Agency Information Collection Activities: Proposed Collection; Comment Request, 69567-69568 [06-9485]
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69567
Federal Register / Vol. 71, No. 231 / Friday, December 1, 2006 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Agency for Healthcare Research
and Quality, Department of Health and
Human Services.
ACTION: Notice.
AGENCY:
SUMMARY: This notice announces the
intention of the Agency for Healthcare
Research and Quality (AHRQ) to request
that the Office of Management and
Budget (OMB) allow the proposed
information collection project:
‘‘Evaluation of a Medication Therapy
Management Program to Improve
Patient Safety in Medicare
Beneficiaries.’’ In accordance with the
Paperwork Reduction Act of 1995,
Public Law 104–13 (44 U.S.C.
3506(c)(2)(A)), AHRQ invites the public
to comment on this proposed
information collection.
DATES: Comments on this notice must be
received by January 30, 2007.
ADDRESSES: Written comments should
be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, 540
Gaither Road, Room #5036, Rockville,
MD 20850.
Copies of the proposed collection
plans, data collection instruments, and
specific details on the estimated burden
can be obtained from AHRQ’s Reports
Clearance Officer.
FOR FURTHER INFORMATION CONTACT:
Doris Lefkowitz, AHRQ, Reports
Clearance Officer, (301) 427–1477.
SUPPLEMENTARY INFORMATION:
Proposed Project
‘‘Evaluation of a Medication Therapy
Management Program (MTMP) To
Improve Patient Safety in Medicare
Beneficiaries’’
The Medicare Modernization Act of
2003 (MMA) requires Medicare
prescription drug plans to have a MTMP
that is developed in cooperation with
licensed and practicing pharmacists and
physicians for targeted beneficiaries.
MTMP is defined in the MMA as a
program of drug therapy management
that is designed to assure, with respect
to targeted beneficiaries, that covered
part D drugs are appropriately used to
optimize therapeutic outcomes through
improved medication use, and to reduce
the risk of adverse events, including
adverse drug interactions.
The proposed MTMP research project
will prospectively evaluate the effects of
a specific drug therapy management
program on health outcomes and patient
safety in a group of research subjects
aged 65 or older, living with multiple
chronic health conditions and taking
multiple part D medications. The
evaluation will be designed as a
randomized, controlled study with
subjects recruited from multiple
ambulatory care or family practice
medical clinics in the States of Illinois,
North Carolina, and Texas. The study
will be coordinated by clinical
scientists, physicians, and pharmacists
affiliated with AHRQ, Baylor Health
Care System, Duke University, RTI
International, and the University of
Illinois at Chicago.
The study protocol and data
collection procedures for the MTMP
research evaluation will be reviewed by
the official Institutional Review Boards
at each participating study site. The
study will be conducted in accordance
with the rules and regulations of the
Health Insurance Protection and
Portability Act and with the ‘‘Guidelines
for the Conduct of Research Involving
Human Subjects.’’ An informed consent
will be obtained (see Table below) prior
to subject enrollment in the study. For
individuals who consent to participate,
confidential identifiable information
will be collected as described in the
informed consent document. Subjects
will be asked to provide information
about medication use, adherence to
prescription instructions, health
rmajette on PROD1PC67 with NOTICES1
Study Participants/Informed Consent ...............................................
Study Participants/Patient Survey ....................................................
Study Investigators and Personnel/Informed Consent .....................
Study Investigators and Personnel/Patient Survey ..........................
Study Investigators and Personnel/Medical Chart Review and Abstraction.
Study Investigators and Personnel/Preparing Electronic Pharmacy
Records.
Total ...........................................................................................
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400
400
400
400
400
..................
..................
..................
..................
..................
.........................
