Agency Information Collection Activities: Submission for OMB Review; Comment Request, 31789-31790 [2010-13302]
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Federal Register / Vol. 75, No. 107 / Friday, June 4, 2010 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Committee on Vital and Health
Statistics: Meeting
Centers for Medicare & Medicaid
Services
Pursuant to the Federal Advisory
Committee Act, the Department of
Health and Human Services (HHS)
announces the following advisory
committee meeting.
srobinson on DSKHWCL6B1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: CMS–10308]
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Name: National Committee on Vital and
Health Statistics (NCVHS), Full Committee
Meeting.
Time and Date: June 16, 2010: 9 a.m.–5
p.m. and June 17, 2010: 9 a.m.–11:30 a.m.
Place: Sheraton Crystal City Hotel, 1800
Jefferson Davis Highway, Arlington, VA
22202.
Status: Open.
Purpose: At this meeting the Committee
will hear presentations and hold discussions
on several health data policy topics. On the
morning of the first day the Committee will
hear updates from the Department, the Center
for Medicare and Medicaid Services, ONC,
and the plans for the NCVHS 60th
Anniversary Symposium. In the afternoon
there will be Subcommittee breakout
sessions.
On the morning of the second day the
Committee will be briefed on the Community
Data Initiative. There will also be a
discussion of Committee plans for September
2010 and future meetings. Upon the
adjournment of the full meeting, the
Committee will convene at the National
Academy of Science Keck Center for the
NCVHS 60th Anniversary Symposium.
The times shown above are for the full
Committee meeting. Subcommittee breakout
sessions are scheduled for late in the
afternoon of the first day. Agendas for these
breakout sessions will be posted on the
NCVHS Web site (URL below) when
available.
Contact Person for More Information:
Substantive program information as well as
summaries of meetings and a roster of
committee members may be obtained from
Marjorie S. Greenberg, Executive Secretary,
NCVHS, National Center for Health Statistics,
Centers for Disease Control and Prevention,
3311 Toledo Road, Room 2402, Hyattsville,
Maryland 20782, telephone (301) 458–4245.
Information also is available on the NCVHS
home page of the HHS Web site: https://
www.ncvhs.hhs.gov/, where further
information including an agenda will be
posted when available.
Should you require reasonable
accommodation, please contact the CDC
Office of Equal Employment Opportunity on
(301) 458–4EEO (4336) as soon as possible.
Dated: May 28, 2010.
James Scanlon,
Deputy Assistant Secretary for Science and
Data Policy, Office of the Assistant Secretary
for Planning and Evaluation.
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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), 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: Part C and D
Complaints Resolution Performance
Measures: Use: Part C Sponsors provide
medical coverage through at-risk
arrangements with CMS. Part C
Sponsors include: Local Coordinated
Care Plans which include health
maintenance organizations (HMOs),
preferred provider organizations (PPOs),
and provider sponsored organizations
(PSO) plans; Private fee-for-service
plans (PFFS); Special needs plans
(SNPs); Medical savings account
(MSAs); and Regional PPOs. Part D
Sponsors provide prescription drug
benefit coverage through private at-risk
prescription drug plans that offer drugonly coverage Prescription Drug Plans,
or through Medicare Advantage (MA)
plans that offer integrated prescription
drug and health care coverage (MA–PD
plans).
Due to Executive Order 13410,
‘‘Promoting Quality and Efficient Health
Care in Federal Government
Administered or Sponsored Health Care
Programs,’’ performance measurement
ratings for Medicare Parts C & D can be
found on Medicare Options Compare
and the Medicare Prescription Drug
PO 00000
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31789
Plan Finder (MPDPF), providing rating
information for beneficiary use with
plans being assigned a performancebased star rating. These ratings are
provided to help beneficiaries make
informed choices among the many plan
alternatives available to them under
Medicare Parts C and D.
