(a) Definition. For purposes of this section, license means a license, permit, registration, or certificate issued by the Texas Department of Health (department) for a food wholesaler and manufacturer, wholesale drug manufacturer and distributor, device manufacturer and distributor, tanning facility, tattoo studio, body piercing studio, salvage broker, salvage establishment, retail food establishment, or narcotic treatment program. This subchapter is not applicable to food manager certification.

(b) General. Time periods for processing and issuing a license.

(1) The date a license application is received by the Bureau of Food and Drug Safety, Texas Department of Health, is the date the original application reaches the department.

(2) An application for a license is complete when the department has received, reviewed, and found acceptable the application information and fee required by the appropriate sections of this title (25 Texas Administrative Code (TAC), Chapter 229, Food and Drug, relating to Licensing Fees, Procedures, Requirements).

(3) An application for an annual renewal of a license is complete when the department has received, reviewed and found acceptable the application information and fee required by the appropriate section of this title (25 TAC, Chapter 229, Food and Drug, relating to Licensing Fees, Procedures, Requirements).

(4) An application for an amendment of a license is complete when the department has received, reviewed, and found acceptable the application information and fee required by the appropriate section of this title (25 TAC, Chapter 229, Food and Drug relating to Licensing Fees, Procedures, Requirements).

(1) The first time period is 45 calendar days, which begins on the date the department receives the application and ends on the date the license is issued. If an incomplete application is received, the period ends on the date the facility is issued a written notice that the application is incomplete. The written notice shall describe the specific information or fee that is required before the application is considered complete.

(2) The second time period is 45 calendar days, which begins on the date the last item (information or fee) necessary to complete the application is received by the department and ends on the date the license is issued, or the facility is issued a written notice that the application is being proposed for denial.

(3) If the applicant fails to submit the requested information and/or fee within 135 days of the date the department issued the written notice to the applicant as described in paragraph (1) of this subsection, that the application is incomplete and/or additional fees are owed, the application is considered withdrawn. Fees paid are not refundable. There will be no refund of the fee except as provided by subsections (d) and (f) of this section. A new application and fee must be submitted to the department.

(d) Reimbursement of fees.

(1) In the event the application is not processed within the time periods stated in subsection (c) of this section, the applicant has the right to make a written request within 30 days of the end of the second period that the department reimburse in full the fee paid in that particular application process.

(2) If the department finds that good cause existed for exceeding the established periods, the request will be denied. The department will notify the applicant in writing of the denial of the reimbursement within 30 days of the department's receipt of the request for reimbursement.

(e) Good cause for exceeding the period established is considered to exist if:

(1) the number of applications for licenses to be processed exceeds by 15% or more the number processed in the same calendar quarter the preceding year;

(2) another public or private entity utilized in the application process caused the delay;

(3) conditions in violation of the rules exist which are noted in recent investigations or inspections;

(4) the application is being held pending completion of an investigation, inspection, or enforcement action;

(5) the application is incomplete in information, signature, and/or fee amount submitted; or

(6) other conditions existed giving good cause for exceeding the established periods.

(f) Appeal. If the request for reimbursement as authorized by subsection (d)(1) of this section is denied, the applicant may, within 30 days of being notified of the denial, appeal to the Commissioner of Health (commissioner) for a resolution of the dispute. The applicant shall give written notice to the commissioner requesting reimbursement of the fee paid because the application was not processed within the established time period. Within 30 days of receiving the appeal, the Bureau of Food and Drug Safety shall submit a written report to the commissioner of the facts related to the processing of the application and describing the good cause for exceeding the established time periods. The commissioner then has 30 days to make the final decision and provide written notification of the decision to the applicant and the Bureau of Food and Drug Safety.

(g) Hearings shall be conducted under the provision of contested case hearings pursuant to the department's formal hearing procedures in Chapter 1 of this title (relating to the Texas Board of Health) and the Administrative Procedure Act, Government Code, Chapter 2001.

Source Note: The provisions of this §229.281 adopted to be effective December 15, 2002, 27 TexReg 11549