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

The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at the Canoga Avenue Facility, Los Angeles County, California, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On May 14, 2010, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:

The Food and Drug Administration (FDA) is announcing a public workshop regarding scientific issues in the design and conduct of clinical trials for antibacterial drug development. The public workshop is intended to provide information for and gain perspectives from health care providers, researchers, academia, industry, and regulators on various aspects of design and conduct of clinical trials for antibacterial drugs. The workshop will focus on the design and conduct of non-inferiority (NI) clinical trials, which are often used in the evaluation of the safety and efficacy of a new antibacterial drug. The input from this public workshop will help in developing topics for further discussion.

NICEATM announces availability of Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Test Method Evaluation Reports (TMERs) recommending two nonradioactive versions of the Local Lymph Node Assay (LLNA) for assessing allergic contact dermatitis (ACD) hazard potential of chemicals and products and expanded uses of the LLNA for pesticide formulations and other products. Related ICCVAM Test Method Recommendations in each report have also been transmitted to Federal agencies for their review and response to ICCVAM in accordance with the provisions of the ICCVAM Authorization Act of 2000. The LLNA: 5-Bromo-2'-deoxyuridine-Enzyme- Linked Immunosorbent Assay (BrdU-ELISA) and LLNA: Daicel Adenosine Triphosphate (DA) do not use radioactive reagents and therefore provide advantages in terms of reduced hazardous waste disposal and broader availability for use by laboratories that cannot use radioactive reagents. ICCVAM concludes that the accuracy and reliability of the LLNA: BrdU-ELISA and LLNA: DA support use of these test methods to identify substances as potential skin sensitizers or nonsensitizers. Based on an updated evaluation, ICCVAM is also recommending expanded use of the LLNA to evaluate the ACD hazard potential of pesticide formulations and other products.

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 Drug Abuse (NIDA), 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.

This proposed rule would revise the Medicare conditions of participation for hospitals and critical access hospitals (CAHs) to ensure the visitation rights of all patients. Medicare- and Medicaid- participating hospitals and CAHs would be required to have written policies and procedures regarding the visitation rights of patients, including those setting forth any clinically necessary or reasonable restriction or limitation that the hospital or CAH may need to place on such rights as well as the reasons for the clinical restriction or limitation.

This notice lists CMS manual instructions, substantive and interpretive regulations, and other Federal Register notices that were published from January through March 2010, 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 tomogrogphy for dementia, and a list of Medicare-approved bariatric surgery facilities.