		II

		109th CONGRESS

		1st Session

		S. 2104

		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.Short titleThis Act may be cited as the

			 American Center for Cures Act of

			 2005.

		2.Table of

			 contentsThe 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.

		3.FindingsCongress finds the following:

			(1)The National

			 Institutes of Health (referred to in this section as the NIH) is

			 the United States premier biomedical research investment with annual

			 appropriations exceeding $28,000,000,000.

			(2)The mission of

			 the NIH is science in pursuit of fundamental knowledge about the nature and

			 behavior of living systems and the application of that knowledge to extend

			 healthy life and reduce the burdens of illness and disability.

			(3)The pace of

			 knowledge application to promote health and reduce disease can be influenced

			 through strategic funding and reorganization of some aspects of the traditional

			 research endeavor. This process is known as translational research

			 investment.

			(4)The United States

			 translational research investment will be key to the Nation responding

			 effectively—

				(A)to acute man-made

			 or natural health threats;

				(B)to the complexity

			 and multi-disciplinary nature of chronic diseases, which are responsible for 7

			 out of every 10 deaths in the United States and for more than 70 percent of the

			 $1,700,000,000,000 spent in the United States on health care each year;

			 and

				(C)to research and

			 development vacuums in the private for-profit market, such as in the fields of

			 vaccine and antibiotic production, drugs for Third World diseases, and medical

			 tools for pediatric populations.

				(5)Key components of

			 the translational research process include research prioritization, an expert

			 workforce, multi-disciplinary collaborative work, facilitated information

			 exchange, strategic risk taking, support of small innovative businesses caught

			 along common pathways in the research and development Valley of Death,

			 simplification and promotion of the clinical research endeavor, and involvement

			 of private entities early on in the translational research endeavor that are

			 skilled in the manufacturing and marketing process.

			4.American Center

			 for Cures

			(a)American Center

			 for CuresTitle IV of the Public Health Service Act (42 U.S.C.

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

					JAmerican Center

				for Cures

						499A.DefinitionsIn this part:

							(1)CenterThe

				term Center means the American Center for Cures established under

				section 499B.

							(2)CouncilThe

				term Council means the Cures Council established under section

				499B.

							(3)DirectorThe

				term Director means the Director of the American Center for

				Cures.

							(4)IncubatorThe

				term incubator means an economic development organization designed

				to accelerate the growth and success of entrepreneurial individuals, concepts,

				and companies.

							(5)Research

				toolThe term research tool means a resource that

				scientists use in their laboratories that has no immediate therapeutic or

				diagnostic value, including cell lines, monoclonal antibodies, reagents,

				laboratory equipment and machines, databases, and computer software.

							(6)Test

				bedThe term test bed means the pilot environment to

				prototype innovation.

							(7)Translational

				researchThe term translational research means

				investigation in which knowledge obtained from fundamental research such as

				with genes, cells, or animals, is transformed through early and late stage

				development prototyping and testing into diagnostic or therapeutic

				interventions that can be applied to the treatment or prevention of disease or

				frailty.

							499B.Establishment

				of American Center for Cures

							(a)In

				generalThere is established within the National Institutes of

				Health an American Center for Cures—

								(1)whose mission

				shall be to increase the capacity of the National Institutes of Health to

				promote translational research, including between the institutes and centers of

				the National Institutes of Health, between the National Institutes of Health

				and other Federal agencies, and between grantees and business partners of the

				National Institutes of Health, so as to speed the development of effective

				therapies, diagnostics, and cures essential to human health and well

				being;

								(2)that shall

				formulate and implement a strategy for the Nation’s translational research

				investment, which strategy shall include—

									(A)a prioritization

				of biomedical research on diseases based on disease burden and research

				promise; and

									(B)funding for

				innovative, multidisciplinary, and collaborative research across the institutes

				and centers of the National Institutes of Health, across Federal agencies, and

				between public and private partners of the National Institutes of

				Health;

									(3)that shall be

				guided, in part, by a series of Grand Challenges formulated

				through collaboration between the Director of Cures and the Council, that shall

				be strategic challenges that direct the public and private health research

				community towards collaborative multi-staged projects that have the potential

				to transform the healthcare environment, such as—

									(A)the creation of

				laboratory diagnostics that enable the Nation to detect quickly and accurately

				acute health threats such as an avian flu pandemic or a bioterrorism

				attack;

									(B)a focus on

				therapeutic delivery systems targeting individual viruses or hard to reach

				cells in the body, such as the brain, using advances in nanotechnology;

									(C)accelerated

				research into the potential of stem cells to replace the form and function of

				tissues lost to patients suffering from diseases such as spinal cord injury,

				Parkinson’s disease, and insulin-dependent diabetes;

									(D)creation of a

				biomedical informatics infrastructure that can organize the human genome and

				the proteins for which the genome codes in ways that scientists can better

				understand the genetic contribution to phenotypic disease;

									(E)the elaboration

				of adjuvant technology that can bolster the effectiveness of vaccines;

