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 Energy and Commerce 

A BILL 

To amend the Public Health Service Act to create a pathway 

for premarket notification and review of laboratory-developed tests, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Modernizing Laboratory Test Standards for Patients Act 

6 of 2011’’. 

7 (b) TABLE OF CONTENTS.—The table of contents of 

8 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. 

1 SEC. 2. NOTIFICATION FOR LABORATORY-DEVELOPED 

2 TESTS. 

3 Section 353 of the Public Health Service Act (42 

4 U.S.C. 263a) is amended by adding at the end the fol5 lowing: 

6 ‘‘SEC. 353A. LABORATORY-DEVELOPED TESTS AND DIRECT7 TO-CONSUMER DNA TESTS. 

8 ‘‘(a) DEFINITIONS.—In this section: 

9 ‘‘(1) The term ‘analytical validity’ means the 

10 ability of a test to identify or measure the analyte 

11 or substance sought to be identified or measured. 

12 ‘‘(2) The term ‘biological product’ has the 

13 meaning given to such term in section 351. 

14 ‘‘(3) The term ‘clinical validity’ means the con15 sistency and accuracy with which a test identifies, 

16 measures, or predicts— 

17 ‘‘(A) a disease or condition in humans; or 

18 ‘‘(B) characteristics related to an individ19 ual’s clinical status (including phenotype). 

20 ‘‘(4) The term ‘direct-to-consumer DNA test’ or 

21 ‘DTC DNA test’ means a test that— 

22 ‘‘(A) is intended to identify, analyze, or in23 terpret an individual’s genetic characteristics 

24 for purposes of predicting, assessing the risk of, 


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1 preventing, or mitigating any disease or condi2 tion, including the prognosis or outcome of a 

3 treatment in an individual; and 

4 ‘‘(B) is offered directly to, is ordered di5 rectly by, and whose results are reported di6 rectly to, an individual consumer, without a test 

7 request by a physician or other health care pro8 vider who has an established provider-patient 

9 relationship with the individual consumer by 

10 which the physician or provider provides health 

11 care services (other than the test in question) 

12 to that individual. 

13 ‘‘(5) The term ‘drug’ has the meaning given to 

14 such term in section 201 of the Federal Food, Drug, 

15 and Cosmetic Act. 

16 ‘‘(6) The terms ‘laboratory’ and ‘clinical labora17 tory’ have the meanings given to such terms in sec18 tion 353. 

19 ‘‘(7) The term ‘laboratory-developed test’ or 

20 ‘LDT’ means a clinical laboratory test that is— 

21 ‘‘(A) developed by a clinical laboratory cer22 tified under section 353; 

23 ‘‘(B) performed by— 

24 ‘‘(i) the clinical laboratory; 


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1 ‘‘(ii) any entity that is owned or con2 trolled by the clinical laboratory; 

3 ‘‘(iii) any entity that owns or controls 

4 the clinical laboratory (in this subpara5 graph referred to as the clinical labora6 tory’s ‘parent corporation’); or 

7 ‘‘(iv) an entity that is owned or con8 trolled by the clinical laboratory’s parent 

9 corporation; and 

10 ‘‘(C)(i) performed solely to furnish clinical 

11 laboratory testing services for the purpose of 

12 providing information for the diagnosis, preven13 tion, or treatment of any disease or impairment 

14 of, or the assessment of the health of, human 

15 beings; and 

16 ‘‘(ii) not otherwise introduced into inter17 state commerce. 

18 ‘‘(8) The term ‘test-offering entity’ means an 

19 entity, other than a laboratory certified under sec20 tion 353, which offers or markets direct-to-consumer 

21 DNA tests based on testing performed by one or 

22 more such laboratories that are not owned by the 

23 entity. 


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1 ‘‘(9) The term ‘test registry data bank’ means 

2 the test registry data bank established under sub3 section (b). 

4 ‘‘(b) TEST REGISTRY DATA BANK.— 

5 ‘‘(1) ESTABLISHMENT.—Not later than one 

6 year after the date of the enactment of this Act, the 

7 Secretary, in consultation with the Director of the 

8 National Institutes of Health, shall establish a sin9 gle, publicly accessible test registry data bank. 

10 ‘‘(2) PROCESS FOR SUBMISSION.— 

11 ‘‘(A) REQUIREMENT.—Each laboratory 

12 and each test-offering entity that offers or mar13 kets an LDT or DTC DNA test shall submit 

14 information on such LDT or DTC DNA test to 

15 the Secretary for inclusion in the test registry 

16 data bank. 

17 ‘‘(B) TIMING.—The submission required 

18 by subparagraph (A) shall occur— 

19 ‘‘(i) in the case of an LDT or DTC 

20 DNA test offered or marketed for the first 

21 time by the laboratory or the test-offering 

22 entity after the date of the enactment of 

23 this section, on or before the later of— 

24 ‘‘(I) the date that is 10 days 

25 after the date on which the laboratory 


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1 or test-offering entity first offers or 

2 markets the LDT or DTC DNA test; 

3 or 

4 ‘‘(II) the date that is 3 months 

5 after the effective date of the regula6 tions for carrying out this section; or 

7 ‘‘(ii) in the case of an LDT or DTC 

8 DNA test offered or marketed on or before 

9 the date of enactment of this section, not 

10 later than 6 months after the effective date 

11 of the regulations for carrying out this 

12 subsection. 

