[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3207 Introduced in House (IH)]

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.

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

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Modernizing 
Laboratory Test Standards for Patients Act of 2011''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Notification for laboratory-developed tests.
Sec. 3. Amendments to the Federal Food, Drug, and Cosmetic Act.
Sec. 4. Fees.

SEC. 2. NOTIFICATION FOR LABORATORY-DEVELOPED TESTS.

    Section 353 of the Public Health Service Act (42 U.S.C. 263a) is 
amended by adding at the end the following:

``SEC. 353A. LABORATORY-DEVELOPED TESTS AND DIRECT-TO-CONSUMER DNA 
              TESTS.

    ``(a) Definitions.--In this section:
            ``(1) The term `analytical validity' means the ability of a 
        test to identify or measure the analyte or substance sought to 
        be identified or measured.
            ``(2) The term `biological product' has the meaning given 
        to such term in section 351.
            ``(3) The term `clinical validity' means the consistency 
        and accuracy with which a test identifies, measures, or 
        predicts--
                    ``(A) a disease or condition in humans; or
                    ``(B) characteristics related to an individual's 
                clinical status (including phenotype).
            ``(4) The term `direct-to-consumer DNA test' or `DTC DNA 
        test' means a test that--
                    ``(A) is intended to identify, analyze, or 
                interpret an individual's genetic characteristics for 
                purposes of predicting, assessing the risk of, 
                preventing, or mitigating any disease or condition, 
                including the prognosis or outcome of a treatment in an 
                individual; and
                    ``(B) is offered directly to, is ordered directly 
                by, and whose results are reported directly to, an 
                individual consumer, without a test request by a 
                physician or other health care provider who has an 
                established provider-patient relationship with the 
                individual consumer by which the physician or provider 
                provides health care services (other than the test in 
                question) to that individual.
            ``(5) The term `drug' has the meaning given to such term in 
        section 201 of the Federal Food, Drug, and Cosmetic Act.
            ``(6) The terms `laboratory' and `clinical laboratory' have 
        the meanings given to such terms in section 353.
            ``(7) The term `laboratory-developed test' or `LDT' means a 
        clinical laboratory test that is--
                    ``(A) developed by a clinical laboratory certified 
                under section 353;
                    ``(B) performed by--
                            ``(i) the clinical laboratory;
                            ``(ii) any entity that is owned or 
                        controlled by the clinical laboratory;
                            ``(iii) any entity that owns or controls 
                        the clinical laboratory (in this subparagraph 
                        referred to as the clinical laboratory's 
                        `parent corporation'); or
                            ``(iv) an entity that is owned or 
                        controlled by the clinical laboratory's parent 
                        corporation; and
                    ``(C)(i) performed solely to furnish clinical 
                laboratory testing services for the purpose of 
                providing information for the diagnosis, prevention, or 
                treatment of any disease or impairment of, or the 
                assessment of the health of, human beings; and
                    ``(ii) not otherwise introduced into interstate 
                commerce.
            ``(8) The term `test-offering entity' means an entity, 
        other than a laboratory certified under section 353, which 
        offers or markets direct-to-consumer DNA tests based on testing 
        performed by one or more such laboratories that are not owned 
        by the entity.
            ``(9) The term `test registry data bank' means the test 
        registry data bank established under subsection (b).
    ``(b) Test Registry Data Bank.--
            ``(1) Establishment.--Not later than one year after the 
        date of the enactment of this Act, the Secretary, in 
        consultation with the Director of the National Institutes of 
        Health, shall establish a single, publicly accessible test 
        registry data bank.
            ``(2) Process for submission.--
                    ``(A) Requirement.--Each laboratory and each test-
                offering entity that offers or markets an LDT or DTC 
                DNA test shall submit information on such LDT or DTC 
                DNA test to the Secretary for inclusion in the test 
                registry data bank.
                    ``(B) Timing.--The submission required by 
                subparagraph (A) shall occur--
                            ``(i) in the case of an LDT or DTC DNA test 
                        offered or marketed for the first time by the 
                        laboratory or the test-offering entity after 
                        the date of the enactment of this section, on 
                        or before the later of--
                                    ``(I) the date that is 10 days 
                                after the date on which the laboratory 
                                or test-offering entity first offers or 
                                markets the LDT or DTC DNA test; or
                                    ``(II) the date that is 3 months 
                                after the effective date of the 
                                regulations for carrying out this 
                                section; or
                            ``(ii) in the case of an LDT or DTC DNA 
                        test offered or marketed on or before the date 
                        of enactment of this section, not later than 6 
                        months after the effective date of the 
                        regulations for carrying out this subsection.
