[Federal Register Volume 69, Number 97 (Wednesday, May 19, 2004)]
[Notices]
[Pages 28894-28895]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-11334]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10113]


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

AGENCY: Center 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), 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 provisions of 
Section 641 of the Medicare Prescription Drug, Improvement, and 
Modernization Act of 2003 (MMA). We cannot reasonably comply with the 
normal clearance procedures because of an unanticipated event and 
possible public harm.
    Section 641 of the MMA provides for the implementation of a 
demonstration under which Medicare would pay under Part B for drugs and 
biologicals that would not otherwise be covered until Part D is 
implemented in 2006. Drugs covered under this demonstration must be 
replacements for existing covered Medicare drugs and biologicals that 
are provided incident to a physicians service or are replacements for 
oral cancer drugs that are otherwise covered under Medicare Part B. 
Cost sharing under the demonstration is to be in the same manner as 
Medicare Part D. The statute also required that the demonstration begin 
90 days after passage of the legislation, which was March 8, 2004. Due 
to the complexities of implementing this demonstration, we were unable 
to meet that deadline. However, because of the importance of this 
demonstration to beneficiaries with serious illnesses and the already 
delayed time frame, it is urgent that there not be further delay.
    CMS is requesting OMB review and approval of this collection by May 
28, 2004, with a 180-day approval period. Written comments and 
recommendation will be accepted from the public if received by the 
individuals designated below by May 25, 2004.
    Type of Information Collection Request: New collection; Title of 
Information Collection: Application for Participation in Medicare 
Replacement Drug Demonstration; Use: Section 641 of the MMA mandated a 
demonstration that would pay for drugs/biologicals prescribed as 
replacements for existing covered Medicare drugs. A report to Congress 
evaluating the impact of this demonstration was also mandated. In order 
to enroll in this demonstration, a beneficiary will be required to 
submit the application forms. Beneficiaries who wish to be considered 
for a low income subsidy must also provide the information on the 
``Application for Financial Assistance''; Form Number: CMS-10113 
(OMB: 0938-NEW); Frequency: Other: Other: once per 
beneficiary; Affected Public: Individuals or Households; Number of 
Respondents: 50,000; Total Annual Responses: 50,000; Total Annual 
Hours: 20,417.
    We have submitted a copy of this notice to OMB for its review of 
these information collections.
    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.gov/regs/prdact95.htm, 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

[[Page 28895]]

mailed and/or faxed to the designees referenced below by May 25, 2004: 
Centers for Medicare & Medicaid Services, Office of Strategic 
Operations and Regulatory Affairs, Division of Regulations Development 
and Issuances, Attention: Dawn Willinghan, CMS-10113, Room C5-14-03, 
7500 Security Boulevard, Baltimore, Maryland 21244-1850; and, Office of 
Information and Regulatory Affairs, Office of Management and Budget, 
Room 10235, New Executive Office Building, Washington, DC 20503, Attn.: 
Brenda Aguilar, Desk Officer, Fax  202-395-6974.

    Dated: May 7, 2004.
John P. Burke, III,
Reports Clearance Officer, Office of Strategic Operations and Strategic 
Affairs, Division of Regulations Development and Issuances.
[FR Doc. 04-11334 Filed 5-18-04; 8:45 am]
BILLING CODE 4120-03-P