									(F)development of

				antigen sparing vaccines such as those based on triggering the innate immune

				response;

									(G)development of

				rapid vaccine manufacturing capacity from new production methods such as viral

				cell culture or bioengineering technology;

									(H)creation of a

				fast track clinical trial infrastructure that incorporates a national doctor

				and patient registry, centralized investigational review boards, electronic

				medical records, and other health information technologies;

									(I)a focus on

				addressing less profitable conditions for which research and development

				efforts are insufficient, such as—

										(i)orphan, small

				population, and third world diseases;

										(ii)antibiotic

				resistance;

										(iii)a threat of a

				flu epidemic or pandemic;

										(iv)diseases

				associated with social stigma such as depression and seizure disorders;

				or

										(v)other comparable

				problems;

										(J)a commitment by

				researchers and manufacturers from all sectors to develop vaccines for the

				world's most deadly infectious diseases, including HIV, tuberculosis, and

				malaria; and

									(K)other appropriate

				challenges; and

									(4)that shall have

				other appropriate purposes.

								(b)Director of the

				Center and the Director of NIH

								(1)In

				generalThe Center shall be administered by a Director of Cures

				who shall be appointed by the President with the advice and consent of the

				Senate. The Director of the NIH, in consultation with the Council, shall

				recommend candidates for the Director of Cures to the President.

								(2)Activities

									(A)Director of

				NIHThe Director of NIH shall—

										(i)work with the

				Director of Cures to promote translational research efforts; and

										(ii)serve as a

				co-chair of the Council.

										(B)Director of

				Cures

										(i)Acceleration

				fund

											(I)In

				generalThe Director of Cures shall have at the Director's

				disposal an annual acceleration fund to provide support for research and

				development of breakthrough biomedical discoveries and to carry out the purpose

				of the Center. Amounts in the fund may be available through grants, contracts,

				and cooperative agreements to public sector entities, private sector entities,

				and non-governmental organizations. The Director of Cures shall allocate not

				less than ½ of the acceleration funds to the Health Advanced Research Projects

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

				to the Federally Funded Research and Development Centers described in subpart 1

				and other activities of the Center.

											(II)Authorization

				of appropriationsThere are authorized to be appropriated to fund

				the acceleration fund under subclause (I) $5,000,000,000 for fiscal year 2007

				and each succeeding fiscal year.

											(ii)Direct other

				officesThe Director of Cures shall direct other offices within

				the Center that are established under this part.

										(c)Council

								(1)EstablishmentThere

				is established within the Center a Cures Council that shall convene not less

				frequently than twice a year to help advise and direct the translational

				research efforts of the Center.

								(2)Membership

									(A)In

				generalThe Council shall be composed of the following

				members:

										(i)The Director of

				NIH and the Director of Cures who shall be Council co-chairs.

										(ii)The heads of the

				institutes and centers of the National Institutes of Health.

										(iii)Heads from not

				less than 9 Federal agencies, including—

											(I)the Administrator

				for the Substance Abuse and Mental Health Services Administration;

											(II)the Under

				Secretary for Science and Technology of the Department of Homeland

				Security;

											(III)the Commanding

				General for the United States Army Medical Research and Materiel

				Command;

											(IV)the Director of

				the Centers for Disease Control and Prevention;

											(V)the Commissioner

				of Food and Drugs;

											(VI)the Director of

				the Office of Science of the Department of Energy;

											(VII)the President

				of the Institute of Medicine;

											(VIII)the Director

				of the Agency for Healthcare Research and Quality; and

											(IX)the Director of

				the Defense Advanced Research Projects Agency.

											(B)Other

				membersMembership of the Council shall also include not fewer

				than 3 leaders from the small business community, 3 leaders from large

				pharmaceutical or biotechnology companies, and 3 leaders from academia, all of

				whom shall be appointed by the President.

									(3)SubcommitteesThe

				Council or the Council co-chairs may form subcommittees of the Council as

				needed.

								(4)Recommendations;

				coordinationThe Council shall make recommendations that help the

				Director of Cures set research priorities for the Center. In making

				recommendations, the Council shall consider risk and burden of disease as well

				as lines of research uniquely poised to deliver effective diagnostics and

				therapies. The Council shall also coordinate research priorities in, and ensure

				sharing of research agendas among, the institutes and centers of the National

				Institutes of Health.

								(5)Office of

				Intramural Risk Opportunity and MappingThe Council shall be

				aided by the Office of Intramural Risk Opportunity and Mapping of the Office of

				Technology Transfer of the Center established in subpart 5.

								(6)Annual

				assessmentThe Council shall make an annual assessment of the

				priorities and progress of the Center and shall make the assessment available

				to the public in written and electronic form.

								(d)Budget and

				fundsThe Director of Cures shall—

								(1)prepare and

				submit, directly to the President for review and transmittal to Congress, an

				annual budget estimate for the Center, after reasonable opportunity for comment

				(but without change) by the Secretary, the Director of NIH, and the Council;

				and

								(2)receive from the

				President and the Office of Management and Budget directly all funds

				appropriated by Congress for obligation and expenditure by the Center.