                    ``(C) Supplemental submissions.--
                            ``(i) In general.--With respect to a LDT or 
                        DTC DNA test offered or marketed by a 
                        laboratory or test-offering entity, such 
                        laboratory or test-offering entity shall 
                        supplement or amend information on such test in 
                        the test registry data bank as necessary to 
                        ensure that the information is accurate and 
                        current.
                            ``(ii) Submission following issuance of 
                        authorization letter.--Not later than 10 
                        working days after the Secretary issues (or is 
                        deemed to have issued) an authorization letter 
                        pursuant to subsection (c)(4)(B) or (c)(4)(F) 
                        for an LDT or a DTC DNA test, the laboratory or 
                        test-offering entity shall supplement or amend 
                        information on such test in the test registry 
                        data bank, as required by clause (i).
            ``(3) Content of submissions.--
                    ``(A) LDT or dtc dna test information.--With 
                respect to an LDT or DTC DNA test, the Secretary shall 
                require the information submitted under paragraph (2) 
                to consist of each of the following:
                            ``(i) The location of the laboratory.
                            ``(ii) The certification and licensure 
                        information of the laboratory.
                            ``(iii) The purpose of the test.
                            ``(iv) The claimed use or uses of the test.
                            ``(v) A description of the test 
                        methodology.
                            ``(vi) Information regarding the analytical 
                        validity of the test.
                            ``(vii) Information regarding the clinical 
                        validity of the test for each of its claimed 
                        uses.
                            ``(viii) Information describing the status 
                        of the test as an existing test (as described 
                        under paragraph (4)), a new test pending review 
                        (under subsection (c)), or an authorized new 
                        test (under subsection (c)(4)(B)).
                    ``(B) DTC DNA test information.--With respect to a 
                DTC DNA test, the Secretary shall require the 
                information submitted under paragraph (2) to consist of 
                the information required by subparagraph (A) and in 
                addition each of the following:
                            ``(i) The identity, location, and 
                        registration information of the test-offering 
                        entity.
                            ``(ii) The identity of the certified 
                        laboratory that will perform the test, and the 
                        certification and licensure information for 
                        such laboratory.
                            ``(iii) Information to demonstrate that the 
                        consumer will be provided with access to pre-
                        test and post-test counseling by a physician or 
                        qualified genetic counselor.
            ``(4) Review of information for existing tests.--If, upon 
        review of the information submitted under paragraph (2) for an 
        LDT or DTC DNA test that is offered or marketed on or before 
        the date of the enactment of this section, the Secretary 
        determines that there is reasonable cause to believe that there 
        is inadequate information for a determination of clinical 
        validity (as described in subsection (c)(4)(B)) of one or more 
        claimed uses of the LDT or DTC DNA test, the Secretary may 
        require that the laboratory or test-offering entity submit 
        notification under subsection (c) for each such claimed use.
    ``(c) Notification Process.--
            ``(1) Applicability.--
                    ``(A) In general.--This subsection applies to an 
                LDT or DTC DNA test only if--
                            ``(i) the test is first offered or marketed 
                        by the laboratory or the test-offering entity 
                        after the date of the enactment of this 
                        section;
                            ``(ii) the test is offered on or before the 
                        date of the enactment of this section and, 
                        after such date, is significantly modified; or
                            ``(iii) the Secretary determines under 
                        subsection (b)(4) that there is reasonable 
                        cause to believe that there is inadequate 
                        information for a determination of clinical 
                        validity of one or more claimed uses of the LDT 
                        or DTC DNA test.
                    ``(B) Significant modification.--For purposes of 
                subparagraph (A)(ii) and paragraph (2)(B), a 
                significant modification means--
                            ``(i) offering or marketing the test for a 
                        new claimed use;
                            ``(ii) any significant change to the 
                        fundamental testing methodology; and
                            ``(iii) any change that significantly 
                        affects the clinical validity of the test.
            ``(2) Notification submission.--
                    ``(A) Premarket notification.--Before marketing an 
                LDT or DTC DNA test, a laboratory or test-offering 
                entity shall submit a premarket notification to the 
                Secretary.
                    ``(B) Supplemental notification for significant 
                modifications.--After any significant modification (as 
                described in paragraph (1)(B)) to an LDT or DTC DNA 
                test for which a premarket notification under 
                subparagraph (A) has been submitted or for which no 
                such premarket notification was required, the 
                laboratory or test-offering entity shall submit a 
                supplemental notification for the LDT or DTC DNA test.
                    ``(C) Supplemental notification in case of 
                inadequate evidence.--If a laboratory or test-offering 
                entity determines, at any time, that the evidence of 
                clinical validity is inadequate to support one or more 
                of the claimed uses in a notification under 
                subparagraph (A) or (B), then not later than 30 
                calendar days after making such determination the 
                laboratory or test-offering entity shall--
                            ``(i) submit a supplemental notification 
                        containing additional information supporting 
                        the clinical validity of the claimed uses; or
                            ``(ii) submit a supplemental notification 
                        withdrawing one or more claimed uses.
