Agency Information Collection Activities: Proposed Collection; Comment Request

AGENCY:

Centers for Medicare and Medicaid Services, HHS.

In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare and Medicaid Services (CMS) (formerly known as the Health Care Financing Administration (HCFA)), Department of Health and Human Services, is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

1. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Clinical Laboratory Improvement Amendments Application Form and Supporting Regulations in 42 CFR 493.1-.2001; Form No.: CMS-116 (OMB# 0938-0581); Use: Clinical Laboratory Certification—The application must be completed by entities performing laboratory testing on human specimens for diagnostic or treatment purposes. This information is vital to the certification process; Frequency: Bi-annually; Affected Public: Business or other for-profit, not-for-profit institutions, Federal government, and State, local, or tribal government; Number of Respondents: 16,000; Total Annual Responses: 16,000; Total Annual Hours: 20,000.

To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS's Web site address at http://cms.hhs.gov/regulations/pra/default.asp,, or e-mail your request, including your address, phone number, OMB number, and CMS document identifier, to paperwork@hcfa.gov, or call the Reports Clearance Office on (410) 786-1326. Written comments and recommendations for the proposed information collections must be mailed within 60 days of this notice directly to the CMS Paperwork Clearance Officer designated at the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development and Issuances, Attention: Melissa Musotto, Room C5-14-03, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.