Modernizing Laboratory Test Standards for Patients Act of 2011 - Amends the Public Health Service Act to require the Secretary of Health and Human Services (HHS) to establish a single publicly accessible test registry data bank of laboratory-developed tests and direct-to-consumer DNA tests, which shall include information on the purpose of each test, the claimed use or uses of each test, and information regarding the analytical validity of each test.
Requires notification to the Secretary: (1) before marketing such a test, (2) after any significant modification of such a test, or (3) if the evidence of clinical validity is inadequate to support one or more of the claimed uses.
Requires the Secretary, within 90 days of receiving such notification, to determine whether the notification demonstrates clinical validity. Deems the Secretary to have authorized marketing of the test if no response is received within 90 days.
Gives the Secretary authority to order a laboratory or test-offering entity to cease offering or marketing a test if the information submitted in notifications does not demonstrate the clinical validity of the claimed uses and the test poses a risk of immediate harm to the public health.
Sets forth requirements for: (1) registration of a test-offering entity, (2) information that must be included in disseminated materials and advertising, (3) notice to the Secretary if a test may have caused or contributed to a death or serious bodily injury, and (4) sanctions for violations of this Act.
Requires the Secretary to administer this section solely through the Centers for Medicare and Medicaid Services (CMS).
[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>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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