II 

110TH CONGRESS 

1ST SESSION S. 736 

To provide for the regulation and oversight of laboratory tests. 

IN THE SENATE OF THE UNITED STATES 

MARCH 1, 2007 

Mr. KENNEDY (for himself and Mr. SMITH) introduced the following bill; 

which was read twice and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To provide for the regulation and oversight of laboratory 

tests. 

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. 

4 This Act may be cited as the ‘‘Laboratory Test Im5 provement Act’’. 

6 SEC. 2. DEFINITIONS. 

7 (a) IN GENERAL.— 

8 (1) FEDERAL FOOD, DRUG, AND COSMETIC

9 ACT.—Section 201 of the Federal Food, Drug, and 

10 Cosmetic Act (referred to in this Act as the 


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1 ‘‘FFDCA’’) (21 U.S.C. 321) is amended by adding 

2 at the end the following: 

3 ‘‘(rr) DEFINITIONS RELATED TO LABORATORY-DE4 VELOPED TESTS.— 

5 ‘‘(1) ANALYTICAL VALIDITY.—The term ‘ana6 lytical validity’, with respect to a laboratory-devel7 oped test, means the extent to which the test can be 

8 used to measure accurately and reliably the property 

9 or characteristic that the test is intended to meas10 ure. 

11 ‘‘(2) CLINICAL VALIDITY.—The term ‘clinical 

12 validity’, with respect to a laboratory-developed test, 

13 means the extent to which the test can be used for 

14 its intended use. 

15 ‘‘(3) DIRECT-TO-CONSUMER TEST.—The term 

16 ‘direct-to-consumer test’ means a laboratory-devel17 oped test that is not a prescription test. 

18 ‘‘(4) INTENDED USE.—The term ‘intended use’, 

19 with respect to a laboratory-developed test, in20 cludes— 

21 ‘‘(A) determining predisposition of an indi22 vidual to a disease or condition; 

23 ‘‘(B) aiding diagnosis of a disease or con24 dition of an individual; 


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1 ‘‘(C) aiding decision-making on how to 

2 treat a disease or condition of an individual; 

3 ‘‘(D) aiding preimplantation genetic diag4 nosis; 

5 ‘‘(E) determining a characteristic of a 

6 human embryo or a human fetus; 

7 ‘‘(F) determining whether an individual is 

8 a carrier of an allele associated with a disease 

9 or condition; or 

10 ‘‘(G) otherwise obtaining information re11 lated to health or disease prevention (including 

12 nutrition) for an individual. 

13 ‘‘(5) IN VITRO DIAGNOSTIC PRODUCT.—The 

14 term ‘in vitro diagnostic product’ shall have the 

15 meaning given the term in section 809.3(a) of title 

16 21, Code of Federal Regulations (or successor regu17 lation). 

18 ‘‘(6) LABORATORY-DEVELOPED TEST.— 

19 ‘‘(A) IN GENERAL.—The term ‘laboratory20 developed test’ means— 

21 ‘‘(i) the use of analytical methods de22 veloped by a laboratory to process a bio23 logical specimen, whether at 1 laboratory 

24 site or multiple sites, to report a test result 


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1 to a health care practitioner, a patient, or 

2 a consumer; and 

3 ‘‘(ii) includes an in vitro diagnostic 

4 product that the laboratory has modified, 

5 unless such modification requires 

6 preclearance or preapproval of such modi7 fied in vitro diagnostic product under this 

8 Act. 

9 ‘‘(B) EXCEPTION.—The term ‘laboratory10 developed test’ does not include— 

11 ‘‘(i) the processing of a biological 

12 specimen to— 

13 ‘‘(I) determine paternity; 

14 ‘‘(II) aid in forensics; or 

15 ‘‘(III) conduct research if the re16 sult of the test is not reported to a 

17 health care provider, a patient, or a 

18 consumer; 

19 ‘‘(ii) an in vitro diagnostic product; or 

20 ‘‘(iii) an analyte specific reagent, as 

21 defined in section 864.4020 of title 21, 

22 Code of Federal Regulations (or successor 

23 regulation). 

