80_FR_79575 80 FR 79331 - Human Studies Review Board; Notification of Public Meetings

80 FR 79331 - Human Studies Review Board; Notification of Public Meetings

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 80, Issue 244 (December 21, 2015)

Page Range79331-79333
FR Document2015-32021

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.

Federal Register, Volume 80 Issue 244 (Monday, December 21, 2015)
[Federal Register Volume 80, Number 244 (Monday, December 21, 2015)]
[Notices]
[Pages 79331-79333]
From the Federal Register Online  [www.thefederalregister.org]
[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.

-----------------------------------------------------------------------

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

[[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]
BILLING CODE P



                                                                             Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Notices                                                 79331

                                                  meeting or teleconference may contact                   panels has a different purpose from                     Accessibility: For information on
                                                  Mr. Aaron Yeow, DFO, EPA Science                        public comment provided to EPA                        access or services for individuals with
                                                  Advisory Board Staff Office (1400R),                    program offices. Therefore, the process               disabilities, please contact Mr. Aaron
                                                  U.S. Environmental Protection Agency,                   for submitting comments to a federal                  Yeow at (202) 564–2050 or yeow.aaron@
                                                  1200 Pennsylvania Avenue NW.,                           advisory committee is different from the              epa.gov. To request accommodation of a
                                                  Washington, DC 20460; by telephone/                     process used to submit comments to an                 disability, please contact Mr. Yeow
                                                  voice mail at (202) 564–2050 or at                      EPA program office.                                   preferably at least ten days prior to each
                                                  yeow.aaron@epa.gov. General                                Federal advisory committees and                    meeting to give EPA as much time as
                                                  information about the CASAC, as well                    panels, including scientific advisory                 possible to process your request.
                                                  as any updates concerning the meetings                  committees, provide independent                         Dated: December 14, 2015.
                                                  announced in this notice, may be found                  advice to EPA. Members of the public                  Thomas H. Brennan,
                                                  on the CASAC Web page at http://www.                    can submit comments for a federal                     Deputy Director, EPA Science Advisory Staff
                                                  epa.gov/casac.                                          advisory committee to consider as it                  Office.
                                                  SUPPLEMENTARY INFORMATION: The                          develops advice for EPA. Interested                   [FR Doc. 2015–31996 Filed 12–18–15; 8:45 am]
                                                  CASAC was established pursuant to the                   members of the public may submit                      BILLING CODE 6560–50–P
                                                  Clean Air Act (CAA) Amendments of                       relevant written or oral information on
                                                  1977, codified at 42 U.S.C. 7409(d)(2), to              the topic of this advisory activity, and/
                                                  review air quality criteria and National                or the group conducting the activity, for             ENVIRONMENTAL PROTECTION
                                                  Ambient Air Quality Standards                           the CASAC to consider during the                      AGENCY
                                                  (NAAQS) and recommend any new                           advisory process. Input from the public
                                                  NAAQS and revisions of existing                         to the CASAC will have the most impact                [EPA–HQ–ORD–2015–0588; FRL–9940–38–
                                                                                                                                                                ORD]
                                                  criteria and NAAQS as may be                            if it provides specific scientific or
                                                  appropriate. The CASAC is a Federal                     technical information or analysis for                 Human Studies Review Board;
                                                  Advisory Committee chartered under                      CASAC panels to consider or if it relates             Notification of Public Meetings
                                                  the Federal Advisory Committee Act                      to the clarity or accuracy of the
                                                  (FACA), 5 U.S.C., App. 2. Section                       technical information. Members of the                 AGENCY: Environmental Protection
                                                  109(d)(1) of the CAA requires that the                  public wishing to provide comment                     Agency (EPA).
                                                  Agency periodically review and revise,                  should contact the DFO directly. Oral                 ACTION: Notice.
                                                  as appropriate, the air quality criteria                Statements: In general, individuals or
                                                  and the NAAQS for the six ‘‘criteria’’ air              groups requesting an oral presentation                SUMMARY:    The Environmental Protection
                                                  pollutants, including sulfur oxides. EPA                at a public face-to-face meeting will be              Agency (EPA) Office of the Science
                                                  is currently reviewing the primary                      limited to five minutes and on a public               Advisor announces two separate public
