II 

109TH CONGRESS 

1ST SESSION S. 2104 

To amend the Public Health Service Act to establish the American Center 

for Cures to accelerate the development of public and private research 

efforts towards tools and therapies for human diseases with the goal 

of early disease detection, prevention, and cure, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

DECEMBER 14, 2005 

Mr. REID (for Mr. LIEBERMAN (for himself, Mr. COCHRAN, Mr. CARPER, and 

Mrs. HUTCHISON)) introduced the following bill; which was read twice 

and referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To amend the Public Health Service Act to establish the 

American Center for Cures to accelerate the development 

of public and private research efforts towards tools and 

therapies for human diseases with the goal of early disease detection, prevention, and cure, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘American Center for 

5 Cures Act of 2005’’. 
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1 SEC. 2. TABLE OF CONTENTS. 

2 The table of contents for this Act is as follows: 

Sec. 1. Short title. 

Sec. 2. Table of contents. 

Sec. 3. Findings. 

Sec. 4. American Center for Cures. 

‘‘PART J—AMERICAN CENTER FOR CURES

‘‘Sec. 499A. Definitions. 

‘‘Sec. 499B. Establishment of American Center for Cures. 

‘‘SUBPART 1—FEDERALLY FUNDED RESEARCH AND DEVELOPMENT CENTERS

‘‘Sec. 499C. Federally Funded Research and Development Centers. 

‘‘SUBPART 2—HEALTH ADVANCED RESEARCH PROJECTS

‘‘Sec. 499D. Health Advanced Research Projects Agency. 

‘‘SUBPART 3—CLINICAL TRIALS

‘‘Sec. 499E. Increasing research study participation. 

‘‘Sec. 499E–1. Grants for quality clinical trial design and execution. 

‘‘Sec. 499E–2. Streamlining the regulatory process governing clinical research. 

‘‘Sec. 499E–3. Training clinical researchers of the future. 

‘‘Sec. 499E–4. Clinical research study and clinical trial. 

‘‘Sec. 499E–5. Authorization of appropriations. 

‘‘SUBPART 4—VALLEY OF DEATH

‘‘Sec. 499F. Small business partnerships. 

‘‘Sec. 499F–1. Rapid access to intervention development. 

‘‘Sec. 499F–2. Toxicity studies. 

‘‘Sec. 499F–3. Additional funding sources and models. 

‘‘Sec. 499F–4. Authorization of appropriations. 

‘‘SUBPART 5—OFFICE OF TECHNOLOGY TRANSFER

‘‘Sec. 499G. Restructuring. 

‘‘Sec. 499G–1. Marketing function. 

‘‘Sec. 499G–2. Office of Intramural Risk Opportunity and Mapping. 

‘‘Sec. 499G–3. Patenting and licensing incentives. 

‘‘Sec. 499G–4. Translational researcher development. 

‘‘Sec. 499G–5. Translational research training program. 

‘‘SUBPART 6—DEVELOPING INFORMATION SYSTEMS

‘‘Sec. 499H. Advancing national health information infrastructure. 

‘‘Sec. 499H–1. Public access requirement for research. 

‘‘Sec. 499H–2. Informatics training and workforce development. 

‘‘Sec. 499H–3. National Library of Medicine expansion of facilities. 

‘‘SUBPART 7—RESEARCH TOOLS

‘‘Sec. 499I. NIH research tool inventory. 

‘‘Sec. 499I–1. Exceptions to tool guidelines. 
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1 SEC. 3. FINDINGS. 

2 Congress finds the following: 

3 (1) The National Institutes of Health (referred 

4 to in this section as the ‘‘NIH’’) is the United 

5 States premier biomedical research investment with 

6 annual appropriations exceeding $28,000,000,000. 

7 (2) The mission of the NIH is science in pur8 suit of fundamental knowledge about the nature and 

9 behavior of living systems and the application of 

10 that knowledge to extend healthy life and reduce the 

11 burdens of illness and disability. 

12 (3) The pace of knowledge application to pro13 mote health and reduce disease can be influenced 

14 through strategic funding and reorganization of 

15 some aspects of the traditional research endeavor. 

16 This process is known as translational research in17 vestment. 

18 (4) The United States translational research in19 vestment will be key to the Nation responding effec20 tively— 

21 (A) to acute man-made or natural health 

22 threats; 

23 (B) to the complexity and multi-discipli24 nary nature of chronic diseases, which are re25 sponsible for 7 out of every 10 deaths in the 

26 United States and for more than 70 percent of 
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1 the $1,700,000,000,000 spent in the United 

2 States on health care each year; and 

3 (C) to research and development vacuums 

4 in the private for-profit market, such as in the 

5 fields of vaccine and antibiotic production, 

6 drugs for Third World diseases, and medical 

7 tools for pediatric populations. 

8 (5) Key components of the translational re9 search process include research prioritization, an ex10 pert workforce, multi-disciplinary collaborative work, 

11 facilitated information exchange, strategic risk tak12 ing, support of small innovative businesses caught 

13 along common pathways in the research and devel14 opment Valley of Death, simplification and pro15 motion of the clinical research endeavor, and involve16 ment of private entities early on in the translational 

17 research endeavor that are skilled in the manufac18 turing and marketing process. 

19 SEC. 4. AMERICAN CENTER FOR CURES. 

20 (a) AMERICAN CENTER FOR CURES.—Title IV of the 

21 Public Health Service Act (42 U.S.C. 281 et seq.) is 

22 amended by adding at the end the following: 

23 ‘‘PART J—AMERICAN CENTER FOR CURES 

24 ‘‘SEC. 499A. DEFINITIONS. 

25 ‘‘In this part: 
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1 ‘‘(1) CENTER.—The term ‘Center’ means the 

2 American Center for Cures established under section 

3 499B. 

4 ‘‘(2) COUNCIL.—The term ‘Council’ means the 

5 Cures Council established under section 499B. 

6 ‘‘(3) DIRECTOR.—The term ‘Director’ means 

7 the Director of the American Center for Cures. 

8 ‘‘(4) INCUBATOR.—The term ‘incubator’ means 

9 an economic development organization designed to 

10 accelerate the growth and success of entrepreneurial 

11 individuals, concepts, and companies. 

12 ‘‘(5) RESEARCH TOOL.—The term ‘research 

13 tool’ means a resource that scientists use in their 

14 laboratories that has no immediate therapeutic or di15 agnostic value, including cell lines, monoclonal anti16 bodies, reagents, laboratory equipment and ma17 chines, databases, and computer software. 

18 ‘‘(6) TEST BED.—The term ‘test bed’ means 

19 the pilot environment to prototype innovation. 

20 ‘‘(7) TRANSLATIONAL RESEARCH.—The term 

21 ‘translational research’ means investigation in which 

22 knowledge obtained from fundamental research such 

23 as with genes, cells, or animals, is transformed 

24 through early and late stage development proto25 typing and testing into diagnostic or therapeutic 
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1 interventions that can be applied to the treatment or 

2 prevention of disease or frailty. 

3 ‘‘SEC. 499B. ESTABLISHMENT OF AMERICAN CENTER FOR 

4 CURES. 

5 ‘‘(a) IN GENERAL.—There is established within the 

6 National Institutes of Health an American Center for 

7 Cures— 

8 ‘‘(1) whose mission shall be to increase the ca9 pacity of the National Institutes of Health to pro10 mote translational research, including between the 

11 institutes and centers of the National Institutes of 

12 Health, between the National Institutes of Health 

13 and other Federal agencies, and between grantees 

14 and business partners of the National Institutes of 

15 Health, so as to speed the development of effective 

16 therapies, diagnostics, and cures essential to human 

17 health and well being; 

18 ‘‘(2) that shall formulate and implement a 

19 strategy for the Nation’s translational research in20 vestment, which strategy shall include— 

21 ‘‘(A) a prioritization of biomedical research 

22 on diseases based on disease burden and re23 search promise; and 

24 ‘‘(B) funding for innovative, multidisci25 plinary, and collaborative research across the 
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1 institutes and centers of the National Institutes 

2 of Health, across Federal agencies, and between 

3 public and private partners of the National In4 stitutes of Health; 

5 ‘‘(3) that shall be guided, in part, by a series 

6 of ‘Grand Challenges’ formulated through collabora7 tion between the Director of Cures and the Council, 

8 that shall be strategic challenges that direct the pub9 lic and private health research community towards 

10 collaborative multi-staged projects that have the po11 tential to transform the healthcare environment, 

