I 
112TH CONGRESS 
1ST SESSION H. R. 3207 
To amend the Public Health Service Act to create a pathway for premarket 
notification and review of laboratory-developed tests, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
OCTOBER 14, 2011 
Mr. BURGESS (for himself, Mr. PAULSEN, Mr. LATTA, and Mrs. BLACKBURN) 
introduced the following bill; which was referred to the Committee on En-
ergy and Commerce 
A BILL 
To amend the Public Health Service Act to create a pathway 
for premarket notification and review of laboratory-devel-
oped tests, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 
(a) SHORT TITLE.—This Act may be cited as the 
‘‘Modernizing Laboratory Test Standards for Patients Act 
of 2011’’. 
(b) TABLE OF CONTENTS.—The table of contents of 
this Act is as follows: 
Sec. 1. Short title; table of contents. 
Sec. 2. Notification for laboratory-developed tests. 
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Sec. 3. Amendments to the Federal Food, Drug, and Cosmetic Act. 
Sec. 4. Fees. 
SEC. 
2. 
NOTIFICATION 
FOR 
LABORATORY-DEVELOPED 
TESTS. 
Section 353 of the Public Health Service Act (42 
U.S.C. 263a) is amended by adding at the end the fol-
lowing: 
‘‘SEC. 353A. LABORATORY-DEVELOPED TESTS AND DIRECT- 
TO-CONSUMER DNA TESTS. 
‘‘(a) DEFINITIONS.—In this section: 
‘‘(1) The term ‘analytical validity’ means the 
ability of a test to identify or measure the analyte 
or substance sought to be identified or measured. 
‘‘(2) The term ‘biological product’ has the 
meaning given to such term in section 351. 
‘‘(3) The term ‘clinical validity’ means the con-
sistency and accuracy with which a test identifies, 
measures, or predicts— 
‘‘(A) a disease or condition in humans; or 
‘‘(B) characteristics related to an individ-
ual’s clinical status (including phenotype). 
‘‘(4) The term ‘direct-to-consumer DNA test’ or 
‘DTC DNA test’ means a test that— 
‘‘(A) is intended to identify, analyze, or in-
terpret an individual’s genetic characteristics 
for purposes of predicting, assessing the risk of, 
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preventing, or mitigating any disease or condi-
tion, including the prognosis or outcome of a 
treatment in an individual; and 
‘‘(B) is offered directly to, is ordered di-
rectly by, and whose results are reported di-
rectly to, an individual consumer, without a test 
request by a physician or other health care pro-
vider who has an established provider-patient 
relationship with the individual consumer by 
which the physician or provider provides health 
care services (other than the test in question) 
to that individual. 
‘‘(5) The term ‘drug’ has the meaning given to 
such term in section 201 of the Federal Food, Drug, 
and Cosmetic Act. 
‘‘(6) The terms ‘laboratory’ and ‘clinical labora-
tory’ have the meanings given to such terms in sec-
tion 353. 
‘‘(7) The term ‘laboratory-developed test’ or 
‘LDT’ means a clinical laboratory test that is— 
‘‘(A) developed by a clinical laboratory cer-
tified under section 353; 
‘‘(B) performed by— 
‘‘(i) the clinical laboratory; 
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‘‘(ii) any entity that is owned or con-
trolled by the clinical laboratory; 
‘‘(iii) any entity that owns or controls 
the clinical laboratory (in this subpara-
graph referred to as the clinical labora-
tory’s ‘parent corporation’); or 
‘‘(iv) an entity that is owned or con-
trolled by the clinical laboratory’s parent 
corporation; and 
‘‘(C)(i) performed solely to furnish clinical 
laboratory testing services for the purpose of 
providing information for the diagnosis, preven-
tion, or treatment of any disease or impairment 
of, or the assessment of the health of, human 
beings; and 
‘‘(ii) not otherwise introduced into inter-
state commerce. 
