[Federal Register Volume 78, Number 117 (Tuesday, June 18, 2013)]
[Notices]
[Pages 36550-36551]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-14435]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-13-13XA]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    In compliance with the requirement of Section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995 for opportunity for public comment on 
proposed data collection projects, the Centers for Disease Control and 
Prevention (CDC) will publish periodic summaries of proposed projects. 
To request more information on the proposed projects or to obtain a 
copy of the data collection plans and instruments, call 404-639-7570 or 
send comments to Ron Otten, 1600 Clifton Road, MS-D74, Atlanta, GA 
30333 or send an email to [email protected].
    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; and (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. Written comments should be received 
within 60 days of this notice.

Proposed Project

    Improving HIV Prevention and Treatment Outcomes Among HIV-Infected 
Persons by Integrating Community Pharmacists and Clinical Sites into a 
Model of 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

    Medication Therapy Management (MTM) is a group of pharmacist 
provided services that is independent of, but can occur in conjunction 
with, provision of medication. Medication Therapy Management 
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 be 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.
    CDC requests OMB approval to collect standardized information, from 
ten project sites over the three year project period. CDC also requests 
approval to conduct one cycle of 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.
    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 will be collected by program. Qualitative 
data will be gathered from program staff through in-person or telephone 
interviews.

[[Page 36551]]

    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. 
There is no cost to participants other than their time.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondent           Form name        respondents    responses per   response  (in    (in hours)
                                                                    respondent        hours)
----------------------------------------------------------------------------------------------------------------
Clinic Data Manager..........  Project clinic                 10               1           30/60               5
                                characteristics
                                form.
Pharmacist...................  Project pharmacy               10               1           30/60               5
                                characteristics
                                form.
Clinic Data Manager..........  Initial medical                10               1              50             500
                                abstraction form.
Clinic Data Manager..........  Follow-up medical              10               4              25           1,000
                                abstraction form.
Pharmacist...................  Pharmacy                       10               4              25           1,000
                                abstraction form.
Clinic and pharmacy staff....  Interview form...              60               4           45/60             180
                                                 ---------------------------------------------------------------
    Total....................  .................  ..............  ..............  ..............           2,690
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Ron A. Otten,
Director, Office of Scientific Integrity, Office of the Associate 
Director for Science, Office of the Director, Centers for Disease 
Control and Prevention.
[FR Doc. 2013-14435 Filed 6-17-13; 8:45 am]
BILLING CODE 4163-18-P