                    ``(D) Concurrent submission for test registry data 
                bank.--Subject to the deadlines and other requirements 
                of subsection (b), a laboratory or test-offering entity 
                may submit information for inclusion in the test 
                registry data bank under subsection (b) concurrently 
                with a notification under this paragraph.
                    ``(E) Acknowledgment of receipt.--Upon receipt of a 
                notification under this paragraph, the Secretary shall 
                send written notice to the submitter--
                            ``(i) acknowledging receipt of the 
                        notification; and
                            ``(ii) indicating the date on which the 
                        Secretary received the notification.
            ``(3) Content of notifications.--
                    ``(A) LDT notifications.--With respect to a 
                premarket or supplemental notification for an LDT under 
                paragraph (2)(A) or (2)(B), the Secretary shall require 
                the notification to consist of each of the types of 
                information listed in clauses (i) through (vii) of 
                subsection (b)(3)(A).
                    ``(B) DTC DNA test notifications.--With respect to 
                a premarket or supplemental notification for a DTC DNA 
                test under paragraph (2)(A) or (2)(B), the Secretary 
                shall require the notification to consist of each of 
                the following:
                            ``(i) The types of information listed in 
                        clauses (i) and (ii) of subsection (b)(3)(B).
                            ``(ii) If informed consent for the 
                        performance of the test is required by State or 
                        Federal law, a copy of the standard informed 
                        consent document to be signed by the individual 
                        to signify such consent.
                            ``(iii) Information to demonstrate that the 
                        consumer will be provided with access to pre-
                        test and post-test counseling by a physician or 
                        qualified genetic counselor.
                    ``(C) Tests offered or marketed only by 
                laboratory.--If a laboratory offers a DTC DNA test that 
                is not offered or marketed by a test-offering entity--
                            ``(i) the laboratory is only required to 
                        submit one premarket notification under 
                        paragraph (2)(A) for the test; and
                            ``(ii) such notification shall include, as 
                        applicable, the information required by 
                        subparagraph (A) for an LDT and the information 
                        required by subparagraph (B) for a DTC DNA 
                        test.
                    ``(D) Tests previously cleared or approved by 
                fda.--Notwithstanding the clearance or approval of an 
                LDT or DTC DNA test under the Federal, Food, Drug, and 
                Cosmetic Act before the date of the enactment of this 
                Act, any review by the Department of Health and Human 
                Services of the LDT or DTC DNA test (or any 
                modification thereto) that occurs on or after such date 
                shall be conducted exclusively under this section and 
                not under the Federal Food, Drug, and Cosmetic Act.
            ``(4) Review and authorization of notifications.--
                    ``(A) In general.--Not later than 90 calendar days 
                after the date on which the Secretary receives a 
                notification under paragraph (2)(A), (2)(B), or 
                (2)(C)(i), the Secretary shall, with respect to each 
                claimed use of a test, review the notification, make a 
                determination as to whether the notification under 
                paragraph (2) demonstrates clinical validity, and--
                            ``(i) issue an authorization letter in 
                        accordance with subparagraph (B); or
                            ``(ii) provide notice under subparagraph 
                        (C)(i) that the submitted information is not 
                        adequate to demonstrate clinical validity.
                    ``(B) Authorization letters; determination of 
                clinical validity.--
                            ``(i) Issuance of authorization letters.--
                        If the Secretary determines, with respect to 
                        one or more claimed uses of a test, that a 
                        notification under paragraph (2) demonstrates 
                        clinical validity, the Secretary shall issue an 
                        authorization letter for such claimed uses to 
                        the submitter of the notification.
                            ``(ii) Standard for issuance.--The 
                        Secretary shall issue such an authorization 
                        letter if the notification provides reasonable 
                        assurance of the clinical validity of such 
                        claimed uses. One or more studies published in 
                        a peer-reviewed journal that is generally 
                        recognized to be of national scope and 
                        reputation, or data from unpublished studies 
                        conducted by the submitter or for which the 
                        submitter has obtained a right of reference, 
                        shall be sufficient to constitute reasonable 
                        assurance of the clinical validity of the 
                        claimed uses.
                            ``(iii) Prohibition.--The Secretary shall 
                        not require a laboratory or test-offering 
                        entity to include (for purposes of 
                        demonstrating clinical validity) evidence of--
                                    ``(I) clinical utility; or
                                    ``(II) the ability of a physician, 
                                provider, or consumer to interpret a 
                                test result or to apply a test result 
                                to achieve a particular health or 
                                clinical outcome.
