Agency Information Collection Request; 60-Day Public Comment Request, 7268-7269 [2010-3071]
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WReier-Aviles on DSKGBLS3C1PROD with NOTICES
7268
Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices
order, physician participants must
participate in active and ongoing
programs to evaluate and modify their
clinical practice patterns in order to
control costs and ensure the quality of
services provided, and the arrangement
must create a high degree of
interdependence and cooperation
among physicians. As with qualified
risk-sharing arrangements, any
agreement concerning price or other
terms of dealing must be reasonably
necessary to achieve the efficiency goals
of the joint arrangement.
Paragraph III, for three years, requires
RFV to notify the Commission before it
enters into any arrangements to act as a
messenger or an agent on behalf of any
physicians, with payers regarding
contracts. Paragraph IV sets out the
information necessary to make the
notification complete.
Paragraph V, for three years, requires
RFV to notify the Commission before
participating in contracting with health
plans on behalf of either a qualified risksharing or a qualified clinicallyintegrated joint arrangement. Paragraph
VI sets out the information necessary to
satisfy the notification requirement.
Paragraph VII imposes other
notification obligations on RFV and
requires the termination of certain
contracts that were entered into
illegally. Paragraph VII.A require RFV to
distribute the complaint and order to (1)
physicians who have participated in
RFV since 2001; (2) to various past and
current personnel of RFV; and (3) to
payers with whom RFV has dealt since
2001. Paragraph VII.B requires RFV, at
any payer’s request and without
penalty, to terminate its existing
contracts with the payer for the
provision of physician services.
Paragraph VII.B allows certain contracts
currently in effect to be extended at the
written request of the payer no longer
than one year from the date that the
order becomes final. Paragraph VII.C
requires RFV to distribute payer
requests for contract termination to
physicians who participate in the
contract Paragraph VII.D requires RFV
for three years, to provide new
members, personnel, and payers not
previously receiving a copy, a copy of
the Order and the Complaint. Paragraph
VII.D also requires RFV to publish
annually a copy of the Order and the
Complaint in its newsletter.
Paragraphs VIII, IX, and X impose
various obligations on RFV to report or
provide access to information to the
VerDate Nov<24>2008
14:39 Feb 17, 2010
Jkt 220001
Commission to facilitate the monitoring
of compliance with the order. Finally,
Paragraph XI provides that the order
will expire in 20 years.
By direction of the Commission.
Donald S. Clark
Secretary.
[FR Doc. 2010–3033 Filed 2–17–10: 7:19 am]
BILLING CODE 6750–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–New]
Agency Information Collection
Request; 60-Day Public Comment
Request
Office of the Secretary, HHS.
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Office of the Secretary (OS), Department
of Health and Human Services, is
publishing the following summary of a
proposed information collection request
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.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, e-mail your request,
including your address, phone number,
OMB number, and OS document
identifier, to
Sherette.funncoleman@hhs.gov, or call
the Reports Clearance Office on (202)
690–6162. Written comments and
recommendations for the proposed
information collections must be directed
to the OS Paperwork Clearance Officer
at the above e-mail address within 60days.
Proposed Project: Evaluation of
Medicare Personal Health Records
Choice Pilot—OMB No. 0990–NEW—
Office of the Assistant Secretary for
Planning and Evaluation.
AGENCY:
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
Abstract: Since 2003, HHS has
worked toward the goal of establishing
electronic, longitudinal health records
for Americans that can be accessed
safely, across the Internet, and anytime
and anywhere by patients, doctors, and
other health care providers. In addition
to electronic health records (EHRs),
where health information is created,
stored and accessed mainly by health
care organizations and practitioners,
personal health records (PHRs),
electronic, patient-centered applications
and services, are gaining increasing
recognition and momentum. Current
PHR business models represent broad
and varied uses, from disease
management to health promotion, with
sponsors consisting of commercial
vendors, heath plans, employers, and
health care providers. We know very
little about why consumers, and
specifically Medicare beneficiaries, elect
to use PHRs and what functionality they
want from a PHR. Understanding these
needs will be critical if HHS and the
Centers for Medicare & Medicaid
Services (CMS) are to pursue PHRs as a
tool to empower consumers to manage
their health and have the capability to
link to their provider’s EHR.