13 ‘‘(C) SUPPLEMENTAL SUBMISSIONS.— 

14 ‘‘(i) IN GENERAL.—With respect to a 

15 LDT or DTC DNA test offered or mar16 keted by a laboratory or test-offering enti17 ty, such laboratory or test-offering entity 

18 shall supplement or amend information on 

19 such test in the test registry data bank as 

20 necessary to ensure that the information is 

21 accurate and current. 

22 ‘‘(ii) SUBMISSION FOLLOWING

23 ISSUANCE OF AUTHORIZATION LETTER.— 

24 Not later than 10 working days after the 

25 Secretary issues (or is deemed to have 


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1 issued) an authorization letter pursuant to 

2 subsection (c)(4)(B) or (c)(4)(F) for an 

3 LDT or a DTC DNA test, the laboratory 

4 or test-offering entity shall supplement or 

5 amend information on such test in the test 

6 registry data bank, as required by clause 

7 (i). 

8 ‘‘(3) CONTENT OF SUBMISSIONS.— 

9 ‘‘(A) LDT OR DTC DNA TEST INFORMA10 TION.—With respect to an LDT or DTC DNA 

11 test, the Secretary shall require the information 

12 submitted under paragraph (2) to consist of 

13 each of the following: 

14 ‘‘(i) The location of the laboratory. 

15 ‘‘(ii) The certification and licensure 

16 information of the laboratory. 

17 ‘‘(iii) The purpose of the test. 

18 ‘‘(iv) The claimed use or uses of the 

19 test. 

20 ‘‘(v) A description of the test method21 ology. 

22 ‘‘(vi) Information regarding the ana23 lytical validity of the test. 


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1 ‘‘(vii) Information regarding the clin2 ical validity of the test for each of its 

3 claimed uses. 

4 ‘‘(viii) Information describing the sta5 tus of the test as an existing test (as de6 scribed under paragraph (4)), a new test 

7 pending review (under subsection (c)), or 

8 an authorized new test (under subsection 

9 (c)(4)(B)). 

10 ‘‘(B) DTC DNA TEST INFORMATION.— 

11 With respect to a DTC DNA test, the Secretary 

12 shall require the information submitted under 

13 paragraph (2) to consist of the information re14 quired by subparagraph (A) and in addition 

15 each of the following: 

16 ‘‘(i) The identity, location, and reg17 istration information of the test-offering 

18 entity. 

19 ‘‘(ii) The identity of the certified lab20 oratory that will perform the test, and the 

21 certification and licensure information for 

22 such laboratory. 

23 ‘‘(iii) Information to demonstrate that 

24 the consumer will be provided with access 


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1 to pre-test and post-test counseling by a 

2 physician or qualified genetic counselor. 

3 ‘‘(4) REVIEW OF INFORMATION FOR EXISTING

4 TESTS.—If, upon review of the information sub5 mitted under paragraph (2) for an LDT or DTC 

6 DNA test that is offered or marketed on or before 

7 the date of the enactment of this section, the Sec8 retary determines that there is reasonable cause to 

9 believe that there is inadequate information for a de10 termination of clinical validity (as described in sub11 section (c)(4)(B)) of one or more claimed uses of the 

12 LDT or DTC DNA test, the Secretary may require 

13 that the laboratory or test-offering entity submit no14 tification under subsection (c) for each such claimed 

15 use. 

16 ‘‘(c) NOTIFICATION PROCESS.— 

17 ‘‘(1) APPLICABILITY.— 

18 ‘‘(A) IN GENERAL.—This subsection ap19 plies to an LDT or DTC DNA test only if— 

20 ‘‘(i) the test is first offered or mar21 keted by the laboratory or the test-offering 

22 entity after the date of the enactment of 

23 this section; 

24 ‘‘(ii) the test is offered on or before 

25 the date of the enactment of this section 


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1 and, after such date, is significantly modi2 fied; or 

3 ‘‘(iii) the Secretary determines under 

4 subsection (b)(4) that there is reasonable 

5 cause to believe that there is inadequate 

6 information for a determination of clinical 

7 validity of one or more claimed uses of the 

8 LDT or DTC DNA test. 

9 ‘‘(B) SIGNIFICANT MODIFICATION.—For 

10 purposes of subparagraph (A)(ii) and para11 graph (2)(B), a significant modification 

12 means— 

13 ‘‘(i) offering or marketing the test for 

14 a new claimed use; 

15 ‘‘(ii) any significant change to the 

16 fundamental testing methodology; and 

17 ‘‘(iii) any change that significantly af18 fects the clinical validity of the test. 

19 ‘‘(2) NOTIFICATION SUBMISSION.— 

20 ‘‘(A) PREMARKET NOTIFICATION.—Before 

21 marketing an LDT or DTC DNA test, a lab22 oratory or test-offering entity shall submit a 

23 premarket notification to the Secretary. 

24 ‘‘(B) SUPPLEMENTAL NOTIFICATION FOR

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1 nificant modification (as described in paragraph 

2 (1)(B)) to an LDT or DTC DNA test for which 

3 a premarket notification under subparagraph 

4 (A) has been submitted or for which no such 

5 premarket notification was required, the labora6 tory or test-offering entity shall submit a sup7 plemental notification for the LDT or DTC 

8 DNA test. 

9 ‘‘(C) SUPPLEMENTAL NOTIFICATION IN

10 CASE OF INADEQUATE EVIDENCE.—If a labora11 tory or test-offering entity determines, at any 

12 time, that the evidence of clinical validity is in13 adequate to support one or more of the claimed 

14 uses in a notification under subparagraph (A) 

15 or (B), then not later than 30 calendar days 

16 after making such determination the laboratory 

17 or test-offering entity shall— 

18 ‘‘(i) submit a supplemental notifica19 tion containing additional information sup20 porting the clinical validity of the claimed 

21 uses; or 

22 ‘‘(ii) submit a supplemental notifica23 tion withdrawing one or more claimed 

24 uses. 


