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pdf121 STAT. 904
21 USC 355 note.
PUBLIC LAW 110–85—SEPT. 27, 2007
(1) striking paragraph (4); and
(2) redesignating paragraphs (5), (6), (7), and (8) as paragraphs (4), (5), (6), and (7), respectively.
(c) EFFECTIVE DATE.—The amendments made by this section
shall take effect on October 1, 2007.
TITLE VIII—CLINICAL TRIAL
DATABASES
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SEC. 801. EXPANDED CLINICAL TRIAL REGISTRY DATA BANK.
(a) IN GENERAL.—Section 402 of the Public Health Service
Act (42 U.S.C. 282) is amended by—
(1) redesignating subsections (j) and (k) as subsections
(k) and (l), respectively; and
(2) inserting after subsection (i) the following:
‘‘(j) EXPANDED CLINICAL TRIAL REGISTRY DATA BANK.—
‘‘(1) DEFINITIONS; REQUIREMENT.—
‘‘(A) DEFINITIONS.—In this subsection:
‘‘(i) APPLICABLE CLINICAL TRIAL.—The term
‘applicable clinical trial’ means an applicable device
clinical trial or an applicable drug clinical trial.
‘‘(ii) APPLICABLE DEVICE CLINICAL TRIAL.—The term
‘applicable device clinical trial’ means—
‘‘(I) a prospective clinical study of health outcomes comparing an intervention with a device
subject to section 510(k), 515, or 520(m) of the
Federal Food, Drug, and Cosmetic Act against a
control in human subjects (other than a small clinical trial to determine the feasibility of a device,
or a clinical trial to test prototype devices where
the primary outcome measure relates to feasibility
and not to health outcomes); and
‘‘(II) a pediatric postmarket surveillance as
required under section 522 of the Federal Food,
Drug, and Cosmetic Act.
‘‘(iii) APPLICABLE DRUG CLINICAL TRIAL.—
‘‘(I) IN GENERAL.—The term ‘applicable drug
clinical trial’ means a controlled clinical investigation, other than a phase I clinical investigation,
of a drug subject to section 505 of the Federal
Food, Drug, and Cosmetic Act or to section 351
of this Act.
‘‘(II) CLINICAL INVESTIGATION.—For purposes
of subclause (I), the term ‘clinical investigation’
has the meaning given that term in section 312.3
of title 21, Code of Federal Regulations (or any
successor regulation).
‘‘(III) PHASE I.—For purposes of subclause (I),
the term ‘phase I’ has the meaning given that
term in section 312.21 of title 21, Code of Federal
Regulations (or any successor regulation).
‘‘(iv) CLINICAL TRIAL INFORMATION.—The term ‘clinical trial information’ means, with respect to an
applicable clinical trial, those data elements that the
responsible party is required to submit under paragraph (2) or under paragraph (3).
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‘‘(v) COMPLETION DATE.—The term ‘completion
date’ means, with respect to an applicable clinical trial,
the date that the final subject was examined or
received an intervention for the purposes of final collection of data for the primary outcome, whether the
clinical trial concluded according to the prespecified
protocol or was terminated.
‘‘(vi) DEVICE.—The term ‘device’ means a device
as defined in section 201(h) of the Federal Food, Drug,
and Cosmetic Act.
‘‘(vii) DRUG.—The term ‘drug’ means a drug as
defined in section 201(g) of the Federal Food, Drug,
and Cosmetic Act or a biological product as defined
in section 351 of this Act.
‘‘(viii) ONGOING.—The term ‘ongoing’ means, with
respect to a clinical trial of a drug or a device and
to a date, that—
‘‘(I) 1 or more patients is enrolled in the clinical trial; and
‘‘(II) the date is before the completion date
of the clinical trial.
‘‘(ix) RESPONSIBLE PARTY.—The term ‘responsible
party’, with respect to a clinical trial of a drug or
device, means—
‘‘(I) the sponsor of the clinical trial (as defined
in section 50.3 of title 21, Code of Federal Regulations (or any successor regulation)); or
‘‘(II) the principal investigator of such clinical
trial if so designated by a sponsor, grantee, contractor, or awardee, so long as the principal investigator is responsible for conducting the trial, has
access to and control over the data from the clinical
trial, has the right to publish the results of the
trial, and has the ability to meet all of the requirements under this subsection for the submission
of clinical trial information.
‘‘(B) REQUIREMENT.—The Secretary shall develop a
mechanism by which the responsible party for each
applicable clinical trial shall submit the identity and contact information of such responsible party to the Secretary
at the time of submission of clinical trial information under
paragraph (2).
‘‘(2) EXPANSION OF CLINICAL TRIAL REGISTRY DATA BANK
WITH RESPECT TO CLINICAL TRIAL INFORMATION.—
‘‘(A) IN GENERAL.—
‘‘(i) EXPANSION OF DATA BANK.—To enhance patient
enrollment and provide a mechanism to track subsequent progress of clinical trials, the Secretary, acting
through the Director of NIH, shall expand, in accordance with this subsection, the clinical trials registry
of the data bank described under subsection (i)(1)
(referred to in this subsection as the ‘registry data
bank’). The Director of NIH shall ensure that the registry data bank is made publicly available through
the Internet.
