Agency Information Collection Activities: Submission for OMB Review; Comment Request, 49494-49495 [2010-19756]
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49494
Federal Register / Vol. 75, No. 156 / Friday, August 13, 2010 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Centers for Medicare & Medicaid
Services
Statement of Organization, Functions,
and Delegations of Authority; Office of
the National Coordinator for Health
and Information Technology;
Correction
[Document Identifier: CMS–265–94, CMS–
1728–94, CMS–10240, CMS–P–0015A and
CMS–10203]
AGENCY:
ACTION:
Office of the Secretary, HHS.
This Notice was previously
published in the Federal Register on
December 1, 2009, but it contained an
error with respect to one of the office
names.
SUMMARY:
emcdonald on DSK2BSOYB1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Marc Weisman, Office of the National
Coordinator, Office of the Secretary, 200
Independence Ave., NW., Washington,
DC 20201, 202–690–6285.
Part A, Office of the Secretary,
Statement of Organization, Functions,
and Delegations of Authority for the
Department of Health and Human
Services, Chapter AR, Office of the
National Coordinator for Health
Information Technology (ONC), as last
amended at 74 FR 62785–62786, dated
December 1, 2009, is corrected as
follows:
I. Under Section AR.10 Organization,
retitle ‘‘B. Office of Economic Modeling
and Analysis (ARB)’’ as B. Office of
Economic Analysis and Modeling
(ARB).’’
II. Under Section AR.20 Functions,
Chapter B, retitle all references to the
‘‘Office of Economic Modeling and
Analysis’’ as the ‘‘Office of Economic
Analysis and Modeling.’’
III. Delegation of Authority. Pending
further delegation, directives or orders
by the Secretary or by the National
Coordinator for Health Information
Technology, all delegations and
redelegations of authority made to
officials and employees of affected
organizational components will
continue in them or their successors
pending further redelegations, provided
they are consistent with this
reorganization.
(Authority: 44 U.S.C. 3101.)
Dated: July 26, 2010.
Kathleen Sebelius,
Secretary.
[FR Doc. 2010–19999 Filed 8–12–10; 8:45 am]
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Centers for Medicare &
Medicaid Services, HHS.
In compliance with the requirement
of section 3506I(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: Independent
Renal Dialysis Facility Cost Report; Use:
The Independent Renal Dialysis Facility
Cost Report, is filed annually by
providers participating in the Medicare
program to identify the specific items of
cost and statistics of facility operation
that independent renal dialysis facilities
are required to report. Form Number:
CMS–265–94 (OMB#: 0938–0236);
Frequency: Yearly; Affected Public:
Business or other for-profits and Notfor-profit institutions; Number of
Respondents: 5,508 Total Annual
Responses: 5,508; Total Annual Hours:
275,400 (For policy questions regarding
this collection contact Gail Duncan at
410–786–7278. For all other issues call
410–786–1326.)
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Home Health
Agency Cost Report; Use: These cost
report forms are filed annually by
freestanding providers participating in
the Medicare program to effect year end
cost settlement for providing services to
AGENCY:
Notice, correction.
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Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
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Medicare beneficiaries. The data
submitted on the cost reports supports
management of Federal programs.
Providers receiving Medicare
reimbursement must provide adequate
cost data based on financial and
statistical records which can be verified
by qualified auditors. The data from
these cost reporting forms will be used
for the purpose of evaluating current
levels of Medicare reimbursement. Form
Number: CMS–1728–94 (OMB#: 0938–
0022); Frequency: Yearly; Affected
Public: Business or other for-profits and
Not-for-profit institutions; Number of
Respondents: 7,479 Total Annual
Responses: 7,479; Total Annual Hours:
1,690,254 (For policy questions
regarding this collection contact Angela
Havrilla at 410–786–4516. For all other
issues call 410–786–1326.)
3. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Data Collection
for the Nursing Home Value-Based
Purchasing (NHVBP) Demonstration;
Use: The goal of the NHVBP
Demonstration is to use financial
incentives to improve the quality of care
in nursing homes. The main purpose of
the NHVBP data collection effort is to
gather information that will enable CMS
to determine which nursing homes will
be eligible to receive incentive
payments under the NHVBP
Demonstration. Information will be
collected from nursing homes
participating in the demonstration on an
ongoing basis. CMS will collect payrollbased staffing, agency staffing and
resident census information to help
assess the quality of care in
participating nursing homes. CMS will
determine which homes qualify for an
incentive payment based on their
relative performance in terms of quality.
Form Number: CMS–10240 (OMB#:
0938–1039); Frequency: Quarterly;
Affected Public: Business or other forprofits and Not-for-profit institutions;
Number of Respondents: 178 Total
Annual Responses: 712; Total Annual
Hours: 5,530 (For policy questions
regarding this collection contact Ron
Lambert at 410–786–6624. For all other
issues call 410–786–1326.)
4. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Medicare
Current Beneficiary Survey; Use: The
Medicare Current Beneficiary Survey
(MCBS) serves to measure what impact
the changes of adding a new benefit
have on the program and its
beneficiaries. The MCBS is a
comprehensive data collection effort
that fills an information gap in the
E:\FR\FM\13AUN1.SGM
13AUN1
emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 75, No. 156 / Friday, August 13, 2010 / Notices
Centers for Medicare and Medicaid
Services, and is depended on to help
manage the program. Being able to
examine various characteristics and to
chart evolving trends offers policy
makers a reliable tool for making
informed decisions. The MCBS is used
to identify potential new policy
direction or modifications to the
Medicare program and once those
program enhancements are
implemented, monitor the impact of
those changes. The central goals of the
MCBS are to determine medical care
expenditures and sources of payment
for all services, including copayments,
deductibles, and non-covered services;
to ascertain all types of health insurance
coverage and relate coverage to actual
payments; and to trace processes over
time, such as changes in health status,
spending down to Medicaid eligibility,
and the impacts of program changes.
Form Number: CMS–P–0015A (OMB#:
0938–0568); Frequency: Yearly; Affected
Public: Business or other for-profits and
Not-for-profit institutions; Number of
Respondents: 16,217 Total Annual
Responses: 48,650; Total Annual Hours:
57,062 (For policy questions regarding
this collection contact William Long at
410–786–7927. For all other issues call
410–786–1326.)
5. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Medicare Health
Outcomes Survey (HOS); Use: CMS has
a responsibility to its Medicare
beneficiaries to require that care
provided by managed care organizations
under contract with CMS is of high
quality. One way of ensuring high
quality care in Medicare Managed Care
Organizations (MCOs), or more
commonly referred to as Medicare
Advantage Organizations (MAOs), is
through the development of
standardized, uniform performance
measures to enable CMS to gather the
data needed to evaluate the care
provided to Medicare beneficiaries.
The goal of the Medicare HOS
program is to gather valid, reliable,
clinically meaningful health status data
in Medicare managed care for use in
quality improvement activities, plan
accountability, public reporting, and
improving health. All managed care
plans with Medicare Advantage (MA)
contracts must participate. CMS, in
collaboration with the National
Committee for Quality Assurance
(NCQA), launched the Medicare HOS as
part of the Effectiveness of Care
component of the former Health Plan
Employer Data and Information Set,
now known as the Healthcare
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16:35 Aug 12, 2010
Jkt 220001
Effectiveness Data and Information Set
(HEDIS®).
The HOS measure was developed
under the guidance of a Technical
Expert Panel comprised of individuals
with specific expertise in the health care
industry and outcomes measurement.
The measure includes the most recent
advances in summarizing physical and
mental health outcomes results and
appropriate risk adjustment techniques.
In addition to health outcomes
measures, the HOS is used to collect the
Management of Urinary Incontinence in
Older Adults, Physical Activity in Older
Adults, Fall Risk Management, and
Osteoporosis Testing in Older Women
HEDIS® measures. The collection of
Medicare HOS is necessary to hold
Medicare managed care contractors
accountable for the quality of care they
are delivering. This reporting
requirement allows CMS to obtain the
information necessary for proper
oversight of the Medicare Advantage
program. Form Number: CMS–10203
(OMB#: 0938–0701); Frequency: Yearly;
Affected Public: Individuals and
households; Number of Respondents:
1,099,560 Total Annual Responses:
1,099,560; Total Annual Hours: 366,520
(For policy questions regarding this
collection contact Chris Haffer at 410–
786–8764. For all other issues call 410–
786–1326.)
