2019-06285. Human Studies Review Board Advisory Committee; Request for Nominations to the Human Studies Review Board (HSRB) Advisory Committee

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

The U.S. Environmental Protection Agency (EPA) invites nominations from a diverse range of qualified candidates with expertise in the areas of toxicology, bioethics, and statistics to be considered for appointment to its Human Studies Review Board (HSRB) federal advisory committee. HSRB vacancies will be filled in the fall of 2019. In addition to this Federal Register Notice, additional sources of nominations may be used to obtain a balanced committee.

DATES:

Submit nominations by May 16, 2019.

SUPPLEMENTARY INFORMATION:

Background

On February 6, 2006, the Agency published a final rule for the protection of human subjects in 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 (Pub. L. 92-463). 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 that include human subjects; (2) reports of completed research with human subjects; and (3) how to strengthen EPA's programs for protection of human subjects of research. Typically, the HSRB reviews protocols and completed studies involving pesticide studies, such as worker exposure studies with agricultural handlers applying pesticides in field conditions; janitorial maintenance personnel applying antimicrobial pesticides in commercial settings; and field efficacy studies for skin applied insect repellent products. The HSRB reports to the EPA Administrator through EPA's Science Advisor. General information concerning the HSRB, including its charter, current membership, and activities can be found on the EPA website at https://www.epa.gov/​osa/​human-studies-review-board.

HSRB members serve as special government employees or regular government employees. Members are appointed by the EPA Administrator for either two or three year terms with the possibility of reappointment for additional terms, with a maximum of six years of service. The HSRB convenes on average four times a year, with most of the meetings being virtual. The average workload for HSRB members is approximately 20 hours per meeting, including the time spent at the meeting. Responsibilities of HSRB members include reviewing extensive background materials prior to 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 assisting with the finalization of HSRB reports. EPA compensates special government employees for their time and provides reimbursement for travel and other incidental expenses associated with official government business related to the HSRB meetings. EPA values and welcomes diversity. In an effort to obtain nominations of diverse candidates, EPA encourages nominations of women and men of all racial and ethnic groups, as well as from a variety of backgrounds (e.g., industry, non-profit organizations, academia, and government).

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.

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 that fully discloses, among other financial interests, the candidate's employment, stocks and bonds, and where applicable, sources of research support. The information provided is strictly 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 will be evaluated on the basis of several criteria, including: The professional background, expertise, and experience that would contribute to the diversity of perspectives of the committee; interpersonal, oral, and written communication skills and other attributes that would contribute to the HSRB's collaborative process; consensus building skills; absence of any financial conflicts of interest or the appearance of a lack of impartiality, or lack of independence, or bias; and the availability to participate in meetings and administrative sessions, participate in teleconferences, develop policy recommendations to the Administrator, and prepare recommendations and advice in reports.

Nominations should include a resume or curriculum vitae providing the nominee's educational background, qualifications, leadership positions in national associations or professional societies, relevant research experience and publications along with a short (one page) biography describing how the nominee meets the above criteria and other information that may be helpful in evaluating the nomination, as well as the nominee's current business address, email address, and daytime telephone number. Interested candidates may self-nominate.

To help the Agency in evaluating the effectiveness of its outreach efforts, nominees are requested to inform the Agency of how you learned of this opportunity.

Final selection of HSRB members is a discretionary function of the Agency and will be announced on the HSRB website at https://www.epa.gov/​osa/​human-studies-review-board as soon as selections are made.

ADDRESSES:

Submit your nominations by May 16, 2019, using any of the following methods:

Email: Submit nominations electronically using the subject line: “HSRB Membership 2019” to [e-mail].

USPS Mail: Human Studies Review Board, DFO, Environmental Protection Agency, Mail code: 8105R, 1200 Pennsylvania Ave. NW, Washington, DC 20460.

Hand or Courier Delivery: Human Studies Review Board, DFO, Room 41249, EPA, Ronald Reagan Building, 1300 Pennsylvania Avenue NW, MC8105R, Washington, DC 20004. 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.

FOR FURTHER INFORMATION CONTACT:

Thomas O'Farrell, Office of the Science Advisor, Mail Code 8105R, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue NW, Washington, DC 20460; telephone number: [phone], fax number: [phone], email: [e-mail].

Dated: March 13, 2019.

Jennifer Orme-Zavaleta,

EPA Science Advisor.