[Federal Register: March 21, 2005 (Volume 70, Number 53)]
[Notices]
[Page 13507-13508]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr21mr05-78]
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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 Paperwork@cms.hhs.gov, 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