81 FR 19609 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 81, Issue 65 (April 5, 2016)
National Institutes of Health
Federal Register Volume 81, Issue 65 (April 5, 2016)
| Page Range | 19609-19609 | |
| FR Document | 2016-07677 |
[Federal Register Volume 81, Number 65 (Tuesday, April 5, 2016)] [Notices] [Page 19609] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-07677] ----------------------------------------------------------------------- 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, [email protected]. (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
![Federal Register / Vol. 81, No. 65 / Tuesday, April 5, 2016 / Notices 19609
potential route of human disease collections and questionnaires every persistence is available. A trained study
transmission and to understand the three days (sweat and breast milk). data manager will collect test results for
most current community barriers to Participants for each module will be all participants in a laboratory results
reaching that final goal. recruited by trained study staff from form.
Persistence of Ebola Virus (EBOV) in Ebola treatment units (ETUs) and Results and analyses are needed to
Body Fluids of EVD Survivors in Sierra survivor registries. Participants will be update relevant counseling messages
Leone is the first systematic followed up at study sites in and recommendations from the Sierra
examination of the post-recovery government hospitals. Leone Ministry of Health, World Health
Specimens will be tested for EBOV Organization, and CDC. The study will
persistence of EBOV and the risks of
ribonucleic acid (RNA) by reverse provide the most current information
transmission from a cohort of
transcription polymerase chain reaction that is critical to the development of
convalescent Ebola survivors during
test (RT–PCR) in Sierra Leone at the public health measures, such as
close or intimate contact. It is important
CDC laboratory facility in Bo. All recommendations about sexual activity,
to fully understand how long the virus
positive RT–PCR samples will be sent to breastfeeding, and other routine
stays active in body fluids other than CDC Atlanta for virus isolation. Each activities and approaches to evaluation
blood in order to target and refine body fluid will be collected until two of survivors to determine whether they
public health interventions to arrest the negative RT–PCR results are obtained. can safely resume sexual activity. These
ongoing spread of disease. Participants will be followed until all approaches in turn are expected to
The research study is comprised of their studied body fluids are negative. reduce the risk of Ebola resurgence and
three modules based on the body fluids They will receive tokens of appreciation mitigate stigma for thousands of
to be studied: A pilot module of adult for their participation at the initial visit survivors. The information is likewise
males (semen) and two full modules: and again at every subsequent follow-up critical to reducing the risk that Ebola
Module A of adult men and women visit [e.g., 120,000 Leones would be introduced in a location that
repeating collections and questionnaires (approximately $28 US dollars) and a has not previously been affected.
every two weeks (semen, vaginal supply of condoms]. For Module A, men The total burden hours requested for
secretions, and saliva, tears, sweat, and women will be recruited in equal the research study in Sierra Leone is
urine, rectal swab), and Module B of numbers for this study until more 1,836 hours. There are no costs to
lactating adult women repeating information on gender effects of viral respondents other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
No. of Average
No. of responses burden per
Type of respondent Form name respondents per response
respondent (hours)
Data manager ................................................. Intake Form .................................................... 1 550 20/60
Pilot participants .............................................. Survivor Questionnaire ................................... 100 1 30/60
Pilot participants .............................................. Survivor Follow-up Questionnaire .................. 100 5 15/60
Pilot participants .............................................. 3 & 6 Month Follow up Questionnaire ........... 100 2 15/60
Main study male participants .......................... Survivor Questionnaire ................................... 120 1 30/60
Main study male participants .......................... Survivor Follow-up Questionnaire .................. 120 12 15/60
Main study male participants .......................... 3 & 6 Month Follow Questionnaire ................ 120 2 15/60
Main study female participants ....................... Survivor Questionnaire ................................... 120 1 30/60
Main study female participants ....................... Survivor Follow-up Questionnaire .................. 120 4 15/60
Main study female participants ....................... 3 & 6 Month Follow up Questionnaire ........... 120 2 15/60
Data manager ................................................. Laboratory Results Form ............................... 1 4,250 10/60
Leroy A. Richardson, The meeting will be closed to the Place: National Institutes of Health, 6701
Chief, Information Collection Review Office, public in accordance with the Rockledge Drive, Room 7178, Bethesda, MD
Office of Scientific Integrity, Office of the 20892 (Virtual Meeting).
provisions set forth in sections
Associate Director for Science, Office of the Contact Person: William J. Johnson, Ph.D.,
552b(c)(4) and 552b(c)(6), title 5 U.S.C., Scientific Review Officer, Office of Scientific
Director, Centers for Disease Control and
Prevention.
as amended. The grant applications and Review/DERA, National Heart, Lung, and
the discussions could disclose Blood Institute, 6701 Rockledge Drive, Room
[FR Doc. 2016–07803 Filed 4–4–16; 8:45 am]
confidential trade secrets or commercial 7178, Bethesda, MD 20892–7924, 301–435–
BILLING CODE 4163–18–P 0725, johnsonwj@nhlbi.nih.gov.
property such as patentable material,
and personal information concerning (Catalogue of Federal Domestic Assistance
individuals associated with the grant Program Nos. 93.233, National Center for
DEPARTMENT OF HEALTH AND Sleep Disorders Research; 93.837, Heart and
HUMAN SERVICES applications, the disclosure of which Vascular Diseases Research; 93.838, Lung
would constitute a clearly unwarranted Diseases Research; 93.839, Blood Diseases
asabaliauskas on DSK3SPTVN1PROD with NOTICES
National Institutes of Health invasion of personal privacy. and Resources Research, National Institutes
Name of Committee: National Heart, Lung, of Health, HHS)
National Heart, Lung, and Blood
and Blood Institute Special Emphasis Panel, Dated: March 30, 2016.
Institute; Notice of Closed Meeting
R13 Conference Grant Application Review. Anna Snouffer,
Pursuant to section 10(d) of the Date: April 28, 2016. Deputy Director, Office of Federal Advisory
Federal Advisory Committee Act, as Time: 9:00 a.m. to 6:00 p.m. Committee Policy.
amended (5 U.S.C. App.), notice is Agenda: To review and evaluate grant [FR Doc. 2016–07677 Filed 4–4–16; 8:45 am]
hereby given of the following meeting. applications. BILLING CODE 4140–01–P
VerDate Sep<11>2014 17:18 Apr 04, 2016 Jkt 238001 PO 00000 Frm 00061 Fmt 4703 Sfmt 9990 E:\FR\FM\05APN1.SGM 05APN1](https://thefederalregister.org/doc/81_FR_19674/page/1.svg)
Document Created: 2018-02-07 13:53:15
Document Modified: 2018-02-07 13:53:15
| 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 | |
| Dates | April 28, 2016. | |
| FR Citation | 81 FR 19609 |
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