                            ``(iv) Partial demonstration of clinical 
                        validity.--If a notification under paragraph 
                        (2) demonstrates clinical validity for some but 
                        not all of the claimed uses of a test, the 
                        Secretary shall issue an authorization letter 
                        under clause (i) with respect to each claimed 
                        use for which clinical validity has been 
                        demonstrated.
                    ``(C) Notice of inadequacy; reply; final 
                determination.--If the Secretary determines, with 
                respect to one or more claimed uses of a test, that a 
                notification under paragraph (2) is not adequate to 
                demonstrate clinical validity--
                            ``(i) the Secretary shall notify the 
                        submitter about such determination and shall 
                        specify in the notice the information which is 
                        required to demonstrate clinical validity for 
                        each such clinical use;
                            ``(ii) not later than the 90-calendar-day 
                        period following receipt of a notice under 
                        clause (i), the submitter may file a response 
                        with the Secretary; and
                            ``(iii) not later than 60 calendar days 
                        after receipt of a response under clause (ii), 
                        the Secretary shall issue a final determination 
                        regarding the clinical validity of each 
                        clinical use subject to the notice under clause 
                        (i).
                    ``(D) Offering or marketing test pending agency 
                action.--
                            ``(i) Applicable time period.--This 
                        subparagraph applies, with respect to a claimed 
                        use of a test, during the period between--
                                    ``(I) submission of a notification 
                                under paragraph (2); and
                                    ``(II) final action by the 
                                Secretary on such notification under 
                                subparagraph (A)(i), (C)(iii), or (G), 
                                as applicable, or the failure to file a 
                                response under clause (ii) of 
                                subparagraph (C) within the period 
                                specified in such clause.
                            ``(ii) Continued offering or marketing.--
                        During a period described in clause (i) with 
                        respect to any claimed use of a test, the 
                        laboratory or test-offering entity may continue 
                        to offer or market the test with respect to 
                        such claimed use as if the Secretary had issued 
                        an authorization letter under subparagraph (B) 
                        for such claimed use.
                            ``(iii) Relation to test registry data 
                        bank.--This subparagraph shall not be construed 
                        to affect the Secretary's authority under 
                        subsection (b).
                            ``(iv) Exception for withdrawn 
                        notification.--Clause (ii) does not apply with 
                        respect to a claimed use of a test for which 
                        notification has been withdrawn under paragraph 
                        (2)(C)(ii).
                    ``(E) Marketing pending authorization.--Beginning 
                on the date of submission of a notification under 
                paragraph (2)(A), (2)(B), or (2)(C)(i), the laboratory 
                or test-offering entity may offer or market the test 
                while the notification is pending, provided that the 
                required information about the test has first been 
                submitted to the test registry data bank as required by 
                subsection (b).
                    ``(F) Failure by secretary to make a 
                determination.--The Secretary is deemed to have issued 
                an authorization letter under subparagraph (B) with 
                respect to a claimed use of a test if--
                            ``(i) the 90-day period under subparagraph 
                        (A) expires and the Secretary has not, with 
                        respect to such claim, issued an authorization 
                        letter under subparagraph (B) or provided 
                        notice under subparagraph (C)(i); or
                            ``(ii) the 60-day period under subparagraph 
                        (C)(iii) expires and the Secretary has not, 
                        with respect to such claim, issued a final 
                        determination regarding clinical validity.
                    ``(G) Risk of immediate harm.--
                            ``(i) Order.--The Secretary may order a 
                        laboratory or test-offering entity to cease 
                        offering or marketing a test with respect to 
                        one or more claimed uses if the Secretary makes 
                        a final determination that--
                                    ``(I) the information submitted in 
                                notifications under paragraph (2) for 
                                such uses does not demonstrate the 
                                clinical validity of the claimed uses; 
                                and
                                    ``(II) the test poses a risk of 
                                immediate harm to the public health 
                                with respect to such claimed uses.
                            ``(ii) Effective upon receipt.--An order 
                        under clause (i) shall be effective immediately 
                        upon receipt by the laboratory or test-offering 
                        entity.
                            ``(iii) Contents.--An order under clause 
                        (i) shall set forth with specificity the 
                        reasons for the determinations under each of 
                        subclauses (I) and (II) of clause (i) and shall 
                        notify the recipient of the right to appeal the 
                        Secretary's determinations and the procedures 
                        for such appeal.
            ``(5) Administrative appeal.--If the Secretary makes a 
        final determination under paragraph (4)(A) or (4)(C)(iii) that 
        clinical validity has not been established, or issues an order 
        under paragraph (4)(G), with respect to one or more clinical 
        uses of a test, the laboratory or test-offering entity may, not 
        later than 30 days after the date of the final determination or 
        issuance of the order, bring an administrative appeal by 
        selecting the procedures set forth in one (and only one) of the 
        following subparagraphs:
                    ``(A) Dispute resolution by advisory committee.--
                            ``(i) In general.--The laboratory or test-
                        offering entity may seek dispute resolution by 
                        referral to an advisory committee of non-
                        governmental experts who are qualified by 
                        training and experience to make a 
                        recommendation regarding the clinical validity 
                        of the claimed uses of the test.
