Human Studies Review Board; Notification of a Public Meeting, 57383-57385 [2013-22745]

Download as PDF Federal Register / Vol. 78, No. 181 / Wednesday, September 18, 2013 / Notices Registration No. 082397–00002 082397–00003 082498–00002 082498–00003 082498–00004 082534–00003 082542–00028 082691–00002 082866–00001 083030–00001 083403–00001 083742–00002 084195–00001 085340–00001 085531–00001 085905–00005 086363–00014 087246–00006 087373–00001 088050–00001 088423–00002 .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. Product name Chem-Fish Synergized Powdered Cube Root Grandslam 4XS Herbicide Glyphosate 41% Super Concentrate Herbicide Glyphosate 2% RTU Herbicide Oxy 2EC Solera IVM Herbicide Stay Clean Additive B Paraquat 3SL Herbicide Citrex Bactiguard Air Filters Pond Weed Defense Iobio Bacteria, Slime and Algae Control Cerro Flow Products Mavea Maxtra CFL–3%-Diflubenzuron Feedthrough KT Propicon 3.6EC Cliniweave AV Powder Argite Fipronil 96.5% Technical Aim-C DTN 1000 Antimicrobial IV. Provisions for Disposition of Existing Stocks ENVIRONMENTAL PROTECTION AGENCY The effective date of cancellation will be the date of the cancellation order. The orders effecting these requested cancellations will generally permit a registrant to sell or distribute existing stocks until January 15, 2014, 1 year after the date on which the fee was due. Existing stocks are those stocks of registered pesticide products which are currently in the United States and which have been packaged, labeled, and released for shipment prior to the effective date of the cancellation order. Unless the provisions of an earlier order apply, existing stocks already in the hands of dealers or users can be distributed, sold, or used legally until they are exhausted, provided that such further sale and use comply with the EPA-approved label and labeling of the affected product. Exception to these general rules will be made in specific cases when more stringent restrictions on sale, distribution, or use of the products or their ingredients have already been imposed, as in a special review action, or where the Agency has identified significant potential risk concerns associated with a particular chemical. [EPA–HQ–ORD–2013–0626; FRL–9900–98– ORD] emcdonald on DSK67QTVN1PROD with NOTICES List of Subjects Environmental protection, Administrative practice and procedure, Pesticides and pests. Dated: August 29, 2013. Steven Bradbury, Director, Office of Pesticide Programs. [FR Doc. 2013–22352 Filed 9–17–13; 8:45 am] BILLING CODE 6560–50–P VerDate Mar<15>2010 57383 16:45 Sep 17, 2013 Jkt 229001 Human Studies Review Board; Notification of a Public Meeting U.S. Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: The EPA Office of the Science Advisor announces a public meeting of the Human Studies Review Board to advise the Agency on the EPA scientific and ethical reviews of research with human subjects. DATES: This public meeting will be held on October 1, 2013, from approximately 12:30 p.m. to approximately 5:30 p.m. Eastern Time. Comments may be submitted on or before noon (Eastern Time) on Thursday, September 24, 2013. SUMMARY: Submit your written comments, identified by Docket ID No. EPA–HQ–ORD–2013–0626, by one of the following methods: Internet: https://www.regulations.gov: Follow the online instructions for submitting comments. Email: ORD.Docket@epa.gov. 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 ADDRESSES: PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 federal holidays. Please call (202) 566– 1744 or email the ORD Docket at ord.docket@epa.gov for instructions. Updates to Public Reading Room access are available on the Web site https:// www.epa.gov/epahome/dockets.htm. Instructions: Direct your comments to Docket ID No. EPA–HQ–ORD–2013– 0626. 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 https://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 https:// www.regulations.gov or email. The https://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 https://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 E:\FR\FM\18SEN1.SGM 18SEN1 57384 Federal Register / Vol. 78, No. 181 / Wednesday, September 18, 2013 / Notices 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: downing.jim@ epa.gov or Lu-Ann Kleibacker on telephone number (202) 564–7189; fax (202) 564–2070; email address kleibacker.lu-ann@epa.gov; 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 https://www.epa.gov/osa/hsrb/. SUPPLEMENTARY INFORMATION: Location: The meeting will be held at the EPA Conference Center—S–4380, One Potomac Yard (South Building), 2777 S. Crystal Drive, Arlington, VA 22202. Meeting access: Seating at the meeting will be on a first-come basis. To request accommodation of a disability, please contact the persons listed under FOR FURTHER INFORMATION CONTACT at least ten business days prior to the meeting using the information under FOR FURTHER INFORMATION CONTACT, so that appropriate arrangements can be made. Procedures for providing public input: Interested members of the public may submit relevant written or oral comments for the HSRB to consider during the advisory process. Additional information concerning submission of relevant written or oral comments is provided in Section I, ‘‘Public Meeting’’ under subsection D. ‘‘How May I Participate in this Meeting?’’ of this notice. emcdonald on DSK67QTVN1PROD with NOTICES 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. Since many entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions VerDate Mar<15>2010 16:45 Sep 17, 2013 Jkt 229001 regarding the applicability of this action to a particular entity, consult Jim Downing or Lu-Ann Kleibacker 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 https:// www.epa.gov/fedrgstr/. Docket: All documents in the docket are listed in the https:// 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 https:// www.regulations.gov or in hard copy at the ORD Docket, EPA/DC, 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 ord.docket@epa.gov for instructions. Updates to Public Reading Room access are available on the Web site (https:// www.epa.gov/epahome/dockets.htm). The Agency’s position paper(s), charge/ questions to the HSRB, and the meeting agenda will be available by the last week of September 2013. In addition, the Agency may provide additional background documents as the materials become available. You may obtain electronic copies of these documents, and certain other related documents that might be available electronically, from the regulations.gov Web site and the EPA HSRB Web site at https:// www.epa.gov/osa/hsrb/. For questions on document availability, or if you do not have access to the Internet, consult either Jim Downing or Lu-Ann Kleibacker 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. PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 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– 2013–0626 in the subject line on the first page of your request. 