05-5563. Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB)

AGENCY:

Center for Medicare & Medicaid Services.

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), 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.

We are, however, requesting an emergency review of the information collection referenced below. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we have submitted to the Office of Management and Budget (OMB) the following requirements for emergency review. We are requesting an emergency review because the collection of this information is needed before the expiration of the normal time limits under OMB's regulations at 5 CFR part 1320. This is necessary to ensure compliance with an initiative of the Administration.

We cannot reasonably comply with the normal clearance procedures because of an unanticipated event and possible public harm. As a result of a statutory deadline, we are requesting expedited review and approval of the Medicare Part B Drug and Biological Competitive Acquisition Program (CAP) bidding forms. Without approval of these forms on an emergency basis, potential vendors/suppliers will not be able to participate in the program for which they are essential.

In particular, CMS has accelerated the normal “statute to regulation” process in order to meet the CAP's statutory implementation deadline of January 1, 2006. CMS placed the proposed rule (CMS-1325-P) on display on February 25, 2005, and the proposed rule was published in the Federal Register on March 4, 2005. CMS anticipates publishing the final rule during the last week of May 2005. We are requesting to use the expedited approval process for the collection requirements so that we can begin collecting bids from potential vendors on June 1, 2005, and award contracts by August 2005. Therefore, we are requesting OMB approval for these forms no later than May 26, 2005. The CAP Physician election process will begin on October 1, 2005. Physicians who elect to participate in the CAP can begin receiving their drugs through a CAP vendor on January 1, 2006.

This request covers the CAP Vendor Application and Bid Form, the CAP Drug Vendor Application Guide, and the CAP Physician Election Agreement. The CAP Vendor Application and Bid Form 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 CAP Drug Vendor Application Guide is an informational piece intended to facilitate completion of the application. The Physician Election Agreement will be used by physicians to elect to participate in the CAP program.

CMS is requesting OMB review and approval of this collection by May 26, 2005, with a 180-day approval period. Written comments and recommendations will be accepted from the public if received by the individuals designated below by May 15, 2005.

Type of Information Collection Request: New collection; Title of Information Collection: Medicare Competitive Acquisition Program Applications; Form No.: CMS-10133 (OMB# 0938-New); Use: The forms included in this request (CAP Vendor Application and Bid Form) will be used by potential vendors to provide information related to the characteristics of their company, record their bid prices for CAP drugs, and provide information about the company's finances. Physicians will use the Physician Election Agreement to elect to participate in the program beginning October 2005 and begin receiving their drugs through a CAP vendor January 2006; Frequency: Upon Occasion; Affected Public: Business or other for-profit, Not-for-profit institutions, Individuals; Number of Respondents: 70,025; Total Annual Responses: 70,025; Total Annual Hours: 18,500.

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/​regulations/​pra 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].

Interested persons are invited to send comments regarding the burden or any other aspect of these collections of information requirements. However, as noted above, comments on these information collection and recordkeeping requirements must be mailed and/or faxed to the designees referenced below by May 15, 2005:

Centers for Medicare and Medicaid Services, Office of Strategic Operations and Regulatory Affairs, Room C5-13-27, 7500 Security Boulevard, Baltimore, MD 21244-1850; Fax Number: [phone]; Attn: William N. Parham, III, (CMS-10133); and,

OMB Human Resources and Housing Branch, Attention: Christopher Martin (CMS-10133), New Executive Office Building, Room 10235, Fax Number [phone]; Washington, DC 20503.

Dated: March 16, 2005.

John P. Burke, III,

CMS Paperwork Reduction Act Reports Clearance Officer, Office of Strategic Operations and Regulatory Affairs, Regulations Development Group.