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PUBLIC LAW 110–85—SEPT. 27, 2007
‘‘(ii) CONTENT.—The clinical trial information
required to be submitted under this paragraph for
an applicable clinical trial shall include—
‘‘(I) descriptive information, including—
‘‘(aa) a brief title, intended for the lay
public;
‘‘(bb) a brief summary, intended for the
lay public;
‘‘(cc) the primary purpose;
‘‘(dd) the study design;
‘‘(ee) for an applicable drug clinical trial,
the study phase;
‘‘(ff) study type;
‘‘(gg) the primary disease or condition
being studied, or the focus of the study;
‘‘(hh) the intervention name and intervention type;
‘‘(ii) the study start date;
‘‘(jj) the expected completion date;
‘‘(kk) the target number of subjects; and
‘‘(ll) outcomes, including primary and secondary outcome measures;
‘‘(II) recruitment information, including—
‘‘(aa) eligibility criteria;
‘‘(bb) gender;
‘‘(cc) age limits;
‘‘(dd) whether the trial accepts healthy volunteers;
‘‘(ee) overall recruitment status;
‘‘(ff) individual site status; and
‘‘(gg) in the case of an applicable drug
clinical trial, if the drug is not approved under
section 505 of the Federal Food, Drug, and
Cosmetic Act or licensed under section 351
of this Act, specify whether or not there is
expanded access to the drug under section 561
of the Federal Food, Drug, and Cosmetic Act
for those who do not qualify for enrollment
in the clinical trial and how to obtain information about such access;
‘‘(III) location and contact information,
including—
‘‘(aa) the name of the sponsor;
‘‘(bb) the responsible party, by official title;
and
‘‘(cc) the facility name and facility contact
information (including the city, State, and zip
code for each clinical trial location, or a tollfree number through which such location
information may be accessed); and
‘‘(IV) administrative data (which the Secretary
may make publicly available as necessary),
including—
‘‘(aa) the unique protocol identification
number;
‘‘(bb) other protocol identification numbers, if any; and
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‘‘(cc) the Food and Drug Administration
IND/IDE protocol number and the record
verification date.
‘‘(iii) MODIFICATIONS.—The Secretary may by regulation modify the requirements for clinical trial
information under this paragraph, if the Secretary provides a rationale for why such a modification improves
and does not reduce such clinical trial information.
‘‘(B) FORMAT AND STRUCTURE.—
‘‘(i) SEARCHABLE CATEGORIES.—The Director of
NIH shall ensure that the public may, in addition
to keyword searching, search the entries in the registry
data bank by 1 or more of the following criteria:
‘‘(I) The disease or condition being studied in
the clinical trial, using Medical Subject Headers
(MeSH) descriptors.
‘‘(II) The name of the intervention, including
any drug or device being studied in the clinical
trial.
‘‘(III) The location of the clinical trial.
‘‘(IV) The age group studied in the clinical
trial, including pediatric subpopulations.
‘‘(V) The study phase of the clinical trial.
‘‘(VI) The sponsor of the clinical trial, which
may be the National Institutes of Health or
another Federal agency, a private industry source,
or a university or other organization.
‘‘(VII) The recruitment status of the clinical
trial.
‘‘(VIII) The National Clinical Trial number or
other study identification for the clinical trial.
‘‘(ii) ADDITIONAL SEARCHABLE CATEGORY.—Not
later than 18 months after the date of the enactment
of the Food and Drug Administration Amendments
Act of 2007, the Director of NIH shall ensure that
the public may search the entries of the registry data
bank by the safety issue, if any, being studied in the
clinical trial as a primary or secondary outcome.
‘‘(iii) OTHER ELEMENTS.—The Director of NIH shall
also ensure that the public may search the entries
of the registry data bank by such other elements as
the Director deems necessary on an ongoing basis.
‘‘(iv) FORMAT.—The Director of the NIH shall
ensure that the registry data bank is easily used by
the public, and that entries are easily compared.
‘‘(C) DATA SUBMISSION.—The responsible party for an
applicable clinical trial, including an applicable drug clinical trial for a serious or life-threatening disease or condition, that is initiated after, or is ongoing on the date
that is 90 days after, the date of the enactment of the
Food and Drug Administration Amendments Act of 2007,
shall submit to the Director of NIH for inclusion in the
registry data bank the clinical trial information described
in of subparagraph (A)(ii) not later than the later of—
‘‘(i) 90 days after such date of enactment;
‘‘(ii) 21 days after the first patient is enrolled in
such clinical trial; or
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‘‘(iii) in the case of a clinical trial that is not
for a serious or life-threatening disease or condition
and that is ongoing on such date of enactment, 1
year after such date of enactment.
‘‘(D) POSTING OF DATA.—
‘‘(i) APPLICABLE DRUG CLINICAL TRIAL.—The
Director of NIH shall ensure that clinical trial information for an applicable drug clinical trial submitted in
accordance with this paragraph is posted in the registry data bank not later than 30 days after such
submission.
‘‘(ii) APPLICABLE DEVICE CLINICAL TRIAL.—The
Director of NIH shall ensure that clinical trial information for an applicable device clinical trial submitted
in accordance with this paragraph is posted publicly
in the registry data bank—
‘‘(I) not earlier than the date of clearance
under section 510(k) of the Federal Food, Drug,
and Cosmetic Act, or approval under section 515
or 520(m) of such Act, as applicable, for a device
that was not previously cleared or approved, and
not later than 30 days after such date; or
‘‘(II) for a device that was previously cleared
or approved, not later than 30 days after the clinical trial information under paragraph (3)(C) is
required to be posted by the Secretary.
‘‘(3) EXPANSION OF REGISTRY DATA BANK TO INCLUDE
RESULTS OF CLINICAL TRIALS.—
‘‘(A) LINKING REGISTRY DATA BANK TO EXISTING
RESULTS.—
‘‘(i) IN GENERAL.—Beginning not later than 90 days
after the date of the enactment of the Food and Drug
Administration Amendments Act of 2007, for those
clinical trials that form the primary basis of an efficacy
claim or are conducted after the drug involved is
approved or after the device involved is cleared or
approved, the Secretary shall ensure that the registry
data bank includes links to results information as
described in clause (ii) for such clinical trial—
‘‘(I) not earlier than 30 days after the date
of the approval of the drug involved or clearance
or approval of the device involved; or
‘‘(II) not later than 30 days after the results
information described in clause (ii) becomes publicly available.