24 ‘‘(7) MANUFACTURER.—The term ‘manufac25 turer’, with respect to a laboratory-developed test, 


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1 means the laboratory that performs the test to proc2 ess a biological specimen. 

3 ‘‘(8) PRESCRIPTION TEST.—The term ‘prescrip4 tion test’ means a laboratory-developed test that is 

5 used to process a biological specimen only upon the 

6 written or oral authorization, based on a practi7 tioner-patient relationship that is valid under appli8 cable Federal and State laws, of a practitioner li9 censed by law to administer or use such test. 

10 ‘‘(9) TYPE.—A laboratory-developed test shall 

11 be considered of the same ‘type’ as an in vitro diag12 nostic product if the test and the product— 

13 ‘‘(A) use similar analytical methods; 

14 ‘‘(B) measure the same, or clinically com15 parable, properties or characteristics; and 

16 ‘‘(C) have the same intended use.’’. 

17 (2) APPLICATION OF DEFINITIONS.—Any term 

18 that is used in this Act that is defined in subsection 

19 (rr) of such section 201 (as added by paragraph (1)) 

20 shall, for purposes of this Act, have the meaning 

21 given such term in such subsection (rr). 

22 (b) IMPLEMENTATION.—A laboratory-developed test 

23 that is a direct-to-consumer test on the date of enactment 

24 of this Act shall be deemed to be a prescription test if, 

25 on the date that is 60 days after the date of enactment 


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1 of this Act and thereafter, such test satisfies the require2 ments of this Act to be a prescription test. 

3 SEC. 3. LABORATORY-DEVELOPED TESTS DEEMED MED4 ICAL DEVICES. 

5 Section 520 of the FFDCA (21 U.S.C. 360j) is 

6 amended by adding at the end the following: 

7 ‘‘(o) LABORATORY-DEVELOPED TESTS.—Any labora8 tory-developed test shall be deemed to be a device under 

9 section 201(h).’’. 

10 SEC. 4. REPORTING ON AND PUBLIC DISCLOSURE ABOUT 

11 LABORATORY-DEVELOPED TESTS. 

12 (a) LABELING OF INTENDED USE AND REGULATORY

13 STATUS OF LABORATORY-DEVELOPED TESTS AND TEST

14 RESULTS.— 

15 (1) IN GENERAL.—Section 520(o) of the 

16 FFDCA, as added by section 3, is amended by— 

17 (A) striking ‘‘TESTS.—Any’’ and inserting 

18 the following: ‘‘TESTS.— 

19 ‘‘(1) IN GENERAL.—Any’’; and 

20 (B) adding at the end the following: 

21 ‘‘(2) TEST RESULTS; LABELING.— 

22 ‘‘(A) IN GENERAL.—Any statement by the 

23 manufacturer of the result of a laboratory-de24 veloped test reported to a health care practi25 tioner, a patient, or a consumer, and any labelVerDate Aug 31 2005 19:19 Mar 03, 2007 Jkt 059200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S736.IS S736

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1 ing for the test, shall prominently and conspicu2 ously include— 

3 ‘‘(i) the intended use of the test; and 

4 ‘‘(ii) if the test has not been cleared 

5 or approved under this Act for such in6 tended use, a statement that the test has 

7 not been cleared or approved under this 

8 Act for such intended use. 

9 ‘‘(B) EFFECT.—The statement required 

10 under subparagraph (A) shall not include a 

11 statement that the test is investigational or not 

12 lawfully marketed.’’. 

13 (2) IMPLEMENTATION.—The requirements of 

14 paragraph (2) of such section 520(o) shall take ef15 fect on the date that is 60 days after the date of en16 actment of this Act. 

