World Trade Center Health Program Scientific and Technical Advisory Committee (WTC-STAC)

Bylaws

Section I: Purpose:

The purpose of the World Trade Center (WTC) Health Program Scientific/Technical Advisory Committee (STAC) is to review scientific and medical evidence and to make recommendations to the Administrator of the WTC Health Program on additional WTC Program eligibility criteria, research needs, and on additional WTC-related health conditions.  The STAC may be consulted on other matters as related to the WTC Health Program and outlined in the James Zadroga 9/11 Health and Compensation Act of 2010 (“Act”).

Section II: Authority

The STAC was established by Public Law 111-347, the James Zadroga 9/11 Health and Compensation Act of 2010, Title XXXIII of the Public Health Service Act, enacted on January 2, 2011 and codified at 42 U.S.C. §§ 300mm-300mm-61.  Section 3302(a) of the Act establishes the STAC and describes its membership composition and other administrative requirements.  Per Section 3302(a)(6), the STAC is subject to the Federal Advisory Committee Act (FACA), 5 U.S.C. App.  The Charter for the STAC was filed with the Congress on May 12, 2011, amended on September 6, 2011.  The charter is filed with the House Energy and Commerce Committee and the Senate Committee on Health, Education, Labor and Pension.

Section III: Membership Selection and Appointment

1. Members
   
   All members of the STAC are appointed by the WTC Program Administrator.  The STAC consists of at least 15 members, including the STAC Chair.  Additional members may be appointed at the discretion of the WTC Program Administrator. Of the 15 required members, four are occupational physicians, at least two of whom have experience treating WTC rescue and recovery workers; one is a physician with expertise in pulmonary medicine; two are environmental medicine or environmental health specialists; two are representatives of WTC responders; two are representatives of certified-eligible WTC survivors; one is an industrial hygienist; one is a toxicologist; one is an epidemiologist; and one is a mental health professional. Members, other than federal government employees, will be deemed special government employees.  Currently, all members of STAC are designated as voting.
   
   
2. Terms
   
   STAC members are appointed to serve overlapping terms of up to four years. The STAC is chartered for two years, and terms of more than two years are contingent upon the renewal of the STAC’s charter by appropriate action prior to its expiration.  A member may continue to serve up to 180 days after the expiration of the member’s term if a successor has not been appointed.
   
   If a vacancy occurs among the appointed members, the WTC Program Administrator shall make every effort to make an appointment to fill the vacancy within 90 days from the date the vacancy occurs. Any individual who is appointed to fill a vacancy for the unexpired term of a member shall be appointed only for the remainder of that term; the new appointee may be reappointed for an additional term at the discretion of the WTC Program Administrator.
   
   
3. Attendance
   
   Membership includes the responsibility to routinely attend STAC meetings personally and physically at the meeting location. No substitutes for members will be permitted.  The WTC Program Administrator reserves the ability to replace any member who is unable to routinely participate personally and physically in the STAC's meetings.
   
   
4. Standing Subcommittees and Work Groups
   
   As deemed necessary, the STAC may establish standing subcommittees or work groups composed of members of the STAC, and, with the approval of the WTC Program Administrator, seek advice from non-member special consultants through oral or written testimony. The DHHS and CDC Committee Management Office shall be notified upon establishment of each standing subcommittee and shall be provided with information on its name, membership, function, and estimated frequency of meetings.
   
   The advice of a standing subcommittee or work group shall be reported to the full STAC. The full STAC shall review reports and any recommendations made by the standing subcommittees or work groups. Findings will be discussed at a public meeting of the full STAC, at which time a vote of the full STAC will be required to determine appropriate action including making a recommendation to the WTC Program Administrator.
   
   
5. STAC Correspondence
   
   Any correspondence (letter, fax, e-mail, etc.) received by a committee member from an entity outside the committee which addresses committee business should be routed to the Committee Management Specialist for the STAC who consults with the Designated Federal  Officer (DFO) to determine the most appropriate respondent.  In some cases, the Chair of the STAC is the appropriate person; in other cases, it may be the DFO or another CDC official.  STAC members are not authorized to represent HHS, CDC, or NIOSH regarding any WTC Health Program matters and in no case should a member reply to official correspondence without consulting the DFO.  The only exception to this rule is that all members are free to respond to questions about established points of fact (e.g., meeting dates, citations for STAC recommendations, etc.).

