49–008 

114TH CONGRESS REPORT " ! HOUSE OF REPRESENTATIVES 1st Session 114–193 

PROVIDING FOR CONSIDERATION OF THE BILL (H.R. 6) TO ACCELERATE 

THE DISCOVERY, DEVELOPMENT, AND DELIVERY OF 21ST CENTURY 

CURES, AND FOR OTHER PURPOSES 

JULY 8, 2015.—Referred to the House Calendar and ordered to be printed 

Mr. BURGESS, from the Committee on Rules, 

submitted the following 

R E P O R T 

[To accompany H. Res. 350] 

The Committee on Rules, having had under consideration House 

Resolution 350, by a nonrecord vote, report the same to the House 

with the recommendation that the resolution be adopted. 

SUMMARY OF PROVISIONS OF THE RESOLUTION

The resolution provides for consideration of H.R. 6, the 21st Century Cures Act, under a structured rule. The resolution provides 

one hour of general debate equally divided and controlled by the 

chair and ranking minority member of the Committee on Energy 

and Commerce. The resolution waives all points of order against 

consideration of the bill. The resolution provides that an amendment in the nature of a substitute consisting of the text of Rules 

Committee Print 114–22 shall be considered as adopted and the 

bill, as amended, shall be considered as read. The resolution waives 

all points of order against provisions in the bill, as amended. The 

resolution makes in order only those further amendments printed 

in this report. Each such amendment may be offered only in the 

order printed in this report, may be offered only by a Member designated in this report, shall be considered as read, shall be debatable for the time specified in this report equally divided and controlled by the proponent and an opponent, shall not be subject to 

amendment, and shall not be subject to a demand for division of 

the question in the House or in the Committee of the Whole. The 

resolution waives all points of order against the amendments printed in this report. The resolution provides one motion to recommit 

with or without instructions. 

EXPLANATION OF WAIVERS

The waiver of all points of order against consideration of the bill 

includes waivers of the following: 


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• Clause 3(e)(1) of rule XIII (‘‘Ramseyer’’), requiring a committee 

report accompanying a bill amending or repealing statutes to show, 

by typographical device, parts of statute affected. The waiver is 

provided because the submission provided by the Committee on Energy and Commerce was insufficient to meet the standards established by the rule in its current form. The Committee on Rules continues to work with the House Office of Legislative Counsel and 

committees to determine the steps necessary to comply with the 

updated rule; • Clause 10 of rule XXI, which prohibits the consideration of a 

bill if it has the net effect of increasing mandatory spending over 

the five-year or ten-year period. This waiver is necessary because 

the bill increases mandatory spending over the five-year period, 

however it is important to note that the bill complies with the rule 

over the ten-year period and reduces the deficit by more than $500 

million over that ten-year period; • Section 302(f) of the Congressional Budget Act, which prohibits 

consideration of legislation providing new budget authority in excess of a 302(a) allocation of such authority; • Section 306 of the Congressional Budget Act, which prohibits 

consideration of legislation within the jurisdiction of the Committee 

on the Budget unless referred to or reported by the Budget Committee. 

The waiver of all points of order against provisions in the bill, 

as amended, includes a waiver of clause 4 of rule XXI, which prohibits reporting a bill or joint resolution carrying an appropriation 

from a committee not having jurisdiction to report an appropriation. 

Although the resolution waives all points of order against the 

amendments printed in this report, the Committee is not aware of 

any points of order. The waiver is prophylactic in nature. 

SUMMARY OF THE AMENDMENTS MADE IN ORDER

1. Brat (VA), McClintock (CA), Garrett (NJ), Stutzman (IN), 

Perry (PA): Reforms the NIH and Cures Innovation Fund to make 

it a discretionary spending program. (10 minutes) 

2. Young (IN), Harris (MD): Creates authority within NIH to conduct a prize program. The intent of the program would be to 

incentivize health innovation by offering competitors the chance to 

win a prize for creating breakthrough research and technology. (10 

minutes) 

3. Lee, Barbara (CA), Schakowsky (IL), Clarke (NY): Strikes the 

provision that applies any policy riders included in the annual 

LHHS Appropriations Bill to NIH funds in H.R. 6. Also strikes the 

provision that applies any policy riders applied to the FDA in the 

annual Agriculture Appropriations bill to FDA funding in H.R. 6. 