								1Federally Funded

				Research and Development Centers

							499C.Federally

				Funded Research and Development Centers

								(a)In

				generalThe Director of Cures

				is authorized to establish 1 or more Federally Funded Research and Development

				Centers that shall carry out activities related to the mission of the Center,

				as described in section 499B(a)(1).

								(b)Duties

									(1)In

				generalThe Federally Funded Research and Development Centers

				shall serve as sites for the performance of multidisciplinary and

				cross-disciplinary research and shall—

										(A)establish, as

				appropriate, technology test beds and incubators;

										(B)utilize

				cooperative agreements with the private sector; and

										(C)conduct

				large-scale multidisciplinary translational research projects in health or

				disease areas that are essential to medical advancement but lack adequate

				private sector funding.

										(2)ConsultationIn

				carrying out the duties described in paragraph (1), the Federally Funded

				Research and Development Centers shall consult widely with representatives from

				private industry, institutions of higher education, nonprofit institutions,

				other Federal governmental agencies, and other federally funded research and

				development centers.

									(c)CompetitionThe

				Director of Cures shall ensure that competitive mechanisms are used to select

				and to promote the ongoing quality and performance of the Federally Funded

				Research and Development Centers.

								(d)Term of

				fundingFederally Funded

				Research and Development Centers shall be funded for not more than 7 years,

				after which time the Federally Funded Research and Development Centers'

				re-funding shall be contingent upon approval by the Director of Cures and the

				Council.

								(e)ReportsEach

				Federally Funded Research and Development Center receiving funding under this

				section shall submit a biannual report to the Director and the appropriate

				committees of Congress on the activities carried out by the Federally Funded

				Research and Development Center under this section.

								(f)Funding for

				supportFor any fiscal year, the Director of Cures may use not

				more than 25 percent of the funds available to the Director under the

				acceleration fund under section 499B(b)(2)(B)(i)(II) to establish Federally

				Funded Research and Development Centers under this section.

								2Health Advanced

				Research Projects

							499D.Health

				Advanced Research Projects Agency

								(a)EstablishmentThere is established within the Center a

				Health Advanced Research Projects Agency (referred to in this section as the

				Research Projects Agency) that shall—

									(1)carry out activities related to the mission

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

									(2)be headed by a Director of the Research

				Projects Agency who is appointed by the Director of Cures.

									(b)CompositionThe

				Research Projects Agency shall be composed of not more than 100 portfolio

				managers in key health areas, which areas are determined by the Director of the

				Research Projects Agency in conjunction with the Director of Cures and the

				Council.

								(c)GuidanceThe

				Research Projects Agency shall be guided by and shall undertake grand

				challenges formulated by the Center that encourage innovative,

				multi-disciplinary, and collaborative research across institutes and centers of

				the National Institutes of Health, across Federal agencies, and between public

				and private partners of the National Institutes of Health.

								(d)Management

				guidanceThe Research Projects Agency shall be guided by the

				following management and organizing principles in directing the Research

				Projects Agency:

									(1)Keep the Research

				Projects Agency small, flexible, entrepreneurial, and non-hierarchical, and

				empower portfolio managers with substantial autonomy to foster research

				opportunities with freedom from bureaucratic impediments in administering the

				manager's portfolios.

									(2)Seek to employ

				the strongest scientific and technical talent in the Nation in research fields

				in which the Research Projects Agency is working.

									(3)Rotate a

				significant portion of the staff after 3 to 5 years of experience to ensure

				continuous entry of new talent into the Research Projects Agency.

									(4)Use whenever

				possible research and development investments by the Research Projects Agency

				to leverage comparable matching investment and coordinated research from other

				institutes and centers of the National Institutes of Health, from other Federal

				agencies, and from the private and non-profit research sectors.

									(5)Utilize

				supporting technical, contracting, and administrative personnel from other

				institutes and centers of the National Institutes of Health in administering

				and implementing research effort to encourage participation, collaboration, and

				cross-fertilization of ideas across the National Institutes of Health.

									(6)Utilize a

				challenge model in Research Projects Agency research efforts, creating a

				translational research model that supports fundamental research breakthroughs,

				early and late stage applied development, prototyping, knowledge diffusion, and

				technology deployment.

									(7)Establish metrics

				to evaluate research success and periodically revisit ongoing research efforts

				to carefully weigh new research opportunities against ongoing research.

									(8)Tolerate

				risk-taking in research pursuits.

									(9)Ensure that

				revolutionary and breakthrough technology research dominates the Research

				Projects Agency’s research agenda and portfolio.

									(e)ActivitiesUsing

				the funds and authorities provided to the Director of Cures, and the

				authorities provided to the Director of NIH, the Research Projects Agency shall

				carry out the following activities:

									(1)The Research

				Projects Agency shall support basic and applied health research to promote

				revolutionary technology changes that promote health needs.

									(2)The Research

				Projects Agency shall advance the development, testing, evaluation,

				prototyping, and deployment of critical health products.