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1 ‘‘(D) CONCURRENT SUBMISSION FOR TEST

2 REGISTRY DATA BANK.—Subject to the dead3 lines and other requirements of subsection (b), 

4 a laboratory or test-offering entity may submit 

5 information for inclusion in the test registry 

6 data bank under subsection (b) concurrently 

7 with a notification under this paragraph. 

8 ‘‘(E) ACKNOWLEDGMENT OF RECEIPT.— 

9 Upon receipt of a notification under this para10 graph, the Secretary shall send written notice 

11 to the submitter— 

12 ‘‘(i) acknowledging receipt of the noti13 fication; and 

14 ‘‘(ii) indicating the date on which the 

15 Secretary received the notification. 

16 ‘‘(3) CONTENT OF NOTIFICATIONS.— 

17 ‘‘(A) LDT NOTIFICATIONS.—With respect 

18 to a premarket or supplemental notification for 

19 an LDT under paragraph (2)(A) or (2)(B), the 

20 Secretary shall require the notification to con21 sist of each of the types of information listed in 

22 clauses (i) through (vii) of subsection (b)(3)(A). 

23 ‘‘(B) DTC DNA TEST NOTIFICATIONS.— 

24 With respect to a premarket or supplemental 

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1 graph (2)(A) or (2)(B), the Secretary shall re2 quire the notification to consist of each of the 

3 following: 

4 ‘‘(i) The types of information listed in 

5 clauses (i) and (ii) of subsection (b)(3)(B). 

6 ‘‘(ii) If informed consent for the per7 formance of the test is required by State 

8 or Federal law, a copy of the standard in9 formed consent document to be signed by 

10 the individual to signify such consent. 

11 ‘‘(iii) Information to demonstrate that 

12 the consumer will be provided with access 

13 to pre-test and post-test counseling by a 

14 physician or qualified genetic counselor. 

15 ‘‘(C) TESTS OFFERED OR MARKETED ONLY

16 BY LABORATORY.—If a laboratory offers a DTC 

17 DNA test that is not offered or marketed by a 

18 test-offering entity— 

19 ‘‘(i) the laboratory is only required to 

20 submit one premarket notification under 

21 paragraph (2)(A) for the test; and 

22 ‘‘(ii) such notification shall include, as 

23 applicable, the information required by 

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1 formation required by subparagraph (B) 

2 for a DTC DNA test. 

3 ‘‘(D) TESTS PREVIOUSLY CLEARED OR AP4 PROVED BY FDA.—Notwithstanding the clear5 ance or approval of an LDT or DTC DNA test 

6 under the Federal, Food, Drug, and Cosmetic 

7 Act before the date of the enactment of this 

8 Act, any review by the Department of Health 

9 and Human Services of the LDT or DTC DNA 

10 test (or any modification thereto) that occurs 

11 on or after such date shall be conducted exclu12 sively under this section and not under the Fed13 eral Food, Drug, and Cosmetic Act. 

14 ‘‘(4) REVIEW AND AUTHORIZATION OF NOTIFI15 CATIONS.— 

16 ‘‘(A) IN GENERAL.—Not later than 90 cal17 endar days after the date on which the Sec18 retary receives a notification under paragraph 

19 (2)(A), (2)(B), or (2)(C)(i), the Secretary shall, 

20 with respect to each claimed use of a test, re21 view the notification, make a determination as 

22 to whether the notification under paragraph (2) 

23 demonstrates clinical validity, and— 

24 ‘‘(i) issue an authorization letter in 

25 accordance with subparagraph (B); or 


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1 ‘‘(ii) provide notice under subpara2 graph (C)(i) that the submitted informa3 tion is not adequate to demonstrate clinical 

4 validity. 

5 ‘‘(B) AUTHORIZATION LETTERS; DETER6 MINATION OF CLINICAL VALIDITY.— 

7 ‘‘(i) ISSUANCE OF AUTHORIZATION

8 LETTERS.—If the Secretary determines, 

9 with respect to one or more claimed uses 

10 of a test, that a notification under para11 graph (2) demonstrates clinical validity, 

12 the Secretary shall issue an authorization 

13 letter for such claimed uses to the sub14 mitter of the notification. 

15 ‘‘(ii) STANDARD FOR ISSUANCE.—The 

16 Secretary shall issue such an authorization 

17 letter if the notification provides reason18 able assurance of the clinical validity of 

19 such claimed uses. One or more studies 

20 published in a peer-reviewed journal that is 

21 generally recognized to be of national scope 

22 and reputation, or data from unpublished 

23 studies conducted by the submitter or for 

24 which the submitter has obtained a right 

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1 stitute reasonable assurance of the clinical 

2 validity of the claimed uses. 

3 ‘‘(iii) PROHIBITION.—The Secretary 

4 shall not require a laboratory or test-offer5 ing entity to include (for purposes of dem6 onstrating clinical validity) evidence of— 

7 ‘‘(I) clinical utility; or 

8 ‘‘(II) the ability of a physician, 

9 provider, or consumer to interpret a 

10 test result or to apply a test result to 

11 achieve a particular health or clinical 

12 outcome. 

