1. (a) Time periods. Completed applications from establishments seeking permits of approval as manufacturers of foods, wholesale distributors of drugs, salvage brokers, salvage establishments, and synthetic narcotic drug treatment facilities shall be processed within the following time periods.

   1. (1) The first time period is the time from receipt by the department of the remittance fee and attached applications to the date of issuance by the department of a permit or a written notice stating the reasons why the application is incomplete or that the facility is not in compliance with the law. The time periods are:

      1. (A) 45 days for food manufacturers' registrations;
      2. (B) 45 days for wholesale drug distributors' registrations;
      3. (C) 60 days for salvage brokers' and salvage establishments' licenses; and
      4. (D) 80 days for synthetic narcotic treatment facilities' permits.

   2. (2) The second time period is a time from receipt by the department of a completed application and/or receipt of an inspection report stating the facility is in compliance. The time periods are:

      1. (A) 30 days for food manufacturers' registrations;
      2. (B) 30 days for wholesale drug distributors' registrations;
      3. (C) 30 days for salvage brokers and salvage establishments' licenses; and
      4. (D) 60 days for synthetic narcotic drug treatment facilities' permits.

2. (b) Reimbursement of fees.

   1. (1) Should an application fail to be processed in the time allotted in subsections (1) or (2) of this section, the applicant has the right to request from the Division of Food and Drugs, Texas Department of Health, full reimbursement of all fees paid in that application process. If the Division of Food and Drugs does not agree that the established periods have been violated or finds that good cause existed for exceeding the established periods, the request will be denied.

   2. (2) Good cause for exceeding the period is considered to exist if:

      1. (A) the number of applications processed exceeds by 15% or more the number processed in the same period of the preceding year;
      2. (B) delays exist due to a public or private entity being utilized in the application process;
      3. (C) other conditions exist giving good cause for exceeding the established time periods (i.e., computer breakdown);
      4. (D) the application is not properly completed;
      5. (E) no signature is provided on the application;
      6. (F) the drug application is not notarized;
      7. (G) the correct fee is not submitted with the application or a non-negotiable check is submitted;
      8. (H) adverse conditions exist which are noted in recent inspections; or
      9. (I) the application is being held pending an inspection.
3. (c) Appeal. If the request for full reimbursement authorized by subsection (b) of this section is denied, the applicant may appeal to the commissioner of health for a resolution of the dispute. The applicant shall give written notice to the commissioner that he requests full reimbursement of all filing fees paid because his application was not processed within the adopted time period. The program administrator 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 will make the final decision and provide written notification of the decision to the applicant and the program administrator.
4. (d) Contested case hearing. If at any time during the processing of the permit during the second time period, a contested case hearing becomes involved, the time periods in §1.34 of this title (relating to Time Periods for Conducting Contested Case Hearings) are applicable.

Source Note:The provisions of this §229.281 adopted to be effective June 1, 1988, 13 TexReg 2086.