[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 2742 Reported in Senate (RS)]

<DOC>





                                                       Calendar No. 429
114th CONGRESS
  2d Session
                                S. 2742

   To amend title IV of the Public Health Service Act regarding the 
         national research institutes, and for other purposes.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             April 4, 2016

  Mr. Alexander (for himself, Mrs. Murray, Mr. Kirk, and Ms. Warren) 
introduced the following bill; which was read twice and referred to the 
          Committee on Health, Education, Labor, and Pensions

                             April 18, 2016

              Reported by Mr. Alexander, with an amendment
 [Strike out all after the enacting clause and insert the part printed 
                               in italic]

_______________________________________________________________________

                                 A BILL


 
   To amend title IV of the Public Health Service Act regarding the 
         national research institutes, and for other purposes.

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

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``Promoting Biomedical 
Research and Public Health for Patients Act''.</DELETED>

<DELETED>SEC. 2. TRIENNIAL REPORTS OF DIRECTOR OF NIH.</DELETED>

<DELETED>    Section 403 of the Public Health Service Act (42 U.S.C. 
283) is amended--</DELETED>
        <DELETED>    (1) in the heading, by striking ``biennial'' and 
        inserting ``triennial''; and</DELETED>
        <DELETED>    (2) in subsection (a)--</DELETED>
                <DELETED>    (A) in the matter preceding paragraph (1), 
                by striking ``biennial'' and inserting 
                ``triennial'';</DELETED>
                <DELETED>    (B) by amending paragraph (3) to read as 
                follows:</DELETED>
        <DELETED>    ``(3) A description of intra-NIH activities, 
        including identification of the percentage of funds made 
        available by each national research institute and national 
        center with respect to each applicable fiscal year for 
        conducting or supporting research that involves collaboration 
        between the institute or center and 1 or more other national 
        research institutes or national centers and recommendations for 
        promoting coordination of information among the centers of 
        excellence.'';</DELETED>
                <DELETED>    (C) in paragraph (4)--</DELETED>
                        <DELETED>    (i) in subparagraph (B), by 
                        striking ``demographic variables and other 
                        variables'' and inserting ``demographic 
                        variables, including biological and social 
                        variables and relevant age categories, and 
                        determinants of health''; and</DELETED>
                        <DELETED>    (ii) in subparagraph (C)(v)--
                        </DELETED>
                                <DELETED>    (I) by striking 
                                ``demographic variables and such'' and 
                                inserting ``demographic variables, 
                                including relevant age categories, 
                                information submitted by each national 
                                research institute and national center 
                                to the Director of NIH under section 
                                492B(f), and such''; and</DELETED>
                                <DELETED>    (II) by striking 
                                ``(regarding inclusion of women and 
                                minorities in clinical research)'' and 
                                inserting ``and other applicable 
                                requirements regarding inclusion of 
                                demographic groups''; and</DELETED>
                <DELETED>    (D) in paragraph (6)--</DELETED>
                        <DELETED>    (i) in the matter preceding 
                        subparagraph (A), by striking ``the 
                        following:'' and inserting ``the following--
                        '';</DELETED>
                        <DELETED>    (ii) in subparagraph (A)--
                        </DELETED>
                                <DELETED>    (I) by striking ``An 
                                evaluation'' and inserting ``an 
                                evaluation''; and</DELETED>
                                <DELETED>    (II) by striking the 
                                period and inserting ``; 
                                and'';</DELETED>
                        <DELETED>    (iii) by striking subparagraphs 
                        (B) and (D);</DELETED>
                        <DELETED>    (iv) by redesignating subparagraph 
                        (C) as subparagraph (B); and</DELETED>
                        <DELETED>    (v) in subparagraph (B), as 
                        redesignated by clause (iv), by striking 
                        ``Recommendations'' and inserting 
                        ``recommendations''.</DELETED>

