[Federal Register Volume 75, Number 109 (Tuesday, June 8, 2010)]
[Notices]
[Pages 32461-32463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-13684]



=======================================================================

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



ENVIRONMENTAL PROTECTION AGENCY



[EPA-HQ-ORD-2010-0381; FRL-9159-9]




Human Studies Review Board; Notice of Public Meeting



AGENCY: Environmental Protection Agency (EPA).



ACTION: Notice.



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



SUMMARY: The U.S. Environmental Protection Agency's (EPA or Agency) 

Office of the Science Advisor (OSA) announces a public meeting of the 

Human Studies Review Board (HSRB) to advise the Agency on EPA's 

scientific and ethical reviews of research with human subjects.



DATES: The public meeting will be held on June 23, 2010, from 

approximately 10 a.m. to approximately 5:30 p.m., Eastern Time.

    Location: Environmental Protection Agency, Conference Center--Lobby 

Level, One Potomac Yard (South Bldg.), 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 

person listed under FOR FURTHER INFORMATION CONTACT at least 10 

business days prior to the meeting, to allow EPA as much time as 

possible to process your request.

    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., under subsection D., SUPPLEMENTARY INFORMATION of this notice.



FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes 

further information should contact Jim Downing, EPA, Office of the 

Science Advisor, (8105R), Environmental Protection Agency, 1200 

Pennsylvania Ave., NW., Washington, DC 20460; telephone number: (202) 

564-2468; fax: (202) 564-2070; e-mail addresses: [email protected]. 

General information concerning the EPA HSRB can be found on the EPA Web 

site at http://www.epa.gov/osa/hsrb/.



ADDRESSES: Submit your written comments, identified by Docket ID No. 

EPA-HQ-ORD-2010-0381, by one of the following methods:

    Internet: http://www.regulations.gov: Follow the on-line 

instructions for submitting comments.

    E-mail: [email protected].

    Mail: Environmental Protection Agency, EPA Docket Center (EPA/DC), 

ORD Docket, Mailcode: 28221T, 1200 Pennsylvania Ave, 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, 

located at 1301 Constitution Ave., 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 e-

mail 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).

    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-

2010-0381. EPA'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 (CBI) 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 e-mail. 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 e-mail comment directly to EPA, without 

going through http://www.regulations.gov, your e-mail 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, EPA recommends that you include your name 

and other contact information in the body of your comment and with any 

disk or CD-ROM you submit. If EPA cannot read your comment due to 

technical difficulties and cannot contact you for clarification, 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.



SUPPLEMENTARY INFORMATION: 



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 interest to persons who conduct or assess human studies, 

especially studies on substances regulated by EPA, or to



[[Page 32462]]



persons who are, or may be required to conduct testing of chemical 

substances under the Federal Food, Drug, and Cosmetic Act (FFDCA) or 

the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Since 

other 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 the person 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 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 http://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, located at 1301 Constitution Ave., NW., Washington, DC 20460. 

The hours of operation are 8:30 am to 4:30 p.m. EST, Monday through 

Friday, excluding Federal holidays. Please call (202) 566-1744 or e-

mail 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). EPA's position paper(s), charge/

questions to the HSRB, and the meeting agenda will be available by 

early June 2010. 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 http://www.epa.gov/osa/hsrb/. For questions on document availability, or if 

you do not have access to the Internet, consult the person listed under 

FOR FURTHER INFORMATION CONTACT.



C. What should I consider as I prepare my comments for 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 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 EPA, it is imperative that 

you identify docket ID number EPA-HQ-ORD-2010-0381 in the subject line 

on the first page of your request.

    1. Oral comments. Requests to present oral comments will be 

accepted up to June 16, 2010. 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 e-mail) to the 

person listed under FOR FURTHER INFORMATION CONTACT no later than noon, 

Eastern Time, June 16, 2010, in order to be included on the meeting 

agenda, and to provide sufficient time for the HSRB Chair and HSRB 

Designated Federal Officer (DFO) to review the agenda to provide an 

appropriate public comment period. The request should identify the name 

of the individual making the presentation, the organization (if any) 

the individual will represent, and any requirements for audiovisual 

equipment (e.g., overhead projector, LCD projector, chalkboard). Oral 

comments before the HSRB are limited to five minutes per individual or 

organization. Please note that this limit applies to the cumulative 

time used by 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 these time limitations by 

having numerous individuals sign up separately to speak on their 

behalf. If additional time is available, there may be flexibility in 

time for public comments. Each speaker should bring 25 copies of his or 

her comments and presentation slides for distribution to the HSRB at 

the meeting.

    2. Written comments. Although you may submit written comments at 

any time, for the HSRB 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 the meeting. If you submit comments after this date, those comments 

will be provided to the Board members, but you should recognize that 

the Board 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, June 16, 2010. You should submit your 

comments using the instructions in section I., under subsection C., 

``What should I consider as I prepare my comments for EPA?'' above in 

this notice. In addition, the Agency also requests that person(s) 

submitting comments directly to the docket also provide a copy of their 

comments to the person listed under FOR FURTHER INFORMATION CONTACT. 

There is no limit on the length of written comments for consideration 

by the HSRB.



 E. Background



    1. Topics for discussion. The HSRB is a Federal advisory committee 

operating in accordance with the Federal Advisory Committee Act (FACA) 

5 U.S.C. App. 2 section 9. The HSRB provides advice, information, and 

recommendations to 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 

EPA's Science Advisor.

    At its meeting on June 23, 2010, EPA's Human Studies Review Board 

will consider scientific and ethical issues surrounding these topics:

    (a) The unpublished report of the completed Carroll-Loye Biological 

Research, Inc. study LNX-002: Field Repellency of Two Picaridin-Based 

Personal Insect Repellents to Black Flies. The protocol for this study 

was



[[Page 32463]]



reviewed favorably by the HSRB at their meeting in June 2009. EPA seeks 

the advice of the HSRB on the scientific soundness of this completed 

study for use to estimate the duration of complete protection against 

black flies provided by the tested repellents, 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.

    (b) The unpublished report of the completed Carroll-Loye Biological 

Research, Inc. study LNX-003: Laboratory Repellency of Two Picaridin-

Based Personal Insect Repellents to Two Species of Ticks. The protocol 

for this study was reviewed favorably by the HSRB at their meeting in 

October 2009. EPA seeks the advice of the HSRB on the scientific 

soundness of this completed study for use to estimate the duration of 

complete protection against ticks provided by the tested repellents, 

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.

    (c) In addition, EPA will present to the HSRB update reports on two 

topics of interest:

    (1) The revised guideline for performance testing of topically 

applied repellent products, for use by investigators and sponsors of 

new studies

    (2) The terms of a recent settlement of litigation related to EPA's 

2006 rule for the protection of human subjects of research, in which 

EPA has agreed to initiate rulemaking to amend the 2006 rule.

    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 http://www.epa.gov/osa/hsrb/ and http://www.regulations.gov. In addition, 

information concerning a Board meeting report, if applicable, can be 

found at http://www.epa.gov/osa/hsrb/ or from the person listed under 

FOR FURTHER INFORMATION CONTACT.



Kevin Teichman,

EPA Science Advisor.

[FR Doc. 2010-13684 Filed 6-7-10; 8:45 am]

BILLING CODE 6560-50-P