17 (b) REGISTRATION OF MANUFACTURERS AND LIST18 ING OF LABORATORY-DEVELOPED TESTS.—The require19 ments of section 510 of the FFDCA (21 U.S.C. 360) with 

20 respect to the registration of the manufacturer of a labora21 tory-developed test and the listing of a laboratory-devel22 oped test shall take effect on the date that is 270 days 

23 after the date of enactment of this Act. 

24 (c) ADVERSE EVENT REPORTING FOR LABORATORY25 DEVELOPED TESTS.—The requirements of section 519 of 


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1 the FFDCA (21 U.S.C. 360i) with respect to records and 

2 reports on a laboratory-developed test shall take effect on 

3 the date that is 1 year after the date of enactment of this 

4 Act. 

5 (d) PUBLIC DATABASE OF INFORMATION ON VALID6 ITY OF LABORATORY-DEVELOPED TESTS.— 

7 (1) IN GENERAL.—Section 520(o) of the 

8 FFDCA, as amended by subsection (a), is amended 

9 by adding at the end the following: 

10 ‘‘(3) DATABASE ON INFORMATION OF ANALYT11 ICAL AND CLINICAL VALIDITY.— 

12 ‘‘(A) IN GENERAL.— 

13 ‘‘(i) SUBMISSION.—Unless a labora14 tory-developed test is cleared under section 

15 510(k) or approved under section 515 or 

16 520(m) for its intended use, the manufac17 turer of the test shall electronically submit 

18 to the Secretary information (in a form 

19 specified by the Secretary and certified as 

20 truthful and accurate) on the analytical 

21 and clinical validity of the test for its in22 tended use. 

23 ‘‘(ii) ANALYTIC INTENDED USE.—If 

24 the intended use of a laboratory-developed 

25 test is limited solely to the measurement of 


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1 an analytical property or characteristic, the 

2 manufacturer of the test shall not submit 

3 any information with respect to the clinical 

4 validity of the test under clause (i) other 

5 than the following statement: ‘This test is 

6 intended to measure only the property or 

7 characteristic that is reported as a result 

8 of use of the test. The test is not intended 

9 to be used to diagnose or screen for any 

10 disease or condition, or to otherwise aid in 

11 decision-making with respect to health, and 

12 this laboratory makes no representations 

13 as to its usefulness for any such purpose.’. 

14 ‘‘(B) INCLUSION.—The Secretary shall 

15 provide for the automated inclusion of the in16 formation submitted under subparagraph (A) in 

17 a database of such information on all labora18 tory-developed tests that shall be available to, 

19 and searchable by, the public on the Internet 

20 website of the Food and Drug Administration. 

21 ‘‘(C) NOTICE.—The Secretary may give 

22 written notice to the manufacturer of a labora23 tory-developed test that— 


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1 ‘‘(i) the information submitted by the 

2 manufacturer for such test under subpara3 graph (A)— 

4 ‘‘(I) does not adequately dem5 onstrate the analytical validity of the 

6 test for its intended use; 

7 ‘‘(II) does not adequately sum8 marize the peer-reviewed biomedical 

9 literature about the clinical validity of 

10 the test for its intended use; 

11 ‘‘(III) relies on, or includes, in12 formation or data on the clinical valid13 ity of the test for its intended use that 

14 has not been published in a peer-re15 viewed biomedical journal; 

16 ‘‘(IV) does not adequately dem17 onstrate the clinical validity of the 

18 test for its intended use; or 

19 ‘‘(V) does not demonstrate that 

20 the analytical validity or the clinical 

21 validity of such test for its intended 

22 use is comparable to the analytical va23 lidity or the clinical validity, as the 

24 case may be, of an in vitro diagnostic 

25 product of the same type that has 


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1 been cleared under section 510(k) or 

2 approved under section 515 or section 

3 520(m); and 

4 ‘‘(ii) information about an intended 

5 use that is not limited solely to the meas6 urement of an analytical property or char7 acteristic, as provided for in the statement 

8 described under subparagraph (A)(ii), has 

9 been included— 

10 ‘‘(I) with a result of the test re11 ported by the manufacturer to a 

12 health care practitioner, a patient, or 

13 a consumer; or 

14 ‘‘(II) in labeling for the test. 

