National Heart, Lung, and Blood Institute; Notice of Closed Meeting, 19609 [2016-07677]

Download as PDF 19609 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] BILLING CODE 4163–18–P 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] BILLING CODE 4140–01–P E:\FR\FM\05APN1.SGM 05APN1

Agencies

[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