80 FR 56993 - 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 182 (September 21, 2015)

Page Range		56993-56995
FR Document		2015-23572

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 request entitled ``A Study of Viral Persistence in Ebola Virus Disease (EVD) Survivors''. The purpose of this information collection is to gather the necessary information for the CDC and the international community to begin the activities necessary to reach the goal of zero new EVD cases throughout West Africa. Once that goal is reached, the 42-day countdown to declare West Africa Ebola-free can begin. ``Persistence of Ebola Virus in Body Fluids of Ebola Virus Disease (EVD) Survivors in Sierra Leone''. This information collection will be the first systematic examination of the post- recovery persistence of Ebola virus and the risks of transmission from a cohort of convalescent Ebola survivors during close or intimate contact.

Federal Register, Volume 80 Issue 182 (Monday, September 21, 2015)

[Federal Register Volume 80, Number 182 (Monday, September 21, 2015)]
[Notices]
[Pages 56993-56995]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-23572]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60 Day-15-15BFV; Docket No. CDC-2015-0085]

Proposed Data Collection Submitted for Public Comment and
Recommendations

AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).

[[Page 56994]]

ACTION: Notice with comment period.

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

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 the proposed
information collection request entitled ``A Study of Viral Persistence
in Ebola Virus Disease (EVD) Survivors''. The purpose of this
information collection is to gather the necessary information for the
CDC and the international community to begin the activities necessary
to reach the goal of zero new EVD cases throughout West Africa. Once
that goal is reached, the 42-day countdown to declare West Africa
Ebola-free can begin. ``Persistence of Ebola Virus in Body Fluids of
Ebola Virus Disease (EVD) Survivors in Sierra Leone''. This information
collection will be the first systematic examination of the post-
recovery persistence of Ebola virus and the risks of transmission from
a cohort of convalescent Ebola survivors during close or intimate
contact.

DATES: Written comments must be received on or before November 20,
2015.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2015-
0085 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: 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 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

Persistence of Ebola Virus in Body Fluids of Ebola Virus Disease
(EVD) Survivors in Sierra Leone--New--National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and
Prevention (CDC).

Background and Brief Description

Much progress has been made in the year since the CDC first
responded to the Ebola outbreak in West Africa, but the agency's
efforts must continue until there are zero new cases of Ebola virus
disease (EVD). As the CDC's 2014 Ebola virus response draws closer to
the international goal of zero new EVD cases in 2015, the agency must
intensify its efforts to identify and prevent every potential route of
human disease transmission and to understand the most current community
barriers to reaching that final goal.
``Persistence of Ebola Virus (EBOV) in Body Fluids of EVD Survivors
in Sierra Leone'' will be the first systematic examination of the post-
recovery persistence of EBOV and the risks of transmission from a
cohort of convalescent Ebola survivors during close or intimate
contact. This activity is currently approved by OMB for emergency use
under OMB Control Number 0920-1064--Persistence of Ebola Virus (EBOV)
in Body Fluids of EVD Survivors in Sierra Leone, which expires on
November 30, 2015. It is important to fully understand how long the
virus stays active in body fluids other than blood in order to target
and refine public health interventions to arrest the ongoing spread of
disease.
The research study is comprised of three modules based on the body
fluids to be studied: A pilot module of adult males (semen) and two
full modules: Module A of adult men and women repeating collections and
questionnaires every two weeks (semen, vaginal secretions, and saliva,
tears, sweat, urine, rectal swab), and Module B of lactating adult
women repeating collections and questionnaires every three days (sweat
and breast milk).
Participants for each module will be recruited by trained study
staff from Ebola treatment units and survivor registries. Participants
will be followed up at study sites in government hospitals.
Specimens will be tested for EBOV ribonucleic acid (RNA) by reverse
transcription polymerase chain reaction test (RT-PCR) in Sierra Leone
at the CDC laboratory facility in Bo. All positive RT-PCR samples will
be sent to CDC for virus isolation. Each body fluid will be collected
until two negative RT-PCR results are obtained.
Participants will be followed until all their studied body fluids
are negative. They will receive tokens of appreciation for their
participation at the initial visit and again at every subsequent
follow-up visit [e.g., 120,000 Leones (approximately $28 US dollars)
and a

