Document ID: EPA-HQ-ORD-2014-0189-0001
Agency: epa
Document Type: Notice
Title: Human Studies Review Board; Notification of a Public Meeting
Posted Date: 2014-03-19T04:00Z

[Federal Register Volume 79, Number 53 (Wednesday, March 19, 2014)]
[Notices]
[Pages 15332-15334]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-05908]

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 ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2014-0189; FRL-9908-30-ORD]

Human Studies Review Board; Notification of a Public Meeting

AGENCY: U.S. Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) Office of the 
Science Advisor announces a public meeting of the Human Studies Review 
Board to advise the Agency on the EPA ethical and scientific reviews of 
research with human subjects.

DATES: This public meeting will be held on April 8-9, 2014, from 
approximately 9:30 p.m. to approximately 5:30 p.m. Eastern Time. 
Comments may be submitted on or before noon (Eastern Time) on Tuesday, 
April 1, 2014.

ADDRESSES: The meeting will be held at the Environmental Protection 
Agency, Conference Center, Lobby Level, One Potomac Yard (South Bldg.), 
2777 S. Crystal Dr., Arlington, VA 22202.
    Comments: Submit your written comments, identified by Docket ID No. 
EPA-HQ-ORD-2014-0189, by one of the following methods:
    Internet: http://www.regulations.gov: Follow the online 
instructions for submitting comments.
    Email: ORD.Docket@epa.gov.
    Mail: The EPA Docket Center EPA/DC, ORD Docket, Mail code: 28221T, 
1200 Pennsylvania Avenue NW., Washington, DC 20460.
    Hand Delivery: The EPA/DC Public Reading Room is located in the EPA 
Headquarters Library, Room Number 3334 in the EPA WJC West, at 1301 
Constitution Avenue NW., Washington, DC 20460. The hours of operation 
are 8:30 a.m. to 4:30 p.m. Eastern Time, Monday through Friday, 
excluding federal holidays. Please call (202) 566-1744 or email the ORD 
Docket at ord.docket@epa.gov for instructions. Updates to Public 
Reading Room access are available on the Web site http://www.epa.gov/epahome/dockets.htm.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2014-0189. The Agency's policy is that all comments received will be 
included in the public docket without change and may be made available 
online at http://www.regulations.gov, including any personal 
information provided, unless the comment includes information claimed 
to be Confidential Business Information or other information the 
disclosure of which is restricted by statute. Do not submit information 
that you consider to be CBI or otherwise protected through http://www.regulations.gov or email. The http://www.regulations.gov Web site 
is an ``anonymous access'' system, which means EPA will not know your 
identity or contact information unless you provide it in the body of 
your comment. If you send an email comment directly to the EPA without 
going through http://www.regulations.gov, your email address will be 
automatically captured and included as part of the comment that is 
placed in the public docket and made available on the Internet. If you 
submit an electronic comment, the EPA recommends that you include your 
name and other contact information in the body of your comment and with 
any electronic storage media you submit. If the EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, the EPA may not be able to consider your comment. 
Electronic files should avoid the use of special characters, any form 
of encryption, and be free of any defects or viruses.

FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes to 
receive further information should contact Jim Downing at telephone 
number (202) 564-2468; fax: (202) 564-2070; email address: 
downing.jim@epa.gov; mailing address Environmental Protection Agency, 
Office of the Science Advisor, Mail code 8105R, 1200 Pennsylvania 
Avenue NW., Washington, DC 20460. General information concerning the 
EPA HSRB can be found on the EPA Web site at http://www.epa.gov/hsrb.

