60 Day FRN - published

56993

Federal Register / Vol. 80, No. 182 / Monday, September 21, 2015 / Notices
Method of Collection
To achieve the goals of this project,
the following data collection will be
implemented: Collect information from
users who populate the RoPR database
system, which will achieve all of the
above goals.
The purpose and the use of the RoPR
is to provide a readily available public
resource strictly for patient registries,
following the model of
ClinicalTrials.gov, allowing for the
increased availability and efficacy of
patient registries. The information being
collected in the RoPR Record is visible
to the public visiting the RoPR Web site,
and is readily available for public use.
The RoPR is an ongoing data collection
initiative.

Estimated Annual Respondent Burden
Between July 2014 and June 2015, 59
respondents entered their RoPR record
manually.
Each respondent need enter his or her
new RoPR record only once. The RoPR
system sends an automated reminder to
any registry owner who has not updated
his or her RoPR record in the past year.
Approximately, 57.25% of RoPR records
were estimated to have been eligible for
updates between July 2014 and June
2015, either on the registry owner’s own
initiative, or prompted by the automated
reminder. As the RoPR continues to
grow and more patient registry records
are added over time, this percentage
represents a growing, cumulative
number.

Prior to the deployment of the live
RoPR system, Quintiles conducted six
(6) usability sessions with RoPR
stakeholders using a web-based
prototype.
In February 2015, Quintiles
conducted a knowledge transfer webinar
for registry contacts to learn how to
enter new records into the RoPR. As a
result of the knowledge gained during
these processes, it is estimated that it
takes users 45 minutes to manually
enter a new RoPR record; and 15
minutes to upload a new RoPR record
(an average of 30 minutes using either
method). It takes 15 minutes for a user
to review and make updates to an
existing RoPR record.

EXHIBIT 1—ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Form name

Number of
responses per
respondent

Minutes per
response
(average)

Total burden
hours
(average)

New RoPR Record (manually—entered or uploaded electronically method)
Review/update existing RoPR Record ............................................................

59
79

1
1

30/60
15/60

29.5
19.75

Total ..........................................................................................................

138

........................

........................

49.25

EXHIBIT 2—ESTIMATED ANNUALIZED COST BURDEN
Number of
respondents

Form name

Total burden
hours

Average
hourly wage
rate †

Total cost
burden

New RoPR Record (manually—entered or uploaded electronically method)
Review/update existing RoPR Record ............................................................

59
79

29.5
19.75

$36.54
36.54

$1,077.93
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
concerns about using the RoPR system
and turning user feedback into future
system maintenance and upgrade
initiatives (increasing the usability of
the RoPR and lowering the burden of
entering patient registry information),
plans for a voluntary user satisfaction
survey is being considered for
development and deployment in 2Q
2016. Its full nature and design is still
in the concept stage and so this survey
is not part of the Estimated Annualized
Respondent Hourly/Cost Burden noted
in Exhibits 1 and 2.
rmajette on DSK7SPTVN1PROD with NOTICES

Request for Comments
In accordance with the Paperwork
Reduction Act, comments on AHRQ’s
information collection are requested
with regard to any of the following: (a)
Whether the proposed collection of
information is necessary for the proper
performance of AHRQ health care

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research and information dissemination
functions, including whether the
information will have practical utility;
(b) the accuracy of AHRQ’s estimate of
burden (including hours and costs) of
the proposed collection(s) of
information; (c) ways to enhance the
quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All

PO 00000

comments will become a matter of
public record.
Sharon Arnold,
Deputy Director.
[FR Doc. 2015–23574 Filed 9–18–15; 8:45 am]
BILLING CODE 4160–90–P

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

AGENCY:

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56994
ACTION:

Federal Register / Vol. 80, No. 182 / Monday, September 21, 2015 / Notices
Notice with comment period.

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 42day 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.
SUMMARY:

rmajette on DSK7SPTVN1PROD with NOTICES

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.

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,

FOR FURTHER INFORMATION CONTACT:

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15:14 Sep 18, 2015

Jkt 235001

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
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).

PO 00000

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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

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56995

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

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.

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

ESTIMATED ANNUALIZED BURDEN HOURS
Total
burden
hours

Pilot participants ................................
Pilot participants ................................
Module A male participants ..............
Module A male participants ..............
Module A female participants ...........
Module A female participants ...........
Module B female participants ...........
Module B female participants ...........
Data manager ...................................

Survivor Questionnaire .....................
Survivor Follow-up Questionnaire ....
Survivor Questionnaire .....................
Survivor Follow-up Questionnaire ....
Survivor Questionnaire .....................
Survivor Follow-up Questionnaire ....
Survivor Questionnaire .....................
Survivor Follow-up Questionnaire ....
Laboratory Results Form .................

80
80
175
175
175
175
100
100
1

1
12
1
12
1
12
1
12
6,890

30/60
10/60
30/60
10/60
30/60
10/60
30/60
10/60
10/60

40
160
88
350
88
350
50
200
1,148

TOTALS .....................................

...........................................................

........................

........................

........................

2,474

[FR Doc. 2015–23572 Filed 9–18–15; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60 Day–15–15BFD; Docket No, CDC–2015–
0082]

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 collection
Active Monitoring of Travelers Coming

SUMMARY:

rmajette on DSK7SPTVN1PROD with NOTICES

Average
burden per
response
(in hours)

Type of
respondent

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.

VerDate Sep<11>2014

15:14 Sep 18, 2015

Jkt 235001

Number of
respondents

Number of
responses per
respondent

Form name

from Ebola-affected Countries and Their
Contacts Currently Residing in State,
Territorial, and Local Jurisdictions.
DATES: Written comments must be
received on or before November 20,
2015.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2015–
0082 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,

PO 00000

Frm 00036

Fmt 4703

Sfmt 4703

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,

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21SEN1