(a) Purpose. The requirements in this section establish
fees for licensing, registration, emergency planning and implementation,
and other regulatory services, and provide for their payment.
(b) Scope. Except as otherwise specifically provided,
the requirements in this section apply to any person who is the following:
(1) an applicant for, or holder of:
(A) a radioactive material license issued in accordance
with §289.252 of this title (relating to Licensing of Radioactive
Material), or §289.259 of this title (relating to Licensing of
Naturally Occurring Radioactive Material (NORM)); or
(B) a general license acknowledgment issued in accordance
with §289.251 of this title (relating to Exemptions, General
Licenses, and General License Acknowledgments); or
(C) a certificate of registration for radiation machines
and/or services, or sources of laser radiation, issued in accordance
with §289.226 of this title (relating to Registration of Radiation
Machine Use and Services), §289.230 of this title (relating to
Certification of Mammography Systems and Mammography Machines Used
for Interventional Breast Radiography), a certificate of registration
for dental radiation machines in accordance with §289.232 of
this title (relating to Radiation Control Regulations for Dental Radiation
Machines), a certificate of registration for radiation machines used
in veterinary medicine in accordance with §289.233 of this title
(relating to Radiation Control Regulations for Radiation Machines
Used in Veterinary Medicine), §289.234 of this title (relating
to Mammography Accreditation), or §289.301 of this title (relating
to Registration and Radiation Safety Requirements for Lasers and Intense-Pulsed
Light Devices); or
(2) the holder of a fixed nuclear facility construction
permit or operating license issued by the United States Nuclear Regulatory
Commission (NRC) in accordance with Title 10, Code of Federal Regulations,
Part 50; or
(3) the operator of any other fixed nuclear facility.
(c) Definitions. The following words and terms when
used in this section shall have the following meaning, unless the
context clearly indicates otherwise.
(1) Contiguous properties--Those locations adjacent
to an existing licensed or permitted area.
(2) Decontamination services--Providing deliberate
operations to reduce or remove residual radioactivity from equipment,
facilities, and land owned, possessed, or controlled by other persons
to a level that permits release of equipment, facilities, and land
for unrestricted use and/or termination of a license.
(3) Emergency planning and implementation--The development
and application of those capabilities necessary for the protection
of the public and the environment from the effects of an accidental
or uncontrolled release of radioactive materials, including the equipping,
training and periodic retraining of response personnel.
(4) Fixed nuclear facility--The following are considered
fixed nuclear facilities:
(A) any nuclear reactor(s) at a single site;
(B) any facility designed or used for the assembly
or disassembly of nuclear weapons; or
(C) any other facility using special nuclear material
for which the agency conducts off-site environmental surveillance
and/or emergency planning and implementation to protect the public
health and safety or the environment.
(5) Limited manufacturer--A manufacturer/distributor
of radioactive material that is not required to submit a decommissioning
funding plan or an emergency plan in accordance with §289.252
of this title.
(6) Processor of radioactive material--A manufacturer/distributor
who converts normal form radioactive material into special form or
a manufacturer/distributor of radioactive sealed sources.
(d) Payment of fees.
(1) Each application for a specific license, general
license acknowledgement, or certificate of registration for which
a fee is prescribed in subsection (e), (g), or (j) of this section
shall be accompanied by a nonrefundable fee equal to the appropriate
fee. Each request for evaluation of a sealed source and/or device
shall be accompanied by a nonrefundable fee prescribed in subsection
(f) of this section. Each application for accreditation of a mammography
facility shall be accompanied by a nonrefundable fee prescribed in
subsection (h) of this section. Each application for an industrial
radiographer certification and an industrial radiographer examination
shall be accompanied by a nonrefundable and non-transferable fee prescribed
in subsection (i) of this section.
(A) An application for a license covering more than
one category of specific license shall be accompanied by the prescribed
fee for the highest category and 25% of the applicable prescribed
fee for each additional requested category.
(B) An application for a certificate of registration
covering more than one category shall be accompanied by the prescribed
fee for the highest category.
(C) No application will be accepted for filing or processed
prior to payment of the full amount specified.
(2) A nonrefundable fee, in accordance with subsection
(e) of this section shall be paid for each radioactive material license
and/or for each general license acknowledgement. The fee shall be
paid every two years based on the month listed as the expiration month
on the license or general license acknowledgement and shall be paid
in full on or before the last day of the expiration month. In the
case of a single license that authorizes more than one category of
use, the fee shall be the prescribed fee for the highest license category
plus 25% of the applicable prescribed fee for each additional license
category authorized.
(3) A nonrefundable fee, in accordance with subsection
(j) of this section, shall be paid for each certificate of registration
for radiation machines and/or services, or sources of laser radiation.
The fee shall be paid every two years based on the month listed as
the expiration month on the certificate of registration and shall
be paid in full on or before the last day of the expiration month.
For certificates of registration with no specified expiration date,
payment shall be paid in full on or before the due date stated on
the invoice.
(4) In the case of a single certificate of registration
that authorizes more than one category of machine/type of use, the
category listed in subsection (j) of this section and assigned the
higher fee will be used.