[[Page 56995]]

supply of condoms]. For Module A, men and women will be recruited in
equal numbers for this study until more information on gender effects
of viral persistence is available. A trained study data manager will
collect test results for all participants in a laboratory results form.
Results and analyses are needed to update relevant counseling
messages and recommendations from the Sierra Leone Ministry of Health,
World Health Organization and CDC. The study will provide the most
current information that is critical to the development of public
health measures, such as recommendations about sexual activity,
breastfeeding, and other routine activities and approaches to
evaluation of survivors to determine whether they can safely resume
sexual activity. These approaches in turn are expected to reduce the
risk of Ebola resurgence and mitigate stigma for thousands of
survivors. The information is likewise critical to reducing the risk
that Ebola would be introduced in a location that has not previously
been affected. The total estimated annualized burden hours are 2,474.

Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Type of Number of Number of burden per Total burden
Form name respondent respondents responses per response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
Pilot participants............ Survivor 80 1 30/60 40
Questionnaire.
Pilot participants............ Survivor Follow- 80 12 10/60 160
up
Questionnaire.
Module A male participants.... Survivor 175 1 30/60 88
Questionnaire.
Module A male participants.... Survivor Follow- 175 12 10/60 350
up
Questionnaire.
Module A female participants.. Survivor 175 1 30/60 88
Questionnaire.
Module A female participants.. Survivor Follow- 175 12 10/60 350
up
Questionnaire.
Module B female participants.. Survivor 100 1 30/60 50
Questionnaire.
Module B female participants.. Survivor Follow- 100 12 10/60 200
up
Questionnaire.
Data manager.................. Laboratory 1 6,890 10/60 1,148
Results Form.
---------------------------------------------------------------------------------
TOTALS.................... ................ .............. .............. .............. 2,474
----------------------------------------------------------------------------------------------------------------

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. 2015-23572 Filed 9-18-15; 8:45 am]
BILLING CODE 4163-18-P

Federal Register / Vol. 80, No. 182 / Monday, September 21, 2015 / Notices 56993

Method of Collection Estimated Annual Respondent Burden Prior to the deployment of the live
To achieve the goals of this project, Between July 2014 and June 2015, 59 RoPR system, Quintiles conducted six
the following data collection will be respondents entered their RoPR record (6) usability sessions with RoPR
implemented: Collect information from manually. stakeholders using a web-based
users who populate the RoPR database Each respondent need enter his or her prototype.
system, which will achieve all of the new RoPR record only once. The RoPR In February 2015, Quintiles
above goals. system sends an automated reminder to conducted a knowledge transfer webinar
The purpose and the use of the RoPR any registry owner who has not updated for registry contacts to learn how to
is to provide a readily available public his or her RoPR record in the past year. enter new records into the RoPR. As a
resource strictly for patient registries, Approximately, 57.25% of RoPR records
result of the knowledge gained during
following the model of were estimated to have been eligible for
these processes, it is estimated that it
ClinicalTrials.gov, allowing for the updates between July 2014 and June
increased availability and efficacy of 2015, either on the registry owner’s own takes users 45 minutes to manually
patient registries. The information being initiative, or prompted by the automated enter a new RoPR record; and 15
collected in the RoPR Record is visible reminder. As the RoPR continues to minutes to upload a new RoPR record
to the public visiting the RoPR Web site, grow and more patient registry records (an average of 30 minutes using either
and is readily available for public use. are added over time, this percentage method). It takes 15 minutes for a user
The RoPR is an ongoing data collection represents a growing, cumulative to review and make updates to an
initiative. number. existing RoPR record.