15 ‘‘(D) SECOND NOTICE.—The Secretary 

16 shall provide to the manufacturer of a labora17 tory-developed test that has received a notice 

18 under subparagraph (C) a second notice if— 

19 ‘‘(i) the manufacturer has submitted 

20 corrected information under subparagraph 

21 (A) for such test within 90 days of having 

22 received a notice under subparagraph (C); 

23 and 


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1 ‘‘(ii)(I) 1 or more of subclauses (I) 

2 through (V) of subparagraph (C)(i) applies 

3 to such corrected information; or 

4 ‘‘(II) the manufacturer has failed to 

5 include in such corrected information nec6 essary information about the intended use 

7 referred to in subparagraph (C)(ii).’’. 

8 (2) IMPLEMENTATION.— 

9 (A) ELECTRONIC SUBMISSION.—Not later 

10 than 1 year after the date of enactment of this 

11 Act, the Secretary of Health and Human Serv12 ices (referred to in this Act as the ‘‘Secretary’’) 

13 shall develop a portal on the Internet website of 

14 the Food and Drug Administration through 

15 which the information required by paragraph 

16 (3) of such section 520(o), as added by this 

17 subsection, shall be submitted to the Secretary. 

18 (B) ELECTRONIC CERTIFICATION.—The 

19 Secretary shall require as a condition of submit20 ting the information required by paragraph (3) 

21 of such section 520(o) that an individual sub22 mitting such information certify electronically 

23 the truthfulness and accuracy of such informa24 tion. 


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1 (C) PUBLICLY ACCESSIBLE DATABASE OF

2 INFORMATION.—Not later than 1 year after the 

3 date of enactment of this Act, the Secretary 

4 shall develop a database of the information sub5 mitted under paragraph (3) of such section 

6 520(o) that shall be available to, and searchable 

7 by, the public on the Internet website of the 

8 Food and Drug Administration and to which 

9 such information shall be automatically in10 cluded upon submission. 

11 (D) LITERATURE REVIEWS AND CLINICAL

12 VALIDITY.—Not later than 270 days after the 

13 date of enactment of this Act, the Secretary 

14 shall issue a guidance document to facilitate the 

15 use of reviews of the peer-reviewed biomedical 

16 literature and other information and data about 

17 the clinical validity of laboratory-developed tests 

18 and in vitro diagnostic products when clearing 

19 or approving such tests and products under the 

20 FFDCA. 

21 (E) MODIFICATIONS.—Not later than 18 

22 months after the date of enactment of this Act, 

23 the Secretary shall issue a guidance document 

24 to clarify when modifications to a laboratory-de25 veloped test require updating of the information 


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1 submitted under paragraph (3) of such section 

2 520(o). To the extent practicable, under such 

3 guidance, modifications to a laboratory-devel4 oped test under such paragraph (3) shall be re5 quired under the same circumstances as the 

6 submission of a report under section 510(k) of 

7 the FFDCA (21 U.S.C. 360(k)) or a supple8 mental premarket application under section 515 

9 of the FFDCA (21 U.S.C. 360e) is required for 

10 modifications to a laboratory-developed test or 

11 an in vitro diagnostic product that is cleared or 

12 approved under the FFDCA. 

13 (F) SUBMISSION OF INFORMATION.—The 

14 requirements of paragraph (3) of such section 

15 520(o) shall take effect on the date that is 18 

16 months after the date of enactment of this Act. 