									(3)The Research

				Projects Agency, consistent with recommendations of the Council, with the

				priorities of the Director of Cures, and with the need to discuss challenges

				described in section 499B(a)(3), shall emphasize—

										(A)translational

				research efforts, including efforts conducted through collaboration with the

				private sector, that pursue—

											(i)innovative health

				products that could significantly and promptly address acute health threats

				such as a flu pandemic, spread of antibiotic resistant hospital acquired

				infections, or other comparable problems;

											(ii)remedies for

				diseases afflicting lesser developed countries;

											(iii)remedies for

				orphan and small population diseases;

											(iv)alternative

				technologies with significant health promise that are not well-supported in the

				system of health research, such as adjuvant technology or technologies for

				vaccines based on the innate immunological response; and

											(v)fast track

				development, including development through accelerated completion of animal and

				human clinical trials, for emerging remedies for significant public health

				problems; and

											(B)other appropriate

				translational research efforts for critical health issues.

										(4)The Research

				Projects Agency shall utilize funds to provide support to outstanding research

				performers in all sectors and encourage cross-disciplinary research

				collaborations that will allow scientists from fields such as information and

				computer sciences, nanotechnology, chemistry, physics, and engineering to work

				alongside top researchers with more traditional biomedical backgrounds.

									(5)The Research

				Projects Agency shall provide selected research projects with single-year or

				multi-year funding and require researchers for such projects to provide interim

				progress reports to the Research Projects Agency on not less frequently than a

				biannual basis.

									(6)The Research

				Projects Agency shall award competitive, merit-reviewed grants, cooperative

				agreements, or contracts to public or private entities, including businesses,

				federally-funded research and development centers, and universities.

									(7)The Research

				Projects Agency shall provide advice to the Director of Cures concerning

				funding priorities.

									(8)The Research

				Projects Agency may solicit proposals for competitions to address specific

				health vulnerabilities identified by the Director and award prizes for

				successful outcomes.

									(9)The Research

				Projects Agency shall periodically hold health research and technology

				demonstrations to improve contact among researchers, technology developers,

				vendors, and acquisition personnel.

									(10)The Research

				Projects Agency shall carry out other activities determined appropriate by the

				Director of Cures.

									(f)Employees

									(1)HiringThe

				Research Projects Agency, in hiring employees for positions with the Research

				Projects Agency, shall have the same hiring and management authorities as

				described in section 1101 of the Strom Thurmond National Defense Authorization

				Act for Fiscal Year 1999 (5 U.S.C. 3104 note).

									(2)Term

										(A)In

				generalExcept as provided in subparagraph (B), the term of such

				appointments for employees of the Research Projects Agency may not exceed 5

				years.

										(B)ExtensionThe

				Director of the Research Projects Agency may, in the case of a particular

				employee of the Research Projects Agency, extend the term to which employment

				is limited under subparagraph (A) by up to 2 years if the Director of the

				Research Projects Agency determines that such action is necessary to promote

				the efficiency of the Research Projects Agency.

										(g)FlexibilityThe

				Research Projects Agency shall have the authority to flexibly fund projects,

				including the prompt awarding, releasing, enhancing, or withdrawal of monies in

				accordance with the assessment of the Research Projects Agency and project

				manager.

								(h)FundingThe

				Research Projects Agency shall utilize funds received from the acceleration

				fund, described in section 499B(b)(2)(B)(i), for the Agency's research and

				development activities. There is authorized to be appropriated from such fund

				$2,500,000,000 to carry out the activities of the Research Projects

				Agency.

								3Clinical

				Trials

							499E.Increasing

				research study participationThe Director of NIH shall establish a

				national clinical study registry within the National Library of Medicine of the

				National Institutes of Health in accordance with section 499H. The Center shall

				publicize the registry, with attention given to minority groups that are

				frequently underrepresented in clinical trials.

							499E–1.Grants for

				quality clinical trial design and executionThe Director of Cures—

								(1)shall award grants for clinical trial

				design and execution to academic centers to fund multi-disciplinary clinical

				research teams, which clinical research teams may be composed of members who

				include project managers, clinicians, epidemiologists, social scientists, and

				nursing staff; and

								(2)may award grants

				for clinical trial design and execution to researchers from small firms with

				highly promising novel therapeutic entities.

								499E–2.Streamlining

				the regulatory process governing clinical research

								(a)Establishment

				of centralized institutional review boards

									(1)In

				generalThe Director of Cures shall establish a series of

				Centralized institutional Review Boards (referred to in this section as

				CIRBs) to serve as human subject safety and well being

				custodians for multi-institutional clinical trials that are funded partially or

				in full by public research dollars.

									(2)Existing

				guidelines and best practicesCIRBs shall be established in

				accordance with professional best practices and Good Clinical Practice (GCP)

				guidelines so that institutions involved in multi-institutional studies

				may—

										(A)use joint

				review;

										(B)rely upon the

				review of another qualified institutional review board; or

										(C)use similar

				arrangements aimed to avoid duplication of effort and to assure a high quality

				of expert oversight.

