[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 736 Introduced in Senate (IS)]







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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Laboratory Test Improvement Act''.

SEC. 2. DEFINITIONS.

    (a) In General.--
            (1) Federal food, drug, and cosmetic act.--Section 201 of 
        the Federal Food, Drug, and Cosmetic Act (referred to in this 
        Act as the ``FFDCA'') (21 U.S.C. 321) is amended by adding at 
        the end the following:
    ``(rr) Definitions Related to Laboratory-Developed Tests.--
            ``(1) Analytical validity.--The term `analytical validity', 
        with respect to a laboratory-developed test, means the extent 
        to which the test can be used to measure accurately and 
        reliably the property or characteristic that the test is 
        intended to measure.
            ``(2) Clinical validity.--The term `clinical validity', 
        with respect to a laboratory-developed test, means the extent 
        to which the test can be used for its intended use.
            ``(3) Direct-to-consumer test.--The term `direct-to-
        consumer test' means a laboratory-developed test that is not a 
        prescription test.
            ``(4) Intended use.--The term `intended use', with respect 
        to a laboratory-developed test, includes--
                    ``(A) determining predisposition of an individual 
                to a disease or condition;
                    ``(B) aiding diagnosis of a disease or condition of 
                an individual;
                    ``(C) aiding decision-making on how to treat a 
                disease or condition of an individual;
                    ``(D) aiding preimplantation genetic diagnosis;
                    ``(E) determining a characteristic of a human 
                embryo or a human fetus;
                    ``(F) determining whether an individual is a 
                carrier of an allele associated with a disease or 
                condition; or
                    ``(G) otherwise obtaining information related to 
                health or disease prevention (including nutrition) for 
                an individual.
            ``(5) In vitro diagnostic product.--The term `in vitro 
        diagnostic product' shall have the meaning given the term in 
        section 809.3(a) of title 21, Code of Federal Regulations (or 
        successor regulation).
            ``(6) Laboratory-developed test.--
                    ``(A) In general.--The term `laboratory-developed 
                test' means--
                            ``(i) the use of analytical methods 
                        developed by a laboratory to process a 
                        biological specimen, whether at 1 laboratory 
                        site or multiple sites, to report a test result 
                        to a health care practitioner, a patient, or a 
                        consumer; and
                            ``(ii) includes an in vitro diagnostic 
                        product that the laboratory has modified, 
                        unless such modification requires preclearance 
                        or preapproval of such modified in vitro 
                        diagnostic product under this Act.
                    ``(B) Exception.--The term `laboratory-developed 
                test' does not include--
                            ``(i) the processing of a biological 
                        specimen to--
                                    ``(I) determine paternity;
                                    ``(II) aid in forensics; or
                                    ``(III) conduct research if the 
                                result of the test is not reported to a 
                                health care provider, a patient, or a 
                                consumer;
                            ``(ii) an in vitro diagnostic product; or
                            ``(iii) an analyte specific reagent, as 
                        defined in section 864.4020 of title 21, Code 
                        of Federal Regulations (or successor 
                        regulation).
            ``(7) Manufacturer.--The term `manufacturer', with respect 
        to a laboratory-developed test, means the laboratory that 
        performs the test to process a biological specimen.
            ``(8) Prescription test.--The term `prescription test' 
        means a laboratory-developed test that is used to process a 
        biological specimen only upon the written or oral 
        authorization, based on a practitioner-patient relationship 
        that is valid under applicable Federal and State laws, of a 
        practitioner licensed by law to administer or use such test.
            ``(9) Type.--A laboratory-developed test shall be 
        considered of the same `type' as an in vitro diagnostic product 
        if the test and the product--
                    ``(A) use similar analytical methods;
                    ``(B) measure the same, or clinically comparable, 
                properties or characteristics; and
                    ``(C) have the same intended use.''.
            (2) Application of definitions.--Any term that is used in 
        this Act that is defined in subsection (rr) of such section 201 
        (as added by paragraph (1)) shall, for purposes of this Act, 
        have the meaning given such term in such subsection (rr).
    (b) Implementation.--A laboratory-developed test that is a direct-
to-consumer test on the date of enactment of this Act shall be deemed 
to be a prescription test if, on the date that is 60 days after the 
date of enactment of this Act and thereafter, such test satisfies the 
requirements of this Act to be a prescription test.

SEC. 3. LABORATORY-DEVELOPED TESTS DEEMED MEDICAL DEVICES.

    Section 520 of the FFDCA (21 U.S.C. 360j) is amended by adding at 
the end the following:
    ``(o) Laboratory-Developed Tests.--Any laboratory-developed test 
shall be deemed to be a device under section 201(h).''.

