[Federal Register Volume 80, Number 103 (Friday, May 29, 2015)]
[Notices]
[Pages 30682-30683]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-12996]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-15-1019]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) has submitted
the following information collection request to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act of 1995. The notice for the proposed
information collection is published to obtain comments from the public
and affected agencies.
Written comments and suggestions from the public and affected
agencies concerning the proposed collection of information are
encouraged. Your comments should address any of the following: (a)
Evaluate whether the proposed collection of information is necessary
for the proper performance of the functions of the agency, including
whether the information will have practical utility; (b) Evaluate the
accuracy of the agencies estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (c) Enhance the quality, utility, and clarity of
the information to be collected; (d) Minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570 or send an email to [email protected]. Written comments and/or
suggestions regarding the items contained in this notice should be
directed to the Attention: CDC Desk Officer, Office of Management and
Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written
comments should be received within 30 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, Hepatitis, STD, and TB Prevention, Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Revisions to this information collection include the addition of an
Interviewer data collection worksheet, Key Informant Interviewer
script, Staff communication questionnaire, Clinic cost form and
Pharmacy cost form. These additions are needed in order to determine
changes to clinic and pharmacy work systems, processes and outcomes in
relation to the model project and how and if the model program improves
patient outcomes through improved communication and collaboration
between patients' clinical providers and pharmacists. In order to
determine the general feasibility of the model program, the time
required conducting program activities and the associated cost of
program activities must be determined. Collection of data from the
previously approved Initial patient information forms, Quarterly
patient information forms, Pharmacy record abstraction forms, Project
clinic characteristics forms, and Project pharmacy characteristics
forms is ongoing. Clinic staff will use the initial information Sheet
to explain the project to patients.
CDC has entered into a partnership with Walgreen Company (a.k.a.
Walgreens pharmacies, a national retail pharmacy chain) and the
University of North Texas Health Science Center 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 at ten sites and will provide patient-
centered HIV care for approximately 1,000 persons.
The patient-centered HIV care model includes the core elements of
pharmacist provided Medication Therapy Management (MTM) as well as
additional pharmacist 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 HIV viral load
suppression.
Pharmacy, laboratory and medical data are collected through
abstraction of participant clients' pharmacy and medical records. These
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
project sites' characteristics, will be collected by project sites.
This information 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. The total estimated annualized burden hours are 6,043.
[[Page 30683]]
Estimated Annualized Burden Hours
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Number of Average burden
Type of respondent Form name Number of responses per per response
respondents respondent (in hours)
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Clinic Data Manager................... Project clinic 10 3 30/60
characteristics form.
Pharmacist............................ Project pharmacy 10 3 30/60
characteristics form.
Clinic Data Manager................... Patient Demographic 10 100 5/60
Information form.
Clinic Data Manager................... Initial patient 10 100 1
information form.
Clinic Data Manager................... Quarterly patient 10 400 30/60
information form.
Pharmacist............................ Pharmacy record 10 400 30/60
abstraction form.
Key informants........................ Interviewer data 60 2 30/60
collection worksheet.
Project pharmacists and clinic staff.. Staff communication 70 2 15/60
questionnaire.
Clinic staff.......................... Clinic cost form........ 20 2 10
Pharmacy staff........................ Pharmacy cost form...... 20 2 10
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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. 2015-12996 Filed 5-28-15; 8:45 am]
BILLING CODE 4163-18-P