81 FR 1951 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 81, Issue 9 (January 14, 2016)
Centers for Disease Control and Prevention
Federal Register Volume 81, Issue 9 (January 14, 2016)
| Page Range | 1951-1952 | |
| FR Document | 2016-00561 |
[Federal Register Volume 81, Number 9 (Thursday, January 14, 2016)] [Notices] [Pages 1951-1952] From the Federal Register Online [www.thefederalregister.org] [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
![Federal Register / Vol. 81, No. 9 / Thursday, January 14, 2016 / Notices 1951
Leroy A. Richardson, send an email to omb@cdc.gov. Direct interventions, and treatment for
Chief, Information Collection Review Office, written comments and/or suggestions substance abuse and HCV infection. In
Office of Scientific Integrity, Office of the regarding the items contained in this addition to providing HCV testing,
Associate Director for Science, Office of the notice to the Attention: CDC Desk participants will be offered testing for
Director, Centers for Disease Control and Officer, Office of Management and the presence of co-infections with
Prevention. Budget, Washington, DC 20503 or by fax hepatitis B virus (HBV) and HIV.
[FR Doc. 2016–00562 Filed 1–13–16; 8:45 am] to (202) 395–5806. Written comments Adherence to prevention services and
BILLING CODE 4163–18–P should be received within 30 days of retention in care will be assessed
this notice. through follow up interviews.
Proposed Project Furthermore, re-infection with HCV will
DEPARTMENT OF HEALTH AND be evaluated through follow-up blood
HUMAN SERVICES Prevent Hepatitis Transmission tests.
among Persons Who Inject Drugs—
Centers for Disease Control and The project will recruit an estimated
New—National Center for HIV/AIDS,
Prevention total of 995 young PWIDs to enroll 895
Viral Hepatitis, STD, and TB Prevention
PWIDs. The participants will be
[30Day–16–15ARG] (NCHHSTP), Centers for Disease Control
recruited from settings where young
and Prevention (CDC).
PWIDs obtain access to care and
Agency Forms Undergoing Paperwork Background and Brief Description treatment services. Recruitment will be
Reduction Act Review direct and in-person by partnering with
Hepatitis C virus (HCV) infection is
The Centers for Disease Control and the most common chronic blood borne local harm reduction sites. Recruiters
Prevention (CDC) has submitted the infection in the United States; will enroll subjects across recruitment
following information collection request approximately three million persons are sites primarily through drug treatment
to the Office of Management and Budget chronically infected. Identifying and programs and syringe exchange
(OMB) for review and approval in reaching persons at risk for HCV programs, as well as persons referred to
accordance with the Paperwork infection is critical to prevent these sites as a result of referral from
Reduction Act of 1995. The notice for transmission and treat and cure if other programs and respondent driven
the proposed information collection is infected. CDC monitors the national sampling. Those who consent to
published to obtain comments from the incidence of acute hepatitis C through participate will be administered an
public and affected agencies. passive surveillance of acute, eligibility interview questionnaire by
Written comments and suggestions symptomatic cases of laboratory trained field staff. If found eligible, the
from the public and affected agencies confirmed hepatitis C cases. Since 2006, participant will take an interviewer-
concerning the proposed collection of surveillance data have shown a trend administered survey that includes
information are encouraged. Your toward reemergence of HCV infection information on initiation of drug use,
comments should address any of the mainly among young persons who inject injection practices, HCV, HBV and HIV
following: (a) Evaluate whether the drugs (PWID) in nonurban counties. Of infection status, access to prevention
proposed collection of information is the cases reported in 2013 with and medical care, desire to receive and
necessary for the proper performance of information on risk factors 62% barriers to receiving HCV treatment, and
the functions of the agency, including indicated injection drug use as the missed opportunities for hepatitis
whether the information will have primary risk for acute hepatitis C. The prevention. Participants will receive
practical utility; (b) Evaluate the prevention of HCV infection among counselling regarding adherence to
accuracy of the agencies estimate of the PWIDs requires an integrated approach medical and/or drug treatment services
burden of the proposed collection of including harm reduction interventions, and prevention services. Participants
information, including the validity of substance abuse treatment, and will be interviewed for a maximum of
the methodology and assumptions used; prevention of other blood borne 5 times within any 12-month interval
(c) Enhance the quality, utility, and infections, and care and treatment of during the course of the study: consent
clarity of the information to be HCV infection. and interview at enrollment/baseline for
collected; (d) Minimize the burden of The purpose of the proposed study is an estimated 60 minutes, and 30-minute
the collection of information on those to address the high prevalence of HCV follow-up interviews every 3 months
who are to respond, including through infection by developing and thereafter. Participants will be
the use of appropriate automated, implementing an integrated approach interviewed throughout the study
electronic, mechanical, or other for detection, prevention, care and during the 3-year project. However,
technological collection techniques or treatment of infection among persons most of the recruitment will be spread
other forms of information technology, aged 18–30 years who reside in non- over first two years to allow for one year
e.g., permitting electronic submission of urban counties. Awardees will develop follow up period of the later recruits.
responses; and (e) Assess information and implement a comprehensive Participation in interviews and
collection costs. strategy to enroll young non-urban responses to all study questions are
To request additional information on PWID, collect epidemiological totally voluntary and there is no cost to
the proposed project or to obtain a copy information, test for viral hepatitis and respondents other than their time. The
of the information collection plan and HIV infection and provide linkage to annualized burden to participants is 974
instruments, call (404) 639–7570 or primary care services, prevention hours.