                                                  (health-based) NAAQS for sulfur                         teleconference will be limited to three               meetings of the Human Studies Review
                                                  dioxide (SO2), as an indicator for health               minutes. Each person making an oral                   Board to advise the Agency on the
                                                  effects caused by the presence of sulfur                statement should consider providing                   ethical and scientific reviews of EPA
                                                  oxides in the ambient air. Pursuant to                  written comments as well as their oral                research with human subjects.
                                                  FACA and EPA policy, notice is hereby                   statement so that the points presented                DATES: A public virtual meeting will be
                                                  given that the CASAC Sulfur Oxides                      orally can be expanded upon in writing.               held on January 12–13, 2016, from 1:00
                                                  Panel will hold a public face-to-face                   Interested parties should contact Mr.                 p.m. to approximately 5:00 p.m. Eastern
                                                  meeting to review EPA’s Integrated                      Aaron Yeow, DFO, in writing                           Standard Time each day. A separate
                                                  Science Assessment for Sulfur Oxides—                   (preferably via email) at the contact                 teleconference meeting is planned for
                                                  Health Criteria (External Review Draft—                 information noted above by January 20,                Wednesday, March 30, 2016, from 1:00
                                                  November 2015). The CASAC Sulfur                        2016, to be placed on the list of public              p.m. to approximately 2:30 p.m. for the
                                                  Oxides Panel will hold a public                         speakers for the face-to-face meeting and             HSRB to finalize its Final Report of the
                                                  teleconference to discuss its draft peer                by March 30, 2016, for the                            January 12–13, 2016 meeting.
                                                  review report and the Chartered CASAC                   teleconference. Written Statements:                   ADDRESSES: Both of these meetings will
                                                  will discuss the disposition of the                     Written statements should be supplied                 be conducted entirely on the Internet
                                                  panel’s report at the end of the                        to the DFO via email at the contact                   using Adobe Connect. For detailed
                                                  teleconference. The Chartered CASAC                     information noted above by January 20,                access information visit the HSRB Web
                                                  and CASAC Sulfur Oxides Panel will                      2016, for the face-to-face meeting and by             site: http://www2.epa.gov/osa/human-
                                                  comply with the provisions of FACA                      March 30, 2016, for the teleconference                studies-review-board.
                                                  and all appropriate SAB Staff Office                    so that the information may be made                      Comments: Submit your written
                                                  procedural policies.                                    available to the Panel members for their              comments, identified by Docket ID No.
                                                     Technical Contacts: Any technical                    consideration. It is the SAB Staff Office             EPA–HQ–ORD–2015–0588, by one of
                                                  questions concerning the Integrated                     general policy to post written comments               the following methods:
                                                  Science Assessment for Sulfur Oxides—                   on the Web page for the advisory                         Internet: http://www.regulations.gov:
                                                  Health Criteria (External Review Draft—                 meeting or teleconference. Submitters                 Follow the online instructions for
                                                  November 2015) should be directed to                    are requested to provide an unsigned                  submitting comments.
                                                  Dr. Tom Long (long.tom@epa.gov), EPA                    version of each document because the                     Email: ORD.Docket@epa.gov.
                                                  Office of Research and Development.                     SAB Staff Office does not publish                        Mail: The EPA Docket Center EPA/
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                                                     Availability of Meeting Materials:                   documents with signatures on its Web                  DC, ORD Docket, Mail code: 28221T,
                                                  Prior to the meeting, the review                        sites. Members of the public should be                1200 Pennsylvania Avenue NW.,
                                                  documents, agenda and other materials                   aware that their personal contact                     Washington, DC 20460.
                                                  will be available on the CASAC Web                      information, if included in any written                  Hand Delivery: The EPA/DC Public
                                                  page at http://www.epa.gov/casac/.                      comments, may be posted to the CASAC                  Reading Room is located in the EPA
                                                     Procedures for Providing Public Input:               Web site. Copyrighted material will not               Headquarters Library, Room Number
                                                  Public comment for consideration by                     be posted without explicit permission of              3334 in the EPA WJC West, at 1301
                                                  EPA’s federal advisory committees and                   the copyright holder.                                 Constitution Avenue NW., Washington,


