| (H) the fee as specified in §289.204(d) of this
title.
(2) Upon a determination that the request for reciprocity
meets the requirements of the department, the department may issue
a notice granting reciprocal recognition authorizing the proposed
use.
(3) Once reciprocity is granted, the out-of-state registrant
shall file a RC Form 252-3 with the department before each entry into
the state. This form shall be filed at least three working days before
the radiation machine is to be used in the state. If, for a specific
case, the three-day period would impose an undue hardship, the out-of-state
registrant may, at the determination of the department, obtain permission
to proceed sooner.
(4) When radiation machines are used as authorized
under reciprocity, the out-of-state registrant shall have the following
in its possession at all times for inspection by the department:
(A) completed RC Form 252-3;
(B) copy of the notice from the department granting
reciprocity;
(C) copy of the out-of-state registrants operating
and safety procedures; and
(D) copy of the applicable rules as specified in the
notice granting reciprocity.
(5) If the state from which the radiation machine is
proposed to be brought does not issue certificates of registration
or equivalent documents, a certificate of registration shall be obtained
from the department per the requirements of this section.
(6) The department may withdraw, limit, or qualify
its acceptance of any certificate of registration or equivalent document
issued by another department upon determining that the action is necessary
to prevent an undue hazard to occupational and public health and safety
or property.
(7) Reciprocal recognition will expire two years from
the date it is granted. A new request for reciprocity shall be submitted
to the department every two years. Reciprocity requests made after
the initial request shall include the following:
(A) completed RC Form 226-1 (Business Information Form);
(B) completed RC Form 226-3 (Application for Registration
of Industrial Radiation Machines);
(C) RSO qualifications in accordance with subsection
(e)(3) of this section.
(D) completed RC Form 252-3 (Notice of Intent to Work
in Texas Under Reciprocity);
(E) completed qualification forms RC Forms 255-E, 255-T
or 255-OS for each radiographer who will be working in Texas if the
reciprocity request is for industrial radiography;
(F) copy of the applicant's current certificate of
registration or equivalent document;
(G) copy of the applicant's current operating and safety
procedures pertinent to the proposed use; and
(H) the fee as specified in §289.204(d) of this
title.
(8) Radiation services provided by a person from out-of-state
will not be granted reciprocity. Whenever radiation services are to
be provided by a person from out-of-state, that person shall apply
for and receive a certificate of registration from the department
before providing radiation services. The application shall be filed
per subsections (e), (i), and (j) of this section, as applicable.
(u) Medical research and investigational devices.
(1) Any research using radiation machines on humans
shall be approved by an Investigational Review Board (IRB) as required
by Title 45, Code of Federal Regulations (CFR), Part 46 and Title
21, CFR, Part 56. The IRB shall include at least one physician to
direct any use of radiation per §289.231(b) of this title.
(2) Facilities with radiation machines with investigational
device exemptions that are involved in clinical studies shall comply
with primary regulations that govern the conduct of clinical studies
and that apply to the manufacturers, sponsors, clinical investigators,
institutional review boards, and the medical device. These regulations
include:
(A) 21 CFR, Part 812, Investigational Device Exemptions;
(B) 21 CFR, Part 50, Protection of Human Subjects;
(C) 21 CFR, Part 56, Institutional Review Boards;
(D) 21 CFR, Part 54, Financial Disclosure by Clinical
Investigators; and
(E) 21 CFR, Part 820, Subpart C, Design Controls of
the Quality System Regulation.
(v) Record/document retention requirements for registration
of radiation machines.
(1) Each registrant shall maintain the following records/documents
at each site, including authorized records sites for mobile services,
at the time intervals specified for inspection by the department.
Attached Graphic
(2) Records listed in paragraph (1) of this subsection
may be maintained in electronic format.
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