                            ``(ii) Process.--In the case of an appeal 
                        under this subparagraph, the committee shall 
                        hold a hearing to consider the evidence of 
                        clinical validity, shall keep a written record 
                        of the hearing, and shall provide an 
                        opportunity for testimony from experts 
                        presented by both the appellant and the 
                        Secretary. The committee shall make a 
                        recommendation to the Secretary at the 
                        conclusion of the hearing. The Secretary shall 
                        consider the record and the recommendations of 
                        the committee and shall make a decision within 
                        90 calendar days after the conclusion of the 
                        hearing.
                            ``(iii) Selection of committee members.--
                        The members of an advisory committee under this 
                        subparagraph shall be selected by the Secretary 
                        from among individuals, including physicians, 
                        with demonstrated expertise in and experience 
                        with the analytical validity and clinical 
                        validity of laboratory-developed tests and the 
                        literature related to the validity of such 
                        tests.
                    ``(B) Review by administrative law judge.--The 
                laboratory or test-offering entity may seek review by 
                an administrative law judge pursuant to procedures 
                established by the Secretary.
            ``(6) Final agency action.--
                    ``(A) In general.--Subject to judicial review under 
                subsection (h), upon final agency action under 
                paragraphs (4) and (5) determining that clinical 
                validity of one or more claimed uses of a test has not 
                been established or upon issuance of an order under 
                paragraph (4)(G) for one or more claimed uses of a 
                test, the laboratory or test-offering entity shall 
                immediately--
                            ``(i) cease offering the test for such 
                        uses; and
                            ``(ii) cease reporting test results to 
                        health care providers or individuals for such 
                        uses.
                    ``(B) Reporting for certain specimens.--For 
                specimens that have been received or tests that have 
                been ordered but results not yet reported, the 
                laboratory or test-offering entity shall notify the 
                person who ordered the test that test results will not 
                be reported because clinical validity for such clinical 
                uses has not been established.
            ``(7) Companion diagnostic tests.--An LDT may be authorized 
        under this subsection for a claimed use as a companion 
        diagnostic test for purposes of specifying the use of a drug or 
        biological product for therapeutic purposes. An LDT for use as 
        a companion diagnostic test shall be reviewed exclusively 
        pursuant to the requirements of this section and not under the 
        Federal Food, Drug, and Cosmetic Act.
    ``(d) Registration by Test-Offering Entities.--
            ``(1) Registration requirement.--A test-offering entity may 
        not offer or market a DTC DNA test unless the entity registers 
        with the Secretary in accordance with this subsection and 
        maintains such registration in effect.
            ``(2) Timing.--
                    ``(A) In general.--Except as provided in 
                subparagraph (B), registration by a test-offering 
                entity under this subsection shall occur before--
                            ``(i) the entity offers or markets a DTC 
                        DNA test; or
                            ``(ii) submits a premarket notification 
                        under subsection (c)(2)(A).
                    ``(B) Exceptions.--
                            ``(i) Entities already offering or 
                        marketing tests.--In the case of a test-
                        offering entity that is offering or marketing a 
                        DTC DNA test as of the date on which the 
                        Secretary establishes interim procedures for 
                        carrying out this subsection under paragraph 
                        (4)(B), registration by the entity shall occur 
                        not later than 60 days after such date.
                            ``(ii) Authority to establish other 
                        exceptions.--The Secretary may establish 
                        exceptions to clause (i) in the regulations 
                        required by paragraph (4)(A).
            ``(3) Inapplicability to certified laboratories.--If a 
        certified laboratory offers a DTC DNA test that is not offered 
        or marketed by a test-offering entity, such laboratory--
                    ``(A) is not required to register as a test-
                offering entity under this subsection; and
                    ``(B) shall not, because of offering such test, be 
                regulated as a test-offering entity instead of a 
                laboratory under section 353 or this section.
            ``(4) Regulations.--
                    ``(A) In general.--In promulgating regulations 
                under subsection (i)(1), the Secretary shall include 
                regulations governing registration under this 
                subsection.
                    ``(B) Interim procedures.--The Secretary shall 
                establish interim procedures governing registration 
                under this subsection during the period beginning on 
                the date of the enactment of this section and ending on 
                the effective date of the regulations required by 
                subparagraph (A). The Secretary shall establish such 
                interim procedures not later than 90 calendar days 
                after the date of the enactment of this section. The 
                Secretary may establish such interim procedures by a 
                guidance document or other means of public 
                notification.