12 such as— 

13 ‘‘(A) the creation of laboratory diagnostics 

14 that enable the Nation to detect quickly and ac15 curately acute health threats such as an avian 

16 flu pandemic or a bioterrorism attack; 

17 ‘‘(B) a focus on therapeutic delivery sys18 tems targeting individual viruses or hard to 

19 reach cells in the body, such as the brain, using 

20 advances in nanotechnology; 

21 ‘‘(C) accelerated research into the potential 

22 of stem cells to replace the form and function 

23 of tissues lost to patients suffering from dis24 eases such as spinal cord injury, Parkinson’s 

25 disease, and insulin-dependent diabetes; 
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1 ‘‘(D) creation of a biomedical informatics 

2 infrastructure that can organize the human ge3 nome and the proteins for which the genome 

4 codes in ways that scientists can better under5 stand the genetic contribution to phenotypic 

6 disease; 

7 ‘‘(E) the elaboration of adjuvant tech8 nology that can bolster the effectiveness of vac9 cines; 

10 ‘‘(F) development of antigen sparing vac11 cines such as those based on triggering the in12 nate immune response; 

13 ‘‘(G) development of rapid vaccine manu14 facturing capacity from new production meth15 ods such as viral cell culture or bioengineering 

16 technology; 

17 ‘‘(H) creation of a fast track clinical trial 

18 infrastructure that incorporates a national doc19 tor and patient registry, centralized investiga20 tional review boards, electronic medical records, 

21 and other health information technologies; 

22 ‘‘(I) a focus on addressing less profitable 

23 conditions for which research and development 

24 efforts are insufficient, such as— 
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1 ‘‘(i) orphan, small population, and 

2 third world diseases; 

3 ‘‘(ii) antibiotic resistance; 

4 ‘‘(iii) a threat of a flu epidemic or 

5 pandemic; 

6 ‘‘(iv) diseases associated with social 

7 stigma such as depression and seizure dis8 orders; or 

9 ‘‘(v) other comparable problems; 

10 ‘‘(J) a commitment by researchers and 

11 manufacturers from all sectors to develop vac12 cines for the world’s most deadly infectious dis13 eases, including HIV, tuberculosis, and malaria; 

14 and 

15 ‘‘(K) other appropriate challenges; and 

16 ‘‘(4) that shall have other appropriate purposes. 

17 ‘‘(b) DIRECTOR OF THE CENTER AND THE DIRECTOR

18 OF NIH.— 

19 ‘‘(1) IN GENERAL.—The Center shall be admin20 istered by a Director of Cures who shall be ap21 pointed by the President with the advice and consent 

22 of the Senate. The Director of the NIH, in consulta23 tion with the Council, shall recommend candidates 

24 for the Director of Cures to the President. 

25 ‘‘(2) ACTIVITIES.— 
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1 ‘‘(A) DIRECTOR OF NIH.—The Director of 

2 NIH shall— 

3 ‘‘(i) work with the Director of Cures 

4 to promote translational research efforts; 

5 and 

6 ‘‘(ii) serve as a co-chair of the Coun7 cil. 

8 ‘‘(B) DIRECTOR OF CURES.— 

9 ‘‘(i) ACCELERATION FUND.— 

10 ‘‘(I) IN GENERAL.—The Director 

11 of Cures shall have at the Director’s 

12 disposal an annual acceleration fund 

13 to provide support for research and 

14 development of breakthrough bio15 medical discoveries and to carry out 

16 the purpose of the Center. Amounts in 

17 the fund may be available through 

18 grants, contracts, and cooperative 

19 agreements to public sector entities, 

20 private sector entities, and non-gov21 ernmental organizations. The Director 

22 of Cures shall allocate not less than 

1 23 ⁄2 of the acceleration funds to the 

24 Health Advanced Research Projects 

25 Agency described in subpart 2. The 
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1 remainder of such funds shall be 

2 available to the Federally Funded Re3 search and Development Centers de4 scribed in subpart 1 and other activi5 ties of the Center. 

6 ‘‘(II) AUTHORIZATION OF APPRO7 PRIATIONS.—There are authorized to 

8 be appropriated to fund the accelera9 tion fund under subclause (I) 

10 $5,000,000,000 for fiscal year 2007 

11 and each succeeding fiscal year. 

12 ‘‘(ii) DIRECT OTHER OFFICES.—The 

13 Director of Cures shall direct other offices 

14 within the Center that are established 

15 under this part. 

16 ‘‘(c) COUNCIL.— 

17 ‘‘(1) ESTABLISHMENT.—There is established 

18 within the Center a Cures Council that shall convene 

19 not less frequently than twice a year to help advise 

20 and direct the translational research efforts of the 

21 Center. 

22 ‘‘(2) MEMBERSHIP.— 

23 ‘‘(A) IN GENERAL.—The Council shall be 

24 composed of the following members: 
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1 ‘‘(i) The Director of NIH and the Di2 rector of Cures who shall be Council co3 chairs. 

4 ‘‘(ii) The heads of the institutes and 

5 centers of the National Institutes of 

6 Health. 

7 ‘‘(iii) Heads from not less than 9 Fed8 eral agencies, including— 

9 ‘‘(I) the Administrator for the 

10 Substance Abuse and Mental Health 

11 Services Administration; 

12 ‘‘(II) the Under Secretary for 

13 Science and Technology of the De14 partment of Homeland Security; 

15 ‘‘(III) the Commanding General 

16 for the United States Army Medical 

17 Research and Materiel Command; 

18 ‘‘(IV) the Director of the Centers 

19 for Disease Control and Prevention; 

20 ‘‘(V) the Commissioner of Food 

21 and Drugs; 

22 ‘‘(VI) the Director of the Office 

23 of Science of the Department of En24 ergy; 
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1 ‘‘(VII) the President of the Insti2 tute of Medicine; 

3 ‘‘(VIII) the Director of the Agen4 cy for Healthcare Research and Qual5 ity; and 

6 ‘‘(IX) the Director of the Defense 

7 Advanced Research Projects Agency. 

8 ‘‘(B) OTHER MEMBERS.—Membership of 

9 the Council shall also include not fewer than 3 

10 leaders from the small business community, 3 

11 leaders from large pharmaceutical or bio12 technology companies, and 3 leaders from aca13 demia, all of whom shall be appointed by the 

14 President. 

15 ‘‘(3) SUBCOMMITTEES.—The Council or the 

16 Council co-chairs may form subcommittees of the 

17 Council as needed. 

18 ‘‘(4) RECOMMENDATIONS; COORDINATION.— 

19 The Council shall make recommendations that help 

20 the Director of Cures set research priorities for the 

21 Center. In making recommendations, the Council 

22 shall consider risk and burden of disease as well as 

23 lines of research uniquely poised to deliver effective 

24 diagnostics and therapies. The Council shall also co25 ordinate research priorities in, and ensure sharing of 
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1 research agendas among, the institutes and centers 

2 of the National Institutes of Health. 

3 ‘‘(5) OFFICE OF INTRAMURAL RISK OPPOR4 TUNITY AND MAPPING.—The Council shall be aided 

5 by the Office of Intramural Risk Opportunity and 

6 Mapping of the Office of Technology Transfer of the 

7 Center established in subpart 5. 

8 ‘‘(6) ANNUAL ASSESSMENT.—The Council shall 

9 make an annual assessment of the priorities and 

10 progress of the Center and shall make the assess11 ment available to the public in written and electronic 

12 form. 

13 ‘‘(d) BUDGET AND FUNDS.—The Director of Cures 

14 shall— 

15 ‘‘(1) prepare and submit, directly to the Presi16 dent for review and transmittal to Congress, an an17 nual budget estimate for the Center, after reason18 able opportunity for comment (but without change) 

19 by the Secretary, the Director of NIH, and the 

20 Council; and 

21 ‘‘(2) receive from the President and the Office 

22 of Management and Budget directly all funds appro23 priated by Congress for obligation and expenditure 

24 by the Center. 
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1 ‘‘Subpart 1—Federally Funded Research and 

2 Development Centers 

3 ‘‘SEC. 499C. FEDERALLY FUNDED RESEARCH AND DEVEL4 OPMENT CENTERS. 

5 ‘‘(a) IN GENERAL.—The Director of Cures is author6 ized to establish 1 or more Federally Funded Research 

7 and Development Centers that shall carry out activities 

8 related to the mission of the Center, as described in sec9 tion 499B(a)(1). 