SEC. 4. REPORTING ON AND PUBLIC DISCLOSURE ABOUT LABORATORY-DEVELOPED 
              TESTS.

    (a) Labeling of Intended Use and Regulatory Status of Laboratory-
Developed Tests and Test Results.--
            (1) In general.--Section 520(o) of the FFDCA, as added by 
        section 3, is amended by--
                    (A) striking ``Tests.--Any'' and inserting the 
                following: ``Tests.--
            ``(1) In general.--Any''; and
                    (B) adding at the end the following:
            ``(2) Test results; labeling.--
                    ``(A) In general.--Any statement by the 
                manufacturer of the result of a laboratory-developed 
                test reported to a health care practitioner, a patient, 
                or a consumer, and any labeling for the test, shall 
                prominently and conspicuously include--
                            ``(i) the intended use of the test; and
                            ``(ii) if the test has not been cleared or 
                        approved under this Act for such intended use, 
                        a statement that the test has not been cleared 
                        or approved under this Act for such intended 
                        use.
                    ``(B) Effect.--The statement required under 
                subparagraph (A) shall not include a statement that the 
                test is investigational or not lawfully marketed.''.
            (2) Implementation.--The requirements of paragraph (2) of 
        such section 520(o) shall take effect on the date that is 60 
        days after the date of enactment of this Act.
    (b) Registration of Manufacturers and Listing of Laboratory-
Developed Tests.--The requirements of section 510 of the FFDCA (21 
U.S.C. 360) with respect to the registration of the manufacturer of a 
laboratory-developed test and the listing of a laboratory-developed 
test shall take effect on the date that is 270 days after the date of 
enactment of this Act.
    (c) Adverse Event Reporting for Laboratory-Developed Tests.--The 
requirements of section 519 of the FFDCA (21 U.S.C. 360i) with respect 
to records and reports on a laboratory-developed test shall take effect 
on the date that is 1 year after the date of enactment of this Act.
    (d) Public Database of Information on Validity of Laboratory-
Developed Tests.--
            (1) In general.--Section 520(o) of the FFDCA, as amended by 
        subsection (a), is amended by adding at the end the following:
            ``(3) Database on information of analytical and clinical 
        validity.--
                    ``(A) In general.--
                            ``(i) Submission.--Unless a laboratory-
                        developed test is cleared under section 510(k) 
                        or approved under section 515 or 520(m) for its 
                        intended use, the manufacturer of the test 
                        shall electronically submit to the Secretary 
                        information (in a form specified by the 
                        Secretary and certified as truthful and 
                        accurate) on the analytical and clinical 
                        validity of the test for its intended use.
                            ``(ii) Analytic intended use.--If the 
                        intended use of a laboratory-developed test is 
                        limited solely to the measurement of an 
                        analytical property or characteristic, the 
                        manufacturer of the test shall not submit any 
                        information with respect to the clinical 
                        validity of the test under clause (i) other 
                        than the following statement: `This test is 
                        intended to measure only the property or 
                        characteristic that is reported as a result of 
                        use of the test. The test is not intended to be 
                        used to diagnose or screen for any disease or 
                        condition, or to otherwise aid in decision-
                        making with respect to health, and this 
                        laboratory makes no representations as to its 
                        usefulness for any such purpose.'.
                    ``(B) Inclusion.--The Secretary shall provide for 
                the automated inclusion of the information submitted 
                under subparagraph (A) in a database of such 
                information on all laboratory-developed tests that 
                shall be available to, and searchable by, the public on 
                the Internet website of the Food and Drug 
                Administration.
                    ``(C) Notice.--The Secretary may give written 
                notice to the manufacturer of a laboratory-developed 
                test that--
                            ``(i) the information submitted by the 
                        manufacturer for such test under subparagraph 
                        (A)--
                                    ``(I) does not adequately 
                                demonstrate the analytical validity of 
                                the test for its intended use;
                                    ``(II) does not adequately 
                                summarize the peer-reviewed biomedical 
                                literature about the clinical validity 
                                of the test for its intended use;
                                    ``(III) relies on, or includes, 
                                information or data on the clinical 
                                validity of the test for its intended 
                                use that has not been published in a 
