2020-15654. Agency Forms Undergoing Paperwork Reduction Act Review

In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled Injection Drug Use Surveillance Project to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on March 9, 2020, to obtain comments from the public and affected agencies. CDC received one non-substantive comment that was not related to the previous notice. This notice serves to allow an additional 30 days for public and affected agency comments.

CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:

(a) 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;

(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(c) Enhance the quality, utility, and clarity of the information to be collected;

(d) 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 submission of responses; and

(e) Assess information collection costs.

To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call [phone]. Comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/​public/​do/​PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, 725 17th Street NW, Washington, DC 20503 or by fax to [phone]. Provide written comments within 30 days of notice publication.

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 (IDU) 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 U.S. 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 SSP and social network strategy 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 screening form. Our target population is 300 participants per site or 9,000 for up to 30 sites. We anticipate that, on average, 16.66% or 1,499 persons (for up to 30 SSPs) will not be interested in completing a survey, yielding a maximum of 10,499 eligible participants. The total annualized burden is 6,125 hours. There are no other costs to respondents other than their time.

Estimated Annualized Burden Hours

Respondent	Form name	Number of respondents	Number of responses per respondent	Average burden per response (hours)
Persons Screened	Eligibility Screening Form	10,499	1	5/60
Persons who give permission	Model Project Permission Form	9,000	1	5/60
Eligible Participants	IDU Survey	9,000	1	30/60

Jeffrey M. Zirger,

Lead, Information Collection Review Office, Office of Scientific Integrity, Office of Science, Centers for Disease Control and Prevention.