[Federal Register: May 19, 2004 (Volume 69, Number 97)]
[Notices]
[Page 28894-28895]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19my04-52]
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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 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
[[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