| (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.
(J) Payment of the fees in subparagraphs (G) and (I)
of this paragraph shall be made within 60 days following the date
of invoice.
(i) Fees for industrial radiographer certification
and for radiographer certification examinations.
(1) The nonrefundable and non-transferable application
fee for examination shall be $120 and shall be submitted to the agency
with the application for examination.
(2) The nonrefundable application fee for radiographer
certification shall be $110 and shall be submitted to the agency with
the application for radiographer certification.
(j) Schedule of fees for certificates of registration
for radiation machines, lasers, and services. The following schedule
contains the fees for certificates of registration for radiation machines,
lasers, and services. As of January 1, 2012, the fees for the dental
radiographic only category and the veterinary category, as specified
in the following schedule, are the applicable fees for those categories.
Attached Graphic
(k) Annual fees for environmental surveillance and
emergency planning and implementation. Fees shall be set annually
by the agency for each facility. Fees for fixed nuclear facilities
shall be the actual expenses for environmental surveillance and emergency
planning and implementation activities. Costs of activities benefiting
more than one facility shall be prorated.
(l) Failure to pay prescribed fees.
(1) In any case where the agency finds that an applicant
for a license or certificate of registration has failed to pay the
fee prescribed in this section, the agency will not process that application
until such fee is paid.
(2) In any case where the agency finds that a licensee
or registrant has failed to pay a fee prescribed by this section by
the due date, the agency may implement compliance procedures as provided
in §289.205 of this title (relating to Hearing and Enforcement
Procedures).
(3) In any case where the agency finds that a fixed
nuclear facility has failed to pay fees for environmental surveillance
or emergency planning and implementation within 90 days following
date of invoice, the agency may issue an order to show cause why those
services should not be terminated.
(m) Electronic fee payments. Renewal payments may be
processed through texas.gov or another electronic payment system specified
by the agency. For all types of electronic fee payments, the agency
will collect additional fees, in amounts determined by texas.gov to
recover costs associated with electronic payment processing.
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| Source Note: The provisions of this §289.204 adopted to be effective February 10, 1998, 23 TexReg 1045; amended to be effective September 1, 1998, 23 TexReg 5971; amended to be effective July 1, 2000, 25 TexReg 5348; amended to be effective May 1, 2002, 27 TexReg 3180; amended to be effective September 1, 2004, 29 TexReg 7308; amended to be effective February 1, 2006, 31 TexReg 509; amended to be effective April 30, 2007, 32 TexReg 2362; amended to be effective October 12, 2008, 33 TexReg 8326; amended to be effective January 1, 2012, 36 TexReg 8829; amended to beeffective September 7, 2014, 39 TexReg 6861 |