13 ‘‘(iv) PARTIAL DEMONSTRATION OF

14 CLINICAL VALIDITY.—If a notification 

15 under paragraph (2) demonstrates clinical 

16 validity for some but not all of the claimed 

17 uses of a test, the Secretary shall issue an 

18 authorization letter under clause (i) with 

19 respect to each claimed use for which clin20 ical validity has been demonstrated. 

21 ‘‘(C) NOTICE OF INADEQUACY; REPLY; 

22 FINAL DETERMINATION.—If the Secretary de23 termines, with respect to one or more claimed 

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1 graph (2) is not adequate to demonstrate clin2 ical validity— 

3 ‘‘(i) the Secretary shall notify the sub4 mitter about such determination and shall 

5 specify in the notice the information which 

6 is required to demonstrate clinical validity 

7 for each such clinical use; 

8 ‘‘(ii) not later than the 90-calendar9 day period following receipt of a notice 

10 under clause (i), the submitter may file a 

11 response with the Secretary; and 

12 ‘‘(iii) not later than 60 calendar days 

13 after receipt of a response under clause 

14 (ii), the Secretary shall issue a final deter15 mination regarding the clinical validity of 

16 each clinical use subject to the notice 

17 under clause (i). 

18 ‘‘(D) OFFERING OR MARKETING TEST

19 PENDING AGENCY ACTION.— 

20 ‘‘(i) APPLICABLE TIME PERIOD.—This 

21 subparagraph applies, with respect to a 

22 claimed use of a test, during the period be23 tween— 

24 ‘‘(I) submission of a notification 

25 under paragraph (2); and 


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1 ‘‘(II) final action by the Sec2 retary on such notification under sub3 paragraph (A)(i), (C)(iii), or (G), as 

4 applicable, or the failure to file a re5 sponse under clause (ii) of subpara6 graph (C) within the period specified 

7 in such clause. 

8 ‘‘(ii) CONTINUED OFFERING OR MAR9 KETING.—During a period described in 

10 clause (i) with respect to any claimed use 

11 of a test, the laboratory or test-offering en12 tity may continue to offer or market the 

13 test with respect to such claimed use as if 

14 the Secretary had issued an authorization 

15 letter under subparagraph (B) for such 

16 claimed use. 

17 ‘‘(iii) RELATION TO TEST REGISTRY

18 DATA BANK.—This subparagraph shall not 

19 be construed to affect the Secretary’s au20 thority under subsection (b). 

21 ‘‘(iv) EXCEPTION FOR WITHDRAWN

22 NOTIFICATION.—Clause (ii) does not apply 

23 with respect to a claimed use of a test for 

24 which notification has been withdrawn 

25 under paragraph (2)(C)(ii). 


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1 ‘‘(E) MARKETING PENDING AUTHORIZA2 TION.—Beginning on the date of submission of 

3 a notification under paragraph (2)(A), (2)(B), 

4 or (2)(C)(i), the laboratory or test-offering enti5 ty may offer or market the test while the notifi6 cation is pending, provided that the required in7 formation about the test has first been sub8 mitted to the test registry data bank as re9 quired by subsection (b). 

10 ‘‘(F) FAILURE BY SECRETARY TO MAKE A

11 DETERMINATION.—The Secretary is deemed to 

12 have issued an authorization letter under sub13 paragraph (B) with respect to a claimed use of 

14 a test if— 

15 ‘‘(i) the 90-day period under subpara16 graph (A) expires and the Secretary has 

17 not, with respect to such claim, issued an 

18 authorization letter under subparagraph 

19 (B) or provided notice under subparagraph 

20 (C)(i); or 

21 ‘‘(ii) the 60-day period under subpara22 graph (C)(iii) expires and the Secretary 

23 has not, with respect to such claim, issued 

24 a final determination regarding clinical va25 lidity. 


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1 ‘‘(G) RISK OF IMMEDIATE HARM.— 

2 ‘‘(i) ORDER.—The Secretary may 

3 order a laboratory or test-offering entity to 

4 cease offering or marketing a test with re5 spect to one or more claimed uses if the 

6 Secretary makes a final determination 

7 that— 

8 ‘‘(I) the information submitted in 

9 notifications under paragraph (2) for 

10 such uses does not demonstrate the 

11 clinical validity of the claimed uses; 

12 and 

13 ‘‘(II) the test poses a risk of im14 mediate harm to the public health 

15 with respect to such claimed uses. 

16 ‘‘(ii) EFFECTIVE UPON RECEIPT.—An 

17 order under clause (i) shall be effective im18 mediately upon receipt by the laboratory or 

19 test-offering entity. 

20 ‘‘(iii) CONTENTS.—An order under 

21 clause (i) shall set forth with specificity the 

22 reasons for the determinations under each 

23 of subclauses (I) and (II) of clause (i) and 

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1 peal the Secretary’s determinations and 

2 the procedures for such appeal. 

3 ‘‘(5) ADMINISTRATIVE APPEAL.—If the Sec4 retary makes a final determination under paragraph 

5 (4)(A) or (4)(C)(iii) that clinical validity has not 

6 been established, or issues an order under paragraph 

7 (4)(G), with respect to one or more clinical uses of 

8 a test, the laboratory or test-offering entity may, not 

9 later than 30 days after the date of the final deter10 mination or issuance of the order, bring an adminis11 trative appeal by selecting the procedures set forth 

12 in one (and only one) of the following subpara13 graphs: 

14 ‘‘(A) DISPUTE RESOLUTION BY ADVISORY

15 COMMITTEE.— 

16 ‘‘(i) IN GENERAL.—The laboratory or 

17 test-offering entity may seek dispute reso18 lution by referral to an advisory committee 

19 of non-governmental experts who are quali20 fied by training and experience to make a 

21 recommendation regarding the clinical va22 lidity of the claimed uses of the test. 