SUPPLEMENTARY INFORMATION: 
    Meeting access: Seating at the meeting will be on a first-come 
basis. To request accommodation of a disability, please contact the 
persons listed under FOR FURTHER INFORMATION CONTACT at least ten 
business days prior to the meeting using the information under FOR 
FURTHER INFORMATION CONTACT, so that appropriate arrangements can be 
made.
    Procedures for providing public input: Interested members of the 
public may submit relevant written or oral comments for the HSRB to 
consider during the advisory process. Additional information concerning 
submission of relevant written or oral comments is provided in Section 
I, ``Public Meeting'' under subsection D. ``How May I Participate in 
this Meeting?'' of this notice.
    Webcast: This meeting may be webcast. Please refer to the HSRB Web 
site, http://www.epa.gov/hsrb/ for information on how to access the 
webcast. Please note that the webcast is a supplementary public process 
provided only for convenience. If difficulties arise resulting in 
webcasting outages, the meeting will continue as planned.

I. Public Meeting

A. Does this action apply to me?

    This action is directed to the public in general. This Notice may, 
however, be of particular interest to persons who conduct or assess 
human studies, especially studies on substances regulated by the EPA, 
or to persons who are, or may be required to conduct testing of 
chemical substances under the Federal Food, Drug, and Cosmetic Act or 
the Federal Insecticide, Fungicide, and Rodenticide Act. This notice 
might also be of special interest to participants of studies involving 
human subjects, or representatives of study participants or

[[Page 15333]]

experts on community engagement. Since many entities may also be 
interested, the Agency has not attempted to describe all the specific 
entities that may be affected by this action. If you have any questions 
regarding the applicability of this action to a particular entity, 
consult Jim Downing listed under FOR FURTHER INFORMATION CONTACT.

B. How can I access electronic copies of this document and other 
related information?

    In addition to using regulations.gov, you may access this Federal 
Register document electronically through the EPA Internet under the 
``Federal Register'' listings at http://www.epa.gov/fedrgstr/.
    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some 
information is not publicly available, e.g., CBI or other information 
whose disclosure is restricted by statute. Certain other material, such 
as copyrighted material, will be publicly available only in hard copy. 
Publicly available docket materials are available either electronically 
in http://www.regulations.gov or in hard copy at the ORD Docket, EPA/
DC, Public Reading Room. The EPA/DC Public Reading Room is located in 
the EPA Headquarters Library, Room Number 3334 in the EPA WJC West, at 
1301 Constitution Avenue NW., Washington, DC 20460. The hours of 
operation are 8:30 a.m. to 4:30 p.m. Eastern Time, Monday through 
Friday, excluding federal holidays. Please call (202) 566-1744 or email 
the ORD Docket at ord.docket@epa.gov for instructions. Updates to 
Public Reading Room access are available on the Web site (http://www.epa.gov/epahome/dockets.htm). The Agency's position paper(s), 
charge/questions to the HSRB, and the meeting agenda will be available 
by the last week of March 2014. In addition, the Agency may provide 
additional background documents as the materials become available. You 
may obtain electronic copies of these documents, and certain other 
related documents that might be available electronically, from the 
regulations.gov Web site and the EPA HSRB Web site at http://www.epa.gov/hsrb/. For questions on document availability, or if you do 
not have access to the Internet, consult Jim Downing listed under FOR 
FURTHER INFORMATION CONTACT.

C. What should I consider as I prepare my comments for the EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data that you 
used to support your views.
    4. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    5. To ensure proper receipt by the EPA, be sure to identify the 
Docket ID number assigned to this action in the subject line on the 
first page of your response. You may also provide the name, date, and 
Federal Register citation.