17 SEC. 5. CLASSIFICATION AND FDA REVIEW OF LABORA18 TORY-DEVELOPED TESTS. 

19 (a) CLASSIFICATION OF LABORATORY-DEVELOPED

20 TESTS.— 

21 (1) IN GENERAL.—Section 520(o) of the 

22 FFDCA, as amended by section 4, is amended by 

23 adding at the end the following: 

24 ‘‘(4) CLASSIFICATION.— 


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1 ‘‘(A) IN GENERAL.—Notwithstanding sec2 tion 513(f)(1), a laboratory-developed test shall 

3 be classified in class II, as defined in section 

4 513(a)(1)(B), subject to both general and spe5 cial controls. 

6 ‘‘(B) CLASS III.—Notwithstanding sub7 paragraph (A), a laboratory-developed test shall 

8 be classified in class III if— 

9 ‘‘(i) the Secretary gives notice to the 

10 manufacturer of such test that such test 

11 meets the requirements of section 

12 513(a)(1)(C) to be in class III; 

13 ‘‘(ii)(I) such test is intended for use in 

14 the diagnosis of a contagious disease or 

15 condition that is highly likely to result in 

16 a fatal outcome; and 

17 ‘‘(II) prompt, accurate diagnosis of 

18 the disease or condition offers the oppor19 tunity to mitigate the public health impact 

20 of the disease or condition; or 

21 ‘‘(iii) such test is intended for use in 

22 donor screening of a disease or condition 

23 for which the Secretary has recommended 

24 or required testing to— 

25 ‘‘(I) safeguard the blood supply; 


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1 ‘‘(II) establish the safe use of 

2 blood and blood products; or 

3 ‘‘(III) establish the safe use of 

4 tissue and tissue products. 

5 ‘‘(C) CLASS I.—Notwithstanding subpara6 graph (A), the Secretary may classify a labora7 tory-developed test in class I if such test meets 

8 the requirements of section 513(a)(1)(A) to be 

9 in class I.’’. 

10 (2) IMPLEMENTATION.— 

11 (A) CLASS III.—The Secretary may not 

12 give notice under paragraph (4)(B)(i) of such 

13 section 520(o) to the manufacturer of a labora14 tory-developed test that is not a direct-to-con15 sumer test before the date that is 2 years after 

16 the date of enactment of this Act. 

17 (B) CLASS I.—The Secretary may not clas18 sify a type of laboratory-developed test in class 

19 I under paragraph (4)(C) of such section 

20 520(o) before the date that is 18 months after 

21 the date of enactment of this Act. 

22 (C) SPECIAL CONTROLS.—Not later than 2 

23 years after the date of enactment of this Act, 

24 the Secretary shall identify in guidance docu25 ments whether there are special controls to 


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1 which all laboratory-developed tests, subcat2 egories of such tests, or specific such tests shall 

3 be subject under section 514 of the FFDCA 

4 (21 U.S.C. 360d). 

5 (b) CLEARANCE AND APPROVAL OF LABORATORY6 DEVELOPED TESTS.— 

7 (1) IN GENERAL.—Section 520(o) of the 

8 FFDCA, as amended by subsection (a), is amended 

9 by adding at the end the following: 

10 ‘‘(5) APPLICATION OF SECTION 510(k), SEC11 TION 515, OR SECTION 520(m).—A laboratory-devel12 oped test shall be exempt from the requirements of 

13 section 510(k), section 515, and section 520(m), ex14 cept that the manufacturer of a laboratory-developed 

15 test shall submit— 

16 ‘‘(A) a report under section 510(k) if— 

17 ‘‘(i) the test is classified in class II; 

18 and 

19 ‘‘(ii) the test is— 

20 ‘‘(I) a direct-to-consumer test; 

21 ‘‘(II) a test for which the manu22 facturer has not submitted corrected 

23 information under paragraph (3)(A) 

24 within 90 days of having received a 

25 notice under paragraph (3)(C); or 


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1 ‘‘(III) a test for which the Sec2 retary has given second notice under 

3 paragraph (3)(D) to the manufacturer 

4 of such test; or 

5 ‘‘(B) an application under section 515 or 

6 section 520(m), as appropriate, if such test is 

7 classified in class III.’’. 

