Proposed Data Collections Submitted for Public Comment and Recommendations, 5114-5115 [2015-01698]
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18:50 Jan 29, 2015
Jkt 235001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–15–1019]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
The Centers for Disease Control and
Prevention (CDC), as part of its
continuing effort to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies to take this opportunity to
comment on proposed and/or
continuing information collections, as
required by the Paperwork Reduction
Act of 1995. To request more
information on the below proposed
project or to obtain a copy of the
information collection plan and
instruments, call 404–639–7570 or send
comments to Leroy A. Richardson, 1600
Clifton Road, MS–D74, Atlanta, GA
30333 or send an email to omb@cdc.gov.
Comments submitted in response to
this notice will be summarized and/or
included in the request for Office of
Management and Budget (OMB)
approval. Comments are invited on: (a)
Whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; (d) ways to
minimize the burden of the collection of
information on respondents, including
through the use of automated collection
techniques or other forms of information
technology; and (e) estimates of capital
or start-up costs and costs of operation,
maintenance, and purchase of services
to provide information. Burden means
the total time, effort, or financial
resources expended by persons to
generate, maintain, retain, disclose or
provide information to or for a Federal
agency. This includes the time needed
to review instructions; to develop,
acquire, install and utilize technology
and systems for the purpose of
collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information; and to
transmit or otherwise disclose the
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Frm 00035
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information. Written comments should
be received within 60 days of this
notice.
Proposed Project
Integrating Community Pharmacists
and Clinical Sites for Patient-Centered
HIV Care (OMB No. 0920–1019, expires
05/31/2017)—Revision—National
Center for HIV/AIDS, Viral Hepatitis,
STD, and TB Prevention, Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Medication Therapy Management
(MTM) is a group of pharmacist
provided services that is independent
of, but can occur in conjunction with,
provision of medication. MTM
encompasses a broad range of
professional activities and cognitive
services within the licensed
pharmacists’ scope of practice and can
include monitoring prescription filling
patterns and timing of refills, checking
for medication interactions, patient
education, and monitoring of patient
response to drug therapy.
HIV specific MTM programs have
demonstrated success in improving HIV
medication therapy adherence and
persistence. While MTM programs have
been shown to be effective in increasing
medication adherence for HIV-infected
persons, no MTM programs have been
expanded to incorporate primary
medical providers in an effort to
establish patient-centered HIV care. To
address this problem CDC has entered
into a public-private partnership with
Walgreen Company (a.k.a Walgreens
pharmacies, a national retail pharmacy
chain) to develop and implement a
model of HIV care that integrates
community pharmacists with primary
medical providers for patient-centered
HIV care. The model program will be
implemented in ten sites and will
provide patient-centered HIV care for
approximately 1,000 persons.
The patient-centered HIV care model
will include the core elements of MTM
as well as additional services such as
individualized medication adherence
counseling, active monitoring of
prescription refills and active
collaboration between pharmacists and
medical clinic providers to identify and
resolve medication related treatment
problems such as treatment
effectiveness, adverse events and poor
adherence. The expected outcomes of
the model program are increased
retention in HIV care, adherence to HIV
medication therapy and viral load
suppression.
On 16 May 2014, OMB approved the
collection of standardized information
from ten project sites over the three-year
E:\FR\FM\30JAN1.SGM
30JAN1
5115
Federal Register / Vol. 80, No. 20 / Friday, January 30, 2015 / Notices
project period and one retrospective
data collection during the first year of
the three-year project period. The
retrospective data collection will
provide information about clients’
baseline characteristics prior to
participation in the model program
which is needed to compare outcomes
before and after program
implementation. Minor formatting
revisions are requested to the previously
approved data collection forms. Lastly,
CDC newly requests approval to
conduct key informant interviews with
program clinic and pharmacy staff in
order to evaluate the program processes
and to collect time and cost data which
will be used to estimate the cost of the
The data collection will allow CDC to
conduct continuous program
performance monitoring which includes
identification of barriers to program
implementation, solutions to those
barriers, and documentation of client
health outcomes. Performance
monitoring will allow the model
program to be adjusted, as needed, in
order to develop a final implementation
model that is self-sustaining and which
can be used to establish similar
collaborations in a variety of clinical
settings. Collection of cost data will
allow for the cost of the program to be
estimated.
There is no cost to participants other
than their time.
model program. The key informant
interviews and time and cost data are
additional data collections from the
original OMB approval.
