Agency Information Collection Activities: Submission for OMB Review; Comment Request, 55218-55219 [E7-19247]
Download as PDF
<![CDATA[
55218
Federal Register / Vol. 72, No. 188 / Friday, September 28, 2007 / Notices
Background and Brief Description
Section 306 of the Public Health
Service (PHS) Act (42 U.S.C. 242k), as
amended, authorizes that the Secretary
of Health and Human Services (DHHS),
acting through NCHS, shall collect
statistics on the extent and nature of
illness and disability of the population
of the United States.
The National Survey of Residential
Care Facilities (NSRCF) is a new
collection. It is designed to complement
data collected by other federal surveys
and to fill a significant data gap about
a major portion of the long-term care
population. Data from the NSRCF will
provide a database on residential care
facilities that researchers and
policymakers can use to address a wide
array of research and policy questions.
The survey will utilize a computerassisted personal interviewing (CAPI)
system to collect information about
facility and resident characteristics.
This computerized system speeds the
flow of data making it possible to
release information on a more timely
interviewed on an annualized basis.
Residents themselves will not be
interviewed. For the national survey,
approximately 2,250 facilities will be
surveyed for an annual average of 750.
Information on 5 residents each will be
collected from an annual average of 750
facility staff. Users of NSRCF data
include, but are not limited to the CDC;
the Congressional Research Office; the
Bureau of Health Professions, Health
Resources and Services Administration;
the Office of the Assistant Secretary for
Planning and Evaluation (ASPE); the
Agency for Healthcare Research and
Quality; the American Association of
Homes and Services for the Aging; the
National Hospice and Palliative Care
Organization; American Health Care
Association, Centers for Medicare and
Medicaid Services (CMS), Bureau of the
Census; and AARP. Other users of these
data include universities, contract
research organizations, many in the
private sector, foundations, and a
variety of users in the print media.
There is no cost to respondents other
than their time to participate.
basis and makes it easier for
respondents to participate in the survey.
A stratified random sample of
residential care facilities across four
strata (small, medium, large and extra
large) will be selected to participate in
the NSRCF. Within each facility a
random sample of residents will be
selected. To be eligible a facility must
have four or more beds, be licensed,
certified, or registered and provide or
arrange for 24 hour supervision and
personal care services for residents.
The facility questionnaire will collect
data about facility characteristics (size,
age, types of rooms), services offered,
characteristics of the resident
population, facility policies and
services, costs of services, and
background of the administrator. The
Resident Questionnaire collects
information on resident demographics,
current living arrangements within the
facility, involvement in activities, use of
services, charges for care, health status,
and cognitive and physical functioning.
In the pretest, 25 facility
administrators, and 25 facility staff
serving as respondents will be
ESTIMATED ANNUALIZED BURDEN HOURS
Facility
Facility
Facility
Facility
Number of
responses per
respondent
Number of
respondents
Type of respondent
Average
burden per
response
(in hours)
Total burden
hours
Administrator (pretest) .........................................................................
Staff (pretest) .......................................................................................
Administrator .......................................................................................
Staff .....................................................................................................
25
25
750
750
1
5
1
5
1
30/60
1
30/60
25
63
750
1,875
Total ..........................................................................................................
........................
........................
........................
2,713
Dated: September 24, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Office of
the Chief Science Officer, Centers for Disease
Control and Prevention.
[FR Doc. E7–19200 Filed 9–27–07; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS-R–312]
jlentini on PROD1PC65 with NOTICES
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
AGENCY:
VerDate Aug<31>2005
17:12 Sep 27, 2007
Jkt 211001
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: Extension of a currently
approved collection; Title of
Information Collection: Conflict of
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
Interest and Ownership and Control
Information; Use: The Conflict of
Interest and Ownership and Control
Information Statement (COI Statement)
is sent to all Medicare Fiscal
Intermediaries (FIs) and Carriers to
collect full and complete information on
any entity’s or individual’s ownership
interest (defined as a 5 per centum or
more) in an organization that may
present a potential conflict of interest in
their role as a Medicare FI or Carrier.
The information gathered in the
survey is used to ensure that all
potential, apparent and actual conflicts
of interest involving Medicare
contractors are appropriately mitigated
and that employees of the contractors,
including officers, directors, trustees
and members of their immediate
families, do not utilize their positions
with the contractor for their own private
business interest to the detriment of the
Medicare program. Information is also
requested on potential organizational
E:\FR\FM\28SEN1.SGM
28SEN1
Federal Register / Vol. 72, No. 188 / Friday, September 28, 2007 / Notices
conflicts of interest involving Medicare
contractors’ ownership of other entities
in the health care industry. If a response
has indicated that a potential conflict of
interest exists, the contractor is
contacted and asked to address how the
conflict can be avoided or mitigated.
Form Number: CMS–R–312 (OMB#:
0938–0795); Frequency: Reporting—
Annually; Affected Public: Private
Sector—Business or other for-profit and
Not-for-profit institutions; Number of
Respondents: 37; Total Annual
Responses: 37; Total Annual Hours:
11,100.
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 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 21, 2007.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E7–19247 Filed 9–27–07; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–2267–N]
Medicare, Medicaid, and CLIA
Programs; Clinical Laboratory
Improvement Amendments of 1988
Exemption of Laboratories Licensed
by the State of Washington
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
jlentini on PROD1PC65 with NOTICES
AGENCY:
SUMMARY: This notice announces that
laboratories located in and licensed by
the State of Washington that possess a
valid license under the Medical Test
Site Licensure Law, Chapter 70.42 of the
Revised Code of Washington, are
VerDate Aug<31>2005
17:12 Sep 27, 2007
Jkt 211001
exempt from the requirements of the
Clinical Laboratory Improvement
Amendments of 1988 until September
28, 2013.