										(b)HousedEach

				CIRB shall be housed—

									(1)at the institute

				or center of the National Institutes of Health with expertise on the subject of

				the clinical trial; or

									(2)at a public or

				private institution with comparable organizational capacity, such as the

				Department of Veterans Affairs.

									(c)ServiceThe

				use of CIRBs shall be available, as appropriate, at the request of public or

				private institutions and shall be funded through user fees of the CIRBs or the

				Center’s funds.

								(d)Review

				process

									(1)In

				generalEach CIRB shall review research protocols and informed

				consent to ensure the protection and safety of research participants enrolled

				in multi-institutional clinical trials.

									(2)ProcessThe

				CIRB review process shall consist of contractual agreements between the CIRB

				and the study sites of multi-institutional clinical trials. The CIRB shall act

				on behalf, in whole or in part, of the bodies ordinarily responsible for the

				safety of research subjects in a locality. In the case in which a locality does

				not have such a body, the locality shall depend solely on the CIRB to oversee

				the protection of human subjects and the CIRB shall assume responsibility for

				ensuring adequate assessment of the local research context.

									(e)Research

				applications

									(1)In

				generalEach CIRB shall review and package research applications

				for facilitated electronic review by local institutional review boards

				participating in a multi-institutional clinical trial.

									(2)Local

				reviewLocal institutional review board review may be performed

				by a subcommittee of the local institutional review board that is empowered to

				make decisions in a timely manner.

									(3)CIRB

				reviewA local institutional review board may accept or reject a

				CIRB review. In the case in which a local institutional review board accepts a

				CIRB review, the CIRB shall assume responsibility for annual, amendment, and

				adverse event reviews.

									(f)Work in

				concertIn the case in which a local institutional review board

				works in concert with a CIRB, the local institutional review board shall be

				responsible for taking into consideration local characteristics (including

				ethnicity, educational level, and other demographic characteristics) of the

				population from which research subjects will be drawn, which influence, among

				other things, whether there is sound selection of research subjects or whether

				adequate provision is made to minimize risks to vulnerable populations.

								(g)Communication

				of important informationEach CIRB shall regularly communicate

				important information in electronic form to the local institutional review

				boards or, in cases where a local institutional review board does not exist, to

				the principal investigator, including regular safety updates or changes in

				research protocol to improve safety.

								(h)CoordinationEach

				CIRB shall fully coordinate with the institute or center of the National

				Institutes of Health that has specialized knowledge of the research area of the

				clinical trial. Other Federal agencies and private entities undertaking

				clinical trials may contract with the Center to use a CIRB.

								499E–3.Training

				clinical researchers of the futureThe Center shall augment the National

				Institutes of Health's investment into programs dedicated to developing the

				clinical research workforce for tomorrow. The programs shall include:

								(1)The National

				Institutes of Health's Mentored Patient-Oriented Research Career Development

				Award to support the career development of investigators who have made a

				commitment to focus their research endeavors on patient-oriented

				research.

								(2)The National

				Institutes of Health's award to encourage mentorship among particularly

				talented early- and mid-career investigators doing clinical research who want

				to train new investigators.

								(3)The National

				Institutes of Health grants to help institutions develop curricula for clinical

				researchers leading to a clinical science certificate or master's

				degree.

								(4)The National

				Institutes of Health grants to fund participants in clinical science programs,

				including clinical science certificates or clinical science masters’

				degrees.

								499E–4.Clinical

				research study and clinical trialThe Director of NIH shall—

								(1)commission the Institute of Medicine of the

				National Academies to study the rules that protect patient safety and anonymity

				so that in a contemporary clinical research context, a better balance can be

				achieved between clinical research promotion and regulatory requirement

				governing research subject safety and privacy; and

								(2)request that the

				Institute of Medicine issue a written report not later than 18 months after the

				date of enactment of this part that shall—

									(A)consider changes

				to the Health Insurance Portability and Accountability Act of 1996 (Public Law

				104–191) and the amendments made by such Act that further promote the clinical

				research endeavor; and

									(B)include

				recommendations for changes that shall not be limited to legislation but shall

				include changes to health care systems and to researcher practice that

				facilitate the clinical research endeavor.

									499E–5.Authorization

				of appropriationsThere are

				authorized to be appropriated from the acceleration fund of the Director of

				Cures described in section 499B(b)(2)(B)(i)—

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

				for fiscal year 2007 and each succeeding fiscal year;

								(2)$50,000,000 to

				carry out section 499E–2 for fiscal year 2007 and each succeeding fiscal

				year;

								(3)$200,000,000 to

				carry out section 499E–3 for fiscal year 2007 and each succeeding fiscal year;

				and

								(4)$2,500,000 to

				carry out section 499E–4.

								4Valley of

				Death

							499F.Small

				business partnerships

								(a)Establishment

				of the office of bioscientific enterprise development

									(1)EstablishmentThere

				is established within the Office of Technology Transfer of the Center (as

				established in subpart 5) an Office of Bioscientific Enterprise Development

				(referred to in the subpart as the OBED).

