[House Report 118-165]
[From the U.S. Government Publishing Office]
118th Congress } { Report
HOUSE OF REPRESENTATIVES
1st Session } { 118-165
======================================================================
GABRIELLA MILLER KIDS FIRST RESEARCH ACT 2.0
_______
August 25, 2023.--Committed to the Committee of the Whole House on the
State of the Union and ordered to be printed
_______
Mrs. Rodgers of Washington, from the Committee on Energy and Commerce,
submitted the following
R E P O R T
[To accompany H.R. 3391]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 3391) to extend the Gabriella Miller Kids First
Pediatric Research Program at the National Institutes of
Health, and for other purposes, having considered the same,
reports favorably thereon with an amendment and recommends that
the bill as amended do pass.
CONTENTS
Page
Purpose and Summary.............................................. 2
Background and Need for Legislation.............................. 2
Committee Action................................................. 3
Committee Votes.................................................. 3
Oversight Findings and Recommendations........................... 5
New Budget Authority, Entitlement Authority, and Tax Expenditures 5
Congressional Budget Office Estimate............................. 5
Federal Mandates Statement....................................... 5
Statement of General Performance Goals and Objectives............ 5
Duplication of Federal Programs.................................. 5
Related Committee and Subcommittee Hearings...................... 5
Committee Cost Estimate.......................................... 6
Earmark, Limited Tax Benefits, and Limited Tariff Benefits....... 6
Advisory Committee Statement..................................... 6
Applicability to Legislative Branch.............................. 6
Section-by-Section Analysis of the Legislation................... 6
Changes in Existing Law Made by the Bill, as Reported............ 7
The amendment is as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Gabriella Miller Kids First Research
Act 2.0''.
SEC. 2. FUNDING FOR THE PEDIATRIC RESEARCH INITIATIVE.
The Public Health Service Act (42 U.S.C. 201 et seq.) is amended--
(1) in section 402A(a)(2) (42 U.S.C. 282a(a)(2))--
(A) in the heading--
(i) by striking ``10-year''; and
(ii) by striking ``through common fund'';
(B) by striking ``to the Common Fund'' and inserting
``to the Division of Program Coordination, Planning,
and Strategic Initiatives'';
(C) by striking ``10-Year'';
(D) by striking ``and reserved under subsection
(c)(1)(B)(i) of this section''; and
(E) by striking ``2014 through 2023'' and inserting
``2024 through 2028'';
(2) in each of paragraphs (1)(A) and (2)(C) of section
402A(c) (42 U.S.C. 282a(c)), by striking ``section
402(b)(7)(B)'' and inserting ``section 402(b)(7)(B)(i)''; and
(3) in section 402(b)(7)(B)(ii) (42 U.S.C. 282(b)(7)(B)(ii)),
by striking ``the Common Fund'' and inserting ``the Division of
Program Coordination, Planning, and Strategic Initiatives''.
SEC. 3. COORDINATION OF NIH FUNDING FOR PEDIATRIC RESEARCH.
(a) Sense of Congress.--It is the sense of the Congress that the
Director of the National Institutes of Health should continue to
oversee and coordinate research that is conducted or supported by the
National Institutes of Health for research on pediatric cancer and
other pediatric diseases and conditions, including through the
Pediatric Research Initiative Fund.
(b) Avoiding Duplication.--Section 402(b)(7)(B)(ii) of the Public
Health Service Act (42 U.S.C. 282(b)(7)(B)(ii)) is amended by inserting
``and shall prioritize, as appropriate, such pediatric research that
does not duplicate existing research activities of the National
Institutes of Health'' before ``; and''.
SEC. 4. REPORT ON PROGRESS AND INVESTMENTS IN PEDIATRIC RESEARCH.
Not later than 5 years after the date of the enactment of this Act,
the Secretary of Health and Human Services shall 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 that--
(1) details pediatric research projects and initiatives
receiving funds allocated pursuant to section 402(b)(7)(B)(ii)
of the Public Health Service Act (42 U.S.C. 282(b)(7)(B)(ii));
and
(2) summarizes advancements made in pediatric research with
funds allocated pursuant to such section.
Purpose and Summary
The bill reauthorizes funding for the National Institute of
Health's (NIH) Gabriella Miller Kids First Pediatric Research
Program. The bill also requires coordinating federal efforts
related to pediatric cancer research, as well as a report
detailing current federally funded programs and initiatives,
and the advancements made.
Background and Need for Legislation
The Gabriella Miller Kids First Pediatric Research Program
(Kids First) was created to facilitate additional research and
education around the relationship between childhood cancer and
structural birth defects, and the shared genetic pathways
between these disorders. It is estimated that over 9,910
children in the United States under the age of 15 will be
diagnosed with cancer in 2023.\1\ At the same time, one in 33
infants born in the United States has a birth defect. Birth
defects are the leading cause of death during the first year of
life, and account for half of all pediatric
hospitalizations.\2\ Research has shown that children with
birth defects have an increased risk of developing childhood
cancer. This suggests there are shared genetic pathways
underlying some types of childhood cancer and structural birth
defects, though more coordinated research and a better
understanding of the role of genetics is needed.