23 ‘‘(ii) PROCESS.—In the case of an ap24 peal under this subparagraph, the com25 mittee shall hold a hearing to consider the 


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1 evidence of clinical validity, shall keep a 

2 written record of the hearing, and shall 

3 provide an opportunity for testimony from 

4 experts presented by both the appellant 

5 and the Secretary. The committee shall 

6 make a recommendation to the Secretary 

7 at the conclusion of the hearing. The Sec8 retary shall consider the record and the 

9 recommendations of the committee and 

10 shall make a decision within 90 calendar 

11 days after the conclusion of the hearing. 

12 ‘‘(iii) SELECTION OF COMMITTEE

13 MEMBERS.—The members of an advisory 

14 committee under this subparagraph shall 

15 be selected by the Secretary from among 

16 individuals, including physicians, with dem17 onstrated expertise in and experience with 

18 the analytical validity and clinical validity 

19 of laboratory-developed tests and the lit20 erature related to the validity of such tests. 

21 ‘‘(B) REVIEW BY ADMINISTRATIVE LAW

22 JUDGE.—The laboratory or test-offering entity 

23 may seek review by an administrative law judge 

24 pursuant to procedures established by the Sec25 retary. 


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1 ‘‘(6) FINAL AGENCY ACTION.— 

2 ‘‘(A) IN GENERAL.—Subject to judicial re3 view under subsection (h), upon final agency ac4 tion under paragraphs (4) and (5) determining 

5 that clinical validity of one or more claimed 

6 uses of a test has not been established or upon 

7 issuance of an order under paragraph (4)(G) 

8 for one or more claimed uses of a test, the lab9 oratory or test-offering entity shall imme10 diately— 

11 ‘‘(i) cease offering the test for such 

12 uses; and 

13 ‘‘(ii) cease reporting test results to 

14 health care providers or individuals for 

15 such uses. 

16 ‘‘(B) REPORTING FOR CERTAIN SPECI17 MENS.—For specimens that have been received 

18 or tests that have been ordered but results not 

19 yet reported, the laboratory or test-offering en20 tity shall notify the person who ordered the test 

21 that test results will not be reported because 

22 clinical validity for such clinical uses has not 

23 been established. 

24 ‘‘(7) COMPANION DIAGNOSTIC TESTS.—An 

25 LDT may be authorized under this subsection for a 


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1 claimed use as a companion diagnostic test for pur2 poses of specifying the use of a drug or biological 

3 product for therapeutic purposes. An LDT for use 

4 as a companion diagnostic test shall be reviewed ex5 clusively pursuant to the requirements of this section 

6 and not under the Federal Food, Drug, and Cos7 metic Act. 

8 ‘‘(d) REGISTRATION BY TEST-OFFERING ENTI9 TIES.— 

10 ‘‘(1) REGISTRATION REQUIREMENT.—A test-of11 fering entity may not offer or market a DTC DNA 

12 test unless the entity registers with the Secretary in 

13 accordance with this subsection and maintains such 

14 registration in effect. 

15 ‘‘(2) TIMING.— 

16 ‘‘(A) IN GENERAL.—Except as provided in 

17 subparagraph (B), registration by a test-offer18 ing entity under this subsection shall occur be19 fore— 

20 ‘‘(i) the entity offers or markets a 

21 DTC DNA test; or 

22 ‘‘(ii) submits a premarket notification 

23 under subsection (c)(2)(A). 

24 ‘‘(B) EXCEPTIONS.— 


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1 ‘‘(i) ENTITIES ALREADY OFFERING OR

2 MARKETING TESTS.—In the case of a test3 offering entity that is offering or mar4 keting a DTC DNA test as of the date on 

5 which the Secretary establishes interim 

6 procedures for carrying out this subsection 

7 under paragraph (4)(B), registration by 

8 the entity shall occur not later than 60 

9 days after such date. 

10 ‘‘(ii) AUTHORITY TO ESTABLISH

11 OTHER EXCEPTIONS.—The Secretary may 

12 establish exceptions to clause (i) in the 

13 regulations required by paragraph (4)(A). 

14 ‘‘(3) INAPPLICABILITY TO CERTIFIED LABORA15 TORIES.—If a certified laboratory offers a DTC 

16 DNA test that is not offered or marketed by a test17 offering entity, such laboratory— 

18 ‘‘(A) is not required to register as a test19 offering entity under this subsection; and 

20 ‘‘(B) shall not, because of offering such 

21 test, be regulated as a test-offering entity in22 stead of a laboratory under section 353 or this 

23 section. 

24 ‘‘(4) REGULATIONS.— 


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1 ‘‘(A) IN GENERAL.—In promulgating regu2 lations under subsection (i)(1), the Secretary 

3 shall include regulations governing registration 

4 under this subsection. 

5 ‘‘(B) INTERIM PROCEDURES.—The Sec6 retary shall establish interim procedures gov7 erning registration under this subsection during 

8 the period beginning on the date of the enact9 ment of this section and ending on the effective 

10 date of the regulations required by subpara11 graph (A). The Secretary shall establish such 

12 interim procedures not later than 90 calendar 

13 days after the date of the enactment of this sec14 tion. The Secretary may establish such interim 

15 procedures by a guidance document or other 

16 means of public notification. 