<DELETED>SEC. 3. ADMINISTRATIVE BURDEN ON INVESTIGATORS.</DELETED>

<DELETED>    (a) Disclosure of Financial Conflicts of Interest.--
</DELETED>
        <DELETED>    (1) In general.--Not later than 2 years after the 
        date of enactment of this Act, the Secretary of Health and 
        Human Services (referred to in this section as the 
        ``Secretary'') shall--</DELETED>
                <DELETED>    (A) lead a review by research funding 
                agencies of all regulations and policies related to the 
                disclosure of financial conflicts of interest, 
                including the minimum threshold for reporting financial 
                conflicts of interest; and</DELETED>
                <DELETED>    (B) make revisions, as appropriate, to 
                harmonize existing policies and reduce administrative 
                burden on researchers while maintaining the integrity 
                and credibility of research findings and protections of 
                human participants.</DELETED>
        <DELETED>    (2) Considerations.--In updating policies under 
        paragraph (1)(B), the Secretary shall consider--</DELETED>
                <DELETED>    (A) modifying the timelines for the 
                reporting of financial conflicts of interest to just in 
                time information by institutions receiving grant or 
                cooperative agreement funding from the National 
                Institutes of Health;</DELETED>
                <DELETED>    (B) ensuring that financial interest 
                disclosure reporting requirements are appropriate for, 
                and relevant to, awards that will directly fund 
                research, which may include modification of the 
                definition of the term ``investigator''; and</DELETED>
                <DELETED>    (C) updating any applicable training 
                modules of the National Institutes of Health related to 
                Federal financial interest disclosure.</DELETED>
<DELETED>    (b) Monitoring of Subrecipients of Funding From the 
National Institutes of Health.--The Director of the National Institutes 
of Health shall implement measures to reduce the administrative burdens 
related to monitoring of subrecipients of grants by primary awardees of 
funding from the National Institutes of Health, which may incorporate 
findings and recommendations from existing and ongoing activities. Such 
measures may include, as appropriate--</DELETED>
        <DELETED>    (1) an exemption from subrecipient monitoring 
        requirements, upon request from the primary awardees, provided 
        that--</DELETED>
                <DELETED>    (A) the subrecipient is subject to Federal 
                audit requirements pursuant to the Uniform Guidance of 
                the Office of Management and Budget;</DELETED>
                <DELETED>    (B) the primary awardee conducts a formal 
                or informal evaluation of each subrecipient's risk of 
                noncompliance with Federal statutes and regulations, 
                and the conditions of the subaward; and</DELETED>
                <DELETED>    (C) such exemption does not absolve the 
                primary awardee of liability for misconduct by 
                subrecipients; and</DELETED>
        <DELETED>    (2) the implementation of alternative grant 
        structures that obviate the need for subrecipient monitoring, 
        which may include collaborative grant models allowing for 
        multiple primary awardees.</DELETED>
<DELETED>    (c) Reporting of Financial Expenditures.--The Secretary, 
in consultation with the Director of the National Institutes of Health, 
shall evaluate financial expenditure reporting procedures and 
requirements for recipients of funding from the National Institutes of 
Health and take action, as appropriate, to avoid duplication between 
department and agency procedures and requirements and minimize burden 
to funding recipients.</DELETED>
<DELETED>    (d) Animal Care and Use in Research.--Not later than 2 
years after the date of enactment of this Act, the Director of the 
National Institutes of Health, in collaboration with the Secretary of 
Agriculture and the Commissioner of Food and Drugs, shall complete a 
review of applicable regulations and policies for the care and use of 
laboratory animals and make revisions, as appropriate, to reduce 
administrative burden on investigators while maintaining the integrity 
and credibility of research findings and protection of research 
animals. In carrying out this effort, the Director shall seek the input 
of experts, as appropriate. The Director shall--</DELETED>
        <DELETED>    (1) identify ways to ensure such regulations and 
        policies are not inconsistent, overlapping, or unnecessarily 
        duplicative, including with respect to inspection and review 
        requirements by Federal agencies and accrediting 
        associations;</DELETED>
        <DELETED>    (2) take steps to eliminate or reduce identified 
        inconsistencies, overlap, or duplication among such regulations 
        and policies; and</DELETED>
        <DELETED>    (3) take other actions, as appropriate, to improve 
        the coordination of regulations and policies with respect to 
        research with laboratory animals.</DELETED>
<DELETED>    (e) Documentation of Personnel Expenses.--The Secretary 
shall clarify the applicability of the requirements under the Office of 
Management and Budget Uniform Guidance for management and certification 
systems adopted by entities receiving Federal research grants through 
the Department of Health and Human Services regarding documentation of 
personnel expenses, including clarification of the extent to which any 
flexibility to such requirements specified in such Uniform Guidance 
applies to entities receiving grants through the Department of Health 
and Human Services.</DELETED>
<DELETED>    (f) Research Policy Board.--</DELETED>
        <DELETED>    (1) Establishment.--Not later than 1 year after 
        the date of enactment of this Act, the Director of the Office 
        of Management and Budget shall establish an advisory committee, 
        to be known as the ``Research Policy Board'' (referred to in 
        this subsection as the ``Board''), to provide the Director and 
        other members of the Federal Government with information on the 
        effects of regulations related to Federal research 
        requirements.</DELETED>
        <DELETED>    (2) Membership.--</DELETED>
                <DELETED>    (A) In general.--The Board shall include 
                not more than 10 Federal members, including each of the 
                following Federal members or their designees:</DELETED>
                        <DELETED>    (i) The Administrator of the 
                        Office of Information and Regulatory Affairs of 
                        the Office of Management and Budget.</DELETED>
                        <DELETED>    (ii) The Director of the Office of 
                        Science and Technology Policy.</DELETED>
                        <DELETED>    (iii) The Secretary of Health and 
                        Human Services.</DELETED>
                        <DELETED>    (iv) The Director of the National 
                        Science Foundation.</DELETED>
                        <DELETED>    (v) The secretaries and directors 
                        of other departments and agencies that support 
                        or regulate scientific research, as determined 
                        by the Director of the Office of Management and 
                        Budget.</DELETED>
                <DELETED>    (B) Non-federal members.--The Board shall 
                be comprised of not less than 9 and not more than 12 
                representatives of academic research institutions, 
                other private, nonprofit research institutions, or 
                other nonprofit organizations with relevant expertise. 
                Such members shall be appointed by a formal process, to 
                be established by the Director of the Office of 
                Management and Budget, in consultation with the Federal 
                membership, and that incorporates--</DELETED>
                        <DELETED>    (i) nomination by members of the 
                        nonprofit scientific research community, 
                        including academic research institutions; 
                        and</DELETED>
                        <DELETED>    (ii) procedures to fill membership 
                        positions vacated before the end of a member's 
                        term.</DELETED>
        <DELETED>    (3) Purpose and responsibilities.--The Board shall 
        make recommendations regarding the modification and 
        harmonization of regulations and policies having similar 
        purposes across research funding agencies to ensure that the 
        administrative burden of such research policy and regulation is 
        minimized to the greatest extent possible and consistent with 
        maintaining responsible oversight of federally funded research. 
        Activities of the Board may include--</DELETED>
                <DELETED>    (A) providing thorough and informed 
                analysis of regulations and policies;</DELETED>
                <DELETED>    (B) identifying negative or adverse 
                consequences of existing policies and making actionable 
                recommendations regarding possible improvement of such 
                policies;</DELETED>
                <DELETED>    (C) making recommendations with respect to 
                efforts within the Federal Government to improve 
                coordination of regulation and policy related to 
                research;</DELETED>
                <DELETED>    (D) creating a forum for the discussion of 
                research policy or regulatory gaps, challenges, 
                clarification, or harmonization of such policies or 
                regulation, and best practices; and</DELETED>
                <DELETED>    (E) conducting ongoing assessment and 
                evaluation of regulatory burden, including development 
                of metrics, periodic measurement, and identification of 
                process improvements and policy changes.</DELETED>
        <DELETED>    (4) Expert subcommittees.--The Board may form 
        temporary expert subcommittees, as appropriate, to develop 
        timely analysis on pressing issues and assist the Board in 
        anticipating future regulatory challenges, including those 
        emerging from new scientific advances.</DELETED>
        <DELETED>    (5) Reporting requirements.--Not later than 2 
        years after the date of enactment of this Act, and once 
        thereafter, the Board shall submit a report to the Director of 
        the Office of Management and Budget, the Administrator of the 
        Office of Information and Regulatory Affairs of the Office of 
        Management and Budget, the Director of the Office of Science 
        and Technology Policy, the heads of relevant Federal 
        departments and agencies, the Committee on Health, Education, 
        Labor, and Pensions of the Senate, and the Committee on Energy 
        and Commerce of the House of Representatives containing formal 
        recommendations on the conceptualization, development, 
        harmonization, and reconsideration of scientific research 
        policy, including the regulatory benefits and 
        burdens.</DELETED>
        <DELETED>    (6) Sunset.--The Board shall terminate on 
        September 30, 2020.</DELETED>
        <DELETED>    (7) GAO report.--Not later than 4 years after the 
        date of enactment of this Act, the Comptroller General of the 
        United States shall conduct an independent evaluation of the 
        activities carried out by the Board pursuant to this subsection 
        and submit to the appropriate committees of Congress a report 
        regarding the results of the independent evaluation. Such 
        report shall review and assess the Board's activities with 
        respect to the responsibilities described in paragraph 
        (3).</DELETED>

<DELETED>SEC. 4. REIMBURSEMENT FOR RESEARCH SUBSTANCES AND LIVING 
              ORGANISMS.</DELETED>

<DELETED>    Section 301 of the Public Health Service Act (42 U.S.C. 
241) is amended--</DELETED>
        <DELETED>    (1) in the flush matter at the end of subsection 
        (a)--</DELETED>
                <DELETED>    (A) by redesignating such matter as 
                subsection (f)(1); and</DELETED>
                <DELETED>    (B) by moving such matter so as to appear 
                at the end of such section; and</DELETED>
        <DELETED>    (2) in subsection (f) (as so redesignated), by 
        adding at the end the following:</DELETED>
<DELETED>    ``(2) Where research substances and living organisms are 
made available under paragraph (1) through contractors, the Secretary 
may direct such contractors to collect payments on behalf of the 
Secretary for the costs incurred to make available such substances and 
organisms and to forward amounts so collected to the Secretary, in the 
time and manner specified by the Secretary.</DELETED>
<DELETED>    ``(3) Amounts collected under paragraph (2) shall be 
credited to the appropriations accounts that incurred the costs to make 
available the research substances and living organisms involved, and 
shall remain available until expended for carrying out activities under 
such accounts.''.</DELETED>