‘‘(8) The term ‘test-offering entity’ means an 
entity, other than a laboratory certified under sec-
tion 353, which offers or markets direct-to-consumer 
DNA tests based on testing performed by one or 
more such laboratories that are not owned by the 
entity. 
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‘‘(9) The term ‘test registry data bank’ means 
the test registry data bank established under sub-
section (b). 
‘‘(b) TEST REGISTRY DATA BANK.— 
‘‘(1) ESTABLISHMENT.—Not later than one 
year after the date of the enactment of this Act, the 
Secretary, in consultation with the Director of the 
National Institutes of Health, shall establish a sin-
gle, publicly accessible test registry data bank. 
‘‘(2) PROCESS FOR SUBMISSION.— 
‘‘(A) 
REQUIREMENT.—Each 
laboratory 
and each test-offering entity that offers or mar-
kets an LDT or DTC DNA test shall submit 
information on such LDT or DTC DNA test to 
the Secretary for inclusion in the test registry 
data bank. 
‘‘(B) TIMING.—The submission required 
by subparagraph (A) shall occur— 
‘‘(i) in the case of an LDT or DTC 
DNA test offered or marketed for the first 
time by the laboratory or the test-offering 
entity after the date of the enactment of 
this section, on or before the later of— 
‘‘(I) the date that is 10 days 
after the date on which the laboratory 
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or test-offering entity first offers or 
markets the LDT or DTC DNA test; 
or 
‘‘(II) the date that is 3 months 
after the effective date of the regula-
tions for carrying out this section; or 
‘‘(ii) in the case of an LDT or DTC 
DNA test offered or marketed on or before 
the date of enactment of this section, not 
later than 6 months after the effective date 
of the regulations for carrying out this 
subsection. 
‘‘(C) SUPPLEMENTAL SUBMISSIONS.— 
‘‘(i) IN GENERAL.—With respect to a 
LDT or DTC DNA test offered or mar-
keted by a laboratory or test-offering enti-
ty, such laboratory or test-offering entity 
shall supplement or amend information on 
such test in the test registry data bank as 
necessary to ensure that the information is 
accurate and current. 
‘‘(ii) 
SUBMISSION
FOLLOWING 
ISSUANCE OF AUTHORIZATION LETTER.— 
Not later than 10 working days after the 
Secretary issues (or is deemed to have 
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issued) an authorization letter pursuant to 
subsection (c)(4)(B) or (c)(4)(F) for an 
LDT or a DTC DNA test, the laboratory 
or test-offering entity shall supplement or 
amend information on such test in the test 
registry data bank, as required by clause 
(i). 
‘‘(3) CONTENT OF SUBMISSIONS.— 
‘‘(A) LDT OR DTC DNA TEST INFORMA-
TION.—With respect to an LDT or DTC DNA 
test, the Secretary shall require the information 
submitted under paragraph (2) to consist of 
each of the following: 
‘‘(i) The location of the laboratory. 
‘‘(ii) The certification and licensure 
information of the laboratory. 
‘‘(iii) The purpose of the test. 
‘‘(iv) The claimed use or uses of the 
test. 
‘‘(v) A description of the test method-
ology. 
‘‘(vi) Information regarding the ana-
lytical validity of the test. 
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‘‘(vii) Information regarding the clin-
ical validity of the test for each of its 
claimed uses. 
‘‘(viii) Information describing the sta-
tus of the test as an existing test (as de-
scribed under paragraph (4)), a new test 
pending review (under subsection (c)), or 
an authorized new test (under subsection 
(c)(4)(B)). 
‘‘(B) DTC DNA TEST
INFORMATION.— 
With respect to a DTC DNA test, the Secretary 
shall require the information submitted under 
paragraph (2) to consist of the information re-
quired by subparagraph (A) and in addition 
each of the following: 
‘‘(i) The identity, location, and reg-
istration information of the test-offering 
entity. 