17 ‘‘(e) INFORMATION REGARDING TEST CAPABILITIES

18 AND LIMITATIONS.— 

19 ‘‘(1) INCLUSION OF INFORMATION.—A labora20 tory or test-offering entity that offers an LDT or a 

21 DTC DNA test shall include in its test result re22 ports, directories of services, marketing materials, 

23 and advertising— 


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1 ‘‘(A) truthful, accurate, and nondeceptive 

2 information regarding the capabilities and limi3 tations of the tests; and 

4 ‘‘(B) a statement that the test has been 

5 validated by the laboratory performing the test 

6 in accordance with the requirements of the 

7 Clinical Laboratory Improvement Amendments 

8 (referred to in this section as ‘CLIA’). 

9 ‘‘(2) CLAIMS NOT IMPUTED TO LABORATORY.— 

10 A laboratory shall not be subject to a sanction or 

11 other action under section 353 or this section be12 cause of a claim made by a test-offering entity. 

13 ‘‘(f) REPORTING.— 

14 ‘‘(1) DEATH OR SERIOUS INJURY REPORT.—If 

15 a laboratory or test-offering entity that offers or 

16 markets an LDT or DTC DNA test has reason to 

17 believe that the test may have caused or contributed 

18 to a death or serious bodily injury— 

19 ‘‘(A) the laboratory or entity shall prompt20 ly investigate the incident; 

21 ‘‘(B) if the laboratory or entity determines 

22 that the LDT or DTC DNA test may have 

23 caused or contributed to a death or serious bod24 ily injury, within 10 working days of making 


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1 such determination the laboratory or entity 

2 shall report the incident to the Secretary; and 

3 ‘‘(C) the laboratory or entity shall provide 

4 such additional information regarding the inci5 dent or the test associated with the incident as 

6 the Secretary may request. 

7 ‘‘(2) COMPLAINT RECORDS.—A laboratory or 

8 test-offering entity that offers or markets an LDT 

9 or DTC DNA test shall maintain a record of— 

10 ‘‘(A) each incident investigated under 

11 paragraph (1)(A), and each report made under 

12 paragraph (1)(B), with respect to the test; and 

13 ‘‘(B) for any incident that was determined 

14 under paragraph (1)(B) not to meet the re15 quirements for reporting to the Secretary, the 

16 basis for such determination. 

17 ‘‘(3) NO ADMISSION OF CAUSATION.—A report 

18 submitted under this subsection with respect to an 

19 event shall not be treated as an admission that the 

20 test, or the laboratory or its employees, caused or 

21 contributed to the event. 

22 ‘‘(g) SANCTIONS.— 

23 ‘‘(1) APPLICABILITY OF SANCTIONS TO CLIN24 ICAL LABORATORIES.— 


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1 ‘‘(A) INTERMEDIATE SANCTIONS.—The 

2 reference in section 353(h)(1) to the ‘require3 ments for the issuance of a certificate’ is 

4 deemed to include the requirements of this sec5 tion. 

6 ‘‘(B) SUSPENSION, REVOCATION, AND LIM7 ITATION OF CERTIFICATE.— 

8 ‘‘(i) The reference in section 

9 353(i)(1)(A) to ‘misrepresentation in ob10 taining the certificate’ is deemed to include 

11 any misrepresentation of information in a 

12 submission to the Secretary pursuant to 

13 this section. 

14 ‘‘(ii) The reference in section 

15 353(i)(1)(F) to ‘any provisions of this sec16 tion’ is deemed to include any provisions of 

17 this section. 

18 ‘‘(2) APPLICABILITY OF SANCTIONS TO TEST19 OFFERING ENTITIES.— 

20 ‘‘(A) INTERMEDIATE SANCTIONS.— 

21 ‘‘(i) IN GENERAL.—If the Secretary 

22 determines that a test-offering entity reg23 istered under subsection (d) is no longer 

24 meeting the requirements of this section, 

25 the Secretary may impose intermediate 


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1 sanctions in lieu of the actions authorized 

2 by subparagraph (B). 

3 ‘‘(ii) TYPES OF SANCTIONS; PROCE4 DURES.—The provisions of paragraphs (2) 

5 and (3) of section 353(h) shall apply with 

6 respect to intermediate sanctions against a 

7 test-offering entity under clause (i) to the 

8 same extent and in the same manner as 

9 such provisions apply with respect to inter10 mediate sanctions against a laboratory 

11 under section 353(h). 

12 ‘‘(B) SUSPENSION, REVOCATION, AND LIM13 ITATION OF REGISTRATION.—The registration 

14 of a test-offering entity under subsection (d) 

15 may be suspended, revoked, or limited if the 

16 Secretary finds, using the procedures applicable 

17 under section 353(i)(1) to suspension, revoca18 tion, or limitation of a laboratory’s certificate, 

19 that the owner or operator or any employee of 

20 the test-offering entity— 

21 ‘‘(i) has misrepresented information in 

22 a submission to the Secretary pursuant to 

23 this section; 

24 ‘‘(ii) has failed to comply with the re25 quirements of this section; 


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1 ‘‘(iii) has failed to comply with rea2 sonable requests of the Secretary for— 

3 ‘‘(I) any information or materials 

4 that the Secretary concludes are nec5 essary to determine the test-offering 

6 entity’s continued compliance with the 

7 requirements of this section; or 

8 ‘‘(II) work on materials, that the 

9 Secretary concludes is necessary to 

10 determine the test-offering entity’s 

11 continued compliance with the re12 quirements of this section; 

13 ‘‘(iv) has refused a reasonable request 

14 of the Secretary (or, if designated by the 

15 Secretary, any Federal officer, government 

16 employee, or a nongovernmental organiza17 tion or an accreditation body designated 

18 under subsection (k)) for permission to in19 spect the test-offering entity and its oper20 ations and pertinent records during the 

21 hours the test-offering entity is in oper22 ation; 

23 ‘‘(v) has violated or aided and abetted 

24 in the violation of any provisions of this 


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1 section or of any regulation promulgated 

2 thereunder; or 

3 ‘‘(vi) has not complied with an inter4 mediate sanction imposed under subpara5 graph (A). 