<DELETED>SEC. 5. STREAMLINING NIH REPORTING REQUIREMENTS.</DELETED>

<DELETED>    (a) Trans-NIH Research Reporting.--Section 402A(c)(2) of 
the Public Health Service Act (42 U.S.C. 282a(c)(2)) is amended--
</DELETED>
        <DELETED>    (1) by amending subparagraph (B) to read as 
        follows:</DELETED>
                <DELETED>    ``(B) Reporting.--Not later than 2 years 
                after the date of enactment of Promoting Biomedical 
                Research and Public Health for Patients Act, the head 
                of each national research institute or national center 
                shall submit to the Director of NIH 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.''; and</DELETED>
        <DELETED>    (2) in subparagraphs (D) and (E) by striking 
        ``(B)(i)'' each place it appears and inserting 
        ``(B)''.</DELETED>
<DELETED>    (b) Fraud and Abuse Reporting.--Section 403B of the Public 
Health Service Act (42 U.S.C. 283a-1) is amended--</DELETED>
        <DELETED>    (1) by striking subsection (b);</DELETED>
        <DELETED>    (2) by redesignating subsection (c) as subsection 
        (b); and</DELETED>
        <DELETED>    (3) in subsection (b) (as so redesignated), by 
        striking ``subsections (a) and (b)'' and inserting ``subsection 
        (a)''.</DELETED>
<DELETED>    (c) Doctoral Degrees Reporting.--Section 403C(a)(2) of the 
Public Health Service Act (42 U.S.C. 283a-2(a)(2)) is amended by 
striking ``(not including any leaves of absence)''.</DELETED>
<DELETED>    (d) Vaccine Reporting.--Section 404B of the Public Health 
Service Act (42 U.S.C. 283d) is amended--</DELETED>
        <DELETED>    (1) by striking subsection (b); and</DELETED>
        <DELETED>    (2) by striking ``(a) Development of New 
        Vaccines.--The Secretary'' and inserting ``The 
        Secretary''.</DELETED>
<DELETED>    (e) National Center for Advancing Translational 
Sciences.--Section 479(c) of the Public Health Service Act (42 U.S.C. 
287(c)) is amended--</DELETED>
        <DELETED>    (1) in the subsection heading, by striking 
        ``Annual'' and inserting ``Biennial''; and</DELETED>
        <DELETED>    (2) in the matter preceding paragraph (1), by 
        striking ``an annual report'' and inserting ``a report on a 
        biennial basis''.</DELETED>
<DELETED>    (f) Review of Centers of Excellence.--</DELETED>
        <DELETED>    (1) Repeal.--Section 404H of the Public Health 
        Service Act (42 U.S.C. 283j) is repealed.</DELETED>
        <DELETED>    (2) Conforming amendment.--Section 399EE(c) of the 
        Public Health Service Act (42 U.S.C. 280i-4(c)) is amended by 
        striking ``399CC, 404H,'' and inserting ``399CC''.</DELETED>
<DELETED>    (g) Rapid HIV Test Report.--Section 502(a) of the Ryan 
White CARE Act Amendments of 2000 (42 U.S.C. 300cc note) is amended--
</DELETED>
        <DELETED>    (1) by striking paragraph (2); and</DELETED>
        <DELETED>    (2) by redesignating paragraph (3) as paragraph 
        (2).</DELETED>
<DELETED>    (h) Biennial Report.--</DELETED>
        <DELETED>    (1) Repeal.--Section 464Y of the Public Health 
        Service Act (42 U.S.C. 285q-3) is repealed.</DELETED>
        <DELETED>    (2) Conforming amendment.--Section 464X(g) of the 
        Public Health Service Act (42 U.S.C. 285q-2(g)) is amended by 
        striking ``biennial report made under section 464Y,'' and 
        inserting ``triennial report made under section 
        403''.</DELETED>

<DELETED>SEC. 6. NATIONAL VACCINE INJURY COMPENSATION 
              PROGRAM.</DELETED>

<DELETED>    (a) Additional Vaccines.--Section 2114(e) of the Public 
Health Service Act (42 U.S.C. 300aa-14(e)) is amended by adding at the 
end the following:</DELETED>
        <DELETED>    ``(3) Vaccines recommended for use in pregnant 
        women.--The Secretary shall revise the Vaccine Injury Table 
        included in subsection (a), through the process described in 
        subsection (c), to include vaccines recommended by the Centers 
        for Disease Control and Prevention for routine administration 
        in pregnant women and the information described in 
        subparagraphs (B) and (C) of paragraph (2) with respect to such 
        vaccines.''.</DELETED>
<DELETED>    (b) Petition Content.--Section 2111 of the Public Health 
Service Act (42 U.S.C. 300aa-11) is amended by adding at the end the 
following:</DELETED>
<DELETED>    ``(f) Maternal Immunization.--</DELETED>
        <DELETED>    ``(1) In general.--Notwithstanding any other 
        provision of law, for purposes of this subtitle, both a woman 
        who received a covered vaccine while pregnant and any child who 
        was in utero at the time such woman received the vaccine shall 
        be considered persons to whom the covered vaccine was 
        administered and persons who received the covered 
        vaccine.</DELETED>
        <DELETED>    ``(2) Definition.--As used in this subsection, the 
        term `child' shall have the meaning given that term by 
        subsections (a) and (b) of section 8 of title 1, United States 
        Code, except that, for purposes of this subsection, such 
        section 8 shall be applied as if the term `include' in 
        subsection (a) of such section were replaced with the term 
        `mean'.''.</DELETED>
<DELETED>    (c) Petitioners.--Section 2111(b)(2) of the Public Health 
Service Act (42 U.S.C. 300aa-11(b)(2)) is amended by adding ``A covered 
vaccine administered to a pregnant woman shall constitute more than one 
administration, one to the mother and one to each child (as such term 
is defined in subsection (f)(2)) who was in utero at the time such 
woman was administered the vaccine.'' at the end.</DELETED>