10 ‘‘(b) DUTIES.— 

11 ‘‘(1) IN GENERAL.—The Federally Funded Re12 search and Development Centers shall serve as sites 

13 for the performance of multidisciplinary and cross14 disciplinary research and shall— 

15 ‘‘(A) establish, as appropriate, technology 

16 test beds and incubators; 

17 ‘‘(B) utilize cooperative agreements with 

18 the private sector; and 

19 ‘‘(C) conduct large-scale multidisciplinary 

20 translational research projects in health or dis21 ease areas that are essential to medical ad22 vancement but lack adequate private sector 

23 funding. 

24 ‘‘(2) CONSULTATION.—In carrying out the du25 ties described in paragraph (1), the Federally Fund26 ed Research and Development Centers shall consult 
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1 widely with representatives from private industry, in2 stitutions of higher education, nonprofit institutions, 

3 other Federal governmental agencies, and other fed4 erally funded research and development centers. 

5 ‘‘(c) COMPETITION.—The Director of Cures shall en6 sure that competitive mechanisms are used to select and 

7 to promote the ongoing quality and performance of the 

8 Federally Funded Research and Development Centers. 

9 ‘‘(d) TERM OF FUNDING.—Federally Funded Re10 search and Development Centers shall be funded for not 

11 more than 7 years, after which time the Federally Funded 

12 Research and Development Centers’ re-funding shall be 

13 contingent upon approval by the Director of Cures and 

14 the Council. 

15 ‘‘(e) REPORTS.—Each Federally Funded Research 

16 and Development Center receiving funding under this sec17 tion shall submit a biannual report to the Director and 

18 the appropriate committees of Congress on the activities 

19 carried out by the Federally Funded Research and Devel20 opment Center under this section. 

21 ‘‘(f) FUNDING FOR SUPPORT.—For any fiscal year, 

22 the Director of Cures may use not more than 25 percent 

23 of the funds available to the Director under the accelera24 tion fund under section 499B(b)(2)(B)(i)(II) to establish 
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1 Federally Funded Research and Development Centers 

2 under this section. 

3 ‘‘Subpart 2—Health Advanced Research Projects 

4 ‘‘SEC. 499D. HEALTH ADVANCED RESEARCH PROJECTS 

5 AGENCY. 

6 ‘‘(a) ESTABLISHMENT.—There is established within 

7 the Center a Health Advanced Research Projects Agency 

8 (referred to in this section as the ‘Research Projects Agen9 cy’) that shall— 

10 ‘‘(1) carry out activities related to the mission 

11 of the Center, as described in section 499B(a)(1); 

12 and 

13 ‘‘(2) be headed by a Director of the Research 

14 Projects Agency who is appointed by the Director of 

15 Cures. 

16 ‘‘(b) COMPOSITION.—The Research Projects Agency 

17 shall be composed of not more than 100 portfolio man18 agers in key health areas, which areas are determined by 

19 the Director of the Research Projects Agency in conjunc20 tion with the Director of Cures and the Council. 

21 ‘‘(c) GUIDANCE.—The Research Projects Agency 

22 shall be guided by and shall undertake grand challenges 

23 formulated by the Center that encourage innovative, 

24 multi-disciplinary, and collaborative research across insti25 tutes and centers of the National Institutes of Health, 
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1 across Federal agencies, and between public and private 

2 partners of the National Institutes of Health. 

3 ‘‘(d) MANAGEMENT GUIDANCE.—The Research 

4 Projects Agency shall be guided by the following manage5 ment and organizing principles in directing the Research 

6 Projects Agency: 

7 ‘‘(1) Keep the Research Projects Agency small, 

8 flexible, entrepreneurial, and non-hierarchical, and 

9 empower portfolio managers with substantial auton10 omy to foster research opportunities with freedom 

11 from bureaucratic impediments in administering the 

12 manager’s portfolios. 

13 ‘‘(2) Seek to employ the strongest scientific and 

14 technical talent in the Nation in research fields in 

15 which the Research Projects Agency is working. 

16 ‘‘(3) Rotate a significant portion of the staff 

17 after 3 to 5 years of experience to ensure continuous 

18 entry of new talent into the Research Projects Agen19 cy. 

20 ‘‘(4) Use whenever possible research and devel21 opment investments by the Research Projects Agen22 cy to leverage comparable matching investment and 

23 coordinated research from other institutes and cen24 ters of the National Institutes of Health, from other 
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1 Federal agencies, and from the private and non2 profit research sectors. 

3 ‘‘(5) Utilize supporting technical, contracting, 

4 and administrative personnel from other institutes 

5 and centers of the National Institutes of Health in 

6 administering and implementing research effort to 

7 encourage participation, collaboration, and cross-fer8 tilization of ideas across the National Institutes of 

9 Health. 

10 ‘‘(6) Utilize a challenge model in Research 

11 Projects Agency research efforts, creating a 

12 translational research model that supports funda13 mental research breakthroughs, early and late stage 

14 applied development, prototyping, knowledge diffu15 sion, and technology deployment. 

16 ‘‘(7) Establish metrics to evaluate research suc17 cess and periodically revisit ongoing research efforts 

18 to carefully weigh new research opportunities 

19 against ongoing research. 

20 ‘‘(8) Tolerate risk-taking in research pursuits. 

21 ‘‘(9) Ensure that revolutionary and break22 through technology research dominates the Research 

23 Projects Agency’s research agenda and portfolio. 

24 ‘‘(e) ACTIVITIES.—Using the funds and authorities 

25 provided to the Director of Cures, and the authorities pro-
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1 vided to the Director of NIH, the Research Projects Agen2 cy shall carry out the following activities: 

3 ‘‘(1) The Research Projects Agency shall sup4 port basic and applied health research to promote 

5 revolutionary technology changes that promote 

6 health needs. 

7 ‘‘(2) The Research Projects Agency shall ad8 vance the development, testing, evaluation, proto9 typing, and deployment of critical health products. 

10 ‘‘(3) The Research Projects Agency, consistent 

11 with recommendations of the Council, with the prior12 ities of the Director of Cures, and with the need to 

13 discuss challenges described in section 499B(a)(3), 

14 shall emphasize— 

15 ‘‘(A) translational research efforts, includ16 ing efforts conducted through collaboration with 

17 the private sector, that pursue— 

18 ‘‘(i) innovative health products that 

19 could significantly and promptly address 

20 acute health threats such as a flu pan21 demic, spread of antibiotic resistant hos22 pital acquired infections, or other com23 parable problems; 

24 ‘‘(ii) remedies for diseases afflicting 

25 lesser developed countries; 
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1 ‘‘(iii) remedies for orphan and small 

2 population diseases; 

3 ‘‘(iv) alternative technologies with sig4 nificant health promise that are not well5 supported in the system of health research, 

6 such as adjuvant technology or tech7 nologies for vaccines based on the innate 

8 immunological response; and 

9 ‘‘(v) fast track development, including 

10 development through accelerated comple11 tion of animal and human clinical trials, 

12 for emerging remedies for significant pub13 lic health problems; and 

14 ‘‘(B) other appropriate translational re15 search efforts for critical health issues. 

16 ‘‘(4) The Research Projects Agency shall utilize 

17 funds to provide support to outstanding research 

18 performers in all sectors and encourage cross-dis19 ciplinary research collaborations that will allow sci20 entists from fields such as information and computer 

21 sciences, nanotechnology, chemistry, physics, and en22 gineering to work alongside top researchers with 

23 more traditional biomedical backgrounds. 

24 ‘‘(5) The Research Projects Agency shall pro25 vide selected research projects with single-year or 
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1 multi-year funding and require researchers for such 

2 projects to provide interim progress reports to the 

3 Research Projects Agency on not less frequently 

4 than a biannual basis. 

5 ‘‘(6) The Research Projects Agency shall award 

6 competitive, merit-reviewed grants, cooperative 

7 agreements, or contracts to public or private entities, 

8 including businesses, federally-funded research and 

9 development centers, and universities. 

10 ‘‘(7) The Research Projects Agency shall pro11 vide advice to the Director of Cures concerning 

12 funding priorities. 

13 ‘‘(8) The Research Projects Agency may solicit 

14 proposals for competitions to address specific health 

15 vulnerabilities identified by the Director and award 

16 prizes for successful outcomes. 

17 ‘‘(9) The Research Projects Agency shall peri18 odically hold health research and technology dem19 onstrations to improve contact among researchers, 

20 technology developers, vendors, and acquisition per21 sonnel. 