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The data will be collected using
several methods at study entry and at
the end of the study. Questionnaire data
will be obtained via direct patient
interview by clinical investigators who
will record the information on a paper
form. In addition, a self-administered
paper patient survey will be collected
during scheduled patient study visits in
both the intervention and control arms
to assess the effects of participation in
the medication therapy management
program. All survey forms will be
entered and maintained in a secure,
password-protected database. Patient
health, medication history, and
hospitalization information will be
obtained through a review of the
subjects’ electronic or paper medical
records. Information on prescriptions
filled (e.g., number of tablets, directions,
date filled) and refill frequency will be
obtained through electronic pharmacy
records, when these records are
available and when access is authorized
by the subject.
Estimated Annual Respondent Burden
The Table below indicates the total
time burden required to obtain all of the
data required to meet the study’s
objectives. The Table does not include
time required to analyze the data and
prepare it for statistical reporting,
analysis and publication.
Average burden
per response
(hours)
1
2
1
2
2
0.25
0.75
0.25
0.75
1
2
4 (from 4 different sites).
Fmt 4703
Methods of Collection
Number of
responses per
respondent
Number of
respondents
Respondents and response type
services use, health status, adverse drug
events, satisfaction with the MTMP, and
demographics. Study pharmacists will
assess subjects’ medication use, the
appropriateness of each prescribed
medication using a validated scale, and
will provide information about their
own satisfaction with the MTMP. All
study information will be entered and
maintained in a secure, passwordprotected database and will be protected
in accordance with AHRQ’s
confidentiality statute, Section 934(c) of
the Public Health Service Act (42 U.S.C.
299c–3(c)).
4
............................
E:\FR\FM\01DEN1.SGM
..............................
01DEN1
Total burden
(hours)
100
600
100
600
800
32
2232
69568
Federal Register / Vol. 71, No. 231 / Friday, December 1, 2006 / Notices
Estimated Costs to the Federal
Government
The cost estimate to the federal
government is $1,400,000.
Request for Comments
In accordance with the above-cited
legislation, comments on AHRQ’s
information collection are requested
with regard to any of the following: (a)
Whether the proposed collection of
information is necessary for the proper
performance of health care research and
information dissemination functions of
AHRQ, including whether the
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) of
information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the request for OMB
approval of the proposed information
collection. All comments will become a
matter of public record.
Dated: November 20, 2006.
Carolyn M. Clancy,
Director.
[FR Doc. 06–9485 Filed 11–30–06; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Notice of Meeting
In accordance with section 10(d) of
the Federal Advisory Committee Act (5
U.S.C., Appendix 2), announcement is
made of a Health Care Policy and
Research Special Emphasis Panel (SEP)
meeting.
A Special Emphasis Panel is a group
of experts in fields related to health care
research who are invited by the Agency
for Healthcare Research and Quality
(AHRQ), and agree to be available, to
conduct on an as needed basis,
scientific reviews of applications for
AHRQ support. Individual members of
the Panel do not attend regularly
scheduled meetings and do not serve for
fixed terms or a long period of time.
Rather, they are asked to participate in
particular review meetings which
require their type of expertise.
Substantial segments of the upcoming
SEP meeting listed below will be closed
to the public in accordance with the
Federal Advisory Committee Act,
section 10(d) of 5 U.S.C., Appendix 2
and 5 U.S.C. 552b(c)(6). Grant
applications for the Announcement of
Availability of Funds for Grants
regarding Adolescent Family Life (AFL)
Research are to be reviewed and
discussed at this meeting. This program
is sponsored by the Office of Population
Affairs. These discussions are likely to
reveal personal information concerning
individuals associated with the
applications. This information is
exempt from mandatory disclosure
under the above-cited statutes.
SEP Meeting on: Announcement of
Availability of Funds for Grants
regarding Adolescent Family Life (AFL)
Research.
Date: December 11, 2006 (Open on
December 11 from 8:30 a.m. to 8:45 a.m.
and closed for the remainder of the
meeting).
Place: John M. Eisenberg Building,
AHRQ Conference Center, 540 Gaither
Road, Rockville, Maryland 20850.
Contact Person: Anyone wishing to
obtain a roster of members, agenda or
minutes of the non-confidential portions
of this meeting should contact Mrs.
