Agency Information Collection Activities: Proposed Collection; Comment Request, 76034 [E8-29543]

Download as PDF 76034 Federal Register / Vol. 73, No. 241 / Monday, December 15, 2008 / Notices the address below, no later than 5 p.m. on January 14, 2009. OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, New Executive Office Building, Room 10235, Washington, DC 20503, Fax Number: (202) 395– 6974. Date: December 5, 2008. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E8–29542 Filed 12–12–08; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–10110, CMS–R– 250 and CMS–668B] pwalker on PROD1PC71 with NOTICES 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. 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: 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 VerDate Aug<31>2005 20:00 Dec 12, 2008 Jkt 217001 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. 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 Governments; Number of Respondents: 15,039; Total Annual Responses: 3,834,945; Total Annual Hours: 2,704,764. 3. 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. 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.hhs.gov/ PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 PaperworkReductionActof1995, or Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov, or call the Reports Clearance Office on (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 February 13, 2009: 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 ll, Room C4–26–05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. Dated: December 5, 2008. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E8–29543 Filed 12–12–08; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0602] Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study of the Impact of Coupons Embedded in Direct-to-Consumer Prescription Drug Print Advertisements on Consumer Perceptions of Product Risks and Benefits AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for E:\FR\FM\15DEN1.SGM 15DEN1

Agencies

[Federal Register Volume 73, Number 241 (Monday, December 15, 2008)]
[Notices]
[Page 76034]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-29543]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

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


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. 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: 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.
    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 Governments; Number of Respondents: 15,039; Total Annual 
Responses: 3,834,945; Total Annual Hours: 2,704,764.
    3. 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.
    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.hhs.gov/PaperworkReductionActof1995, 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 on (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 February 13, 2009:
    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: December 5, 2008.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
 [FR Doc. E8-29543 Filed 12-12-08; 8:45 am]
BILLING CODE 4120-01-P