83 FR 45452 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 83, Issue 174 (September 7, 2018)
Centers for Disease Control and Prevention
Federal Register Volume 83, Issue 174 (September 7, 2018)
| Page Range | 45452-45453 | |
| FR Document | 2018-19380 |
[Federal Register Volume 83, Number 174 (Friday, September 7, 2018)] [Notices] [Pages 45452-45453] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-19380] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [30Day-18-18MY] 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 Network Epidemiology of Syphilis Transmission (NEST) 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 03/05/2018 to obtain comments from the public and affected agencies. CDC received 1 (one) comment 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 (404) 639-7570 or send an email to [email protected]. 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 (202) 395-5806. Provide written comments within 30 days of notice publication. Proposed Project Network Epidemiology of Syphilis Transmission (NEST)--New--National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC). Background and Brief Description CDC, Division of STD Prevention (DSTDP), requests a 3-year approval for a new data collection entitled, Network Epidemiology of Syphilis Transmission (NEST). Study participants' sociodemographic, risk behavior, and insurance coverage information will be collected as part of study enrollment. This study is funded by a cooperative agreement between CDC and three study grantees, two universities (Ohio State University and University of Illinois at Chicago) and one local health department (Baltimore City Health Department) in collaboration with a university (Johns Hopkins School of Medicine). The recruitment of study participants as well as the data collection activities will be carried out at university-affiliated sites including local health departments, community LGBT organizations, local STD clinics and HIV/AIDS care facilities. The overall objective of NEST is to support the establishment of cohorts of MSM at high risk for syphilis and to prospectively collect behavioral, social, and sexual network data, and biological specimens. Study participants will attend study visits every three months for a period of up to 24 months. NEST is a multi-site study, with a target [[Page 45453]] enrollment of approximately 720 MSM aged 18 years and older from three geographic areas of the United States: (1) Chicago, Illinois, (2) Baltimore, Maryland, and (3) Columbus, Ohio. At each study visit, study participants will be interviewed and biological specimens (blood and urine) will be collected to facilitate testing for syphilis, gonorrhea, chlamydia, and HIV, which are part of the routine clinical care at participating sites. All data will be collected using Form 1--Questionnaire and Data Elements (Attachment 3) and submitted electronically directly to the CDC NEST data manager. All personal identifying information (e.g., name, address) collected on individual patients will be retained by the local NEST site, will not be collected on NEST data collection forms, and will not be transmitted to CDC. The United States is currently experiencing an ongoing syphilis epidemic. MSM are disproportionately impacted by syphilis and the majority of incident syphilis cases in the United States occur among MSM. However, factors influencing syphilis transmission within this population, such as social and sexual network characteristics, sexual behaviors, and healthcare access and utilization, are poorly understood. In order to address these knowledge gaps, both individual- level and network-level data needs to be collected among this population. As such, we need to develop a better understanding of the feasibility of collecting complex sexual network data among this population. The collection of complex sexual network data--in addition to more traditional individual-level data, such as demographics and individual-level sexual and social behaviors--will help to collectively address some of the knowledge gaps in the transmission dynamics and epidemiology of syphilis among MSM in the United States and point towards effective public health interventions to slow the spread of syphilis. The goal of NEST is to pilot the use of survey instruments to collect complex longitudinal sexual network data among MSM at high risk for syphilis in the United States. The feasibility of data collection on basic information about recent partners of persons diagnosed with syphilis is clear and is routinely performed by public health officials. However, the feasibility and optimal approaches for serial collection of complex sexual network data among populations that may have dynamic networks are not at all clear. Specifically, it is not clear what the optimal recruitment strategies are to recruit and enroll MSM at high risk for syphilis. The optimal approaches for retaining men as study participants for follow-up visits over a defined study period have not been well defined. Furthermore the best survey format for our proposed data collection activities has not been established. For example, it is not known whether study participants would prefer a survey that is completely self-administered and whether data collected using a self-administered survey will result in complete and valid data being collected or whether a survey administered by study staff would be a better format. CDC is not engaged in research, and therefore not involved in data collection activities. The grantees