                                peer-reviewed biomedical journal;
                                    ``(IV) does not adequately 
                                demonstrate the clinical validity of 
                                the test for its intended use; or
                                    ``(V) does not demonstrate that the 
                                analytical validity or the clinical 
                                validity of such test for its intended 
                                use is comparable to the analytical 
                                validity or the clinical validity, as 
                                the case may be, of an in vitro 
                                diagnostic product of the same type 
                                that has been cleared under section 
                                510(k) or approved under section 515 or 
                                section 520(m); and
                            ``(ii) information about an intended use 
                        that is not limited solely to the measurement 
                        of an analytical property or characteristic, as 
                        provided for in the statement described under 
                        subparagraph (A)(ii), has been included--
                                    ``(I) with a result of the test 
                                reported by the manufacturer to a 
                                health care practitioner, a patient, or 
                                a consumer; or
                                    ``(II) in labeling for the test.
                    ``(D) Second notice.--The Secretary shall provide 
                to the manufacturer of a laboratory-developed test that 
                has received a notice under subparagraph (C) a second 
                notice if--
                            ``(i) the manufacturer has submitted 
                        corrected information under subparagraph (A) 
                        for such test within 90 days of having received 
                        a notice under subparagraph (C); and
                            ``(ii)(I) 1 or more of subclauses (I) 
                        through (V) of subparagraph (C)(i) applies to 
                        such corrected information; or
                            ``(II) the manufacturer has failed to 
                        include in such corrected information necessary 
                        information about the intended use referred to 
                        in subparagraph (C)(ii).''.
            (2) Implementation.--
                    (A) Electronic submission.--Not later than 1 year 
                after the date of enactment of this Act, the Secretary 
                of Health and Human Services (referred to in this Act 
                as the ``Secretary'') shall develop a portal on the 
                Internet website of the Food and Drug Administration 
                through which the information required by paragraph (3) 
                of such section 520(o), as added by this subsection, 
                shall be submitted to the Secretary.
                    (B) Electronic certification.--The Secretary shall 
                require as a condition of submitting the information 
                required by paragraph (3) of such section 520(o) that 
                an individual submitting such information certify 
                electronically the truthfulness and accuracy of such 
                information.
                    (C) Publicly accessible database of information.--
                Not later than 1 year after the date of enactment of 
                this Act, the Secretary shall develop a database of the 
                information submitted under paragraph (3) of such 
                section 520(o) that shall be available to, and 
                searchable by, the public on the Internet website of 
                the Food and Drug Administration and to which such 
                information shall be automatically included upon 
                submission.
                    (D) Literature reviews and clinical validity.--Not 
                later than 270 days after the date of enactment of this 
                Act, the Secretary shall issue a guidance document to 
                facilitate the use of reviews of the peer-reviewed 
                biomedical literature and other information and data 
                about the clinical validity of laboratory-developed 
                tests and in vitro diagnostic products when clearing or 
                approving such tests and products under the FFDCA.
                    (E) Modifications.--Not later than 18 months after 
                the date of enactment of this Act, the Secretary shall 
                issue a guidance document to clarify when modifications 
                to a laboratory-developed test require updating of the 
                information submitted under paragraph (3) of such 
                section 520(o). To the extent practicable, under such 
                guidance, modifications to a laboratory-developed test 
                under such paragraph (3) shall be required under the 
                same circumstances as the submission of a report under 
                section 510(k) of the FFDCA (21 U.S.C. 360(k)) or a 
                supplemental premarket application under section 515 of 
                the FFDCA (21 U.S.C. 360e) is required for 
                modifications to a laboratory-developed test or an in 
                vitro diagnostic product that is cleared or approved 
                under the FFDCA.
                    (F) Submission of information.--The requirements of 
                paragraph (3) of such section 520(o) shall take effect 
                on the date that is 18 months after the date of 
                enactment of this Act.