1. Oral comments. Requests to present oral comments will be accepted up to Tuesday, September 24, 2013. To the extent that time permits, interested persons who have not pre-registered may be permitted by the Chair of the HSRB to present oral comments at the meeting. Each individual or group wishing to make brief oral comments to the HSRB is strongly advised to submit their request (preferably via email) to Jim Downing or Lu-Ann Kleibacker, under FOR FURTHER INFORMATION CONTACT no later than noon, Eastern Time, Tuesday, September 24, 2013, 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 E:\FR\FM\18SEN1.SGM 18SEN1 Federal Register / Vol. 78, No. 181 / Wednesday, September 18, 2013 / Notices In addition, the EPA will present general information about EPA’s Repellency Awareness Program and discuss possible implications of this program for the HSRB. E. Background [EPA–HQ–OPP–2013–0069; FRL–9383–4] 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. Topic for discussion. At its meeting on October 1, 2013, EPA’s Human Studies Review Board will consider scientific and ethical issues surrounding this topic: emcdonald on DSK67QTVN1PROD with NOTICES comments as it deliberates on its report, you should submit your comments at least five business days prior to the beginning of this meeting. 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 making a decision. Thus, if you plan to submit written comments, the agency strongly encourages you to submit such comments no later than noon, Eastern Time, Tuesday, September 24, 2013. 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 or Lu-Ann Kleibacker listed under FOR FURTHER INFORMATION CONTACT. There is no limit on the length of written comments for consideration by the HSRB. Pesticide Emergency Exemptions; Agency Decisions and State and Federal Agency Crisis Declarations A new scenario design and associated protocol from the Antimicrobial Exposure Assessment Task Force II (AEATF–II) describing proposed research to monitor the dermal and inhalation exposure during manual pouring of solid formulation antimicrobial products. EPA requests the advice of the HSRB concerning whether, if it is revised as suggested in EPA’s review and if it is performed as described, this research is likely to generate scientifically reliable data, useful for assessing the exposure of those who pour solid formulation antimicrobial pesticide products, and to meet the applicable requirements of 40 CFR part 26, subparts K and L. VerDate Mar<15>2010 16:45 Sep 17, 2013 Jkt 229001 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 https:// www.epa.gov/osa/hsrb/ www.regulations.gov. In addition, information regarding the Board’s final meeting report, will be found at https://www.epa.gov/osa/hsrb/ or from the person listed under FOR FURTHER INFORMATION CONTACT. Dated: September 9, 2013. Glenn Paulson, Science Advisor. [FR Doc. 2013–22745 Filed 9–17–13; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: EPA has granted emergency exemptions under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for use of pesticides as listed in this notice. The exemptions were granted during the period October 1, 2012 through March 31, 2013 to control unforeseen pest outbreaks. FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; telephone number: (703) 305–7090; email address: RDFRNotices@epa.gov. SUPPLEMENTARY INFORMATION: SUMMARY: I. General Information A. Does this action apply to me? You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 57385 Potentially affected entities may include: • Crop production (NAICS code 111). • Animal production (NAICS code 112). • Food manufacturing (NAICS code 311). • Pesticide manufacturing (NAICS code 32532). B. How can I get copies of this document and other related information? The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2013–0069, is available at https://www.regulations.gov or at the Office of Pesticide Programs Regulatory Public Docket (OPP Docket) in the Environmental Protection Agency Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460–0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the OPP Docket is (703) 305–5805. Please review the visitor instructions and additional information about the docket available at https://www.epa.gov/dockets. II. Background EPA has granted emergency exemptions to the following State and Federal agencies. The emergency exemptions may take the following form: Crisis, public health, quarantine, or specific. Under FIFRA section 18, EPA can authorize the use of a pesticide when emergency conditions exist. Authorizations (commonly called emergency exemptions) are granted to State and Federal agencies and are of four types: 1. A ‘‘specific exemption’’ authorizes use of a pesticide against specific pests on limited acreage in a particular State. Most emergency exemptions are specific exemptions. 2. ‘‘Quarantine’’ and ‘‘public health’’ exemptions are emergency exemptions issued for quarantine or public health purposes. These are rarely requested. 3. A ‘‘crisis exemption’’ is initiated by a State or Federal agency (and is confirmed by EPA) when there is insufficient time to request and obtain EPA permission for use of a pesticide in an emergency. EPA may deny an emergency exemption: If the State or Federal agency cannot demonstrate that an emergency exists, if the use poses unacceptable risks to the environment, or if EPA cannot reach a conclusion that the proposed pesticide use is likely to E:\FR\FM\18SEN1.SGM 18SEN1