‘‘(ii) The identity of the certified lab-
oratory that will perform the test, and the 
certification and licensure information for 
such laboratory. 
‘‘(iii) Information to demonstrate that 
the consumer will be provided with access 
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to pre-test and post-test counseling by a 
physician or qualified genetic counselor. 
‘‘(4) REVIEW OF INFORMATION FOR EXISTING 
TESTS.—If, upon review of the information sub-
mitted under paragraph (2) for an LDT or DTC 
DNA test that is offered or marketed on or before 
the date of the enactment of this section, the Sec-
retary determines that there is reasonable cause to 
believe that there is inadequate information for a de-
termination of clinical validity (as described in sub-
section (c)(4)(B)) of one or more claimed uses of the 
LDT or DTC DNA test, the Secretary may require 
that the laboratory or test-offering entity submit no-
tification under subsection (c) for each such claimed 
use. 
‘‘(c) NOTIFICATION PROCESS.— 
‘‘(1) APPLICABILITY.— 
‘‘(A) IN
GENERAL.—This subsection ap-
plies to an LDT or DTC DNA test only if— 
‘‘(i) the test is first offered or mar-
keted by the laboratory or the test-offering 
entity after the date of the enactment of 
this section; 
‘‘(ii) the test is offered on or before 
the date of the enactment of this section 
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and, after such date, is significantly modi-
fied; or 
‘‘(iii) the Secretary determines under 
subsection (b)(4) that there is reasonable 
cause to believe that there is inadequate 
information for a determination of clinical 
validity of one or more claimed uses of the 
LDT or DTC DNA test. 
‘‘(B) SIGNIFICANT
MODIFICATION.—For 
purposes of subparagraph (A)(ii) and para-
graph 
(2)(B), 
a 
significant 
modification 
means— 
‘‘(i) offering or marketing the test for 
a new claimed use; 
‘‘(ii) any significant change to the 
fundamental testing methodology; and 
‘‘(iii) any change that significantly af-
fects the clinical validity of the test. 
‘‘(2) NOTIFICATION SUBMISSION.— 
‘‘(A) PREMARKET NOTIFICATION.—Before 
marketing an LDT or DTC DNA test, a lab-
oratory or test-offering entity shall submit a 
premarket notification to the Secretary. 
‘‘(B) SUPPLEMENTAL NOTIFICATION FOR 
SIGNIFICANT
MODIFICATIONS.—After any sig-
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nificant modification (as described in paragraph 
(1)(B)) to an LDT or DTC DNA test for which 
a premarket notification under subparagraph 
(A) has been submitted or for which no such 
premarket notification was required, the labora-
tory or test-offering entity shall submit a sup-
plemental notification for the LDT or DTC 
DNA test. 
‘‘(C) SUPPLEMENTAL
NOTIFICATION
IN 
CASE OF INADEQUATE EVIDENCE.—If a labora-
tory or test-offering entity determines, at any 
time, that the evidence of clinical validity is in-
adequate to support one or more of the claimed 
uses in a notification under subparagraph (A) 
or (B), then not later than 30 calendar days 
after making such determination the laboratory 
or test-offering entity shall— 
‘‘(i) submit a supplemental notifica-
tion containing additional information sup-
porting the clinical validity of the claimed 
uses; or 
‘‘(ii) submit a supplemental notifica-
tion withdrawing one or more claimed 
uses. 
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‘‘(D) CONCURRENT SUBMISSION FOR TEST 
REGISTRY DATA BANK.—Subject to the dead-
lines and other requirements of subsection (b), 
a laboratory or test-offering entity may submit 
information for inclusion in the test registry 
data bank under subsection (b) concurrently 
with a notification under this paragraph. 
‘‘(E) ACKNOWLEDGMENT
OF
RECEIPT.— 
Upon receipt of a notification under this para-
graph, the Secretary shall send written notice 
to the submitter— 
‘‘(i) acknowledging receipt of the noti-
fication; and 
‘‘(ii) indicating the date on which the 
Secretary received the notification. 