In January 2009, CMS launched a new
program in Arizona and Utah, the
Medicare PHR Choice Pilot (PHRC).
This pilot encourages Medicare fee-forservice (FFS) beneficiaries to take
advantage of the newer, more robust
Internet-based tools for tracking their
health and health care services. This is
the first pilot to offer a choice of PHRs
to Medicare FFS beneficiaries, including
PHRs with additional functionality and
direct data linkages for the consumers.
Pilot participants can choose among
GoogleHealthTM, NoMoreClipboardTM,
PassportMDTM, and HealthTrioTM,
competitors in the open PHR market.
HHS’ Office of the Assistant Secretary
for Planning and Evaluation (ASPE) has
contracted with Mathematica Policy
Research to conduct an evaluation of
this pilot program, including a PHR
enrollee user satisfaction survey to
assess barriers, facilitators, and
satisfaction with the PHRs. A selfadministered paper-and-pencil
instrument will be the primary data
collection mode for the PHRC user
satisfaction survey, with telephone
followup for mail nonrespondents. The
one-time data collection field period is
expected to be 12 weeks in Fall 2010.
E:\FR\FM\18FEN1.SGM
18FEN1
7269
Federal Register / Vol. 75, No. 32 / Thursday, February 18, 2010 / Notices
ESTIMATED ANNUALIZED BURDEN TABLE
Forms
(if necessary)
Type of
respondent
Self-administered questionnaire .......
Medicare beneficiaries .....................
Seleda Perryman,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. 2010–3071 Filed 2–17–10; 8:45 am]
BILLING CODE 4150–05–P
Food and Drug Administration
[Docket No. FDA–2010–N–0074]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Registration and
Product Listing for Owners and
Operators of Domestic Tobacco
Product Establishments and Listing of
Ingredients in Tobacco Products
Food and Drug Administration,
HHS.
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
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, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the proposed extension of an existing
collection of information pertaining to
registration and product listing for
owners and operators of domestic
tobacco product establishments and to
listing of ingredients in tobacco
products under the Family Smoking
Prevention and Tobacco Control Act
(the Tobacco Control Act).
DATES: Submit written or electronic
comments on the collection of
information by April 19, 2010.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
VerDate Nov<24>2008
16:37 Feb 17, 2010
Jkt 220001
Total burden
hours
500
1
25/60
208
........................
........................
208
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3794,
Jonnalynn.Capezzuto@fda.hhs.gov.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
Average
burden hours
per response
500
Total ...........................................
AGENCY:
Number of
responses per
respondent
Number of
respondents
Under the
PRA (44 U.S.C. 3501–3520), Federal
agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined in
44 U.S.C. 3502(3) and 5 CFR 1320.3(c)
and includes agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires Federal agencies
to provide a 60-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
Registration and Product Listing for
Owners and Operators of Domestic
Tobacco Product Establishments and
Listing of Ingredients in Tobacco
Products (OMB Control Number 0910–
0650)—Extension
On June 22, 2009, the President
signed the Tobacco Control Act (Public
Law 111–31) into law. The Tobacco
Control Act amended the Federal Food,
Drug, and Cosmetic Act (the act) (21
U.S.C. 301 et seq.) by, among other
things, adding a new chapter granting
FDA important new authority to
regulate the manufacture, marketing,
and distribution of tobacco products to
protect the public health generally and
to reduce tobacco use by minors.
Section 905(b) of the act (21 U.S.C.
