Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Notices 59623 

Dated: October 6, 2008. 

Sara Hisel-McCoy, 

Director, Collection Strategies Division. 

[FR Doc. E8–24029 Filed 10–8–08; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–ORD–2008–0720; FRL–8728–2] 

Request for Nominations to the EPA 

Human Studies Review Board 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: The U.S. Environmental 

Protection Agency (EPA or Agency) 

Office of the Science Advisor (OSA) is 

soliciting nominations of people 

qualified in the areas of bioethics, 

biostatistics, human health risk 

assessment and human toxicology to 

serve on the Human Studies Review 

Board (HSRB). The HSRB is a Federal 

advisory committee, operating in 

accordance with the Federal Advisory 

Committee Act (FACA) 5 U.S.C. App. 2 

§ 9, providing advice and 

recommendations to EPA on scientific 

and ethical aspects of research with 

human subjects. 

DATES: Nominations (‘‘comments’’) 

should be submitted to EPA no later 

than November 10, 2008. 

ADDRESSES: Submit your nominations, 

identified by Docket ID No. EPA–HQ– 

ORD–2008–0720, by any of the 

following methods: 

Internet: http://www.regulations.gov: 

Follow the on-line instructions for 

submitting comments. 

E-mail: ORD.Docket@epa.gov. 

USPS Mail: ORD Docket, 

Environmental Protection Agency, 

Mailcode: 28221T, 1200 Pennsylvania 

Ave. NW., Washington, DC 20460. 

Hand or Courier Delivery: EPA Docket 

Center (EPA/DC), Room 3304, EPA West 

Building, 1301 Constitution Avenue 

NW., Washington, DC 20460, Attention 

Docket ID No. EPA–HQ–ORD–2008– 

0720. Deliveries are accepted from 8:30 

a.m. to 4:30 p.m., Monday through 

Friday, excluding legal holidays. 

Special arrangements should be made 

for deliveries of boxed information. 

Instructions: Direct your nominations 

to Docket ID No. EPA–HQ–ORD–2008– 

0720. EPA’s policy is that all 

nominations 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 nomination includes 

information claimed to be Confidential 

Business Information (CBI) or other 

information whose disclosure is 

restricted by statute. Do not submit 

information through http:// 

www.regulations.gov or e-mail that you 

consider to be CBI or otherwise 

protected from disclosure. 

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 

nomination. By contrast, if you send an 

e-mail nomination directly to EPA 

without going through http:// 

www.regulations.gov, your e-mail 

address will be automatically captured 

and included as part of the nomination 

that is placed in the public docket and 

made available on the Internet. If you 

submit a nomination electronically, EPA 

recommends that you include your 

name and other contact information in 

the body of your nomination and with 

any disk or CD–ROM you submit. If EPA 

cannot read your nomination due to 

technical difficulties and cannot contact 

you for clarification, EPA may not be 

able to consider it. Electronic files 

should avoid the use of special 

characters, any form of encryption, and 

be free of any defects or viruses. 

Docket: All documents in the docket 

are listed in the http:// 

www.regulations.gov index under the 

docket number. Even though it will be 

listed by title in the index, some 

information is not publicly available, 

e.g., CBI or other information whose 

disclosure is restricted by statute. 

Copyright material will be publicly 

available only in hard copy. Publicly 

available docket materials are available 

either electronically through http:// 

www.regulations.gov or in hard copy at 

the ORD Docket, EPA/DC, Room 3334, 

EPA West, 1301 Constitution Ave. NW., 

Washington, DC. 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 ORD Docket is (202) 566–1752. 

FOR FURTHER INFORMATION CONTACT: Paul 

I. Lewis, Office of the Science Advisor, 

Mail Code 8105R, Environmental 

Protection Agency, 1200 Pennsylvania 

Avenue NW., Washington, DC 20460; 

telephone number: (202) 564–8381, fax 

number: (202) 564–2070, e-mail: 

lewis.paul@epa.gov. 

