[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
----------------------------------------------------------------------------------------------------------------
                                                                                                      Average
                                                                     Number of       Number of      burden per
          Type of respondent                    Form name           respondents    responses per   response  (in
                                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
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