[Federal Register Volume 79, Number 250 (Wednesday, December 31, 2014)]
[Notices]
[Pages 78861-78863]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-30408]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2014-0882; FRL-9920-92-ORD]


Human Studies Review Board; Notification of a Public Meeting

AGENCY: 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 January 14, 2015, from 
approximately 10:00 a.m. to approximately 5:00 p.m. Eastern Time. 
Comments may be submitted on or before noon (Eastern Time) on 
Wednesday, January 7, 2015.

ADDRESSES: The meeting will be conducted entirely on the Internet using 
Adobe Connect. Registration is required to attend this meeting. Please 
visit the HSRB Web site: http://www.epa.gov/hsrb to register.
    Comments: Submit your written comments, identified by Docket ID No. 
EPA-HQ-ORD-2014-0882, by one of the following methods:
    Internet: http://www.regulations.gov: Follow the online 
instructions for submitting comments.
    Email: <a href="/cdn-cgi/l/email-protection#37786573197358545c52437752475619505841"><span class="__cf_email__" data-cfemail="d49b8690fa90bbb7bfb1a094b1a4b5fab3bba2">[email protected]</span></a>.
    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 <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="0e617c6a206a616d656b7a4e6b7e6f20696178">[email protected]</a> 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: 
<a href="/cdn-cgi/l/email-protection#4a2e253d2423242d642023270a2f3a2b642d253c"><span class="__cf_email__" data-cfemail="1d79726a7374737a337774705d786d7c337a726b">[email protected]</span></a>; 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: Access to this Internet meeting is open to all at 
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.

[[Page 78862]]

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 <a href="/cdn-cgi/l/email-protection" class="__cf_email__" data-cfemail="e48b9680ca808b878f8190a4819485ca838b92">[email protected]</a> 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 early January 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 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-2014-0882 in the subject 
line on the first page of your request.
    1. Oral comments. Requests to present oral comments during the 
conference call will be accepted up to Noon Eastern Time on Wednesday, 
January 7, 2015. 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 the call. 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, listed 
under FOR FURTHER INFORMATION CONTACT no later than noon, Eastern Time, 
Wednesday, January 7, 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. 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 on or before noon (Eastern Time) on Wednesday, 
January 7, 2015. 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 Wednesday, January 14, 
2015, EPA's Human Studies Review Board will consider scientific and 
ethical issues surrounding three topics:
    a. A published report: Repeated Nitrogen Dioxide Exposures and 
Eosinophilic Airway Inflammation in Asthmatics: A Randomized Crossover 
Study
    b. A published report: Tissue response of gastric mucosa after 
ingestion of fluoride
    c. A published report: The Effect of Flouride and Calcium on Spinal 
Bone Mineral Content: A Controlled, Prospective (three year) Study
    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.


[[Page 78863]]


    Dated: December 16, 2014.
Robert Kavlock,
Interim Agency Science Advisor.
[FR Doc. 2014-30408 Filed 12-30-14; 8:45 am]
BILLING CODE 6560-50-P


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