---------------------------------------------------------------------------
\1\Key Statistics for Childhood Cancers, American Cancer Society,
https://www.cancer.org/
cancer/types/cancer-in children/key-statistics.html.
\2\Overview, Gabriella Miller Kids First Pediatric Research Program
(Kids First), NIH, https://commonfund.nih.gov/kidsfirst/overview.
---------------------------------------------------------------------------
Committee Action
On June 14, 2023, the Subcommittee on Health held a hearing
on H.R. 3391. The Subcommittee received testimony from:
Dr. Elizabeth Cherot, MD, MBA, Senior Vice
President and Chief Medical Health Officer, March of
Dimes;
Dr. Alexis A. Thompson, MD, MPH, Chief of
Division of Hematology, Elias Schwartz MD Endowed Chair
in Hematology, Children's Hospital of Philadelphia,
Professor of Pediatrics, University of Pennsylvania
Perelman School of Medicine;
Dr. Meredithe McNamara, MD, MS, FAAP,
Assistant Professor, Yale School of Medicine;
Dr. Miriam Grossman, MD, Child, Adolescent,
and Adult Psychiatrist;
Mr. George Manahan, Parkinson's Advocate and
Patient; and,
Mr. Kevin O'Connor, Assistant to the General
President for Government Affairs and Political Action,
International Association of Fire Fighters.
On, July 13, 2023, the Subcommittee on Health met in open
markup session and forwarded H.R. 3391, as amended, to the full
Committee by a record vote of 27 yeas and 0 nays. On July 19,
2023, the full Committee on Energy and Commerce met in open
markup session and ordered H.R. 3391, as amended, favorably
reported to the House by a record vote of 50 yeas and 0 nays.
Committee Votes
Clause 3(b) of rule XIII requires the Committee to list the
record votes on the motion to report legislation and amendments
thereto. The following reflects the record votes taken during
the Committee consideration:
Oversight Findings and Recommendations
Pursuant to clause 2(b)(1) of rule X and clause 3(c)(1) of
rule XIII, the Committee held a hearing and made findings that
are reflected in this report.
New Budget Authority, Entitlement Authority, and
Tax Expenditures
Pursuant to clause 3(c)(2) of rule XIII, the Committee
finds that H.R. 3391 would result in no new or increased budget
authority, entitlement authority, or tax expenditures or
revenues.
Congressional Budget Office Estimate
Pursuant to clause 3(c)(3) of rule XIII, at the time this
report was filed, the cost estimate prepared by the Director of
the Congressional Budget Office pursuant to section 402 of the
Congressional Budget Act of 1974 was not available.
Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
Statement of General Performance Goals and Objectives
Pursuant to clause 3(c)(4) of rule XIII, the general
performance goal or objective of this legislation is to
facilitate research and education around the relationship
between childhood cancer and structural birth defects by
reauthorizing funding for the National Institute of Health's
Gabriella Miller Kids First Pediatric Research Program and
coordinating federal efforts related to pediatric cancer
research.
Duplication of Federal Programs
Pursuant to clause 3(c)(5) of rule XIII, no provision of
H.R. 3391 is known to be duplicative of another Federal
program, including any program that was included in a report to
Congress pursuant to section 21 of Public Law 111-139 or the
most recent Catalog of Federal Domestic Assistance.
Related Committee and Subcommittee Hearings
Pursuant to clause 3(c)(6) of rule XIII, the following
related hearing was used to develop or consider H.R. 3391:
On June 14, 2023, the Subcommittee on Health
held a hearing on H.R. 3391. The Subcommittee received
testimony from:
Dr. Elizabeth Cherot, MD, MBA,
Senior Vice President and Chief Medical Health
Officer, March of Dimes;
Dr. Alexis A. Thompson, MD, MPH,
Chief of Division of Hematology, Elias Schwartz
MD Endowed Chair in Hematology, Children's
Hospital of Philadelphia, Professor of
Pediatrics, University of Pennsylvania Perelman
School of Medicine;
Dr. Meredithe McNamara, MD, MS,
FAAP, Assistant Professor, Yale School of
Medicine;
Dr. Miriam Grossman, MD, Child,
Adolescent, and Adult Psychiatrist;
Mr. George Manahan, Parkinsons
Advocate and Patient; and,
Mr. Kevin O'Connor, Assistant to
the General President for Government Affairs
and Political Action, International Association
of Fire Fighters.
Committee Cost Estimate
Pursuant to clause 3(d)(1) of rule XIII, the Committee
adopts as its own the cost estimate prepared by the Director of
the Congressional Budget Office pursuant to section 402 of the
Congressional Budget Act of 1974. At the time this report was
filed, the estimate was not available.
Earmark, Limited Tax Benefits, and Limited Tariff Benefits
Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the
Committee finds that H.R. 3391 contains no earmarks, limited
tax benefits, or limited tariff benefits.