395(b)), as amended by the Tobacco
Control Act, requires that ‘‘every person
who owns or operates any establishment
in any State engaged in the
manufacture, preparation,
compounding, or processing of a
tobacco product or tobacco products
* * *’’ register with FDA the name,
places of business, and all
establishments owned or operated by
that person. Every person must register
by December 31 of each year. Section
905(i)(1) of the act, as amended by the
Tobacco Control Act, requires that all
registrants ‘‘shall, at the time of
registration under any such subsection,
file with [FDA] a list of all tobacco
products which are being manufactured,
prepared, compounded, or processed by
that person for commercial
distribution,’’ along with certain
accompanying consumer information,
such as all labeling and a representative
sampling of advertisements. Section
904(a)(1) of the act, as amended by the
Tobacco Control Act, requires each
tobacco product manufacturer or
importer, or agent thereof, to submit ‘‘a
listing of all ingredients, including
tobacco, substances, compounds, and
additives that are * * * added by the
manufacturer to the tobacco, paper,
filter, or other part of each tobacco
product by brand and by quantity in
each brand and subbrand.’’ Since the
Tobacco Control act was enacted on
June 22, 2009, the information required
under section 904(a)(1) must be
submitted to FDA by December 22,
E:\FR\FM\18FEN1.SGM
18FEN1
Agencies
[Federal Register Volume 75, Number 32 (Thursday, February 18, 2010)]
[Notices]
[Pages 7268-7269]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-3071]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-New]
Agency Information Collection Request; 60-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS.
In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Office of the Secretary (OS),
Department of Health and Human Services, is publishing the following
summary of a proposed information collection request 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.
To obtain copies of the supporting statement and any related forms
for the proposed paperwork collections referenced above, e-mail your
request, including your address, phone number, OMB number, and OS
document identifier, to Sherette.funncoleman@hhs.gov, or call the
Reports Clearance Office on (202) 690-6162. Written comments and
recommendations for the proposed information collections must be
directed to the OS Paperwork Clearance Officer at the above e-mail
address within 60-days.
Proposed Project: Evaluation of Medicare Personal Health Records
Choice Pilot--OMB No. 0990-NEW--Office of the Assistant Secretary for
Planning and Evaluation.
Abstract: Since 2003, HHS has worked toward the goal of
establishing electronic, longitudinal health records for Americans that
can be accessed safely, across the Internet, and anytime and anywhere
by patients, doctors, and other health care providers. In addition to
electronic health records (EHRs), where health information is created,
stored and accessed mainly by health care organizations and
practitioners, personal health records (PHRs), electronic, patient-
centered applications and services, are gaining increasing recognition
and momentum. Current PHR business models represent broad and varied
uses, from disease management to health promotion, with sponsors
consisting of commercial vendors, heath plans, employers, and health
care providers. We know very little about why consumers, and
specifically Medicare beneficiaries, elect to use PHRs and what
functionality they want from a PHR. Understanding these needs will be
critical if HHS and the Centers for Medicare & Medicaid Services (CMS)
are to pursue PHRs as a tool to empower consumers to manage their
health and have the capability to link to their provider's EHR.
In January 2009, CMS launched a new program in Arizona and Utah,
the Medicare PHR Choice Pilot (PHRC). This pilot encourages Medicare
fee-for-service (FFS) beneficiaries to take advantage of the newer,
more robust Internet-based tools for tracking their health and health
care services. This is the first pilot to offer a choice of PHRs to
Medicare FFS beneficiaries, including PHRs with additional
functionality and direct data linkages for the consumers. Pilot
participants can choose among GoogleHealth\TM\, NoMoreClipboard\TM\,
PassportMD\TM\, and HealthTrio\TM\, competitors in the open PHR market.
HHS' Office of the Assistant Secretary for Planning and Evaluation
(ASPE) has contracted with Mathematica Policy Research to conduct an
evaluation of this pilot program, including a PHR enrollee user
satisfaction survey to assess barriers, facilitators, and satisfaction
with the PHRs. A self-administered paper-and-pencil instrument will be
the primary data collection mode for the PHRC user satisfaction survey,
with telephone followup for mail nonrespondents. The one-time data
collection field period is expected to be 12 weeks in Fall 2010.
[[Page 7269]]
Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Forms (if necessary) Type of Number of responses per hours per Total burden
respondent respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Self-administered Medicare 500 1 25/60 208
questionnaire. beneficiaries.
---------------------------------------------------------------
Total..................... 500 .............. .............. 208
----------------------------------------------------------------------------------------------------------------
Seleda Perryman,
Office of the Secretary, Paperwork Reduction Act Reports Clearance
Officer.
[FR Doc. 2010-3071 Filed 2-17-10; 8:45 am]
BILLING CODE 4150-05-P