D. How may I participate in this meeting?

    You may participate in this meeting by following the instructions 
in this section. To ensure proper receipt by the EPA, it is imperative 
that you identify Docket ID number EPA-HQ-ORD-2014-0189 in the subject 
line on the first page of your request.
    1. Oral comments. Requests to present oral comments will be 
accepted up to Tuesday, April 1, 2014. To the extent that time permits, 
interested persons who have not pre-registered may be permitted by the 
Chair of the HSRB to present oral comments at the meeting. Each 
individual or group wishing to make brief oral comments to the HSRB is 
strongly advised to submit their request (preferably via email) to Jim 
Downing, under FOR FURTHER INFORMATION CONTACT no later than noon, 
Eastern Time, Tuesday, April 1, 2014, in order to be included on the 
meeting agenda and to provide sufficient time for the HSRB Chair and 
HSRB Designated Federal Official to review the meeting agenda to 
provide an appropriate public comment period. The request should 
identify the name of the individual making the presentation and the 
organization (if any) the individual will represent. Oral comments 
before the HSRB are generally limited to five minutes per individual or 
organization. Please note that this includes all individuals appearing 
either as part of, or on behalf of, an organization. While it is our 
intent to hear a full range of oral comments focused on the ethical and 
scientific issues of the topics being considered by the Board, we do 
not intend to permit organizations to expand the time limitations by 
having numerous individuals sign up separately to speak on their 
behalf. If additional time is available, further public comments may be 
possible.
    2. Written comments. Submit your written comments prior to the 
meeting. For the Board to have the best opportunity to review and 
consider your comments as it deliberates on its report, you should 
submit your comments at least five business days prior to the beginning 
of this meeting. If you submit comments after this date, those comments 
will be provided to the Board members, but you should recognize that 
the HSRB members may not have adequate time to consider those comments 
prior to making a decision. Thus, if you plan to submit written 
comments, the agency strongly encourages you to submit such comments no 
later than noon, Eastern Time, Tuesday, April 1, 2014. You should 
submit your comments using the instructions in Section I., under 
subsection C., ``What Should I Consider as I Prepare My Comments for 
the EPA?'' In addition, the agency also requests that persons 
submitting comments directly to the docket also provide a copy of their 
comments to Jim Downing listed under FOR FURTHER INFORMATION CONTACT. 
There is no limit on the length of written comments for consideration 
by the HSRB.

E. 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 to the EPA on 
issues related to scientific and ethical aspects of human subjects 
research. The major objectives of the HSRB are to provide advice and 
recommendations on: (1) Research proposals and protocols; (2) reports 
of completed research with human subjects; and (3) how to strengthen 
EPA's programs for protection of human subjects of research. The HSRB 
reports to the EPA Administrator through the Agency's Science Advisor.
    1. Topics for discussion. At its meeting on April 8-9, 2014, EPA's 
Human Studies Review Board will consider ethical and scientific issues 
surrounding the following topics:

a. AEATF-II Protocol: A Study for Measurement of Potential Dermal and 
Inhalation Exposure During Manual Pouring of Two Solid Formulations 
Containing an Antimicrobial
b. AEATF-II Protocol: A Study for Measurement of Potential Dermal and 
Inhalation Exposure During Application of Latex Paint Containing

[[Page 15334]]

an Antimicrobial Pesticide Product Using a Brush and Roller for Indoor 
Surface Painting
c. AEATF Protocol: Determination of Removal Efficiency of 1,2-
Benzisothiazol-3(2H)-one (BIT) from Hand Surfaces Using an Isopropyl 
Alcohol/Water Wipe and Wash Procedure
d. Laboratory Evaluation of Bite Protection from Repellent Impregnated 
Clothing for the United States Military
e. Background presentation on the Repellency Awareness Graphic and 
possible implications for the HSRB
f. Report from the HSRB Work Group of the Return of Individual Research 
Results

    2. Meeting minutes and reports. Minutes of the meeting, summarizing 
the matters discussed and recommendations, if any, made by the advisory 
committee regarding such matters, will be released within 90 calendar 
days of the meeting. Such minutes will be available at http://www.epa.gov/osa/hsrb/ and http://www.regulations.gov. In addition, 
information regarding the Board's final meeting report, will be found 
at http://www.epa.gov/osa/hsrb/ or from the person listed under FOR 
FURTHER INFORMATION CONTACT.

    Dated: March 10, 2014.
Glenn Paulson,
Science Advisor.
[FR Doc. 2014-05908 Filed 3-18-14; 8:45 am]
BILLING CODE 6560-50-P