‘‘(ii) REQUIRED INFORMATION.—
‘‘(I) FDA INFORMATION.—The Secretary shall
ensure that the registry data bank includes links
to the following information:
‘‘(aa) If an advisory committee considered
at a meeting an applicable clinical trial, any
posted Food and Drug Administration summary document regarding such applicable clinical trial.
‘‘(bb) If an applicable drug clinical trial
was conducted under section 505A or 505B
of the Federal Food, Drug, and Cosmetic Act,
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a link to the posted Food and Drug Administration assessment of the results of such trial.
‘‘(cc) Food and Drug Administration public
health advisories regarding the drug or device
that is the subject of the applicable clinical
trial, if any.
‘‘(dd) For an applicable drug clinical trial,
the Food and Drug Administration action
package for approval document required under
section 505(l)(2) of the Federal Food, Drug,
and Cosmetic Act.
‘‘(ee) For an applicable device clinical trial,
in the case of a premarket application under
section 515 of the Federal Food, Drug, and
Cosmetic Act, the detailed summary of
information respecting the safety and
effectiveness of the device required under section 520(h)(1) of such Act, or, in the case of
a report under section 510(k) of such Act, the
section 510(k) summary of the safety and
effectiveness data required under section
807.95(d) of title 21, Code of Federal Regulations (or any successor regulation).
‘‘(II) NIH INFORMATION.—The Secretary shall
ensure that the registry data bank includes links
to the following information:
‘‘(aa) Medline citations to any publications
focused on the results of an applicable clinical
trial.
‘‘(bb) The entry for the drug that is the
subject of an applicable drug clinical trial in
the National Library of Medicine database of
structured product labels, if available.
‘‘(iii) RESULTS FOR EXISTING DATA BANK ENTRIES.—
The Secretary may include the links described in clause
(ii) for data bank entries for clinical trials submitted
to the data bank prior to enactment of the Food and
Drug Administration Amendments Act of 2007, as
available.
‘‘(B) INCLUSION OF RESULTS.—The Secretary, acting
through the Director of NIH, shall—
‘‘(i) expand the registry data bank to include the
results of applicable clinical trials (referred to in this
subsection as the ‘registry and results data bank’);
‘‘(ii) ensure that such results are made publicly
available through the Internet;
‘‘(iii) post publicly a glossary for the lay public
explaining technical terms related to the results of
clinical trials; and
‘‘(iv) in consultation with experts on risk communication, provide information with the information
included under subparagraph (C) in the registry and
results data bank to help ensure that such information
does not mislead the patients or the public.
‘‘(C) BASIC RESULTS.—Not later than 1 year after the
date of the enactment of the Food and Drug Administration
Amendments Act of 2007, the Secretary shall include in
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121 STAT. 910
the registry and results data bank the following elements
for drugs that are approved under section 505 of the Federal Food, Drug, and Cosmetic Act or licensed under section
351 of this Act and devices that are cleared under section
510(k) of the Federal Food, Drug, and Cosmetic Act or
approved under section 515 or 520(m) of such Act:
‘‘(i) DEMOGRAPHIC AND BASELINE CHARACTERISTICS
OF PATIENT SAMPLE.—A table of the demographic and
baseline data collected overall and for each arm of
the clinical trial to describe the patients who participated in the clinical trial, including the number of
patients who dropped out of the clinical trial and the
number of patients excluded from the analysis, if any.
‘‘(ii) PRIMARY AND SECONDARY OUTCOMES.—The
primary and secondary outcome measures as submitted
under paragraph (2)(A)(ii)(I)(ll), and a table of values
for each of the primary and secondary outcome measures for each arm of the clinical trial, including the
results of scientifically appropriate tests of the statistical significance of such outcome measures.
‘‘(iii) POINT OF CONTACT.—A point of contact for
scientific information about the clinical trial results.
‘‘(iv) CERTAIN AGREEMENTS.—Whether there exists
an agreement (other than an agreement solely to
comply with applicable provisions of law protecting
the privacy of participants) between the sponsor or
its agent and the principal investigator (unless the
sponsor is an employer of the principal investigator)
that restricts in any manner the ability of the principal
investigator, after the completion date of the trial,
to discuss the results of the trial at a scientific meeting
or any other public or private forum, or to publish
in a scientific or academic journal information concerning the results of the trial.
‘‘(D) EXPANDED REGISTRY AND RESULTS DATA BANK.—
‘‘(i) EXPANSION BY RULEMAKING.—To provide more
complete results information and to enhance patient
access to and understanding of the results of clinical
trials, not later than 3 years after the date of the
enactment of the Food and Drug Administration
Amendments Act of 2007, the Secretary shall by regulation expand the registry and results data bank as
provided under this subparagraph.
‘‘(ii) CLINICAL TRIALS.—
‘‘(I) APPROVED PRODUCTS.—The regulations
under this subparagraph shall require the inclusion of the results information described in clause
(iii) for—
‘‘(aa) each applicable drug clinical trial for
a drug that is approved under section 505
of the Federal Food, Drug, and Cosmetic Act
or licensed under section 351 of this Act; and
‘‘(bb) each applicable device clinical trial
for a device that is cleared under section
510(k) of the Federal Food, Drug, and Cosmetic Act or approved under section 515 or
520(m) of such Act.
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‘‘(II) UNAPPROVED PRODUCTS.—The regulations
under this subparagraph shall establish whether
or not the results information described in clause
(iii) shall be required for—
‘‘(aa) an applicable drug clinical trial for
a drug that is not approved under section 505
of the Federal Food, Drug, and Cosmetic Act
and not licensed under section 351 of this
Act (whether approval or licensure was sought
or not); and
‘‘(bb) an applicable device clinical trial for
a device that is not cleared under section
510(k) of the Federal Food, Drug, and Cosmetic Act and not approved under section 515
or section 520(m) of such Act (whether clearance or approval was sought or not).