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
the address below, no later than 5 p.m.
on September 13, 2010.
OMB, Office of Information and
Regulatory Affairs, Attention: CMS Desk
Officer, Fax Number: (202) 395–6974, Email: OIRA_submission@omb.eop.gov.
Dated: August 6, 2010.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2010–19756 Filed 8–12–10; 8:45 am]
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49495
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0248]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Format and
Content Requirements for Over-theCounter Drug Product Labeling
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by September
13, 2010.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0340. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.Berbakos@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUMMARY:
Format and Content Requirements for
Over-the-Counter Drug Product
Labeling—OMB Control Number 0910–
0340—Reinstatement
In the Federal Register of March 17,
1999 (64 FR 13254) (the 1999 labeling
final rule), we amended our regulations
governing requirements for human drug
products to establish standardized
format and content requirements for the
labeling of all marketed over-thecounter (OTC) drug products in part 201
(21 CFR part 201). The regulations in
part 201 require OTC drug product
labeling to include uniform headings
E:\FR\FM\13AUN1.SGM
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]]>Agencies
[Federal Register Volume 75, Number 156 (Friday, August 13, 2010)]
[Notices]
[Pages 49494-49495]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-19756]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-265-94, CMS-1728-94, CMS-10240, CMS-P-0015A
and CMS-10203]
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
AGENCY: Centers for Medicare & Medicaid Services, HHS.
In compliance with the requirement of section 3506I(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: Independent Renal
Dialysis Facility Cost Report; Use: The Independent Renal Dialysis
Facility Cost Report, is filed annually by providers participating in
the Medicare program to identify the specific items of cost and
statistics of facility operation that independent renal dialysis
facilities are required to report. Form Number: CMS-265-94
(OMB: 0938-0236); Frequency: Yearly; Affected Public: Business
or other for-profits and Not-for-profit institutions; Number of
Respondents: 5,508 Total Annual Responses: 5,508; Total Annual Hours:
275,400 (For policy questions regarding this collection contact Gail
Duncan at 410-786-7278. For all other issues call 410-786-1326.)
2. Type of Information Collection Request: Extension of a currently
approved collection; Title of Information Collection: Home Health
Agency Cost Report; Use: These cost report forms are filed annually by
freestanding providers participating in the Medicare program to effect
year end cost settlement for providing services to Medicare
beneficiaries. The data submitted on the cost reports supports
management of Federal programs. Providers receiving Medicare
reimbursement must provide adequate cost data based on financial and
statistical records which can be verified by qualified auditors. The
data from these cost reporting forms will be used for the purpose of
evaluating current levels of Medicare reimbursement. Form Number: CMS-
1728-94 (OMB: 0938-0022); Frequency: Yearly; Affected Public:
Business or other for-profits and Not-for-profit institutions; Number
of Respondents: 7,479 Total Annual Responses: 7,479; Total Annual
Hours: 1,690,254 (For policy questions regarding this collection
contact Angela Havrilla at 410-786-4516. For all other issues call 410-
786-1326.)
3. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Data Collection
for the Nursing Home Value-Based Purchasing (NHVBP) Demonstration; Use:
The goal of the NHVBP Demonstration is to use financial incentives to
improve the quality of care in nursing homes. The main purpose of the
NHVBP data collection effort is to gather information that will enable
CMS to determine which nursing homes will be eligible to receive
incentive payments under the NHVBP Demonstration. Information will be
collected from nursing homes participating in the demonstration on an
ongoing basis. CMS will collect payroll-based staffing, agency staffing
and resident census information to help assess the quality of care in
participating nursing homes. CMS will determine which homes qualify for
an incentive payment based on their relative performance in terms of
quality. Form Number: CMS-10240 (OMB: 0938-1039); Frequency:
Quarterly; Affected Public: Business or other for-profits and Not-for-
profit institutions; Number of Respondents: 178 Total Annual Responses:
712; Total Annual Hours: 5,530 (For policy questions regarding this
collection contact Ron Lambert at 410-786-6624. For all other issues
call 410-786-1326.)
4. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Medicare Current
Beneficiary Survey; Use: The Medicare Current Beneficiary Survey (MCBS)
serves to measure what impact the changes of adding a new benefit have
on the program and its beneficiaries. The MCBS is a comprehensive data
collection effort that fills an information gap in the
[[Page 49495]]
Centers for Medicare and Medicaid Services, and is depended on to help
manage the program. Being able to examine various characteristics and
to chart evolving trends offers policy makers a reliable tool for
making informed decisions. The MCBS is used to identify potential new
policy direction or modifications to the Medicare program and once
those program enhancements are implemented, monitor the impact of those
changes. The central goals of the MCBS are to determine medical care
expenditures and sources of payment for all services, including
copayments, deductibles, and non-covered services; to ascertain all
types of health insurance coverage and relate coverage to actual
payments; and to trace processes over time, such as changes in health
status, spending down to Medicaid eligibility, and the impacts of
program changes. Form Number: CMS-P-0015A (OMB: 0938-0568);
Frequency: Yearly; Affected Public: Business or other for-profits and
Not-for-profit institutions; Number of Respondents: 16,217 Total Annual
Responses: 48,650; Total Annual Hours: 57,062 (For policy questions
regarding this collection contact William Long at 410-786-7927. For all
other issues call 410-786-1326.)
5. Type of Information Collection Request: Revision of a currently
approved collection; Title of Information Collection: Medicare Health
Outcomes Survey (HOS); Use: CMS has a responsibility to its Medicare
beneficiaries to require that care provided by managed care
organizations under contract with CMS is of high quality. One way of
ensuring high quality care in Medicare Managed Care Organizations
(MCOs), or more commonly referred to as Medicare Advantage
Organizations (MAOs), is through the development of standardized,
uniform performance measures to enable CMS to gather the data needed to
evaluate the care provided to Medicare beneficiaries.
The goal of the Medicare HOS program is to gather valid, reliable,
clinically meaningful health status data in Medicare managed care for
use in quality improvement activities, plan accountability, public
reporting, and improving health. All managed care plans with Medicare
Advantage (MA) contracts must participate. CMS, in collaboration with
the National Committee for Quality Assurance (NCQA), launched the
Medicare HOS as part of the Effectiveness of Care component of the
former Health Plan Employer Data and Information Set, now known as the
Healthcare Effectiveness Data and Information Set (HEDIS[reg]).
The HOS measure was developed under the guidance of a Technical
Expert Panel comprised of individuals with specific expertise in the
health care industry and outcomes measurement. The measure includes the
most recent advances in summarizing physical and mental health outcomes
results and appropriate risk adjustment techniques. In addition to
health outcomes measures, the HOS is used to collect the Management of
Urinary Incontinence in Older Adults, Physical Activity in Older
Adults, Fall Risk Management, and Osteoporosis Testing in Older Women
HEDIS[reg] measures. The collection of Medicare HOS is necessary to
hold Medicare managed care contractors accountable for the quality of
care they are delivering. This reporting requirement allows CMS to
obtain the information necessary for proper oversight of the Medicare
Advantage program. Form Number: CMS-10203 (OMB: 0938-0701);
Frequency: Yearly; Affected Public: Individuals and households; Number
of Respondents: 1,099,560 Total Annual Responses: 1,099,560; Total
Annual Hours: 366,520 (For policy questions regarding this collection
contact Chris Haffer at 410-786-8764. For all other issues call 410-
786-1326.)
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 the address below, no later than 5 p.m. on September 13,
2010.
OMB, Office of Information and Regulatory Affairs, Attention: CMS
Desk Officer, Fax Number: (202) 395-6974, E-mail: OIRA_submission@omb.eop.gov.
Dated: August 6, 2010.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations
and Regulatory Affairs.
[FR Doc. 2010-19756 Filed 8-12-10; 8:45 am]
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