									(2)Transfers

										(A)In

				generalThe OBED shall include the functions (including related

				personnel and resources) of the following programs of the Office of Extramural

				Research in the Office of the Director of the National Institutes of

				Health:

											(i)The Small

				Business Innovation Research program (referred to in this subpart as the

				SBIR).

											(ii)The Small

				Business Technology Transfer program (referred to in this subpart as the

				STTR).

											(B)Time for

				transfersThe Secretary shall ensure that the programs described

				in subparagraph (A) are transferred to the OBED not later than 6 months after

				the date of enactment of this part.

										(b)SBIR and STTR

				grants and contracts

									(1)In

				generalNot less than 35 percent of the grants and contracts

				awarded by the SBIR and STTR shall be awarded on a competitive basis by an OBED

				program manager with sufficient managerial, technical, and translational

				research expertise to expertly assess the quality of a SBIR or STTR proposal.

				The OBED, through such project manager, shall place special emphasis on SBIR

				and STTR grant and contract applications that identify from the onset products

				with commercial potential that influence human health.

									(2)Potential

				purchasers or investorsThe OBED shall administer non-peer

				reviewed grants and contracts under this subsection through program managers

				who shall place special emphasis on partnering grantees and entities awarded

				contracts from the very beginning of the research and development process with

				potential purchasers or investors of the products, including large

				pharmaceutical or biotechnology companies, venture capital firms, and Federal

				agencies (including the National Institutes of Health).

									(3)Phase I and

				IIThe OBED shall reduce the time period between Phase I and

				Phase II funding of grants and contracts under the SBIR and STTR to—

										(A)6 months;

				or

										(B)less than 6

				months if the grantee or entity awarded a contract demonstrates that the

				grantee or entity awarded a contract has interest from third parties to buy or

				fund the product developed with the grant or contract.

										(4)Phase

				III

										(A)FundingA

				program manager under this subsection may petition the Director of Cures for

				Phase III funding of the grant or contract for a project that requires a boost

				to finalize procurement of a product. The maximum funding for Phase III funding

				of a project shall be $2,000,000 for a maximum of 2 years. Such Phase III

				funding shall come from the acceleration fund, as described in section

				499B(b)(2)(B)(i), of the Director of Cures.

										(B)Report

				successEach recipient of a SBIR or STTR grant or contract, as a

				condition of receiving such grant or contract, shall report to the OBED whether

				there was eventual commercial success of the product developed with the

				assistance of the grant or contract.

										(5)Record

										(A)In

				generalThe OBED shall keep a publicly accessible electronic

				record of all SBIR or STTR investments in research and development.

										(B)ContentsThe

				record described in subparagraph (A) shall include, at minimum, the following

				information:

											(i)The grantee or

				entity awarded a contract.

											(ii)A description of

				the research being funded.

											(iii)The amount of

				money awarded in each phase of SBIR or STTR funding.

											(iv)If applicable,

				the purchaser of the product, current use of the product, and estimated annual

				revenue resulting from the procurement.

											(6)BonusFor

				each fiscal year, for the non-peer reviewed SBIR and STTR grants or contracts,

				the 2 program managers who are most successful in terms of the number of

				grantees or entities awarded a contract who complete Phase III shall each be

				awarded a $10,000 bonus.

									499F–1.Rapid

				access to intervention development

								(a)Establishment

				of officeThe Office of Technology Transfer of the Center shall

				establish an Office of Rapid Access to Intervention Development (referred to in

				this subpart as the RAID) that—

									(1)is designed to

				assist translating promising, novel, and scientifically meritorious therapeutic

				interventions to clinical use by providing support to help investigators

				navigate the product development pipeline;

									(2)shall aim to

				remove barriers between laboratory discoveries and clinical trials of new

				molecular therapies, technologies, and other clinical interventions;

									(3)shall aim to

				progress, augment, and complement the innovation and research conducted in

				private entities to reduce duplicative and redundant work using public funds;

				and

									(4)shall coordinate

				with the offices of the National Institutes of Health that promote

				translational research in the pre-clinical phase across the National Institutes

				of Health.

									(b)Projects

									(1)In

				generalThe RAID, in collaboration with the Director of Cures,

				shall carry out a program that shall select, in accordance with paragraph (2),

				projects of eligible entities that shall receive access to laboratories,

				facilities, and other support resources of the National Institutes of Health

				for the pre-clinical development of drugs, biologics, diagnostics, and

				devices.

									(2)SelectionNot

				less than 35 percent of the projects selected under paragraph (1) shall be

				selected on a competitive basis by a program manager with sufficient

				managerial, technical, and translational research expertise to adequately

				assess the quality of a project proposal. Projects under paragraph (1) may also

				be selected from a peer review process.

									(3)Eligible

				entitiesIn this subsection, the term eligible

				entity means—

										(A)a university

				researcher;

										(B)a nonprofit

				research organization; or

										(C)a firm of less

				than 100 employees in collaboration with 1 or more universities or nonprofit

				organizations.