are responsible for implementing the testing and collecting data and specimens from the participants. Before starting any data collection activities a short eligibility screener (Attachment 4) will be administered to prospective study participants and if determined to be eligible consent from the participant will be obtained. Once consent is obtained data collection will begin and will include a baseline visit and follow-up visits every three months for a total follow-up period of 24 months. At each visit participants will provide biological specimens (blood and urine) to facilitate testing for syphilis, gonorrhea, chlamydia, and HIV. In addition to providing biological specimens, participants will complete a standardized survey which will be delivered electronically on a tablet or computer and will collect information on the participants' sexual network, individual behaviors, healthcare access and demographics (Attachment 3). The survey consists of 13 questionnaire modules with a range of 5 to 15 questions per module (Attachment 3). A small subset of sexual behavior questions will be delivered to the participant closer to real time using an open survey format and a weekly format (Attachment 5). The open survey format is a brief survey that participants can respond to at any to record a sexual encounter or other event. The weekly format will be sent on Sunday nights with a reminder on Monday evening, to address sexual behavior in the last week. These brief surveys will be delivered electronically to participants and each survey is expected to take 2 minutes or less. Data collected on electronic devices will be stored on a secure web- accessible local server at each site which will only be accessible with a user name and password. Study site investigators provided input (based on knowledge of relevant local communities) into development of the survey. The total estimated annualized hourly burden anticipated for this study is 6,828 hours. Estimated Annualized Burden Hours ---------------------------------------------------------------------------------------------------------------- Number of Average burden Type of respondent Form name Number of responses per per response respondents respondent (in hours) ---------------------------------------------------------------------------------------------------------------- Potential participants................ Screener................ 900 1 2/60 Site data manager..................... Form 1--Questionnaire... 3 5 10 Study participant..................... Form 1--Questionnaire... 720 5 1.5 Study participant..................... Smartphone survey....... 720 52 2/60 ---------------------------------------------------------------------------------------------------------------- Jeffrey M. Zirger, Acting 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. 2018-19380 Filed 9-6-18; 8:45 am] BILLING CODE 4163-18-P
![45452 Federal Register / Vol. 83, No. 174 / Friday, September 7, 2018 / Notices
measured. Participants will complete process through which the TLC minutes. The assessment will take 60
the assessment at baseline and again at intervention influences HIV risk minutes (one hour) to complete and will
4- and 8-month follow-ups after joining behavior, and the role of the be administered to 150 participants a
the TLC program. intervention in addressing social total of three times. The interview will
We will also examine intervention determinates of health (housing, take 60 minutes (one hour) to complete
experiences through semi-structured employment, legal issues, health care and will be administered to 30
interview with 20 of the 150 TLC access). participants (20 intervention
participants and 10 TLC staff members It is expected that 50% of transgender participants and 10 TLC staff) one time.
involved in the delivery of services women screened will meet study
through the TLC intervention. The eligibility. We expect the initial There are no costs to the respondents
audio-recorded interviews will capture screening to take approximately four other than their time. The total
participants and staff views about the minutes to complete and that providing estimated annualized burden hours are
TLC implementation process, the contact information will take four 255.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondent Form name responses per
respondents response
respondent (in hours)
General Public-Adults ..................................... Eligibility Screener .......................................... 150 1 4/60
Contact Information ........................................ 75 1 4/60
Baseline Assessment ..................................... 75 1 1
Follow Up Assessment .................................. 75 2 1
Participant Interview ....................................... 10 1 1
Staff Interview ................................................ 5 1 1
Jeffrey M. Zirger, is particularly interested in comments Proposed Project
Acting Chief, Information Collection Review that: Network Epidemiology of Syphilis
Office, Office of Scientific Integrity, Office (a) Evaluate whether the proposed Transmission (NEST)—New—National
of the Associate Director for Science, Office collection of information is necessary
of the Director, Centers for Disease Control
Center for HIV/AIDS, Viral Hepatitis,
for the proper performance of the STD, and TB Prevention (NCHHSTP),
and Prevention.
functions of the agency, including Centers for Disease Control and
[FR Doc. 2018–19379 Filed 9–6–18; 8:45 am]
whether the information will have Prevention (CDC).