I. General Information 

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 EPA, and to persons who 

may sponsor or conduct research with 

human subjects with the intention to 

submit it to EPA for consideration under 

the Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) or section 408 

of the Federal Food, Drug, and Cosmetic 

Act (FFDCA). 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? 

You may access this Federal Register 

document electronically either through 

http://www.regulations.gov or through 

the EPA Web site under the ‘‘Federal 

Register’’ listings at http:// 

www.epa.gov/fedrgstr/. 

C. What Should I Consider as I Prepare 

My Nomination for EPA? 

You may find the following 

suggestions helpful for preparing your 

nomination: 

1. Provide as much supporting 

information as possible about the 

nominee, including contact information. 

2. Make sure to submit your 

nomination by the deadline in this 

document. 

3. To ensure proper receipt by EPA, 

be sure to include 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. 

SUPPLEMENTARY INFORMATION

Background 

On February 6, 2006 the Agency 

published a final rule for protection of 

human subjects of research (71 FR 24 

6138) that called for creating a new, 

independent human studies review 

board (i.e. HSRB). The HSRB is a 

Federal advisory committee operating in 

accordance with the Federal Advisory 

Committee Act (FACA) 5 U.S.C. App. 2 

§ 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 


sroberts on PROD1PC70 with NOTICES
59624 Federal Register / Vol. 73, No. 197 / Thursday, October 9, 2008 / Notices 

EPA’s programs for protection of human 

subjects of research. The HSRB reports 

to the EPA Administrator through EPA’s 

Science Advisor. 

This notice solicits nominations of 

individuals with expertise in bioethics, 

biostatistics, human health risk 

assessment and/or human toxicology to 

fill anticipated vacancies on the Board. 

General information concerning the 

HSRB, including its charter, current 

membership, and activities can be found 

on the EPA Web site at http:// 

www.epa.gov/osa/hsrb/. 

Process and Deadline for Submitting 

Nominations 

Any interested person or organization 

may nominate someone to be 

considered as prospective nominees for 

the HSRB. Additional avenues and 

resources may be utilized in the 

solicitation of nominees to encourage a 

broad pool of expertise. Nominees 

should be experts who have sufficient 

professional qualifications, by training 

and experience, to provide expert 

comment on the ethical and scientific 

issues that may come before the HSRB. 

Responsibilities of HSRB members 

include reviewing extensive background 

materials between meetings of the 

Board, preparing draft responses to 

Agency charge questions, attending 

Board meetings, participating in the 

discussion and deliberations at these 

meetings, drafting assigned sections of 

meeting reports, and reviewing and 

helping to finalize Board reports. 

EPA seeks nominees who are 

nationally recognized experts in one or 

more of the following areas: 

• Bioethics: Expertise in the ethics of 

research with human subjects. 

• Biostatistics: Expertise in statistical 

design and analysis of research with 

human subjects, especially research 

with small sample sizes. 

• Human health risk assessment: 

Expertise in epidemiology, exposure 

analysis, public health or human 

research regulations. 

• Human toxicology: Expertise in 

toxicity of environmental substances, 

mechanisms of toxicity and/or clinical 

studies. 

All nominations should include: (1) A 

current curriculum vitae (C.V.) 

providing the nominee’s educational 

background, qualifications, leadership 

positions in national associations or 

professional societies, relevant research 

experience and publications; and (2) a 

summary of the above in a one-page 

biographical sketch. 

The qualifications of nominees for 

membership on the HSRB will be 

assessed in terms of the specific 

expertise sought for the HSRB. Qualified 

nominees who agree to be considered 

further will be included in a smaller 

‘‘Short List’’. The Short List of 

nominees’ names and biographical 

sketches will be posted for 14 calendar 

days for public comment on the EPA 

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

index.htm. The public will be 

encouraged to provide additional 

information about the nominees that 

EPA should consider. At the completion 

of this comment period, EPA will select 

new Board members from the Short List. 