6 ‘‘(C) ACTION BEFORE A HEARING.—If the 

7 Secretary determines that— 

8 ‘‘(i) the failure of a test-offering enti9 ty to comply with the requirements of this 

10 section presents an imminent and serious 

11 risk to human health; or 

12 ‘‘(ii) a test-offering entity has engaged 

13 in an action described in clause (iv) or (v) 

14 of subparagraph (B), 

15 the Secretary may suspend or limit the registra16 tion of the laboratory before holding a hearing 

17 under subparagraph (B) regarding such failure 

18 or refusal. The opportunity for a hearing shall 

19 be provided no later than 60 days from the ef20 fective date of the suspension or limitation. A 

21 suspension or limitation under this subpara22 graph shall stay in effect until the decision of 

23 the Secretary made after the hearing under 

24 subparagraph (B). 


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1 ‘‘(D) INJUNCTIONS.—If the Secretary has 

2 reason to believe the continuation of any activ3 ity by a test-offering entity would constitute a 

4 significant hazard to the public health, the Sec5 retary may bring suit in any district court of 

6 the United States that has jurisdiction over 

7 such entity to enjoin continuation of such activ8 ity. Upon proper showing, a temporary injunc9 tion or restraining order against continuation of 

10 such activity pending issuance of a final order 

11 under this subparagraph shall be granted with12 out bond by such court. 

13 ‘‘(3) APPLICABILITY OF CRIMINAL SANCTIONS

14 TO ALL PERSONS.—The reference in section 353(l) 

15 to ‘any requirement of this section’ is deemed to in16 clude any requirement of this section. 

17 ‘‘(4) REPORTING.—In promulgating regulations 

18 under subsection (i)(1), the Secretary may include 

19 sanctions specific to violations of subsection (f) (re20 garding reporting), including the following: 

21 ‘‘(A) Civil money penalties in an amount 

22 not to exceed $10,000 for each such violation. 

23 ‘‘(B) Directed plans of correction. 

24 ‘‘(C) For repeat or intentional violations, 

25 an order requiring the test-offering entity to 


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1 cease offering or marketing the DTC DNA test 

2 involved for one or more claimed uses. 

3 ‘‘(h) JUDICIAL REVIEW.—If a laboratory or test-of4 fering entity is subject to a sanction or other action pursu5 ant to subsection (g) or is adversely affected by final agen6 cy action under subsection (c), the laboratory or entity 

7 may appeal such sanction or action by filing a petition 

8 for judicial review with the United States court of appeals 

9 for the circuit where the laboratory or entity has its prin10 cipal place of business. The provisions of section 353(k) 

11 applicable to judicial review of sanctions and actions under 

12 section 353 shall apply to judicial review of sanctions and 

13 actions under this section. 

14 ‘‘(i) REGULATIONS.— 

15 ‘‘(1) IN GENERAL.—Not later than 1 year after 

16 the date of the enactment of this section, the Sec17 retary shall promulgate final regulations to carry out 

18 this section. 

19 ‘‘(2) RARE DISEASES AND CONDITIONS.—In 

20 carrying out paragraph (1), the Secretary shall in21 clude regulations specific to any LDT or DTC DNA 

22 test used in connection with a rare disease or condi23 tion (as such term is defined in section 526(a)(2) of 

24 the Federal Food, Drug, and Cosmetic Act). Such 

25 regulations— 


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1 ‘‘(A) shall provide for expedited review of 

2 premarket notifications under subsection 

3 (c)(2)(A) for such tests; 

4 ‘‘(B) shall contain standards of evidence 

5 for demonstrating the clinical validity of such 

6 test that takes into account special issues relat7 ing to studies in small populations; 

8 ‘‘(C) shall take into account relevant tech9 nical standards and guidelines applicable to 

10 testing for such a rare disease and condition; 

11 and 

12 ‘‘(D) may authorize the Secretary to waive 

13 any requirement of this section if the Secretary 

14 determines that application of such requirement 

15 would unreasonably delay or prevent access to 

16 such test. 

17 ‘‘(3) EMERGENCY USE.—In carrying out para18 graph (1), the Secretary shall include regulations 

19 authorizing the Secretary to waive any requirement 

20 of this section in order to allow the emergency use 

21 of an LDT for detecting or diagnosing serious or 

22 life-threatening infectious pathogens or diseases. 

23 Such regulations shall apply standards of evidence 

24 for demonstrating the clinical validity of such a test 


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1 that take into account special issues relating to in2 fectious pathogens and public health threats. 

3 ‘‘(4) EXTERNAL QUALITY ASSESSMENT.—In 

4 carrying out paragraph (1), the Secretary, in con5 sultation with proficiency testing organizations ap6 proved under section 353(f)(C), shall include regula7 tions establishing an external review process to 

8 evaluate the analytical validity of LDTs. 

