[Federal Register Volume 76, Number 73 (Friday, April 15, 2011)]
[Notices]
[Pages 21370-21371]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-9025]


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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 Information Collection Activities: Proposed Collection; 
Comment Request

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.

[[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 
[email protected], 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