Code of Federal Regulations Title 21. Food and Drugs § 21.14.31 Consultation by an advisory committee with other persons

(a) A committee may confer with any person who may have information or views relevant to any matter pending before the committee.

(b) An interested person may submit to the committee a written request that it confer with specific persons about any matter pending before the committee. The request is to contain adequate justification. The committee may, in its discretion, grant the request.

(c) A committee may confer with a person who is not a Federal Government executive branch employee only during the open portions of a meeting. The person may, however, submit views in writing to the committee as part of the administrative record under § 14.70. The person may participate at the closed portions of a meeting only if appointed as a special Government employee by the Commissioner as provided in paragraph (e) of this section. This paragraph (c) is not intended to bar the testimony of a person during a closed portion of a meeting about matters prohibited from public disclosure under §§ 14.25(c) and 14.27(c).

(d) To prevent inadvertent violation of Federal conflict of interest laws and laws prohibiting disclosure of trade secrets (18 U.S.C. 208, 21 U.S.C. 331(j), 18 U.S.C. 1905), Federal executive branch employees who are not employees of the Department may not confer, testify, or otherwise participate (other than as observers) at any portion of an advisory committee meeting unless they are appointed as special Government employees by the Commissioner under paragraph (e) of this section. this paragraph does not apply to Federal executive branch employees who are appointed as members of TEPRSSC, as provided in § 14.127.

(e) The Commissioner may appoint persons as special Government employees to be consultants to an advisory committee. Consultants may be appointed to provide expertise, generally concerning a highly technical matter, not readily available from the members of the committee. Consultants may be either from outside the Government or from agencies other than the Food and Drug Administration. Reports, data, information, and other written submissions made to a public advisory committee by a consultant are part of the administrative record itemized in § 14.70.

(a) The advisory committee Chairperson has the authority to conduct hearings and meetings, including the authority to adjourn a hearing or meeting if the Chairperson determines that adjournment is in the public interest, to discontinue discussion of a matter, to conclude the open portion of a meeting, or to take any other action to further a fair and expeditious hearing or meeting.

(b) If the Chairperson is not a full-time employee of FDA, the Designated Federal Officer or other designated agency employee, or alternate, is to be the designated Federal employee who is assigned to the advisory committee. The designated Federal employee is also authorized to adjourn a hearing or meeting if the employee determines adjournment to be in the public interest.