<DELETED>SEC. 7. VACCINE MEETINGS; REPORT ON VACCINE 
              INNOVATION.</DELETED>

<DELETED>    (a) Vaccine Meetings.--The Director of the Centers for 
Disease Control and Prevention shall ensure that appropriate staff 
within the relevant centers and divisions of the Office of Infectious 
Diseases, and others, as appropriate, coordinate with respect to the 
public health needs, epidemiology, and program planning and 
implementation considerations related to immunization, including with 
regard to meetings with stakeholders related to such topics.</DELETED>
<DELETED>    (b) Report on Vaccine Innovation.--</DELETED>
        <DELETED>    (1) In general.--Not later than 1 year after the 
        date of enactment of this Act, the Secretary of Health and 
        Human Services (referred to in this section as the 
        ``Secretary''), in collaboration with appropriate agencies or 
        offices within the Department of Health and Human Services, 
        including the National Institute of Allergy and Infectious 
        Diseases and the Biomedical Advanced Research and Development 
        Authority, shall issue to the Committee on Health, Education, 
        Labor, and Pensions of the Senate and the Committee on Energy 
        and Commerce of the House of Representatives, and post publicly 
        on the Internet website of the Department of Health and Human 
        Services, a report on ways to promote innovation in the 
        development of vaccines that minimize the burden of infectious 
        disease.</DELETED>
        <DELETED>    (2) Contents.--The report described in paragraph 
        (1) shall review the current status of vaccine development and, 
        as appropriate--</DELETED>
                <DELETED>    (A) consider the optimal process to 
                determine which vaccines would be beneficial and how 
                information on such vaccines is disseminated to key 
                stakeholders;</DELETED>
                <DELETED>    (B) examine and identify whether obstacles 
                exist that inhibit the development of beneficial 
                vaccines; and</DELETED>
                <DELETED>    (C) make recommendations about how best to 
                remove any obstacles identified under subparagraph (B) 
                in order to promote and incentivize vaccine innovation 
                and development.</DELETED>
        <DELETED>    (3) Consultation.--In preparing the report under 
        subsection (a), the Secretary may consult with--</DELETED>
                <DELETED>    (A) representatives of relevant Federal 
                agencies and departments, including the Department of 
                Defense and the Department of Veterans 
                Affairs;</DELETED>
                <DELETED>    (B) academic researchers;</DELETED>
                <DELETED>    (C) developers and manufacturers of 
                vaccines;</DELETED>
                <DELETED>    (D) medical and public health 
                practitioners;</DELETED>
                <DELETED>    (E) representatives of patient, policy, 
                and advocacy organizations; and</DELETED>
                <DELETED>    (F) representatives of other entities, as 
                the Secretary determines appropriate.</DELETED>

<DELETED>SEC. 8. TECHNICAL UPDATES TO CLINICAL TRIALS 
              DATABASE.</DELETED>

<DELETED>    Section 402(j)(2)(D) of the Public Health Service Act (42 
U.S.C. 282(j)(2)(D)) is amended--</DELETED>
        <DELETED>    (1) in clause (ii)(I), by inserting before the 
        semicolon ``, unless the responsible party affirmatively 
        requests that the Director of NIH publicly post such clinical 
        trial information for an applicable device clinical trial prior 
        to such date of clearance or approval''; and</DELETED>
        <DELETED>    (2) by adding at the end the following:</DELETED>
                        <DELETED>    ``(iii) Option to make certain 
                        clinical trial information available earlier.--
                        The Director of NIH 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).</DELETED>
                        <DELETED>    ``(iv) Combination products.--An 
                        applicable clinical trial for a product that is 
                        a combination of drug, device, or biological 
                        product shall be considered--</DELETED>
                                <DELETED>    ``(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</DELETED>
                                <DELETED>    ``(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.''.</DELETED>

<DELETED>SEC. 9. COMPLIANCE ACTIVITIES REPORTS.</DELETED>

<DELETED>    (a) Definitions.--In this section:</DELETED>
        <DELETED>    (1) Applicable clinical trial.--The term 
        ``applicable clinical trial'' has the meaning given the term in 
        section 402(j) of the Public Health Service Act (42 U.S.C. 
        282(j)).</DELETED>
        <DELETED>    (2) Director of nih.--The term ``Director of NIH'' 
        means the Director of the National Institutes of 
        Health.</DELETED>
        <DELETED>    (3) Secretary.--The term ``Secretary'' means the 
        Secretary of Health and Human Services.</DELETED>
<DELETED>    (b) Report on Activities To Encourage Compliance.--Not 
later than 2 years after the date of enactment of this Act, the 
Secretary, acting through the Director of NIH and in collaboration with 
the Commissioner of Food and Drugs, shall submit to the Committee on 
Health, Education, Labor, and Pensions of the Senate and the Committee 
on Energy and Commerce of the House of Representatives, a report that 
describes education and outreach, guidance, enforcement, and other 
activities undertaken to encourage compliance with section 402(j) of 
the Public Health Service Act (42 U.S.C. 282(j)).</DELETED>
<DELETED>    (c) Reports on Clinical Trials.--</DELETED>
        <DELETED>    (1) In general.--Not later than 2 years after the 
        final compliance date under the final rule implementing section 
        402(j) of the Public Health Service Act, and every 2 years 
        thereafter for the next 4 years, the Secretary, acting through 
        the Director of NIH and in collaboration with the Commissioner 
        of Food and Drugs, shall submit to the Committee on Health, 
        Education, Labor, and Pensions of the Senate and the Committee 
        on Energy and Commerce of the House of Representatives, a 
        report describing--</DELETED>
                <DELETED>    (A) the total number of applicable 
                clinical trials with complete data bank registration 
                information registered during the period for which the 
                report is being prepared (broken down by each year of 
                such reporting period);</DELETED>
                <DELETED>    (B) the total number of applicable 
                clinical trials registered during the period for which 
                the report is being prepared for which results have 
                been submitted to the data bank (broken down by each 
                year of such reporting period);</DELETED>
                <DELETED>    (C) the activities undertaken by the 
                Secretary during the period for which the report is 
                being prepared to educate responsible persons about 
                data bank registration and results submission 
                requirements, including through issuance of guidance 
                documents, informational meetings, and training 
                sessions; and</DELETED>
                <DELETED>    (D) the activities described in the report 
                submitted under subsection (b).</DELETED>
        <DELETED>    (2) Actions to enforce compliance.--After the 
        Secretary has undertaken the educational activities described 
        in paragraph (1)(C), the Secretary shall include in subsequent 
        reports submitted under paragraph (1) the number of actions 
        taken by the Secretary during the period for which the report 
        is being prepared to enforce compliance with data bank 
        registration and results submission requirements.</DELETED>

<DELETED>SEC. 10. APPOINTMENT OF DIRECTORS OF NATIONAL RESEARCH 
              INSTITUTES AND NATIONAL CENTERS.</DELETED>