Candidates not selected for HSRB 

membership at this time may be 

considered for HSRB membership as 

vacancies arise in the future, or for 

service as consultants to the HSRB. The 

Agency estimates that the names of 

Short List candidates will be posted in 

February, 2009. However, please be 

advised that this is an approximate time 

frame and the date could change. Thus, 

if you have any questions concerning 

posting of Short List candidates on the 

OSA Web site, please consult the person 

listed under FOR FURTHER INFORMATION

CONTACT. 

Interested candidates who are 

employees of a federal department or 

agency (other than EPA) or are members 

of another federal advisory committee 

are eligible to serve on the HSRB, and 

their nominations are welcome. Other 

factors that will be considered include: 

Availability to participate in the Board’s 

scheduled meetings, absence of any 

conflicts of interest and absence of an 

appearance of a lack of impartiality, and 

independence with respect to the 

matters likely to come under HSRB 

review. Though financial conflicts of 

interest or the appearance of a lack of 

impartiality, lack of independence, or 

bias may lead to nonselection, the 

absence of such concerns does not 

ensure that a candidate will be selected 

to serve on the HSRB. Numerous 

qualified candidates are likely to be 

identified. Selection decisions will 

involve careful weighing of many 

factors, including, but not limited to, the 

candidates’ areas of expertise and 

professional qualifications, and 

responses to the Short List in achieving 

the overall balance of different 

perspectives and areas of expertise on 

the Board. 

Members of the HSRB are subject to 

the provisions of 5 CFR part 2634, 

Executive Branch Financial Disclosure, 

as supplemented by the EPA in 5 CFR 

part 6401. In anticipation of this 

requirement, each nominee will be 

asked to submit confidential financial 

information which shall fully disclose, 

among other financial interests, the 

candidate’s employment, stocks and 

bonds, and where applicable, sources of 

research support. The information 

provided is confidential and will not be 

disclosed to the public. Before a 

candidate is considered further for 

service on the HSRB, EPA will evaluate 

each candidate to assess whether there 

is any conflict of financial interest, 

appearance of a lack of impartiality, or 

prior involvement with matters likely to 

be reviewed by the Board. 

Nominations should be submitted by 

one of the methods listed under 

ADDRESSEES. The Agency will consider 

all nominations received on or before 

November 10, 2008. Final selection of 

members is a discretionary function of 

the Agency and will be announced on 

the EPA Web site at http:// 

www.epa.gov/osa/hsrb as soon as they 

are made. 

Dated: September 26, 2008. 

George M. Gray, 

Science Advisor. 

[FR Doc. E8–24032 Filed 10–8–08; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[FRL–8726–7] 

National and Governmental Advisory 

Committees to the U.S. Representative 

to the Commission for Environmental 

Cooperation 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice of meeting. 

SUMMARY: Under the Federal Advisory 

Committee Act, Pub. L. 92–463, EPA 

gives notice of a meeting of the National 

Advisory Committee (NAC) and 

Governmental Advisory Committee 

(GAC) to the U.S. Representative to the 

North American Commission for 

Environmental Cooperation (CEC). The 

National and Governmental Advisory 

Committees advise the EPA 

Administrator in his capacity as the U.S. 

Representative to the CEC Council. The 

Committees are authorized under 

Articles 17 and 18 of the North 

American Agreement on Environmental 

Cooperation (NAAEC), North American 

Free Trade Agreement Implementation 

Act, Pub. L. 103–182, and as directed by 

Executive Order 12915, entitled 

‘‘Federal Implementation of the North 

American Agreement on Environmental 

Cooperation.’’ The NAC is composed of 

12 members representing academia, 

environmental non-governmental 

organizations, and private industry. The 

GAC consists of 12 members 

representing state, local, and Tribal 

governments. The Committees are 


sroberts on PROD1PC70 with NOTICES