BILLING CODE 4163–18–P
practical utility;
Background and Brief Description
(b) Evaluate the accuracy of the
agencies estimate of the burden of the CDC, Division of STD Prevention
DEPARTMENT OF HEALTH AND (DSTDP), requests a 3-year approval for
HUMAN SERVICES proposed collection of information,
including the validity of the a new data collection entitled, Network
Centers for Disease Control and methodology and assumptions used; Epidemiology of Syphilis Transmission
Prevention (c) Enhance the quality, utility, and (NEST). Study participants’
clarity of the information to be sociodemographic, risk behavior, and
[30Day–18–18MY] collected; insurance coverage information will be
collected as part of study enrollment.
(d) Minimize the burden of the This study is funded by a cooperative
Agency Forms Undergoing Paperwork collection of information on those who
Reduction Act Review agreement between CDC and three study
are to respond, including, through the grantees, two universities (Ohio State
In accordance with the Paperwork use of appropriate automated, University and University of Illinois at
Reduction Act of 1995, the Centers for electronic, mechanical, or other Chicago) and one local health
Disease Control and Prevention (CDC) technological collection techniques or department (Baltimore City Health
has submitted the information other forms of information technology, Department) in collaboration with a
collection request titled Network e.g., permitting electronic submission of university (Johns Hopkins School of
Epidemiology of Syphilis Transmission responses; and Medicine). The recruitment of study
(NEST) to the Office of Management and (e) Assess information collection participants as well as the data
Budget (OMB) for review and approval. costs. collection activities will be carried out
CDC previously published a ‘‘Proposed To request additional information on at university-affiliated sites including
Data Collection Submitted for Public the proposed project or to obtain a copy local health departments, community
Comment and Recommendations’’ of the information collection plan and LGBT organizations, local STD clinics
notice on 03/05/2018 to obtain instruments, call (404) 639–7570 or and HIV/AIDS care facilities.
comments from the public and affected send an email to omb@cdc.gov. Direct The overall objective of NEST is to
agencies. CDC received 1 (one) comment written comments and/or suggestions support the establishment of cohorts of
daltland on DSKBBV9HB2PROD with NOTICES
related to the previous notice. This regarding the items contained in this MSM at high risk for syphilis and to
notice serves to allow an additional 30 notice to the Attention: CDC Desk prospectively collect behavioral, social,
days for public and affected agency Officer, Office of Management and and sexual network data, and biological
comments. Budget, 725 17th Street NW, specimens. Study participants will
CDC will accept all comments for this Washington, DC 20503 or by fax to (202) attend study visits every three months
proposed information collection project. 395–5806. Provide written comments for a period of up to 24 months. NEST
The Office of Management and Budget within 30 days of notice publication. is a multi-site study, with a target
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![Federal Register / Vol. 83, No. 174 / Friday, September 7, 2018 / Notices 45453
enrollment of approximately 720 MSM address some of the knowledge gaps in determined to be eligible consent from
aged 18 years and older from three the transmission dynamics and the participant will be obtained. Once
geographic areas of the United States: epidemiology of syphilis among MSM consent is obtained data collection will
(1) Chicago, Illinois, (2) Baltimore, in the United States and point towards begin and will include a baseline visit
Maryland, and (3) Columbus, Ohio. effective public health interventions to and follow-up visits every three months
At each study visit, study participants slow the spread of syphilis. for a total follow-up period of 24
will be interviewed and biological The goal of NEST is to pilot the use months. At each visit participants will
specimens (blood and urine) will be of survey instruments to collect provide biological specimens (blood and
collected to facilitate testing for complex longitudinal sexual network urine) to facilitate testing for syphilis,
syphilis, gonorrhea, chlamydia, and data among MSM at high risk for gonorrhea, chlamydia, and HIV. In
HIV, which are part of the routine syphilis in the United States. The addition to providing biological
clinical care at participating sites. All feasibility of data collection on basic specimens, participants will complete a
data will be collected using Form 1— information about recent partners of standardized survey which will be
Questionnaire and Data Elements persons diagnosed with syphilis is clear delivered electronically on a tablet or
