83 FR 14636 - Human Studies Review Board; Notification of Public Meetings

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 66 (April 5, 2018)

The Environmental Protection Agency (EPA), Office of the Science Advisor announces two separate public meetings of the Human Studies Review Board (HSRB) to advise the Agency on the ethical and scientific review of research involving human subjects.

[Federal Register Volume 83, Number 66 (Thursday, April 5, 2018)]
[Notices]
[Pages 14636-14637]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-06990]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9976-38-ORD]


Human Studies Review Board; Notification of Public Meetings

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA), Office of the 
Science Advisor announces two separate public meetings of the Human 
Studies Review Board (HSRB) to advise the Agency on the ethical and 
scientific review of research involving human subjects.

DATES: A virtual public meeting will be held on Tuesday, April 24, 
2018, Wednesday, April 25, 2018, and Thursday, April 26, 2018 from 1:00 
p.m. to approximately 5:30 p.m. Eastern Time on all dates. A separate, 
subsequent teleconference meeting is planned for Thursday, June 14, 
2018, from 2:00 p.m. to approximately 3:30 p.m. Eastern Time for the 
HSRB to finalize its Final Report of the April 24-26, 2018 meeting and 
review other possible topics.

ADDRESSES: All of these meetings will be conducted entirely by 
telephone and on the internet using Adobe Connect. For detailed access 
information visit the HSRB website: http://www2.epa.gov/osa/human-studies-review-board.

FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes to 
receive further information should contact the HSRB Designated Federal 
Official (DFO), Thomas O'Farrell on telephone number (202) 564-8451; 
fax number: (202) 564-2070; email address: [email protected]; or 
mailing address: Environmental Protection Agency, Office of the Science 
Advisor, Mail code 8105R, 1200 Pennsylvania Avenue NW, Washington, DC 
20460.

SUPPLEMENTARY INFORMATION: 
    Meeting access: These meetings will be open to the public. The full 
Agenda and meeting materials will be available at the HSRB website: 
http://www2.epa.gov/osa/human-studies-review-board . For questions on 
document availability, or if you do not have access to the internet, 
consult with the DFO, Thomas O'Farrell, listed under FOR FURTHER 
INFORMATION, CONTACT.
    Special accommodations. For information on access or services for 
individuals with disabilities, or to request accommodation of a 
disability, please contact the DFO listed under FOR FURTHER 
INFORMATION, CONTACT at least 10 days prior to the meeting to give EPA 
as much time as possible to process your request.

How may I participate in this meeting?

    The HSRB encourages the public's input. You may participate in 
these meetings by following the instructions in this section.
    1. Oral comments. To pre-register to make oral comments, please 
contact the DFO, Thomas O'Farrell, listed under FOR FURTHER 
INFORMATION, CONTACT. Requests to present oral comments during either 
meeting will be accepted up to Noon Eastern Time on Tuesday, April 17, 
2018, for the April 24-26, 2018 meeting and up to Noon Eastern Time on 
Thursday, June 7, 2018 for the June 14, 2018 meeting. To the extent 
that time permits, interested persons who have not pre-registered may 
be permitted by the HSRB Chair to present oral comments during either 
meeting at the designated time on the agenda. Oral comments before the 
HSRB are generally limited to five minutes per individual or 
organization. If additional time is available, further public comments 
may be possible.
    2. Written comments. Submit your written comments prior to the 
meetings. For the Board to have the best opportunity to review and 
consider your comments as it deliberates, you should submit your 
comments by Noon Eastern Time on Tuesday, April 17, 2018, for the April 
24-26, 2018 meeting and up to Noon Eastern Time on Thursday, June 7, 
2018 for the June 14, 2018 meeting. If you submit comments after these 
dates, those comments will be provided to the HSRB members, but you 
should recognize that the HSRB members may not have adequate time to 
consider your comments prior to their discussion. You should submit 
your comments to the DFO, Thomas O'Farrell listed under FOR FURTHER 
INFORMATION, CONTACT. There is no limit on the length of written 
comments for consideration by the HSRB.

Background

    The HSRB is a Federal advisory committee operating in accordance 
with the Federal Advisory Committee Act 5 U.S.C. App.2 Sec.  9. The 
HSRB provides advice, information, and recommendations on issues 
related to scientific and ethical aspects of third-party human subjects 
research that are submitted to the Office of Pesticide Programs (OPP) 
to be used for regulatory purposes.
    Topic for discussion. On April 24-26, 2018, EPA's Human Studies 
Review Board will consider four topics: (1) A protocol for laboratory-
based testing of a tick repellent containing Oil of Lemon Eucalyptus, 
submitted by ARCTEC (Arthropod Control Product Centre) and by sponsored 
by Citrefine International, (2) a published article titled ``Assessing 
key safety concerns of a Wolbachia-based strategy to control dengue 
transmission by Aedes mosquitoes'', authored by Jean Popovici, Luciano 
A Moriera, Anne Poinsignon, Inaki Iturbe-Ormaetxe, Darlene McNaughton, 
and Scott O'Neill, (3) a completed study submitted by the Antimicrobial 
Exposure Assessment Task Force: ``Determination of Removal Efficiency 
of 1,2-Benzisothiazol-3(2H)-one (BIT) from Hand Surfaces Using an 
Isopropyl Alcohol/Water Wipe and Wash Procedure'', and (4) a completed 
study submitted by the Antimicrobial Exposure Assessment Task Force: 
``A Study for Measurement of Potential Dermal and Inhalation Exposure 
During Application of a Latex Paint Containing an Antimicrobial 
Pesticide Product Using a Brush and Roller for Indoor Surface 
Painting''.
    The Agenda and meeting materials for these topics will be available 
in advance of the meeting at http://www2.epa.gov/osa/human-studies-review-board.
    On June 14, 2018, the HSRB will review and finalize their draft 
Final Report from the April 24-26, 2018 meeting, in addition to other 
topics that may come before the Board. The HSRB may also discuss 
planning for future HSRB meetings. The agenda and the draft report will 
be available prior to the meeting at http://www2.epa.gov/osa/human-studies-review-board.
    Meeting minutes and final reports. Minutes of these meetings, 
summarizing the matters discussed and recommendations made by the HSRB, 
will be released within 90 calendar days of the meeting. These minutes 
will be available at http://www2.epa.gov/osa/

[[Page 14637]]

human-studies-review-board. In addition, information regarding the 
HSRB's Final Report, will be found at http://www2.epa.gov/osa/human-studies-review-board or from Thomas O'Farrell listed under FOR FURTHER 
INFORMATION, CONTACT.

    Dated: March 26, 2018.
Jennifer Orme-Zavaleta,
EPA Science Advisor.
[FR Doc. 2018-06990 Filed 4-4-18; 8:45 am]
 BILLING CODE 6560-50-P