[Federal Register Volume 83, Number 49 (Tuesday, March 13, 2018)]
[Notices]
[Pages 10853-10855]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-05000]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-2018-1091; Docket No. CDC-2018-0022]


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 effort to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies the opportunity to comment on a proposed and/or 
continuing information collection, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on a proposed 
information collection project titled ''Using Qualitative Methods to 
Understand Issues in HIV Prevention, Care and Treatment in the United 
States.'' CDC's goal for this generic information collection mechanism 
is to conduct qualitative studies to quickly identify barriers and 
facilitators to HIV prevention, care and treatment in specific regions 
with high HIV burden in the US.

DATES: CDC must receive written comments on or before May 14, 2018.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2018-
0022 by any of the following methods:
     Federal eRulemaking Portal: Regulations.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. CDC will post, without change, all relevant comments 
to Regulations.gov.

    Please note:  Submit all comments 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 Leroy A. Richardson, 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 the OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    The OMB is particularly interested in comments that will help:
    1. 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;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected; and
    4. 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 
submissions of responses.
    5. Assess information collection costs.

Proposed Project

    Using Qualitative Methods to Understand Issues in HIV Prevention, 
Care and Treatment in the United States (OMB Control Number 0920-1091; 
expires 12/31/2018)--Extension--National Center for HIV/AIDS, Viral 
Hepatitis, STD, and TB Prevention, Centers for Disease Control and 
Prevention (CDC).

[[Page 10854]]

Background and Brief Description

    The CDC's National Center on HIV/AIDS, Viral Hepatitis, STD and TB 
Prevention (NCHHSTP), Division of HIV/AIDS Prevention (DHAP) seeks a 
three-year extension to conduct qualitative studies to quickly identify 
barriers and facilitators to HIV prevention, care and treatment in 
specific regions with high HIV burden in the US. Proposed activities 
remain consistent with the national HIV prevention goals, the CDC 
Division of HIV/AIDS Prevention (DHAP) Strategic Plan, and DHAP's High-
impact HIV Prevention approach.
    The purposes for each data collection study supported under this 
umbrella generic information collection plan will be to understand 
specific barriers and facilitators to local HIV prevention, care and 
treatment in the United States and territories. For example, each study 
will seek to identify ways to improve programmatic activities along the 
continuum of HIV prevention, treatment and care for different 
populations residing in different geographic settings with greatest 
burden of HIV.
    The target populations for the studies include, but are not limited 
to: (1) Persons living with HIV who are in treatment; (2) persons 
living with HIV who are out of treatment and who may or may not be 
seeking treatment at healthcare facilities; (3) persons at high risk 
for HIV acquisition (HIV negative) and HIV transmission (HIV positive); 
(4) persons from groups at high risk for HIV including gay, bisexual 
and other MSM, transgender persons, and injection and non-injection 
drug users; (5) persons from racial and ethnic minorities; and (6) 
healthcare providers or other professionals who provide HIV prevention, 
care and treatment services. Other populations may include individuals 
who provide non-HIV services or otherwise interact with persons living 
with HIV or persons at risk for HIV acquisition.
    Studies will only provide local contextual information about the 
barriers and facilitators to HIV prevention, care, and treatment 
experienced by specific communities at risk for acquiring HIV 
infection, by HIV-positive persons across the HIV care continuum, and 
by organizations or individuals providing HIV prevention, care, 
treatment, and related support services.
    Data collection methods used in any of the specific studies 
primarily will consist of rapid qualitative assessment methodologies, 
such as semi-structured and in-depth qualitative interviews, focus 
groups; direct observations; document reviews; and short structured 
surveys. Data will be analyzed using well-established qualitative 
analysis methods, such as coding interviews for themes about barriers 
and successes to HIV prevention, care, and treatment. Structured 
response surveys will be analyzed using descriptive statistics and 
other appropriate statistical methods.
    CDC will use the results from each specific data collection study 
to help identify ways to improve local programmatic activities for 
specific communities along the continuum of HIV prevention, treatment 
and care for populations and areas with the greatest HIV burden. CDC 
will communicate study outcomes to local stakeholders and organizations 
in positions to consider and implement site-specific improvements in 
HIV prevention, care, and treatment for each of the study sites 
examined. For stakeholders, organizations, or agencies outside the 
local affected communities, all communications will include clear 
discussion of the limitations of the region-specific, qualitative 
methods and the non-generalizability of the study outcomes.
    For a given year, each separate data collection will range from 30 
(minimum) to 200 (maximum) respondents, based on the nature and scope 
of the research purposes. For example, if there are three data 
collections, the maximum combined number of expected respondents is 
600. In a given year, CDC anticipates the need to screen 1,600 persons 
to identify 800 eligible persons, of which 600 persons will agree to 
participate.
    CDC anticipates that screener forms will take 5 minutes to complete 
each, contact information forms will take 1 minute to complete each, 
and consent forms will take 5 minutes to complete each. CDC anticipates 
study eligibility for 50 percent of the targeted populations screened. 
Of eligible persons, 75% will agree to participate.
    Brief structured surveys will take 15 minutes to complete. In-depth 
interviews or focus groups with respondents are expected to take 60 
minutes (1 hour) to complete. In-depth interviews or focus groups with 
healthcare providers are expected to take 45 minutes to complete.
    The total annual response burden, based on an average of 600 study 
respondents per year (assuming three large data collections involving 
200 participants each), is 918 hours.

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                                                                     Number of    Average burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent      (in hours)      (in hours)
----------------------------------------------------------------------------------------------------------------
General Public--Adults........  Study Screener..           1,600               1            5/60             133
General Public--Adults........  Contact                      600               1            1/60              10
                                 Information
                                 Form.
General Public--Adults........  Consent Form....             600               1            5/60              50
General Public--Adults........  Demographic                  500               1           15/60             125
                                 Survey.
General Public--Adults........  Interview Guide.             500               1               1             500
General Public--Adults........  Provider                     100               1           15/60              25
                                 Demographic
                                 Survey.
General Public--Adults........  Provider                     100               1           45/60              75
                                 Interview Guide.
                                                                                                 ---------------
    Total.....................  ................  ..............  ..............  ..............             918
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[[Page 10855]]

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. 2018-05000 Filed 3-12-18; 8:45 am]
 BILLING CODE 4163-18-P