                                             VerDate Sep<11>2014   17:38 Dec 18, 2015   Jkt 238001   PO 00000   Frm 00030   Fmt 4703   Sfmt 4703   E:\FR\FM\21DEN1.SGM   21DEN1


                                                  79332                      Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Notices

                                                  DC 20460. The hours of operation are                      Procedures for providing public input:              excluding federal holidays. Please call
                                                  8:30 a.m. to 4:30 p.m. Eastern Time,                    Interested members of the public may                  (202) 566–1744 or email the ORD
                                                  Monday through Friday, excluding                        submit relevant written or oral                       Docket at ord.docket@epa.gov for
                                                  federal holidays. Please call (202) 566–                comments for the HSRB to consider                     instructions. Updates to Public Reading
                                                  1744 or email the ORD Docket at                         during the advisory process. Additional               Room access are available on the Web
                                                  ord.docket@epa.gov for instructions.                    information concerning submission of                  site (http://www.epa.gov/epahome/
                                                  Updates to Public Reading Room access                   relevant written or oral comments is                  dockets.htm).
                                                  are available on the Web site at: http://               provided in Section I, ‘‘Public Meeting’’                The Agency’s position paper(s),
                                                  www.epa.gov/epahome/dockets.htm.                        under subsection D. ‘‘How May I                       charge/questions to the HSRB, and the
                                                     Instructions: The Agency’s policy is                 Participate in this Meeting?’’ of this                meeting agenda will be available by late
                                                  that all comments received will be                      notice.                                               December 2015. In addition, the Agency
                                                  included in the public docket without                                                                         may provide additional background
                                                                                                          I. Public Meeting                                     documents as the materials become
                                                  change and may be made available
                                                  online at http://www.regulations.gov,                   A. Does this action apply to me?                      available. You may obtain electronic
                                                  including any personal information                        This action is directed to the public               copies of these documents, and other
                                                  provided, unless the comment includes                   in general. This Notice may, however,                 related documents that are available
                                                  information claimed to be Confidential                  be of particular interest to persons who              electronically, from the regulations.gov
                                                  Business Information or other                           conduct or assess human studies,                      Web site and the EPA HSRB Web site
                                                  information the disclosure of which is                  especially studies on substances                      at http://www2.epa.gov/osa/human-
                                                  restricted by statute. Do not submit                    regulated by the EPA, or to persons who               studies-review-board. For questions on
                                                  information that you consider to be CBI                 are, or may be required to conduct                    document availability, or if you do not
                                                  or otherwise protected through http://                  testing of chemical substances under the              have access to the Internet, consult with
                                                  www.regulations.gov or email. The                       Federal Food, Drug, and Cosmetic Act                  Jim Downing listed under FOR FURTHER
                                                  http://www.regulations.gov Web site is                                                                        INFORMATION CONTACT.
                                                                                                          or the Federal Insecticide, Fungicide,
                                                  an ‘‘anonymous access’’ system, which                   and Rodenticide Act. This notice might                C. What should I consider as I prepare
                                                  means EPA will not know your identity                   also be of special interest to participants           my comments for the EPA?
                                                  or contact information unless you                       of studies involving human subjects, or
                                                  provide it in the body of your comment.                                                                          You may find the following
                                                                                                          representatives of study participants or              suggestions helpful for preparing your
                                                  If you send an email comment directly                   experts on community engagement. The
                                                  to the EPA without going through http://                                                                      comments:
                                                                                                          Agency has not attempted to describe all                 1. Explain your views as clearly as
                                                  www.regulations.gov, your email                         the specific entities that may have
                                                  address will be automatically captured                                                                        possible.
                                                                                                          interest in human subjects research. If                  2. Describe any assumptions that you
                                                  and included as part of the comment                     you have any questions regarding this
                                                  that is placed in the public docket and                                                                       used.
