[Federal Register Volume 70, Number 53 (Monday, March 21, 2005)]
[Notices]
[Pages 13507-13508]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-5563]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & 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 & 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 [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 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: (410) 786-0262; 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 (202) 395-6974; Washington, DC 20503.


[[Page 13508]]


    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.
[FR Doc. 05-5563 Filed 3-18-05; 8:45 am]
BILLING CODE 4120-03-P