E6-5833. Agency Information Collection Activities: Proposed Collection; Comment Request

AGENCY:

Centers for Medicare & 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 & Medicaid Services (CMS) 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: New Collection; Title of Information Collection: Medicare Clinical Laboratory Services Competitive Bidding Demonstration Project—Bidding Form; Use: The Medicare Clinical Laboratory Competitive Bidding Demonstration is mandated by section 302(b) of the Medicare Prescription Drug, Improvement and Modernization Act (MMA) of 2003. The purpose of the demonstration is to determine whether competitive bidding can be used to provide quality laboratory services at prices below current Medicare reimbursement rates. The application is to collect information from organizations that supply clinical laboratory services to Medicare beneficiaries in the Competitive Bidding Area (CBA). This information will be used to determine bidding status, winners under the bidding competition, and the competitively-determined fee schedule for demonstration tests. The winning laboratories will be selected based on multiple criteria, including price bid, laboratory capacity, service area, and quality. Multiple winners are expected in each competitive acquisition areas; Form Number: CMS-10193 (OMB#: 0938-New); Frequency: Reporting—Other: Once every three years; Affected Public: Business or other for-profit; Number of Respondents: 80; Total Annual Responses: 80; Total Annual Hours: 7010.

2. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Competitive Acquisition Program (CAP) for Medicare Part B Drugs: Vendor Application and Bid Form; Use: The CAP Vendor Application and Bid Form is a collection tool which will be used by potential vendors to provide information related to the characteristics of their company and to submit their bid prices for CAP drugs. The information collected on the CAP Vendor Application and Bid Form will be used by CMS during the bidding evaluation process to evaluate the vendors bid prices, their credentials, experience and to assess their ability to provide quality service to physicians and beneficiaries. Competitive bidding is seen as a means of using the dynamics of the marketplace to provide incentives for suppliers to provide reasonably priced products and services of high quality in an efficient manner. The CAP's objectives include providing an alternative method for physicians to obtain Part B drugs to administer to Medicare beneficiaries and reducing drug acquisition and billing burdens for physicians; Form Number: CMS-10133 (OMB#: 0938-0955); Frequency: Reporting—Other, during the bidding process; Affected Public: Business or other for-profit; Number of Respondents: 12; Total Annual Responses: 12; Total Annual Hours: 480.

To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS' Web Site address at http://www.cms.hhs.gov/​PaperworkReductionActof1995,, or e-mail your request, including your address, phone number, OMB number, and CMS document identifier, to [e-mail], or call the Reports Clearance Office on [phone].

To be assured consideration, comments and recommendations for the proposed information collections must be received at the address below, no later than 5 p.m. on June 20, 2006.

CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development—C, Attention: Bonnie L. Harkless, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.

Dated: April 12, 2006.

Michelle Shortt,

Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs.