Document Headings

                    Document headings vary by document type but may contain                    the following:                  
                -                       the agency or agencies that issued and signed a document                    
                -                       the number of the CFR title and the number of each part                      the document amends, proposes to amend, or is directly                      related to                    
                -                       the agency docket number / agency internal file number                    
                -                       the RIN which identifies each regulatory action listed in                      the Unified Agenda of Federal Regulatory and Deregulatory                      Actions                    

                    See the                                          Document Drafting Handbook                                        for more details.                  

###### Department of Health and Human Services

###### Centers for Medicare & Medicaid Services

          - [Document Identifier: CMS-304 and CMS-304a; and CMS-368 and CMS-R-144]

# AGENCY:

Centers 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) is publishing the following summary of proposed collections for public comment.                           ( print page 21371)                        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.                

                    1.                     *Type of Information Collection Request:*                     Revision of a currently approved collection;                     *Title of Information Collection:*                     Medicaid Drug Rebate Program—Labelers Reconciliation of State Invoice (CMS-304) and Prior Quarter Adjustment Statement (CMS-304a);                     *Use:*                     Section 1927(b)(2) of the Social Security Act establishes manufacturer requirements for paying quarterly rebates to States as part of the Medicaid Drug Rebate Program. Specifically, in order to receive a rebate on drugs dispensed to Medicaid recipients, States are required to submit quarterly utilization data to drug manufacturers that have national rebate agreements with the Federal Government. Form CMS-304 is used by manufacturers for both unit adjustments and disputes in response to the State's invoice for current quarter utilization. The form CMS-304a is required only in those instances where a manufacturer discovers unit adjustments and/or disputes from a previous quarter's State invoice. Both forms are used to reconcile drug rebate payments made by manufacturers with the State invoices of rebates due;                     *Form Numbers:*                     CMS-304 and CMS-304a (OMB#: 0938-0676);                     *Frequency:*                     Quarterly;                     *Affected Public:*                     Private Sector: Business or other for-profits;                     *Number of Respondents:*                     1,011;                     *Total Annual Responses:*                     4,044;                     *Total Annual Hours:*                     183,120. (For policy questions regarding this collection contact Andrea Wellington at 410-786-3490. For all other issues call 410-786-1326.)                

                    2.                     *Type of Information Collection Request:*                     Revision of a currently approved collection;                     *Title of Information Collection:*                     State Medicaid Drug Rebate Forms: CMS-R-144 (Quarterly Report Data) and CMS-368 (Administrative Data);                     *Use:*                     Section 1927(b)(2) of the Social Security Act establishes State requirements for reporting drug utilization data to CMS and to drug manufacturers participating in the Medicaid Drug Rebate Program. Specifically, in order to receive a rebate on drugs dispensed to Medicaid recipients, States are required to submit quarterly utilization data reports to drug manufacturers that have national rebate agreements with the Federal Government. In addition, a copy of these reports must also be submitted to CMS. Form CMS-R-144 is used by the States to submit this utilization information to both manufacturers and CMS. Form CMS-368 is a report of contact for the State to name the individuals involved in the drug rebate program and is required only in those instances where a change to the original data submittal is necessary. The ability to require the reporting of any changes to these data is necessary to the efficient operation of the rebate program;                     *Form Numbers:*                     CMS-R-144 and CMS-368 (OMB#: 0938-0852);                     *Frequency:*                     Quarterly;                     *Affected Public:*                     State, Local or Tribal Governments;                     *Number of Respondents:*                     56;                     *Total Annual Responses:*                     224;                     *Total Annual Hours:*                     12,101. (For policy questions regarding this collection contact Andrea Wellington at 410-786-3490. 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 at                     *http://www.cms.gov/​PaperworkReductionActof1995/​PRAL/​list.asp#TopOfPage*                     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 at 410-786-1326.                

                    In commenting on the proposed information collections please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in one of the following ways by                     *June 14, 2011:*

                    1. Electronically. You may submit your comments electronically to                     *http://www.regulations.gov.*                     Follow the instructions for “Comment or Submission” or “More Search Options” to find the information collection document(s) accepting comments.                

2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850.

Dated: April 8, 2011. 

Michelle Shortt,

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

[FR Doc. 2011-9025 Filed 4-14-11; 8:45 am]

BILLING CODE 4120-01-P