22 ‘‘(10) The Research Projects Agency shall carry 

23 out other activities determined appropriate by the 

24 Director of Cures. 

25 ‘‘(f) EMPLOYEES.— 
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1 ‘‘(1) HIRING.—The Research Projects Agency, 

2 in hiring employees for positions with the Research 

3 Projects Agency, shall have the same hiring and 

4 management authorities as described in section 1101 

5 of the Strom Thurmond National Defense Author6 ization Act for Fiscal Year 1999 (5 U.S.C. 3104 

7 note). 

8 ‘‘(2) TERM.— 

9 ‘‘(A) IN GENERAL.—Except as provided in 

10 subparagraph (B), the term of such appoint11 ments for employees of the Research Projects 

12 Agency may not exceed 5 years. 

13 ‘‘(B) EXTENSION.—The Director of the 

14 Research Projects Agency may, in the case of 

15 a particular employee of the Research Projects 

16 Agency, extend the term to which employment 

17 is limited under subparagraph (A) by up to 2 

18 years if the Director of the Research Projects 

19 Agency determines that such action is necessary 

20 to promote the efficiency of the Research 

21 Projects Agency. 

22 ‘‘(g) FLEXIBILITY.—The Research Projects Agency 

23 shall have the authority to flexibly fund projects, including 

24 the prompt awarding, releasing, enhancing, or withdrawal 
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1 of monies in accordance with the assessment of the Re2 search Projects Agency and project manager. 

3 ‘‘(h) FUNDING.—The Research Projects Agency shall 

4 utilize funds received from the acceleration fund, described 

5 in section 499B(b)(2)(B)(i), for the Agency’s research and 

6 development activities. There is authorized to be appro7 priated from such fund $2,500,000,000 to carry out the 

8 activities of the Research Projects Agency. 

9 ‘‘Subpart 3—Clinical Trials 

10 ‘‘SEC. 499E. INCREASING RESEARCH STUDY PARTICIPA11 TION. 

12 ‘‘The Director of NIH shall establish a national clin13 ical study registry within the National Library of Medicine 

14 of the National Institutes of Health in accordance with 

15 section 499H. The Center shall publicize the registry, with 

16 attention given to minority groups that are frequently 

17 underrepresented in clinical trials. 

18 ‘‘SEC. 499E–1. GRANTS FOR QUALITY CLINICAL TRIAL DE19 SIGN AND EXECUTION. 

20 ‘‘The Director of Cures— 

21 ‘‘(1) shall award grants for clinical trial design 

22 and execution to academic centers to fund multi-dis23 ciplinary clinical research teams, which clinical re24 search teams may be composed of members who in-
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1 clude project managers, clinicians, epidemiologists, 

2 social scientists, and nursing staff; and 

3 ‘‘(2) may award grants for clinical trial design 

4 and execution to researchers from small firms with 

5 highly promising novel therapeutic entities. 

6 ‘‘SEC. 499E–2. STREAMLINING THE REGULATORY PROCESS 

7 GOVERNING CLINICAL RESEARCH. 

8 ‘‘(a) ESTABLISHMENT OF CENTRALIZED INSTITU9 TIONAL REVIEW BOARDS.— 

10 ‘‘(1) IN GENERAL.—The Director of Cures shall 

11 establish a series of Centralized institutional Review 

12 Boards (referred to in this section as ‘CIRBs’) to 

13 serve as human subject safety and well being 

14 custodians for multi-institutional clinical trials that 

15 are funded partially or in full by public research dol16 lars. 

17 ‘‘(2) EXISTING GUIDELINES AND BEST PRAC18 TICES.—CIRBs shall be established in accordance 

19 with professional best practices and Good Clinical 

20 Practice (GCP) guidelines so that institutions in21 volved in multi-institutional studies may— 

22 ‘‘(A) use joint review; 

23 ‘‘(B) rely upon the review of another quali24 fied institutional review board; or 
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1 ‘‘(C) use similar arrangements aimed to 

2 avoid duplication of effort and to assure a high 

3 quality of expert oversight. 

4 ‘‘(b) HOUSED.—Each CIRB shall be housed— 

5 ‘‘(1) at the institute or center of the National 

6 Institutes of Health with expertise on the subject of 

7 the clinical trial; or 

8 ‘‘(2) at a public or private institution with com9 parable organizational capacity, such as the Depart10 ment of Veterans Affairs. 

11 ‘‘(c) SERVICE.—The use of CIRBs shall be available, 

12 as appropriate, at the request of public or private institu13 tions and shall be funded through user fees of the CIRBs 

14 or the Center’s funds. 

15 ‘‘(d) REVIEW PROCESS.— 

16 ‘‘(1) IN GENERAL.—Each CIRB shall review re17 search protocols and informed consent to ensure the 

18 protection and safety of research participants en19 rolled in multi-institutional clinical trials. 

20 ‘‘(2) PROCESS.—The CIRB review process shall 

21 consist of contractual agreements between the CIRB 

22 and the study sites of multi-institutional clinical 

23 trials. The CIRB shall act on behalf, in whole or in 

24 part, of the bodies ordinarily responsible for the 

25 safety of research subjects in a locality. In the case 
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1 in which a locality does not have such a body, the 

2 locality shall depend solely on the CIRB to oversee 

3 the protection of human subjects and the CIRB 

4 shall assume responsibility for ensuring adequate as5 sessment of the local research context. 

6 ‘‘(e) RESEARCH APPLICATIONS.— 

7 ‘‘(1) IN GENERAL.—Each CIRB shall review 

8 and package research applications for facilitated 

9 electronic review by local institutional review boards 

10 participating in a multi-institutional clinical trial. 

11 ‘‘(2) LOCAL REVIEW.—Local institutional re12 view board review may be performed by a sub13 committee of the local institutional review board that 

14 is empowered to make decisions in a timely manner. 

15 ‘‘(3) CIRB REVIEW.—A local institutional re16 view board may accept or reject a CIRB review. In 

17 the case in which a local institutional review board 

18 accepts a CIRB review, the CIRB shall assume re19 sponsibility for annual, amendment, and adverse 

20 event reviews. 

21 ‘‘(f) WORK IN CONCERT.—In the case in which a 

22 local institutional review board works in concert with a 

23 CIRB, the local institutional review board shall be respon24 sible for taking into consideration local characteristics (in25 cluding ethnicity, educational level, and other demographic 
28 

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1 characteristics) of the population from which research 

2 subjects will be drawn, which influence, among other 

3 things, whether there is sound selection of research sub4 jects or whether adequate provision is made to minimize 

5 risks to vulnerable populations. 

6 ‘‘(g) COMMUNICATION OF IMPORTANT INFORMA7 TION.—Each CIRB shall regularly communicate impor8 tant information in electronic form to the local institu9 tional review boards or, in cases where a local institutional 

10 review board does not exist, to the principal investigator, 

11 including regular safety updates or changes in research 

12 protocol to improve safety. 

13 ‘‘(h) COORDINATION.—Each CIRB shall fully coordi14 nate with the institute or center of the National Institutes 

15 of Health that has specialized knowledge of the research 

16 area of the clinical trial. Other Federal agencies and pri17 vate entities undertaking clinical trials may contract with 

18 the Center to use a CIRB. 

19 ‘‘SEC. 499E–3. TRAINING CLINICAL RESEARCHERS OF THE 

20 FUTURE. 

21 ‘‘The Center shall augment the National Institutes 

22 of Health’s investment into programs dedicated to devel23 oping the clinical research workforce for tomorrow. The 

24 programs shall include: 
29 

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1 ‘‘(1) The National Institutes of Health’s 

2 Mentored Patient-Oriented Research Career Devel3 opment Award to support the career development of 

4 investigators who have made a commitment to focus 

5 their research endeavors on patient-oriented re6 search. 

7 ‘‘(2) The National Institutes of Health’s award 

8 to encourage mentorship among particularly talented 

9 early- and mid-career investigators doing clinical re10 search who want to train new investigators. 

11 ‘‘(3) The National Institutes of Health grants 

12 to help institutions develop curricula for clinical re13 searchers leading to a clinical science certificate or 

14 master’s degree. 

15 ‘‘(4) The National Institutes of Health grants 

16 to fund participants in clinical science programs, in17 cluding clinical science certificates or clinical science 

18 masters’ degrees. 

