80 FR 37264 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 80, Issue 125 (June 30, 2015)

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 ``Prevent Hepatitis Transmission among Persons Who Inject Drugs''. The purpose of this study is to address the high prevalence of HCV infection by developing an integrated approach for detection, prevention, care and treatment of infection among persons aged 18-30 years who reside in non-urban counties.

[Federal Register Volume 80, Number 125 (Tuesday, June 30, 2015)]
[Notices]
[Pages 37264-37265]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-16027]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60-Day-15-15ARG; Docket No. CDC-2015-0047]


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 ``Prevent 
Hepatitis Transmission among Persons Who Inject Drugs''. The purpose of 
this study is to address the high prevalence of HCV infection by 
developing an integrated approach for detection, prevention, care and 
treatment of infection among persons aged 18-30 years who reside in 
non-urban counties.

DATES: Written comments must be received on or before August 31, 2015.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0047 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 
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

[[Page 37265]]

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

Prevent Hepatitis Transmission Among Persons Who Inject Drugs--New--
National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention 
(NCHHSTP), Centers for Disease Control and Prevention (CDC)

Background and Brief Description

    Hepatitis C virus (HCV) infection is the most common chronic blood 
borne infection in the United States; approximately 3 million persons 
are chronically infected. Identifying and reaching persons at risk for 
HCV infection is critical to prevent transmission and treat and cure if 
infected. CDC monitors the national incidence of acute hepatitis C 
through passive surveillance of acute, symptomatic cases of laboratory 
confirmed hepatitis C cases. Since 2006, surveillance data have shown a 
trend toward reemergence of HCV infection mainly among young persons 
who inject drugs (PWID) in nonurban counties. Of the cases reported in 
2013 with information on risk factors 62% indicated injection drug use 
as the primary risk for acute hepatitis C. The prevention of HCV 
infection among PWIDs requires an integrated approach including harm 
reduction interventions, substance abuse treatment, prevention of other 
blood borne infections, and care and treatment of HCV infection.
    The purpose of the proposed study is to address the high prevalence 
of HCV infection by developing and implementing an integrated approach 
for detection, prevention, care and treatment of infection among 
persons aged 18-30 years who reside in non-urban counties. Awardees 
will develop and implement a comprehensive strategy to enroll young 
non-urban PWID, collect epidemiological information, test for HCV 
infection and provide linkage to primary care services, prevention 
interventions, and treatment for substance abuse and HCV infection. In 
addition to providing HCV testing, participants will be offered testing 
for the presence of co-infections with hepatitis B virus (HBV) and HIV. 
Rates of HCV infection or re-infection will be evaluated through 
follow-up blood tests. Furthermore, adherence to prevention services 
and retention in care will be assessed through follow up interviews.
    The project will recruit an estimated total of 1,500 young PWIDs to 
enroll 1,000. The participants will be recruited from settings where 
young PWIDs obtain access to care and treatment services. Recruitment 
will be direct and in-person by partnering with local harm reduction 
sites. Recruiters will enroll subjects across recruitment sites 
primarily through drug treatment programs and syringe exchange 
programs, as well as persons referred to these sites as a result of 
referral from other programs and respondent driven sampling. Those who 
consent to participate will be administered an eligibility interview 
questionnaire by trained field staff. If found eligible, the 
participant will take an interviewer-administered survey that includes 
information on initiation of drug use, injection practices, HCV and HIV 
infection status, access to prevention and medical care, desire to 
receive and barriers to receiving HCV treatment, and missed 
opportunities for hepatitis prevention. Participants will receive 
counselling regarding adherence to medical and/or drug treatment 
services and prevention services. Participants will be interviewed for 
a maximum of 5 times within any 12-month interval during the course of 
the study: Consent and interview at enrollment/baseline for an 
estimated 60 minutes, and 30-minute follow-up interviews every 3 months 
thereafter. Participants who are recruited early in the study have more 
follow-up interviews than those who are recruited in the later part of 
the study during the 3-year project. However, recruitment will be 
spread over 2 years and on average, the duration of follow-up is 
estimated to be one year.
    Participation in interviews and responses to all study questions 
are totally voluntary and there is no cost to respondents other than 
their time. The maximum burden is 3,375 hours.

                                        Estimated Annualized Burden Hours
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                                                                                      Average
                                                     Number of       Number of      burden per     Total burden
      Type of respondents           Form name       respondents    responses per   response  (in     (in hrs.)
                                                                    respondent         hrs.)
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Young PWIDs...................  Screener........            1500               1           15/60             375
Eligible young PWIDs..........  Initial Survey..            1000               1           60/60            1000
Eligible young PWIDs..........  Follow-up survey            1000               4           30/60            2000
                                                 ---------------------------------------------------------------
    Total.....................  ................  ..............  ..............  ..............            3375
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Maryam I. Daneshvar,
Deputy Director, Office of Scientific Integrity, Office of the 
Associate Director for Science, Office of the Director, Centers for 
Disease Control and Prevention.
[FR Doc. 2015-16027 Filed 6-29-15; 8:45 am]
 BILLING CODE 4163-18-P