Agency Information Collection Activities: Proposed Collection; Comment Request, 31790 [2010-13303]
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31790
Federal Register / Vol. 75, No. 107 / Friday, June 4, 2010 / Notices
Dated: May 28, 2010.
Martique Jones,
Director, Regulations Development DivisionB, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2010–13302 Filed 6–3–10; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10203]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services.
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: 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 to 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
srobinson on DSKHWCL6B1PROD with NOTICES
AGENCY:
VerDate Mar<15>2010
16:01 Jun 03, 2010
Jkt 220001
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®).
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 techinques.
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 Medicar 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
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.
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 August 3, 2010:
1. Electronically. You may submit
your comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
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, Room C4–26–05, 7500
Security Boulevard, Baltimore,
Maryland 21244–1850.
Date: May 28, 2010.
Martique Jones,
Director, Regulations Development DivisionB, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2010–13303 Filed 6–3–10; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–P–0278]
Determination That Cysteine
Hydrochloride Injection, USP, 7.25%,
Was Not Withdrawn From Sale for
Reasons of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing its
determination that Cysteine
Hydrochloride Injection, USP, 7.25%
(Cysteine HCl), was not withdrawn from
sale for reasons of safety or
effectiveness. This determination will
allow FDA to approve abbreviated new
drug applications (ANDAs) for Cysteine
HCl if all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT:
David Joy, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 6358, Silver Spring,
MD 20993–0002, 301–796–3601.
SUPPLEMENTARY INFORMATION: In 1984,
Congress enacted the Drug Price
Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) (the 1984 amendments), which
authorized the approval of duplicate
versions of drug products approved
under an ANDA procedure. ANDA
applicants must, with certain
exceptions, show that the drug for
which they are seeking approval
contains the same active ingredient in
the same strength and dosage form as
the ‘‘listed drug,’’ which is a version of
the drug that was previously approved.
E:\FR\FM\04JNN1.SGM
04JNN1
]]>Agencies
[Federal Register Volume 75, Number 107 (Friday, June 4, 2010)]
[Notices]
[Page 31790]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-13303]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10203]
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Centers for Medicare & Medicaid Services.
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: 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 to 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[supreg]).
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 techinques. 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[supreg] 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 Medicar
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 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.
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 August 3, 2010:
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, Room C4-26-05, 7500 Security Boulevard, Baltimore,
Maryland 21244-1850.
Date: May 28, 2010.
Martique Jones,
Director, Regulations Development Division-B, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2010-13303 Filed 6-3-10; 8:45 am]
BILLING CODE 4120-01-P