(10 minutes) 

4. Castro (TX): Ensures underrepresented individuals, such as 

women and minorities, are included in the Supporting Young 

Emerging Scientists Report. (10 minutes) 

5. Slaughter (NY): Directs the CDC to conduct a study to determine how the additional payments are affecting the development of 

drug resistance. (10 minutes) 

6. Fitzpatrick (PA): Expresses a sense of Congress that recording 

Unique Device Identifiers at the point-of-care in electronic health 


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record systems could significantly enhance the availability of medical device data for post-market surveillance purposes. (10 minutes) 

7. Polis (CO): Directs the Food and Drug Administration to issue 

a report on the risks and benefits associated with a two-tiered approval process that would permit certain medical devices to provisionally come to market if they have demonstrated safety but not 

efficacy. (10 minutes) 

8. Jackson Lee (TX): Directs the Secretary of Health and Human 

Services to conduct outreach to Historically Black Colleges and 

Universities; Hispanic Serving Institutions; Native American Colleges; and rural Colleges to ensure that health professionals from 

underrepresented populations are aware of research opportunities 

under this Act. (10 minutes) 

TEXT OF AMENDMENTS MADE IN ORDER

1. AN AMENDMENT TO BE OFFERED BY REPRESENTATIVE BRAT OF

VIRGINIA OR HIS DESIGNEE, DEBATABLE FOR 10 MINUTES

Page 5, beginning on line 6, strike paragraph (1) and insert the 

following: 

(1) AUTHORIZATION OF APPROPRIATIONS.—There is authorized 

to be appropriated to the NIH and Cures Innovation Fund 

$1,860,000,000 for each of fiscal years 2016 through 2020. 

Page 13, beginning on line 3, strike subsection (f). 

2. AN AMENDMENT TO BE OFFERED BY REPRESENTATIVE YOUNG OF

INDIANA OR HIS DESIGNEE, DEBATABLE FOR 10 MINUTES

Page 6, line 19, strike ‘‘409K’’ and insert ‘‘409L’’. 

Page 15, after line 6, insert the following: 

SEC. 1002. PRIZE COMPETITIONS. 

Part B of title IV of the Public Health Service Act (42 U.S.C. 284 

et seq.) is amended by adding at the end the following: 

‘‘SEC. 409K. PRIZE COMPETITIONS FOR IMPROVING HEALTH OUTCOMES AND REDUCING FEDERAL EXPENDITURES. 

‘‘(a) ESTABLISHMENT; GOALS.—The Director of NIH shall establish and implement an Innovation Prizes Program for one or both 

of the following goals: 

‘‘(1) Identifying and funding areas of biomedical science that 

could realize significant advancements through the creation of 

a prize competition. 

‘‘(2) Improving health outcomes, particularly with respect to 

human diseases and conditions for which public and private investment in research is disproportionately small relative to 

Federal Government expenditures on prevention and treatment activities, thereby reducing Federal expenditures on 

health programs. 

