[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,
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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
[[Page 79333]]
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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