‘‘(iii) REQUIRED ELEMENTS.—The regulations under
this subparagraph shall require, in addition to the
elements described in subparagraph (C), information
within each of the following categories:
‘‘(I) A summary of the clinical trial and its
results that is written in non-technical, understandable language for patients, if the Secretary
determines that such types of summary can be
included without being misleading or promotional.
‘‘(II) A summary of the clinical trial and its
results that is technical in nature, if the Secretary
determines that such types of summary can be
included without being misleading or promotional.
‘‘(III) The full protocol or such information
on the protocol for the trial as may be necessary
to help to evaluate the results of the trial.
‘‘(IV) Such other categories as the Secretary
determines appropriate.
‘‘(iv) RESULTS SUBMISSION.—The results information described in clause (iii) shall be submitted to the
Director of NIH for inclusion in the registry and results
data bank as provided by subparagraph (E), except
that the Secretary shall by regulation determine—
‘‘(I) whether the 1-year period for submission
of clinical trial information described in subparagraph (E)(i) should be increased from 1 year to
a period not to exceed 18 months;
‘‘(II) whether the clinical trial information
described in clause (iii) should be required to be
submitted for an applicable clinical trial for which
the clinical trial information described in subparagraph (C) is submitted to the registry and results
data bank before the effective date of the regulations issued under this subparagraph; and
‘‘(III) in the case when the clinical trial
information described in clause (iii) is required
to be submitted for the applicable clinical trials
described in clause (ii)(II), the date by which such
clinical trial information shall be required to be
submitted, taking into account—
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‘‘(aa) the certification process under
subparagraph (E)(iii) when approval, licensure, or clearance is sought; and
‘‘(bb) whether there should be a delay of
submission when approval, licensure, or clearance will not be sought.
‘‘(v) ADDITIONAL PROVISIONS.—The regulations
under this subparagraph shall also establish—
‘‘(I) a standard format for the submission of
clinical trial information under this paragraph to
the registry and results data bank;
‘‘(II) additional information on clinical trials
and results that is written in nontechnical, understandable language for patients;
‘‘(III) considering the experience under the
pilot quality control project described in paragraph
(5)(C), procedures for quality control, including
using representative samples, with respect to
completeness and content of clinical trial information under this subsection, to help ensure that
data elements are not false or misleading and are
non-promotional;
‘‘(IV) the appropriate timing and requirements
for updates of clinical trial information, and
whether and, if so, how such updates should be
tracked;
‘‘(V) a statement to accompany the entry for
an applicable clinical trial when the primary and
secondary outcome measures for such clinical trial
are submitted under paragraph (4)(A) after the
date specified for the submission of such information in paragraph (2)(C); and
‘‘(VI) additions or modifications to the manner
of reporting of the data elements established under
subparagraph (C).
‘‘(vi) CONSIDERATION OF WORLD HEALTH ORGANIZATION DATA SET.—The Secretary shall consider the
status of the consensus data elements set for reporting
clinical trial results of the World Health Organization
when issuing the regulations under this subparagraph.
‘‘(vii) PUBLIC MEETING.—The Secretary shall hold
a public meeting no later than 18 months after the
date of the enactment of the Food and Drug Administration Amendments Act of 2007 to provide an opportunity for input from interested parties with regard
to the regulations to be issued under this subparagraph.
‘‘(E) SUBMISSION OF RESULTS INFORMATION.—
‘‘(i) IN GENERAL.—Except as provided in clauses
(iii), (iv), (v), and (vi) the responsible party for an
applicable clinical trial that is described in clause (ii)
shall submit to the Director of NIH for inclusion in
the registry and results data bank the clinical trial
information described in subparagraph (C) not later
than 1 year, or such other period as may be provided
by regulation under subparagraph (D), after the earlier
of—
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‘‘(I) the estimated completion date of the trial
as described in paragraph (2)(A)(ii)(I)(jj)); or
‘‘(II) the actual date of completion.
‘‘(ii) CLINICAL TRIALS DESCRIBED.—An applicable
clinical trial described in this clause is an applicable
clinical trial subject to—
‘‘(I) paragraph (2)(C); and
‘‘(II)(aa) subparagraph (C); or
‘‘(bb) the regulations issued under subparagraph (D).
‘‘(iii) DELAYED SUBMISSION OF RESULTS WITH CERTIFICATION.—If the responsible party for an applicable
clinical trial submits a certification that clause (iv)
or (v) applies to such clinical trial, the responsible
party shall submit to the Director of NIH for inclusion
in the registry and results data bank the clinical trial
information described in subparagraphs (C) and (D)
as required under the applicable clause.
‘‘(iv) SEEKING INITIAL APPROVAL OF A DRUG OR
DEVICE.—With respect to an applicable clinical trial
that is completed before the drug is initially approved
under section 505 of the Federal Food, Drug, and Cosmetic Act or initially licensed under section 351 of
this Act, or the device is initially cleared under section
510(k) or initially approved under section 515 or 520(m)
of the Federal Food, Drug, and Cosmetic Act, the
responsible party shall submit to the Director of NIH
for inclusion in the registry and results data bank
the clinical trial information described in subparagraphs (C) and (D) not later than 30 days after the
drug or device is approved under such section 505,
licensed under such section 351, cleared under such
section 510(k), or approved under such section 515
or 520(m), as applicable.