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![1952 Federal Register / Vol. 81, No. 9 / Thursday, January 14, 2016 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondents Form name responses per
respondents response
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, Docket Number. All relevant comments technology; and (e) estimates of capital
Chief, Information Collection Review Office, received will be posted without change or start-up costs and costs of operation,
Office of Scientific Integrity, Office of the to Regulations.gov, including any maintenance, and purchase of services
Associate Director for Science, Office of the personal information provided. For to provide information. Burden means
Director, Centers for Disease Control and access to the docket to read background the total time, effort, or financial
Prevention. documents or comments received, go to resources expended by persons to
[FR Doc. 2016–00561 Filed 1–13–16; 8:45 am] Regulations.gov. generate, maintain, retain, disclose or
BILLING CODE 4163–18–P
Please note: All public comment should be provide information to or for a Federal
submitted through the Federal eRulemaking agency. This includes the time needed
portal (Regulations.gov) or by U.S. mail to the to review instructions; to develop,
DEPARTMENT OF HEALTH AND address listed above. acquire, install and utilize technology
HUMAN SERVICES and systems for the purpose of
FOR FURTHER INFORMATION CONTACT: To collecting, validating and verifying
Centers for Disease Control and request more information on the information, processing and
Prevention proposed project or to obtain a copy of maintaining information, and disclosing
[60Day–16–16JD; Docket No. CDC–2016– the information collection plan and and providing information; to train
0004] instruments, contact the Information personnel and to be able to respond to
Collection Review Office, Centers for a collection of information, to search
Proposed Data Collection Submitted Disease Control and Prevention, 1600 data sources, to complete and review
for Public Comment and Clifton Road NE., MS–D74, Atlanta, the collection of information; and to
Recommendations Georgia 30329; phone: 404–639–7570; transmit or otherwise disclose the
AGENCY: Centers for Disease Control and Email: omb@cdc.gov. information.
Prevention (CDC), Department of Health SUPPLEMENTARY INFORMATION: Under the Proposed Project
and Human Services (HHS). Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), Federal agencies Cohort Study of HIV, STIs and
ACTION: Notice with comment period. Preventive Interventions among Young
must obtain approval from the Office of
SUMMARY: The Centers for Disease Management and Budget (OMB) for each MSM in Thailand—New—National
Control and Prevention (CDC), as part of collection of information they conduct Center for HIV/AIDS, Viral Hepatitis,
its continuing efforts to reduce public or sponsor. In addition, the PRA also STD, and TB Prevention (NCHHSTP),
burden and maximize the utility of requires Federal agencies to provide a Centers for Disease Control and
government information, invites the 60-day notice in the Federal Register Prevention (CDC).
general public and other Federal concerning each proposed collection of Background and Brief Description
agencies to take this opportunity to information, including each new This is a new information collection
comment on proposed and/or proposed collection, each proposed request for 3 years of data collection.
continuing information collections, as extension of existing collection of In Thailand, there is a very high HIV
required by the Paperwork Reduction information, and each reinstatement of incidence in men who have sex with
Act of 1995. This notice invites previously approved information men (MSM) and transgender women
comment on the proposed information collection before submitting the (TGW). It is estimated that over 50% of
collection entitled ‘‘Young Men who collection to OMB for approval. To all new HIV infections are occurring in
have Sex with Men (YMSM) Study comply with this requirement, we are MSM and TGW. At Silom Community
Thailand’’. CDC is requesting a three- publishing this notice of a proposed Clinic @Tropical Medicine (SCC
year approval for this new project. data collection as described below. @TropMed), there is a reported average
DATES: Written comments must be Comments are invited on: (a) Whether HIV prevalence of 28% and HIV
received on or before March 14, 2016. the proposed collection of information incidence of 8 per 100 person-years in
ADDRESSES: You may submit comments, is necessary for the proper performance young men.
identified by Docket No. CDC–2016– of the functions of the agency, including An area with gaps of understanding
0004 by any of the following methods: whether the information shall have regarding the HIV epidemic in Thailand,
• Federal eRulemaking Portal: practical utility; (b) the accuracy of the as well as globally, is the epidemiology,
Regulation.gov. Follow the instructions agency’s estimate of the burden of the risk factors, and HIV beliefs and
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for submitting comments. proposed collection of information; (c) knowledge of gay identified and
• Mail: Leroy A. Richardson, ways to enhance the quality, utility, and transgender youth. In 2013, UNAIDS
Information Collection Review Office, clarity of the information to be reported that 95% of new HIV infections
Centers for Disease Control and collected; (d) ways to minimize the were in low- and middle-income
Prevention, 1600 Clifton Road NE., MS– burden of the collection of information countries, where more than one third
D74, Atlanta, Georgia 30329. on respondents, including through the were in young people (<18 years) who
Instructions: All submissions received use of automated collection techniques were unaware of their HIV status.
must include the agency name and or other forms of information Adolescents living with HIV are more
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Document Created: 2016-01-14 02:50:49
Document Modified: 2016-01-14 02:50:49
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| FR Citation | 81 FR 1951 |
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