Agencies

[Federal Register Volume 78, Number 181 (Wednesday, September 18, 2013)]
[Notices]
[Pages 57383-57385]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-22745]


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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2013-0626; FRL-9900-98-ORD]


Human Studies Review Board; Notification of a Public Meeting

AGENCY: U.S. Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The EPA Office of the Science Advisor announces a public 
meeting of the Human Studies Review Board to advise the Agency on the 
EPA scientific and ethical reviews of research with human subjects.

DATES: This public meeting will be held on October 1, 2013, from 
approximately 12:30 p.m. to approximately 5:30 p.m. Eastern Time. 
Comments may be submitted on or before noon (Eastern Time) on Thursday, 
September 24, 2013.

ADDRESSES: Submit your written comments, identified by Docket ID No. 
EPA-HQ-ORD-2013-0626, by one of the following methods:
    Internet: https://www.regulations.gov: Follow the online 
instructions for submitting comments.
    Email: ORD.Docket@epa.gov.
    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 ord.docket@epa.gov for instructions. Updates to Public 
Reading Room access are available on the Web site https://www.epa.gov/epahome/dockets.htm.
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2013-0626. 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 https://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 https://www.regulations.gov or email. The https://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 https://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

[[Page 57384]]

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: 
downing.jim@epa.gov or Lu-Ann Kleibacker on telephone number (202) 564-
7189; fax (202) 564-2070; email address kleibacker.lu-ann@epa.gov; 
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 https://www.epa.gov/osa/hsrb/.