‘‘(v) SEEKING APPROVAL OF A NEW USE FOR THE
DRUG OR DEVICE.—
‘‘(I) IN GENERAL.—With respect to an
applicable clinical trial where the manufacturer
of the drug or device is the sponsor of an applicable
clinical trial, and such manufacturer has filed, or
will file within 1 year, an application seeking
approval under section 505 of the Federal Food,
Drug, and Cosmetic Act, licensing under section
351 of this Act, or clearance under section 510(k),
or approval under section 515 or 520(m), of the
Federal Food, Drug, and Cosmetic Act for the use
studied in such clinical trial (which use is not
included in the labeling of the approved drug or
device), then the responsible party shall submit
to the Director of NIH for inclusion in the registry
and results data bank the clinical trial information
described in subparagraphs (C) and (D) on the
earlier of the date that is 30 days after the date—
‘‘(aa) the new use of the drug or device
is approved under such section 505, licensed
under such section 351, cleared under such
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section 510(k), or approved under such section
515 or 520(m);
‘‘(bb) the Secretary issues a letter, such
as a complete response letter, not approving
the submission or not clearing the submission,
a not approvable letter, or a not substantially
equivalent letter for the new use of the drug
or device under such section 505, 351, 510(k),
515, or 520(m); or
‘‘(cc) except as provided in subclause (III),
the application or premarket notification
under such section 505, 351, 510(k), 515, or
520(m) is withdrawn without resubmission for
no less than 210 days.
‘‘(II) REQUIREMENT THAT EACH CLINICAL TRIAL
IN APPLICATION BE TREATED THE SAME.—If a manufacturer makes a certification under clause (iii)
that this clause applies with respect to a clinical
trial, the manufacturer shall make such a certification with respect to each applicable clinical trial
that is required to be submitted in an application
or report for licensure, approval, or clearance
(under section 351 of this Act or section 505,
510(k), 515, or 520(m) of the Federal Food, Drug,
and Cosmetic Act, as applicable) of the use studied
in the clinical trial.
‘‘(III) TWO-YEAR LIMITATION.—The responsible
party shall submit to the Director of NIH for inclusion in the registry and results data bank the
clinical trial information subject to subclause (I)
on the date that is 2 years after the date a certification under clause (iii) was made to the Director
of NIH, if an action referred to in item (aa), (bb),
or (cc) of subclause (I) has not occurred by such
date.
‘‘(vi) EXTENSIONS.—The Director of NIH may provide an extension of the deadline for submission of
clinical trial information under clause (i) if the responsible party for the trial submits to the Director a
written request that demonstrates good cause for the
extension and provides an estimate of the date on
which the information will be submitted. The Director
of NIH may grant more than one such extension for
a clinical trial.
‘‘(F) NOTICE TO DIRECTOR OF NIH.—The Commissioner
of Food and Drugs shall notify the Director of NIH when
there is an action described in subparagraph (E)(iv) or
item (aa), (bb), or (cc) of subparagraph (E)(v)(I) with respect
to an application or a report that includes a certification
required under paragraph (5)(B) of such action not later
than 30 days after such action.
‘‘(G) POSTING OF DATA.—The Director of NIH shall
ensure that the clinical trial information described in subparagraphs (C) and (D) for an applicable clinical trial submitted in accordance with this paragraph is posted publicly
in the registry and results database not later than 30
days after such submission.
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‘‘(H) WAIVERS REGARDING CERTAIN
RESULTS.—The Secretary may waive
CLINICAL
121 STAT. 915
TRIAL
any applicable
requirements of this paragraph for an applicable clinical
trial, upon a written request from the responsible party,
if the Secretary determines that extraordinary circumstances justify the waiver and that providing the
waiver is consistent with the protection of public health,
or in the interest of national security. Not later than 30
days after any part of a waiver is granted, the Secretary
shall notify, in writing, the appropriate committees of Congress of the waiver and provide an explanation for why
the waiver was granted.
‘‘(I) ADVERSE EVENTS.—
‘‘(i) REGULATIONS.—Not later than 18 months after
the date of the enactment of the Food and Drug
Administration Amendments Act of 2007, the Secretary
shall by regulation determine the best method for
including in the registry and results data bank appropriate results information on serious adverse and frequent adverse events for drugs described in subparagraph (C) in a manner and form that is useful and
not misleading to patients, physicians, and scientists.
‘‘(ii) DEFAULT.—If the Secretary fails to issue the
regulation required by clause (i) by the date that is
24 months after the date of the enactment of the
Food and Drug Administration Amendments Act of
2007, clause (iii) shall take effect.
‘‘(iii) ADDITIONAL ELEMENTS.—Upon the application
of clause (ii), the Secretary shall include in the registry
and results data bank for drugs described in subparagraph (C), in addition to the clinical trial information
described in subparagraph (C), the following elements:
‘‘(I) SERIOUS ADVERSE EVENTS.—A table of
anticipated and unanticipated serious adverse
events grouped by organ system, with number and
frequency of such event in each arm of the clinical
trial.
‘‘(II) FREQUENT ADVERSE EVENTS.—A table of
anticipated and unanticipated adverse events that
are not included in the table described in subclause
(I) that exceed a frequency of 5 percent within
any arm of the clinical trial, grouped by organ
system, with number and frequency of such event
in each arm of the clinical trial.
‘‘(iv) POSTING OF OTHER INFORMATION.—In carrying
out clause (iii), the Secretary shall, in consultation
with experts in risk communication, post with the
tables information to enhance patient understanding
and to ensure such tables do not mislead patients
or the lay public.
‘‘(v) RELATION TO SUBPARAGRAPH (C).—Clinical trial
information included in the registry and results data
bank pursuant to this subparagraph is deemed to be
clinical trial information included in such data bank
pursuant to subparagraph (C).
‘‘(4) ADDITIONAL SUBMISSIONS OF CLINICAL TRIAL INFORMATION.—
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121 STAT. 916
‘‘(A) VOLUNTARY SUBMISSIONS.—A responsible party for
a clinical trial that is not an applicable clinical trial, or
that is an applicable clinical trial that is not subject to
paragraph (2)(C), may submit complete clinical trial
information described in paragraph (2) or paragraph (3)
provided the responsible party submits clinical trial
information for each applicable clinical trial that is required
to be submitted under section 351 or under section 505,
510(k), 515, or 520(m) of the Federal Food, Drug, and
Cosmetic Act in an application or report for licensure,
approval, or clearance of the drug or device for the use
studied in the clinical trial.