<DELETED>    Subsection (a) of section 405 of the Public Health Service 
Act (42 U.S.C. 284) is amended as follows:</DELETED>
<DELETED>    ``(a) Appointment.--</DELETED>
        <DELETED>    ``(1) In general.--The Director of the National 
        Cancer Institute shall be appointed by the President and the 
        Directors of the other national research institutes and centers 
        shall be appointed by the Secretary, acting through the 
        Director of NIH. Each Director of a national research institute 
        or national center shall report directly to the Director of 
        NIH.</DELETED>
        <DELETED>    ``(2) Appointment.--</DELETED>
                <DELETED>    ``(A) Term.--A Director of a national 
                research institute or national center who is appointed 
                by the Secretary, acting through the Director of NIH, 
                shall be appointed for 5 years.</DELETED>
                <DELETED>    ``(B) Reappointment.--At the end of the 
                term of a Director of a national research institute or 
                national center, the Director may be reappointed. There 
                shall be no limit on the number of terms that a 
                Director may serve.</DELETED>
                <DELETED>    ``(C) Vacancies.--If the office of a 
                Director of a national research institute or national 
                center becomes vacant before the end of such Director's 
                term, the Director appointed to fill the vacancy shall 
                be appointed for a 5-year term starting on the date of 
                such appointment.</DELETED>
                <DELETED>    ``(D) Current directors.--Each Director of 
                a national research institute or national center who is 
                serving on the date of enactment of the Promoting 
                Biomedical Research and Public Health for Patients Act 
                shall be deemed to be appointed for a 5-year term under 
                this subsection beginning on such date of 
                enactment.</DELETED>
                <DELETED>    ``(E) Rule of construction.--Nothing in 
                this subsection shall be construed to limit the ability 
                of the Director of NIH or a Director of a national 
                research institute or center to terminate the 
                appointment of such Director of a national research 
                institute or center prior to the expiration of such 
                Director's 5-year term.</DELETED>
        <DELETED>    ``(3) Nonapplication of certain provision.--The 
        restrictions contained in section 202 of the Departments of 
        Labor, Health and Human Services, and Education, and Related 
        Agencies Appropriations Act, 1993 (Public Law 102-394; 42 
        U.S.C. 238f note) related to consultants and individual 
        scientists appointed for limited periods of time shall not 
        apply to Directors appointed under this 
        subsection.''.</DELETED>

<DELETED>SEC. 11. NATIONAL CENTER FOR ADVANCING TRANSLATIONAL 
              SCIENCES.</DELETED>

<DELETED>    Section 479(b) of the Public Health Service Act (42 U.S.C. 
287(b)) is amended--</DELETED>
        <DELETED>    (1) in paragraph (1), by striking ``phase IIA'' 
        and inserting ``phase IIB''; and</DELETED>
        <DELETED>    (2) in paragraph (2)--</DELETED>
                <DELETED>    (A) in the matter preceding subparagraph 
                (A), by striking ``phase IIB'' and inserting ``phase 
                III'';</DELETED>
                <DELETED>    (B) in subparagraph (A), by striking 
                ``phase IIB'' and inserting ``phase III'';</DELETED>
                <DELETED>    (C) in subparagraph (B), by striking 
                ``phase IIA'' and inserting ``phase IIB''; 
                and</DELETED>
                <DELETED>    (D) in subparagraph (C), by striking 
                ``phase IIB'' and inserting ``phase III''.</DELETED>

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Promoting Biomedical Research and 
Public Health for Patients Act''.

SEC. 2. TRIENNIAL REPORTS OF DIRECTOR OF NIH.

    Section 403 of the Public Health Service Act (42 U.S.C. 283) is 
amended--
            (1) in the section heading, by striking ``biennial'' and 
        inserting ``triennial''; and
            (2) in subsection (a)--
                    (A) in the matter preceding paragraph (1), by 
                striking ``biennial'' and inserting ``triennial'';
                    (B) by amending paragraph (3) to read as follows:
            ``(3) A description of intra-NIH activities, including 
        identification of the percentage of funds made available by 
        each national research institute and national center with 
        respect to each applicable fiscal year for conducting or 
        supporting research that involves collaboration between the 
        institute or center and 1 or more other national research 
        institutes or national centers and recommendations for 
        promoting coordination of information among the centers of 
        excellence.'';
                    (C) in paragraph (4)--
                            (i) in subparagraph (B), by striking 
                        ``demographic variables and other variables'' 
                        and inserting ``demographic variables, 
                        including biological and social variables and 
                        relevant age categories, and determinants of 
                        health''; and
                            (ii) in subparagraph (C)(v)--
                                    (I) by striking ``demographic 
                                variables and such'' and inserting 
                                ``demographic variables, including 
                                relevant age categories, information 
                                submitted by each national research 
                                institute and national center to the 
                                Director of NIH under section 492B(f), 
                                and such''; and
                                    (II) by striking ``(regarding 
                                inclusion of women and minorities in 
                                clinical research)'' and inserting 
                                ``and other applicable requirements 
                                regarding inclusion of demographic 
                                groups''; and
                    (D) in paragraph (6)--
                            (i) in the matter preceding subparagraph 
                        (A), by striking ``the following:'' and 
                        inserting ``the following--'';
                            (ii) in subparagraph (A)--
                                    (I) by striking ``An evaluation'' 
                                and inserting ``an evaluation''; and
                                    (II) by striking the period and 
                                inserting ``; and'';
                            (iii) by striking subparagraphs (B) and 
                        (D);
                            (iv) by redesignating subparagraph (C) as 
                        subparagraph (B); and
                            (v) in subparagraph (B), as redesignated by 
                        clause (iv), by striking ``Recommendations'' 
                        and inserting ``recommendations''.

SEC. 3. ADMINISTRATIVE BURDEN ON INVESTIGATORS.