Advisory Committee Statement
No advisory committees within the meaning of section 5(b)
of the Federal Advisory Committee Act were created by this
legislation.
Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
Section-by-Section Analysis of the Legislation
Section 1. Short title
Section 1 provides a short title of ``Gabriella Miller Kids
First Research Act 2.0''.
Section 2. Funding for the pediatric research initiative
Section 2 amends section 402 of the Public Health Service
Act to extend funding for the Division of Program Coordination,
Planning, and Strategic Initiatives for fiscal years 2024
through 2028.
Section 3. Coordination of NIH funding for pediatric research
Section 3 expresses the sense of Congress that the Director
of the National Institutes of Health oversee and coordinate
pediatric research supported by the NIH and amends section 402
of the Public Health Service Act to clarify pediatric research
should not duplicate existing research activities of the NIH.
Section 4. Report on progress and investment in pediatric research
Section 4 directs the Secretary of Health and Human
Services to submit a report no later than 5 years after the
bill's enactment detailing current federally funded pediatric
research programs and initiatives and advancements made.
Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italics, and existing law in which no
change is proposed is shown in roman):
PUBLIC HEALTH SERVICE ACT
* * * * * * *
TITLE IV--NATIONAL RESEARCH INSTITUTES
Part A--National Institutes of Health
* * * * * * *
appointment and authority of director of nih
Sec. 402. (a) The National Institutes of Health shall be
headed by the Director of NIH who shall be appointed by the
President by and with the advice and consent of the Senate. The
Director of NIH shall perform functions as provided under
subsection (b) and as the Secretary may otherwise prescribe.
(b) In carrying out the purposes of section 301, the
Secretary, acting through the Director of NIH--
(1) shall carry out this title, including being
responsible for the overall direction of the National
Institutes of Health and for the establishment and
implementation of general policies respecting the
management and operation of programs and activities
within the National Institutes of Health;
(2) shall coordinate and oversee the operation of the
national research institutes, national centers, and
administrative entities within the National Institutes
of Health;
(3) shall, in consultation with the heads of the
national research institutes and national centers, be
responsible for program coordination across the
national research institutes and national centers,
including conducting priority-setting reviews, to
ensure that the research portfolio of the National
Institutes of Health is balanced and free of
unnecessary duplication, and takes advantage of
collaborative, cross-cutting research;
(4) shall assemble accurate data to be used to assess
research priorities, including--
(A) information to better evaluate scientific
opportunity, public health burdens, and
progress in reducing health disparities; and
(B) data on study populations of clinical
research, funded by or conducted at each
national research institute and national
center, which--
(i) specifies the inclusion of--
(I) women;
(II) members of minority
groups;
(III) relevant age
categories, including pediatric
subgroups; and
(IV) other demographic
variables as the Director of
the National Institutes of
Health determines appropriate;
(ii) is disaggregated by research
area, condition, and disease
categories; and
(iii) is to be made publicly
available on the Internet website of
the National Institutes of Health;
(5) shall ensure that scientifically based strategic
planning is implemented in support of research
priorities as determined by the agencies of the
National Institutes of Health, and through the
development, implementation, and updating of the
strategic plan developed under subsection (m);
(6) shall ensure that the resources of the National
Institutes of Health are sufficiently allocated for
research projects identified in strategic plans;
(7)(A) shall, through the Division of Program
Coordination, Planning, and Strategic Initiatives--
(i) identify research that represents
important areas of emerging scientific
opportunities, rising public health challenges,
or knowledge gaps that deserve special emphasis
and would benefit from conducting or supporting
additional research that involves collaboration
between 2 or more national research institutes
or national centers, or would otherwise benefit
from strategic coordination and planning;
(ii) include information on such research in
reports under section 403; and
(iii) in the case of such research supported
with funds referred to in subparagraph (B)--
(I) require as appropriate that
proposals include milestones and goals
for the research;
(II) require that the proposals
include timeframes for funding of the
research; and
(III) ensure appropriate
consideration of proposals for which
the principal investigator is an
individual who has not previously
served as the principal investigator of
research conducted or supported by the
National Institutes of Health;
(B)(i) may, with respect to funds reserved under
section 402A(c)(1) for the Common Fund, allocate such
funds to the national research institutes and national
centers for conducting and supporting research that is
identified under subparagraph (A); and
(ii) shall, with respect to funds appropriated to
[the Common Fund] the Division of Program Coordination,
Planning, and Strategic Initiatives pursuant to section
402A(a)(2), allocate such funds to the national
research institutes and national centers for making
grants for pediatric research that is identified under
subparagraph (A) and shall prioritize, as appropriate,
such pediatric research that does not duplicate
existing research activities of the National Institutes
of Health; and
(C) may assign additional functions to the Division
in support of responsibilities identified in
subparagraph (A), as determined appropriate by the
Director;
(8) shall, in coordination with the heads of the
national research institutes and national centers,
ensure that such institutes and centers--
(A) preserve an emphasis on investigator-
initiated research project grants, including
with respect to research involving
collaboration between 2 or more such institutes
or centers;
(B) when appropriate, maximize investigator-
initiated research project grants in their
annual research portfolios;
(C) foster collaboration between clinical
research projects funded by the respective
national research institutes and national
