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

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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 Start Printed Page 10976proposing 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​PaperworkReductionActof1995, or e-mail your request, including your address, phone number, OMB number, and CMS document identifier, to, 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.

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Dated: February 23, 2006.

Michelle Shortt,

Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs.

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[FR Doc. 06-1920 Filed 3-2-06; 8:45 am]