Agency Information Collection Activities: Submission for OMB Review; Comment Request, 52568 [E7-18117]

Download as PDF 52568 Federal Register / Vol. 72, No. 178 / Friday, September 14, 2007 / Notices Dated: September 5, 2007. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E7–18116 Filed 9–13–07; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–10236 and CMS– 10079] Agency Information Collection Activities: Submission for OMB Review; Comment Request 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: New collection; Title of Information Collection: Disclosure of Financial Relationships Report (‘‘DFRR’’); Form Number: CMS–10236 (OMB#: 0938–New); Use: Section 1877(f) of the Social Security Act requires that each entity providing covered items or services for which payment may be made shall provide the Secretary with information concerning the entity’s ownership, investment, and compensation arrangements, in such form, manner, and at such times as the Secretary shall specify. DFRR is a new collection instrument that will be used by CMS to obtain information necessary to analyze each hospital’s compliance with section 1877 of the Social Security Act (‘‘the physician self-referral law’’), and implementing regulations (42 Code of Federal Regulations, Subpart J). Based rmajette on PROD1PC64 with NOTICES AGENCY: VerDate Aug<31>2005 15:44 Sep 13, 2007 Jkt 211001 upon public comments and CMS review, a number of changes were made to the DFRR. The most significant change to the DFRR involves the addition of worksheets to capture information concerning indirect ownership. Refer to the ‘‘Summary of Changes to the Disclosure of Financial Relationships Report (DFRR)’’ document to view a list of changes. Frequency: Reporting—Once; Affected Public: Business or other for-profit and not-forprofit institutions; Number of Respondents: 500; Total Annual Responses: 500; Total Annual Hours: 3,000. 2. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Hospital Wage Index Occupational Mix Survey and Supporting Regulations in 42 CFR, section 412.64; Use: Section 304(c) of Public Law 106–554 mandates an occupational mix adjustment to the wage index, requiring the collection of data every 3 years on the occupational mix of employees for each short-term, acute care hospital participating in the Medicare program. The 2007/2008 revised survey will provide for the collection of hospital-specific wages and hours data for a 1-year prospective reporting period (July 1, 2007 through June 30, 2008), additional clarifications to the survey instructions, the elimination of the RN subcategories, some refinements to the definitions for the occupational categories, and the inclusion of additional cost centers that typically provide nursing services. Additional revisions include expanding the current cost center list to include cost center 57—Renal Dialysis. For more details, please refer to the ‘‘Medicare Wage Index Occupational Mix Survey— Summary of Changes’’ document. The 2007/2008 Medicare occupational mix survey will be applied beginning with the FY 2010 wage index. Each of the approximately 3,600 inpatient prospective payment system providers participating in the Medicare program will be required to complete the revised Medicare Wage Index Occupational Mix Survey. The revised survey will be forwarded to hospitals through CMS’s fiscal intermediaries and will be made available on CMS’s Web site. Form Number: CMS–10079 (OMB#: 0938– 0907); Frequency: Reporting: Yearly, biennially and occasionally; Affected Public: Business or other for-profit and not-for-profit institutions; Number of Respondents: 3,600; Total Annual Responses: 3,600; Total Annual Hours: 1,728,000. To obtain copies of the supporting statement and any related forms for the PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 proposed paperwork collections referenced above, access CMS Web site address at https://www.cms.hhs.gov/ 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. Written comments and recommendations for the proposed information collections must be mailed or faxed within 30 days of this notice directly to the OMB desk officer: OMB Human Resources and Housing Branch, Attention: Carolyn Lovett, New Executive Office Building, Room 10235, Washington, DC 20503, Fax Number: (202) 395–6974. Dated: September 6, 2007. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E7–18117 Filed 9–13–07; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D–0336] Guidance for Industry and Food and Drug Administration Staff; Commercially Distributed Analyte Specific Reagents: Frequently Asked Questions; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘Commercially Distributed Analyte Specific Reagents (ASRs): Frequently Asked Questions.’’ FDA is issuing this guidance to clarify the regulations regarding commercially distributed ASRs and the role and responsibilities of ASR manufacturers. The draft of this guidance was issued September 7, 2006. DATES: Submit written or electronic comments on this guidance at any time. General comments on agency guidance documents are welcome at any time. Manufacturers should ensure their Class II or Class III in vitro diagnostic devices, that are currently inappropriately labeled and marketed as ASRs, comply with the law by September 15, 2008. ADDRESSES: Submit written requests for single copies of the guidance document E:\FR\FM\14SEN1.SGM 14SEN1