                                                                                                          notice, consult with Jim Downing listed                  3. Provide copies of any technical
                                                  made available on the Internet. If you                  under FOR FURTHER INFORMATION
                                                  submit an electronic comment, the EPA                                                                         information and/or data that you used to
                                                                                                          CONTACT.                                              support your views.
                                                  recommends that you include your
                                                                                                          B. How can I access electronic copies of                 4. Provide specific examples to
                                                  name and other contact information in
                                                                                                          this document and other related                       illustrate your concerns and suggest
                                                  the body of your comment and with any
                                                                                                          information?                                          alternatives.
                                                  electronic storage media you submit. If
                                                                                                                                                                   5. To ensure proper receipt by the
                                                  the EPA cannot read your comment due                       In addition to using regulations.gov,              EPA, be sure to identify the Docket ID
                                                  to technical difficulties and cannot                    you may access this Federal Register                  number assigned to this action in the
                                                  contact you for clarification, the EPA                  document electronically through the                   subject line on the first page of your
                                                  may not be able to consider your                        EPA Internet under the ‘‘Federal                      response. You may also provide the
                                                  comment. Electronic files should avoid                  Register’’ listings at http://                        name, date, and Federal Register
                                                  the use of special characters, any form                 www.epa.gov/fedrgstr/.                                citation.
                                                  of encryption, and be free of any defects                  Docket: All documents in the docket
                                                  or viruses.                                             are listed in the http://                             D. How may I participate in this
                                                  FOR FURTHER INFORMATION CONTACT: Any                    www.regulations.gov index. Although                   meeting?
                                                  member of the public who wishes to                      all documents are listed in the index,                   You may participate in these meetings
                                                  receive further information should                      certain documents are not publicly                    by following the instructions in this
                                                  contact Jim Downing on telephone                        available, e.g., CBI or other information             section. To ensure proper receipt by the
                                                  number (202) 564–2468; fax number:                      whose disclosure is restricted by statute.            EPA, it is imperative that you identify
                                                  (202) 564–2070; email address:                          Certain other material, such as                       Docket ID number EPA–HQ–ORD–
                                                  downing.jim@epa.gov; or mailing                         copyrighted material, will be publicly                2015–0588 in the subject line on the
                                                  address Environmental Protection                        available only in hard copy. Publicly                 first page of your request.
                                                  Agency, Office of the Science Advisor,                  available docket materials are available                 1. Oral comments. Requests to present
                                                  Mail code 8105R, 1200 Pennsylvania                      either electronically in http://                      oral comments during either conference
                                                  Avenue NW., Washington, DC 20460.                       www.regulations.gov or in hard copy at                call will be accepted up to Noon Eastern
                                                  General information concerning the EPA                  the ORD Docket, EPA Docket Center, in                 Time on Wednesday, January 6, 2016,
                                                  HSRB can be found on the EPA Web site
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                                                                                                          the Public Reading Room. The Public                   for the January 12–13, 2016 meeting and
                                                  at: http://www2.epa.gov/osa/human-                      Reading Room is located in the EPA                    up to Noon Eastern Time on
                                                  studies-review-board.                                   Headquarters Library, Room Number                     Wednesday, March 23, 2016 for the
                                                  SUPPLEMENTARY INFORMATION:                              3334 in the EPA WJC West, at 1301                     March 30, 2016 conference call. To the
                                                     Meeting access: Access to these                      Constitution Avenue NW., Washington,                  extent that time permits, interested
                                                  Internet meetings are open to all by                    DC 20460. The hours of operation are                  persons who have not pre-registered
                                                  following the information provided                      8:30 a.m. to 4:30 p.m. Eastern Standard               may be permitted by the Chair of the
                                                  above.                                                  Time, Monday through Friday,                          HSRB to present oral comments during


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                                                                             Federal Register / Vol. 80, No. 244 / Monday, December 21, 2015 / Notices                                                 79333