Pharmacy, laboratory and medical
data will be collected through
abstraction of all participant clients’
pharmacy and medical records.
Pharmacy, laboratory and medical data
are needed to monitor retention in care,
adherence to therapy, viral load
suppression and other health outcomes.
Program specific data, such as the
number of MTM elements completed
per project site and time spent on
program activities, will be collected by
program. Qualitative data will be
gathered from program staff through inperson or telephone interviews.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
(in hours)
Type of respondent
Form name
Clinic Data Manager ......
Pharmacist .....................
Clinic Data Manager ......
Clinic Data Manager ......
Clinic Data Manager ......
Pharmacist .....................
Key informants ...............
Clinic staff ......................
Pharmacy staff ...............
Project clinic characteristics form ........................
Project pharmacy characteristics form ................
Patient Demographic Information form ...............
Initial patient information form .............................
Quarterly patient information form .......................
Pharmacy record abstraction form ......................
Interviewer data collection worksheet .................
Clinic cost form ....................................................
Pharmacy cost form ............................................
10
10
10
10
10
10
60
20
20
3
3
100
100
400
400
2
2
2
30/60
30/60
5/60
1
30/60
30/60
30/60
10
10
15
15
83
1,000
2,000
2,000
60
400
400
Total ........................
..............................................................................
........................
........................
........................
5,973
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2015–01698 Filed 1–29–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
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Advisory Committee on Immunization
Practices: Notice of Charter
Amendment
This gives notice under the Federal
Advisory Committee Act (Pub. L. 92–
463) of October 6, 1972, that the
Advisory Committee on Immunization
Practices, Centers for Disease Control
and Prevention (CDC), Department of
Health and Human Services (HHS), has
amended their charter to reflect the
change in the filing date. The amended
filing date is January 13, 2015.
VerDate Sep<11>2014
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Jkt 235001
For information, contact Dr. Larry
Pickering, Designated Federal Officer,
Advisory Committee on Immunization
Practices, HHS, CDC, 1600 Clifton Road
NE., Mailstop E05, Atlanta, Georgia
30333, telephone (404) 639–8562 or fax
(404) 639–8626.
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and Services Office, has been delegated
the authority to sign Federal Register
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meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
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Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 2015–01767 Filed 1–29–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Advisory Committee to the Director
(ACD), Centers for Disease Control and
Prevention—Health Disparities
Subcommittee (HDS)
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following meeting of the
aforementioned subcommittee:
Time and Date: 11:00 a.m.–12:30 p.m. EST,
February 26, 2015.
Place: This meeting will be held by
teleconference.
Status: This meeting is open to the public,
limited only by the availability of telephone
ports. The public is welcome to participate
during the public comment, which is
tentatively scheduled from 12:15 to 12:30
p.m. To participate in the teleconference,
please dial (866) 763–0273 Passcode:
6158968.
Purpose: The Subcommittee will provide
advice to the CDC Director through the ACD
on strategic and other health disparities and
E:\FR\FM\30JAN1.SGM
30JAN1
Agencies
[Federal Register Volume 80, Number 20 (Friday, January 30, 2015)]
[Notices]
[Pages 5114-5115]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01698]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-15-1019]
Proposed Data Collections Submitted for Public Comment and
Recommendations
The Centers for Disease Control and Prevention (CDC), as part of
its continuing effort to reduce public burden and maximize the utility
of government information, invites the general public and other Federal
agencies to take this opportunity to comment on proposed and/or
continuing information collections, as required by the Paperwork
Reduction Act of 1995. To request more information on the below
proposed project or to obtain a copy of the information collection plan
and instruments, call 404-639-7570 or send comments to Leroy A.
Richardson, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an
email to omb@cdc.gov.
Comments submitted in response to this notice will be summarized
and/or included in the request for Office of Management and Budget
(OMB) approval. Comments are invited on: (a) Whether the proposed
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information shall
have practical utility; (b) the accuracy of the agency's estimate of
the burden of the proposed collection of information; (c) ways to
enhance the quality, utility, and clarity of the information to be
collected; (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology; and (e)
estimates of capital or start-up costs and costs of operation,
maintenance, and purchase of services to provide information. Burden
means the total time, effort, or financial resources expended by
persons to generate, maintain, retain, disclose or provide information
to or for a Federal agency. This includes the time needed to review
instructions; to develop, acquire, install and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information, to search data sources, to complete and
review the collection of information; and to transmit or otherwise
disclose the information. Written comments should be received within 60
days of this notice.
