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10976 Federal Register / Vol. 71, No.

42 / Friday, March 3, 2006 / Notices

proposing that the expiration date of the mail your request, including your and Budget (OMB) the following
last lot sold must be reported to CMS address, phone number, OMB number, requirements for emergency review. We
once at the end of utilization of the NDC and CMS document identifier, to are requesting an emergency review
or when there are no sales for three Paperwork@cms.hhs.gov, or call the because the collection of this
consecutive quarters. Reports Clearance Office on (410) 786– information is needed before the
On November 21, 2005, we published 1326. expiration of the normal time limits
an interim final rule (70 FR 70478) Written comments and under OMB’s regulations at 5 CFR part
stating that, during the first three years recommendations for the proposed 1320. This is necessary to ensure
of the Part B Drug Competitive information collections must be mailed compliance with an initiative of the
Acquisition Program (CAP), sales and within 30 days of this notice directly to Administration. CMS does not have
price concessions associated with units the OMB desk officer: OMB Human sufficient time to complete the normal
administered to a beneficiary by a Resources and Housing Branch, PRA clearance process. We request this
participating CAP vendor are excluded Attention: Carolyn Lovett, New Paperwork Reduction Act clearance
from the ASP units and price. We Executive Office Building, Room 10235, under an emergency approval process to
propose to collect the number of CAP Washington, DC 20503. meet the statutorily-mandated reporting
units excluded from the ASP Dated: February 23, 2006. requirement under the Medicare
calculation. Frequency: Recordkeeping Michelle Shortt, Prescription Drug, Improvement, and
and Reporting—Quarterly; Affected Modernization Act of 2003 (MMA) and
Director, Regulations Development Group,
Public: Business or other for-profit; Office of Strategic Operations and Regulatory to accommodate the operational
Number of Respondents: 120; Total Affairs. schedule for the bidding process for
Annual Responses: 480; Total Annual [FR Doc. 06–1920 Filed 3–2–06; 8:45 am] prospective and renewing Part D
Hours: 17,760. Sponsors. In order to uphold the MMA
2. Type of Information Collection reporting requirement in conjunction
Request: Extension of a currently with the bid deadline for contract year
approved collection; Title of DEPARTMENT OF HEALTH AND 2007, key preceding events must occur.
Information Collection: Retiree Drug HUMAN SERVICES If these events do not occur, prospective
Subsidy (RDS) Payment Request and and renewing Part D Sponsors will be
Instructions; Form Number: CMS–10170 Centers for Medicare and Medicaid unable to adjust their bids to reflect
(OMB #0938–0977); Use: Under section Services compliance with these reporting
1860D–22 of the Social Security Act requirements. Inaccuracies in Part D
(Act), added by the Medicare [Document Identifier: CMS–10185]
bids will cause many adverse
Prescription Drug, Improvement and Emergency Clearance: Public consequences to Part D Sponsors, their
Modernization Act of 2003, plan Information Collection Requirements enrolled Medicare beneficiaries, and
sponsors (employers, unions) who offer Submitted to the Office of Management CMS.
prescription drug coverage to their and Budget (OMB) 1. Type of Information Collection
qualified covered retirees are eligible to Request: New Collection; Title of
receive a 28 percent tax-free subsidy for AGENCY: Centers for Medicare and Information Collection: Medicare Part D
allowable drug costs. To receive the Medicaid Services. Reporting Requirements; Use: Data
subsidy, plan sponsors must submit In compliance with the requirement collected via Medicare Part D Reporting
required prescription cost data. CMS of section 3506(c)(2)(A) of the Requirements will be an integral
has contracted with an outside vendor Paperwork Reduction Act of 1995, the resource for oversight, monitoring,
(ViPS) to assist in the administration of Centers for Medicare and Medicaid compliance and auditing activities
the retiree drug subsidy (RDS) program; Services (CMS), Department of Health necessary to ensure quality provision of
this effort is called the RDS Center. Plan and Human Services, is publishing the the Medicare Prescription Drug Benefit
sponsors will request subsidy payments following summary of proposed to beneficiaries. Data will be validated,
on-line by logging on to the RDS secure collections for public comment. analyzed, and utilized for trend
Web site. Cost data required for each Interested persons are invited to send reporting by CMS. If outliers or other
payment request may be entered into comments regarding this burden data anomalies are detected, CMS will
the RDS secure Web site, or uploaded to estimate or any other aspect of this work in collaboration with other CMS
the RDS Center mainframe. Once the collection of information, including any divisions for follow-up and resolution.
plan sponsor submits the payment of the following subjects: (1) The Form Number: CMS–10185 (OMB
request, the RDS Center will process the necessity and utility of the proposed #0938–New); Frequency: Reporting:
request to determine if payment is due information collection for the proper Quarterly and Semi-annually; Affected
and the amount of the payment; performance of the agency’s functions; Public: Business or other for-profit;
Frequency: Recordkeeping and (2) the accuracy of the estimated Number of Respondents: 3,203; Total
Reporting—Monthly, Quarterly and burden; (3) ways to enhance the quality, Annual Responses: 12,812; Total
Annually; Affected Public: Not-for-profit utility, and clarity of the information to Annual Hours: 102,496.
institutions, Business or other for-profit, be collected; and (4) the use of CMS is requesting OMB review and
Federal Government, State, Local, or automated collection techniques or approval of these collections by April
Tribal Government; Number of other forms of information technology to 14, 2006, with a 180-day approval
Respondents: 6,000; Total Annual minimize the information collection period. Written comments and
Responses: 6,000; Total Annual Hours: burden. recommendations will be considered
222,000. We are, however, requesting an from the public if received by the
To obtain copies of the supporting emergency review of the information individuals designated below by April
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statement and any related forms for the collection referenced below. In 3, 2006.
proposed paperwork collections compliance with the requirement of To obtain copies of the supporting
referenced above, access CMS Web site section 3506(c)(2)(A) of the Paperwork statement and any related forms for the
address at http://www.cms.hhs.gov/ Reduction Act of 1995, we have proposed paperwork collections
PaperworkReductionActof1995, or e- submitted to the Office of Management referenced above, access CMS’ Web site

