Human Studies Review Board; Notification of a Public Meeting, 80938-80940 [2011-33156]

Download as PDF 80938 Federal Register / Vol. 76, No. 248 / Tuesday, December 27, 2011 / Notices includes information claimed as CBI, a copy of the material that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information marked as CBI will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. Docket: All documents in the docket are listed in the 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 www.regulations.gov or in hard copy at the Water Docket, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave. NW., Washington, DC 20004. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding federal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the Water Docket is (202) 566–2426. Submit your comments on the 2011 Effluent Guidelines Reviews identified by Docket ID No. EPA–HQ–OW–2010– 0824 using one of the methods described above. FOR FURTHER INFORMATION CONTACT: Mr. William F. Swietlik, Engineering and Analysis Division, Office of Water, 4303T, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC., 20460; telephone number: (202) 566–1129; fax number: (202) 566–1053; email address: swietlik.william@epa.gov. SUPPLEMENTARY INFORMATION: sroberts on DSK5SPTVN1PROD with NOTICES I. General Information A. Supporting Documents for the Final 2010 Effluent Guidelines Program Plan Key documents providing additional information about EPA’s annual reviews and the final 2010 Effluent Guidelines Program Plan include the following: • Technical Support Document for the 2010 Effluent Guidelines Program Plan, EPA–820–R–10–021, DCN 07320; • Coalbed Methane Point Source Category: Detailed Study Report, EPA–820–R–10–022, DCN 09999; • Draft Guidance Document: Best Management Practices for Unused Pharmaceuticals at Health Care Facilities, August 26, 2010, EPA– 821–R–10–006. • Ore Mining and Dressing Category Preliminary Study, EPA–820–R–10– 025, DCN 07369. VerDate Mar<15>2010 22:00 Dec 23, 2011 Jkt 226001 B. How can I get copies of these documents and other related information? 1. Docket. EPA has established official public dockets for these actions under Docket ID Nos. EPA–HQ–OW–2008– 0517 and EPA–HQ–OW–2010–0824. The official public docket is the collection of materials that is available for public viewing at the Water Docket in the EPA Docket Center, (EPA/DC) EPA West, Room 3334, 1301Constitution Ave, NW., Washington, DC 20460. 2. Electronic Access. You may access this Federal Register document electronically through the United States government online source for Federal regulations at https:// www.regulations.gov. C. What should I consider as I prepare my comments for EPA? 1. Tips for Preparing Your Comments. When submitting comments, remember to: • Identify the rulemaking by docket number and other identifying information (subject heading, Federal Register date and page number). • Follow directions—The agency might ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number. • Explain why you agree or disagree, suggest alternatives, and substitute language for your requested changes. • Describe any assumptions and provide any technical information and/ or data that you used. • If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced. • Provide specific examples to illustrate your concerns, and suggest alternatives. • Explain your views as clearly as possible. • Make sure to submit your comments by the comment period deadline identified. II. Re-Opening of the Public Comment Period for the Final 2010 Effluent Guidelines Program Plan (‘‘Final 2010 Plan’’) and the 2011 Effluent Guidelines Reviews On October 26, 2011 (76 FR 66286), EPA published its final 2010 Effluent Guidelines Program Plan (‘‘final 2010 Plan’’), which, as required under the Clean Water Act (CWA), identified new or existing industrial dischargers, both those discharging directly to surface waters and those discharging to publicly PO 00000 Frm 00071 Fmt 4703 Sfmt 4703 owned treatment works (POTWs), selected for effluent guidelines rulemaking, and provided a schedule for such rulemakings. The Agency solicited comments from the public on the final Plan for 30 days (to have been submitted on or before November 25, 2011). The notice also solicited data and information (during the same 30-day period) for EPA’s 2011 Effluent Guidelines Reviews pursuant to the authority of CWA sections 304(b), 304(g), 301(d) and 307(b). The Agency received several requests for additional time to submit comments. In response, EPA is re-opening the public comment period and will accept additional public comments on its final 2010 Effluent Guidelines Program Plan, which announced schedules to develop standards for wastewater discharges produced by natural gas extraction from underground coalbed and shale formations as well as mercury discharges from dental offices. EPA is also accepting additional data and information for its 2011 Effluent Guidelines Program Reviews, which were announced as a part of the 2010 Plan released in October. For more information visit https://water.epa.gov/ lawsregs/lawsguidance/cwa/304m/ index.cfm. EPA believes that this additional 60-day comment period will assist in providing interested stakeholders, as well as other members of the public, adequate time to review the documents and provide written comments. Dated: December 19, 2011. Nancy K. Stoner, Acting Assistant Administrator for Water. [FR Doc. 2011–33153 Filed 12–23–11; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–ORD–2011–0954; FRL–9611–6] Human Studies Review Board; Notification of a Public Meeting U.S. Environmental Protection Agency. 