‘‘(b) DESIGN OF PRIZE COMPETITIONS.—Not later than 6 months 

after the date of enactment of this section, the Director of NIH 

shall— 

‘‘(1) design prize competitions— 

‘‘(A) to cooperate with competitors to realize innovations 

to identify and address areas of biomedical science that 


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could realize significant advancements through the creation of a prize competition; and 

‘‘(B) to award one or more prizes— 

‘‘(i) if appropriate, at the beginning of or during the 

competitions, to the competitors whose innovations are 

most promising or demonstrate progress; and 

‘‘(ii) at the end of the competitions, to the competitors whose innovations prove to be the best solutions; 

‘‘(2) ensure that the design of such competitions— 

‘‘(A) is realistic, given the amount of funds to be awarded 

as prizes; 

‘‘(B) does not reflect any bias concerning the type of innovations which will prove to be the best solutions; and 

‘‘(C) allows any person to participate as a competitor 

without regard to the person’s place of incorporation, primary place of business, citizenship, and residency, as applicable; and 

‘‘(3) submit to the Congress a report on the design of such 

competitions. 

‘‘(c) INNOVATION PRIZES ADVISORY BOARD.— 

‘‘(1) ESTABLISHMENT.—The Director of NIH shall establish 

and maintain a board, to be known as the I-Prize Board, to advise and assist the Director of NIH in carrying out this section. 

‘‘(2) COMPOSITION; TERMS.— ‘‘(A) COMPOSITION.—The I-Prize Board shall be composed 

of 9 voting members as follows: 

‘‘(i) The Director of NIH (or the Director’s designee). 

‘‘(ii) Four members appointed by the Director of 

NIH. 

‘‘(iii) One member appointed by the Speaker of the 

House of Representatives. 

‘‘(iv) One member appointed by the majority leader 

of the Senate. 

‘‘(v) One member appointed by the minority leader 

of the House of Representatives. 

‘‘(vi) One member appointed by the minority leader 

in the Senate. 

‘‘(B) INCLUSION OF CERTAIN EXPERTS.—The members of 

the I-Prize Board appointed under clauses (ii) through (vi) 

of subparagraph (A) shall, collectively, include medical, 

economic, budgetary, innovation, or venture capital experts 

from for-profit and not-for-profit private sector entities 

with experience in awarding prizes similar to the prizes 

under this section. 

‘‘(C) TERMS.—The appointed members of the I-Prize 

Board shall each be appointed for a term of 5 years. 

‘‘(D) APPOINTMENT OF INITIAL MEMBERS.—The initial appointed members of the I-Prize Board shall be appointed 

not later than 120 days after the date of enactment of this 

section. 

‘‘(3) RESPONSIBILITIES.—The I-Prize Board shall be responsible for advising the Director of NIH by— 

‘‘(A) identifying areas of biomedical science that could realize significant advancements through the creation of a 

prize competition; 


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‘‘(B) making recommendations on establishing the criteria for prize competitions under this section; 

‘‘(C) making recommendations on which business organizations or other entities have successfully met the criteria 

established for the prize competition; and 

‘‘(D) gaining insight from researchers, health economists, 

academia, and industry on how to conduct prize competitions. 

‘‘(d) RESTRICTIONS.— 

‘‘(1) NO FINANCIAL CONFLICTS OF INTEREST.—Any member of 

the I-Prize Board, and any officer or employee of the National 

Institutes of Health responsible for carrying out this section, 

may not personally or substantially participate in the consideration or determination by the I-Board of any matter that would 

directly or predictably effect any financial interest of— 

‘‘(A) the individual or a relative (as such term is defined 

in section 109(16) of the Ethics in Government Act of 1978) 

of the individual; or 

‘‘(B) of any business organization or other entity— 

‘‘(i) of which the individual is an officer or employee; 

‘‘(ii) with respect to which the individual is negotiating for employment; or 

‘‘(iii) in which the individual has any other financial 

interest. 

‘‘(2) NO AWARDS TO COMPETITORS LIKELY TO REAP FINANCIAL

BENEFIT FROM INNOVATION.—The Director of NIH may not, 

with respect to an innovation, award a prize under this section 

to any individual or entity that has a vested financial interest 

in any product or procedure that is likely to be developed or 

marketed because of such innovation. 

‘‘(e) PROCESS OF AWARD.—The full monetary amount of any prize 

awarded under this section shall be made available to the prize 

winner not later than 90 days after the date of such award. 