19 ‘‘SEC. 499E–4. CLINICAL RESEARCH STUDY AND CLINICAL 

20 TRIAL. 

21 ‘‘The Director of NIH shall— 

22 ‘‘(1) commission the Institute of Medicine of 

23 the National Academies to study the rules that pro24 tect patient safety and anonymity so that in a con25 temporary clinical research context, a better balance 
30 

•S 2104 IS

1 can be achieved between clinical research promotion 

2 and regulatory requirement governing research sub3 ject safety and privacy; and 

4 ‘‘(2) request that the Institute of Medicine issue 

5 a written report not later than 18 months after the 

6 date of enactment of this part that shall— 

7 ‘‘(A) consider changes to the Health Insur8 ance Portability and Accountability Act of 1996 

9 (Public Law 104–191) and the amendments 

10 made by such Act that further promote the 

11 clinical research endeavor; and 

12 ‘‘(B) include recommendations for changes 

13 that shall not be limited to legislation but shall 

14 include changes to health care systems and to 

15 researcher practice that facilitate the clinical re16 search endeavor. 

17 ‘‘SEC. 499E–5. AUTHORIZATION OF APPROPRIATIONS. 

18 ‘‘There are authorized to be appropriated from the 

19 acceleration fund of the Director of Cures described in sec20 tion 499B(b)(2)(B)(i)— 

21 ‘‘(1) $100,000,000 to carry out section 499E– 

22 1(1) for fiscal year 2007 and each succeeding fiscal 

23 year; 

24 ‘‘(2) $50,000,000 to carry out section 499E–2 

25 for fiscal year 2007 and each succeeding fiscal year; 
31 

•S 2104 IS

1 ‘‘(3) $200,000,000 to carry out section 499E– 

2 3 for fiscal year 2007 and each succeeding fiscal 

3 year; and 

4 ‘‘(4) $2,500,000 to carry out section 499E–4. 

5 ‘‘Subpart 4—Valley of Death 

6 ‘‘SEC. 499F. SMALL BUSINESS PARTNERSHIPS. 

7 ‘‘(a) ESTABLISHMENT OF THE OFFICE OF BIOSCI8 ENTIFIC ENTERPRISE DEVELOPMENT.— 

9 ‘‘(1) ESTABLISHMENT.—There is established 

10 within the Office of Technology Transfer of the Cen11 ter (as established in subpart 5) an Office of Biosci12 entific Enterprise Development (referred to in the 

13 subpart as the ‘OBED’). 

14 ‘‘(2) TRANSFERS.— 

15 ‘‘(A) IN GENERAL.—The OBED shall in16 clude the functions (including related personnel 

17 and resources) of the following programs of the 

18 Office of Extramural Research in the Office of 

19 the Director of the National Institutes of 

20 Health: 

21 ‘‘(i) The Small Business Innovation 

22 Research program (referred to in this sub23 part as the ‘SBIR’). 
32 

•S 2104 IS

1 ‘‘(ii) The Small Business Technology 

2 Transfer program (referred to in this sub3 part as the ‘STTR’). 

4 ‘‘(B) TIME FOR TRANSFERS.—The Sec5 retary shall ensure that the programs described 

6 in subparagraph (A) are transferred to the 

7 OBED not later than 6 months after the date 

8 of enactment of this part. 

9 ‘‘(b) SBIR AND STTR GRANTS AND CONTRACTS.— 

10 ‘‘(1) IN GENERAL.—Not less than 35 percent of 

11 the grants and contracts awarded by the SBIR and 

12 STTR shall be awarded on a competitive basis by an 

13 OBED program manager with sufficient managerial, 

14 technical, and translational research expertise to 

15 expertly assess the quality of a SBIR or STTR pro16 posal. The OBED, through such project manager, 

17 shall place special emphasis on SBIR and STTR 

18 grant and contract applications that identify from 

19 the onset products with commercial potential that 

20 influence human health. 

21 ‘‘(2) POTENTIAL PURCHASERS OR INVES22 TORS.—The OBED shall administer non-peer re23 viewed grants and contracts under this subsection 

24 through program managers who shall place special 

25 emphasis on partnering grantees and entities award-
33 

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1 ed contracts from the very beginning of the research 

2 and development process with potential purchasers 

3 or investors of the products, including large pharma4 ceutical or biotechnology companies, venture capital 

5 firms, and Federal agencies (including the National 

6 Institutes of Health). 

7 ‘‘(3) PHASE I AND II.—The OBED shall reduce 

8 the time period between Phase I and Phase II fund9 ing of grants and contracts under the SBIR and 

10 STTR to— 

11 ‘‘(A) 6 months; or 

12 ‘‘(B) less than 6 months if the grantee or 

13 entity awarded a contract demonstrates that 

14 the grantee or entity awarded a contract has in15 terest from third parties to buy or fund the 

16 product developed with the grant or contract. 

17 ‘‘(4) PHASE III.— 

18 ‘‘(A) FUNDING.—A program manager 

19 under this subsection may petition the Director 

20 of Cures for Phase III funding of the grant or 

21 contract for a project that requires a boost to 

22 finalize procurement of a product. The max23 imum funding for Phase III funding of a 

24 project shall be $2,000,000 for a maximum of 

25 2 years. Such Phase III funding shall come 
34 

•S 2104 IS

1 from the acceleration fund, as described in sec2 tion 499B(b)(2)(B)(i), of the Director of Cures. 

3 ‘‘(B) REPORT SUCCESS.—Each recipient of 

4 a SBIR or STTR grant or contract, as a condi5 tion of receiving such grant or contract, shall 

6 report to the OBED whether there was even7 tual commercial success of the product devel8 oped with the assistance of the grant or con9 tract. 

10 ‘‘(5) RECORD.— 

11 ‘‘(A) IN GENERAL.—The OBED shall keep 

12 a publicly accessible electronic record of all 

13 SBIR or STTR investments in research and de14 velopment. 

15 ‘‘(B) CONTENTS.—The record described in 

16 subparagraph (A) shall include, at minimum, 

17 the following information: 

18 ‘‘(i) The grantee or entity awarded a 

19 contract. 

20 ‘‘(ii) A description of the research 

21 being funded. 

22 ‘‘(iii) The amount of money awarded 

23 in each phase of SBIR or STTR funding. 

24 ‘‘(iv) If applicable, the purchaser of 

25 the product, current use of the product, 
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•S 2104 IS

1 and estimated annual revenue resulting 

2 from the procurement. 

3 ‘‘(6) BONUS.—For each fiscal year, for the non4 peer reviewed SBIR and STTR grants or contracts, 

5 the 2 program managers who are most successful in 

6 terms of the number of grantees or entities awarded 

7 a contract who complete Phase III shall each be 

8 awarded a $10,000 bonus. 

9 ‘‘SEC. 499F–1. RAPID ACCESS TO INTERVENTION DEVELOP10 MENT. 

11 ‘‘(a) ESTABLISHMENT OF OFFICE.—The Office of 

12 Technology Transfer of the Center shall establish an Of13 fice of Rapid Access to Intervention Development (re14 ferred to in this subpart as the ‘RAID’) that— 

15 ‘‘(1) is designed to assist translating promising, 

16 novel, and scientifically meritorious therapeutic 

17 interventions to clinical use by providing support to 

18 help investigators navigate the product development 

19 pipeline; 

20 ‘‘(2) shall aim to remove barriers between lab21 oratory discoveries and clinical trials of new molec22 ular therapies, technologies, and other clinical inter23 ventions; 

24 ‘‘(3) shall aim to progress, augment, and com25 plement the innovation and research conducted in 
36 

•S 2104 IS

1 private entities to reduce duplicative and redundant 

2 work using public funds; and 

3 ‘‘(4) shall coordinate with the offices of the Na4 tional Institutes of Health that promote 

5 translational research in the pre-clinical phase across 

6 the National Institutes of Health. 

7 ‘‘(b) PROJECTS.— 

8 ‘‘(1) IN GENERAL.—The RAID, in collaboration 

9 with the Director of Cures, shall carry out a pro10 gram that shall select, in accordance with paragraph 

11 (2), projects of eligible entities that shall receive ac12 cess to laboratories, facilities, and other support re13 sources of the National Institutes of Health for the 

14 pre-clinical development of drugs, biologics, 

15 diagnostics, and devices. 

16 ‘‘(2) SELECTION.—Not less than 35 percent of 

17 the projects selected under paragraph (1) shall be 

18 selected on a competitive basis by a program man19 ager with sufficient managerial, technical, and 

20 translational research expertise to adequately assess 

21 the quality of a project proposal. Projects under 

22 paragraph (1) may also be selected from a peer re23 view process. 

