all others interested in ACOs are invited to participate, in person or by calling into the teleconference. The meeting is open to the public, but attendance is limited to space and teleconference lines available. An agenda will be posted on the CMS Web site at https://www.cms.gov/center/ physician.asp prior to the session.

In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for the opportunity for public comment on proposed data collection projects, the National Institute on Aging (NIA), 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. Proposed Collection: Title: Recruitment and Screening for the Insight into Determination of Exceptional Aging and Longevity (IDEAL) Study. Type of Information Collection Request: NEW. Need and Use of Information Collection: The purpose of the project for is to conduct recruitment and screening for the IDEAL Study. A multifaceted recruitment approach will be used to reach the target audience in a wide variety of ways. Those who are interested in participating in the IDEAL study will be asked to complete a two stage recruitment process consisting of a telephone interview and a physical exam. The Stage One interview consists of questions concerning demographics, physical ability, health status, and medical conditions. Those who are eligible after completing the telephone interview will be asked to complete the second stage of the screening process. The physical examination is a modified version of the full BLSA assessment protocol consisting of the following components: general appearance; vital signs; chest and heart auscultation; sensory systems including vision, hearing, sensory proprioception, neuropathy and balance; and movement and strength of the upper and lower extremities. In addition the potential participant will also be asked to complete physical performance tests, cognitive exams, an electrocardiogram and a blood draw. Frequency of Response: Once. Affected Public: Individuals or households. Type of Respondents: Healthy individuals who are at least 80 years of age. The annual reporting burden is as follows: Estimated Number of Respondents: 1,500; Estimated Number of Responses per Respondent: 1; Average Burden Hours per Response: 0.833; and Estimated Total Annual Burden Hours Requested: 701. There is no annualized cost to respondents. There are no Capital costs to report. There are no Operating or Maintenance Costs to report.

The Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) are considering establishing a process for overlapping evaluations of premarket, FDA-regulated medical products when the product sponsor and both agencies agree to such parallel review. This process will serve the public interest by reducing the time between FDA marketing approval or clearance decisions and CMS national coverage determinations (NCDs). The agencies are establishing a docket to receive information and comment from the public on what products would be appropriate for parallel review by the two agencies, what procedures should be developed, how a parallel review process should be implemented, and other issues related to the effective operation of the process. The agencies are also announcing their intent to create a pilot program for parallel review of medical devices. The pilot program will begin after both agencies have reviewed the public comments on this notice. A memorandum of understanding (MOU) concerning the exchange of data and information has been completed between the two agencies. See https://www.fda.gov/AboutFDA/ PartnershipsCollaborations/MemorandaofUnderstandingMOUs/Domes ticMOUs/ ucm217585.htm.

HHS gives notice of a decision to designate a class of employees from the Blockson Chemical Company in Joliet, Illinois, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On September 3, 2010, the Secretary of HHS designated the following class of employees as an addition to the SEC:

AHRQ has accepted a notification of voluntary relinquishment from the Coalition for Quality and Patient Safety of Chicagoland (CQPS) of its status as a Patient Safety Organization (PSO). The Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act), Public Law 109-41, 42 U.S.C. 299b-21-b-26, provides for the formation of PSOs, which collect, aggregate, and analyze confidential information regarding the quality and safety of health care delivery. The Patient Safety and Quality Improvement Final Rule (Patient Safety Rule), 42 CFR Part 3, authorizes AHRQ, on behalf of the Secretary of HHS, to list as a PSO an entity that attests that it meets the statutory and regulatory requirements for listing. A PSO can be ``delisted'' by the Secretary if it is found to no longer meet the requirements of the Patient Safety Act and Patient Safety Rule, including when a PSO chooses to voluntarily relinquish its status as a PSO for any reason.