07-376. 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 implementation of Public Law 109-171 Deficit Reduction Act (DRA) of 2005. CMS does not have sufficient time to complete the normal PRA clearance process.

1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Medicaid Drug Program Monthly Quarterly Drug Reporting Format. Use: Section 1927 of the Social Security Act requires drug manufacturers to enter into and have in effect a rebate agreement with the Federal Government for States to receive funding for drugs dispensed to Medicaid beneficiaries. The Deficit Reduction Act (DRA) of 2005 modified Section 1927 to require additional reporting requirements beyond the quarterly data currently collected; therefore, we are seeking approval of a revision to this collection to reflect changes implemented by the DRA. Such changes include the addition of nominal pricing as another quarterly data element. CMS form 367 identifies the data fields that manufacturers must submit to CMS on both a monthly and quarterly basis. Form Number: CMS-367 (OMB#: 0938-0578); Frequency: Reporting: Monthly and quarterly; Affected Public: Business or other for-profit; Number of Respondents: 540; Total Annual Responses: 8,640; Total Annual Hours: 51,840.

CMS is requesting OMB review and approval of this collection by March 5, 2007, with a 180-day approval period. Written comments and recommendations will be considered from the public if received by the individuals designated below by March 3, 2007.

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 [e-mail], or call the Reports Clearance Office on [phone].

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 received by the designees referenced below by March 3, 2007:

Centers for Medicare & Medicaid Services, Office of Strategic Operations and Regulatory Affairs, Room C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850, Attn: Melissa Musotto (CMS-367)

  and,

OMB Human Resources and Housing Branch, Attention: Katherine Astrich, New Executive Office Building, Room 10235, Washington, DC 20503.

Dated: January 23, 2007.

Michelle Shortt,

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