[Federal Register Volume 85, Number 46 (Monday, March 9, 2020)]
[Notices]
[Pages 13655-13656]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-04722]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-20-20KH; Docket No. CDC-2020-0027]


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 Injection Drug Use Surveillance 
Project, which proposes to assess (1) the risk behaviors, injection 
risk networks, receipt of prevention services, and barriers to 
prevention and care among persons who inject drugs (PWID) and their 
drug-using peers; and (2) the prevalence of HIV and Hepatitis C 
infections among PWID and their drug using peers.

DATES: CDC must receive written comments on or before May 8, 2020.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2020-
0027 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Jeffrey M. Zirger, 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 Jeffrey M. Zirger, 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

    Injection Drug Use Surveillance Project--New--National Center for 
HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers 
for Disease Control and Prevention (CDC).

Background and Brief Description

    The purpose of the Injection Drug Use Surveillance Project (IDU-SP) 
is to develop a surveillance system to monitor drug use risk and 
prevention behaviors and the infectious disease consequences of high-
risk drug use in 6-30 select urban and non-urban areas of the US that 
have been impacted by the opioid crisis. Such a surveillance system is 
needed to inform prevention efforts and policy. The specific objectives 
of the project are to assess the following among persons who use drugs 
(i.e., via injecting and non-injecting routes of administration) who 
are recruited in syringe services programs (SSPs) and through peer-
driven recruitment: (1) drug use and sex risk behaviors, injection risk 
networks, receipt of prevention services, and barriers to prevention 
and care; and (2) the prevalence of HIV and Hepatitis C (HCV) 
infections.
    The project will involve a two-stage sampling approach. First, 6-30 
SSPs will be selected to ensure geographic diversity and representation 
of key program characteristics, such as syringe distribution model 
(needs-based vs all other) and length in operation (<5 years, 5 years 
or longer). Second, SSP clients and their drug using peers will be 
recruited through a combination of random recruitment at SSPs, and 
social network strategies to partake in a survey and HCV and HIV 
testing. Clients of SSPs and their peers who meet eligibility criteria 
will complete a survey using the Research Electronic Data Capture 
(REDCap) system, a secure web-based application for administering 
online surveys.
    The survey will include questions on drug use and sex risk 
behaviors, risk networks, transitions from non-injection drug use to 
drug injection, drug treatment history, history of drug use related 
adverse health outcomes, such as overdose, experiences with law 
enforcement, experiences with violence and access, HIV and HCV testing 
experience, and use of prevention and health care services. Lastly, 
participants will be offered anonymous HIV and HCV testing in 
conjunction with the survey, which they may refuse with no effect on 
participation in the survey.
    Approximately 10,500 individuals will complete the eligibility 
screener. Our target population is 300 participants per site or 9,000 
from up to 30 sites. We anticipate that, on average, 16.66% or 1,499 
persons (from up to 30 SSPs), will be either not interested in 
completing a questionnaire, yielding a maximum of 10,499 eligible 
participants.
    Data from the IDU-SP will be used to inform planning and evaluation 
of prevention programs at the local and national level that aim to 
reduce adverse health outcomes of injecting and non-injecting drug use 
and to contribute to the overall opioid crisis response efforts. Data 
from the IDU-SP will also inform establishing an ongoing surveillance 
system in the U.S. to monitor drug use and the infectious disease 
consequences of drugs. The total annualized burden is

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6,125 hours. There are no other costs to respondents other than their 
time.

                                        Estimated Annualized Burden Hours
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                                                                     Number of    Average burden
          Respondent                  Form           Number of     responses per   per response    Total burden
                                                    respondents     respondent        (hours)       (in hours)
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Persons Screened..............  Eligibility               10,499               1            5/60             875
                                 Screening Form.
Informed Consent..............  Informed Consent            9000               1            5/60             750
                                 Form.
Eligible Participants.........  IDU Survey......            9000               1           30/60           4,500
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............           6,125
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Jeffrey M. Zirger,
Lead, Information Collection Review Office, Office of Scientific 
Integrity, Office of Science, Centers for Disease Control and 
Prevention.
[FR Doc. 2020-04722 Filed 3-6-20; 8:45 am]
 BILLING CODE 4163-18-P