24 ‘‘(3) ELIGIBLE ENTITIES.—In this subsection, 

25 the term ‘eligible entity’ means— 
37 

•S 2104 IS

1 ‘‘(A) a university researcher; 

2 ‘‘(B) a nonprofit research organization; or 

3 ‘‘(C) a firm of less than 100 employees in 

4 collaboration with 1 or more universities or 

5 nonprofit organizations. 

6 ‘‘(4) DISCONTINUE SUPPORT.—The RAID may 

7 discontinue support of a project if the project fails 

8 to meet commercialization success criteria estab9 lished by the RAID. 

10 ‘‘(c) DISCOVERIES FROM LAB TO CLINIC.—The pro11 gram under subsection (b) shall accelerate the process of 

12 bringing discoveries from the laboratory to the clinic 

13 through— 

14 ‘‘(1) the development of pharmacological assays; 

15 ‘‘(2) the scale-up of production from lab scale 

16 to clinical-trials scale; 

17 ‘‘(3) the development of suitable formulations; 

18 ‘‘(4) the evaluation of chemical stability; 

19 ‘‘(5) the evaluation of materials testing for du20 rability or reactivity; 

21 ‘‘(6) undertaking initial toxicology studies; 

22 ‘‘(7) planning clinical trials; and 

23 ‘‘(8) advice regarding the investigational new 

24 drug or investigational new device filing with the 

25 Food and Drug Administration. 
38 

•S 2104 IS

1 ‘‘(d) ONGOING REVIEW.—The RAID shall review, on 

2 an ongoing basis, potential products and may not support 

3 products past the proof-of-principle stage. 

4 ‘‘SEC. 499F–2. TOXICITY STUDIES. 

5 ‘‘(a) ONGOING RESEARCH.—The Center shall sup6 port ongoing research into the most efficient methods of 

7 screening for in vivo toxicity, including using cell-based 

8 and animal model technologies. 

9 ‘‘(b) OFFER OF STUDIES.—The Director of Cures 

10 shall direct the Office of Technology Transfer of the Cen11 ter to offer toxicity studies as an available feature to pre12 cede completion of licensing agreement contracts because 

13 toxicity studies are expensive and rate-limiting barriers to 

14 the licensing of intellectual property from the National In15 stitutes of Health. 

16 ‘‘SEC. 499F–3. ADDITIONAL FUNDING SOURCES AND MOD17 ELS. 

18 ‘‘The Director of Cures may provide acceleration 

19 funds, described in section 499B(b)(2)(B)(i), for innova20 tive custom contracts for translational research develop21 ment to entities that license intellectual property from the 

22 National Institutes of Health where such contracts sup23 port innovation and new models of cooperation and com24 mercialization. 
39 

•S 2104 IS

1 ‘‘SEC. 499F–4. AUTHORIZATION OF APPROPRIATIONS. 

2 ‘‘There are authorized to be appropriated from the 

3 acceleration fund of the Director of Cures described in sec4 tion 499B(b)(2)(B)(i)— 

5 ‘‘(1) $400,000,000 to carry out section 499F 

6 for fiscal year 2007 and each succeeding fiscal year; 

7 and 

8 ‘‘(2) $100,000,000 to carry out section 499F– 

9 1 for fiscal year 2007 and each succeeding fiscal 

10 year. 

11 ‘‘Subpart 5—Office of Technology Transfer 

12 ‘‘SEC. 499G. RESTRUCTURING. 

13 ‘‘(a) ESTABLISHMENT.—There is established within 

14 the Center an Office of Technology Transfer (referred to 

15 in this subpart as the ‘OTT’). 

16 ‘‘(b) TRANSFERS.—The OTT shall include the func17 tions (and related personnel and resources) of the Office 

18 of Technology Transfer in the Office of the Director of 

19 the National Institutes of Health. 

20 ‘‘SEC. 499G–1. MARKETING FUNCTION. 

21 ‘‘(a) IN GENERAL.—The OTT shall establish a pro22 gram that— 

23 ‘‘(1) cultivates industry interest in funded re24 search of the National Institutes of Health; 

25 ‘‘(2) reaches out to potential industry partners; 
40 

•S 2104 IS

1 ‘‘(3) coordinates patents from the other insti2 tutes and centers of the National Institutes of 

3 Health; and 

4 ‘‘(4) manages Cooperative Research and Devel5 opment Agreements, biological licensing agreements, 

6 material transfer agreements, and intellectual prop7 erty licensing. 

8 ‘‘(b) PROMOTION.—The program under subsection 

9 (a) shall assist in promoting the success of government 

10 and industry partnerships for the development of new 

11 technologies by soliciting involvement of the private sector 

12 from the beginning of the translational research process, 

13 including by creating an electronic database within the 

14 National Library of Medicine, which shall be updated reg15 ularly, that tabulates translational research efforts occur16 ring at the National Institutes of Health. The OTT shall 

17 hold an annual national translational research conference 

18 that brings together researchers and industry representa19 tives from across fields from both the private and public 

20 sectors. 

21 ‘‘(c) TRANSFER MANAGEMENT AND SUPPORT.—The 

22 OTT shall develop a program for transfer management 

23 and support that is familiar with the National Institutes 

24 of Health’s intramural and extramural research portfolio, 

25 which program’s mission is to reach out to potential indus-
41 

•S 2104 IS

1 try partners to cultivate interest in collaboration with pub2 lic researchers with the goal of product development and 

3 procurement. For those Institutes or Centers with their 

4 own Office of Technology Transfer Offices, the OTT shall 

5 work closely with those offices to coordinate industry out6 reach efforts. Those offices, on a biannual basis, shall 

7 meet with the OTT and shall submit a report to the OTT 

8 describing the translational research efforts of the Center 

9 or Institute and corresponding efforts to attract commer10 cial interest in their research portfolio. 

11 ‘‘(d) MANAGEMENT.— 

12 ‘‘(1) IN GENERAL.—The OTT shall manage the 

13 Cooperative Research and Development Agreements 

14 between industry and public research partners. 

15 ‘‘(2) REGISTRATION.—The OTT shall— 

16 ‘‘(A) as appropriate, register the agree17 ments within a publicly accessible electronic 

18 database maintained by the National Library of 

19 Medicine of the National Institutes of Health; 

20 and 

21 ‘‘(B) oversee the collaborative process in 

22 terms of pre-determined outputs, negotiating 

23 problems that may occur between collaborating 

24 entities, and assuring intellectual property pro-
42 

•S 2104 IS

1 tections necessary for successful product devel2 opment. 

3 ‘‘SEC. 499G–2. OFFICE OF INTRAMURAL RISK OPPORTUNITY 

4 AND MAPPING. 

5 ‘‘(a) ESTABLISHMENT.—There is established in the 

6 Office of Technology Transfer of the Center, an Office of 

7 Intramural Risk Opportunity and Mapping that shall 

8 oversee the intramural research programs of the National 

9 Institutes of Health to be certain they are complementary 

10 and distinct from extramural and private programs. 

11 ‘‘(b) REVIEWS AND REPORTS.—The Office of Intra12 mural Risk Opportunity and Mapping shall— 

13 ‘‘(1) conduct regular reviews of the intramural 

14 research programs of the National Institutes of 

15 Health; and 

16 ‘‘(2) report every 2 years on such reviews. 

17 ‘‘(c) HEALTH RISKS AND OPPORTUNITIES.—The Of18 fice of Intramural Risk Opportunity and Mapping shall— 

19 ‘‘(1) identify and map public health risks and 

20 scientific opportunities and keep data on such topics 

21 current and updated; and 

22 ‘‘(2) provide the information described in para23 graph (1) to the Council on a biannual basis to help 

24 the Council prioritize the Nation’s translation re25 search investment. 
43 

•S 2104 IS

1 ‘‘(d) TRANS-NIH COLLABORATIVE RESEARCH.— 

2 ‘‘(1) IN GENERAL.—The Office of Intramural 

3 Risk Opportunity and Mapping shall make, in co4 ordination with the Director of Cures and the Direc5 tor of NIH, funds available to groups of institutes 

6 and centers of the National Institutes of Health to 

7 promote engagement in multi-institute projects that 

8 focus on translational research endeavors. 

9 ‘‘(2) FUNDING.—Funding levels and periods of 

10 funding under paragraph (1) shall be flexible as nec11 essary to achieve trans-institute project objectives. 

12 Preference for funding shall be given to projects that 

13 promote high levels of cross-disciplinary collabora14 tion, that address diseases with the greatest burden 

15 or research promise, and that are most likely to re16 sult in the development of a diagnostic or thera17 peutic prototype. 