                                                  either call. Individuals or groups                      E. Background                                         SC Johnson Personal Mosquito
                                                  wishing to make brief oral comments to                     The HSRB is a Federal advisory                     Repellent Products to Support their Use
                                                  the HSRB on January 12–13, 2016 are                     committee operating in accordance with                of the EPA Repellency Awareness
                                                  strongly advised to submit their request                the Federal Advisory Committee Act 5                  Graphic, GLP Study Number 873E1, C.
                                                  (preferably via email) to Jim Downing,                  U.S.C. App.2 9. The HSRB provides                     Talbert, October 21, 2015. Test
                                                  listed under FOR FURTHER INFORMATION                    advice, information, and                              Substance: MARK–8 OFF! Deep Woods
                                                  CONTACT no later than noon, Eastern                     recommendations to the EPA on issues                  Insect Repellent V (OFF! Insect
                                                  Time, Wednesday, January 6, 2016 in                     related to scientific and ethical aspects             Repellent Formula, EPA Reg. No. 4822–
                                                  order to be included on the meeting                     of human subjects research. The major                 167)
                                                  agenda and to provide sufficient time                   objectives of the HSRB are to provide                   On Wednesday, March 30, 2016 the
                                                  for the HSRB Chair and HSRB                             advice and recommendations on: (1)                    HSRB will approve its Final Report of
                                                  Designated Federal Official to review                   Research proposals and protocols; (2)                 the January 12–13, 2016 meeting.
                                                  the meeting agenda to provide an                        reports of completed research with                      2. Meeting minutes and reports.
                                                  appropriate public comment period.                      human subjects; and (3) how to                        Minutes of these meetings, summarizing
                                                  Individuals or groups wishing to make                   strengthen EPA’s programs for                         the matters discussed and
                                                  brief oral comments to the HSRB during                  protection of human subjects of                       recommendations, if any, made by the
                                                  the March 30, 2016 teleconference                       research. The HSRB reports to the EPA                 advisory committee regarding such
                                                  should submit their request by Noon                     Administrator through the Agency’s                    matters, will be released within 90
                                                  Eastern Time on Wednesday, March 23,                    Science Advisor.                                      calendar days of the meeting. Such
                                                  2016. The request should identify the                      1. Topics for discussion. On Tuesday,              minutes will be available at http://
                                                  name of the individual making the                       January 12–13, 2016, EPA’s Human                      www2.epa.gov/osa/human-studies-
                                                                                                          Studies Review Board will consider                    review-board and http://
                                                  presentation and the organization (if
                                                                                                          seven scientific and ethical topics: (1)              www.regulations.gov. In addition,
                                                  any) the individual will represent. Oral
                                                                                                          Assessing intermittent pesticide                      information regarding the HSRB’s Final
                                                  comments before the HSRB are
                                                                                                          exposure from flea control collars                    Report, will be found at http://
                                                  generally limited to five minutes per
                                                                                                          containing the organophosphorus                       www2.epa.gov/osa/human-studies-
                                                  individual or organization. Please note
                                                                                                          insecticide tetrachlorvinphos, authored               review-board or from the person listed
                                                  that this includes all individuals
                                                                                                          by M. Keith Davis, J. Scott Boone, John               under FOR FURTHER INFORMATION
                                                  appearing either as part of, or on behalf
                                                                                                          E. Moran, John W. Tyler, and Janice E.                CONTACT.
                                                  of, an organization. While it is our
                                                  intent to hear a full range of oral                     Chambers. Journal of Exposure Science                   Dated: December 14, 2015.
                                                  comments on the science and ethics                      and Environmental Epidemiology (2008)                 Thomas A. Burke,
                                                  issues under discussion, it is not our                  18, 564–570; (2) Field Testing of SC                  EPA Science Advisor.
                                                  intent to permit organizations to expand                Johnson Personal Mosquito Repellent                   [FR Doc. 2015–32021 Filed 12–18–15; 8:45 am]
                                                  the time limitations by having                          Products to Support their Use of the
                                                                                                                                                                BILLING CODE P
                                                  numerous individuals sign up                            EPA Repellency Awareness Graphic,
                                                  separately to speak on their behalf. If                 GLP Study Number 865E1, J. Palm,