    (a) Disclosure of Financial Conflicts of Interest.--
            (1) In general.--Not later than 2 years after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services (referred to in this section as the ``Secretary'') 
        shall--
                    (A) lead a review by research funding agencies of 
                all regulations and policies related to the disclosure 
                of financial conflicts of interest, including the 
                minimum threshold for reporting financial conflicts of 
                interest; and
                    (B) make revisions, as appropriate, to harmonize 
                existing policies and reduce administrative burden on 
                researchers while maintaining the integrity and 
                credibility of research findings and protections of 
                human participants.
            (2) Considerations.--In updating policies under paragraph 
        (1)(B), the Secretary shall consider--
                    (A) modifying the timelines for the reporting of 
                financial conflicts of interest to just in time 
                information by institutions receiving grant or 
                cooperative agreement funding from the National 
                Institutes of Health;
                    (B) ensuring that financial interest disclosure 
                reporting requirements are appropriate for, and 
                relevant to, awards that will directly fund research, 
                which may include modification of the definition of the 
                term ``investigator''; and
                    (C) updating any applicable training modules of the 
                National Institutes of Health related to Federal 
                financial interest disclosure.
    (b) Monitoring of Subrecipients of Funding From the National 
Institutes of Health.--The Director of the National Institutes of 
Health shall implement measures to reduce the administrative burdens 
related to monitoring of subrecipients of grants by primary awardees of 
funding from the National Institutes of Health, which may incorporate 
findings and recommendations from existing and ongoing activities. Such 
measures may include, as appropriate--
            (1) an exemption from subrecipient monitoring requirements, 
        upon request from the primary awardees, provided that--
                    (A) the subrecipient is subject to Federal audit 
                requirements pursuant to the Uniform Guidance of the 
                Office of Management and Budget;
                    (B) the primary awardee conducts a formal or 
                informal evaluation of each subrecipient's risk of 
                noncompliance with Federal statutes and regulations, 
                and the conditions of the subaward; and
                    (C) such exemption does not absolve the primary 
                awardee of liability for misconduct by subrecipients; 
                and
            (2) the implementation of alternative grant structures that 
        obviate the need for subrecipient monitoring, which may include 
        collaborative grant models allowing for multiple primary 
        awardees.
    (c) Reporting of Financial Expenditures.--The Secretary, in 
consultation with the Director of the National Institutes of Health, 
shall evaluate financial expenditure reporting procedures and 
requirements for recipients of funding from the National Institutes of 
Health and take action, as appropriate, to avoid duplication between 
department and agency procedures and requirements and minimize burden 
to funding recipients.
    (d) Animal Care and Use in Research.--Not later than 2 years after 
the date of enactment of this Act, the Director of the National 
Institutes of Health, in collaboration with the Secretary of 
Agriculture and the Commissioner of Food and Drugs, shall complete a 
review of applicable regulations and policies for the care and use of 
laboratory animals and make revisions, as appropriate, to reduce 
administrative burden on investigators while maintaining the integrity 
and credibility of research findings and protection of research 
animals. In carrying out this effort, the Director shall seek the input 
of experts, as appropriate. The Director shall--
            (1) identify ways to ensure such regulations and policies 
        are not inconsistent, overlapping, or unnecessarily 
        duplicative, including with respect to inspection and review 
        requirements by Federal agencies and accrediting associations;
            (2) take steps to eliminate or reduce identified 
        inconsistencies, overlap, or duplication among such regulations 
        and policies; and
            (3) take other actions, as appropriate, to improve the 
        coordination of regulations and policies with respect to 
        research with laboratory animals.
    (e) Documentation of Personnel Expenses.--The Secretary shall 
clarify the applicability of the requirements under the Office of 
Management and Budget Uniform Guidance for management and certification 
systems adopted by entities receiving Federal research grants through 
the Department of Health and Human Services regarding documentation of 
personnel expenses, including clarification of the extent to which any 
flexibility to such requirements specified in such Uniform Guidance 
applies to entities receiving grants through the Department of Health 
and Human Services.
    (f) Research Policy Board.--
            (1) Establishment.--Not later than 1 year after the date of 
        enactment of this Act, the Director of the Office of Management 
        and Budget shall establish an advisory committee, to be known 
        as the ``Research Policy Board'' (referred to in this 
        subsection as the ``Board''), to provide the Director and other 
        members of the Federal Government with information on the 
        effects of regulations related to Federal research 
        requirements.
            (2) Membership.--
                    (A) In general.--The Board shall include not more 
                than 10 Federal members, including each of the 
                following Federal members or their designees:
                            (i) The Administrator of the Office of 
                        Information and Regulatory Affairs of the 
                        Office of Management and Budget.
                            (ii) The Director of the Office of Science 
                        and Technology Policy.
                            (iii) The Secretary of Health and Human 
                        Services.
                            (iv) The Director of the National Science 
                        Foundation.
                            (v) The secretaries and directors of other 
                        departments and agencies that support or 
                        regulate scientific research, as determined by 
                        the Director of the Office of Management and 
                        Budget.
                    (B) Non-federal members.--The Board shall be 
                comprised of not less than 9 and not more than 12 
                representatives of academic research institutions, 
                other private, nonprofit research institutions, or 
                other nonprofit organizations with relevant expertise. 
                Such members shall be appointed by a formal process, to 
                be established by the Director of the Office of 
                Management and Budget, in consultation with the Federal 
                membership, and that incorporates--
                            (i) nomination by members of the nonprofit 
                        scientific research community, including 
                        academic research institutions; and
                            (ii) procedures to fill membership 
                        positions vacated before the end of a member's 
                        term.
            (3) Purpose and responsibilities.--The Board shall make 
        recommendations regarding the modification and harmonization of 
        regulations and policies having similar purposes across 
        research funding agencies to ensure that the administrative 
        burden of such research policy and regulation is minimized to 
        the greatest extent possible and consistent with maintaining 
        responsible oversight of federally funded research. Activities 
        of the Board may include--
                    (A) providing thorough and informed analysis of 
                regulations and policies;
                    (B) identifying negative or adverse consequences of 
                existing policies and making actionable recommendations 
                regarding possible improvement of such policies;
                    (C) making recommendations with respect to efforts 
                within the Federal Government to improve coordination 
                of regulation and policy related to research;
                    (D) creating a forum for the discussion of research 
                policy or regulatory gaps, challenges, clarification, 
                or harmonization of such policies or regulation, and 
                best practices; and
                    (E) conducting ongoing assessment and evaluation of 
                regulatory burden, including development of metrics, 
                periodic measurement, and identification of process 
                improvements and policy changes.
            (4) Expert subcommittees.--The Board may form temporary 
        expert subcommittees, as appropriate, to develop timely 
        analysis on pressing issues and assist the Board in 
        anticipating future regulatory challenges, including those 
        emerging from new scientific advances.
            (5) Reporting requirements.--Not later than 2 years after 
        the date of enactment of this Act, and once thereafter, the 
        Board shall submit a report to the Director of the Office of 
        Management and Budget, the Administrator of the Office of 
        Information and Regulatory Affairs of the Office of Management 
        and Budget, the Director of the Office of Science and 
        Technology Policy, the heads of relevant Federal departments 
        and agencies, the Committee on Health, Education, Labor, and 
        Pensions of the Senate, and the Committee on Energy and 
        Commerce of the House of Representatives containing formal 
        recommendations on the conceptualization, development, 
        harmonization, and reconsideration of scientific research 
        policy, including the regulatory benefits and burdens.
            (6) Sunset.--The Board shall terminate on September 30, 
        2020.
            (7) GAO report.--Not later than 4 years after the date of 
        enactment of this Act, the Comptroller General of the United 
        States shall conduct an independent evaluation of the 
        activities carried out by the Board pursuant to this subsection 
        and submit to the appropriate committees of Congress a report 
        regarding the results of the independent evaluation. Such 
        report shall review and assess the Board's activities with 
        respect to the responsibilities described in paragraph (3).

SEC. 4. REIMBURSEMENT FOR RESEARCH SUBSTANCES AND LIVING ORGANISMS.

    Section 301 of the Public Health Service Act (42 U.S.C. 241) is 
amended--
            (1) in the flush matter at the end of subsection (a)--
                    (A) by redesignating such matter as subsection 
                (f)(1); and
                    (B) by moving such matter so as to appear at the 
                end of such section; and
            (2) in subsection (f) (as so redesignated), by adding at 
        the end the following:
    ``(2) Where research substances and living organisms are made 
available under paragraph (1) through contractors, the Secretary may 
direct such contractors to collect payments on behalf of the Secretary 
for the costs incurred to make available such substances and organisms 
and to forward amounts so collected to the Secretary, in the time and 
manner specified by the Secretary.
    ``(3) Amounts collected under paragraph (2) shall be credited to 
the appropriations accounts that incurred the costs to make available 
the research substances and living organisms involved, and shall remain 
available until expended for carrying out activities under such 
accounts.''.

SEC. 5. STREAMLINING NIH REPORTING REQUIREMENTS.