SEC. 5. CLASSIFICATION AND FDA REVIEW OF LABORATORY-DEVELOPED TESTS.

    (a) Classification of Laboratory-Developed Tests.--
            (1) In general.--Section 520(o) of the FFDCA, as amended by 
        section 4, is amended by adding at the end the following:
            ``(4) Classification.--
                    ``(A) In general.--Notwithstanding section 
                513(f)(1), a laboratory-developed test shall be 
                classified in class II, as defined in section 
                513(a)(1)(B), subject to both general and special 
                controls.
                    ``(B) Class iii.--Notwithstanding subparagraph (A), 
                a laboratory-developed test shall be classified in 
                class III if--
                            ``(i) the Secretary gives notice to the 
                        manufacturer of such test that such test meets 
                        the requirements of section 513(a)(1)(C) to be 
                        in class III;
                            ``(ii)(I) such test is intended for use in 
                        the diagnosis of a contagious disease or 
                        condition that is highly likely to result in a 
                        fatal outcome; and
                            ``(II) prompt, accurate diagnosis of the 
                        disease or condition offers the opportunity to 
                        mitigate the public health impact of the 
                        disease or condition; or
                            ``(iii) such test is intended for use in 
                        donor screening of a disease or condition for 
                        which the Secretary has recommended or required 
                        testing to--
                                    ``(I) safeguard the blood supply;
                                    ``(II) establish the safe use of 
                                blood and blood products; or
                                    ``(III) establish the safe use of 
                                tissue and tissue products.
                    ``(C) Class i.--Notwithstanding subparagraph (A), 
                the Secretary may classify a laboratory-developed test 
                in class I if such test meets the requirements of 
                section 513(a)(1)(A) to be in class I.''.
            (2) Implementation.--
                    (A) Class iii.--The Secretary may not give notice 
                under paragraph (4)(B)(i) of such section 520(o) to the 
                manufacturer of a laboratory-developed test that is not 
                a direct-to-consumer test before the date that is 2 
                years after the date of enactment of this Act.
                    (B) Class i.--The Secretary may not classify a type 
                of laboratory-developed test in class I under paragraph 
                (4)(C) of such section 520(o) before the date that is 
                18 months after the date of enactment of this Act.
                    (C) Special controls.--Not later than 2 years after 
                the date of enactment of this Act, the Secretary shall 
                identify in guidance documents whether there are 
                special controls to which all laboratory-developed 
                tests, subcategories of such tests, or specific such 
                tests shall be subject under section 514 of the FFDCA 
                (21 U.S.C. 360d).
    (b) Clearance and Approval of Laboratory-Developed Tests.--
            (1) In general.--Section 520(o) of the FFDCA, as amended by 
        subsection (a), is amended by adding at the end the following:
            ``(5) Application of section 510(k), section 515, or 
        section 520(m).--A laboratory-developed test shall be exempt 
        from the requirements of section 510(k), section 515, and 
        section 520(m), except that the manufacturer of a laboratory-
        developed test shall submit--
                    ``(A) a report under section 510(k) if--
                            ``(i) the test is classified in class II; 
                        and
                            ``(ii) the test is--
                                    ``(I) a direct-to-consumer test;
                                    ``(II) a test for which the 
                                manufacturer has not submitted 
                                corrected information under paragraph 
                                (3)(A) within 90 days of having 
                                received a notice under paragraph 
                                (3)(C); or
                                    ``(III) a test for which the 
                                Secretary has given second notice under 
                                paragraph (3)(D) to the manufacturer of 
                                such test; or
                    ``(B) an application under section 515 or section 
                520(m), as appropriate, if such test is classified in 
                class III.''.
            (2) Implementation.--
                    (A) Direct-to-consumer tests.--The requirement to 
                submit a report under section 510(k) of the FFDCA (21 
                U.S.C. 360(k)) or an application under section 515 or 
                section 520(m) of the FFDCA (21 U.S.C. 360e or 
                360j(m)), as the case may be, under paragraph (5) of 
                such section 520(o), as added by this subsection, for a 
                direct-to-consumer test as provided in clause (ii) of 
                such paragraph shall take effect on the date that is 
                180 days after the date of enactment of this Act.
                    (B) Class ii prescription tests.--The requirement 
                to submit a report under such section 510(k) under 
                paragraph (5) of such section 520(o) for a class II 
                prescription device shall take effect on the date that 
                is 90 days after the date of the notice to the 
                manufacturer of such test referred to in subclause (II) 
                or (III) of paragraph (5)(A)(ii) of such section 
                520(o).
                    (C) Class iii prescription tests.--The requirement 
                to submit an application under such section 515 or such 
                section 520(m) under paragraph (5) of such section 
                520(o) for a class III prescription device shall take 
                effect on the date that is--
                            (i) 1 year after the date on which the 
                        Secretary gives notice to the manufacturer of 
                        such test that such test is classified in class 
                        III as provided under paragraph (4)(B)(i) of 
                        such section 520(o); or
                            (ii) 1 year after the date of enactment of 
                        this Act if such test is classified in class 
                        III as provided under clause (ii) or (iii) of 
                        paragraph (4)(B) of such section 520(o).
    (c) Removal of Laboratory-Developed Tests From the Market.--Section 
520(o) of the FFDCA, as amended by subsection (b), is amended by adding 
at the end the following:
            ``(6) Failure to make submission; nonclearance or 
        disapproval.--The manufacturer of a laboratory-developed test--
                    ``(A) may commence and continue to report, or offer 
                to report, a result of such test to any person until 
                the date that--
                            ``(i)(I) the manufacturer is required to 
                        submit information under paragraph (3)(A); and
                            ``(II) the manufacturer fails to submit 
                        such information;
                            ``(ii)(I) the manufacturer has received a 
                        notice under paragraph (3)(C); and
                            ``(II) the manufacturer has failed to 
                        submit corrected information under paragraph 
                        (3)(A);
                            ``(iii)(I) the manufacturer is required to 
                        submit under paragraph (5)--
                                    ``(aa) a report with respect to 
                                such test under section 510(k); or
                                    ``(bb) an application under section 
                                515 or 520(m); and
                            ``(II) the manufacturer fails to submit 
                        such report or application, as the case may be;
                            ``(iv) the report with respect to such test 
                        under section 510(k) is not cleared by the 
                        Secretary; or
                            ``(v) approval of such application is 
                        denied by the Secretary; and
                    ``(B) shall immediately cease to report, or offer 
                to report, a result of such test to any person on such 
                date.''.

