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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 229FOOD AND DRUG
SUBCHAPTER XLICENSING OF DEVICE DISTRIBUTORS AND MANUFACTURERS
RULE §229.444Device Distributors and Manufacturers Advisory Committee

(a) The committee. An advisory committee shall be appointed under and governed by this section.

  (1) The name of the committee shall be the Device Distributors and Manufacturers Advisory Committee (committee).

  (2) The committee is required to be established by the Executive Commissioner of the Health and Human Services Commission by Health and Safety Code, §431.275 and is subject to the Health and Safety Code, §11.016.

(b) Applicable law. The committee is subject to the Government Code, Chapter 2110, concerning state agency advisory committees.

(c) Purpose. The purpose of the committee is to provide advice to the Executive Commissioner of the Health and Human Services Commission in the area of licensure of device distributors and manufacturers.

(d) Tasks.

  (1) The committee shall advise the Executive Commissioner of the Health and Human Services Commission concerning rules relating to licensing of device distributors and manufacturers.

  (2) The committee shall advise the Executive Commissioner of the Health and Human Services Commission in the development of standards and procedures relating to the licensing of device distributors and manufacturers; make recommendations to the Executive Commissioner of the Health and Human Services Commission relating to the content of the rules adopted to implement the licensing of device distributors and manufacturers; and perform any other functions requested by the Executive Commissioner of the Health and Human Services Commission to implement and administer the rules regarding the licensing of device distributors and manufacturers.

  (3) The committee shall carry out any other tasks given to the committee by the Executive Commissioner of the Health and Human Services Commission.

(e) Review and duration. By September 1, 2007, the Executive Commissioner of the Health and Human Services Commission will initiate and complete a review of the committee to determine whether the committee should be continued, consolidated with another committee, or abolished. If the committee is not continued or consolidated, the committee shall be abolished on that date.

(f) Composition. The committee shall be composed of five members appointed by the Executive Commissioner of the Health and Human Services Commission. The composition of the committee shall include:

  (1) two consumer representatives;

  (2) one person representing a distributor of devices; and

  (3) two persons representing manufacturers of devices.

(g) Terms of office. The term of office of each member shall be three years. Members shall serve after expiration of their term until a replacement is appointed.

  (1) Members shall be appointed for staggered terms so that the terms of a substantial equivalent number of members will expire on August 31st of each odd-numbered year.

  (2) If a vacancy occurs, a person shall be appointed to serve the unexpired portion of that term.

(h) Officers. The committee shall elect a presiding officer and an assistant presiding officer at its first meeting after August 31st of each year.

  (1) Each officer shall serve until the next regular election of officers.

  (2) The presiding officer shall preside at all committee meetings at which he or she is in attendance, call meetings in accordance with this section, appoint subcommittees of the committee as necessary, and cause proper reports to be made to the Executive Commissioner of the Health and Human Services Commission. The presiding officer may serve as an ex-officio member of any subcommittee of the committee.

  (3) The assistant presiding officer shall perform the duties of the presiding officer in case of the absence or disability of the presiding officer. In case the office of presiding officer becomes vacant, the assistant presiding officer will serve until a successor is elected to complete the unexpired portion of the term of the office of presiding officer.

  (4) A vacancy which occurs in the offices of presiding officer or assistant presiding officer may be filled at the next committee meeting.

  (5) A member shall serve no more than two consecutive terms as presiding officer and/or assistant presiding officer.

  (6) The committee may reference its officers by other terms such as chairperson and vice-chairperson.

(i) Meetings. The committee shall meet only as necessary to conduct committee business.

  (1) A meeting may be called by agreement of department staff and either the presiding officer or at least three members of the committee.

  (2) Meeting arrangements shall be made by department staff. Department staff shall contact committee members to determine availability for a meeting date and place.

  (3) The committee is not a "governmental body" as defined in the Open Meetings Act. However, in order to promote public participation, each meeting of the committee shall be announced and conducted in accordance with the Open Meetings Act, Texas Government Code, Chapter 551, with the exception that the provisions allowing executive sessions shall not apply.

  (4) Each member of the committee shall be informed of a committee meeting at least five working days before the meeting.

  (5) A simple majority of the members of the committee shall constitute a quorum for the purpose of transacting official business.

  (6) The committee is authorized to transact official business only when in a legally constituted meeting with quorum present.

  (7) The agenda for each committee meeting shall include an item entitled public comment under which any person will be allowed to address the committee on matters relating to committee business. The presiding officer may establish procedures for public comment, including a time limit on each comment.

(j) Attendance. Members shall attend committee meetings as scheduled. Members shall attend meetings of subcommittees to which the member is assigned.

  (1) A member shall notify the presiding officer or appropriate department staff if he or she is unable to attend a scheduled meeting.

  (2) It is grounds for removal from the committee if a member cannot discharge the member's duties for a substantial part of the term for which the member is appointed because of illness or disability, is absent from more than half of the committee and subcommittee meetings during a calendar year, or is absent from at least three consecutive committee meetings.

  (3) The validity of an action of the committee is not affected by the fact that it is taken when a ground for removal of a member exists.

(k) Staff. Staff support for the committee shall be provided by the department.

(l) Procedures. Roberts Rules of Order, Newly Revised, shall be the basis of parliamentary decisions except where otherwise provided by law or rule.

  (1) Any action taken by the committee must be approved by a majority vote of the members present once quorum is established.

  (2) Each member shall have one vote.

  (3) A member may not authorize another individual to represent the member by proxy.

  (4) The committee shall make decisions in the discharge of its duties without discrimination based on any person's race, creed, gender, religion, national origin, age, physical condition, or economic status.

  (5) Minutes of each committee meeting shall be taken by department staff.

    (A) A draft of the minutes approved by the presiding officer shall be provided to the Executive Commissioner of the Health and Human Services Commission and each member of the committee within 30 days of each meeting.

    (B) After approval by the committee, the minutes shall be signed by the presiding officer.

(m) Subcommittees. The committee may establish subcommittees as necessary to assist the committee in carrying out its duties.

  (1) The presiding officer shall appoint members of the committee to serve on subcommittees and to act as subcommittee chairpersons. The presiding officer may also appoint nonmembers of the committee to serve on subcommittees.

  (2) Subcommittees shall meet when called by the subcommittee chairperson or when so directed by the committee.

  (3) A subcommittee chairperson shall make regular reports to the advisory committee at each committee meeting or in interim written reports as needed. The reports shall include an executive summary or minutes of each subcommittee meeting.

(n) Statement by members.

Cont'd...

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