[Federal Register Volume 79, Number 56 (Monday, March 24, 2014)]
[Notices]
[Pages 16002-16003]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-06317]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-14-13XA]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
(404) 639-7570 or send an email to [email protected]. Send written comments
to 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--New--National Center for HIV/AIDS, Viral Hepatitis,
STD and TB Prevention (NCHHSTP), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The CDC has entered into a partnership with Walgreen Company
[[Page 16003]]
(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 will include 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.
CDC requests OMB approval to collect standardized information from
ten project sites over the three year project period. CDC also requests
approval to conduct retrospective data collection during the first year
of the three-year project period. This retrospective data collection
will be used to determine both project sites' and participants'
baseline characteristics which are needed to compare outcomes before
and after program implementation.
Pharmacy, laboratory, and medical data will be 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 site
personnel.
The data collection will allow CDC to conduct continuous program
performance monitoring. Program performance monitoring will allow
adjustment of the model program, as needed, in order to develop a final
implementation model which can be used to establish similar
collaborations in a variety of clinical settings. The data collection
will also allow comparison of project outcomes within the project
cohort.
There is no cost to participants other than their time. The total
estimated annualized burden hours are 5,113.
Estimated Annualized Burden Hours
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Average
Number of Number of burden per
Type of respondent Form name respondents responses per response (in
respondent 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.
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LeRoy 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. 2014-06317 Filed 3-21-14; 8:45 am]
BILLING CODE 4163-18-P