(Attachment 3) and submitted and is routinely performed by public computer and will collect information
electronically directly to the CDC NEST health officials. However, the feasibility on the participants’ sexual network,
data manager. All personal identifying and optimal approaches for serial individual behaviors, healthcare access
information (e.g., name, address) collection of complex sexual network and demographics (Attachment 3). The
collected on individual patients will be data among populations that may have survey consists of 13 questionnaire
retained by the local NEST site, will not dynamic networks are not at all clear. modules with a range of 5 to 15
be collected on NEST data collection Specifically, it is not clear what the questions per module (Attachment 3). A
optimal recruitment strategies are to small subset of sexual behavior
forms, and will not be transmitted to
recruit and enroll MSM at high risk for questions will be delivered to the
CDC.
syphilis. The optimal approaches for participant closer to real time using an
The United States is currently retaining men as study participants for
experiencing an ongoing syphilis open survey format and a weekly format
follow-up visits over a defined study (Attachment 5). The open survey format
epidemic. MSM are disproportionately period have not been well defined.
impacted by syphilis and the majority of is a brief survey that participants can
Furthermore the best survey format for respond to at any to record a sexual
incident syphilis cases in the United our proposed data collection activities
States occur among MSM. However, encounter or other event. The weekly
has not been established. For example, format will be sent on Sunday nights
factors influencing syphilis it is not known whether study
transmission within this population, with a reminder on Monday evening, to
participants would prefer a survey that address sexual behavior in the last
such as social and sexual network is completely self-administered and
characteristics, sexual behaviors, and week. These brief surveys will be
whether data collected using a self- delivered electronically to participants
healthcare access and utilization, are administered survey will result in
poorly understood. In order to address and each survey is expected to take 2
complete and valid data being collected minutes or less. Data collected on
these knowledge gaps, both individual- or whether a survey administered by
level and network-level data needs to be electronic devices will be stored on a
study staff would be a better format. secure web-accessible local server at
collected among this population. As CDC is not engaged in research, and
such, we need to develop a better each site which will only be accessible
therefore not involved in data collection
understanding of the feasibility of with a user name and password. Study
activities. The grantees are responsible
collecting complex sexual network data for implementing the testing and site investigators provided input (based
among this population. The collection collecting data and specimens from the on knowledge of relevant local
of complex sexual network data—in participants. communities) into development of the
addition to more traditional individual- Before starting any data collection survey.
level data, such as demographics and activities a short eligibility screener The total estimated annualized hourly
individual-level sexual and social (Attachment 4) will be administered to burden anticipated for this study is
behaviors—will help to collectively prospective study participants and if 6,828 hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per
Type of respondent Form name responses per
respondents response
respondent (in hours)
Potential participants ....................................................... Screener ......................................................................... 900 1 2/60
Site data manager ........................................................... Form 1—Questionnaire .................................................. 3 5 10
Study participant .............................................................. Form 1—Questionnaire .................................................. 720 5 1.5
Study participant .............................................................. Smartphone survey ......................................................... 720 52 2/60
Jeffrey M. Zirger,
Acting Chief, Information Collection Review
daltland on DSKBBV9HB2PROD with NOTICES
Office, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
[FR Doc. 2018–19380 Filed 9–6–18; 8:45 am]
BILLING CODE 4163–18–P
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Document Created: 2018-09-07 00:15:51
Document Modified: 2018-09-07 00:15:51
| 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 | 83 FR 45452 |
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