section or of any regulation promulgated 
thereunder; or 
‘‘(vi) has not complied with an inter-
mediate sanction imposed under subpara-
graph (A). 
‘‘(C) ACTION BEFORE A HEARING.—If the 
Secretary determines that— 
‘‘(i) the failure of a test-offering enti-
ty to comply with the requirements of this 
section presents an imminent and serious 
risk to human health; or 
‘‘(ii) a test-offering entity has engaged 
in an action described in clause (iv) or (v) 
of subparagraph (B), 
the Secretary may suspend or limit the registra-
tion of the laboratory before holding a hearing 
under subparagraph (B) regarding such failure 
or refusal. The opportunity for a hearing shall 
be provided no later than 60 days from the ef-
fective date of the suspension or limitation. A 
suspension or limitation under this subpara-
graph shall stay in effect until the decision of 
the Secretary made after the hearing under 
subparagraph (B). 
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‘‘(D) INJUNCTIONS.—If the Secretary has 
reason to believe the continuation of any activ-
ity by a test-offering entity would constitute a 
significant hazard to the public health, the Sec-
retary may bring suit in any district court of 
the United States that has jurisdiction over 
such entity to enjoin continuation of such activ-
ity. Upon proper showing, a temporary injunc-
tion or restraining order against continuation of 
such activity pending issuance of a final order 
under this subparagraph shall be granted with-
out bond by such court. 
‘‘(3) APPLICABILITY OF CRIMINAL SANCTIONS 
TO ALL PERSONS.—The reference in section 353(l) 
to ‘any requirement of this section’ is deemed to in-
clude any requirement of this section. 
‘‘(4) REPORTING.—In promulgating regulations 
under subsection (i)(1), the Secretary may include 
sanctions specific to violations of subsection (f) (re-
garding reporting), including the following: 
‘‘(A) Civil money penalties in an amount 
not to exceed $10,000 for each such violation. 
‘‘(B) Directed plans of correction. 
‘‘(C) For repeat or intentional violations, 
an order requiring the test-offering entity to 
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cease offering or marketing the DTC DNA test 
involved for one or more claimed uses. 
‘‘(h) JUDICIAL REVIEW.—If a laboratory or test-of-
fering entity is subject to a sanction or other action pursu-
ant to subsection (g) or is adversely affected by final agen-
cy action under subsection (c), the laboratory or entity 
may appeal such sanction or action by filing a petition 
for judicial review with the United States court of appeals 
for the circuit where the laboratory or entity has its prin-
cipal place of business. The provisions of section 353(k) 
applicable to judicial review of sanctions and actions under 
section 353 shall apply to judicial review of sanctions and 
actions under this section. 
‘‘(i) REGULATIONS.— 
‘‘(1) IN GENERAL.—Not later than 1 year after 
the date of the enactment of this section, the Sec-
retary shall promulgate final regulations to carry out 
this section. 
‘‘(2) RARE
DISEASES
AND
CONDITIONS.—In 
carrying out paragraph (1), the Secretary shall in-
clude regulations specific to any LDT or DTC DNA 
test used in connection with a rare disease or condi-
tion (as such term is defined in section 526(a)(2) of 
the Federal Food, Drug, and Cosmetic Act). Such 
regulations— 
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‘‘(A) shall provide for expedited review of 
premarket 
notifications 
under 
subsection 
(c)(2)(A) for such tests; 
‘‘(B) shall contain standards of evidence 
for demonstrating the clinical validity of such 
test that takes into account special issues relat-
ing to studies in small populations; 
‘‘(C) shall take into account relevant tech-
nical standards and guidelines applicable to 
testing for such a rare disease and condition; 
and 
‘‘(D) may authorize the Secretary to waive 
any requirement of this section if the Secretary 
determines that application of such requirement 
would unreasonably delay or prevent access to 
such test. 
‘‘(3) EMERGENCY USE.—In carrying out para-
graph (1), the Secretary shall include regulations 
authorizing the Secretary to waive any requirement 
of this section in order to allow the emergency use 
of an LDT for detecting or diagnosing serious or 
life-threatening infectious pathogens or diseases. 
Such regulations shall apply standards of evidence 
for demonstrating the clinical validity of such a test 
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that take into account special issues relating to in-
fectious pathogens and public health threats. 
‘‘(4) EXTERNAL
QUALITY
ASSESSMENT.—In 
carrying out paragraph (1), the Secretary, in con-
sultation with proficiency testing organizations ap-
proved under section 353(f)(C), shall include regula-
tions establishing an external review process to 
evaluate the analytical validity of LDTs. 
‘‘(j) INSPECTIONS.— 
‘‘(1) LABORATORIES.—During an inspection 
under section 353(g), the Secretary— 
‘‘(A) may use the authorities specified in 
section 353(g)(1) for purposes of determining 
compliance with this section; and 
‘‘(B) may require a laboratory to provide 
evidence of clinical validity for any claim made 
for an LDT offered by that laboratory. 
‘‘(2) TEST-OFFERING
ENTITIES.—The Sec-
retary— 
‘‘(A) shall have the same authority to con-
duct inspections of a test-offering entity for 
purposes of determining compliance with this 
section as the Secretary has under paragraph 
(1) and section 353(g)(1) to conduct inspec-
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