06-6191. 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. If these events do not occur according to the statutorily mandated timeline, other statutory requirements will not be able to be met. Section 6001(c) of the Deficit Reduction Act of 2005 (DRA) requires CMS and the Office of Inspector General to analyze and, if appropriate, redefine the Average Manufacturer Price (AMP). We have determined that this information collection is needed because we do not currently collect the necessary data needed to perform the AMP data analysis as mandated by the DRA.

1. Type of Information Collection Request: New collection; Title of Information Collection: Voluntary Sample Average Manufacturer Price (AMP) Collection; Use: Section 1927 of the Social Security Act requires each participating drug manufacturer to report quarterly product and pricing information to CMS. The DRA modified parts of Section 1927 to require that AMP be analyzed and redefined; Form Number: CMS-10205 (OMB#: 0938-NEW); Frequency: Reporting—As needed; Affected Public: Business or other for-profit; Number of Respondents: 550; Total Annual Responses: 550; Total Annual Hours: 11,000.

CMS is requesting OMB review and approval of this collection by July 31, 2006, with a 180-day approval period. Written comments and recommendation will be considered from the public if received by the individuals designated below by July 29, 2006.

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/​regulations/​pra 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 mailed and/or faxed to the designees referenced below by July 29, 2006:

CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development—A, Attn: Melissa Musotto (CMS-10205), Room C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850

  and,

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

Dated: July 10, 2006.

Michelle Shortt,

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