[Federal Register Volume 81, Number 32 (Thursday, February 18, 2016)]
[Notices]
[Pages 8203-8204]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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)
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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 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