    ``(e) Information Regarding Test Capabilities and Limitations.--
            ``(1) Inclusion of information.--A laboratory or test-
        offering entity that offers an LDT or a DTC DNA test shall 
        include in its test result reports, directories of services, 
        marketing materials, and advertising--
                    ``(A) truthful, accurate, and nondeceptive 
                information regarding the capabilities and limitations 
                of the tests; and
                    ``(B) a statement that the test has been validated 
                by the laboratory performing the test in accordance 
                with the requirements of the Clinical Laboratory 
                Improvement Amendments (referred to in this section as 
                `CLIA').
            ``(2) Claims not imputed to laboratory.--A laboratory shall 
        not be subject to a sanction or other action under section 353 
        or this section because of a claim made by a test-offering 
        entity.
    ``(f) Reporting.--
            ``(1) Death or serious injury report.--If a laboratory or 
        test-offering entity that offers or markets an LDT or DTC DNA 
        test has reason to believe that the test may have caused or 
        contributed to a death or serious bodily injury--
                    ``(A) the laboratory or entity shall promptly 
                investigate the incident;
                    ``(B) if the laboratory or entity determines that 
                the LDT or DTC DNA test may have caused or contributed 
                to a death or serious bodily injury, within 10 working 
                days of making such determination the laboratory or 
                entity shall report the incident to the Secretary; and
                    ``(C) the laboratory or entity shall provide such 
                additional information regarding the incident or the 
                test associated with the incident as the Secretary may 
                request.
            ``(2) Complaint records.--A laboratory or test-offering 
        entity that offers or markets an LDT or DTC DNA test shall 
        maintain a record of--
                    ``(A) each incident investigated under paragraph 
                (1)(A), and each report made under paragraph (1)(B), 
                with respect to the test; and
                    ``(B) for any incident that was determined under 
                paragraph (1)(B) not to meet the requirements for 
                reporting to the Secretary, the basis for such 
                determination.
            ``(3) No admission of causation.--A report submitted under 
        this subsection with respect to an event shall not be treated 
        as an admission that the test, or the laboratory or its 
        employees, caused or contributed to the event.
    ``(g) Sanctions.--
            ``(1) Applicability of sanctions to clinical 
        laboratories.--
                    ``(A) Intermediate sanctions.--The reference in 
                section 353(h)(1) to the `requirements for the issuance 
                of a certificate' is deemed to include the requirements 
                of this section.
                    ``(B) Suspension, revocation, and limitation of 
                certificate.--
                            ``(i) The reference in section 353(i)(1)(A) 
                        to `misrepresentation in obtaining the 
                        certificate' is deemed to include any 
                        misrepresentation of information in a 
                        submission to the Secretary pursuant to this 
                        section.
                            ``(ii) The reference in section 
                        353(i)(1)(F) to `any provisions of this 
                        section' is deemed to include any provisions of 
                        this section.
            ``(2) Applicability of sanctions to test-offering 
        entities.--
                    ``(A) Intermediate sanctions.--
                            ``(i) In general.--If the Secretary 
                        determines that a test-offering entity 
                        registered under subsection (d) is no longer 
                        meeting the requirements of this section, the 
                        Secretary may impose intermediate sanctions in 
                        lieu of the actions authorized by subparagraph 
                        (B).
                            ``(ii) Types of sanctions; procedures.--The 
                        provisions of paragraphs (2) and (3) of section 
                        353(h) shall apply with respect to intermediate 
                        sanctions against a test-offering entity under 
                        clause (i) to the same extent and in the same 
                        manner as such provisions apply with respect to 
                        intermediate sanctions against a laboratory 
                        under section 353(h).
                    ``(B) Suspension, revocation, and limitation of 
                registration.--The registration of a test-offering 
                entity under subsection (d) may be suspended, revoked, 
                or limited if the Secretary finds, using the procedures 
                applicable under section 353(i)(1) to suspension, 
                revocation, or limitation of a laboratory's 
                certificate, that the owner or operator or any employee 
                of the test-offering entity--
                            ``(i) has misrepresented information in a 
                        submission to the Secretary pursuant to this 
                        section;
                            ``(ii) has failed to comply with the 
                        requirements of this section;
                            ``(iii) has failed to comply with 
                        reasonable requests of the Secretary for--
                                    ``(I) any information or materials 
                                that the Secretary concludes are 
                                necessary to determine the test-
                                offering entity's continued compliance 
                                with the requirements of this section; 
                                or
                                    ``(II) work on materials, that the 
                                Secretary concludes is necessary to 
                                determine the test-offering entity's 
                                continued compliance with the 
                                requirements of this section;
                            ``(iv) has refused a reasonable request of 
                        the Secretary (or, if designated by the 
                        Secretary, any Federal officer, government 
                        employee, or a nongovernmental organization or 
                        an accreditation body designated under 
                        subsection (k)) for permission to inspect the 
                        test-offering entity and its operations and 
                        pertinent records during the hours the test-
                        offering entity is in operation;
                            ``(v) has violated or aided and abetted in 
                        the violation of any provisions of this section 
                        or of any regulation promulgated thereunder; or
                            ``(vi) has not complied with an 
                        intermediate sanction imposed under 
                        subparagraph (A).