centers that--
(i) conduct research involving human
subjects; and
(ii) collect similar data; and
(D) encourage the collaboration described in
subparagraph (C) to--
(i) allow for an increase in the
number of subjects studied; and
(ii) utilize diverse study
populations, with special consideration
to biological, social, and other
determinants of health that contribute
to health disparities;
(9) shall ensure that research conducted or supported
by the National Institutes of Health is subject to
review in accordance with section 492 and that, after
such review, the research is reviewed in accordance
with section 492A(a)(2) by the appropriate advisory
council under section 406 before the research proposals
are approved for funding;
(10) shall have authority to review and approve the
establishment of all centers of excellence recommended
by the national research institutes;
(11)(A) shall oversee research training for all of
the national research institutes and National Research
Service Awards in accordance with section 487; and
(B) may conduct and support research training--
(i) for which fellowship support is not
provided under section 487; and
(ii) that does not consist of residency
training of physicians or other health
professionals;
(12) may, from funds appropriated under section
402A(b), reserve funds to provide for research on
matters that have not received significant funding
relative to other matters, to respond to new issues and
scientific emergencies, and to act on research
opportunities of high priority;
(13) may, subject to appropriations Acts, collect and
retain registration fees obtained from third parties to
defray expenses for scientific, educational, and
research-related conferences;
(14) for the national research institutes and
administrative entities within the National Institutes
of Health--
(A) may acquire, construct, improve, repair,
operate, and maintain, at the site of such
institutes and entities, laboratories, and
other research facilities, other facilities,
equipment, and other real or personal property,
and
(B) may acquire, without regard to the Act of
March 3, 1877 (40 U.S.C. 34), by lease or
otherwise through the Administrator of General
Services, buildings or parts of buildings in
the District of Columbia or communities located
adjacent to the District of Columbia for use
for a period not to exceed ten years;
(15) may secure resources for research conducted by
or through the National Institutes of Health;
(16) may, without regard to the provisions of title
5, United States Code, governing appointments in the
competitive service, and without regard to the
provisions of chapter 51 and subchapter III of chapter
53 of such title relating to classification and General
Schedule pay rates, establish such technical and
scientific peer review groups and scientific program
advisory committees as are needed to carry out the
requirements of this title and appoint and pay the
members of such groups, except that officers and
employees of the United States shall not receive
additional compensation for service as members of such
groups;
(17) may secure for the National Institutes of Health
consultation services and advice of persons from the
United States or abroad;
(18) may use, with their consent, the services,
equipment, personnel, information, and facilities of
other Federal, State, or local public agencies, with or
without reimbursement therefor;
(19) may, for purposes of study, admit and treat at
facilities of the National Institutes of Health
individuals not otherwise eligible for such treatment;
(20) may accept voluntary and uncompensated services;
(21) may perform such other administrative functions
as the Secretary determines are needed to effectively
carry out this title;
(22) may appoint physicians, dentists, and other
health care professionals, subject to the provisions of
title 5, United States Code, relating to appointments
and classifications in the competitive service, and may
compensate such professionals subject to the provisions
of chapter 74 of title 38, United States Code;
(23) shall designate a contact point or office to
help innovators and physicians identify sources of
funding available for pediatric medical device
development;
(24) implement the Cures Acceleration Network
described in section 480;
(25) may require recipients of National Institutes of
Health awards to share scientific data, to the extent
feasible, generated from such National Institutes of
Health awards in a manner that is consistent with all
applicable Federal laws and regulations, including such
laws and regulations for the protection of--
(A) human research participants, including
with respect to privacy, security, informed
consent, and protected health information; and
(B) proprietary interests, confidential
commercial information, and the intellectual
property rights of the funding recipient;
(26) shall consult with the Assistant Secretary for
Preparedness and Response, the Director of the
Biomedical Advanced Research and Development Authority,
the Director of the Centers for Disease Control and
Prevention, and the heads of other Federal agencies and
offices, as appropriate, regarding research needs to
advance medical countermeasures to diagnose, mitigate,
prevent, or treat harm from any biological agent or
toxin, including emerging infectious diseases,
chemical, radiological, or nuclear agent that may cause
a public health emergency or other research needs
related to emerging public health threats;
(27) shall consult with the Director of the Office of
National Security within the Department of Health and
Human Services, the Assistant Secretary for
Preparedness and Response, the Director of National
Intelligence, the Director of the Federal Bureau of
Investigation, and the heads of other appropriate
agencies on a regular basis, regarding biomedical
research conducted or supported by the National
Institutes of Health that may affect or be affected by
matters of national security;
(28) shall ensure that recipients of awards from the
National Institutes of Health, and, as appropriate and
practicable, entities collaborating with such
recipients, have in place and are adhering to
appropriate technology practices and policies for the
security of identifiable, sensitive information,
including information collected, stored, managed, or
analyzed by domestic and non-domestic entities; and
(29) shall ensure that recipients of awards from the
National Institutes of Health are in compliance with
the terms and conditions of such award, which may
include activities to support awareness of, and
compliance with, such terms and conditions by any
subrecipients of the award.
