[Federal Register Volume 79, Number 101 (Tuesday, May 27, 2014)]
[Notices]
[Pages 30135-30137]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-12172]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2014-0411; FRL 9911-45-OA]


Human Studies Review Board; Notification of a Public Meeting

AGENCY: U. S. Environmental Protection Agency.

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 ethical and scientific reviews of EPA 
research with human subjects.

DATES: This public meeting will be held on June 11, 2014, from 
approximately 10:30 a.m. to approximately 4:00 p.m. Eastern Time. 
Comments may be submitted on or before noon (Eastern Time) on Friday, 
June 4, 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-2014-0411, by one of the following methods:
    Internet: http://www.regulations.gov: Follow the online 
instructions for submitting comments.
    Email: [email protected].
    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 [email protected] for instructions. Updates to Public 
Reading Room access are available on the Web site http://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 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: 
[email protected]; 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.
    Web cast: 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 experts on 
community engagement. The Agency has not attempted to describe all

[[Page 30136]]

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 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, in the 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 
[email protected] 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 May 2014. 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 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-2014-0411 in the subject 
line on the first page of your request.
    1. Oral comments. Requests to present oral comments will be 
accepted up to Friday, June 6, 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, Friday, June 6, 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 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 comments as it deliberates on its report, you should 
submit your comments by June 4, 2014. 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 their discussion during the meeting. 
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 June 11, 2014, EPA's 
Human Studies Review Board will consider scientific and ethical issues 
surrounding these topics:
    a. Published report by Gardner et al (1988) of an intentional 
exposure human study measuring the effects of low dose oral iodide 
supplementation on thyroid function
    b. Published report by Paul et al (1988) of an intentional exposure 
human study measuring the effects of small increases of dietary iodine 
on thyroid function
    c. Published report by Lemar et al (1995) of an intentional 
exposure human study measuring the effects of chronic tetraglycine 
hydroperiodide water purification tablet use on thyroid function
    d. Discussion of a 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

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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: May 15, 2014.
Robert Kavlock,
Interim Agency Science Advisor.
[FR Doc. 2014-12172 Filed 5-23-14; 8:45 am]
BILLING CODE 6560-50-P