2014-16132. Extension of Solicitation for Nominations for Membership on the National Vaccine Advisory Committee

AGENCY:

Department of Health and Human Services, Office of the Secretary, Office of the Assistant Secretary for Health, National Vaccine Program Office.

ACTION:

Notice.

Authority: 42 U.S.C. 300aa-5, Section 2105 of the Public Health Service (PHS) Act, as amended. The National Vaccine Advisory Committee is governed by the provisions of Public Law 92-463, as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory committees.

SUMMARY:

The National Vaccine Program Office (NVPO), a program office within the Office of the Assistant Secretary for Health, Department of Health and Human Services (HHS), is extending the solicitation period for nominations of qualified candidates to be considered for appointment as public members to the National Vaccine Advisory Committee (NVAC). NVPO is taking this action to allow more time for qualified candidates to be identified to be considered for appointment as public members of the NVAC. NVPO is seeking additional candidates that meet the expertise and qualifications needed to constitute a balanced membership as outlined in the Committee's charter and to ensure that the membership will be fairly balanced in terms of the points of view represented and the Committee's function. Management and support of the NVAC and its activities are the responsibility of the NVPO.

The NVAC serves an advisory role, providing peer review, consultation, advice, and recommendations to the Assistant Secretary for Health, in his capacity as Director of the National Vaccine Program, on matters related to the Program's responsibilities. Specifically, the Committee studies and recommends ways to encourage the availability of an adequate supply of safe and effective vaccination products in the United States; recommends research priorities and other measures to enhance the safety and efficacy of vaccines. The Committee also advises the Assistant Secretary for Health in the implementation of Sections 2102 and 2103 of the PHS Act; and identifies annually the most important areas of government and non-government cooperation that should be considered in implementing Sections 2102 and 2103 of the PHS Act.

DATES:

All nominations for membership on the Committee must be received no later than 5:00 p.m. EDT on August 11, 2014, to the address listed below.

ADDRESSES:

All nominations should be mailed or delivered to: Bruce Gellin, M.D., M.P.H., Executive Secretary, NVAC, Office of the Assistant Secretary for Health, Department of Health and Human Services, 200 Independence Avenue SW., Room 715H, Washington, DC 20201.

FOR FURTHER INFORMATION CONTACT:

Jennifer Gordon, Ph.D., Public Health Analyst, National Vaccine Program Office, Department of Health and Human Services, 200 Independence Avenue SW., Room 715H, Washington, DC 20201; [phone]; [e-mail].

A copy of the Committee charter, which includes the NVAC's structure and functions as well as a list of the current membership, can be obtained by contacting Dr. Gordon or by accessing the NVAC Web site at: www.hhs.gov/​nvpo/​nvac.

SUPPLEMENTARY INFORMATION:

Committee Function, Qualifications, and Information Required: Individuals selected for appointment to the NVAC will serve as voting members. The NVAC consists of 17 voting members: 15 public members, including the Chair, and two representative members. Individuals selected for appointment to the NVAC can be invited to serve terms of up to four years. Selection of members is based on candidates' qualifications to contribute to the accomplishment of NVAC's objectives. Interested candidates should demonstrate a willingness to commit time to NVAC activities and the ability to work constructively and effectively on committees. This announcement is to solicit nominations of qualified candidates to fill positions in the public member category of the NVAC that are scheduled to be vacated during the 2015 calendar year.

Expertise sought for NVAC: NVPO is extending the solicitation period for nominations to the Committee to allow for additional nominations of candidates that meet the expertise and qualifications needed to constitute a balanced membership as outlined in the Committee's charter and to ensure that the membership will be fairly balanced in terms of the points of view represented and the Committee's function. NVPO is seeking nominations of individuals to serve on the NVAC as public members in the following disciplines/topic areas:

• Members of parent organizations concerned with immunizations
• Individuals engaged in vaccine research and development, vaccine clinical trials, and vaccine regulatory science

How to submit nominations: Nominations should be typewritten. Submitted nominations must include all required information. Nominations that do not include all of the required information will be considered ineligible and will not be processed for consideration. The following information should be included in the package of material submitted for each individual being nominated for consideration:

(1) A letter of nomination that clearly states the name and affiliation of the nominee and the basis for the nomination (i.e., specific attributes which qualify the nominee for service in this capacity);

(2) a signed statement from the nominee that the nominee is willing and able to serve as a member of the Committee;

(3) the nominator's name, address and daytime telephone number, home and/or work address, telephone number, and email address; and

(4) a current copy of the nominee's curriculum vitae.

The letter from the nominator and the letter certifying availability from the nominated individual must both bear original signatures. Digital signatures or reproduced copies of signatures are not acceptable and will cause a nomination to be considered ineligible. Individuals can nominate themselves for consideration of appointment to the Committee. Applications cannot be submitted by facsimile or via email. The names of federal employees should not be nominated for consideration of appointment to this Committee.

The Department makes every effort to ensure that the membership of HHS federal advisory committees is fairly balanced in terms of points of view represented and the committee's function. Every effort is made to ensure that a broad representation of geographic areas, gender, ethnic and minority groups, and the disabled are given consideration for membership on HHS federal advisory committees. Appointment to this Committee shall be made without discrimination on the basis of age, race, ethnicity, gender, sexual orientation, disability, and cultural, religious, or socioeconomic status.

Definitions

• Public Members: Public members are individuals who are appointed to the NVAC to exercise their own independent best judgment on behalf of the government. It is expected that public members will discuss and deliberate in a manner that is free from conflicts of interest. Public members to the NVAC shall be selected from individuals who are engaged in vaccine research or the manufacture of vaccines, or who are physicians, members of parent organizations concerned with immunizations, representatives of state or local health agencies, or public health organizations.
• Representative Members: Representative members are individuals who are appointed to the NVAC to provide the views of the vaccine industry. While they may be experts in various topic areas discussed by the Committee, they should not present their own viewpoints, but rather those of the industry they represent. NVAC representative members shall serve specifically to represent the viewpoints or perspectives of the vaccine manufacturing industry or groups engaged in vaccine research or the manufacture of vaccines.

Travel reimbursement and compensation for services provided to the Committee: All NVAC members are authorized to receive the prescribed per diem allowance and reimbursement for travel expenses that are incurred to attend meetings and conduct authorized NVAC-related business, in accordance with standard government travel regulations. Members appointed to the NVAC as public members (see definition above) also are authorized to receive a stipend for services provided at public meetings of the Committee. All other services that are performed by the public members outside the Committee meetings shall be provided without compensation. Representative members (see definition above) will serve without compensation.

The Standards of Ethical Conduct for Employees of the Executive Branch (www.oge.gov/​Laws-and-Regulations/​Employee-Standards-of-Conduct/​Employee-Standards-of-Conduct) are applicable to individuals who are appointed as public members of federal advisory committees. Individuals appointed to serve as public members of federal advisory committees are classified as special government employees (SGEs). SGEs are government employees for purposes of the conflict of interest laws. Therefore, individuals appointed to serve as public members of NVAC are subject to an annual ethics review to determine if the individual has any interests and/or activities in the private sector that may conflict with performance of their official duties as a member of the NVAC. Individuals appointed to serve as public members of the NVAC will be required to disclose information regarding financial holdings, consultancies, research grants and/or contracts, and the absence of an appearance of a loss of impartiality.

Dated: July 1, 2014.

Jennifer L. Gordon,

Alternate Designated Federal Official, National Vaccine Advisory Committee, Public Health Analyst, National Vaccine Program Office.