Agency Forms Undergoing Paperwork Reduction Act Review, 1951-1952 [2016-00561]

Download as PDF Federal Register / Vol. 81, No. 9 / Thursday, January 14, 2016 / Notices 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. 2016–00562 Filed 1–13–16; 8:45 am] BILLING CODE 4163–18–P 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). DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day–16–15ARG] mstockstill on DSK4VPTVN1PROD with NOTICES Agency Forms Undergoing Paperwork Reduction Act Review The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies. Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (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 (404) 639–7570 or VerDate Sep<11>2014 16:39 Jan 13, 2016 Jkt 238001 send an email to omb@cdc.gov. Direct written comments and/or suggestions regarding the items contained in this notice to the Attention: CDC Desk Officer, Office of Management and Budget, Washington, DC 20503 or by fax to (202) 395–5806. Written comments should be received within 30 days of this notice. Background and Brief Description Hepatitis C virus (HCV) infection is the most common chronic blood borne infection in the United States; approximately three 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, and 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 nonurban counties. Awardees will develop and implement a comprehensive strategy to enroll young non-urban PWID, collect epidemiological information, test for viral hepatitis and HIV infection and provide linkage to primary care services, prevention PO 00000 Frm 00015 Fmt 4703 Sfmt 4703 1951 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. Adherence to prevention services and retention in care will be assessed through follow up interviews. Furthermore, re-infection with HCV will be evaluated through follow-up blood tests. The project will recruit an estimated total of 995 young PWIDs to enroll 895 PWIDs. 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 intervieweradministered survey that includes information on initiation of drug use, injection practices, HCV, HBV 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 will be interviewed throughout the study during the 3-year project. However, most of the recruitment will be spread over first two years to allow for one year follow up period of the later recruits. Participation in interviews and responses to all study questions are totally voluntary and there is no cost to respondents other than their time. The annualized burden to participants is 974 hours. E:\FR\FM\14JAN1.SGM 14JAN1 1952 Federal Register / Vol. 81, No. 9 / Thursday, January 14, 2016 / Notices ESTIMATED ANNUALIZED BURDEN HOURS Number of respondents Type of respondents Form name Young PWIDs ................................................. Eligible young PWIDs ..................................... Eligible young PWIDs ..................................... Screener ......................................................... Initial Survey ................................................... Follow-up survey ............................................ 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. 2016–00561 Filed 1–13–16; 8:45 am] BILLING CODE 4163–18–P 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. DEPARTMENT OF HEALTH AND HUMAN SERVICES [60Day–16–16JD; Docket No. CDC–2016– 0004] Proposed Data Collection Submitted for Public Comment and Recommendations Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice with comment period. AGENCY: 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 the proposed information collection entitled ‘‘Young Men who have Sex with Men (YMSM) Study Thailand’’. CDC is requesting a threeyear approval for this new project. DATES: Written comments must be received on or before March 14, 2016. ADDRESSES: You may submit comments, identified by Docket No. CDC–2016– 0004 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 mstockstill on DSK4VPTVN1PROD with NOTICES VerDate Sep<11>2014 16:39 Jan 13, 2016 Jkt 238001 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: omb@cdc.gov. 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 FOR FURTHER INFORMATION CONTACT: Centers for Disease Control and Prevention SUMMARY: 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. PO 00000 Frm 00016 Fmt 4703 Sfmt 4703 332 298 298 Number of responses per respondent 1 1 4 Average burden per response (in hours) 10/60 60/60 30/60 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 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 Cohort Study of HIV, STIs and Preventive Interventions among Young MSM in Thailand—New—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC). Background and Brief Description This is a new information collection request for 3 years of data collection. In Thailand, there is a very high HIV incidence in men who have sex with men (MSM) and transgender women (TGW). It is estimated that over 50% of all new HIV infections are occurring in MSM and TGW. At Silom Community Clinic @Tropical Medicine (SCC @TropMed), there is a reported average HIV prevalence of 28% and HIV incidence of 8 per 100 person-years in young men. An area with gaps of understanding regarding the HIV epidemic in Thailand, as well as globally, is the epidemiology, risk factors, and HIV beliefs and knowledge of gay identified and transgender youth. In 2013, UNAIDS reported that 95% of new HIV infections were in low- and middle-income countries, where more than one third were in young people (<18 years) who were unaware of their HIV status. Adolescents living with HIV are more E:\FR\FM\14JAN1.SGM 14JAN1

Agencies

[Federal Register Volume 81, Number 9 (Thursday, January 14, 2016)]
[Notices]
[Pages 1951-1952]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-00561]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-16-15ARG]


Agency Forms Undergoing Paperwork Reduction Act Review

    The Centers for Disease Control and Prevention (CDC) has submitted 
the following information collection request to the Office of 
Management and Budget (OMB) for review and approval in accordance with 
the Paperwork Reduction Act of 1995. The notice for the proposed 
information collection is published to obtain comments from the public 
and affected agencies.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collection of information are 
encouraged. Your comments should address any of the following: (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 
(404) 639-7570 or send an email to omb@cdc.gov. Direct written comments 
and/or suggestions regarding the items contained in this notice to the 
Attention: CDC Desk Officer, Office of Management and Budget, 
Washington, DC 20503 or by fax to (202) 395-5806. Written comments 
should be received within 30 days of this notice.

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 three 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, and 
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 viral 
hepatitis and HIV 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. Adherence to prevention services and 
retention in care will be assessed through follow up interviews. 
Furthermore, re-infection with HCV will be evaluated through follow-up 
blood tests.
    The project will recruit an estimated total of 995 young PWIDs to 
enroll 895 PWIDs. 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, HBV 
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 will be interviewed throughout the study 
during the 3-year project. However, most of the recruitment will be 
spread over first two years to allow for one year follow up period of 
the later recruits.
    Participation in interviews and responses to all study questions 
are totally voluntary and there is no cost to respondents other than 
their time. The annualized burden to participants is 974 hours.

[[Page 1952]]



                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Young PWIDs...........................  Screener................             332               1           10/60
Eligible young PWIDs..................  Initial Survey..........             298               1           60/60
Eligible young PWIDs..................  Follow-up survey........             298               4           30/60
----------------------------------------------------------------------------------------------------------------


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. 2016-00561 Filed 1-13-16; 8:45 am]
 BILLING CODE 4163-18-P