Human Studies Review Board; Notification of a Public Meetings, 57607-57608 [2015-24342]

Agencies

• ENVIRONMENTAL PROTECTION AGENCY

[Federal Register Volume 80, Number 185 (Thursday, September 24, 2015)]
[Notices]
[Pages 57607-57608]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24342]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2015-0588; FRL-9934-66-ORD]


Human Studies Review Board; Notification of a 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 to advise the Agency on the ethical and scientific 
reviews of EPA research with human subjects.

DATES: A public virtual meeting will be held on October 19-20, 2015, 
from 1:00 p.m. to approximately 5:00 p.m. Eastern Time each day. A 
separate teleconference meeting is planned for Monday, December 7, 
2015, from 1:00 p.m. to approximately 2:30 p.m. for the HSRB to 
finalize its Final Report of the October 19-20, 2015 meeting.

ADDRESSES: Both of these meetings will be conducted entirely on the 
Internet using Adobe Connect. Registration is required to attend this 
meeting. Please visit the HSRB Web site: https://www.epa.gov/hsrb to 
register.
    Comments: Submit your written comments, identified by Docket ID No. 
EPA-HQ-ORD-2015-0588, by one of the following methods:
    Internet: https://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 at: https://www.epa.gov/epahome/dockets.htm.
    Instructions: 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 https://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 https://www.regulations.gov or email. The https://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 https://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 on telephone 
number (202) 564-2468; fax number: (202) 564-2070; email address: 
downing.jim@epa.gov; or 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: https://www.epa.gov/hsrb.

SUPPLEMENTARY INFORMATION: 
    Meeting access: Access to these Internet meetings are open to all 
by following the information provided above.
    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. The Agency has not attempted to describe all the 
specific entities that may have interest in human subjects research. If 
you have any questions regarding this notice, 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 https://www.epa.gov/fedrgstr/.
    Docket: All documents in the docket are listed in the https://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 https://www.regulations.gov or in hard copy at the ORD Docket, EPA 
Docket Center, in the Public Reading Room. The 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.

[[Page 57608]]

Updates to Public Reading Room access are available on the Web site 
(https://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 early October 2015. In addition, the Agency may provide 
additional background documents as the materials become available. You 
may obtain electronic copies of these documents, and other related 
documents that are available electronically, from the regulations.gov 
Web site and the EPA HSRB Web site at https://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.

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 these meetings 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-2015-0588 in the subject 
line on the first page of your request.
    1. Oral comments. Requests to present oral comments during either 
conference call will be accepted up to Noon Eastern Time on Wednesday, 
October 14, 2015, for the October 19-20 meeting and up to Noon Eastern 
Time on Wednesday, December 2, 2015, for the December 7, 2015 
conference call. 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 during either call. Individuals or groups 
wishing to make brief oral comments to the HSRB on October 19 or 20, 
2015, are strongly advised to submit their request (preferably via 
email) to Jim Downing, listed under FOR FURTHER INFORMATION CONTACT no 
later than noon, Eastern Time, Wednesday, October 14, 2015, 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. 
Individuals or groups wishing to make brief oral comments to the HSRB 
during the December 7, 2015 teleconference should submit their request 
by Noon Eastern Time on Wednesday, December 2, 2015. 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 
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 Wednesday, October 14, 2015, for the 
October 19-20 meeting, and by noon Eastern Time on Wednesday, December 
2, 2015, for the December 7, 2015 teleconference. 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 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. On Monday, October 19, 2015, EPA's Human 
Studies Review Board will consider scientific and ethical issues 
surrounding: A completed study from the U.S. Department of Agriculture 
Describing Laboratory Evaluation of Bite Protection from Repellent-
Impregnated Clothing for the United States Military. At the 
continuation of the October meeting on Tuesday, October 20, 2015, EPA's 
Human Studies Review Board will consider scientific and ethical issues 
surrounding: Protocol for Testing of S.C. Johnson Personal Tick 
Repellent Products to Support Use of EPA Repellency Awareness Graphic.
    2. Then on Monday, December 7, 2015 the HSRB will finalize its 
Final Report for the October 19-20, 2015 meeting.
    2. Meeting minutes and reports. Minutes of these meetings, 
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 
https://www.epa.gov/osa/hsrb/ and https://www.regulations.gov. In 
addition, information regarding the HSRB's final meeting report, will 
be found at https://www.epa.gov/osa/hsrb/ or from the person listed 
under FOR FURTHER INFORMATION CONTACT.

    Dated: September 17, 2015.
Thomas A. Burke,
EPA Science Advisor.
[FR Doc. 2015-24342 Filed 9-23-15; 8:45 am]
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