18 ‘‘(3) AUTHORIZATION OF APPROPRIATIONS.— 

19 There is authorized to be appropriated, from the ac20 celeration fund of the Director of Cures described in 

21 section 499B(b)(2)(B)(i), to carry out this sub22 section $150,000,000. 
44 

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1 ‘‘SEC. 499G–3. PATENTING AND LICENSING INCENTIVES. 

2 ‘‘(a) IN GENERAL.—The OTT shall make every effort 

3 to increase licensing throughput in order to stimulate the 

4 availability of useful products for patients. 

5 ‘‘(b) INCENTIVES.—The OTT shall develop incentives 

6 that create private sector, financial, commercial, and aca7 demic interest in the National Institutes of Health’s intel8 lectual property portfolio, which incentives may include 

9 the following: 

10 ‘‘(1) The patent extension of National Insti11 tutes of Health’s health patents, in which there is an 

12 extension of the time during which the licensee has 

13 exclusive right to the intellectual property. 

14 ‘‘(2) The patent restoration of National Insti15 tutes of Health’s health patents, in which there is 

16 restoration of the full patent life, or another agreed 

17 upon term, of a technology to the licensee from the 

18 time of Food and Drug Administration passage or 

19 other agreed upon milestone. 

20 ‘‘(3) Partnering options, which are options to 

21 pursue exclusive and nonexclusive licensing to 1 or 

22 more partners in the government, industrial, or aca23 demic sectors. 

24 ‘‘(c) CUSTOMIZED MODELS.—The Director of Cures 

25 shall encourage the OTT to cultivate customized models 
45 

•S 2104 IS

1 for contracts that fulfill the needs of industry and the pub2 lic. 

3 ‘‘SEC. 499G–4. TRANSLATIONAL RESEARCHER DEVELOP4 MENT. 

5 ‘‘(a) IN GENERAL.—The Director of Cures shall over6 see the development of a curriculum for internships in 

7 interdisciplinary research that will encompass rotations 

8 through multiple institutes and centers of the National In9 stitutes of Health (including the National Library of Med10 icine), the clinical trial design process, and other related 

11 disciplines with an emphasis on practical experience. 

12 ‘‘(b) TUITION GRANTS.—The Director of Cures shall 

13 award tuition grants for extramural interdisciplinary re14 search programs. 

15 ‘‘(c) TRAINING.—The Center shall train interdiscipli16 nary scientists in the science and art of risk analysis and 

17 mapping through a program of internships and fellow18 ships. 

19 ‘‘SEC. 499G–5. TRANSLATIONAL RESEARCH TRAINING PRO20 GRAM. 

21 ‘‘The Director of NIH shall ensure that each institute 

22 and center of the National Institutes of Health has estab23 lished, or contracted for the establishment of, a 

24 translational research training program at the institute or 

25 center. 
46 

•S 2104 IS

1 ‘‘Subpart 6—Developing Information Systems 

2 ‘‘SEC. 499H. ADVANCING NATIONAL HEALTH INFORMATION 

3 INFRASTRUCTURE. 

4 ‘‘(a) GENOMIC DATA.— 

5 ‘‘(1) IN GENERAL.—The National Center for 

6 Biotechnology Information of the National Library 

7 of Medicine of the National Institutes of Health 

8 shall develop new computational methods to aid in 

9 the processing of genomic data by novice and experi10 enced researchers. 

11 ‘‘(2) AUTHORIZATION OF APPROPRIATIONS.— 

12 There is authorized to be appropriated, from the ac13 celeration fund of the Director of Cures described in 

14 section 499B(b)(2)(B)(i), to carry out paragraph (1) 

15 $8,000,000, of which— 

16 ‘‘(A) $2,500,000 is authorized to be appro17 priated to support the program’s computational 

18 infrastructure; and 

19 ‘‘(B) $5,500,000 is authorized to be appro20 priated for hiring biologists and computer sci21 entists who are trained in bioinformatics. 

22 ‘‘(b) DATABASE.—The Secretary, acting through the 

23 Director of NIH, shall undertake, in collaboration with the 

24 National Library of Medicine of the National Institutes 

25 of Health, construction of a clinical study registry and re-
47 

•S 2104 IS

1 sults database that may expand upon the National Library 

2 of Medicine’s information system and database. 

3 ‘‘(c) CLINICAL TRIAL INFORMATION.— 

4 ‘‘(1) IN GENERAL.— 

5 ‘‘(A) IN GENERAL.—The clinical study reg6 istry and results database, described in sub7 section (b), shall consist of a registry of phase 

8 III clinical trials taking place in the United 

9 States and a database of their results. 

10 ‘‘(B) CLINICAL STUDY REGISTRY.—Partici11 pation in the clinical study registry shall be 

12 mandatory for both public and private entities. 

13 ‘‘(C) RESULTS DATABASE.—Participation 

14 in the clinical trial results database shall be 

15 mandatory for both public and private entities. 

16 The clinical trial results database shall include 

17 even negative studies, which demonstrate no 

18 therapeutic effect. 

19 ‘‘(2) REGISTRY OF CLINICAL TRIALS.—The reg20 istry of clinical trials shall include not less than the 

21 following: 

22 ‘‘(A) The clinical trial title. 

23 ‘‘(B) A description of the product under 

24 study. 

25 ‘‘(C) The hypothesis to be tested. 
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•S 2104 IS

1 ‘‘(D) The intervention. 

2 ‘‘(E) The study design, methodology, dura3 tion, and location. 

4 ‘‘(F) Participation criteria. 

5 ‘‘(G) Contact information. 

6 ‘‘(H) Sponsoring organization. 

7 ‘‘(3) CLINICAL TRIAL RESULTS.—The database 

8 of clinical trial results shall consist of not less than 

9 the following: 

10 ‘‘(A) The trial start date and completion 

11 date. 

12 ‘‘(B) A summary of the results of the trial 

13 in a standard, non-promotional summary for14 mat. 

15 ‘‘(C) Summary data tables with respect to 

16 the primary and secondary outcome measures. 

17 ‘‘(D) Information on the statistical signifi18 cance of the results and publications in peer re19 viewed journals relating to the trial, with, when 

20 available, an electronic link to the journal arti21 cle. 

22 ‘‘(E) A description of the process used to 

23 review the results of the trial, including a state24 ment about whether the results have been peer 
49 

•S 2104 IS

1 reviewed by reviewers independent of the trial 

2 sponsor. 

3 ‘‘(F) Safety data concerning the trial, in4 cluding a summary of all adverse events speci5 fying the number and type of events. 

6 ‘‘(G) Reference information to the clinical 

7 trial in the clinical registry. 

8 ‘‘(d) REGISTRATION OF TRIALS AND REPORTING OF

9 RESULTS.— 

10 ‘‘(1) WEBSITE PUBLICATION.—Each principal 

11 investigator of a public clinical trial or responsible 

12 person for a private clinical trial shall register phase 

13 III clinical trials in accordance with paragraph (2) 

14 and report phase III clinical trial results in accord15 ance with paragraph (2) with the National Library 

16 of Medicine of the National Institutes of Health. 

17 The National Library of Medicine shall make the in18 formation available for viewing on the Library’s 

19 Website, www.clinicaltrials.gov. The National Li20 brary of Medicine shall electronically link each reg21 istered clinical trial with its database of results and 

22 link each database of results with its registered clin23 ical trial. 

24 ‘‘(2) TIMELINE OF REGISTRATION.— 
50 

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1 ‘‘(A) IN GENERAL.—An entity described in 

2 paragraph (1) shall register a clinical trial not 

3 later than 3 months after the Food and Drug 

4 Administration has approved the entity’s clin5 ical trial protocol and report clinical trial re6 sults not later than 3 months after completing 

7 the clinical trial, which shall be defined as the 

8 point where the specified trial duration has 

9 been surpassed and the analysis of the data is 

10 complete or the trial is stopped because of vital 

11 positive or negative findings, or as the point de12 termined by the judgment of the Secretary. All 

13 information submitted to the National Library 

14 of Medicine shall be accurate and updated. 

15 ‘‘(B) LOSS OF FUNDING.—In the case in 

16 which an entity described in paragraph (1) does 

17 not register a clinical trial or report on clinical 

18 trial results in accordance with subparagraph 

19 (A), the Secretary may— 

20 ‘‘(i) not award a grant, contract, co21 operative agreements, or any other award 

22 to the principal investigators of such entity 

23 until the principal investigators comply 

24 with the requirements under subparagraph 

25 (A); and 
51 

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1 ‘‘(ii) in the case of an entity that does 

2 not receive Federal funding for the clinical 

3 trial, fine the entity $10,000 a day for a 

4 sum not to exceed $2,000,000 until the re5 sponsible person for the clinical trial com6 plies with the requirements under subpara7 graph (A). 

