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

AGENCY:

Centers for Medicare & Medicaid Services, HHS.

In compliance with the requirement of section 3506I(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 approval collection; Title of Information Collection: Medicaid Drug Program Monthly and Quarterly Drug Reporting Format; Use: In order for payment to be made under Medicaid, the drug labeler must complete and sign a drug rebate agreement and fill in the information on the related documents. The Patient Protection and Affordable Care Act of 2010 added two new data elements to potentially be reported by manufacturers. In addition, the Food and Drug Administration has informed us that “DESI” is now obsolete; therefore, we are replacing it with a more appropriate “rebate eligibility code” that will more accurately describe how a product is eligible for coverage under the drug rebate program. Form Number: CMS-367 (OMB#: 0938-0578); Frequency: Monthly and Quarterly; Affected Public: Private Sector: Business or other for-profits; Number of Respondents: 580; Total Annual Responses: 9,280; Total Annual Hours: 137,344 (For policy questions regarding this collection contact Gail Sexton at 410-786-4583. For all other issues call 410-786-1326.)

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 Paperwork@cms.hhs.gov, or call the Reports Clearance Office on (410) 786-1326.

To be assured consideration, comments and recommendations for the proposed information collections must be received by the OMB desk officer at the address below, no later than 5 p.m. on November 1, 2010. OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395-6974, E-mail: OIRA_submission@omb.eop.gov.