‘‘(3) CONTENT OF NOTIFICATIONS.— 
‘‘(A) LDT NOTIFICATIONS.—With respect 
to a premarket or supplemental notification for 
an LDT under paragraph (2)(A) or (2)(B), the 
Secretary shall require the notification to con-
sist of each of the types of information listed in 
clauses (i) through (vii) of subsection (b)(3)(A). 
‘‘(B) DTC DNA TEST NOTIFICATIONS.— 
With respect to a premarket or supplemental 
notification for a DTC DNA test under para-
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graph (2)(A) or (2)(B), the Secretary shall re-
quire the notification to consist of each of the 
following: 
‘‘(i) The types of information listed in 
clauses (i) and (ii) of subsection (b)(3)(B). 
‘‘(ii) If informed consent for the per-
formance of the test is required by State 
or Federal law, a copy of the standard in-
formed consent document to be signed by 
the individual to signify such consent. 
‘‘(iii) Information to demonstrate that 
the consumer will be provided with access 
to pre-test and post-test counseling by a 
physician or qualified genetic counselor. 
‘‘(C) TESTS OFFERED OR MARKETED ONLY 
BY LABORATORY.—If a laboratory offers a DTC 
DNA test that is not offered or marketed by a 
test-offering entity— 
‘‘(i) the laboratory is only required to 
submit one premarket notification under 
paragraph (2)(A) for the test; and 
‘‘(ii) such notification shall include, as 
applicable, the information required by 
subparagraph (A) for an LDT and the in-
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formation required by subparagraph (B) 
for a DTC DNA test. 
‘‘(D) TESTS PREVIOUSLY CLEARED OR AP-
PROVED BY FDA.—Notwithstanding the clear-
ance or approval of an LDT or DTC DNA test 
under the Federal, Food, Drug, and Cosmetic 
Act before the date of the enactment of this 
Act, any review by the Department of Health 
and Human Services of the LDT or DTC DNA 
test (or any modification thereto) that occurs 
on or after such date shall be conducted exclu-
sively under this section and not under the Fed-
eral Food, Drug, and Cosmetic Act. 
‘‘(4) REVIEW AND AUTHORIZATION OF NOTIFI-
CATIONS.— 
‘‘(A) IN GENERAL.—Not later than 90 cal-
endar days after the date on which the Sec-
retary receives a notification under paragraph 
(2)(A), (2)(B), or (2)(C)(i), the Secretary shall, 
with respect to each claimed use of a test, re-
view the notification, make a determination as 
to whether the notification under paragraph (2) 
demonstrates clinical validity, and— 
‘‘(i) issue an authorization letter in 
accordance with subparagraph (B); or 
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‘‘(ii) provide notice under subpara-
graph (C)(i) that the submitted informa-
tion is not adequate to demonstrate clinical 
validity. 
‘‘(B) AUTHORIZATION
LETTERS; DETER-
MINATION OF CLINICAL VALIDITY.— 
‘‘(i) ISSUANCE
OF
AUTHORIZATION 
LETTERS.—If the Secretary determines, 
with respect to one or more claimed uses 
of a test, that a notification under para-
graph (2) demonstrates clinical validity, 
the Secretary shall issue an authorization 
letter for such claimed uses to the sub-
mitter of the notification. 
‘‘(ii) STANDARD FOR ISSUANCE.—The 
Secretary shall issue such an authorization 
letter if the notification provides reason-
able assurance of the clinical validity of 
such claimed uses. One or more studies 
published in a peer-reviewed journal that is 
generally recognized to be of national scope 
and reputation, or data from unpublished 
studies conducted by the submitter or for 
which the submitter has obtained a right 
of reference, shall be sufficient to con-
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stitute reasonable assurance of the clinical 
validity of the claimed uses. 
