[Federal Register Volume 81, Number 86 (Wednesday, May 4, 2016)]
[Notices]
[Pages 26795-26797]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-10399]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-16-16AHI; Docket No. CDC-2016-0041]


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 a proposed 
information collection project entitled ``Community-Based Organization 
Outcome Monitoring Projects for CBO HIV Prevention Services Clients''.

DATES: Written comments must be received on or before July 5, 2016.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2016-
0041 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

[[Page 26796]]

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

    ``Community-Based Organization Outcome Monitoring Projects for CBO 
HIV Prevention Services Clients''--New--National Center for HIV/AIDS, 
Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease 
Control and Prevention (CDC).

Background and Brief Description

    Community-Based Organizations (CBOs) play an essential role in 
reaching persons at high risk of transmitting and acquiring HIV 
infection. Through Cooperative Agreement #CDC-RFA-PS15-1502 (CBO-HPS), 
CDC funds 90 CBOs to provide comprehensive HIV prevention services to 
HIV-positive persons and high-risk HIV-negative persons. However, the 
CBO-HIV Prevention Services (HPS) awardees are not required to monitor 
or report on critical outcomes such as whether HIV-positive persons who 
are linked to HIV medical care were retained in care or prescribed ART, 
and whether high-risk HIV-negative persons who were referred to Pre-
Exposure Prophylaxis (PrEP) initiated its use. Also, CBO-HPS CBOs are 
not required to collect and report data about clients' perceived 
barriers to accessing HIV prevention services.
    CBO-OMP will fund a subset of CBO-HPS awardees to collect and 
report data to CDC about the utilization and outcomes of the HIV 
prevention and support services. This will increase understanding of 
HIV prevention and support services received by CBO-HPS clients, the 
outcomes of these services, and successes and challenges related to 
service provision and utilization.
    The respondent universe will comprise clients at 15-18 CBOs funded 
by CBO-HPS. CBO-OPM is organized in two categories: Category 1--HIV-
positive clients and Category 2--high-risk HIV-negative clients.
    This information collection will evaluate HIV-prevention services 
over time through participant interviews, record/chart review, CBO-HPS 
staff interviews, and focus groups. Participant interviews will include 
questions for participants living with HIV-positive and high-risk HIV-
negative clients at CBOs funded by CBO-HPS about demographics, HIV-
related risk behaviors, HIV prevention and support services received, 
service outcomes, and experiences with services over time; staff 
interviews about strategies for and barriers to recruiting and engaging 
clients in HIV prevention and support services; and focus groups with 
clients who are receiving HIV prevention services at CBOs.
    For Category 1, self-reported client interview data will be 
collected at baseline, 3, 6, 9 and 15 months. For Category 2, self-
reported client level data will be collected at baseline, 3, 6, and 9 
months. Participants will complete a 30-minute, staff-facilitated 
interview at baseline and 20-minute staff-facilitated interviews at 
each follow-up, to assess the outcomes of HIV-prevention services they 
receive.
    This project will also collect information from CBO-HPS Staff. Two 
CBO-HPS staff interviews will be conducted for Category 1 and two staff 
interviews will be conducted for Category 2. All interviews are 
expected to last 2.5 hours.
    This project will also collect information from participant focus 
groups. Respondents will also complete a short demographic 
questionnaire. Focus groups will occur twice during the project period 
and will last approximately 90 minutes.
    All electronic data will be password protected and accessible only 
to project staff and direct supervisors. Data will be stored on network 
drives which are regularly backed up by staff. Participation in this 
project is strictly voluntary. The consent process will be implemented 
according to the local/state policies of the funded agencies. Consent 
forms are provided. The consent process for CBO-OMP involves the agency 
staff providing an overview of the project that includes a description 
of the benefits of as well as the risks and discomforts to 
participation as well as the protections for the respondent's privacy. 
Participants must sign the consent form prior to enrolling into the 
project.
    The information collected by each funded agency may include 
personally identifiable information, such as name and contact 
information, in order to provide continuity of service, follow-up of 
referrals, schedule follow-up interviews and other outreach activities. 
Personally identifiable information will be kept in a locked file 
cabinet and will be accessible only to appropriate agency staff. Any 
individually identifiable information collected by funded agencies will 
not be submitted to CDC.
    The category 1 information collection will occur over 33 months and 
will involve up to 15 CBOs. The population targeted by Category 1 are 
HIV-positive clients who are receiving CBO-HPS services and have been 
provided a CBO-HPS referral to HIV medical care. They will be screened, 
interviewed and CBO staff will collect their medical records related to 
their HIV-medical care visits, CD4 count and viral loads, and 
prescription to ART.
    The Category 2 information collection will occur over 21 months and 
involve up to 3 CBOs who will target high-risk HIV-negative clients who 
are receiving CBO-HPS services. CBOs will screen 225 persons each year. 
CBO staff will collect their medical records about medical care visits, 
PrEP prescriptions and information about which CBO-HPS referrals. 
Participants will be administered a baseline interview as well as 
interviews at 3 months, 6 months, and 9 months. Each CBO will also 
conduct two focus groups over the project period, one in each year of 
the evaluation.
    Each of the CBOs funded to participate in this project will be 
required to submit data they've collected each month to CDC, including 
the screener, medical records and CBO-HPS referrals, baseline 
interview, 3-month follow-up interview, 6-month follow-up interview, 9-
month follow-up interview, focus groups, and staff interviews, 
respectively. There is no cost to respondents other than their time. 
Total burden hours are 1,125.

[[Page 26797]]



                                                            Estimated Annualized Burden Hours
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                                                                                                             Number of    Average burden
               Type of respondent                               Form name                    Number of     responses per     response      Total burden
                                                                                            respondents     respondent        (hours)         (hours)
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General public.................................  Screener Participant Interview Category             175               1            3/60               9
                                                  1.
Facility office staff..........................  Medical records abstraction Category 1.             120               3            3/60              18
CBO-HPS grantees...............................  CBO-HPS Referrals Category 1...........             120               3            3/60              18
General public.................................  Baseline Interview Category 1..........             150               1           40/60             100
General public.................................  3,6,9, and 15 Month Follow-up Interview             120               4           30/60             240
                                                  Category 1.
General public.................................  Screener Focus Group Category 1........             150               1            3/60               8
General Public.................................  Focus Group Questionnaire Category 1...              90               1            2/60               3
General public.................................  Focus Group Category 1.................              90               1             1.5             135
CBO-HPS grantees...............................  Staff Interview Category 1.............              30               1             2.5              75
CBO-OMP CBOs...................................  Data submission Category 1 and 2.......              18              12           10/60              36
General public.................................  Screener Participant Interview Category             225               1            3/60              12
                                                  2.
Facility office staff..........................  Medical records abstraction Category 2.             168               2            3/60              17
CBO-HPS grantees...............................  CBO-HPS Referrals Category 2...........             168               2            3/60              17
General public.................................  Baseline Interview Category 2..........             210               1           40/60             140
General public.................................  3,6, and 9 Month Follow-up Interview                168               3           30/60             252
                                                  Category 2.
General Public.................................  Screener Focus group Category 2........              30               1            3/60               2
General Public.................................  Focus Group Questionnaire Category 2...              18               1            2/60               1
General public.................................  Focus Group Category 2.................              18               1             1.5              27
CBO-HPS grantees...............................  Staff Interview Category 2.............               6               1             2.5              15
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............           1,125
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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. 2016-10399 Filed 5-3-16; 8:45 am]
BILLING CODE 4163-18-P