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 January 26, 2012, from approximately 9 a.m. to approximately 5:30 p.m. Eastern Time. Comments may SUMMARY: E:\FR\FM\27DEN1.SGM 27DEN1 sroberts on DSK5SPTVN1PROD with NOTICES Federal Register / Vol. 76, No. 248 / Tuesday, December 27, 2011 / Notices be submitted on or before Thursday, January 19, 2012. ADDRESSES: Submit your written comments, identified by Docket ID No. EPA–HQ–ORD–2011–0954, 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 West Building, 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–2011– 0954. 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 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 of encryption, and be free of any defects or viruses. VerDate Mar<15>2010 22:00 Dec 23, 2011 Jkt 226001 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—Lobby Level, 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. FOR FURTHER INFORMATION CONTACT: I. Public Meeting A. Does this action apply to me? This action is directed to the public in general. This action 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 PO 00000 Frm 00072 Fmt 4703 Sfmt 4703 80939 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 West Building, 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 first week of January 2012. 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. E:\FR\FM\27DEN1.SGM 27DEN1 80940 Federal Register / Vol. 76, No. 248 / Tuesday, December 27, 2011 / Notices sroberts on DSK5SPTVN1PROD with NOTICES 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– 2011–0954 in the subject line on the first page of your request. 1. Oral comments. Requests to present oral comments will be accepted up to Thursday, January 19, 2012. 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, Thursday, January 19, 2012, 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 VerDate Mar<15>2010 22:00 Dec 23, 2011 Jkt 226001 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, Thursday, January 19, 2012. 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 § 9. The HSRB provides advice, information, and recommendations to the EPA on issues related to scientific and ethical aspects of human subjects research. The major objectives of the HSRB are to provide advice and recommendations on: (1) Research proposals and protocols; (2) reports of completed research with human subjects; and (3) how to strengthen EPA’s programs for protection of human subjects of research. The HSRB reports to the EPA Administrator through the Agency’s Science Advisor. 1. Topics for discussion. At its meeting on January 26, 2012, the EPA’s Human Studies Review Board will consider scientific and ethical issues surrounding these topics: a. A new scenario design and associated protocol from the Agricultural Handler Exposure Task Force describing proposed research to measure dermal and inhalation exposure to workers who mix, load, and apply liquid pesticides with powered handgun equipment. The Agency requests the advice of the HSRB concerning whether, if it is revised as suggested in the 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 mix, load, and apply liquid pesticides with powered PO 00000 Frm 00073 Fmt 4703 Sfmt 4703 handgun equipment, and to meet the applicable requirements of 40 CFR part 26, subparts K and L. b. The report of a completed scenario monograph and study report from the Antimicrobial Exposure Assessment Task Force II in which the dermal and inhalation exposure of professional janitorial workers was monitored as they applied a liquid antimicrobial pesticide product for indoor surface disinfecting using a pressurized aerosol can. The EPA seeks the advice of the HSRB on the scientific soundness of this completed research and on its appropriateness for use in estimating the exposure of professional janitorial workers who apply liquid antimicrobial pesticide products to indoor surfaces using pressurized aerosol cans, and on whether available information supports a determination that the study was conducted in substantial compliance with subparts K and L of 40 CFR part 26. 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: December 19, 2011. Paul T. Anastas, EPA Science Advisor. [FR Doc. 2011–33156 Filed 12–23–11; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [FRL–9611–5] Environmental Laboratory Advisory Board Meeting Dates and Agenda U.S. Environmental Protection Agency. ACTION: Notice of teleconference and face-to-face meetings. AGENCY: The EPA Environmental Laboratory Advisory Board, as previously announced, holds teleconference meetings on the third Wednesday of each month at 1 p.m. Eastern Time, and two face-to-face meetings each calendar year. For 2012, teleconference only meetings will be February 15, 2012 at 1 p.m. Eastern SUMMARY: E:\FR\FM\27DEN1.SGM 27DEN1

