Current through Reg. 49, No. 38; September 20, 2024
(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).
(c) Time Periods. An application for a
license shall be processed in accordance with the following time periods.
(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.
