E7-5484. 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 qualified individuals in the area of biostatistics 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 section 9, providing advice, information, and recommendations to EPA on issues related to scientific and ethical aspects of human subjects research.

DATES:

Nominations should be submitted to EPA no later than April 25, 2007.

ADDRESSES:

Submit your nominations (“comments”), identified by Docket ID No. EPA-HQ-ORD-2007-0143, by one of the following methods:

Internet: http://www.regulations.gov: Follow the on-line instructions for submitting comments.

E-mail: [e-mail].

Mail: ORD Docket, Environmental Protection Agency, Mailcode: 28221T, 1200 Pennsylvania Ave., NW., Washington, DC 20460.

Hand 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-2007-0143. Deliveries are only 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-2007-0143. 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 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 nomination. 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. 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, 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 [phone], and the telephone number for the ORD Docket is [phone].

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: [phone], fax number: [phone], e-mail: [e-mail].

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 interest to persons who conduct or assess human studies, especially studies on substances regulated by EPA or to persons who are or may be required to conduct testing of 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/​.

C. What Should I Consider as I Prepare My Nomination for EPA?

You may find the following suggestions helpful for preparing your nomination:

1. Providing 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 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.

SUPPLEMENTARY INFORMATION:

Background

On August 2, 2005, the President signed into law the Department of Interior, Environment, and Related Agencies Appropriations Act, 2006, Pub. L. 109-54 (Appropriations Act), which provided appropriated funds for the Environmental Protection Agency and other Federal departments and agencies. The Appropriations Act, among other points, addressed intentional dosing human toxicity studies for pesticides and directed the Agency to establish an independent Human Subjects Review Board to review such studies. On February 6, 2006 the Agency published a final rule for protections for subjects in human research (71 FR 6138) that called for creating a new, independent Human Studies Review Board and described its responsibilities in the following language:

The Human Studies Review Board shall comment on the scientific and ethical aspects of research proposals and reports of completed research with human subjects submitted by EPA for its review and on request, advise EPA on ways to strengthen its programs for protection of human subjects of research. 40 CFR 26.1603(b)

A charter for the Human Studies Review Board dated February 21, 2006 was issued in accordance with the provisions of the Federal Advisory Committee Act (FACA), 5 U.S.C. App.2 Section 9(c) stating that the HSRB will:

Provide advice, information and recommendations on issues related to scientific and ethical aspects of human subjects research. The major objectives are to provide advice and recommendations on: (a) Research proposals and protocols; (b) reports of completed research with human subjects; and (c) how to strengthen EPA's programs for protection of human subjects.

This notice requests nominations of candidates to serve as a member of the HSRB in the area of biostatistics. General information concerning the HSRB 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 individuals to be considered as prospective candidates 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, including training and experience, to be capable of providing expert comments on the ethical and/or scientific issues that may be considered by the HSRB. EPA is seeking nominees who are nationally recognized experts in biostatistics, specifically expertise in statistical design and analysis of research involving human subjects.

All nominations should include: (1) A current curriculum vitae (C.V.) which provides the nominee's educational background, qualifications, leadership positions in national associations or professional publications, relevant research experience and publications; and (2) a summary of the above in a biographical sketch (“biosketch”) of no more than one page.

The qualifications of nominees received in reply to this notice 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 subset (known as the “Short List”). This Short List consisting of nominee's name and biosketch will be posted for public comment on the OSA Web site http://www.epa.gov/​osa/​index.htm. The public will be requested to provide relevant information or other documentation on nominees that OSA should consider in evaluating the candidates. Public comments will be accepted for 14 calendar days on the Short List. Board members will be selected from the Short List. Short List candidates not selected for HSRB membership may be considered for future HSRB membership as vacancies become available or as HSRB consultants for future HSRB meetings. The Agency estimates posting the names of Short List candidates sometime in late May. 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.

For the HSRB, a balanced panel is characterized by inclusion of members who possess the necessary domains of knowledge, the relevant technical perspectives, and the collective breadth of experience to adequately address the Agency's charge. 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, independence with respect to the matters under review, and public comments in response to the Short List. 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 a number of factors including, but not limited to, the candidates' areas of expertise and professional qualifications, and responses to the Short List in achieving an overall balance of different perspectives on the Board.

People who are hired to serve on the Board 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 a Confidential Financial Disclosure Form for Special Government Employees Serving on Federal Advisory Committees at the U.S. Environmental Protection Agency (EPA Form 3110-48 [5-02]). This form seeks information regarding the candidate's financial interests, the candidate's employment, stocks, and bonds, and where applicable, sources of research support. However, this form is confidential and will not be disclosed to the public. The EPA will evaluate the candidate's financial disclosure form to assess whether there are financial conflicts of interest, appearance of a lack of impartiality, or any prior involvement with the development of the documents under consideration, including previous scientific peer review, before the candidate is considered further for service on the HSRB.

Candidates selected from the Short List will be appointed to the HSRB. HSRB members are to perform several activities including 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.

Nominations should be submitted by one of the methods listed under ADDRESSEES.

The Agency will consider all nominations for HSRB membership that are received on or before April 25, 2007. However, final selection of members is a discretionary function of the Agency and will be announced on the OSA Web site http://www.epa.gov/​osa/​index.htm soon after comments are received on the Short List.

Dated: March 19, 2007.

George M. Gray,

Science Advisor.