9 ‘‘(j) INSPECTIONS.— 

10 ‘‘(1) LABORATORIES.—During an inspection 

11 under section 353(g), the Secretary— 

12 ‘‘(A) may use the authorities specified in 

13 section 353(g)(1) for purposes of determining 

14 compliance with this section; and 

15 ‘‘(B) may require a laboratory to provide 

16 evidence of clinical validity for any claim made 

17 for an LDT offered by that laboratory. 

18 ‘‘(2) TEST-OFFERING ENTITIES.—The Sec19 retary— 

20 ‘‘(A) shall have the same authority to con21 duct inspections of a test-offering entity for 

22 purposes of determining compliance with this 

23 section as the Secretary has under paragraph 

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1 tions of laboratories for compliance with this 

2 section and section 353; and 

3 ‘‘(B) during an inspection under subpara4 graph (A), may require a test-offering entity to 

5 provide evidence of clinical validity for any 

6 claim made for a DTC DNA test offered or 

7 marketed by that entity. 

8 ‘‘(3) PROPRIETARY OR CONFIDENTIAL INFOR9 MATION.—The Secretary shall establish procedures 

10 to protect any proprietary or confidential informa11 tion concerning an LDT or DTC DNA test that may 

12 be disclosed during an inspection under this sub13 section. 

14 ‘‘(k) DELEGATION.—The Secretary shall administer 

15 this section solely through the Centers for Medicare & 

16 Medicaid Services. The Administrator may— 

17 ‘‘(1) pursuant to agreement, designate a non18 governmental organization that has qualifications 

19 and expertise in the evaluation of laboratory testing 

20 and in evaluating the analytical and clinical validity 

21 of laboratory tests to assist in the review of pre22 market notifications and test registry data bank in23 formation and in the performance of inspections au24 thorized under subsection (j); and 


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1 ‘‘(2) subject to the provisions of section 353(e), 

2 designate an accreditation organization to assist in 

3 the review of premarket notifications and test reg4 istry data bank information and in the performance 

5 of inspections authorized under subsection (j). 

6 ‘‘(l) FEDERAL TRADE COMMISSION.—Nothing in this 

7 section shall be construed to limit regulation of advertising 

8 under the Federal Trade Commission Act.’’. 

9 SEC. 3. AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND 

10 COSMETIC ACT. 

11 (a) DEVICE DEFINITION.—Section 201(h) of the 

12 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

13 321(h)) is amended by adding at the end the following: 

14 ‘‘The term ‘device’ does not include a laboratory-developed 

15 test or a direct-to-consumer DNA test as defined in sec16 tion 353A of the Public Health Service Act.’’. 

17 (b) REGISTRATION EXCLUSION.—Section 510(g) of 

18 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

19 360(g)) is amended— 

20 (1) by redesignating paragraphs (4) and (5) as 

21 (5) and (6), respectively; and 

22 (2) by inserting after paragraph (3) the fol23 lowing: 


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1 ‘‘(4) clinical laboratories certified under section 

2 353 of the Public Health Service Act insofar as such 

3 laboratories— 

4 ‘‘(A) use devices to perform laboratory 

5 tests; or 

6 ‘‘(B) create and perform laboratory-devel7 oped tests as defined in section 353A of such 

8 Act;’’. 

9 SEC. 4. FEES. 

10 Section 353(m) of the Public Health Service Act (42 

11 U.S.C. 263a(m)) is amended— 

12 (1) in paragraph (2), by adding at the end the 

13 following sentence: ‘‘In the case of a laboratory or 

14 test-offering entity that is required to submit infor15 mation under section 353A(b)(2)(A), the Secretary 

16 shall also require the payment of fees for reviews of 

17 premarket notifications and supplemental notifica18 tions submitted pursuant to subparagraph (A), (B), 

19 or (C) of section 353A(c)(2), registration of test-of20 fering entities under section 353A(d), and inspec21 tions conducted pursuant to section 353A(j).’’; 

22 (2) in paragraph (3)(B)— 

23 (A) by striking ‘‘inspections and pro24 ficiency testing described in paragraph (2)’’ and 

25 inserting ‘‘inspections and proficiency testing 


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1 described in the first sentence of paragraph 

2 (2)’’; and 

3 (B) by striking the period at the end and 

4 inserting ‘‘, review of premarket notifications 

5 and supplemental notifications submitted pursu6 ant to subparagraph (A), (B), or (C) of section 

7 353A(c)(2), registration of test-offering entities 

8 under section 353A(d), and inspections con9 ducted pursuant to section 353A(j)’’; and 

10 (3) by adding at the end the following new 

11 paragraph: 

12 ‘‘(4) FISCAL REPORT.—By December 31, 2011, 

13 and by the end of each calendar year thereafter, the 

14 Secretary shall prepare and submit to the Com15 mittee on Energy and Commerce of the House of 

16 Representatives and the Committee on Health, Edu17 cation, Labor, and Pensions of the Senate a report 

18 on the amount of fees collected during the preceding 

19 fiscal year under this subsection and the amount of 

20 fees collected under this subsection available to sup21 port activities under this section and section 353A. 

22 Before increasing the amount of any fee required by 

23 this subsection, the Secretary shall include in a re24 port under this paragraph an explanation of the 

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1 nues and expenses expected to be incurred. The ef2 fective date of any such increase shall not be sooner 

3 than the date that is 120 days after the submission 

4 of the report containing such explanation.’’. 

Æ 


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