[Federal Register Volume 80, Number 20 (Friday, January 30, 2015)]
[Notices]
[Pages 5114-5115]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-01698]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-15-1019]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    The Centers for Disease Control and Prevention (CDC), as part of 
its continuing effort to reduce public burden and maximize the utility 
of government information, invites the general public and other Federal 
agencies to take this opportunity to comment on proposed and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. To request more information on the below 
proposed project or to obtain a copy of the information collection plan 
and instruments, call 404-639-7570 or send comments to Leroy A. 
Richardson, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an 
email to [email protected].
    Comments submitted in response to this notice will be summarized 
and/or included in the request for Office of Management and Budget 
(OMB) approval. 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; (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; and (e) 
estimates of capital or start-up costs and costs of operation, 
maintenance, and purchase of services to provide information. Burden 
means the total time, effort, or financial resources expended by 
persons to generate, maintain, retain, disclose or provide information 
to or for a Federal agency. This includes the time needed to review 
instructions; to develop, acquire, install and utilize technology and 
systems for the purpose of collecting, validating and verifying 
information, processing and maintaining information, and disclosing and 
providing information; to train personnel and to be able to respond to 
a collection of information, to search data sources, to complete and 
review the collection of information; and to transmit or otherwise 
disclose the information. Written comments should be received within 60 
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/AIDS, Viral Hepatitis, STD, and TB Prevention, 
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. MTM 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 been 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 16 May 2014, OMB approved the collection of standardized 
information from ten project sites over the three-year

[[Page 5115]]

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. 
Minor formatting revisions are requested to the previously approved 
data collection forms. Lastly, CDC newly requests approval to conduct 
key informant interviews with program clinic and pharmacy staff in 
order to evaluate the program processes and to collect time and cost 
data which will be used to estimate the cost of the model program. The 
key informant interviews and time and cost data are additional data 
collections from the original OMB approval.
    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.
    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.

                                                            Estimated Annualized Burden Hours
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                                                                                                             Number of    Average burden
               Type of respondent                               Form name                    Number of     responses per   per response    Total burden
                                                                                            respondents     respondent      (in hours)      (in hours)
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Clinic Data Manager............................  Project clinic characteristics form....              10               3           30/60              15
Pharmacist.....................................  Project pharmacy characteristics form..              10               3           30/60              15
Clinic Data Manager............................  Patient Demographic Information form...              10             100            5/60              83
Clinic Data Manager............................  Initial patient information form.......              10             100               1           1,000
Clinic Data Manager............................  Quarterly patient information form.....              10             400           30/60           2,000
Pharmacist.....................................  Pharmacy record abstraction form.......              10             400           30/60           2,000
Key informants.................................  Interviewer data collection worksheet..              60               2           30/60              60
Clinic staff...................................  Clinic cost form.......................              20               2              10             400
Pharmacy staff.................................  Pharmacy cost form.....................              20               2              10             400
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............           5,973
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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. 2015-01698 Filed 1-29-15; 8:45 am]
BILLING CODE 4163-18-P