‘‘(f) SIMULATION.—The Director of NIH may— 

‘‘(1) award one or more contracts— 

‘‘(A) to perform a simulation of the prize competitions to 

be conducted under this section, based on the designs developed under subsection (b); and 

‘‘(B) to use the simulation to assess the effectiveness of 

the design; and 

‘‘(2) not later than 4 months after awarding such one or more 

contracts, submit to the Congress a report on the results of the 

simulation and assessment. 

‘‘(g) IMPLEMENTATION OF PRIZE COMPETITIONS.— 

‘‘(1) IN GENERAL.—The Director of NIH may enter into an 

agreement with one or more entities described in section 

501(c), and exempt from tax under section 501(a), of the Internal Revenue Code of 1986 to implement prize competitions 

based on the designs developed under subsection (b). 

‘‘(2) MINIMUM PERCENTAGE FOR PRIZES.—If the Director of 

NIH enters into an agreement under paragraph (1) to provide 

funds or other assistance (including in-kind contributions and 

testing or other technical support) to an entity to implement a 

prize competition under this section— 


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‘‘(A) not more than 15 percent of such assistance shall be 

for administration of the prize competition; and 

‘‘(B) not less than 85 percent of such assistance shall be 

for activities in direct support of competitors such as demonstration, testing, education, and prize awards. 

‘‘(h) TRACKING; REPORTING.—The Director of NIH shall— 

‘‘(1) collect information on— 

‘‘(A) the medical efficacy of innovations funded through 

the prize competitions under this section; and 

‘‘(B) the actual and potential effect of the innovations on 

Federal expenditures; and 

‘‘(2) not later than one year after the conclusion of the prize 

competitions under this section, and not later than the end of 

each of the 4 succeeding years, submit to the Congress a report 

on the information collected under paragraph (1). 

‘‘(i) INTELLECTUAL PROPERTY.— ‘‘(1) PROHIBITION ON THE GOVERNMENT ACQUIRING INTELLEC- TUAL PROPERTY RIGHTS.—The Federal Government may not 

gain an interest in intellectual property developed by a participant in a prize competition under this section without the written consent of the participant. 

‘‘(2) LICENSES.—The Federal Government may negotiate a license for the use of intellectual property developed by a participant in a prize competition under this section.’’. 

Page 26, line 11, insert ‘‘, as amended by section 1002 of this 

Act,’’ after ‘‘et seq.)’’ 

Page 26, line 13, strike ‘‘409K’’ and insert ‘‘409L’’. 

3. AN AMENDMENT TO BE OFFERED BY REPRESENTATIVE LEE OF

CALIFORNIA OR HER DESIGNEE, DEBATABLE FOR 10 MINUTES

Page 13, strike lines 8 through 13 (and make such conforming 

changes as may be necessary). 

4. AN AMENDMENT TO BE OFFERED BY REPRESENTATIVE CASTRO OF

TEXAS OR HIS DESIGNEE, DEBATABLE FOR 10 MINUTES

Page 32, line 8, insert before the period the following: ‘‘, including underrepresented individuals in the sciences, such as women 

and other minorities’’. 

5. AN AMENDMENT TO BE OFFERED BY REPRESENTATIVE SLAUGH- TER OF NEW YORK OR HER DESIGNEE, DEBATABLE FOR 10 MIN- UTES

Page 152, insert after line 9 the following new subsection: 

(c) STUDY AND REPORT ON THE IMPACT OF ADDITIONAL MEDICARE

PAYMENT FOR DISARM DRUGS ON USAGE PRACTICES AND DEVELOP- MENT OF RESISTANCE.— (1) STUDY.—The Director of the Centers for Disease Control 

and Prevention shall conduct a study to examine the effects of 

the additional payment for DISARM drugs under the Medicare 

program provided under subparagraph (M) of section 

1886(d)(5) of the Social Security Act (42 U.S.C. 1395ww(d)(5)), 

as added by subsection (a), on— 


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(A) the usage of DISARM drugs (as defined by clause 

(iii) of such subparagraph) by subsection (d) hospitals (as 

defined in section 1886(d)(1)(B) of such Act); and 

(B) the development of resistance by individuals to such 

DISARM drugs. 

