Agency Information Collection Activities: Submission for OMB Review; Comment Request, 76032-76034 [E8-29542]
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Federal Register / Vol. 73, No. 241 / Monday, December 15, 2008 / Notices
determine the following for each
candidate product:
a. Product package insert or detailed
instructions for use
b. Detailed information to determine
if the product is calibrated to a
recognized standard
c. Preliminary data demonstrating
suitability for validation studies
Organizations that have products
selected by CDC for this comparative
analysis will be required to enter into an
appropriate agreement prior to the
transfer of any material to CDC. Sample
agreements may be viewed at the
following Web site: https://www.cdc.gov/
od/ads/techtran/forms.htm.
All information submitted to CDC will
be kept confidential as allowed by
relevant federal law, including the
Freedom of Information Act (5 U.S.C.
552) and the Trade Secrets Act (18
U.S.C. 1905). Only information
submitted within thirty days of
publication of this notice will be
reviewed to determine if the offered
product(s) will be acceptable for
possible inclusion in this comparative
analysis.
Responses are preferred in electronic
format and can be e-mailed to the
attention of Jacqueline Goolsby
jgoolsby@cdc.gov. Mailed responses can
be sent to the following address: Jackie
Goolsby, Branch Manager, Centers for
Disease Control and Prevention,
National Center for Immunization and
Respiratory Diseases, Division of
Bacterial Diseases, 404–639–1319
(Phone), 404–639–3059 (Fax), 1600
Clifton Rd. NE., Mail Stop C–09,
Atlanta, GA 30333.
FOR FURTHER INFORMATION CONTACT:
Technical
Dr. M. Lucia Tondella, Division of
Bacterial Diseases, National Center for
Immunization and Respiratory Diseases,
Centers for Disease Control and
Prevention (CDC), 1600 Clifton Road
NE., Mail Stop D–11, Atlanta, GA
30333. Telephone (404) 639–1239, EMail at mtondella@cdc.gov.
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Business
Lisa Blake-DiSpigna, Technology
Development Coordinator, National
Center for Immunization and
Respiratory Diseases, Centers for
Disease Control and Prevention (CDC),
1600 Clifton Road NE., Mail Stop A–42,
Atlanta, GA 30333. Telephone (404)
639–2620, E-Mail at LBlakeDiSpigna@cdc.gov.
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Dated: December 3, 2008.
James D. Seligman,
Chief Information Officer, Centers for Disease
Control and Prevention.
[FR Doc. E8–29580 Filed 12–12–08; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10272, CMS–R–
254, CMS–29/30, CMS–372, CMS–10001,
CMS–10009, CMS–10242 and CMS–R–52]
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: Hospital
Leadership Quality Assessment Tool
(HLQAT); Use: In 2006, the Hospital
Leadership Collaborative (HLC)
launched a public-private partnership to
develop a CMS-endorsed selfassessment tool, ‘‘The Hospital
Leadership and Quality Assessment
Tool’’ (HLQAT) to assist hospitals in the
improvement of quality through
enhanced hospital governance,
executive, physician, and clinical
engagement. Hospitals leaders will take
the HLQAT instrument via Web-based
technology. This function will be
carried out in conjunction with CMS
and the Quality Improvement
Organization (QIO) 9th Scope of Work
(SOW), to convey the importance of this
effort in relation to Medicare and other
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public priorities. This administration of
the HLQAT seeks responses from
approximately a dozen leaders in each
hospital, including physicians (e.g.,
CEO, CMO), board members, directorlevel, and mid-level clinical managers—
these responses can provide a multilevel representation of hospital
leadership showing its commitment to
institutional change. Form Number:
CMS–10272 (OMB# 0938–New);
Frequency: Occasionally; Affected
Public: Private Sector—Business or
Other for-profits; Number of
Respondents: 18,000; Total Annual
Responses: 36,000; Total Annual Hours:
44,820.
2. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: National
Medicare & You Education Program
(NMEP) Survey of Medicare
Beneficiaries Use: The Centers for
Medicare and Medicaid Services is
requesting a revision of this information
collection request to continue to collect
information from Medicare
beneficiaries, caregivers, health care
providers, and health information
providers. It is critical for this agency to
obtain feedback from the
aforementioned groups so that the
agency can accurately assess the needs
of the Medicare audience. Using random
digit dial and/or an administrative
sample, members of the Medicare
audience will be called and asked to
complete the survey via telephone. The
results of this survey will be compiled
and studied so that communication may
be amended to benefit Medicare’s
audience. The survey has the following
objectives: To assess satisfaction with
and knowledge of the Medicare
program; to gather information on
health behaviors and quality of health
care; to determine the most used source
for Medicare information; and to gather
information from health care provider
and health information providers. Form
Number: CMS–R–254 (OMB# 0938–
0738); Frequency: Once; Affected
Public: Individuals and Households,
Private Sector—Business or other forprofits; Number of Respondents: 7,000;
Total Annual Responses: 7,000; Total
Annual Hours: 1,750.
3. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Request for
Certification as Rural Health Clinic
(RHC) and RHC Survey Report Form
and Supporting Regulations in 42 CFR
491.1–491.11; Use: The CMS–29 is
utilized as an application to be
completed by suppliers of RHC services
requesting participation in the
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Federal Register / Vol. 73, No. 241 / Monday, December 15, 2008 / Notices
Medicare/Medicaid programs. This form
initiates the process of obtaining a
decision as to whether the conditions
for certification are met as a supplier of
RHC services. It also promotes data
reduction or introduction to and
retrieval from the Automated Survey
Process Environment (ASPEN) and
related survey and certification
databases by the CMS Regional Offices.
Form Number: CMS–29/30 (OMB#
0938–0074); Frequency: Yearly; Affected
Public: State, Local, or Tribal
Governments; Number of Respondents:
766; Total Annual Responses: 766; Total
Annual Hours: 192.
4. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Annual Report
on Home and Community Based
Services Waivers and Supporting
Regulations in 42 CFR 440.180 and
441.300–310.; Use: States within an
approved waiver under section 1915(c)
of the act are required to submit a report
annually in order for CMS to: (1) Verify
that State assurances regarding waiver
cost-neutrality are met; and, (2)
Determine the waiver’s impact on the
type, amount, and cost of services
provided under the State Plan and
health welfare of recipients. Form
Number: CMS–372 (OMB# 0938–0272);
Frequency: Yearly; Affected Public:
State, Local, or Tribal Governments;
Number of Respondents: 49; Total
Annual Responses: 305; Total Annual
Hours: 13,115.
5. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Health
Insurance Portability and
Accountability Act (HIPAA)
Nondiscrimination Provisions and
Supporting Regulations in 45 CFR
146.121(h) and 121(i)(2)(i); Use: If
coverage has been denied to any
individual because the sponsor of a selffunded non-Federal governmental plan
had exempt the plan from the
nondiscrimination requirements under
45 CFR 146.180 ‘‘Treatment of NonFederal Governmental Plans’’, and the
plan sponsor subsequently chooses to
bring the plan into compliance, the plan
sponsor must comply with the
requirements under 45 CFR
146.121(i)(2)(i) ‘‘Special Transitional
Rule for Self-Funded Non-Federal
Governmental Plans Exempted under 45
CFR 146.180’’. To bring the plan into
compliance with the requirements, the
plan must notify the individual that the
plan will be coming into compliance,
afford the individual an opportunity to
enroll, specify the effective date of
compliance, and inform the individual
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Jkt 217001
regarding any enrollment restrictions
that may apply under the terms of the
plan once the plan is in compliance.
Form Number: CMS–10001 (OMB#
0938–0827); Frequency: Yearly; Affected
Public: State, Local, or Tribal
Governments; Number of Respondents:
18; Total Annual Responses: 18; Total
Annual Hours: 194.
6. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Health
Insurance Portability and
Accountability Act (HIPAA)
Nondiscrimination Provisions and
Supporting Regulations in 45 CFR
146.121 (f)(2)(v)(A); Use: Section
146.121 of the regulations requires
Health plans or issuers to disclose in all
plan materials the terms of certain
wellness programs including the
availability of a reasonable alternative
standard. Plan participants and their
dependents need this information to
understand the rights they have under
HIPAA. States and the Federal
government may need the information
supplied by issuers to properly perform
their regulatory functions. Form
Number: CMS–10009 (OMB# 0938–
0819); Frequency: Yearly; Affected
Public: State, Local, or Tribal
Governments; Number of Respondents:
2,600; Total Annual Responses: 2,600;
Total Annual Hours: 1,300.
7. Type of Information Collection
Request: New collection; Title of
Information Collection: Emergency and
Non-Emergency Ambulance Transports
and Beneficiary Signature Requirements
in 42 CFR 424.36(b); Use: In the CY
2008 Physician Fee Schedule (PFS) final
rule with comment period, we created
an additional exception to the
beneficiary signature requirements in
§ 424.36(b) for emergency ambulance
transports (72 FR 66406). The exception
allows ambulance providers and
suppliers to sign the claim on behalf of
the beneficiary, at the time of transport,
provided that certain documentation
requirements are met. Following
publication of the CY 2008 PFS final
rule with comment period, ambulance
provider and supplier stakeholders
requested that we extend the exception
in § 424.36(b)(6) to non-emergency
ambulance transports, in instances
where the beneficiary is physically or
mentally incapable of signing the claim
form.
The current submission of this
information collection request relates to
the collection of documentation
pertaining to non-emergency ambulance
transports. In addition, we are updating
the collection of information that relates
to the collection of documentation
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76033
pertaining to emergency ambulance
transports. Form Number: CMS–10242
(OMB# 0938–1049); Frequency:
Occasionally; Affected Public: Private
Sector—Business or Other for-profits
and Not-for-profit institutions; Number
of Respondents: 9,000; Total Annual
Responses: 13,185,835; Total Annual
Hours: 1,098,819.
8. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Conditions for
Coverage of Suppliers of End Stage
Renal Disease (ESRD) Services and
Supporting Regulations Contained in 42
CFR 405.2100–405.2171; Use: The
information collection requirements
described herein are part of the
Medicare and Medicaid Programs;
Conditions for Coverage for End-Stage
Renal Disease Facilities. The
requirements fall into two categories:
Recordkeeping requirements and
reporting requirements. With regard to
the recordkeeping requirements, CMS
uses these conditions for coverage to
certify health care facilities that want to
participate in the Medicare or Medicaid
programs. For the reporting
requirements, the information is needed
to assess and ensure proper distribution
and effective utilization of ESRD
treatment resources while maintaining
or improving quality of care. The
recordkeeping requirements imposed by
this collection are no different than
other conditions for coverage in that
they reflect comparable standards
developed by industry organizations
such as the Renal Physicians
Association, American Society of
Transplant Surgeons, National Kidney
Foundation, and the National
Association of Patients on Hemodialysis
and Transplantation. Form Number:
CMS–R–52 (OMB#: 0938–0386);
Frequency: Recordkeeping and
Reporting—Annually; Affected Public:
Business or other for-profit and Federal
government; Number of Respondents:
5,415; Total Annual Responses: 5,415;
Total Annual Hours: 131,720.
