[Federal Register Volume 80, Number 244 (Monday, December 21, 2015)]
[Notices]
[Pages 79331-79333]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-32021]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2015-0588; FRL-9940-38-ORD]


Human Studies Review Board; Notification of 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 January 12-13, 2016, 
from 1:00 p.m. to approximately 5:00 p.m. Eastern Standard Time each 
day. A separate teleconference meeting is planned for Wednesday, March 
30, 2016, from 1:00 p.m. to approximately 2:30 p.m. for the HSRB to 
finalize its Final Report of the January 12-13, 2016 meeting.

ADDRESSES: Both of these meetings will be conducted entirely on the 
Internet using Adobe Connect. For detailed access information visit the 
HSRB Web site: http://www2.epa.gov/osa/human-studies-review-board.
    Comments: Submit your written comments, identified by Docket ID No. 
EPA-HQ-ORD-2015-0588, 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,

[[Page 79332]]

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 at: 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 on telephone 
number (202) 564-2468; fax number: (202) 564-2070; email address: 
[email protected]; 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: http://www2.epa.gov/osa/human-studies-review-board.

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 with 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 all documents are listed in the 
index, certain documents are 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 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 
Standard 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 late December 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://www2.epa.gov/osa/human-studies-review-board. For 
questions on document availability, or if you do not have access to the 
Internet, consult with 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 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, 
January 6, 2016, for the January 12-13, 2016 meeting and up to Noon 
Eastern Time on Wednesday, March 23, 2016 for the March 30, 2016 
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

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either call. Individuals or groups wishing to make brief oral comments 
to the HSRB on January 12-13, 2016 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, 
January 6, 2016 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 March 30, 2016 teleconference should 
submit their request by Noon Eastern Time on Wednesday, March 23, 2016. 
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, January 6, 2016 for the 
January 12-13, 2016 meeting, and by noon Eastern Time on Wednesday, 
March 23, 2016 for the March 30, 2016 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 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 Tuesday, January 12-13, 2016, EPA's 
Human Studies Review Board will consider seven scientific and ethical 
topics: (1) Assessing intermittent pesticide exposure from flea control 
collars containing the organophosphorus insecticide tetrachlorvinphos, 
authored by M. Keith Davis, J. Scott Boone, John E. Moran, John W. 
Tyler, and Janice E. Chambers. Journal of Exposure Science and 
Environmental Epidemiology (2008) 18, 564-570; (2) Field Testing of SC 
Johnson Personal Mosquito Repellent Products to Support their Use of 
the EPA Repellency Awareness Graphic, GLP Study Number 865E1, J. Palm, 
September 24, 2015. Test Substance: MARK-3 OFF! Deep Woods Sportsmen 
Insect Repellent I (Maximum Strength Pump Spray Deep Woods OFF! EPA 
Reg. No. 4822-276); (3) Field Testing of SC Johnson Personal Mosquito 
Repellent Products to Support their Use of the EPA Repellency Awareness 
Graphic, GLP Study Number 864E1, J. Palm, September 24, 2015. Test 
Substance: MARK-2 OFF! Deep Woods Sportsmen Insect Repellent II 
(UNSCENTED DEEP WOODS OFF! EPA Reg. No. 4822-397); (4) Field Testing of 
SC Johnson Personal Mosquito Repellent Products to Support their Use of 
the EPA Repellency Awareness Graphic, GLP Study Number 867E1, E. 
Laznicka, October 21, 2015. Test Substance: MARK-5 OFF! Family Care 
Insect Repellent IV (Unscented) (UNSCENTED OFF! SKINTASTIC SPRAY INSECT 
REPELLENT, EPA Reg. No. 4822-395); (5) Field Testing of SC Johnson 
Personal Mosquito Repellent Products to Support their Use of the EPA 
Repellency Awareness Graphic, GLP Study Number 866E1, E. Laznicka, 
October 21, 2015. Test Substance: MARK-4 OFF! Active Insect Repellent I 
(Unscented OFF! Insect Repellent, EPA Reg. No. 4822-380); 6.) Field 
Testing of SC Johnson Personal Mosquito Repellent Products to Support 
their Use of the EPA Repellency Awareness Graphic, GLP Study Number 
873E1, C. Talbert, October 21, 2015. Test Substance: MARK-8 OFF! Deep 
Woods Insect Repellent V (OFF! Insect Repellent Formula, EPA Reg. No. 
4822-167)
    On Wednesday, March 30, 2016 the HSRB will approve its Final Report 
of the January 12-13, 2016 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 
http://www2.epa.gov/osa/human-studies-review-board and http://www.regulations.gov. In addition, information regarding the HSRB's 
Final Report, will be found at http://www2.epa.gov/osa/human-studies-review-board or from the person listed under FOR FURTHER INFORMATION 
CONTACT.

    Dated: December 14, 2015.
Thomas A. Burke,
EPA Science Advisor.
[FR Doc. 2015-32021 Filed 12-18-15; 8:45 am]
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