‘‘(iii) PROHIBITION.—The Secretary 
shall not require a laboratory or test-offer-
ing entity to include (for purposes of dem-
onstrating clinical validity) evidence of— 
‘‘(I) clinical utility; or 
‘‘(II) the ability of a physician, 
provider, or consumer to interpret a 
test result or to apply a test result to 
achieve a particular health or clinical 
outcome. 
‘‘(iv) PARTIAL
DEMONSTRATION
OF 
CLINICAL
VALIDITY.—If 
a 
notification 
under paragraph (2) demonstrates clinical 
validity for some but not all of the claimed 
uses of a test, the Secretary shall issue an 
authorization letter under clause (i) with 
respect to each claimed use for which clin-
ical validity has been demonstrated. 
‘‘(C) NOTICE
OF
INADEQUACY; REPLY; 
FINAL DETERMINATION.—If the Secretary de-
termines, with respect to one or more claimed 
uses of a test, that a notification under para-
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graph (2) is not adequate to demonstrate clin-
ical validity— 
‘‘(i) the Secretary shall notify the sub-
mitter about such determination and shall 
specify in the notice the information which 
is required to demonstrate clinical validity 
for each such clinical use; 
‘‘(ii) not later than the 90-calendar- 
day period following receipt of a notice 
under clause (i), the submitter may file a 
response with the Secretary; and 
‘‘(iii) not later than 60 calendar days 
after receipt of a response under clause 
(ii), the Secretary shall issue a final deter-
mination regarding the clinical validity of 
each clinical use subject to the notice 
under clause (i). 
‘‘(D) OFFERING
OR
MARKETING
TEST 
PENDING AGENCY ACTION.— 
‘‘(i) APPLICABLE TIME PERIOD.—This 
subparagraph applies, with respect to a 
claimed use of a test, during the period be-
tween— 
‘‘(I) submission of a notification 
under paragraph (2); and 
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‘‘(II) final action by the Sec-
retary on such notification under sub-
paragraph (A)(i), (C)(iii), or (G), as 
applicable, or the failure to file a re-
sponse under clause (ii) of subpara-
graph (C) within the period specified 
in such clause. 
‘‘(ii) CONTINUED OFFERING OR MAR-
KETING.—During a period described in 
clause (i) with respect to any claimed use 
of a test, the laboratory or test-offering en-
tity may continue to offer or market the 
test with respect to such claimed use as if 
the Secretary had issued an authorization 
letter under subparagraph (B) for such 
claimed use. 
‘‘(iii) RELATION
TO
TEST
REGISTRY 
DATA BANK.—This subparagraph shall not 
be construed to affect the Secretary’s au-
thority under subsection (b). 
‘‘(iv) EXCEPTION
FOR
WITHDRAWN 
NOTIFICATION.—Clause (ii) does not apply 
with respect to a claimed use of a test for 
which notification has been withdrawn 
under paragraph (2)(C)(ii). 
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‘‘(E) MARKETING
PENDING
AUTHORIZA-
TION.—Beginning on the date of submission of 
a notification under paragraph (2)(A), (2)(B), 
or (2)(C)(i), the laboratory or test-offering enti-
ty may offer or market the test while the notifi-
cation is pending, provided that the required in-
formation about the test has first been sub-
mitted to the test registry data bank as re-
quired by subsection (b). 
‘‘(F) FAILURE BY SECRETARY TO MAKE A 
DETERMINATION.—The Secretary is deemed to 
have issued an authorization letter under sub-
paragraph (B) with respect to a claimed use of 
a test if— 
‘‘(i) the 90-day period under subpara-
graph (A) expires and the Secretary has 
not, with respect to such claim, issued an 
authorization letter under subparagraph 
(B) or provided notice under subparagraph 
(C)(i); or 
‘‘(ii) the 60-day period under subpara-
graph (C)(iii) expires and the Secretary 
has not, with respect to such claim, issued 
a final determination regarding clinical va-
lidity. 
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