[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