‘‘(B) REQUIRED SUBMISSIONS.—
‘‘(i) IN GENERAL.—Notwithstanding paragraphs (2)
and (3) and subparagraph (A), in any case in which
the Secretary determines for a specific clinical trial
described in clause (ii) that posting in the registry
and results data bank of clinical trial information for
such clinical trial is necessary to protect the public
health—
‘‘(I) the Secretary may require by notification
that such information be submitted to the Secretary in accordance with paragraphs (2) and (3)
except with regard to timing of submission;
‘‘(II) unless the responsible party submits a
certification under paragraph (3)(E)(iii), such
information shall be submitted not later than 30
days after the date specified by the Secretary in
the notification; and
‘‘(III) failure to comply with the requirements
under subclauses (I) and (II) shall be treated as
a violation of the corresponding requirement of
such paragraphs.
‘‘(ii) CLINICAL TRIALS DESCRIBED.—A clinical trial
described in this clause is—
‘‘(I) an applicable clinical trial for a drug that
is approved under section 505 of the Federal Food,
Drug, and Cosmetic Act or licensed under section
351 of this Act or for a device that is cleared
under section 510(k) of the Federal Food, Drug,
and Cosmetic Act or approved under section 515
or section 520(m) of such Act, whose completion
date is on or after the date 10 years before the
date of the enactment of the Food and Drug
Administration Amendments Act of 2007; or
‘‘(II) an applicable clinical trial that is
described by both by paragraph (2)(C) and paragraph (3)(D)(ii)(II)).
‘‘(C) UPDATES TO CLINICAL TRIAL DATA BANK.—
‘‘(i) SUBMISSION OF UPDATES.—The responsible
party for an applicable clinical trial shall submit to
the Director of NIH for inclusion in the registry and
results data bank updates to reflect changes to the
clinical trial information submitted under paragraph
(2). Such updates—
‘‘(I) shall be provided not less than once every
12 months, unless there were no changes to the
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PUBLIC LAW 110–85—SEPT. 27, 2007
121 STAT. 917
clinical trial information during the preceding 12month period;
‘‘(II) shall include identification of the dates
of any such changes;
‘‘(III) not later than 30 days after the recruitment status of such clinical trial changes, shall
include an update of the recruitment status; and
‘‘(IV) not later than 30 days after the completion date of the clinical trial, shall include notification to the Director that such clinical trial is complete.
‘‘(ii) PUBLIC AVAILABILITY OF UPDATES.—The
Director of NIH shall make updates submitted under
clause (i) publicly available in the registry data bank.
Except with regard to overall recruitment status, individual site status, location, and contact information,
the Director of NIH shall ensure that updates to elements required under subclauses (I) to (V) of paragraph
(2)(A)(ii) do not result in the removal of any information from the original submissions or any preceding
updates, and information in such databases is presented in a manner that enables users to readily access
each original element submission and to track the
changes made by the updates. The Director of NIH
shall provide a link from the table of primary and
secondary outcomes required under paragraph (3)(C)(ii)
to the tracked history required under this clause of
the primary and secondary outcome measures submitted under paragraph (2)(A)(ii)(I)(ll).
‘‘(5) COORDINATION AND COMPLIANCE.—
‘‘(A) CLINICAL TRIALS SUPPORTED BY GRANTS FROM FEDERAL AGENCIES.—
‘‘(i) GRANTS FROM CERTAIN FEDERAL AGENCIES.—
If an applicable clinical trial is funded in whole or
in part by a grant from any agency of the Department
of Health and Human Services, including the Food
and Drug Administration, the National Institutes of
Health, or the Agency for Healthcare Research and
Quality, any grant or progress report forms required
under such grant shall include a certification that the
responsible party has made all required submissions
to the Director of NIH under paragraphs (2) and (3).
‘‘(ii) VERIFICATION BY FEDERAL AGENCIES.—The
heads of the agencies referred to in clause (i), as
applicable, shall verify that the clinical trial information for each applicable clinical trial for which a
grantee is the responsible party has been submitted
under paragraphs (2) and (3) before releasing any
remaining funding for a grant or funding for a future
grant to such grantee.
‘‘(iii) NOTICE AND OPPORTUNITY TO REMEDY.—If the
head of an agency referred to in clause (i), as
applicable, verifies that a grantee has not submitted
clinical trial information as described in clause (ii),
such agency head shall provide notice to such grantee
of such non-compliance and allow such grantee 30 days
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121 STAT. 918
to correct such non-compliance and submit the required
clinical trial information.
‘‘(iv) CONSULTATION WITH OTHER FEDERAL AGENCIES.—The Secretary shall—
‘‘(I) consult with other agencies that conduct
research involving human subjects in accordance
with any section of part 46 of title 45, Code of
Federal Regulations (or any successor regulations),
to determine if any such research is an applicable
clinical trial; and
‘‘(II) develop with such agencies procedures
comparable to those described in clauses (i), (ii),
and (iii) to ensure that clinical trial information
for such applicable clinical trial is submitted under
paragraphs (2) and (3).
‘‘(B) CERTIFICATION TO ACCOMPANY DRUG, BIOLOGICAL
PRODUCT, AND DEVICE SUBMISSIONS.—At the time of submission of an application under section 505 of the Federal
Food, Drug, and Cosmetic Act, section 515 of such Act,
section 520(m) of such Act, or section 351 of this Act,
or submission of a report under section 510(k) of such
Act, such application or submission shall be accompanied
by a certification that all applicable requirements of this
subsection have been met. Where available, such certification shall include the appropriate National Clinical Trial
control numbers.