                    ``(C) Action before a hearing.--If the Secretary 
                determines that--
                            ``(i) the failure of a test-offering entity 
                        to comply with the requirements of this section 
                        presents an imminent and serious risk to human 
                        health; or
                            ``(ii) a test-offering entity has engaged 
                        in an action described in clause (iv) or (v) of 
                        subparagraph (B),
                the Secretary may suspend or limit the registration of 
                the laboratory before holding a hearing under 
                subparagraph (B) regarding such failure or refusal. The 
                opportunity for a hearing shall be provided no later 
                than 60 days from the effective date of the suspension 
                or limitation. A suspension or limitation under this 
                subparagraph shall stay in effect until the decision of 
                the Secretary made after the hearing under subparagraph 
                (B).
                    ``(D) Injunctions.--If the Secretary has reason to 
                believe the continuation of any activity by a test-
                offering entity would constitute a significant hazard 
                to the public health, the Secretary may bring suit in 
                any district court of the United States that has 
                jurisdiction over such entity to enjoin continuation of 
                such activity. Upon proper showing, a temporary 
                injunction or restraining order against continuation of 
                such activity pending issuance of a final order under 
                this subparagraph shall be granted without bond by such 
                court.
            ``(3) Applicability of criminal sanctions to all persons.--
        The reference in section 353(l) to `any requirement of this 
        section' is deemed to include any requirement of this section.
            ``(4) Reporting.--In promulgating regulations under 
        subsection (i)(1), the Secretary may include sanctions specific 
        to violations of subsection (f) (regarding reporting), 
        including the following:
                    ``(A) Civil money penalties in an amount not to 
                exceed $10,000 for each such violation.
                    ``(B) Directed plans of correction.
                    ``(C) For repeat or intentional violations, an 
                order requiring the test-offering entity to cease 
                offering or marketing the DTC DNA test involved for one 
                or more claimed uses.
    ``(h) Judicial Review.--If a laboratory or test-offering entity is 
subject to a sanction or other action pursuant to subsection (g) or is 
adversely affected by final agency action under subsection (c), the 
laboratory or entity may appeal such sanction or action by filing a 
petition for judicial review with the United States court of appeals 
for the circuit where the laboratory or entity has its principal place 
of business. The provisions of section 353(k) applicable to judicial 
review of sanctions and actions under section 353 shall apply to 
judicial review of sanctions and actions under this section.
    ``(i) Regulations.--
            ``(1) In general.--Not later than 1 year after the date of 
        the enactment of this section, the Secretary shall promulgate 
        final regulations to carry out this section.
            ``(2) Rare diseases and conditions.--In carrying out 
        paragraph (1), the Secretary shall include regulations specific 
        to any LDT or DTC DNA test used in connection with a rare 
        disease or condition (as such term is defined in section 
        526(a)(2) of the Federal Food, Drug, and Cosmetic Act). Such 
        regulations--
                    ``(A) shall provide for expedited review of 
                premarket notifications under subsection (c)(2)(A) for 
                such tests;
                    ``(B) shall contain standards of evidence for 
                demonstrating the clinical validity of such test that 
                takes into account special issues relating to studies 
                in small populations;
                    ``(C) shall take into account relevant technical 
                standards and guidelines applicable to testing for such 
                a rare disease and condition; and
                    ``(D) may authorize the Secretary to waive any 
                requirement of this section if the Secretary determines 
                that application of such requirement would unreasonably 
                delay or prevent access to such test.
            ``(3) Emergency use.--In carrying out paragraph (1), the 
        Secretary shall include regulations authorizing the Secretary 
        to waive any requirement of this section in order to allow the 
        emergency use of an LDT for detecting or diagnosing serious or 
        life-threatening infectious pathogens or diseases. Such 
        regulations shall apply standards of evidence for demonstrating 
        the clinical validity of such a test that take into account 
        special issues relating to infectious pathogens and public 
        health threats.
            ``(4) External quality assessment.--In carrying out 
        paragraph (1), the Secretary, in consultation with proficiency 
        testing organizations approved under section 353(f)(C), shall 
        include regulations establishing an external review process to 
        evaluate the analytical validity of LDTs.