										(4)Discontinue

				supportThe RAID may discontinue support of a project if the

				project fails to meet commercialization success criteria established by the

				RAID.

									(c)Discoveries

				from lab to clinicThe program under subsection (b) shall

				accelerate the process of bringing discoveries from the laboratory to the

				clinic through—

									(1)the development

				of pharmacological assays;

									(2)the scale-up of

				production from lab scale to clinical-trials scale;

									(3)the development

				of suitable formulations;

									(4)the evaluation of

				chemical stability;

									(5)the evaluation of

				materials testing for durability or reactivity;

									(6)undertaking

				initial toxicology studies;

									(7)planning clinical

				trials; and

									(8)advice regarding

				the investigational new drug or investigational new device filing with the Food

				and Drug Administration.

									(d)Ongoing

				reviewThe RAID shall review, on an ongoing basis, potential

				products and may not support products past the proof-of-principle stage.

								499F–2.Toxicity

				studies

								(a)Ongoing

				researchThe Center shall

				support ongoing research into the most efficient methods of screening for in

				vivo toxicity, including using cell-based and animal model technologies.

								(b)Offer of

				studiesThe Director of Cures

				shall direct the Office of Technology Transfer of the Center to offer toxicity

				studies as an available feature to precede completion of licensing agreement

				contracts because toxicity studies are expensive and rate-limiting barriers to

				the licensing of intellectual property from the National Institutes of

				Health.

								499F–3.Additional

				funding sources and modelsThe

				Director of Cures may provide acceleration funds, described in section

				499B(b)(2)(B)(i), for innovative custom contracts for translational research

				development to entities that license intellectual property from the National

				Institutes of Health where such contracts support innovation and new models of

				cooperation and commercialization.

							499F–4.Authorization

				of appropriationsThere are

				authorized to be appropriated from the acceleration fund of the Director of

				Cures described in section 499B(b)(2)(B)(i)—

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

				fiscal year 2007 and each succeeding fiscal year; and

								(2)$100,000,000 to

				carry out section 499F–1 for fiscal year 2007 and each succeeding fiscal

				year.

								5Office of

				Technology Transfer

							499G.Restructuring

								(a)EstablishmentThere

				is established within the Center an Office of Technology Transfer (referred to

				in this subpart as the OTT).

								(b)TransfersThe

				OTT shall include the functions (and related personnel and resources) of the

				Office of Technology Transfer in the Office of the Director of the National

				Institutes of Health.

								499G–1.Marketing

				function

								(a)In

				generalThe OTT shall establish a program that—

									(1)cultivates

				industry interest in funded research of the National Institutes of

				Health;

									(2)reaches out to

				potential industry partners;

									(3)coordinates

				patents from the other institutes and centers of the National Institutes of

				Health; and

									(4)manages

				Cooperative Research and Development Agreements, biological licensing

				agreements, material transfer agreements, and intellectual property

				licensing.

									(b)PromotionThe

				program under subsection (a) shall assist in promoting the success of

				government and industry partnerships for the development of new technologies by

				soliciting involvement of the private sector from the beginning of the

				translational research process, including by creating an electronic database

				within the National Library of Medicine, which shall be updated regularly, that

				tabulates translational research efforts occurring at the National Institutes

				of Health. The OTT shall hold an annual national translational research

				conference that brings together researchers and industry representatives from

				across fields from both the private and public sectors.

								(c)Transfer

				management and supportThe OTT shall develop a program for

				transfer management and support that is familiar with the National Institutes

				of Health's intramural and extramural research portfolio, which program's

				mission is to reach out to potential industry partners to cultivate interest in

				collaboration with public researchers with the goal of product development and

				procurement. For those Institutes or Centers with their own Office of

				Technology Transfer Offices, the OTT shall work closely with those offices to

				coordinate industry outreach efforts. Those offices, on a biannual basis, shall

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

				translational research efforts of the Center or Institute and corresponding

				efforts to attract commercial interest in their research portfolio.

								(d)Management

									(1)In

				generalThe OTT shall manage the Cooperative Research and

				Development Agreements between industry and public research partners.

									(2)RegistrationThe

				OTT shall—

										(A)as appropriate,

				register the agreements within a publicly accessible electronic database

				maintained by the National Library of Medicine of the National Institutes of

				Health; and

										(B)oversee the

				collaborative process in terms of pre-determined outputs, negotiating problems

				that may occur between collaborating entities, and assuring intellectual

				property protections necessary for successful product development.

										499G–2.Office of

				Intramural Risk Opportunity and Mapping

								(a)EstablishmentThere

				is established in the Office of Technology Transfer of the Center, an Office of

				Intramural Risk Opportunity and Mapping that shall oversee the intramural

				research programs of the National Institutes of Health to be certain they are

				complementary and distinct from extramural and private programs.

								(b)Reviews and

				reportsThe Office of Intramural Risk Opportunity and Mapping

				shall—

									(1)conduct regular

				reviews of the intramural research programs of the National Institutes of

				Health; and

									(2)report every 2

				years on such reviews.