8 (2) IMPLEMENTATION.— 

9 (A) DIRECT-TO-CONSUMER TESTS.—The 

10 requirement to submit a report under section 

11 510(k) of the FFDCA (21 U.S.C. 360(k)) or an 

12 application under section 515 or section 520(m) 

13 of the FFDCA (21 U.S.C. 360e or 360j(m)), as 

14 the case may be, under paragraph (5) of such 

15 section 520(o), as added by this subsection, for 

16 a direct-to-consumer test as provided in clause 

17 (ii) of such paragraph shall take effect on the 

18 date that is 180 days after the date of enact19 ment of this Act. 

20 (B) CLASS II PRESCRIPTION TESTS.—The 

21 requirement to submit a report under such sec22 tion 510(k) under paragraph (5) of such section 

23 520(o) for a class II prescription device shall 

24 take effect on the date that is 90 days after the 

25 date of the notice to the manufacturer of such 


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1 test referred to in subclause (II) or (III) of 

2 paragraph (5)(A)(ii) of such section 520(o). 

3 (C) CLASS III PRESCRIPTION TESTS.—The 

4 requirement to submit an application under 

5 such section 515 or such section 520(m) under 

6 paragraph (5) of such section 520(o) for a class 

7 III prescription device shall take effect on the 

8 date that is— 

9 (i) 1 year after the date on which the 

10 Secretary gives notice to the manufacturer 

11 of such test that such test is classified in 

12 class III as provided under paragraph 

13 (4)(B)(i) of such section 520(o); or 

14 (ii) 1 year after the date of enactment 

15 of this Act if such test is classified in class 

16 III as provided under clause (ii) or (iii) of 

17 paragraph (4)(B) of such section 520(o). 

18 (c) REMOVAL OF LABORATORY-DEVELOPED TESTS

19 FROM THE MARKET.—Section 520(o) of the FFDCA, as 

20 amended by subsection (b), is amended by adding at the 

21 end the following: 

22 ‘‘(6) FAILURE TO MAKE SUBMISSION; NON23 CLEARANCE OR DISAPPROVAL.—The manufacturer 

24 of a laboratory-developed test— 


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1 ‘‘(A) may commence and continue to re2 port, or offer to report, a result of such test to 

3 any person until the date that— 

4 ‘‘(i)(I) the manufacturer is required to 

5 submit information under paragraph 

6 (3)(A); and 

7 ‘‘(II) the manufacturer fails to submit 

8 such information; 

9 ‘‘(ii)(I) the manufacturer has received 

10 a notice under paragraph (3)(C); and 

11 ‘‘(II) the manufacturer has failed to 

12 submit corrected information under para13 graph (3)(A); 

14 ‘‘(iii)(I) the manufacturer is required 

15 to submit under paragraph (5)— 

16 ‘‘(aa) a report with respect to 

17 such test under section 510(k); or 

18 ‘‘(bb) an application under sec19 tion 515 or 520(m); and 

20 ‘‘(II) the manufacturer fails to submit 

21 such report or application, as the case may 

22 be; 

23 ‘‘(iv) the report with respect to such 

24 test under section 510(k) is not cleared by 

25 the Secretary; or 


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1 ‘‘(v) approval of such application is 

2 denied by the Secretary; and 

3 ‘‘(B) shall immediately cease to report, or 

4 offer to report, a result of such test to any per5 son on such date.’’. 

6 SEC. 6. INSPECTION OF LABORATORIES; EXEMPTION FROM 

7 REQUIREMENT FOR FDA TO INSPECT EVERY 

8 2 YEARS. 