‘‘(C) QUALITY CONTROL.—
‘‘(i) PILOT QUALITY CONTROL PROJECT.—Until the
effective date of the regulations issued under paragraph (3)(D), the Secretary, acting through the Director
of NIH and the Commissioner of Food and Drugs,
shall conduct a pilot project to determine the optimal
method of verification to help to ensure that the clinical
trial information submitted under paragraph (3)(C) is
non-promotional and is not false or misleading in any
particular under subparagraph (D). The Secretary shall
use the publicly available information described in
paragraph (3)(A) and any other information available
to the Secretary about applicable clinical trials to verify
the accuracy of the clinical trial information submitted
under paragraph (3)(C).
‘‘(ii) NOTICE OF COMPLIANCE.—If the Secretary
determines that any clinical trial information was not
submitted as required under this subsection, or was
submitted but is false or misleading in any particular,
the Secretary shall notify the responsible party and
give such party an opportunity to remedy such noncompliance by submitting the required revised clinical
trial information not later than 30 days after such
notification.
‘‘(D) TRUTHFUL CLINICAL TRIAL INFORMATION.—
‘‘(i) IN GENERAL.—The clinical trial information
submitted by a responsible party under this subsection
shall not be false or misleading in any particular.
‘‘(ii) EFFECT.—Clause (i) shall not have the effect
of—
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PUBLIC LAW 110–85—SEPT. 27, 2007
121 STAT. 919
‘‘(I) requiring clinical trial information with
respect to an applicable clinical trial to include
information from any source other than such clinical trial involved; or
‘‘(II) requiring clinical trial information
described in paragraph (3)(D) to be submitted for
purposes of paragraph (3)(C).
‘‘(E) PUBLIC NOTICES.—
‘‘(i) NOTICE OF VIOLATIONS.—If the responsible
party for an applicable clinical trial fails to submit
clinical trial information for such clinical trial as
required under paragraphs (2) or (3), the Director of
NIH shall include in the registry and results data
bank entry for such clinical trial a notice—
‘‘(I) that the responsible party is not in compliance with this Act by—
‘‘(aa) failing to submit required clinical
trial information; or
‘‘(bb) submitting false or misleading clinical trial information;
‘‘(II) of the penalties imposed for the violation,
if any; and
‘‘(III) whether the responsible party has corrected the clinical trial information in the registry
and results data bank.
‘‘(ii) NOTICE OF FAILURE TO SUBMIT PRIMARY AND
SECONDARY OUTCOMES.—If the responsible party for
an applicable clinical trial fails to submit the primary
and secondary outcomes as required under section
2(A)(ii)(I)(ll), the Director of NIH shall include in the
registry and results data bank entry for such clinical
trial a notice that the responsible party is not in
compliance by failing to register the primary and secondary outcomes in accordance with this act, and that
the primary and secondary outcomes were not publicly
disclosed in the database before conducting the clinical
trial.
‘‘(iii) FAILURE TO SUBMIT STATEMENT.—The notice
under clause (i) for a violation described in clause
(i)(I)(aa) shall include the following statement: ‘The
entry for this clinical trial was not complete at the
time of submission, as required by law. This may or
may not have any bearing on the accuracy of the
information in the entry.’.
‘‘(iv) SUBMISSION OF FALSE INFORMATION STATEMENT.—The notice under clause (i) for a violation
described in clause (i)(I)(bb) shall include the following
statement: ‘The entry for this clinical trial was found
to be false or misleading and therefore not in compliance with the law.’.
‘‘(v) NON-SUBMISSION OF STATEMENT.—The notice
under clause (ii) for a violation described in clause
(ii) shall include the following statement: ‘The entry
for this clinical trial did not contain information on
the primary and secondary outcomes at the time of
submission, as required by law. This may or may not
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121 STAT. 920
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have any bearing on the accuracy of the information
in the entry.’.
‘‘(vi) COMPLIANCE SEARCHES.—The Director of NIH
shall provide that the public may easily search the
registry and results data bank for entries that include
notices required under this subparagraph.
‘‘(6) LIMITATION ON DISCLOSURE OF CLINICAL TRIAL
INFORMATION.—
‘‘(A) IN GENERAL.—Nothing in this subsection (or under
section 552 of title 5, United States Code) shall require
the Secretary to publicly disclose, by any means other
than the registry and results data bank, information
described in subparagraph (B).
‘‘(B) INFORMATION DESCRIBED.—Information described
in this subparagraph is—
‘‘(i) information submitted to the Director of NIH
under this subsection, or information of the same general nature as (or integrally associated with) the
information so submitted; and
‘‘(ii) information not otherwise publicly available,
including because it is protected from disclosure under
section 552 of title 5, United States Code.
‘‘(7) AUTHORIZATION OF APPROPRIATIONS.—There are
authorized to be appropriated to carry out this subsection
$10,000,000 for each fiscal year.’’.
(b) CONFORMING AMENDMENTS.—
(1) PROHIBITED ACTS.—Section 301 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding
at the end the following:
‘‘(jj)(1) The failure to submit the certification required by section
402(j)(5)(B) of the Public Health Service Act, or knowingly submitting a false certification under such section.
‘‘(2) The failure to submit clinical trial information required
under subsection (j) of section 402 of the Public Health Service
Act.
‘‘(3) The submission of clinical trial information under subsection (j) of section 402 of the Public Health Service Act that
is false or misleading in any particular under paragraph (5)(D)
of such subsection (j).’’.
(2) CIVIL MONEY PENALTIES.—Subsection (f) of section 303
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333),
as redesignated by section 226, is amended—
(A) by redesignating paragraphs (3), (4), and (5) as
paragraphs (5), (6), and (7), respectively;
(B) by inserting after paragraph (2) the following:
‘‘(3)(A) Any person who violates section 301(jj) shall be subject
to a civil monetary penalty of not more than $10,000 for all violations adjudicated in a single proceeding.