(2) REPORT.—Not later than three years after the date of the 

enactment of this Act, such Director shall submit to Congress 

a report on the study conducted under paragraph (1). 

6. AN AMENDMENT TO BE OFFERED BY REPRESENTATIVE

FITZPATRICK OF PENNSYLVANIA OR HIS DESIGNEE, DEBATABLE

FOR 10 MINUTES

Page 235, after line 2, insert the following: 

Subtitle R—Other Provisions 

SEC. 2321. SENSE OF CONGRESS. 

It is the sense of the Congress that recording unique device identifiers at the point-of-care in electronic health record systems could 

significantly enhance the availability of medical device data for 

postmarket surveillance purposes. 

7. AN AMENDMENT TO BE OFFERED BY REPRESENTATIVE POLIS OF

COLORADO OR HIS DESIGNEE, DEBATABLE FOR 10 MINUTES

Page 235, insert after line 2 the following new subtitle: 

Subtitle R—Other Provisions 

SEC. 2321. STUDY ON TWO-TIERED APPROVAL PROCESS FOR DEVICES 

BY FDA. 

(a) IN GENERAL.—Not later than one year after the date of the 

enactment of this Act, the Secretary of Health and Human Services 

shall submit to Congress a report assessing the feasibility, benefits, 

and risks associated with establishing an expedited, two-tiered approval process for devices (as defined in section 201 of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 321)) that would enable 

devices to be lawfully marketed as of the date on which the device 

has been shown to be safe— 

(1) regardless of whether the device has been shown to be effective; and 

(2) so long as the person submitting the application for approval of the device has made no false claims with respect to 

whether the device is safe or effective. 

(b) INCLUDED ELEMENTS OF REPORT.—The report described in 

subsection (a) shall include— 

(1) an analysis of the impact of such a process on survival 

rates and quality of life measures for seniors and individuals 

with disabilities; 

(2) an analysis of the impact of such a process on survival 

rates and quality of life measures of individuals suffering from 


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life-threatening or irreversibly debilitating human diseases or 

conditions; 

(3) an estimation of the impact such a process would have 

on national health care costs; 

(4) an analysis of the extent to which such a process could 

be designed so as to guarantee that patient safety is not compromised; 

(5) an analysis of the extent to which fraudulent or ineffective devices could be marketed to patients under such a process and how such risks could be successfully mitigated; 

(6) proposals for providing device manufacturers with incentives to show the effectiveness of devices after the Secretary of 

Health and Human Services has approved such devices to be 

lawfully marketed under such a system, such as— 

(A) by permitting only limited marketing of a device, the 

effectiveness of which has not yet been shown; or 

(B) by revoking approval of any device, the effectiveness 

of which has not been shown within a specified timeframe; 

and 

(7) recommendations for whether such a process should be 

applicable to all devices or to only devices that have been 

granted specific designations by the Secretary or been determined eligible to be approved under specific approval programs 

under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

301 et seq.). 

8. AN AMENDMENT TO BE OFFERED BY REPRESENTATIVE JACKSON

LEE OF TEXAS OR HER DESIGNEE, DEBATABLE FOR 10 MINUTES

Page 352, after line 8, insert the following: 

SEC. 4062. OUTREACH TO HISTORICALLY BLACK COLLEGES AND UNIVERSITIES. 

The Secretary of Health and Human Services shall conduct outreach to historically Black colleges and universities, Hispanic-serving institutions, Native American colleges, and rural colleges to ensure that health professionals from underrepresented populations 

are aware of research opportunities under this Act. 

Æ 


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