Section IV: Meeting Procedures

Meetings of the full STAC shall be held at a frequency determined by the WTC Program Administrator based on program needs and based on support available under the World Trade Center Health Program Fund described in Section 3351(c)(2) of the Act.  Meetings will be called by the DFO in consultation with the STAC Chair, according to the following considerations:

A. Agenda: The DFO shall approve the agenda for all meetings. Items for the agenda may be requested by the WTC Program Administrator, the Chair, or any member of the STAC.  Suggested agenda items must be submitted to the DFO. The DFO will distribute the agenda to the members prior to each meeting and, publish an outline of the agenda in the Federal Register prior to the meeting date.

B. Minutes and Records: The DFO will ensure that detailed minutes of each meeting are prepared in accordance with CDC-GA-2002-02, “Federal Advisory Committee Meeting Minutes” policy, and distribute copies to each STAC member. Minutes of open meetings will be made available to the public the WTCHP website. Minutes of closed meetings also will be available to the public upon request, subject to the withholding of matters which are exempt from disclosure in accordance with the FACA, Government in the Sunshine Act, and the Freedom of Information Act. The minutes will include a record of the persons present (names of STAC members, staff and members of the public from whom written or public presentations were made), a complete and accurate description of the matters discussed and conclusions reached and copies of all reports received, issued or approved by the STAC. All documents, reports, or other materials prepared by, or for, STAC constitute official government records and will be maintained according to FACA policies and procedures, in accordance with General Records Schedule 26, Item 2 and the agency-approved agency records disposition schedule. Records of the meeting proceedings are kept and will be posted within approximately 60 days of the STAC meeting.  Transcripts of open meetings will be taken and provided at the WTCHP website.

C. Quorum.    No Federal advisory committee will hold any meeting in the absence of a quorum.  Unless otherwise established in the charter of the committee, a quorum shall consist of a majority (one more than one-half) of the committee's authorized membership,   Based on the current membership, the required number of members for a quorum for STAC is 10.

D. Open Meetings. All STAC meetings shall be open to the public except as determined otherwise by the DFO, in accordance with the Government in the Sunshine Act, at 5 U.S.C. § 552b(c), and the FACA. Meeting dates are determined by the DFO in consultation with the STAC.

1. Meeting Notification.
   
   The DFO will publish a meeting notice in the Federal Register as soon as dates are confirmed. The DFO will make every effort to provide notice ahead of the 15-day minimum notice required by FACA to facilitate public attendance at the meeting.
   
   
2. Public Comment
   
   Members of the public attending any meeting or portion of a meeting that is not closed to the public may, at the determination of the STAC Chair and DFO, orally address the STAC during specially designated times at the meeting. Specific information regarding the opportunity for public comment shall be provided in the Federal Register meeting announcement. The DFO and STAC Chair will determine the amount of time permitted for public comment as necessary.
   
   In rare instances, the DFO and STAC Chair may decide in advance to exclude public comment during a meeting, in which case the meeting announcement published in the Federal Register will note that oral public comment during the meeting will be excluded, but that written comment will be accepted.
   
   
3. Access to Submissions
   
   When materials are brought before, or presented to, the STAC for an open meeting, and are received by the deadline posted in the Federal Register meeting announcement, efforts will be made to make the materials available to the public for review at the meeting. Written materials submitted by the deadline will be uploaded and made available for public access.  All materials may be subject to review and redaction to address concerns regarding privacy and personally identifiable information or personal health information.
   
   
4. Electronic Recording by Public Media
   
   FACA states that advisory committee meetings should be open to the public to the extent allowed by law and physical environment.  The DFO has the authority to regulate all aspects of the meetings, including electronic coverage.  To ensure the meeting is conducted in a fair and expeditious manner, the DFO may restrict or deny use of electronic recording equipment.  Any member finding lights or recording equipment disruptive to the conduct of business at the meeting should inform the DFO.

E. Closed Meetings: STAC meetings will be closed only in limited circumstances and in accordance with applicable federal law. A meeting may be closed or partially closed to the public in accordance with the Federal Advisory Committee Act and the Government in the Sunshine Act at 5 U.S.C. § 552b(c). If it is determined that sufficient justification exists to close a meeting, the DFO shall provide notice of the determination to the public in the Federal Register meeting announcement. Committee management guidelines from the Department of Health and Human Services and CDC will be followed if a request to close a meeting is initiated.