Bonnie Campbell, Committee
Management Officer, Office of
Extramural Research, Education and
Priority Populations, AHRQ, 540
Gaither Road, Room 2038, Rockville,
Maryland 20850, Telephone (301) 427–
1554.
Agenda items for this meeting are
subject to change as priorities dictate.
Dated: November 20, 2006.
Carolyn M. Clancy,
Director.
[FR Doc. 06–9486 Filed 11–30–06; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Itemized Undistributed
Collections (Schedule UDC).
OMB No.: 0970–0268.
Description: State agencies
administering the Child Support
Enforcement Program under Title IV–D
of the Social Security Act are required
to provide information each fiscal
quarter to the Office of Child Support
Enforcement (OCSE) concerning
administrative expenditures and the
receipt and disposition of child support
payments from non-custodial parents
(Forms OCSE–396A and OCSE–34A—
OMB NO. 0970–0181). Together with a
third quarterly report, ‘‘Itemized
Undistributed Collections,’’ these forms
provide information from each State
that is used to compute the quarterly
grant awards, the annual incentive
payments and provide valuable
information on program finances. This
information is also included in a
published annual statistical and
financial report, available to the general
public.
Public Law 109–171, the Deficit
Reduction Act of 2005, contains a
number of provisions that will impact
the States’ completion and submission
of these quarterly financial reports.
These changes become effective in fiscal
years 2006, 2007 and 2008. These
changes require revisions to some of the
data entry lines and reporting
instructions currently contained on
these forms. In addition, a periodic
review of the data currently requested
on these forms will assure that OCSE
collects the information needed in the
most efficient format feasible.
Respondents: State agencies
administering the Child Support
Enforcement Program.
ANNUAL BURDEN ESTIMATES
rmajette on PROD1PC67 with NOTICES1
Instrument
Number of
respondents
Number of
responses per
respondent
Average burden
hours per
response
Total burden
hours
Schedule UDC .................................................................................................
54
4
4
864
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01DEN1
]]>Agencies
[Federal Register Volume 71, Number 231 (Friday, December 1, 2006)]
[Notices]
[Pages 69567-69568]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-9485]
[[Page 69567]]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Agency Information Collection Activities: Proposed Collection;
Comment Request
AGENCY: Agency for Healthcare Research and Quality, Department of
Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces the intention of the Agency for
Healthcare Research and Quality (AHRQ) to request that the Office of
Management and Budget (OMB) allow the proposed information collection
project: ``Evaluation of a Medication Therapy Management Program to
Improve Patient Safety in Medicare Beneficiaries.'' In accordance with
the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C.
3506(c)(2)(A)), AHRQ invites the public to comment on this proposed
information collection.
DATES: Comments on this notice must be received by January 30, 2007.
ADDRESSES: Written comments should be submitted to: Doris Lefkowitz,
Reports Clearance Officer, AHRQ, 540 Gaither Road, Room 5036,
Rockville, MD 20850.
Copies of the proposed collection plans, data collection
instruments, and specific details on the estimated burden can be
obtained from AHRQ's Reports Clearance Officer.
FOR FURTHER INFORMATION CONTACT: Doris Lefkowitz, AHRQ, Reports
Clearance Officer, (301) 427-1477.
SUPPLEMENTARY INFORMATION:
Proposed Project
``Evaluation of a Medication Therapy Management Program (MTMP) To
Improve Patient Safety in Medicare Beneficiaries''
The Medicare Modernization Act of 2003 (MMA) requires Medicare
prescription drug plans to have a MTMP that is developed in cooperation
with licensed and practicing pharmacists and physicians for targeted
beneficiaries. MTMP is defined in the MMA as a program of drug therapy
management that is designed to assure, with respect to targeted
beneficiaries, that covered part D drugs are appropriately used to
optimize therapeutic outcomes through improved medication use, and to
reduce the risk of adverse events, including adverse drug interactions.
