81 FR 8203 - Agency Forms Undergoing Paperwork Reduction Act Review

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 81, Issue 32 (February 18, 2016)

[Federal Register Volume 81, Number 32 (Thursday, February 18, 2016)]
[Notices]
[Pages 8203-8204]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-03304]



[[Page 8203]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30 Day-16-1019]


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 0920-1019, expires 8/31/2018)--Revision--
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.
    On May 16, 2014 OMB approved the collection of standardized 
information from ten project sites over the three-year project period 
and one 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. On August 17, 2015, OMB 
approved the conduct of key informant interviews with program clinic 
and pharmacy staff in order to evaluate the program processes, 
administration of a staff communication questionnaire, and OMB approved 
the collection of time and cost data to be used to estimate the cost of 
the model program.
    CDC newly requests approval to administer a staff communication 
questionnaire for medical providers in order to determine how and if 
the model program improves patient outcomes through improved 
communication and collaboration between patients' clinical providers 
and pharmacists. The staff communication questionnaire for medical 
providers will be administered twice to program clinic staff. The staff 
communication questionnaire for medical providers is different from the 
previously improved staff communication questionnaire; the staff 
communication questionnaire for medical providers will be administered 
to program clinic staff whereas the staff communication questionnaire 
will be administered to program pharmacy staff.
    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 and time spent on program activities, will 
be collected by program. Qualitative data will be gathered from program 
staff through in-person or telephone interviews and through a 
questionnaire to program pharmacy staff and a separate questionnaire to 
program clinic staff.
    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. 
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 8204]]



                                        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)
----------------------------------------------------------------------------------------------------------------
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 staff (pharmacists)...........  Staff communication                   30               2           30/60
                                         questionnaire.
Project staff (medical providers).....  Staff communication                   40               2           30/60
                                         questionnaire for
                                         medical providers.
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. 2016-03304 Filed 2-17-16; 8:45 am]
 BILLING CODE 4163-18-P