    (a) Trans-NIH Research Reporting.--Section 402A(c)(2) of the Public 
Health Service Act (42 U.S.C. 282a(c)(2)) is amended--
            (1) by amending subparagraph (B) to read as follows:
                    ``(B) Reporting.--Not later than 2 years after the 
                date of enactment of Promoting Biomedical Research and 
                Public Health for Patients Act, the head of each 
                national research institute or national center shall 
                submit to the Director of NIH 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.''; and
            (2) in subparagraphs (D) and (E) by striking ``(B)(i)'' 
        each place it appears and inserting ``(B)''.
    (b) Fraud and Abuse Reporting.--Section 403B of the Public Health 
Service Act (42 U.S.C. 283a-1) is amended--
            (1) by striking subsection (b);
            (2) by redesignating subsection (c) as subsection (b); and
            (3) in subsection (b) (as so redesignated), by striking 
        ``subsections (a) and (b)'' and inserting ``subsection (a)''.
    (c) Doctoral Degrees Reporting.--Section 403C(a)(2) of the Public 
Health Service Act (42 U.S.C. 283a-2(a)(2)) is amended by striking 
``(not including any leaves of absence)''.
    (d) Vaccine Reporting.--Section 404B of the Public Health Service 
Act (42 U.S.C. 283d) is amended--
            (1) by striking subsection (b); and
            (2) by striking ``(a) Development of New Vaccines.--The 
        Secretary'' and inserting ``The Secretary''.
    (e) National Center for Advancing Translational Sciences.--Section 
479(c) of the Public Health Service Act (42 U.S.C. 287(c)) is amended--
            (1) in the subsection heading, by striking ``Annual'' and 
        inserting ``Biennial''; and
            (2) in the matter preceding paragraph (1), by striking ``an 
        annual report'' and inserting ``a report on a biennial basis''.
    (f) Review of Centers of Excellence.--
            (1) Repeal.--Section 404H of the Public Health Service Act 
        (42 U.S.C. 283j) is repealed.
            (2) Conforming amendment.--Section 399EE(c) of the Public 
        Health Service Act (42 U.S.C. 280i-4(c)) is amended by striking 
        ``399CC, 404H,'' and inserting ``399CC''.
    (g) Rapid HIV Test Report.--Section 502(a) of the Ryan White CARE 
Act Amendments of 2000 (42 U.S.C. 300cc note) is amended--
            (1) by striking paragraph (2); and
            (2) by redesignating paragraph (3) as paragraph (2).
    (h) Biennial Report.--
            (1) Repeal.--Section 464Y of the Public Health Service Act 
        (42 U.S.C. 285q-3) is repealed.
            (2) Conforming amendment.--Section 464X(g) of the Public 
        Health Service Act (42 U.S.C. 285q-2(g)) is amended by striking 
        ``biennial report made under section 464Y,'' and inserting 
        ``triennial report made under section 403''.

SEC. 6. NATIONAL VACCINE INJURY COMPENSATION PROGRAM.

    (a) Additional Vaccines.--Section 2114(e) of the Public Health 
Service Act (42 U.S.C. 300aa-14(e)) is amended by adding at the end the 
following:
            ``(3) Vaccines recommended for use in pregnant women.--The 
        Secretary shall revise the Vaccine Injury Table included in 
        subsection (a), through the process described in subsection 
        (c), to include vaccines recommended by the Centers for Disease 
        Control and Prevention for routine administration in pregnant 
        women and the information described in subparagraphs (B) and 
        (C) of paragraph (2) with respect to such vaccines.''.
    (b) Petition Content.--Section 2111 of the Public Health Service 
Act (42 U.S.C. 300aa-11) is amended by adding at the end the following:
    ``(f) Maternal Immunization.--
            ``(1) In general.--Notwithstanding any other provision of 
        law, for purposes of this subtitle, both a woman who received a 
        covered vaccine while pregnant and any child who was in utero 
        at the time such woman received the vaccine shall be considered 
        persons to whom the covered vaccine was administered and 
        persons who received the covered vaccine.
            ``(2) Definition.--As used in this subsection, the term 
        `child' shall have the meaning given that term by subsections 
        (a) and (b) of section 8 of title 1, United States Code, except 
        that, for purposes of this subsection, such section 8 shall be 
        applied as if the term `include' in subsection (a) of such 
        section were replaced with the term `mean'.''.
    (c) Petitioners.--Section 2111(b)(2) of the Public Health Service 
Act (42 U.S.C. 300aa-11(b)(2)) is amended by adding ``A covered vaccine 
administered to a pregnant woman shall constitute more than one 
administration, one to the mother and one to each child (as such term 
is defined in subsection (f)(2)) who was in utero at the time such 
woman was administered the vaccine.'' at the end.

SEC. 7. VACCINE MEETINGS; REPORT ON VACCINE INNOVATION.

    (a) Vaccine Meetings.--The Director of the Centers for Disease 
Control and Prevention shall ensure that appropriate staff within the 
relevant centers and divisions of the Office of Infectious Diseases, 
and others, as appropriate, coordinate with respect to the public 
health needs, epidemiology, and program planning and implementation 
considerations related to immunization, including with regard to 
meetings with stakeholders related to such topics.
    (b) Report on Vaccine Innovation.--
            (1) In general.--Not later than 1 year after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services (referred to in this section as the ``Secretary''), in 
        collaboration with appropriate agencies or offices within the 
        Department of Health and Human Services, including the National 
        Institutes of Health, the Centers for Disease Control and 
        Prevention, and the Biomedical Advanced Research and 
        Development Authority, shall issue to the Committee on Health, 
        Education, Labor, and Pensions of the Senate and the Committee 
        on Energy and Commerce of the House of Representatives, and 
        post publicly on the Internet website of the Department of 
        Health and Human Services, a report on ways to promote 
        innovation in the development of vaccines that minimize the 
        burden of infectious disease.
            (2) Contents.--The report described in paragraph (1) shall 
        review the current status of vaccine development and, as 
        appropriate--
                    (A) consider the optimal process to determine which 
                vaccines would be beneficial and how information on 
                such vaccines is disseminated to key stakeholders;
                    (B) examine and identify whether obstacles exist 
                that inhibit the development of beneficial vaccines; 
                and
                    (C) make recommendations about how best to remove 
                any obstacles identified under subparagraph (B) in 
                order to promote and incentivize vaccine innovation and 
                development.
            (3) Consultation.--In preparing the report under this 
        subsection, the Secretary may consult with--
                    (A) representatives of relevant Federal agencies 
                and departments, including the Department of Defense 
                and the Department of Veterans Affairs;
                    (B) academic researchers;
                    (C) developers and manufacturers of vaccines;
                    (D) medical and public health practitioners;
                    (E) representatives of patient, policy, and 
                advocacy organizations; and
                    (F) representatives of other entities, as the 
                Secretary determines appropriate.

SEC. 8. TECHNICAL UPDATES TO CLINICAL TRIALS DATABASE.