9 Section 520(o) of the FFDCA, as amended by section 

10 4, is amended by adding at the end the following: 

11 ‘‘(7) INSPECTION.—The requirement of section 

12 510(h) with respect to the inspection of a registered 

13 establishment at least once in every 2-year period 

14 shall not apply to a manufacturer of a laboratory15 developed test that is classified in class II, unless 

16 section 510(h) applies to such establishment because 

17 of a drug or another device classified in class II or 

18 III.’’. 

19 SEC. 7. THE CLINICAL LABORATORY IMPROVEMENT 

20 AMENDMENTS OF 1988. 

21 (a) COMPLIANCE WITH THIS ACT.—Compliance with 

22 the requirements under this Act shall have no effect on 

23 the obligation to comply with any requirement under sec24 tion 353 of the Public Health Service Act (42 U.S.C. 

25 263a). 


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1 (b) COMPLIANCE WITH CLIA OF 1988.—Except as 

2 provided in subsection (c), compliance with the require3 ments under section 353 of the Public Health Service Act 

4 (42 U.S.C. 263a) shall have no effect on the obligation 

5 to comply with any requirement of this Act. 

6 (c) GOOD MANUFACTURING PRACTICE REQUIRE7 MENTS AND CLIA OF 1988.—For a laboratory-developed 

8 test, compliance with the requirements under section 353 

9 of the Public Health Service Act (42 U.S.C. 263a) shall 

10 be deemed to satisfy the requirements under section 

11 520(f) of the FFDCA (21 U.S.C. 360j(f)) unless and 

12 until, after providing for public comment, the Secretary 

13 issues a final guidance document— 

14 (1) in which the Secretary finds that— 

15 (A) compliance with the requirements 

16 under such section 353 does not satisfy the re17 quirements under such section 520(f); and 

18 (B) compliance with the requirements of 

19 such section 520(f) are necessary to protect the 

20 public health; 

21 (2) explaining the least burdensome approach 

22 for manufacturers of laboratory-developed tests to 

23 comply with the requirements of such section 520(f); 

24 and 


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1 (3) providing for coordination of inspection ef2 forts to ensure compliance with such section 353 

3 and such section 520(f). 

4 (d) RULEMAKING BY SECRETARY.— 

5 (1) PROPOSED RULE.—Not later than 1 year 

6 after the date of enactment of this Act, the Sec7 retary shall issue a proposed rule to establish a spe8 cialty area under section 353 of the Public Health 

9 Service Act (42 U.S.C. 263a) for laboratory-devel10 oped tests to acquire genetic information, including 

11 mutations, genotypes, gene expression, and chromo12 somal structure. 

13 (2) FINAL RULE.— 

14 (A) IN GENERAL.—The Secretary shall 

15 issue a final rule not later than the date that 

16 is 3 years after the date of enactment of this 

17 Act, which shall be effective 1 year after the 

18 date such rule is issued. 

19 (B) CONTENT.—Such final rule shall in20 clude standards for proficiency testing of such 

21 laboratory-developed tests, as provided under 

22 section 353 of the Public Health Service Act 

23 (42 U.S.C. 263a). 

24 (3) EFFECT OF FAILURE TO ISSUE FINAL

25 RULE.—If the Secretary fails to issue the final rule 


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1 on or before the date that is 3 years after the date 

2 of enactment of this Act, such laboratory-developed 

3 tests shall be subject to the requirements of such 

4 section 520(f) after such date and until such final 

5 rule becomes effective. 

6 SEC. 8. ENHANCED REIMBURSEMENT UNDER FEDERAL 

7 HEALTH PROGRAMS. 

8 The Secretary shall develop a mechanism to provide 

9 enhanced reimbursement under Federal health programs 

10 for in vitro diagnostic products and laboratory-developed 

11 tests that are cleared under section 510(k) of the FFDCA 

12 (21 U.S.C. 360(k)), or approved under section 515 or 

13 520(m) of such Act (21 U.S.C. 360e or 21 U.S.C. 360j). 

14 SEC. 9. AUTHORIZATION OF APPROPRIATIONS. 

15 There are authorized to be appropriated such sums 

16 as may be necessary for each of fiscal years 2007 through 

17 2010 to carry out this Act. 

Æ 


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