80 FR 71806 - Proposed Data Collection Submitted for Public Comment and Recommendations

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

Federal Register Volume 80, Issue 221 (November 17, 2015)

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts 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. This notice invites comment on Integrating Community Pharmacists and Clinical Sites for Patient-Centered HIV Care. CDC is requesting a 3-year approval for revision to the previously approved project 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.

[Federal Register Volume 80, Number 221 (Tuesday, November 17, 2015)]
[Notices]
[Pages 71806-71807]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-29274]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-16-1019; Docket No. CDC-2015-0102]


Proposed Data Collection Submitted for Public Comment and 
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Notice with comment period.

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SUMMARY: The Centers for Disease Control and Prevention (CDC), as part 
of its continuing efforts 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.
    This notice invites comment on Integrating Community Pharmacists 
and Clinical Sites for Patient-Centered HIV Care. CDC is requesting a 
3-year approval for revision to the previously approved project 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.

DATES: Written comments must be received on or before January 19, 2016.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0102 by any of the following methods:
     Federal eRulemaking Portal: Regulation.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, Information Collection Review 
Office, Centers for Disease Control and Prevention, 1600 Clifton Road 
NE., MS-D74, Atlanta, Georgia 30329.
Instructions: All submissions received must include the agency name and 
Docket Number. All relevant comments received will be posted without 
change to Regulations.gov, including any personal information provided. 
For access to the docket to read background documents or comments 
received, go to Regulations.gov.
    Please note: All public comment should be submitted through the 
Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the 
address listed above.

FOR FURTHER INFORMATION CONTACT: To request more information on the 
proposed project or to obtain a copy of the information collection plan 
and instruments, contact the Information Collection Review Office, 
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected].

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from 
the Office of Management and Budget (OMB) for each collection of 
information they conduct or sponsor. In addition, the PRA also requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, including each new 
proposed collection, each proposed extension of existing collection of 
information, and each reinstatement of previously approved information 
collection before submitting the collection to OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    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.

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

[[Page 71807]]

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 seeks 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.

                                        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                10               3           30/60              15
                                 characteristics
                                 form.
Pharmacist....................  Project pharmacy              10               3           30/60              15
                                 characteristics
                                 form.
Clinic Data Manager...........  *Patient                      10             100            5/60              83
                                 Demographic
                                 Information
                                 form.
Clinic Data Manager...........  *Initial patient              10             100               1           1,000
                                 information
                                 form.
Clinic Data Manager...........  Quarterly                     10             400           30/60           2,000
                                 patient
                                 information
                                 form.
Pharmacist....................  Pharmacy record               10             400           30/60           2,000
                                 abstraction
                                 form.
Key informants................  Interviewer data              60               2           30/60              60
                                 collection
                                 worksheet.
Project staff (pharmacists)...  Staff                         30               2           30/60              30
                                 communication
                                 questionnaire.
Project staff (medical          Staff                         40               2           30/60              40
 providers).                     communication
                                 questionnaire
                                 for medical
                                 providers.
Clinic staff..................  Clinic cost form              20               2              10             400
Pharmacy staff................  Pharmacy cost                 20               2              10             400
                                 form.
                               ---------------------------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           6,043
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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. 2015-29274 Filed 11-16-15; 8:45 am]
 BILLING CODE 4163-18-P