SUPPLEMENTARY INFORMATION:
    Location: The meeting will be held at the EPA Conference Center--S-
4380, One Potomac Yard (South Building), 2777 S. Crystal Drive, 
Arlington, VA 22202.
    Meeting access: Seating at the meeting will be on a first-come 
basis. To request accommodation of a disability, please contact the 
persons listed under FOR FURTHER INFORMATION CONTACT at least ten 
business days prior to the meeting using the information under FOR 
FURTHER INFORMATION CONTACT, so that appropriate arrangements can be 
made.
    Procedures for providing public input: Interested members of the 
public may submit relevant written or oral comments for the HSRB to 
consider during the advisory process. Additional information concerning 
submission of relevant written or oral comments is provided in Section 
I, ``Public Meeting'' under subsection D. ``How May I Participate in 
this Meeting?'' of this notice.

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. Since many entities may also be interested, the 
Agency has not attempted to describe all the specific entities that may 
be affected by this action. If you have any questions regarding the 
applicability of this action to a particular entity, consult Jim 
Downing or Lu-Ann Kleibacker 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 https://www.epa.gov/fedrgstr/.
    Docket: All documents in the docket are listed in the https://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 https://www.regulations.gov or in hard copy at the ORD Docket, EPA/
DC, 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 ord.docket@epa.gov for instructions. Updates to 
Public Reading Room access are available on the Web site (https://www.epa.gov/epahome/dockets.htm). The Agency's position paper(s), 
charge/questions to the HSRB, and the meeting agenda will be available 
by the last week of September 2013. In addition, the Agency may provide 
additional background documents as the materials become available. You 
may obtain electronic copies of these documents, and certain other 
related documents that might be available electronically, from the 
regulations.gov Web site and the EPA HSRB Web site at https://www.epa.gov/osa/hsrb/. For questions on document availability, or if 
you do not have access to the Internet, consult either Jim Downing or 
Lu-Ann Kleibacker 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-2013-0626 in the subject 
line on the first page of your request.
    1. Oral comments. Requests to present oral comments will be 
accepted up to Tuesday, September 24, 2013. To the extent that time 
permits, interested persons who have not pre-registered may be 
permitted by the Chair of the HSRB to present oral comments at the 
meeting. Each individual or group wishing to make brief oral comments 
to the HSRB is strongly advised to submit their request (preferably via 
email) to Jim Downing or Lu-Ann Kleibacker, under FOR FURTHER 
INFORMATION CONTACT no later than noon, Eastern Time, Tuesday, 
September 24, 2013, 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

[[Page 57385]]

comments as it deliberates on its report, you should submit your 
comments at least five business days prior to the beginning of this 
meeting. 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 
making a decision. Thus, if you plan to submit written comments, the 
agency strongly encourages you to submit such comments no later than 
noon, Eastern Time, Tuesday, September 24, 2013. 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 or Lu-Ann Kleibacker 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. Topic for discussion. At its meeting on October 1, 2013, EPA's 
Human Studies Review Board will consider scientific and ethical issues 
surrounding this topic:

    A new scenario design and associated protocol from the 
Antimicrobial Exposure Assessment Task Force II (AEATF-II) 
describing proposed research to monitor the dermal and inhalation 
exposure during manual pouring of solid formulation antimicrobial 
products. EPA requests the advice of the HSRB concerning whether, if 
it is revised as suggested in EPA's review and if it is performed as 
described, this research is likely to generate scientifically 
reliable data, useful for assessing the exposure of those who pour 
solid formulation antimicrobial pesticide products, and to meet the 
applicable requirements of 40 CFR part 26, subparts K and L.
    In addition, the EPA will present general information about 
EPA's Repellency Awareness Program and discuss possible implications 
of this program for the HSRB.

    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 https://www.epa.gov/osa/hsrb/ and https://www.regulations.gov. In addition, 
information regarding the Board's final meeting report, will be found 
at https://www.epa.gov/osa/hsrb/ or from the person listed under FOR 
FURTHER INFORMATION CONTACT.

    Dated: September 9, 2013.
Glenn Paulson,
Science Advisor.
[FR Doc. 2013-22745 Filed 9-17-13; 8:45 am]
BILLING CODE 6560-50-P
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