    Section 402(j)(2)(D) of the Public Health Service Act (42 U.S.C. 
282(j)(2)(D)) is amended--
            (1) in clause (ii)(I), by inserting before the semicolon 
        ``, unless the responsible party affirmatively requests that 
        the Director of NIH publicly post such clinical trial 
        information for an applicable device clinical trial prior to 
        such date of clearance or approval''; and
            (2) by adding at the end the following:
                            ``(iii) Option to make certain clinical 
                        trial information available earlier.--The 
                        Director of NIH 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.''.

SEC. 9. COMPLIANCE ACTIVITIES REPORTS.

    (a) Definitions.--In this section:
            (1) Applicable clinical trial.--The term ``applicable 
        clinical trial'' has the meaning given the term in section 
        402(j) of the Public Health Service Act (42 U.S.C. 282(j)).
            (2) Director of nih.--The term ``Director of NIH'' means 
        the Director of the National Institutes of Health.
            (3) Secretary.--The term ``Secretary'' means the Secretary 
        of Health and Human Services.
    (b) Report on Activities to Encourage Compliance.--Not later than 2 
years after the date of enactment of this Act, the Secretary, acting 
through the Director of NIH and in collaboration with the Commissioner 
of Food and Drugs, shall submit to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Committee on Energy and 
Commerce of the House of Representatives, a report that describes 
education and outreach, guidance, enforcement, and other activities 
undertaken to encourage compliance with section 402(j) of the Public 
Health Service Act (42 U.S.C. 282(j)).
    (c) Reports on Clinical Trials.--
            (1) In general.--Not later than 2 years after the final 
        compliance date under the final rule implementing section 
        402(j) of the Public Health Service Act, and every 2 years 
        thereafter for the next 4 years, the Secretary, acting through 
        the Director of NIH and in collaboration with the Commissioner 
        of Food and Drugs, shall submit to the Committee on Health, 
        Education, Labor, and Pensions of the Senate and the Committee 
        on Energy and Commerce of the House of Representatives, a 
        report describing--
                    (A) the total number of applicable clinical trials 
                with complete data bank registration information 
                registered during the period for which the report is 
                being prepared (broken down by each year of such 
                reporting period);
                    (B) the total number of applicable clinical trials 
                registered during the period for which the report is 
                being prepared for which results have been submitted to 
                the data bank (broken down by each year of such 
                reporting period);
                    (C) the activities undertaken by the Secretary to 
                educate responsible persons about data bank 
                registration and results submission requirements, 
                including through issuance of guidance documents, 
                informational meetings, and training sessions; and
                    (D) the activities described in the report 
                submitted under subsection (b).
            (2) Actions to enforce compliance.--After the Secretary has 
        undertaken the educational activities described in paragraph 
        (1)(C), the Secretary shall include in subsequent reports 
        submitted under paragraph (1) the number of actions taken by 
        the Secretary during the period for which the report is being 
        prepared to enforce compliance with data bank registration and 
        results submission requirements.

SEC. 10. APPOINTMENT OF DIRECTORS OF NATIONAL RESEARCH INSTITUTES AND 
              NATIONAL CENTERS.

    Subsection (a) of section 405 of the Public Health Service Act (42 
U.S.C. 284) is amended to read as follows:
    ``(a) Appointment.--
            ``(1) In general.--The Director of the National Cancer 
        Institute shall be appointed by the President, and the 
        Directors of the other national research institutes and centers 
        shall be appointed by the Secretary, acting through the 
        Director of NIH. Each Director of a national research institute 
        or national center shall report directly to the Director of 
        NIH.
            ``(2) Appointment.--
                    ``(A) Term.--A Director of a national research 
                institute or national center who is appointed by the 
                Secretary, acting through the Director of NIH, shall be 
                appointed for 5 years.
                    ``(B) Reappointment.--At the end of the term of a 
                Director of a national research institute or national 
                center, the Director may be reappointed. There shall be 
                no limit on the number of terms that a Director may 
                serve.
                    ``(C) Vacancies.--If the office of a Director of a 
                national research institute or national center becomes 
                vacant before the end of such Director's term, the 
                Director appointed to fill the vacancy shall be 
                appointed for a 5-year term starting on the date of 
                such appointment.
                    ``(D) Current directors.--Each Director of a 
                national research institute or national center who is 
                serving on the date of enactment of the Promoting 
                Biomedical Research and Public Health for Patients Act 
                shall be deemed to be appointed for a 5-year term under 
                this subsection beginning on such date of enactment.
                    ``(E) Rule of construction.--Nothing in this 
                subsection shall be construed to limit the ability of 
                the Director of NIH or a Director of a national 
                research institute or center to terminate the 
                appointment of such Director of a national research 
                institute or center prior to the expiration of such 
                Director's 5-year term.
            ``(3) Nonapplication of certain provision.--The 
        restrictions contained in section 202 of the Departments of 
        Labor, Health and Human Services, and Education, and Related 
        Agencies Appropriations Act, 1993 (Public Law 102-394; 42 
        U.S.C. 238f note) related to consultants and individual 
        scientists appointed for limited periods of time shall not 
        apply to Directors appointed under this subsection.''.

SEC. 11. NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES.

    (a) In General.--Section 479(b) of the Public Health Service Act 
(42 U.S.C. 287(b)) is amended--
            (1) in paragraph (1), by striking ``phase IIA'' and 
        inserting ``phase IIB''; and
            (2) in paragraph (2)--
                    (A) in the matter preceding subparagraph (A), by 
                striking ``phase IIB'' and inserting ``phase III'';
                    (B) in subparagraph (A), by striking ``phase IIB'' 
                and inserting ``phase III'';
                    (C) in subparagraph (B), by striking ``phase IIA'' 
                and inserting ``phase IIB''; and
                    (D) in subparagraph (C), by striking ``phase IIB'' 
                and inserting ``phase III''.
    (b) Increased Transparency.--Section 479 of the Public Health 
Service Act (42 U.S.C. 287) is amended--
            (1) in subsection (c)--
                    (A) in paragraph (4)(D), by striking ``and'' at the 
                end;
                    (B) in paragraph (5), by striking the period and 
                inserting a semicolon; and
                    (C) by adding at the end the following:
            ``(6) the methods and tools, if any, that have been 
        developed since the last biennial report was prepared; and
            ``(7) the methods and tools, if any, that have been 
        developed and are being utilized by the Food and Drug 
        Administration to support medical product reviews.''; and
            (2) by adding at the end the following:
    ``(d) Inclusion of List.--The first biennial report submitted under 
this section after the date of enactment of this subsection shall 
include a complete list of all of the methods and tools, if any, which 
have been developed by research supported by the Center.
    ``(e) Rule of Construction.--Nothing in this section shall be 
construed as authorizing the Secretary to disclose any information that 
is a trade secret, or other privileged or confidential information 
subject to section 552(b)(4) of title 5, United States Code, or section 
1905 of title 18, United States Code.''.
                                                       Calendar No. 429

114th CONGRESS

  2d Session

                                S. 2742

_______________________________________________________________________

                                 A BILL

   To amend title IV of the Public Health Service Act regarding the 
         national research institutes, and for other purposes.

_______________________________________________________________________

                             April 18, 2016

                       Reported with an amendment