E9-4791. 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# 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# 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# 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-668B (OMB# 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 [e-mail], or call the Reports Clearance Office on [phone].

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: [phone], E-mail: [e-mail].

Dated: February 27, 2009.

Michelle Shortt,

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