[Federal Register Volume 70, Number 203 (Friday, October 21, 2005)]
[Notices]
[Pages 61292-61293]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-21101]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare and Medicaid Services

[Document Identifier: CMS-10133]


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

AGENCY: Center for Medicare and Medicaid Services.

    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), 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 the use of normal clearance procedures 
will jeopardize program implementation by a statutorily mandated 
deadline and could contribute to impaired beneficiary access to Part B 
drugs.
    Section 303(d) of the MMA provides an alternative payment 
methodology for Part B drugs that are not paid on a cost or prospective 
payment basis. In particular, Section 303(d) of the MMA amends Title 
XVIII of the Social Security Act (the Act) by adding a new section 
1847B, which establishes a competitive acquisition program for the 
acquisition of and payment for Part B covered drugs and biologicals 
furnished on or after January 1, 2006. Beginning in 2006, physicians 
will have a choice between acquiring and billing for Part B covered 
drugs under the Average Sales Price (ASP) drug payment methodology or 
electing to receive these drugs from vendors/suppliers selected for the 
Competitive Acquisition Program (CAP), through a competitive bidding 
process. The provisions for this new payment system are described in 
the proposed rule (42 CFR Part 414 Subpart K) published March 4, 2005 
(70 FR 10746), the interim final rule published July 6, 2005 (70 FR 
39022), and a final rule that is expected to be published in November 
2005.
    1. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Competitive 
Acquisition Program 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 
enrollment; Affected Public: Business or other for-profit; Number of 
Respondents: 12; Total Annual Responses: 12; Total Annual Hours: 480.
    CMS is requesting OMB review and approval of this collection by 
November 1, 2005, with a 180-day approval period. Written comments and 
recommendations will be considered from the public if received by the 
individuals designated below by October 28, 2005.
    To obtain copies of the supporting statement and any related forms 
for the proposed paperwork collections referenced above, access the 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 [email protected], or call the Reports 
Clearance Office on (410) 786-1326.
    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 to the 
designees referenced below by October 28, 2005:

[[Page 61293]]

    Centers for Medicare and Medicaid Services, Office of Strategic 
Operations and Regulatory Affairs, Room C4-26-05, 7500 Security 
Boulevard, Baltimore, MD 21244-1850, Fax Number: (410) 786-5267, Attn: 
William N. Parham, III and, OMB Human Resources and Housing Branch, 
Attention: CMS Desk Officer, New Executive Office Building, Room 10235, 
Washington, DC 20503.

    Dated: October 17, 2005.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
[FR Doc. 05-21101 Filed 10-20-05; 8:45 am]
BILLING CODE 4120-01-P