Agencies

[Federal Register Volume 76, Number 248 (Tuesday, December 27, 2011)]
[Notices]
[Pages 80938-80940]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-33156]


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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2011-0954; FRL-9611-6]


Human Studies Review Board; Notification of a Public Meeting

AGENCY: U.S. Environmental Protection Agency.

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 January 26, 2012, from 
approximately 9 a.m. to approximately 5:30 p.m. Eastern Time. Comments 
may

[[Page 80939]]

be submitted on or before Thursday, January 19, 2012.

ADDRESSES: Submit your written comments, identified by Docket ID No. 
EPA-HQ-ORD-2011-0954, 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 West Building, 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-
2011-0954. 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 
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--
Lobby Level, 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 action 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 West 
Building, 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 first week of January 2012. 
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.

[[Page 80940]]

    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-2011-0954 in the subject 
line on the first page of your request.
    1. Oral comments. Requests to present oral comments will be 
accepted up to Thursday, January 19, 2012. 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, Thursday, January 
19, 2012, in order to be included on the meeting agenda and to provide 
sufficient time for the HSRB Chair and HSRB Designated Federal Official 
to review the meeting agenda to provide an appropriate public comment 
period. The request should identify the name of the individual making 
the presentation and the organization (if any) the individual will 
represent. Oral comments before the HSRB are generally limited to five 
minutes per individual or organization. Please note that this includes 
all individuals appearing either as part of, or on behalf of, an 
organization. While it is our intent to hear a full range of oral 
comments on the science and ethics issues under discussion, it is not 
our intent to permit organizations to expand the time limitations by 
having numerous individuals sign up separately to speak on their 
behalf. If additional time is available, further public comments may be 
possible.
    2. Written comments. Submit your written comments prior to the 
meeting. For the Board to have the best opportunity to review and 
consider your comments as it deliberates on its report, you should 
submit your comments 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, Thursday, January 19, 2012. 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. Topics for discussion. At its meeting on January 26, 2012, the 
EPA's Human Studies Review Board will consider scientific and ethical 
issues surrounding these topics:
    a. A new scenario design and associated protocol from the 
Agricultural Handler Exposure Task Force describing proposed research 
to measure dermal and inhalation exposure to workers who mix, load, and 
apply liquid pesticides with powered handgun equipment. The Agency 
requests the advice of the HSRB concerning whether, if it is revised as 
suggested in the 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 mix, load, and apply liquid 
pesticides with powered handgun equipment, and to meet the applicable 
requirements of 40 CFR part 26, subparts K and L.
    b. The report of a completed scenario monograph and study report 
from the Antimicrobial Exposure Assessment Task Force II in which the 
dermal and inhalation exposure of professional janitorial workers was 
monitored as they applied a liquid antimicrobial pesticide product for 
indoor surface disinfecting using a pressurized aerosol can. The EPA 
seeks the advice of the HSRB on the scientific soundness of this 
completed research and on its appropriateness for use in estimating the 
exposure of professional janitorial workers who apply liquid 
antimicrobial pesticide products to indoor surfaces using pressurized 
aerosol cans, and on whether available information supports a 
determination that the study was conducted in substantial compliance 
with subparts K and L of 40 CFR part 26.
    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: December 19, 2011.
Paul T. Anastas,
EPA Science Advisor.
[FR Doc. 2011-33156 Filed 12-23-11; 8:45 am]
BILLING CODE 6560-50-P
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