[Federal Register Volume 71, Number 42 (Friday, March 3, 2006)]
[Notices]
[Pages 10975-10976]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-1920]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10110 and CMS-10170]


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

AGENCY: Centers 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 function; (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.
    1. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Manufacturer 
Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs 
and Biologicals And Supporting Regulations in 42 CFR 414.804; Form No.: 
CMS-10110 (OMB 0938-0921); Use: In accordance with section 
1847A of the Social Security Act (the Act), Medicare Part B covered 
drugs and biologicals not paid on a cost or prospective payment basis 
are paid based on the average sales price of the drug or biological, 
beginning in CY 2005. The ASP data reporting requirements are specified 
in section 1927 of the Act. The reported ASP data are used to establish 
the Medicare payment amounts. CMS will utilize the ASP data to 
determine the drug payment amounts for CY 2005 and beyond. In the 
interim final rule which published April 6, 2004 (69 FR 17935), the ASP 
reporting format, (Addendum A), was specified. In addition, we stated 
that, as we gain more experience with the ASP methodology, we may seek 
to modify the reporting requirements (data elements and format for 
submission) in the future. Based on our experience during the initial 
six reporting periods, we have found it necessary for carrying out 
section 1847A of the Act, to expand the ASP data collected from 
manufacturers.
    We are proposing that, in addition to the original data elements 
(manufacturer name, National Drug Code (NDC), manufacturer's ASP, and 
number of units), the following data elements must be submitted 
quarterly by manufacturers:
     Name of drug or biological;
     Strength of the product;
     Volume per item;
     Number of items per NDC;
     Wholesale acquisition costs (applies to NDCs assigned to 
single source drug and biological billing codes and NDCs during the 
initial period under section1847A(c)(4) of the Act);
     Expiration date of the last lot sold;
     Date NDC was first available for sale; and
     Date of first sale.
    We are also proposing that manufacturers would no longer report ASP 
data for an NDC beginning the reporting period after the expiration 
date of the last lot sold. For NDCs first made available for sale or 
sold on or after October 1, 2005, we are also proposing to collect the 
date the NDC was first available for sale and the date of first sale. 
We are also proposing that manufacturers be required to submit these 
dates to us once with the first or second, if applicable, data 
submission for new NDCs. In addition, we are

[[Page 10976]]

proposing that the expiration date of the last lot sold must be 
reported to CMS once at the end of utilization of the NDC or when there 
are no sales for three consecutive quarters.
    On November 21, 2005, we published an interim final rule (70 FR 
70478) stating that, during the first three years of the Part B Drug 
Competitive Acquisition Program (CAP), sales and price concessions 
associated with units administered to a beneficiary by a participating 
CAP vendor are excluded from the ASP units and price. We propose to 
collect the number of CAP units excluded from the ASP calculation. 
Frequency: Recordkeeping and Reporting--Quarterly; Affected Public: 
Business or other for-profit; Number of Respondents: 120; Total Annual 
Responses: 480; Total Annual Hours: 17,760.
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Retiree Drug 
Subsidy (RDS) Payment Request and Instructions; Form Number: CMS-10170 
(OMB 0938-0977); Use: Under section 1860D-22 of the Social 
Security Act (Act), added by the Medicare Prescription Drug, 
Improvement and Modernization Act of 2003, plan sponsors (employers, 
unions) who offer prescription drug coverage to their qualified covered 
retirees are eligible to receive a 28 percent tax-free subsidy for 
allowable drug costs. To receive the subsidy, plan sponsors must submit 
required prescription cost data. CMS has contracted with an outside 
vendor (ViPS) to assist in the administration of the retiree drug 
subsidy (RDS) program; this effort is called the RDS Center. Plan 
sponsors will request subsidy payments on-line by logging on to the RDS 
secure Web site. Cost data required for each payment request may be 
entered into the RDS secure Web site, or uploaded to the RDS Center 
mainframe. Once the plan sponsor submits the payment request, the RDS 
Center will process the request to determine if payment is due and the 
amount of the payment; Frequency: Recordkeeping and Reporting--Monthly, 
Quarterly and Annually; Affected Public: Not-for-profit institutions, 
Business or other for-profit, Federal Government, State, Local, or 
Tribal Government; Number of Respondents: 6,000; Total Annual 
Responses: 6,000; Total Annual Hours: 222,000.
    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/PaperworkReductionActof1995, 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.
    Written comments and recommendations for the proposed information 
collections must be mailed within 30 days of this notice directly to 
the OMB desk officer: OMB Human Resources and Housing Branch, 
Attention: Carolyn Lovett, New Executive Office Building, Room 10235, 
Washington, DC 20503.

    Dated: February 23, 2006.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
[FR Doc. 06-1920 Filed 3-2-06; 8:45 am]
BILLING CODE 4120-01-P