[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.

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