Agency Forms Undergoing Paperwork Reduction Act Review
Federal Register, Volume 80 Issue 103 (Friday, May 29, 2015)
Federal Register Volume 80, Number 103 (Friday, May 29, 2015)
Notices
Pages 30682-30683
From the Federal Register Online via the Government Publishing Office www.gpo.gov
FR Doc No: 2015-12996
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
30Day-15-1019
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 omb@cdc.gov. 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 No. 0920-1019, Expires 05/31/2017)--Revision--
National Center for HIV, Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention (CDC).
Background and Brief Description
Revisions to this information collection include the addition of an Interviewer data collection worksheet, Key Informant Interviewer script, Staff communication questionnaire, Clinic cost form and Pharmacy cost form. These additions are needed in order to determine changes to clinic and pharmacy work systems, processes and outcomes in relation to the model project and how and if the model program improves patient outcomes through improved communication and collaboration between patients' clinical providers and pharmacists. In order to determine the general feasibility of the model program, the time required conducting program activities and the associated cost of program activities must be determined. Collection of data from the previously approved Initial patient information forms, Quarterly patient information forms, Pharmacy record abstraction forms, Project clinic characteristics forms, and Project pharmacy characteristics forms is ongoing. Clinic staff will use the initial information Sheet to explain the project to patients.
CDC has entered into a partnership with Walgreen Company (a.k.a. Walgreens pharmacies, a national retail pharmacy chain) and the University of North Texas Health Science Center 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 at ten sites and will provide patient-
centered HIV care for approximately 1,000 persons.
The patient-centered HIV care model includes the core elements of pharmacist provided Medication Therapy Management (MTM) as well as additional pharmacist 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 HIV viral load suppression.
Pharmacy, laboratory and medical data are collected through abstraction of participant clients' pharmacy and medical records. These 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 project sites' characteristics, will be collected by project sites.
This information 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 30683
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 pharmacists and clinic staff.. Staff communication 70 2 15/60
questionnaire.
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. 2015-12996 Filed 5-28-15; 8:45 am
BILLING CODE 4163-18-P