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.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received by the OMB desk officer at
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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
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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 https://www.cms.hhs.gov/
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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 https://
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
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]]>Agencies
[Federal Register Volume 73, Number 241 (Monday, December 15, 2008)]
[Notices]
[Pages 76032-76034]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-29542]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10272, CMS-R-254, CMS-29/30, CMS-372, CMS-
10001, CMS-10009, CMS-10242 and CMS-R-52]
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: Hospital Leadership Quality Assessment Tool
(HLQAT); Use: In 2006, the Hospital Leadership Collaborative (HLC)
launched a public-private partnership to develop a CMS-endorsed self-
assessment tool, ``The Hospital Leadership and Quality Assessment
Tool'' (HLQAT) to assist hospitals in the improvement of quality
through enhanced hospital governance, executive, physician, and
clinical engagement. Hospitals leaders will take the HLQAT instrument
via Web-based technology. This function will be carried out in
conjunction with CMS and the Quality Improvement Organization (QIO) 9th
Scope of Work (SOW), to convey the importance of this effort in
relation to Medicare and other public priorities. This administration
of the HLQAT seeks responses from approximately a dozen leaders in each
hospital, including physicians (e.g., CEO, CMO), board members,
director-level, and mid-level clinical managers--these responses can
provide a multi-level representation of hospital leadership showing its
commitment to institutional change. Form Number: CMS-10272
(OMB 0938-New); Frequency: Occasionally; Affected Public:
Private Sector--Business or Other for-profits; Number of Respondents:
18,000; Total Annual Responses: 36,000; Total Annual Hours: 44,820.
2. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: National Medicare
& You Education Program (NMEP) Survey of Medicare Beneficiaries Use:
The Centers for Medicare and Medicaid Services is requesting a revision
of this information collection request to continue to collect
information from Medicare beneficiaries, caregivers, health care
providers, and health information providers. It is critical for this
agency to obtain feedback from the aforementioned groups so that the
agency can accurately assess the needs of the Medicare audience. Using
random digit dial and/or an administrative sample, members of the
Medicare audience will be called and asked to complete the survey via
telephone. The results of this survey will be compiled and studied so
that communication may be amended to benefit Medicare's audience. The
survey has the following objectives: To assess satisfaction with and
knowledge of the Medicare program; to gather information on health
behaviors and quality of health care; to determine the most used source
for Medicare information; and to gather information from health care
provider and health information providers. Form Number: CMS-R-254
(OMB 0938-0738); Frequency: Once; Affected Public: Individuals
and Households, Private Sector--Business or other for-profits; Number
of Respondents: 7,000; Total Annual Responses: 7,000; Total Annual
Hours: 1,750.
3. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Request for
Certification as Rural Health Clinic (RHC) and RHC Survey Report Form
and Supporting Regulations in 42 CFR 491.1-491.11; Use: The CMS-29 is
utilized as an application to be completed by suppliers of RHC services
requesting participation in the
[[Page 76033]]
Medicare/Medicaid programs. This form initiates the process of
obtaining a decision as to whether the conditions for certification are
met as a supplier of RHC services. It also promotes data reduction or
introduction to and retrieval from the Automated Survey Process
Environment (ASPEN) and related survey and certification databases by
the CMS Regional Offices. Form Number: CMS-29/30 (OMB 0938-
0074); Frequency: Yearly; Affected Public: State, Local, or Tribal
Governments; Number of Respondents: 766; Total Annual Responses: 766;
Total Annual Hours: 192.
4. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Annual Report on
Home and Community Based Services Waivers and Supporting Regulations in
42 CFR 440.180 and 441.300-310.; Use: States within an approved waiver
under section 1915(c) of the act are required to submit a report
annually in order for CMS to: (1) Verify that State assurances
regarding waiver cost-neutrality are met; and, (2) Determine the
waiver's impact on the type, amount, and cost of services provided
under the State Plan and health welfare of recipients. Form Number:
CMS-372 (OMB 0938-0272); Frequency: Yearly; Affected Public:
State, Local, or Tribal Governments; Number of Respondents: 49; Total
Annual Responses: 305; Total Annual Hours: 13,115.
5. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Health Insurance
Portability and Accountability Act (HIPAA) Nondiscrimination Provisions
and Supporting Regulations in 45 CFR 146.121(h) and 121(i)(2)(i); Use:
If coverage has been denied to any individual because the sponsor of a
self-funded non-Federal governmental plan had exempt the plan from the
nondiscrimination requirements under 45 CFR 146.180 ``Treatment of Non-
Federal Governmental Plans'', and the plan sponsor subsequently chooses
to bring the plan into compliance, the plan sponsor must comply with
the requirements under 45 CFR 146.121(i)(2)(i) ``Special Transitional
Rule for Self-Funded Non-Federal Governmental Plans Exempted under 45
CFR 146.180''. To bring the plan into compliance with the requirements,
the plan must notify the individual that the plan will be coming into
compliance, afford the individual an opportunity to enroll, specify the
effective date of compliance, and inform the individual regarding any
enrollment restrictions that may apply under the terms of the plan once
the plan is in compliance. Form Number: CMS-10001 (OMB 0938-
0827); Frequency: Yearly; Affected Public: State, Local, or Tribal
Governments; Number of Respondents: 18; Total Annual Responses: 18;
Total Annual Hours: 194.
6. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Health Insurance
Portability and Accountability Act (HIPAA) Nondiscrimination Provisions
and Supporting Regulations in 45 CFR 146.121 (f)(2)(v)(A); Use: Section
146.121 of the regulations requires Health plans or issuers to disclose
in all plan materials the terms of certain wellness programs including
the availability of a reasonable alternative standard. Plan
participants and their dependents need this information to understand
the rights they have under HIPAA. States and the Federal government may
need the information supplied by issuers to properly perform their
regulatory functions. Form Number: CMS-10009 (OMB 0938-0819);
Frequency: Yearly; Affected Public: State, Local, or Tribal
Governments; Number of Respondents: 2,600; Total Annual Responses:
2,600; Total Annual Hours: 1,300.
7. Type of Information Collection Request: New collection; Title of
Information Collection: Emergency and Non-Emergency Ambulance
Transports and Beneficiary Signature Requirements in 42 CFR 424.36(b);
Use: In the CY 2008 Physician Fee Schedule (PFS) final rule with
comment period, we created an additional exception to the beneficiary
signature requirements in Sec. 424.36(b) for emergency ambulance
transports (72 FR 66406). The exception allows ambulance providers and
suppliers to sign the claim on behalf of the beneficiary, at the time
of transport, provided that certain documentation requirements are met.
Following publication of the CY 2008 PFS final rule with comment
period, ambulance provider and supplier stakeholders requested that we
extend the exception in Sec. 424.36(b)(6) to non-emergency ambulance
transports, in instances where the beneficiary is physically or
mentally incapable of signing the claim form.
The current submission of this information collection request
relates to the collection of documentation pertaining to non-emergency
ambulance transports. In addition, we are updating the collection of
information that relates to the collection of documentation pertaining
to emergency ambulance transports. Form Number: CMS-10242 (OMB
0938-1049); Frequency: Occasionally; Affected Public: Private Sector--
Business or Other for-profits and Not-for-profit institutions; Number
of Respondents: 9,000; Total Annual Responses: 13,185,835; Total Annual
Hours: 1,098,819.
8. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Conditions for
Coverage of Suppliers of End Stage Renal Disease (ESRD) Services and
Supporting Regulations Contained in 42 CFR 405.2100-405.2171; Use: The
information collection requirements described herein are part of the
Medicare and Medicaid Programs; Conditions for Coverage for End-Stage
Renal Disease Facilities. The requirements fall into two categories:
Recordkeeping requirements and reporting requirements. With regard to
the recordkeeping requirements, CMS uses these conditions for coverage
to certify health care facilities that want to participate in the
Medicare or Medicaid programs. For the reporting requirements, the
information is needed to assess and ensure proper distribution and
effective utilization of ESRD treatment resources while maintaining or
improving quality of care. The recordkeeping requirements imposed by
this collection are no different than other conditions for coverage in
that they reflect comparable standards developed by industry
organizations such as the Renal Physicians Association, American
Society of Transplant Surgeons, National Kidney Foundation, and the
National Association of Patients on Hemodialysis and Transplantation.
Form Number: CMS-R-52 (OMB: 0938-0386); Frequency:
Recordkeeping and Reporting--Annually; Affected Public: Business or
other for-profit and Federal government; Number of Respondents: 5,415;
Total Annual Responses: 5,415; Total Annual Hours: 131,720.
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.
To be assured consideration, comments and recommendations for the
proposed information collections must be received by the OMB desk
officer at
[[Page 76034]]
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
