[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]
[[Page 13655]]
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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
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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