National Heart, Lung, and Blood Institute; Notice of Closed Meeting, 19609 [2016-07677]
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Federal Register / Vol. 81, No. 65 / Tuesday, April 5, 2016 / Notices
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 is 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. 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 (ETUs) 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 Atlanta 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
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 burden hours requested for
the research study in Sierra Leone is
1,836 hours. There are no costs to
respondents other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
No. of
respondents
Type of respondent
Form name
Data manager .................................................
Pilot participants ..............................................
Pilot participants ..............................................
Pilot participants ..............................................
Main study male participants ..........................
Main study male participants ..........................
Main study male participants ..........................
Main study female participants .......................
Main study female participants .......................
Main study female participants .......................
Data manager .................................................
Intake Form ....................................................
Survivor Questionnaire ...................................
Survivor Follow-up Questionnaire ..................
3 & 6 Month Follow up Questionnaire ...........
Survivor Questionnaire ...................................
Survivor Follow-up Questionnaire ..................
3 & 6 Month Follow Questionnaire ................
Survivor Questionnaire ...................................
Survivor Follow-up Questionnaire ..................
3 & 6 Month Follow up Questionnaire ...........
Laboratory Results Form ...............................
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. 2016–07803 Filed 4–4–16; 8:45 am]
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asabaliauskas on DSK3SPTVN1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
VerDate Sep<11>2014
17:18 Apr 04, 2016
Jkt 238001
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel,
R13 Conference Grant Application Review.
Date: April 28, 2016.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
PO 00000
Frm 00061
Fmt 4703
Sfmt 9990
No. of
responses
per
respondent
1
100
100
100
120
120
120
120
120
120
1
Average
burden per
response
(hours)
550
1
5
2
1
12
2
1
4
2
4,250
20/60
30/60
15/60
15/60
30/60
15/60
15/60
30/60
15/60
15/60
10/60
Place: National Institutes of Health, 6701
Rockledge Drive, Room 7178, Bethesda, MD
20892 (Virtual Meeting).
Contact Person: William J. Johnson, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7178, Bethesda, MD 20892–7924, 301–435–
0725, johnsonwj@nhlbi.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: March 30, 2016.
Anna Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–07677 Filed 4–4–16; 8:45 am]
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[Federal Register Volume 81, Number 65 (Tuesday, April 5, 2016)]
[Notices]
[Page 19609]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-07677]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed
Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is hereby given of the following
meeting.
The meeting will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Heart, Lung, and Blood Institute
Special Emphasis Panel, R13 Conference Grant Application Review.
Date: April 28, 2016.
Time: 9:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive, Room
7178, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: William J. Johnson, Ph.D., Scientific Review
Officer, Office of Scientific Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room 7178, Bethesda, MD
20892-7924, 301-435-0725, johnsonwj@nhlbi.nih.gov.
(Catalogue of Federal Domestic Assistance Program Nos. 93.233,
National Center for Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung Diseases Research; 93.839,
Blood Diseases and Resources Research, National Institutes of
Health, HHS)
Dated: March 30, 2016.
Anna Snouffer,
Deputy Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2016-07677 Filed 4-4-16; 8:45 am]
BILLING CODE 4140-01-P