F. Disqualifications: The DFO, in consultation with the CDC Committee Management Office and as necessary, the Department of Health and Human Services Office of the General Counsel, will review conflict of interest statements in conjunction with the topics to be discussed to determine whether any member(s) should be disqualified from reviewing a given topic.  Any disqualification will be announced at the STAC meeting before discussions on the topic at issue begin.

Section V: Developing Recommendations

1. Requests for Recommendations on Health Conditions from WTC Program Administrator: If an interested party submits a petition to the WTC Program Administrator to add a health condition to the covered list and the Administrator requests a recommendation from the STAC with respect to adding a health condition to the list of covered conditions, then the STAC shall submit its recommendation to the WTC Program Administrator not later than 60 days after the date of the WTC Program Administrator’s request or by such date (not to exceed 180 days after such date of request) as specified by the WTC Program Administrator.
   
   
   1. The process of developing STAC recommendations will include a thorough review of the scientific literature on the health condition, relevant exposures, and strength of the association between the relevant exposures and the health condition.  Consideration will be given to the relevance, quality, and quantity of the literature and data.
      
      
   2. Each recommendation will include a description of the scientific and/or technical evidence relied on, an assessment of the quality of the supporting data, the methods used for developing the recommendation, and the vote counts to allow the WTC Program Administrator to evaluate the basis for the recommendation and make decisions regarding the recommendation. 
      
      
2. Other Requests for Advice. When the Administrator seeks advice from the Advisory Committee on matters other than a health conditions when a petition has been received by the Program Administrator, the STAC will develop recommendations based on a thorough review of the available information.  Consideration will be given to the relevance, quality, and quantity of the available information.  Each recommendation will include a description of the evidence relied on, an assessment of the quality of the supporting data, the methods used for developing the recommendation, and the vote counts to allow the WTC Program Administrator to evaluate the basis for the recommendation and make decisions regarding the recommendation. 

All recommendations of the STAC will be published on the public Web site established for the WTC Health Program.

Section VI: Voting

No decision or recommendation can be voted upon unless a quorum, as defined in Section C. of these by-laws, of committee members are present.

When a decision or recommendation of the STAC is required, the Chairperson will request a motion for a vote. Any member, including the Chairperson, may make a motion for a vote. A second after a proper motion will be required to bring any issue to vote. Only members participating during a meeting may vote.  Voting via proxy is strictly prohibited.
A decision or recommendation will be considered passed if a majority of the voting members vote in favor the motion.

Section VII: Role of STAC Officials

STAC Chair: The STAC Chair works with the DFO and STAC members to establish priorities and identify issues which must be addressed.  In addition, the STAC Chair is responsible for certifying the accuracy of minutes of STAC meetings.

Designated Federal Officer: The DFO serves as the government's agent for all matters related to the STAC's activities. The DFO shall:
(1) Approve or call the meeting of the STAC;
(2) Approve agendas;
(3) Attend all meetings;
(4) Adjourn the meetings when such adjournment is in the public interest; and
(5) Chair meetings of the STAC, when so directed by the WTC Program Administrator.

In addition, the DFO is responsible for providing adequate staff support to the STAC, including the performance of the following functions:
(1) Notifying members of the time and place for each meeting;
(2) Maintaining records of all meetings, including subcommittee activities, as required by Law;
(3) Conducting roll call at the beginning of the meeting and at appropriate intervals in order to maintain quorum for the duration of the meeting
(4) Preparing the minutes of all meetings of the STAC's deliberations, including subcommittee and work group activities;
(5) Attending to official correspondence;
(6) Maintaining official STAC records and filing all papers and submissions prepared for or by the STAC, including those items generated by subcommittees and work groups;
(7) Acting as the STAC's agent to collect, validate and pay all vouchers for pre-approved expenditures; and
(8) Preparing and handling all reports, including the annual report as required by FACA.

Section VIII: Expenses and Reimbursement

Members shall be paid at the prevailing rate, plus per diem and travel expenses, as authorized by Section 5703, Title 5 U.S.C., as amended, for persons employed intermittently in the Government service. Members who are full-time officers or employees of the United States Government shall not receive compensation for service on the STAC. The government will pay travel and per diem for non-government members at a rate equivalent to that allowable for Federal employees. A summary of the STAC's activities, including estimated expenses related to meeting costs and compensation for staff and STAC members' travel expenses is provided in an annual report and accessible to the public via GSA's FACA Shared Management System.