Chapter 10 of title 5, United States Code, shall not apply to
the duration of a peer review group appointed under paragraph
(16). The members of such a group shall be individuals who by
virtue of their training or experience are eminently qualified
to perform the review functions of such group. Not more than
one-fourth of the members of any such group shall be officers
or employees of the United States.
(c) The Director of NIH may make available to individuals and
entities, for biomedical and behavioral research, substances
and living organisms. Such substances and organisms shall be
made available under such terms and conditions (including
payment for them) as the Secretary determines appropriate.
(d)(1) The Director of NIH may obtain (in accordance with
section 3109 of title 5, United States Code, but without regard
to the limitation in such section on the period of service) the
services of not more than 220 experts or consultants, with
scientific or other professional qualifications, for the
National Institutes of Health.
(2)(A) Except as provided in subparagraph (B), experts and
consultants whose services are obtained under paragraph (1)
shall be paid or reimbursed, in accordance with title 5, United
States Code, for their travel to and from their place of
service and for other expenses associated with their
assignment.
(B) Expenses specified in subparagraph (A) shall not be
allowed in connection with the assignment of an expert or
consultant whose services are obtained under paragraph (1)
unless the expert or consultant has agreed in writing to
complete the entire period of the assignment or one year of the
assignment, whichever is shorter, unless separated or
reassigned for reasons which are beyond the control of the
expert or consultant and which are acceptable to the Secretary.
If the expert or consultant violates the agreement, the money
spent by the United States for such expenses is recoverable
from the expert or consultant as a debt due the United States.
The Secretary may waive in whole or in part a right of recovery
under this subparagraph.
(e) The Director of NIH shall--
(1) advise the agencies of the National Institutes of
Health on medical applications of research;
(2) coordinate, review, and facilitate the systematic
identification and evaluation of, clinically relevant
information from research conducted by or through the
national research institutes;
(3) promote the effective transfer of the information
described in paragraph (2) to the health care community
and to entities that require such information;
(4) monitor the effectiveness of the activities
described in paragraph (3); and
(5) ensure that, after January 1, 1994, all new or
revised health education and promotion materials
developed or funded by the National Institutes of
Health and intended for the general public are in a
form that does not exceed a level of functional
literacy, as defined in the National Literacy Act of
1991 (Public Law 102-73).
(f) There shall be in the National Institutes of Health an
Associate Director for Prevention. The Director of NIH shall
delegate to the Associate Director for Prevention the functions
of the Director relating to the promotion of the disease
prevention research programs of the national research
institutes and the coordination of such programs among the
national research institutes and between the national research
institutes and other public and private entities, including
elementary, secondary, and post-secondary schools. The
Associate Director shall--
(1) annually review the efficacy of existing policies
and techniques used by the national research institutes
to disseminate the results of disease prevention and
behavioral research programs; and
(2) recommend, coordinate, and oversee the
modification or reconstruction of such policies and
techniques to ensure maximum dissemination, using
advanced technologies to the maximum extent
practicable, of research results to such entities.
(h) The Secretary, acting through the Director of NIH and the
Directors of the agencies of the National Institutes of Health,
shall, in conducting and supporting programs for research,
research training, recruitment, and other activities, provide
for an increase in the number of women and individuals from
disadvantaged backgrounds (including racial and ethnic
minorities) in the fields of biomedical and behavioral
research.
(i)(1)(A) The Secretary, acting through the Director of NIH,
shall establish, maintain, and operate a data bank of
information on clinical trials for drugs for serious or life-
threatening diseases and conditions (in this subsection
referred to as the ``data bank''). The activities of the data
bank shall be integrated and coordinated with related
activities of other agencies of the Department of Health and
Human Services, and to the extent practicable, coordinated with
other data banks containing similar information.
(B) The Secretary shall establish the data bank after
consultation with the Commissioner of Food and Drugs, the
directors of the appropriate agencies of the National
Institutes of Health (including the National Library of
Medicine), and the Director of the Centers for Disease Control
and Prevention.
(2) In carrying out paragraph (1), the Secretary shall
collect, catalog, store, and disseminate the information
described in such paragraph. The Secretary shall disseminate
such information through information systems, which shall
include toll-free telephone communications, available to
individuals with serious or life-threatening diseases and
conditions, to other members of the public, to health care
providers, and to researchers.
(3) The data bank shall include the following:
(A) A registry of clinical trials (whether federally
or privately funded) of experimental treatments for
serious or life-threatening diseases and conditions
under regulations promulgated pursuant to section
505(i) of the Federal Food, Drug, and Cosmetic Act,
which provides a description of the purpose of each
experimental drug, either with the consent of the
protocol sponsor, or when a trial to test effectiveness
begins. Information provided shall consist of
eligibility criteria for participation in the clinical
trials, a description of the location of trial sites,
and a point of contact for those wanting to enroll in
the trial, and shall be in a form that can be readily
understood by members of the public. Such information
shall be forwarded to the data bank by the sponsor of
the trial not later than 21 days after the approval of
the protocol.
