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