The purpose of the project is to
develop and support implementation of
a performance measure for the Medicare
Advantage (Part C) and Prescription
Drug (Part D) programs that represents
plan resolution of beneficiary
complaints from the beneficiary
perspective. The project includes
development of methodologies for: (1)
Identifying a statistically valid sample
of beneficiary complaints needed to
analyze the complaint’s closure; (2)
contacting, interviewing, and
summarizing beneficiary experience;
and, (3) summarizing/analyzing the
resultant data to assess accuracy of the
resolution of beneficiary complaints
from the perspective of the beneficiaries
via objective exploration of the
beneficiary’s complaint resolution
experience. For a summary of changes,
refer to the Part C and D Complaints
Resolution Performance Measures
Summary of Revisions document. Form
Number: CMS–10308 (OMB#: 0938–
New); Frequency: Yearly; Affected
Public: Individuals and households;
Number of Respondents: 5,300; Total
Annual Responses: 5,300; Total Annual
Hours: 884. (For policy questions
regarding this collection contact Rachel
Schreiber at 410–786–8657. 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 July 6, 2010.
OMB, Office of Information and
Regulatory Affairs, Attention: CMS Desk
Officer, Fax Number: (202) 395–6974, Email: OIRA_submission@omb.eop.gov.
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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]
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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
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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
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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]
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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.
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Agencies
[Federal Register Volume 75, Number 107 (Friday, June 4, 2010)]
[Notices]
[Pages 31789-31790]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-13302]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifier: CMS-10308]
Agency Information Collection Activities: Submission for OMB
Review; 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), 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: Part C and D Complaints Resolution Performance
Measures: Use: Part C Sponsors provide medical coverage through at-risk
arrangements with CMS. Part C Sponsors include: Local Coordinated Care
Plans which include health maintenance organizations (HMOs), preferred
provider organizations (PPOs), and provider sponsored organizations
(PSO) plans; Private fee-for-service plans (PFFS); Special needs plans
(SNPs); Medical savings account (MSAs); and Regional PPOs. Part D
Sponsors provide prescription drug benefit coverage through private at-
risk prescription drug plans that offer drug-only coverage Prescription
Drug Plans, or through Medicare Advantage (MA) plans that offer
integrated prescription drug and health care coverage (MA-PD plans).
Due to Executive Order 13410, ``Promoting Quality and Efficient
Health Care in Federal Government Administered or Sponsored Health Care
Programs,'' performance measurement ratings for Medicare Parts C & D
can be found on Medicare Options Compare and the Medicare Prescription
Drug Plan Finder (MPDPF), providing rating information for beneficiary
use with plans being assigned a performance-based star rating. These
ratings are provided to help beneficiaries make informed choices among
the many plan alternatives available to them under Medicare Parts C and
D.
The purpose of the project is to develop and support implementation
of a performance measure for the Medicare Advantage (Part C) and
Prescription Drug (Part D) programs that represents plan resolution of
beneficiary complaints from the beneficiary perspective. The project
includes development of methodologies for: (1) Identifying a
statistically valid sample of beneficiary complaints needed to analyze
the complaint's closure; (2) contacting, interviewing, and summarizing
beneficiary experience; and, (3) summarizing/analyzing the resultant
data to assess accuracy of the resolution of beneficiary complaints
from the perspective of the beneficiaries via objective exploration of
the beneficiary's complaint resolution experience. For a summary of
changes, refer to the Part C and D Complaints Resolution Performance
Measures Summary of Revisions document. Form Number: CMS-10308
(OMB: 0938-New); Frequency: Yearly; Affected Public:
Individuals and households; Number of Respondents: 5,300; Total Annual
Responses: 5,300; Total Annual Hours: 884. (For policy questions
regarding this collection contact Rachel Schreiber at 410-786-8657. 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 July 6, 2010.
OMB, Office of Information and Regulatory Affairs, Attention: CMS
Desk Officer, Fax Number: (202) 395-6974, E-mail: OIRA_submission@omb.eop.gov.
[[Page 31790]]
Dated: May 28, 2010.
Martique Jones,
Director, Regulations Development Division-B, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2010-13302 Filed 6-3-10; 8:45 am]
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