                                                  additional time is available, further                   September 24, 2015. Test Substance:                   ENVIRONMENTAL PROTECTION
                                                  public comments may be possible.                        MARK–3 OFF! Deep Woods Sportsmen                      AGENCY
                                                                                                          Insect Repellent I (Maximum Strength
                                                     2. Written comments. Submit your                     Pump Spray Deep Woods OFF! EPA                        [FLR–9940–43–Region 10]
                                                  written comments prior to the meetings.                 Reg. No. 4822–276); (3) Field Testing of
                                                  For the Board to have the best                                                                                Proposed Reissuance of NPDES
                                                                                                          SC Johnson Personal Mosquito
                                                  opportunity to review and consider your                                                                       General Permit for Discharges From
                                                                                                          Repellent Products to Support their Use
                                                  comments as it deliberates, you should                                                                        Federal Aquaculture Facilities and
                                                                                                          of the EPA Repellency Awareness
                                                  submit your comments by Noon Eastern                                                                          Aquaculture Facilities Located in
                                                                                                          Graphic, GLP Study Number 864E1, J.
                                                  Time on Wednesday, January 6, 2016 for                                                                        Indian Country Within the Boundaries
                                                                                                          Palm, September 24, 2015. Test
                                                  the January 12–13, 2016 meeting, and by                                                                       of Washington State (Permit Number
                                                                                                          Substance: MARK–2 OFF! Deep Woods
                                                  noon Eastern Time on Wednesday,                                                                               WAG130000)
                                                                                                          Sportsmen Insect Repellent II
                                                  March 23, 2016 for the March 30, 2016                   (UNSCENTED DEEP WOODS OFF! EPA                        AGENCY:  Environmental Protection
                                                  teleconference. If you submit comments                  Reg. No. 4822–397); (4) Field Testing of              Agency (EPA).
                                                  after these dates, those comments will                  SC Johnson Personal Mosquito                          ACTION: Notice of proposed reissuance of
                                                  be provided to the HSRB members, but                    Repellent Products to Support their Use               NPDES General Permit and request for
                                                  you should recognize that the HSRB                      of the EPA Repellency Awareness                       public comment.
                                                  members may not have adequate time to                   Graphic, GLP Study Number 867E1, E.
                                                  consider your comments prior to their                   Laznicka, October 21, 2015. Test                      SUMMARY:   The Director, Office of Water
                                                  discussion. You should submit your                      Substance: MARK–5 OFF! Family Care                    and Watersheds, Environmental
                                                  comments using the instructions in                      Insect Repellent IV (Unscented)                       Protection Agency (EPA) Region 10, is
                                                  Section I., under subsection C., ‘‘What                 (UNSCENTED OFF! SKINTASTIC                            proposing to reissue a National
                                                  Should I Consider as I Prepare My                       SPRAY INSECT REPELLENT, EPA Reg.                      Pollutant Discharge Elimination System
                                                  Comments for the EPA?’’ In addition,                    No. 4822–395); (5) Field Testing of SC                (NPDES) General Permit for Federal
                                                  the agency also requests that persons
mstockstill on DSK4VPTVN1PROD with NOTICES




                                                                                                          Johnson Personal Mosquito Repellent                   Aquaculture Facilities and Aquaculture
                                                  submitting comments directly to the                     Products to Support their Use of the                  Facilities Located in Indian Country
                                                  docket also provide a copy of their                     EPA Repellency Awareness Graphic,                     within the Boundaries of Washington
                                                  comments to Jim Downing listed under                    GLP Study Number 866E1, E. Laznicka,                  State (General Permit). The draft
                                                  FOR FURTHER INFORMATION CONTACT.                        October 21, 2015. Test Substance:                     General Permit contains effluent
                                                  There is no limit on the length of                      MARK–4 OFF! Active Insect Repellent I                 limitations, along with administrative
                                                  written comments for consideration by                   (Unscented OFF! Insect Repellent, EPA                 reporting and monitoring requirements,
                                                  the HSRB.                                               Reg. No. 4822–380); 6.) Field Testing of              as well as standard conditions,


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Document Created: 2015-12-19 02:57:11
Document Modified: 2015-12-19 02:57:11
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesA 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.
ContactAny member of the public who wishes to receive further information should contact Jim Downing on telephone
FR Citation80 FR 79331 

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