SEC. 6. INSPECTION OF LABORATORIES; EXEMPTION FROM REQUIREMENT FOR FDA 
              TO INSPECT EVERY 2 YEARS.

    Section 520(o) of the FFDCA, as amended by section 4, is amended by 
adding at the end the following:
            ``(7) Inspection.--The requirement of section 510(h) with 
        respect to the inspection of a registered establishment at 
        least once in every 2-year period shall not apply to a 
        manufacturer of a laboratory-developed test that is classified 
        in class II, unless section 510(h) applies to such 
        establishment because of a drug or another device classified in 
        class II or III.''.

SEC. 7. THE CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF 1988.

    (a) Compliance With This Act.--Compliance with the requirements 
under this Act shall have no effect on the obligation to comply with 
any requirement under section 353 of the Public Health Service Act (42 
U.S.C. 263a).
    (b) Compliance With CLIA of 1988.--Except as provided in subsection 
(c), compliance with the requirements under section 353 of the Public 
Health Service Act (42 U.S.C. 263a) shall have no effect on the 
obligation to comply with any requirement of this Act.
    (c) Good Manufacturing Practice Requirements and CLIA of 1988.--For 
a laboratory-developed test, compliance with the requirements under 
section 353 of the Public Health Service Act (42 U.S.C. 263a) shall be 
deemed to satisfy the requirements under section 520(f) of the FFDCA 
(21 U.S.C. 360j(f)) unless and until, after providing for public 
comment, the Secretary issues a final guidance document--
            (1) in which the Secretary finds that--
                    (A) compliance with the requirements under such 
                section 353 does not satisfy the requirements under 
                such section 520(f); and
                    (B) compliance with the requirements of such 
                section 520(f) are necessary to protect the public 
                health;
            (2) explaining the least burdensome approach for 
        manufacturers of laboratory-developed tests to comply with the 
        requirements of such section 520(f); and
            (3) providing for coordination of inspection efforts to 
        ensure compliance with such section 353 and such section 
        520(f).
    (d) Rulemaking by Secretary.--
            (1) Proposed rule.--Not later than 1 year after the date of 
        enactment of this Act, the Secretary shall issue a proposed 
        rule to establish a specialty area under section 353 of the 
        Public Health Service Act (42 U.S.C. 263a) for laboratory-
        developed tests to acquire genetic information, including 
        mutations, genotypes, gene expression, and chromosomal 
        structure.
            (2) Final rule.--
                    (A) In general.--The Secretary shall issue a final 
                rule not later than the date that is 3 years after the 
                date of enactment of this Act, which shall be effective 
                1 year after the date such rule is issued.
                    (B) Content.--Such final rule shall include 
                standards for proficiency testing of such laboratory-
                developed tests, as provided under section 353 of the 
                Public Health Service Act (42 U.S.C. 263a).
            (3) Effect of failure to issue final rule.--If the 
        Secretary fails to issue the final rule on or before the date 
        that is 3 years after the date of enactment of this Act, such 
        laboratory-developed tests shall be subject to the requirements 
        of such section 520(f) after such date and until such final 
        rule becomes effective.

SEC. 8. ENHANCED REIMBURSEMENT UNDER FEDERAL HEALTH PROGRAMS.

    The Secretary shall develop a mechanism to provide enhanced 
reimbursement under Federal health programs for in vitro diagnostic 
products and laboratory-developed tests that are cleared under section 
510(k) of the FFDCA (21 U.S.C. 360(k)), or approved under section 515 
or 520(m) of such Act (21 U.S.C. 360e or 21 U.S.C. 360j).

SEC. 9. AUTHORIZATION OF APPROPRIATIONS.

    There are authorized to be appropriated such sums as may be 
necessary for each of fiscal years 2007 through 2010 to carry out this 
Act.
                                 <all>