Agencies

[Federal Register Volume 72, Number 178 (Friday, September 14, 2007)]
[Notices]
[Page 52568]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-18117]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10236 and CMS-10079]


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: New collection; Title of 
Information Collection: Disclosure of Financial Relationships Report 
(``DFRR''); Form Number: CMS-10236 (OMB: 0938-New); Use: 
Section 1877(f) of the Social Security Act requires that each entity 
providing covered items or services for which payment may be made shall 
provide the Secretary with information concerning the entity's 
ownership, investment, and compensation arrangements, in such form, 
manner, and at such times as the Secretary shall specify. DFRR is a new 
collection instrument that will be used by CMS to obtain information 
necessary to analyze each hospital's compliance with section 1877 of 
the Social Security Act (``the physician self-referral law''), and 
implementing regulations (42 Code of Federal Regulations, Subpart J). 
Based upon public comments and CMS review, a number of changes were 
made to the DFRR. The most significant change to the DFRR involves the 
addition of worksheets to capture information concerning indirect 
ownership. Refer to the ``Summary of Changes to the Disclosure of 
Financial Relationships Report (DFRR)'' document to view a list of 
changes. Frequency: Reporting--Once; Affected Public: Business or other 
for-profit and not-for-profit institutions; Number of Respondents: 500; 
Total Annual Responses: 500; Total Annual Hours: 3,000.
    2. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Hospital Wage 
Index Occupational Mix Survey and Supporting Regulations in 42 CFR, 
section 412.64; Use: Section 304(c) of Public Law 106-554 mandates an 
occupational mix adjustment to the wage index, requiring the collection 
of data every 3 years on the occupational mix of employees for each 
short-term, acute care hospital participating in the Medicare program. 
The 2007/2008 revised survey will provide for the collection of 
hospital-specific wages and hours data for a 1-year prospective 
reporting period (July 1, 2007 through June 30, 2008), additional 
clarifications to the survey instructions, the elimination of the RN 
subcategories, some refinements to the definitions for the occupational 
categories, and the inclusion of additional cost centers that typically 
provide nursing services. Additional revisions include expanding the 
current cost center list to include cost center 57--Renal Dialysis. For 
more details, please refer to the ``Medicare Wage Index Occupational 
Mix Survey--Summary of Changes'' document.
    The 2007/2008 Medicare occupational mix survey will be applied 
beginning with the FY 2010 wage index. Each of the approximately 3,600 
inpatient prospective payment system providers participating in the 
Medicare program will be required to complete the revised Medicare Wage 
Index Occupational Mix Survey. The revised survey will be forwarded to 
hospitals through CMS's fiscal intermediaries and will be made 
available on CMS's Web site. Form Number: CMS-10079 (OMB: 
0938-0907); Frequency: Reporting: Yearly, biennially and occasionally; 
Affected Public: Business or other for-profit and not-for-profit 
institutions; Number of Respondents: 3,600; Total Annual Responses: 
3,600; Total Annual Hours: 1,728,000.
    To obtain copies of the supporting statement and any related forms 
for the proposed paperwork collections referenced above, access CMS Web 
site address at https://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.
    Written comments and recommendations for the proposed information 
collections must be mailed or faxed within 30 days of this notice 
directly to the OMB desk officer: OMB Human Resources and Housing 
Branch, Attention: Carolyn Lovett, New Executive Office Building, Room 
10235, Washington, DC 20503, Fax Number: (202) 395-6974.

    Dated: September 6, 2007.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
 [FR Doc. E7-18117 Filed 9-13-07; 8:45 am]
BILLING CODE 4120-01-P
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