[Federal Register Volume 78, Number 29 (Tuesday, February 12, 2013)]
[Notices]
[Pages 9923-9924]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-03196]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-13-13GX]


Proposed Data Collections Submitted for Public Comment and 
Recommendations

    In compliance with the requirement of Section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995 for opportunity for public comment on 
proposed data collection projects, the Centers for Disease Control and 
Prevention (CDC) will publish periodic summaries of proposed projects. 
To request more information on the proposed projects or to obtain a 
copy of the data collection plans and instruments, call 404-639-7570 or 
send comments to Ron Otten, 1600 Clifton Road, MS-D74, Atlanta, GA 
30333 or send an email to [email protected].
    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; and (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. Written comments should be received 
within 60 days of this notice.

Proposed Project

    Assessment of a Comprehensive Human immunodeficiency virus (HIV) 
Clinic-Based Intervention to Promote Patients' Health and Reduce 
Transmission Risk--New--National Center for HIV/AIDS, Viral Hepatitis, 
STD, and TB Prevention (NCHHSTP), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    CDC is requesting Office of Management and Budget (OMB) approval to 
collect data that will be used to evaluate an HIV clinic-based 
intervention to increase the number of HIV patients who (1) have 
undetectable levels of HIV in their blood, (2) adhere optimally to 
antiretroviral therapy (ART), (3) attend clinic regularly for primary 
care, and (4) practice safer sex. These are objectives of the National 
HIV/AIDS Strategy and goals of the strategic plan of the Division of 
HIV/AIDS Prevention, Centers for Disease Control and Prevention.
    The project will be conducted at six HIV clinics in the United 
States. This proposed data collection will occur over 3 years.
    The intervention that is part of this project focuses primarily on 
HIV patients who have a detectable viral load, i.e., their viral load 
is not as low as it can be and is not fully controlled. The 
intervention components include: (1) Brief counseling from medical 
providers during primary care visits informed by a behavioral screener 
completed by patients; (2) a computer-based intervention (CBI) in which 
patients see short videos of HIV medical providers (not their own 
providers) talking about the importance of regular clinic attendance, 
adherence to ART, and safer sex; and (3) one-on-one counseling from a 
prevention specialist if needed.
    The following data will be collected in this project:
     A data manager at each clinic will electronically transmit 
patient clinical data to CDC using a unique study identification code 
as the only means of identifying a patient's data. The data files sent 
to CDC will not contain any medical record numbers, names, or social 
security numbers. The information will be encrypted and stored in a 
secure CDC server. The data

[[Page 9924]]

collected from patients include (1) a behavioral screener self-
administered by patients each time they have a primary care visit. 
Patients complete the screener in the waiting room before seeing their 
primary care provider. (2) CBI assessment items on demographic factors, 
clinic attendance, ART status, ART adherence, and sexual risk behavior 
that are completed before patients see the CBI videos. Patients with 
detectable viral loads will be asked to do the CBI three times, spaced 
approximately three months apart. Patients' CBI responses are not 
shared with their clinic providers. (3) On a quarterly basis, 50 
patients at each clinic will be asked to complete a brief exit survey 
after their medical exam, asking about topics that the provider may 
have discussed with them at their medical visit (e.g., adherence, 
clinic attendance).
     Data collected from primary care medical providers 
includes a quarterly survey asking them to indicate the types of 
topics/issues they discussed with their HIV patients.

There are no costs to respondents other than their time.

                                                            Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                             Number of    Average burden
               Type of respondent                               Form name                    Number of     responses per   per response    Total burden
                                                                                            respondents     respondent        (hours)          hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Data manager at clinic.........................  Electronic transmittal of clinical                    6               4              24             576
                                                  variables archived in clinic databases
                                                  (no form).
Patient........................................  Behavioral screener (patients with                6,315               4            5/60           2,105
                                                  detectable or undetectable VL; paper
                                                  form).
Patient........................................  CBI assessment items for patients with            2,069               3           10/60           1,035
                                                  detectable VL (electronic form).
Patient........................................  Patient exit survey (electronic form)..           1,200               1            5/60             100
Primary care provider..........................  Provider survey (electronic form)......             120               4           10/60              80
    Total......................................  .......................................  ..............  ..............  ..............           3,896
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Kimberly S. Lane,
Deputy Director, Office of Scientific Integrity, Office of the 
Associate Director for Science, Office of the Director, Centers for 
Disease Control and Prevention.
[FR Doc. 2013-03196 Filed 2-11-13; 8:45 am]
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