(B) Information pertaining to experimental treatments
for serious or life-threatening diseases and conditions
that may be available--
(i) under a treatment investigational new
drug application that has been submitted to the
Secretary under section 561(c) of the Federal
Food, Drug, and Cosmetic Act; or
(ii) as a Group C cancer drug (as defined by
the National Cancer Institute).
The data bank may also include information pertaining
to the results of clinical trials of such treatments,
with the consent of the sponsor, including information
concerning potential toxicities or adverse effects
associated with the use or administration of such
experimental treatments.
(4) The data bank shall not include information relating to
an investigation if the sponsor has provided a detailed
certification to the Secretary that disclosure of such
information would substantially interfere with the timely
enrollment of subjects in the investigation, unless the
Secretary, after the receipt of the certification, provides the
sponsor with a detailed written determination that such
disclosure would not substantially interfere with such
enrollment.
(5) Fees collected under section 736 of the Federal Food,
Drug, and Cosmetic Act shall not be used in carrying out this
subsection.
(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).
(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.
(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 toll-
free 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
(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
(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, unless
the responsible party
affirmatively requests that the
Director of the National
Institutes of Health publicly
post such clinical trial
information for an applicable
device clinical trial prior to
such date of clearance or
approval; 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.
(iii) Option to make certain clinical
trial information available earlier.--
The Director of the National Institutes
of Health shall inform responsible
parties of the option to request that
clinical trial information for an
applicable device clinical trial be
publicly posted prior to the date of
clearance or approval, in accordance
with clause (ii)(I).
(iv) Combination products.--An
applicable clinical trial for a product
that is a combination of drug, device,
or biological product shall be
considered--
(I) an applicable drug
clinical trial, if the
Secretary determines under
section 503(g) of the Federal
Food, Drug, and Cosmetic Act
that the primary mode of action
of such product is that of a
drug or biological product; or
(II) an applicable device
clinical trial, if the
Secretary determines under such
section that the primary mode
of action of such product is
that of a device.
(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, 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 the registry and
results data bank for each 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 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, the following elements:
(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.
(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--
(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--
(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
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.
(H) Waivers regarding certain clinical trial
results.--The Secretary may waive 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
applicable clinical trials 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 applicable
clinical trials 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.--
(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 clinical trial information
during the preceding 12-month
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 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--
(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 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.
(k)(1) The Director of NIH may establish a program to provide
day care services for the employees of the National Institutes
of Health similar to those services provided by other Federal
agencies (including the availability of day care service on a
24-hour-a-day basis).
(2) Any day care provider at the National Institutes of
Health shall establish a sliding scale of fees that takes into
consideration the income and needs of the employee.
(3) For purposes regarding the provision of day care
services, the Director of NIH may enter into rental or lease
purchase agreements.
(l) Council of Councils.--
(1) Establishment.--Not later than 90 days after the
date of the enactment of the National Institutes of
Health Reform Act of 2006, the Director of NIH shall
establish within the Office of the Director an advisory
council to be known as the ``Council of Councils''
(referred to in this subsection as the ``Council'') for
the purpose of advising the Director on matters related
to the policies and activities of the Division of
Program Coordination, Planning, and Strategic
Initiatives, including making recommendations with
respect to the conduct and support of research
described in subsection (b)(7).
(2) Membership.--
(A) In general.--The Council shall be
composed of 27 members selected by the Director
of NIH with approval from the Secretary from
among the list of nominees under subparagraph
(C).
(B) Certain requirements.--In selecting the
members of the Council, the Director of NIH
shall ensure--
(i) the representation of a broad
range of disciplines and perspectives;
and
(ii) the ongoing inclusion of at
least 1 representative from each
national research institute whose
budget is substantial relative to a
majority of the other institutes.
(C) Nomination.--The Director of NIH shall
maintain an updated list of individuals who
have been nominated to serve on the Council,
which list shall consist of the following:
(i) For each national research
institute and national center, 3
individuals nominated by the head of
such institute or center from among the
members of the advisory council of the
institute or center, of which--
(I) two shall be scientists;
and
(II) one shall be from the
general public or shall be a
leader in the field of public
policy, law, health policy,
economics, or management.
(ii) For each office within the
Division of Program Coordination,
Planning, and Strategic Initiatives, 1
individual nominated by the head of
such office.
(iii) Members of the Council of
Public Representatives.
(3) Terms.--
(A) In general.--The term of service for a
member of the Council shall be 6 years, except
as provided in subparagraphs (B) and (C).
(B) Terms of initial appointees.--Of the
initial members selected for the Council, the
Director of NIH shall designate--
(i) nine for a term of 6 years;
(ii) nine for a term of 4 years; and
(iii) nine for a term of 2 years.
