[Federal Register Volume 74, Number 43 (Friday, March 6, 2009)]
[Notices]
[Pages 9819-9820]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-4791]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10110, CMS-R-250, CMS-R-144/CMS-368 and CMS-
668B]


Agency Information Collection Activities: Submission for OMB 
Review; 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), 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 function; (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: Manufacturer 
Submission of Average Sales Price (ASP) Data for Medicare Part B Drugs 
and Biologicals; Use: Section 1847A of the Social Security Act requires 
that the Medicare Part B payment amounts for covered drugs and 
biologicals not paid on a cost or prospective payment basis be based 
upon manufacturers' average sales price data submitted to CMS. CMS will 
utilize the ASP data to determine the Medicare Part B drug payment 
amounts. Form Number: CMS-10110 (OMB<greek-i> 0938-0921); Frequency: 
Quarterly; Affected Public: Business or other for-profits; Number of 
Respondents: 180; Total Annual Responses: 720; Total Annual Hours: 
28,800. (For policy questions regarding this collection contact 
Catherine Jansto at 410-786-7762. For all other issues call 410-786-
1326.)
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: MPAF Data and 
Supporting Regulations in 42 CFR 413.337, 413.343, 424.32 and 483.20; 
Use: Resident assessment information that Skilled Nursing Facilities 
(SNFs) are required to submit is described under section 42 CFR 413.343 
and 483.20. The manner necessary to administer the payment rate 
methodology is described under section 42 CFR 413.337. An assessment 
form comprised of a subset of resident assessment information has been 
developed for use by SNFs to satisfy Medicare payment requirements, in 
lieu of a full Minimum Data Set. The associated burden is the time the 
SNF staff is required to complete the Medicare PPS Assessment Form 
(MPAF), SNF staff time to encode, and SNF staff time spent in 
transmitting the data. Form Number: CMS-R-250 (OMB<greek-i> 0938-0739); 
Frequency: Occasionally; Affected Public: Business or other for-profits 
and not-for-profit institutions, State, Local, or Tribal Governments, 
and Federal Government; Number of Respondents: 15,039; Total Annual 
Responses: 3,834,945; Total Annual Hours: 2,704,764. (For policy 
questions regarding this collection contact Julie Stankivic at 410-786-
5725. For all other issues call 410-786-1326.)
    3. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: State Medicaid 
Drug Rebate; Use: Section 1927 of the Social Security Act requires each 
State Medicaid agency to report quarterly prescription drug utilization 
information to drug manufacturers and to CMS. As part of this 
information, the State Medicaid agencies are required to report the 
total Medicaid rebate amount they claim they are owed by each drug 
manufacturer for each covered prescription drug product each quarter. 
Form Number: CMS-R-144 and CMS-368 (OMB<greek-i> 0938-0582); Frequency: 
Quarterly; Affected Public: State, Local or Tribal Governments; Number 
of Respondents: 51; Total Annual Responses: 204; Total Annual Hours: 
9,389. (For policy questions regarding this collection contact Dusty 
Kerhart at 410-786-3273. For all other issues call 410-786-1326.)
    4. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Post Clinical 
Laboratory Survey Questionnaire and Supporting Regulations in 42 CFR 
493.1771, 493.1773, and 493.1777; Use: This form is used by the State 
agency to determine a laboratory's compliance with the Clinical 
Laboratory Improvement Amendments of 1988 (CLIA). This information is 
needed for a laboratory's CLIA certification and recertification. Form 
Number: CMS-

[[Page 9820]]

668B (OMB<greek-i> 0938-0653); Frequency: Biennially; Affected Public: 
Business or other for-profits and not-for-profit institutions. State, 
Local, or Tribal Government, Federal Government; Number of Respondents: 
21,000; Total Annual Responses: 10,500; Total Annual Hours: 2,625. (For 
policy questions regarding this collection contact Kathleen Todd at 
410-786-3385. 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 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 <a href="/cdn-cgi/l/email-protection#356554455047425a475e755658461b5d5d461b525a43"><span class="__cf_email__" data-cfemail="eebe8f9e8b9c99819c85ae8d839dc086869dc0898198">[email protected]</span></a>, or call the 
Reports Clearance Office on (410) 786-1326.
    To be assured consideration, comments and recommendations for the 
proposed information collections must be received by the OMB desk 
officer at the address below, no later than 5 p.m. on April 6, 2009.
    OMB, Office of Information and Regulatory Affairs, Attention: CMS 
Desk Officer, Fax Number: (202) 395-6974, E-mail: <a href="/cdn-cgi/l/email-protection#8dc2c4dfccd2fef8efe0e4fefee4e2e3cde2e0efa3e8e2fda3eae2fb"><span class="__cf_email__" data-cfemail="450a0c17041a363027282c36362c2a2b052a28276b202a356b222a33">[email protected]</span></a>.

    Dated: February 27, 2009.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
[FR Doc. E9-4791 Filed 3-5-09; 8:45 am]
BILLING CODE 4120-01-P


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