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of Minutes per Total burden
Number of
Form name responses per response hours
respondents respondent (average) (average)

New RoPR Record (manually—entered or uploaded electronically method) 59 1 30/60 29.5
Review/update existing RoPR Record ............................................................ 79 1 15/60 19.75

Total .......................................................................................................... 138 ........................ ........................ 49.25

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Average
Number of Total burden Total cost
Form name hourly wage
respondents hours burden
rate †

New RoPR Record (manually—entered or uploaded electronically method) 59 29.5 $36.54 $1,077.93
Review/update existing RoPR Record ............................................................ 79 19.75 36.54 721.67

Total .......................................................................................................... 138 44.25 ........................ $1,799.60
†*Based on the mean wages for Healthcare Practitioners and Technical Occupations, 29–0000. National Compensation Survey: Occupational
wages in the United States May 2014, ‘‘U.S. Department of Labor, Bureau of Labor Statistics.’’ Available at: http://www.bls.gov/oes/current/oes_
nat.htm#b29-0000..

In order to highlight patient registry research and information dissemination comments will become a matter of
concerns about using the RoPR system functions, including whether the public record.
and turning user feedback into future information will have practical utility; Sharon Arnold,
system maintenance and upgrade (b) the accuracy of AHRQ’s estimate of
initiatives (increasing the usability of Deputy Director.
burden (including hours and costs) of
the RoPR and lowering the burden of [FR Doc. 2015–23574 Filed 9–18–15; 8:45 am]
the proposed collection(s) of
entering patient registry information), information; (c) ways to enhance the BILLING CODE 4160–90–P
plans for a voluntary user satisfaction quality, utility, and clarity of the
survey is being considered for information to be collected; and (d)
development and deployment in 2Q DEPARTMENT OF HEALTH AND
ways to minimize the burden of the HUMAN SERVICES
2016. Its full nature and design is still collection of information upon the
in the concept stage and so this survey respondents, including the use of Centers for Disease Control and
is not part of the Estimated Annualized Prevention
automated collection techniques or
Respondent Hourly/Cost Burden noted
other forms of information technology.
in Exhibits 1 and 2.
Comments submitted in response to [60 Day–15–15BFV; Docket No. CDC–2015–
Request for Comments this notice will be summarized and 0085]
rmajette on DSK7SPTVN1PROD with NOTICES

In accordance with the Paperwork included in the Agency’s subsequent Proposed Data Collection Submitted
Reduction Act, comments on AHRQ’s request for OMB approval of the for Public Comment and
information collection are requested proposed information collection. All Recommendations
with regard to any of the following: (a)
Whether the proposed collection of AGENCY: Centers for Disease Control and
information is necessary for the proper Prevention (CDC), Department of Health
performance of AHRQ health care and Human Services (HHS).

VerDate Sep<11>2014 15:14 Sep 18, 2015 Jkt 235001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\21SEN1.SGM 21SEN1

Federal Register / Vol. 80, No. 182 / Monday, September 21, 2015 / Notices 56995

supply of condoms]. For Module A, men and recommendations from the Sierra can safely resume sexual activity. These
and women will be recruited in equal Leone Ministry of Health, World Health approaches in turn are expected to
numbers for this study until more Organization and CDC. The study will reduce the risk of Ebola resurgence and
information on gender effects of viral provide the most current information mitigate stigma for thousands of
persistence is available. A trained study that is critical to the development of survivors. The information is likewise
data manager will collect test results for public health measures, such as critical to reducing the risk that Ebola
all participants in a laboratory results recommendations about sexual activity, would be introduced in a location that
form. breastfeeding, and other routine has not previously been affected. The
Results and analyses are needed to activities and approaches to evaluation total estimated annualized burden hours
update relevant counseling messages of survivors to determine whether they are 2,474.

ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of Total
Type of Number of burden per
Form name responses per burden
respondent respondents response
respondent hours
(in hours)

Pilot participants ................................ Survivor Questionnaire ..................... 80 1 30/60 40
Pilot participants ................................ Survivor Follow-up Questionnaire .... 80 12 10/60 160
Module A male participants .............. Survivor Questionnaire ..................... 175 1 30/60 88
Module A male participants .............. Survivor Follow-up Questionnaire .... 175 12 10/60 350
Module A female participants ........... Survivor Questionnaire ..................... 175 1 30/60 88
Module A female participants ........... Survivor Follow-up Questionnaire .... 175 12 10/60 350
Module B female participants ........... Survivor Questionnaire ..................... 100 1 30/60 50
Module B female participants ........... Survivor Follow-up Questionnaire .... 100 12 10/60 200
Data manager ................................... Laboratory Results Form ................. 1 6,890 10/60 1,148