8 ‘‘(C) WAIVER.—The Secretary may waive 

9 the requirements of subparagraph (A) upon a 

10 written request from the responsible person if 

11 the Secretary determines that extraordinary cir12 cumstances justify the waiver and that pro13 viding the waiver is in the public’s interest or 

14 consistent with the protection of public health. 

15 ‘‘SEC. 499H–1. PUBLIC ACCESS REQUIREMENT FOR RE16 SEARCH. 

17 ‘‘(a) IN GENERAL.—The Secretary shall require all 

18 funded investigators, whether direct employees of the De19 partment of Health and Human Services or recipients of 

20 grants, contracts, or other support of the National Insti21 tutes of Health, the Centers for Disease Control and Pre22 vention, or the Agency for Healthcare Research and Qual23 ity, to submit to the National Library of Medicine of the 

24 National Institutes of Health (referred to in this section 

25 as the ‘National Library of Medicine’), upon acceptance 
52 

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1 for publication in a journal or other publication included 

2 in the PubMed directory, final manuscripts resulting from 

3 research in which direct costs are supported in whole or 

4 in part by the National Institutes of Health, the Centers 

5 for Disease Control and Prevention, or the Agency for 

6 Healthcare Research and Quality. 

7 ‘‘(b) PUBLIC AVAILABILITY.— 

8 ‘‘(1) IN GENERAL.—The National Library of 

9 Medicine shall include all such manuscripts de10 scribed in subsection (a), after peer review, for dis11 play in the National Library of Medicine’s digital li12 brary archive, PubMed Central. The copyright hold13 er of a manuscript described in subsection (a) may 

14 request the author’s manuscript be replaced with 

15 final published text. 

16 ‘‘(2) TIMELINE.—A manuscript described in 

17 subsection (a) shall become publicly available on the 

18 Internet through PubMed Central not later than 6 

19 months after the date of publication of the manu20 script. 

21 ‘‘(3) LOSS OF FUNDING FOR FAILURE TO SUB22 MIT ON TIME.—Failure to submit required informa23 tion under this section to the National Library of 

24 Medicine within 6 months of the date of publication 

25 of the manuscript involved shall be considered by the 
53 

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1 Secretary in the context of grant compliance review 

2 and may result in the loss of public funding for the 

3 investigators involved as determined appropriate by 

4 the agency involved. 

5 ‘‘SEC. 499H–2. INFORMATICS TRAINING AND WORKFORCE 

6 DEVELOPMENT. 

7 ‘‘(a) IN GENERAL.—The Director of NIH shall de8 velop a multi-faceted approach to increasing the number 

9 of persons trained in clinical bioinformatics by imple10 menting appropriate programs, including the programs 

11 described in subsection (b). 

12 ‘‘(b) PROGRAMS.—The programs under this sub13 section are the following: 

14 ‘‘(1) K–12 SCIENCE PROGRAM.—The National 

15 Library of Medicine of the National Institutes of 

16 Health shall develop with the National Science 

17 Foundation a kindergarten through grade 12 clinical 

18 informatics education curriculum that shall include 

19 an assessment component. The National Library of 

20 Medicine shall award not more than 500 schools 

21 each $30,000 to implement the curriculum. 

22 ‘‘(2) UNDERGRADUATE DEGREE PROGRAMS IN

23 BIOINFORMATICS.—The National Library of Medi24 cine of the National Institutes of Health shall— 
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1 ‘‘(A) award grants to academic health cen2 ters and graduate training programs to collabo3 rate with an undergraduate institution of high4 er education’s department of biology, chemistry, 

5 or computer science to develop curricula leading 

6 to a bachelor’s degree in bioinformatics; and 

7 ‘‘(B) encourage grantees to form an inter8 institutional consortium. 

9 ‘‘(3) INCREASING THE NUMBER OF NIH

10 BIOINFORMATICS GRADUATE TRAINING PRO11 GRAMS.—The National Library of Medicine of the 

12 National Institutes of Health shall increase the 

13 number of bioinformatics graduate training pro14 grams through funding existing graduate training 

15 programs of the National Institutes of Health to 

16 meet the expanding needs for training and outreach 

17 to the biomedical community. The programs shall 

18 focus on the skills needed to apply bioinformatics 

19 methods specifically to problems of human health 

20 and disease. The Director of NIH shall hire 12 indi21 viduals with a doctorate in molecular biology and ex22 pertise in training and developing educational pro23 grams to assist in carrying out the programs under 

24 this paragraph. 
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1 ‘‘(4) CENTERS OF EXCELLENCE IN CLINICAL

2 BIOINFORMATICS.—The National Library of Medi3 cine of the National Institutes of Health, through 

4 the Center, shall establish Centers of Excellence in 

5 Clinical Bioinformatics that shall have state-of-the6 art computational methods and tools applicable to 

7 human disease prevention, diagnosis, and treatment. 

8 The Centers of Excellence in Clinical Bioinformatics 

9 shall provide graduate student and postdoctoral sup10 port, through distinguished faculty, in order to con11 tribute to the highest level of training in the 

12 bioinformatics workforce pipeline. 

13 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.—There 

14 is authorized to be appropriated, from the acceleration 

15 fund of the Director of Cures described in section 

16 499B(b)(2)(B)(i), to carry out this section $50,000,000 

17 for fiscal year 2007 and each succeeding fiscal year of 

18 which— 

19 ‘‘(1) $15,000,000 is authorized to be appro20 priated for fiscal year 2007 and each succeeding fis21 cal year to carry out subsection (b)(1); and 

22 ‘‘(2) $2,000,000 is authorized to be appro23 priated to carry out subsection (b)(3). 
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1 ‘‘SEC. 499H–3. NATIONAL LIBRARY OF MEDICINE EXPAN2 SION OF FACILITIES. 

3 ‘‘(a) SENSE OF CONGRESS.—It is the sense of Con4 gress that Congress should make special effort to fund the 

5 expansion of facilities of the National Library of Medicine 

6 of the National Institutes of Health. These facilities are 

7 essential to the National Library of Medicine being able 

8 to fulfill its many informatics functions, which include pro9 viding essential informational resources to scientists 

10 worldwide and advancing the underpinning of much of the 

11 National Institutes of Health conducted biomedical re12 search. 

13 ‘‘(b) REPORT.—The Director shall request that the 

14 Institute of Medicine of the National Academies report to 

15 Congress on the impact of not providing funding for the 

16 expansion of facilities described in subsection (a). 

17 ‘‘Subpart 7—Research Tools 

18 ‘‘SEC. 499I. NIH RESEARCH TOOL INVENTORY. 

19 ‘‘(a) ANNUAL REVIEW.—The Director of NIH shall 

20 direct the head of each institute and center of the National 

21 Institutes of Health to perform an annual review of the 

22 institute or center’s research tool inventory for the specific 

23 purpose of enabling each institute or center to understand 

24 the research tool distribution, frequency of use, intellectual 

25 property status, and utility. Each institute and center of 

26 the National Institutes of Health shall describe in the in-
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1 stitute or center’s annual review the type and quantity of 

2 research tools the institute or center desires to obtain to 

3 better fulfill the institute or center’s research and develop4 ment goals. 

5 ‘‘(b) DATABASE.—The Director of Cures shall— 

6 ‘‘(1) enter the information obtained from the 

7 annual review under subsection (a) into an electronic 

8 research tool database; and 

9 ‘‘(2) use such database to oversee the 

10 prioritization and funding of new projects to fulfill 

11 pressing needs and promising technologies. 

12 ‘‘SEC. 499I–1. EXCEPTIONS TO TOOL GUIDELINES. 

13 ‘‘The Director of Cures may advise the Office of 

14 Technology Transfer of the Center to provide exceptions 

15 to prohibitions against patenting and licensing research 

16 tools under some circumstances of customized contracts 

17 when exclusive or non-exclusive licensing provides the 

18 swiftest and most efficacious final development of an im19 portant health care technology.’’. 

20 (b) CONFORMING AMENDMENT.—Section 401(b)(1) 

21 of the Public Health Service Act (42 U.S.C. 281(b)(1)) 

22 is amended by adding at the end the following: 

23 ‘‘(S) The American Center for Cures.’’. 

Æ