EFFECTIVE DATES: The exemption granted
by the notice is effective until
September 28, 2013.
FOR FURTHER INFORMATION CONTACT:
Sandra Farragut (410)786–3531.
SUPPLEMENTARY INFORMATION:
I. Background
Section 353 of the Public Health
Service Act (PHSA), as amended by the
Clinical Laboratory Improvement
Amendments of 1988 (CLIA) (Pub. L.
100–578) enacted on October 31, 1988,
generally provides that no laboratory
may perform tests on human specimens
for the diagnosis, prevention or
treatment of any disease or impairment
of, or assessment of the health of human
beings unless it has a certificate to
perform that category of tests issued by
the Secretary of the Department of
Health and Human Services (HHS).
Under section 1861(s) of the Social
Security Act (the Act), the Medicare
program will only pay for laboratory
services if the laboratory has a CLIA
certificate. Section 1902(a)(9)(C) of the
Act requires that State Medicaid plans
pay only for laboratory services
furnished by CLIA-certified laboratories.
Thus, although subject to specified
exemptions and exceptions, laboratories
generally must have a current and valid
CLIA certificate to test human
specimens for medical purposes noted
above to be eligible for payment for
those tests from the Medicare or
Medicaid programs. Regulations
implementing section 353 of the PHS
Act are contained in 42 CFR part 493.
Section 353(p) of the PHS Act
provides for the exemption of
laboratories from CLIA requirements in
States that enact legal requirements that
are equal to or more stringent than
CLIA’s statutory and regulatory
requirements.
Section 353(p) of the PHS Act is
implemented in subpart E of regulations
at 42 CFR part 493. Sections 493.551
and 493.553 provide that we may
exempt from CLIA requirements, for a
period not to exceed 6 years, all State
licensed or approved laboratories in a
State if the State Licensure Program
meets the specified conditions. Section
493.559 provides that we will publish a
notice in the Federal Register when we
grant exemption to an approved State
laboratory licensure program. It also
provides that the notice will include the
following:
• The basis for granting the
exemption.
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
55219
• A description of how the laboratory
requirements are equal to or more
stringent than those of CLIA.
• The term of approval, not to exceed
6 years.
State of Washington’s Application for
CLIA Exemption of Its Laboratories
The State of Washington has applied
for exemption of its laboratories from
CLIA program requirements. The State
of Washington submitted all of the
applicable information and attestations
required by § 493.551, § 493.553, and
§ 493.557 for State licensure programs
seeking exemption of their licensed
laboratories from CLIA program
requirements.
Examples of documents and
information submitted are: A
comparison of its laboratory licensure
requirements with comparable CLIA
condition-level requirements (that is, a
crosswalk); a description of its
inspection process; proficiency testing
monitoring process; its data
management and analysis system; its
investigative and response procedures
for complaints received against
laboratories; and its policy regarding
announcement and unannouncement of
inspections.
CMS Analysis of Washington’s
Application and Supporting
Documentation
In order to determine whether we
should grant a CLIA exemption to
laboratories licensed by a State, we
review the application and additional
documentation that the State submits to
CMS and conduct a detailed and indepth comparison of State licensure
program and CLIA requirements to
determine whether the State program
meets the requirements at subpart E of
part 493.
In summary, the State generally must
demonstrate that its State licensure
program meets the following
requirements:
• Have State laws in effect that
provide for laboratory requirements that
are equal to or more stringent than CLIA
condition-level requirements for
laboratories.
• Have a State licensure program with
requirements that are equal to or more
stringent than the CLIA condition-level
requirements such that the State
program licenses laboratory would meet
the CLIA condition-level requirements if
it were inspected against those
requirements.
• Is shown to meet the requirements
of § 493.553, § 493.555, and § 493.557(b)
and is approved by CMS under
§ 493.551. For example, among other
things, programs would need to:
E:\FR\FM\28SEN1.SGM
28SEN1
]]>Agencies
[Federal Register Volume 72, Number 188 (Friday, September 28, 2007)]
[Notices]
[Pages 55218-55219]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-19247]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-R-312]
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: Extension of a currently
approved collection; Title of Information Collection: Conflict of
Interest and Ownership and Control Information; Use: The Conflict of
Interest and Ownership and Control Information Statement (COI
Statement) is sent to all Medicare Fiscal Intermediaries (FIs) and
Carriers to collect full and complete information on any entity's or
individual's ownership interest (defined as a 5 per centum or more) in
an organization that may present a potential conflict of interest in
their role as a Medicare FI or Carrier.
The information gathered in the survey is used to ensure that all
potential, apparent and actual conflicts of interest involving Medicare
contractors are appropriately mitigated and that employees of the
contractors, including officers, directors, trustees and members of
their immediate families, do not utilize their positions with the
contractor for their own private business interest to the detriment of
the Medicare program. Information is also requested on potential
organizational
[[Page 55219]]
conflicts of interest involving Medicare contractors' ownership of
other entities in the health care industry. If a response has indicated
that a potential conflict of interest exists, the contractor is
contacted and asked to address how the conflict can be avoided or
mitigated. Form Number: CMS-R-312 (OMB: 0938-0795); Frequency:
Reporting--Annually; Affected Public: Private Sector--Business or other
for-profit and Not-for-profit institutions; Number of Respondents: 37;
Total Annual Responses: 37; Total Annual Hours: 11,100.
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 21, 2007.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. E7-19247 Filed 9-27-07; 8:45 am]
BILLING CODE 4120-01-P