TOTALS ..................................... ........................................................... ........................ ........................ ........................ 2,474

Leroy A. Richardson, from Ebola-affected Countries and Their Georgia 30329; phone: 404–639–7570;
Chief, Information Collection Review Office, Contacts Currently Residing in State, Email: omb@cdc.gov.
Office of Scientific Integrity, Office of the Territorial, and Local Jurisdictions. SUPPLEMENTARY INFORMATION: Under the
Associate Director for Science, Office of the DATES: Written comments must be Paperwork Reduction Act of 1995 (PRA)
Director, Centers for Disease Control and received on or before November 20,
Prevention.
(44 U.S.C. 3501–3520), Federal agencies
2015. must obtain approval from the Office of
[FR Doc. 2015–23572 Filed 9–18–15; 8:45 am]
ADDRESSES: You may submit comments, Management and Budget (OMB) for each
BILLING CODE 4163–18–P
identified by Docket No. CDC–2015– collection of information they conduct
0082 by any of the following methods: or sponsor. In addition, the PRA also
DEPARTMENT OF HEALTH AND • Federal eRulemaking Portal: requires Federal agencies to provide a
Regulation.gov. Follow the instructions 60-day notice in the Federal Register
HUMAN SERVICES
for submitting comments. concerning each proposed collection of
Centers for Disease Control and • Mail: Leroy A. Richardson, information, including each new
Prevention Information Collection Review Office, proposed collection, each proposed
Centers for Disease Control and extension of existing collection of
[60 Day–15–15BFD; Docket No, CDC–2015– Prevention, 1600 Clifton Road NE., MS– information, and each reinstatement of
0082] D74, Atlanta, Georgia 30329. previously approved information
Instructions: All submissions received collection before submitting the
Proposed Data Collection Submitted
must include the agency name and collection to OMB for approval. To
for Public Comment and
Docket Number. All relevant comments comply with this requirement, we are
Recommendations
received will be posted without change publishing this notice of a proposed
AGENCY: Centers for Disease Control and to Regulations.gov, including any data collection as described below.
Prevention (CDC), Department of Health personal information provided. For Comments are invited on: (a) Whether
and Human Services (HHS). access to the docket to read background the proposed collection of information
ACTION: Notice with comment period. documents or comments received, go to is necessary for the proper performance
Regulations.gov. of the functions of the agency, including
SUMMARY: The Centers for Disease Please note: All public comment whether the information shall have
Control and Prevention (CDC), as part of should be submitted through the practical utility; (b) the accuracy of the
its continuing efforts to reduce public Federal eRulemaking portal agency’s estimate of the burden of the
burden and maximize the utility of (Regulations.gov) or by U.S. mail to the proposed collection of information; (c)
government information, invites the address listed above. ways to enhance the quality, utility, and
general public and other Federal FOR FURTHER INFORMATION CONTACT: To clarity of the information to be
rmajette on DSK7SPTVN1PROD with NOTICES

agencies to take this opportunity to request more information on the collected; (d) ways to minimize the
comment on proposed and/or proposed project or to obtain a copy of burden of the collection of information
continuing information collections, as the information collection plan and on respondents, including through the
required by the Paperwork Reduction instruments, contact the Information use of automated collection techniques
Act of 1995. This notice invites Collection Review Office, Centers for or other forms of information
comment on the proposed collection Disease Control and Prevention, 1600 technology; and (e) estimates of capital
Active Monitoring of Travelers Coming Clifton Road NE., MS–D74, Atlanta, or start-up costs and costs of operation,

VerDate Sep<11>2014 15:14 Sep 18, 2015 Jkt 235001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\21SEN1.SGM 21SEN1

Document Created: 2015-12-15 09:38:46
Document Modified: 2015-12-15 09:38:46

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
Action		Notice with comment period.
Dates		Written comments must be received on or before November 20, 2015.
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]
FR Citation		80 FR 56993

80 FR 56993 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

Federal Register Volume 80, Issue 182 (September 21, 2015)

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