[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