The proposed MTMP research project will prospectively evaluate the
effects of a specific drug therapy management program on health
outcomes and patient safety in a group of research subjects aged 65 or
older, living with multiple chronic health conditions and taking
multiple part D medications. The evaluation will be designed as a
randomized, controlled study with subjects recruited from multiple
ambulatory care or family practice medical clinics in the States of
Illinois, North Carolina, and Texas. The study will be coordinated by
clinical scientists, physicians, and pharmacists affiliated with AHRQ,
Baylor Health Care System, Duke University, RTI International, and the
University of Illinois at Chicago.
The study protocol and data collection procedures for the MTMP
research evaluation will be reviewed by the official Institutional
Review Boards at each participating study site. The study will be
conducted in accordance with the rules and regulations of the Health
Insurance Protection and Portability Act and with the ``Guidelines for
the Conduct of Research Involving Human Subjects.'' An informed consent
will be obtained (see Table below) prior to subject enrollment in the
study. For individuals who consent to participate, confidential
identifiable information will be collected as described in the informed
consent document. Subjects will be asked to provide information about
medication use, adherence to prescription instructions, health services
use, health status, adverse drug events, satisfaction with the MTMP,
and demographics. Study pharmacists will assess subjects' medication
use, the appropriateness of each prescribed medication using a
validated scale, and will provide information about their own
satisfaction with the MTMP. All study information will be entered and
maintained in a secure, password-protected database and will be
protected in accordance with AHRQ's confidentiality statute, Section
934(c) of the Public Health Service Act (42 U.S.C. 299c-3(c)).
Methods of Collection
The data will be collected using several methods at study entry and
at the end of the study. Questionnaire data will be obtained via direct
patient interview by clinical investigators who will record the
information on a paper form. In addition, a self-administered paper
patient survey will be collected during scheduled patient study visits
in both the intervention and control arms to assess the effects of
participation in the medication therapy management program. All survey
forms will be entered and maintained in a secure, password-protected
database. Patient health, medication history, and hospitalization
information will be obtained through a review of the subjects'
electronic or paper medical records. Information on prescriptions
filled (e.g., number of tablets, directions, date filled) and refill
frequency will be obtained through electronic pharmacy records, when
these records are available and when access is authorized by the
subject.
Estimated Annual Respondent Burden
The Table below indicates the total time burden required to obtain
all of the data required to meet the study's objectives. The Table does
not include time required to analyze the data and prepare it for
statistical reporting, analysis and publication.
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Respondents and response type Number of respondents responses per per response Total burden
respondent (hours) (hours)
----------------------------------------------------------------------------------------------------------------
Study Participants/Informed 400................... 1 0.25 100
Consent.
Study Participants/Patient Survey 400................... 2 0.75 600
Study Investigators and Personnel/ 400................... 1 0.25 100
Informed Consent.
Study Investigators and Personnel/ 400................... 2 0.75 600
Patient Survey.
Study Investigators and Personnel/ 400................... 2 1 800
Medical Chart Review and
Abstraction.
Study Investigators and Personnel/ 4 (from 4 different 2 4 32
Preparing Electronic Pharmacy sites).
Records.
����������������������������������
Total........................ ...................... ................ ................. 2232
----------------------------------------------------------------------------------------------------------------
[[Page 69568]]
Estimated Costs to the Federal Government
The cost estimate to the federal government is $1,400,000.
Request for Comments
In accordance with the above-cited legislation, comments on AHRQ's
information collection are requested with regard to any of the
following: (a) Whether the proposed collection of information is
necessary for the proper performance of health care research and
information dissemination functions of AHRQ, including whether the
information will have practical utility; (b) the accuracy of AHRQ's
estimate of burden (including hours and costs) of the proposed
collection(s) of information; (c) ways to enhance the quality, utility,
and clarity of the information to be collected; and (d) ways to
minimize the burden of the collection of information upon the
respondents, including the use of automated collection techniques or
other forms of information technology.
Comments submitted in response to this notice will be summarized
and included in the request for OMB approval of the proposed
information collection. All comments will become a matter of public
record.
Dated: November 20, 2006.
Carolyn M. Clancy,
Director.
[FR Doc. 06-9485 Filed 11-30-06; 8:45 am]
BILLING CODE 4160-90-M