(C) Vacancies.--Any member appointed to fill
a vacancy occurring before the expiration of
the term for which the member's predecessor was
appointed shall be appointed only for the
remainder of that term. A member may serve
after the expiration of that member's term
until a successor has taken office.
(m) National Institutes of Health Strategic Plan.--
(1) In general.--Not later than 2 years after the
date of enactment of the 21st Century Cures Act, and at
least every 6 years thereafter, the Director of the
National Institutes of Health shall develop and submit
to the appropriate committees of Congress and post on
the Internet website of the National Institutes of
Health, a coordinated strategy (to be known as the
``National Institutes of Health Strategic Plan'') to
provide direction to the biomedical research
investments made by the National Institutes of Health,
to facilitate collaboration across the institutes and
centers, to leverage scientific opportunity, and to
advance biomedicine.
(2) Requirements.--The strategy under paragraph (1)
shall--
(A) identify strategic research priorities
and objectives across biomedical research,
including--
(i) an assessment of the state of
biomedical and behavioral research,
including areas of opportunity with
respect to basic, clinical, and
translational research;
(ii) priorities and objectives to
advance the treatment, cure, and
prevention of health conditions;
(iii) emerging scientific
opportunities, rising public health
challenges, and scientific knowledge
gaps; and
(iv) the identification of near-,
mid-, and long-term scientific needs;
(B) consider, in carrying out subparagraph
(A)--
(i) disease burden in the United
States and the potential for return on
investment to the United States;
(ii) rare diseases and conditions;
(iii) biological, social, and other
determinants of health that contribute
to health disparities; and
(iv) other factors the Director of
National Institutes of Health
determines appropriate;
(C) include multi-institute priorities,
including coordination of research among
institutes and centers;
(D) include strategic priorities for funding
research through the Common Fund, in accordance
with section 402A(c)(1)(C);
(E) address the National Institutes of
Health's proposed and ongoing activities
related to training and the biomedical
workforce; and
(F) describe opportunities for collaboration
with other agencies and departments, as
appropriate.
(3) Use of plans.--Strategic plans developed and
updated by the national research institutes and
national centers of the National Institutes of Health
shall be prepared regularly and in such a manner that
such plans will be informed by the strategic plans
developed and updated under this subsection. Such plans
developed by and updated by the national research
institutes and national centers shall have a common
template.
(4) Consultation.--The Director of National
Institutes of Health shall develop the strategic plan
under paragraph (1) in consultation with the directors
of the national research institutes and national
centers, researchers, patient advocacy groups, and
industry leaders.
(n) Unique Research Initiatives.--
(1) In general.--The Director of NIH may approve,
after consideration of a proposal under paragraph
(2)(A), requests by the national research institutes
and centers, or program officers within the Office of
the Director to engage in transactions other than a
contract, grant, or cooperative agreement with respect
to projects that carry out--
(A) the Precision Medicine Initiative under
section 498E;
(B) section 402(b)(7), except that not more
than 50 percent of the funds available for a
fiscal year through the Common Fund under
section 402A(c)(1) for purposes of carrying out
such section 402(b)(7) may be used to engage in
such other transactions; or
(C) high impact cutting-edge research that
fosters scientific creativity and increases
fundamental biological understanding leading to
the prevention, diagnosis, or treatment of
diseases and disorders, or research urgently
required to respond to a public health threat.
(2) Requirements.--The authority provided under this
subsection may be used to conduct or support high
impact cutting-edge research described in paragraph (1)
using the other transactions authority described in
such paragraph if the institute, center, or office--
(A) submits a proposal to the Director of NIH
for the use of such authority before conducting
or supporting the research, including why the
use of such authority is essential to promoting
the success of the project;
(B) receives approval for the use of such
authority from the Director of NIH; and
(C) for each year in which the institute,
center, or office has used such authority in
accordance with this subsection, submits a
report to the Director of NIH on the activities
of the institute, center, or office relating to
such research.
(o) Regenerative Medicine.--The Director of NIH shall, as
appropriate, continue to consult with the directors of relevant
institutes and centers of the National Institutes of Health,
other relevant experts from such institutes and centers, and
relevant experts within the Food and Drug Administration, to
further the field of regenerative medicine using adult stem
cells, including autologous stem cells, therapeutic tissue
engineering products, human cell and tissue products, human
gene therapies, and genetically modified cells.
SEC. 402A. AUTHORIZATION OF APPROPRIATIONS.
(a) In General.--
(1) This title.--For purposes of carrying out this
title, there are authorized to be appropriated--
(A) $30,331,309,000 for fiscal year 2007;
(B) $32,831,309,000 for fiscal year 2008;
(C) such sums as may be necessary for fiscal
year 2009;
(D) $34,851,000,000 for fiscal year 2018;
(E) $35,585,871,000 for fiscal year 2019; and
(F) $36,472,442,775 for fiscal year 2020.