‘‘(B) If a violation of section 301(jj) is not corrected within
the 30-day period following notification under section 402(j)(5)(C)(ii),
the person shall, in addition to any penalty under subparagraph
(A), be subject to a civil monetary penalty of not more than $10,000
for each day of the violation after such period until the violation
is corrected.’’;
(C) in paragraph (2)(C), by striking ‘‘paragraph (3)(A)’’
and inserting ‘‘paragraph (5)(A)’’;
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121 STAT. 921
(D) in paragraph (5), as so redesignated, by striking
‘‘paragraph (1) or (2)’’ each place it appears and inserting
‘‘paragraph (1), (2), or (3)’’;
(E) in paragraph (6), as so redesignated, by striking
‘‘paragraph (3)(A)’’ and inserting ‘‘paragraph (5)(A)’’; and
(F) in paragraph (7), as so redesignated, by striking
‘‘paragraph (4)’’ each place it appears and inserting ‘‘paragraph (6)’’.
(3) NEW DRUGS AND DEVICES.—
(A) INVESTIGATIONAL NEW DRUGS.—Section 505(i) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i))
is amended in paragraph (4), by adding at the end the
following: ‘‘The Secretary shall update such regulations
to require inclusion in the informed consent documents
and process a statement that clinical trial information for
such clinical investigation has been or will be submitted
for inclusion in the registry data bank pursuant to subsection (j) of section 402 of the Public Health Service Act.’’.
(B) NEW DRUG APPLICATIONS.—Section 505(b) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b))
is amended by adding at the end the following:
‘‘(6) An application submitted under this subsection shall
be accompanied by the certification required under section
402(j)(5)(B) of the Public Health Service Act. Such certification
shall not be considered an element of such application.’’.
(C) DEVICE REPORTS UNDER SECTION 510(k).—Section
510(k) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360(k)) is amended by adding at the end the following:
‘‘A notification submitted under this subsection that contains clinical trial data for an applicable device clinical trial (as defined
in section 402(j)(1) of the Public Health Service Act) shall be accompanied by the certification required under section 402(j)(5)(B) of
such Act. Such certification shall not be considered an element
of such notification.’’.
(D) DEVICE PREMARKET APPROVAL APPLICATION.—Section 515(c)(1) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360e(c)(1)) is amended—
(i) in subparagraph (F), by striking ‘‘; and’’ and
inserting a semicolon;
(ii) by redesignating subparagraph (G) as subparagraph (H); and
(iii) by inserting after subparagraph (F) the following:
‘‘(G) the certification required under section 402(j)(5)(B)
of the Public Health Service Act (which shall not be considered an element of such application); and’’.
(E) HUMANITARIAN DEVICE EXEMPTION.—Section
520(m)(2) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360e(c)) is amended in the first sentence in
the matter following subparagraph (C), by inserting at
the end before the period ‘‘and such application shall
include the certification required under section 402(j)(5)(B)
of the Public Health Service Act (which shall not be considered an element of such application)’’.
(c) SURVEILLANCES.—Not later than 12 months after the date
of the enactment of this Act, the Secretary of Health and Human
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42 USC 282 note.
PUBLIC LAW 110–85—SEPT. 27, 2007
Services shall issue guidance on how the requirements of section
402(j) of the Public Health Service Act, as added by this section,
apply to a pediatric postmarket surveillance described in paragraph
(1)(A)(ii)(II) of such section 402(j) that is not a clinical trial.
(d) PREEMPTION.—
(1) IN GENERAL.—Upon the expansion of the registry and
results data bank under section 402(j)(3)(D) of the Public Health
Service Act, as added by this section, no State or political
subdivision of a State may establish or continue in effect any
requirement for the registration of clinical trials or for the
inclusion of information relating to the results of clinical trials
in a database.
(2) RULE OF CONSTRUCTION.—The fact of submission of
clinical trial information, if submitted in compliance with subsection (j) of section 402 of the Public Health Service Act
(as amended by this section), that relates to a use of a drug
or device not included in the official labeling of the approved
drug or device shall not be construed by the Secretary of
Health and Human Services or in any administrative or judicial
proceeding, as evidence of a new intended use of the drug
or device that is different from the intended use of the drug
or device set forth in the official labeling of the drug or device.
The availability of clinical trial information through the registry
and results data bank under such subsection (j), if submitted
in compliance with such subsection, shall not be considered
as labeling, adulteration, or misbranding of the drug or device
under the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
301 et seq.).
TITLE IX—ENHANCED AUTHORITIES
REGARDING POSTMARKET SAFETY OF
DRUGS
Subtitle A—Postmarket Studies and
Surveillance
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SEC. 901. POSTMARKET STUDIES AND CLINICAL TRIALS REGARDING
HUMAN DRUGS; RISK EVALUATION AND MITIGATION
STRATEGIES.
(a) IN GENERAL.—Section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355) is amended by adding at the end
the following subsections:
‘‘(o) POSTMARKET STUDIES AND CLINICAL TRIALS; LABELING.—
‘‘(1) IN GENERAL.—A responsible person may not introduce
or deliver for introduction into interstate commerce the new
drug involved if the person is in violation of a requirement
established under paragraph (3) or (4) with respect to the
drug.
‘‘(2) DEFINITIONS.—For purposes of this subsection:
‘‘(A) RESPONSIBLE PERSON.—The term ‘responsible person’ means a person who—
‘‘(i) has submitted to the Secretary a covered
application that is pending; or
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| File Type | application/pdf |
| File Title | PUBL085.PS |
| File Modified | 2007-12-12 |
| File Created | 2007-12-05 |