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Federal Register / Vol. 71, No. 42 / Friday, March 3, 2006 / Notices 10977

address at http://www.cms.hhs.gov/ DEPARTMENT OF HEALTH AND has submitted the following proposed
PaperworkReductionActof1995/ or e- HUMAN SERVICES collection of information to OMB for
mail your request, including your review and clearance.
address, phone number, OMB number, Food and Drug Administration
Filing Objections and Requests for a
and CMS document identifier, to [Docket No. 2005N–0427] Hearing on a Regulation or Order
Paperwork@cms.hhs.gov, or call the —(OMB Control Number 0910–0184)—
Reports Clearance Office on (410) 786– Agency Information Collection Extension
1326. Activities; Submission for Office of
Management and Budget Review; Under part 12 (21 CFR part 12),
Interested persons are invited to send § 12.22, issued under section 701(e)(2)
Comment Request; Filing Objections
comments regarding the burden or any and Requests for a Hearing on a of the Federal Food, Drug, and Cosmetic
other aspect of these collections of Regulation or Order Act (21 U.S.C. 371(e)(2)), sets forth the
information requirements. However, as instructions for filing objections and
noted above, comments on these AGENCY: Food and Drug Administration, requests for a hearing on a regulation or
information collection and HHS. order under § 12.20(d). Objections and
recordkeeping requirements must be ACTION: Notice. requests must be submitted within the
mailed to the designees referenced SUMMARY: The Food and Drug time specified in § 12.20(e). Each
below by April 14, 2006: Administration (FDA) is announcing objection for which a hearing has been
that a proposed collection of requested must be separately numbered
Centers for Medicare and Medicaid
information has been submitted to the and specify the provision of the
Services, Office of Strategic regulation or the proposed order. In
Operations and Regulatory Affairs, Office of Management and Budget
(OMB) for review and clearance under addition, each objection must include a
Room C4–26–05, 7500 Security detailed description and analysis of the
Boulevard, Baltimore, MD 21244– the Paperwork Reduction Act of 1995.
factual information and any other
1850, Attn: Bonnie L Harkless, DATES: Fax written comments on the
document, with some exceptions,
collection of information by April 3,
and, supporting the objection. Failure to
include this information constitutes a
OMB Human Resources and Housing ADDRESSES: OMB is still experiencing waiver of the right to a hearing on that
Branch, Attention: Carolyn Lovett, significant delays in the regular mail, objection. FDA uses the description and
New Executive Office Building, Room including first class and express mail, analysis to determine whether a hearing
10235, Washington, DC 20503. and messenger deliveries are not being request is justified. The description and
Dated: February 23, 2006.
accepted. To ensure that comments on analysis may be used only for the
the information collection are received, purpose of determining whether a
Michelle Shortt, OMB recommends that written hearing has been justified under § 12.24
Director, Regulations Development Group, comments be faxed to the Office of and do not limit the evidence that may
Office of Strategic Operations and Regulatory Information and Regulatory Affairs, be presented if a hearing is granted.
Affairs. OMB, Attn: Fumie Yokota, Desk Officer Respondents to this information
[FR Doc. 06–1921 Filed 3–2–06; 8:45 am] for FDA, FAX: 202–395–6974. collection are those parties that may be
BILLING CODE 4120–01–P FOR FURTHER INFORMATION CONTACT: adversely affected by an order or
Jonna Capezzuto, Office of Management regulation.
Programs (HFA–250), Food and Drug In the Federal Register of November
Administration, 5600 Fishers Lane, 16, 2005 (70 FR 69577), FDA published
Rockville, MD 20857, 301–827–4659. a 60-day notice requesting public
SUPPLEMENTARY INFORMATION: In comment on the information collection
compliance with 44 U.S.C. 3507, FDA provisions. No comments were received.


No. of Annual Frequency Total Annual Hours per
21 CFR Section Total Hours
Respondents per Response Responses Response

12.22 10 1 10 20 200
1There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: February 24, 2006. DEPARTMENT OF HEALTH AND This notice announces a forthcoming
Jeffrey Shuren, HUMAN SERVICES meeting of a public advisory committee
Assistant Commissioner for Policy. of the Food and Drug Administration
[FR Doc. E6–3020 Filed 3–2–06; 8:45 am] Food and Drug Administration (FDA). The meeting will be open to the
Peripheral and Central Nervous
Name of Committee: Peripheral and
System Drugs Advisory Committee;
Central Nervous System Drugs Advisory
Notice of Meeting
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AGENCY: Food and Drug Administration, General Function of the Committee:

HHS. To provide advice and
recommendations to the agency on
ACTION: Notice.
FDA’s regulatory issues.

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