(2) Funding for [10-year] pediatric research
initiative [through common fund].--For the purpose of
carrying out section 402(b)(7)(B)(ii), there is
authorized to be appropriated [to the Common Fund] to
the Division of Program Coordination, Planning, and
Strategic Initiatives, out of the [10-Year] Pediatric
Research Initiative Fund described in section 9008 of
the Internal Revenue Code of 1986, and in addition to
amounts otherwise made available under paragraph (1) of
this subsection [and reserved under subsection
(c)(1)(B)(i) of this section], $12,600,000 for each of
fiscal years [2014 through 2023] 2024 through 2028.
(b) Office of the Director.--Of the amount authorized to be
appropriated under subsection (a) for a fiscal year, there are
authorized to be appropriated for programs and activities under
this title carried out through the Office of the Director of
NIH such sums as may be necessary for each of the fiscal years
2007 through 2009.
(c) Trans-NIH Research.--
(1) Common fund.--
(A) Account.--For the purpose of allocations
under [section 402(b)(7)(B)] section
402(b)(7)(B)(i) (relating to research
identified by the Division of Program
Coordination, Planning, and Strategic
Initiatives), there is established an account
to be known as the Common Fund.
(B) Reservation.--
(i) In general.--Of the total amount
appropriated under subsection (a)(1)
for fiscal year 2007 or any subsequent
fiscal year, the Director of NIH shall
reserve an amount for the Common Fund,
subject to any applicable provisions in
appropriations Acts.
(ii) Minimum amount.--For each fiscal
year, the percentage constituted by the
amount reserved under clause (i)
relative to the total amount
appropriated under subsection (a)(1)
for such year may not be less than the
percentage constituted by the amount so
reserved for the preceding fiscal year
relative to the total amount
appropriated under subsection (a)(1)
for such preceding fiscal year, subject
to any applicable provisions in
appropriations Acts.
(C) Common fund strategic planning report.--
As part of the National Institutes of Health
Strategic Plan required under section 402(m),
the Secretary, acting through the Director of
NIH, shall submit a report to the Congress
containing a strategic plan for funding
research described in section 402(b)(7)(A)(i)
(including personnel needs) through the Common
Fund. Each such plan shall include the
following:
(i) An estimate of the amounts
determined by the Director of NIH to be
appropriate for maximizing the
potential of such research.
(ii) An estimate of the amounts
determined by the Director of NIH to be
sufficient only for continuing to fund
research activities previously
identified by the Division of Program
Coordination, Planning, and Strategic
Initiatives.
(iii) An estimate of the amounts
determined by the Director of NIH to be
necessary to fund research described in
section 402(b)(7)(A)(i)--
(I) that is in addition to
the research activities
described in clause (ii); and
(II) for which there is the
most substantial need.
(D) Evaluation.--During the 6-month period
following the end of the first fiscal year for
which the total amount reserved under
subparagraph (B) is equal to 5 percent of the
total amount appropriated under subsection
(a)(1) for such fiscal year, the Secretary,
acting through the Director of NIH, in
consultation with the advisory council
established under section 402(k), shall submit
recommendations to the Congress for changes
regarding amounts for the Common Fund.
(2) Trans-nih research reporting.--
(A) Limitation.--With respect to the total
amount appropriated under subsection (a) for
fiscal year 2008 or any subsequent fiscal year,
if the head of a national research institute or
national center fails to submit the report
required by subparagraph (B) for the preceding
fiscal year, the amount made available for the
institute or center for the fiscal year
involved may not exceed the amount made
available for the institute or center for
fiscal year 2006.
(B) Reporting.--Not later than 2 years after
the date of enactment of 21st Century Cures
Act, the head of each national research
institute or national center shall submit to
the Director of the National Institutes of
Health a report, to be included in the
triennial report under section 403, on the
amount made available by the institute or
center for conducting or supporting research
that involves collaboration between the
institute or center and 1 or more other
national research institutes or national
centers.
(C) Determination.--For purposes of
determining the amount or percentage of funds
to be reported under subparagraph (B), any
amounts made available to an institute or
center under [section 402(b)(7)(B)] section
402(b)(7)(B)(i) shall be included.
(D) Verification of amounts.--Upon receipt of
each report submitted under subparagraph (B),
the Director of NIH shall review and, in cases
of discrepancy, verify the accuracy of the
amounts specified in the report.
(E) Waiver.--At the request of any national
research institute or national center, the
Director of NIH may waive the application of
this paragraph to such institute or center if
the Director finds that the conduct or support
of research described in subparagraph (B) is
inconsistent with the mission of such institute
or center.
(d) Transfer Authority.--Of the total amount appropriated
under subsection (a)(1) for a fiscal year, the Director of NIH
may (in addition to the reservation under subsection (c)(1) for
such year) transfer not more than 1 percent for programs or
activities that are authorized in this title and identified by
the Director to receive funds pursuant to this subsection. In
making such transfers, the Director may not decrease any
appropriation account under subsection (a)(1) by more than 1
percent.
(e) Rule of Construction.--This section may not be construed
as affecting the authorities of the Director of NIH under
section 401.
* * * * * * *