[Federal Register Volume 78, Number 181 (Wednesday, September 18, 2013)]
[Pages 57383-57385]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-22745]



[EPA-HQ-ORD-2013-0626; FRL-9900-98-ORD]

Human Studies Review Board; Notification of a Public Meeting

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

ACTION: Notice.


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

DATES: This public meeting will be held on October 1, 2013, from 
approximately 12:30 p.m. to approximately 5:30 p.m. Eastern Time. 
Comments may be submitted on or before noon (Eastern Time) on Thursday, 
September 24, 2013.

ADDRESSES: Submit your written comments, identified by Docket ID No. 
EPA-HQ-ORD-2013-0626, 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-
2013-0626. 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

[[Page 57384]]

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 or Lu-Ann Kleibacker on telephone number (202) 564-
7189; fax (202) 564-2070; email address kleibacker.lu-ann@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/osa/hsrb/.

    Location: The meeting will be held at the EPA Conference Center--S-
4380, One Potomac Yard (South Building), 2777 S. Crystal Drive, 
Arlington, VA 22202.
    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 
    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.

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 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 or Lu-Ann Kleibacker listed under FOR FURTHER INFORMATION 

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 September 2013. 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/osa/hsrb/. For questions on document availability, or if 
you do not have access to the Internet, consult either Jim Downing or 
Lu-Ann Kleibacker 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 
    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-2013-0626 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, September 24, 2013. 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 or Lu-Ann Kleibacker, under FOR FURTHER 
INFORMATION CONTACT no later than noon, Eastern Time, Tuesday, 
September 24, 2013, 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 on the science and ethics issues under discussion, it 
is not our intent 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

[[Page 57385]]

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, September 24, 2013. 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 or Lu-Ann Kleibacker 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. Topic for discussion. At its meeting on October 1, 2013, EPA's 
Human Studies Review Board will consider scientific and ethical issues 
surrounding this topic:

    A new scenario design and associated protocol from the 
Antimicrobial Exposure Assessment Task Force II (AEATF-II) 
describing proposed research to monitor the dermal and inhalation 
exposure during manual pouring of solid formulation antimicrobial 
products. EPA requests the advice of the HSRB concerning whether, if 
it is revised as suggested in EPA's review and if it is performed as 
described, this research is likely to generate scientifically 
reliable data, useful for assessing the exposure of those who pour 
solid formulation antimicrobial pesticide products, and to meet the 
applicable requirements of 40 CFR part 26, subparts K and L.
    In addition, the EPA will present general information about 
EPA's Repellency Awareness Program and discuss possible implications 
of this program for the HSRB.

    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 

    Dated: September 9, 2013.
Glenn Paulson,
Science Advisor.
[FR Doc. 2013-22745 Filed 9-17-13; 8:45 am]