    ``(j) Inspections.--
            ``(1) Laboratories.--During an inspection under section 
        353(g), the Secretary--
                    ``(A) may use the authorities specified in section 
                353(g)(1) for purposes of determining compliance with 
                this section; and
                    ``(B) may require a laboratory to provide evidence 
                of clinical validity for any claim made for an LDT 
                offered by that laboratory.
            ``(2) Test-offering entities.--The Secretary--
                    ``(A) shall have the same authority to conduct 
                inspections of a test-offering entity for purposes of 
                determining compliance with this section as the 
                Secretary has under paragraph (1) and section 353(g)(1) 
                to conduct inspections of laboratories for compliance 
                with this section and section 353; and
                    ``(B) during an inspection under subparagraph (A), 
                may require a test-offering entity to provide evidence 
                of clinical validity for any claim made for a DTC DNA 
                test offered or marketed by that entity.
            ``(3) Proprietary or confidential information.--The 
        Secretary shall establish procedures to protect any proprietary 
        or confidential information concerning an LDT or DTC DNA test 
        that may be disclosed during an inspection under this 
        subsection.
    ``(k) Delegation.--The Secretary shall administer this section 
solely through the Centers for Medicare & Medicaid Services. The 
Administrator may--
            ``(1) pursuant to agreement, designate a nongovernmental 
        organization that has qualifications and expertise in the 
        evaluation of laboratory testing and in evaluating the 
        analytical and clinical validity of laboratory tests to assist 
        in the review of premarket notifications and test registry data 
        bank information and in the performance of inspections 
        authorized under subsection (j); and
            ``(2) subject to the provisions of section 353(e), 
        designate an accreditation organization to assist in the review 
        of premarket notifications and test registry data bank 
        information and in the performance of inspections authorized 
        under subsection (j).
    ``(l) Federal Trade Commission.--Nothing in this section shall be 
construed to limit regulation of advertising under the Federal Trade 
Commission Act.''.

SEC. 3. AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.

    (a) Device Definition.--Section 201(h) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321(h)) is amended by adding at the end the 
following: ``The term `device' does not include a laboratory-developed 
test or a direct-to-consumer DNA test as defined in section 353A of the 
Public Health Service Act.''.
    (b) Registration Exclusion.--Section 510(g) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360(g)) is amended--
            (1) by redesignating paragraphs (4) and (5) as (5) and (6), 
        respectively; and
            (2) by inserting after paragraph (3) the following:
            ``(4) clinical laboratories certified under section 353 of 
        the Public Health Service Act insofar as such laboratories--
                    ``(A) use devices to perform laboratory tests; or
                    ``(B) create and perform laboratory-developed tests 
                as defined in section 353A of such Act;''.

SEC. 4. FEES.

    Section 353(m) of the Public Health Service Act (42 U.S.C. 263a(m)) 
is amended--
            (1) in paragraph (2), by adding at the end the following 
        sentence: ``In the case of a laboratory or test-offering entity 
        that is required to submit information under section 
        353A(b)(2)(A), the Secretary shall also require the payment of 
        fees for reviews of premarket notifications and supplemental 
        notifications submitted pursuant to subparagraph (A), (B), or 
        (C) of section 353A(c)(2), registration of test-offering 
        entities under section 353A(d), and inspections conducted 
        pursuant to section 353A(j).'';
            (2) in paragraph (3)(B)--
                    (A) by striking ``inspections and proficiency 
                testing described in paragraph (2)'' and inserting 
                ``inspections and proficiency testing described in the 
                first sentence of paragraph (2)''; and
                    (B) by striking the period at the end and inserting 
                ``, review of premarket notifications and supplemental 
                notifications submitted pursuant to subparagraph (A), 
                (B), or (C) of section 353A(c)(2), registration of 
                test-offering entities under section 353A(d), and 
                inspections conducted pursuant to section 353A(j)''; 
                and
            (3) by adding at the end the following new paragraph:
            ``(4) Fiscal report.--By December 31, 2011, and by the end 
        of each calendar year thereafter, the Secretary shall prepare 
        and submit to the Committee on Energy and Commerce of the House 
        of Representatives and the Committee on Health, Education, 
        Labor, and Pensions of the Senate a report on the amount of 
        fees collected during the preceding fiscal year under this 
        subsection and the amount of fees collected under this 
        subsection available to support activities under this section 
        and section 353A. Before increasing the amount of any fee 
        required by this subsection, the Secretary shall include in a 
        report under this paragraph an explanation of the need for such 
        an increase, including the likely revenues and expenses 
        expected to be incurred. The effective date of any such 
        increase shall not be sooner than the date that is 120 days 
        after the submission of the report containing such 
        explanation.''.
                                 <all>