(5) An additional nonrefundable fee equal to 5% of
the total fee for each specific license shall be paid with the specified
fee by each holder of a specific license, excluding licensees that
are authorized only for diagnostic nuclear medicine.
(A) The fees collected by the agency in accordance
with this paragraph shall be deposited to the credit of the agency's
Radiation and Perpetual Care Account.
(B) The agency shall collect the fees in accordance
with this paragraph so long as the sum of the balances of the perpetual
care accounts specified under Health and Safety Code, §401.307,
does not exceed $100 million; and if the sum of such balances subsequently
is reduced to $50 million or less, the agency shall reinstitute assessment
of the fee until the sum of such balances reaches $100 million.
(6) Each application for reciprocal recognition of
an out-of-state license in accordance with §289.252(s) of this
title, an out-of-state registration in accordance with §289.226
of this title, or an out-of-state laser registration in accordance
with §289.301 of this title, shall be accompanied by the applicable
fee, provided that no such fee has been submitted within 24 months
of the date of commencement of the proposed activity.
(7) Each holder of a fixed nuclear facility construction
permit or operating license or an operator of any other fixed nuclear
facility shall submit an annual fee for services received. This fee
shall recover for the State of Texas the actual expenses arising from
environmental surveillance and emergency planning and implementation
activities. Payment shall be made within 90 days following the date
of invoice.
(8) Fee payments shall be in cash or by check or money
order made payable to the Department of State Health Services. The
payments may be made by personal delivery to the central office, Radiation
Control, Department of State Health Services, 1100 West 49th Street,
Austin, Texas, or mailed to Radiation Control, Department of State
Health Services, P.O. Box 149347, MC 2003, Austin, Texas, 78714-9347.
(9) Any applicant requesting authorization for any
of the categories in subsection (e) of this section for veterinary
use will be assessed the fee for the corresponding category.
(e) Schedule of fees for radioactive material licenses.
The following schedule contains the fees for radioactive material
licenses:
Attached Graphic
(f) Fee for evaluation of a sealed source and/or device.
(1) Each time a manufacturer submits a request for
evaluation of a unique sealed source, one of the following fees shall
be paid:
(A) for an initial evaluation, a fee of $5,320; or
(B) for an amendment requiring re-evaluation, a fee
of $2,660.
(2) Each time a manufacturer submits a request for
evaluation of a unique device, one of the following fees shall be
paid:
(A) for an initial evaluation, a fee of $10,650; or
(B) for an amendment requiring re-evaluation, a fee
of $5,330.
(3) A manufacturer shall pay a $1,000 record maintenance
fee, beginning one year after initial sealed source and device authorization
listing and every two years thereafter.
(4) No request for evaluation will be processed prior
to payment of the full amount specified.
(g) Fees for certification of mammography systems and
mammography machines used for interventional breast radiography. No
application will be accepted for filing or processed prior to payment
of the full amount specified in paragraph (1) of this subsection.
(1) An application for certification of mammography
systems shall be accompanied by a nonrefundable fee of $2,010. Additional
mammography systems that have not been assigned a separate United
States Food and Drug Administration (FDA) identification number shall
be authorized on the same certification. A nonrefundable fee of $240
for each additional mammography system on the same certification shall
be included in the nonrefundable application fee.
(2) The annual fee for mammography systems is $2,010.
A fee of $240 for each additional mammography system on the same certification
shall be included in the annual fee.
(3) Fees for mammography machines used for interventional
breast radiography shall be as follows:
(A) An application for certification of machines used
for interventional breast radiography shall be accompanied by a nonrefundable
fee of $490. A nonrefundable fee of $240 for each machine used for
interventional breast radiography on the same certification shall
be included in the nonrefundable application fee.
(B) The annual fee for machines used for interventional
breast radiography is $490. A fee of $240 for each additional machine
used for interventional breast radiography on the same certification
shall be included in the annual fee.
(h) Fees for accreditation of mammography facilities.
(1) Each application for accreditation or re-accreditation
of a mammography facility shall be accompanied by a nonrefundable
fee. No application will be accepted for filing or processed prior
to payment of the full amount specified in paragraph (2) of this subsection.
(2) Fees for accreditation of mammography facilities
are as follows.
(A) The accreditation fee for the first mammography
machine is $1,025.
(B) The accreditation fee for each additional mammography
machine is $610.
(C) The fee for re-evaluation of clinical images due
to failure during the accreditation process is $330 per mammography
machine.
(D) The fee for re-evaluation of phantom images due
to failure during the accreditation process is $300 per machine.
(E) The fee for an additional mammography review will
be based on the number of clinical image sets reviewed and the type
of review.
(F) The fee for reinstatement of a mammography machine
is $610.
(G) Each facility for which a targeted clinical image
review is required will be charged for actual expenses to the agency
arising from the visit.
(H) The fee for the review of clinical images for dual
modality mammography machines, if utilized, is $330 for the alternative
modality.
(I) Each facility for which an on-site visit due to
three denials of accreditation is required will be charged for actual
expenses to the agency arising from such visit.
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