Proposed Project
Integrating Community Pharmacists and Clinical Sites for Patient-
Centered HIV Care (OMB No. 0920-1019, expires 05/31/2017)--Revision--
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention,
Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Medication Therapy Management (MTM) is a group of pharmacist
provided services that is independent of, but can occur in conjunction
with, provision of medication. MTM encompasses a broad range of
professional activities and cognitive services within the licensed
pharmacists' scope of practice and can include monitoring prescription
filling patterns and timing of refills, checking for medication
interactions, patient education, and monitoring of patient response to
drug therapy.
HIV specific MTM programs have demonstrated success in improving
HIV medication therapy adherence and persistence. While MTM programs
have been shown to be effective in increasing medication adherence for
HIV-infected persons, no MTM programs have been expanded to incorporate
primary medical providers in an effort to establish patient-centered
HIV care. To address this problem CDC has entered into a public-private
partnership with Walgreen Company (a.k.a Walgreens pharmacies, a
national retail pharmacy chain) to develop and implement a model of HIV
care that integrates community pharmacists with primary medical
providers for patient-centered HIV care. The model program will be
implemented in ten sites and will provide patient-centered HIV care for
approximately 1,000 persons.
The patient-centered HIV care model will include the core elements
of MTM as well as additional services such as individualized medication
adherence counseling, active monitoring of prescription refills and
active collaboration between pharmacists and medical clinic providers
to identify and resolve medication related treatment problems such as
treatment effectiveness, adverse events and poor adherence. The
expected outcomes of the model program are increased retention in HIV
care, adherence to HIV medication therapy and viral load suppression.
On 16 May 2014, OMB approved the collection of standardized
information from ten project sites over the three-year
[[Page 5115]]
project period and one retrospective data collection during the first
year of the three-year project period. The retrospective data
collection will provide information about clients' baseline
characteristics prior to participation in the model program which is
needed to compare outcomes before and after program implementation.
Minor formatting revisions are requested to the previously approved
data collection forms. Lastly, CDC newly requests approval to conduct
key informant interviews with program clinic and pharmacy staff in
order to evaluate the program processes and to collect time and cost
data which will be used to estimate the cost of the model program. The
key informant interviews and time and cost data are additional data
collections from the original OMB approval.
Pharmacy, laboratory and medical data will be collected through
abstraction of all participant clients' pharmacy and medical records.
Pharmacy, laboratory and medical data are needed to monitor retention
in care, adherence to therapy, viral load suppression and other health
outcomes. Program specific data, such as the number of MTM elements
completed per project site and time spent on program activities, will
be collected by program. Qualitative data will be gathered from program
staff through in-person or telephone interviews.
The data collection will allow CDC to conduct continuous program
performance monitoring which includes identification of barriers to
program implementation, solutions to those barriers, and documentation
of client health outcomes. Performance monitoring will allow the model
program to be adjusted, as needed, in order to develop a final
implementation model that is self-sustaining and which can be used to
establish similar collaborations in a variety of clinical settings.
Collection of cost data will allow for the cost of the program to be
estimated.
There is no cost to participants other than their time.
Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent Form name Number of responses per per response Total burden
respondents respondent (in hours) (in hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Clinic Data Manager............................ Project clinic characteristics form.... 10 3 30/60 15
Pharmacist..................................... Project pharmacy characteristics form.. 10 3 30/60 15
Clinic Data Manager............................ Patient Demographic Information form... 10 100 5/60 83
Clinic Data Manager............................ Initial patient information form....... 10 100 1 1,000
Clinic Data Manager............................ Quarterly patient information form..... 10 400 30/60 2,000
Pharmacist..................................... Pharmacy record abstraction form....... 10 400 30/60 2,000
Key informants................................. Interviewer data collection worksheet.. 60 2 30/60 60
Clinic staff................................... Clinic cost form....................... 20 2 10 400
Pharmacy staff................................. Pharmacy cost form..................... 20 2 10 400
---------------------------------------------------------------
Total...................................... ....................................... .............. .............. .............. 5,973
--------------------------------------------------------------------------------------------------------------------------------------------------------
Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for Science, Office of the
Director, Centers for Disease Control and Prevention.
[FR Doc. 2015-01698 Filed 1-29-15; 8:45 am]
BILLING CODE 4163-18-P