									(c)Health risks

				and opportunitiesThe Office of Intramural Risk Opportunity and

				Mapping shall—

									(1)identify and map

				public health risks and scientific opportunities and keep data on such topics

				current and updated; and

									(2)provide the

				information described in paragraph (1) to the Council on a biannual basis to

				help the Council prioritize the Nation’s translation research

				investment.

									(d)Trans-NIH

				collaborative research

									(1)In

				generalThe Office of Intramural Risk Opportunity and Mapping

				shall make, in coordination with the Director of Cures and the Director of NIH,

				funds available to groups of institutes and centers of the National Institutes

				of Health to promote engagement in multi-institute projects that focus on

				translational research endeavors.

									(2)FundingFunding

				levels and periods of funding under paragraph (1) shall be flexible as

				necessary to achieve trans-institute project objectives. Preference for funding

				shall be given to projects that promote high levels of cross-disciplinary

				collaboration, that address diseases with the greatest burden or research

				promise, and that are most likely to result in the development of a diagnostic

				or therapeutic prototype.

									(3)Authorization

				of appropriationsThere is authorized to be appropriated, from

				the acceleration fund of the Director of Cures described in section

				499B(b)(2)(B)(i), to carry out this subsection $150,000,000.

									499G–3.Patenting

				and licensing incentives

								(a)In

				generalThe OTT shall make every effort to increase licensing

				throughput in order to stimulate the availability of useful products for

				patients.

								(b)IncentivesThe

				OTT shall develop incentives that create private sector, financial, commercial,

				and academic interest in the National Institutes of Health's intellectual

				property portfolio, which incentives may include the following:

									(1)The patent

				extension of National Institutes of Health's health patents, in which there is

				an extension of the time during which the licensee has exclusive right to the

				intellectual property.

									(2)The patent

				restoration of National Institutes of Health's health patents, in which there

				is restoration of the full patent life, or another agreed upon term, of a

				technology to the licensee from the time of Food and Drug Administration

				passage or other agreed upon milestone.

									(3)Partnering

				options, which are options to pursue exclusive and nonexclusive licensing to 1

				or more partners in the government, industrial, or academic sectors.

									(c)Customized

				modelsThe Director of Cures shall encourage the OTT to cultivate

				customized models for contracts that fulfill the needs of industry and the

				public.

								499G–4.Translational

				researcher development

								(a)In

				generalThe Director of Cures shall oversee the development of a

				curriculum for internships in interdisciplinary research that will encompass

				rotations through multiple institutes and centers of the National Institutes of

				Health (including the National Library of Medicine), the clinical trial design

				process, and other related disciplines with an emphasis on practical

				experience.

								(b)Tuition

				grantsThe Director of Cures shall award tuition grants for

				extramural interdisciplinary research programs.

								(c)TrainingThe

				Center shall train interdisciplinary scientists in the science and art of risk

				analysis and mapping through a program of internships and fellowships.

								499G–5.Translational

				research training programThe

				Director of NIH shall ensure that each institute and center of the National

				Institutes of Health has established, or contracted for the establishment of, a

				translational research training program at the institute or center.

							6Developing

				Information Systems

							499H.Advancing

				national health information infrastructure

								(a)Genomic

				data

									(1)In

				generalThe National Center for Biotechnology Information of the

				National Library of Medicine of the National Institutes of Health shall develop

				new computational methods to aid in the processing of genomic data by novice

				and experienced researchers.

									(2)Authorization

				of appropriationsThere is authorized to be appropriated, from

				the acceleration fund of the Director of Cures described in section

				499B(b)(2)(B)(i), to carry out paragraph (1) $8,000,000, of which—

										(A)$2,500,000 is

				authorized to be appropriated to support the program's computational

				infrastructure; and

										(B)$5,500,000 is

				authorized to be appropriated for hiring biologists and computer scientists who

				are trained in bioinformatics.

										(b)DatabaseThe

				Secretary, acting through the Director of NIH, shall undertake, in

				collaboration with the National Library of Medicine of the National Institutes

				of Health, construction of a clinical study registry and results database that

				may expand upon the National Library of Medicine's information system and

				database.

								(c)Clinical trial

				information

									(1)In

				general

										(A)In

				generalThe clinical study registry and results database,

				described in subsection (b), shall consist of a registry of phase III clinical

				trials taking place in the United States and a database of their

				results.

										(B)Clinical study

				registryParticipation in the clinical study registry shall be

				mandatory for both public and private entities.

										(C)Results

				databaseParticipation in the clinical trial results database

				shall be mandatory for both public and private entities. The clinical trial

				results database shall include even negative studies, which demonstrate no

				therapeutic effect.

										(2)Registry of

				clinical trialsThe registry of clinical trials shall include not

				less than the following:

										(A)The clinical

				trial title.

										(B)A description of

				the product under study.

										(C)The hypothesis to

				be tested.

										(D)The

				intervention.

										(E)The study design,

				methodology, duration, and location.

										(F)Participation

				criteria.

										(G)Contact

				information.

										(H)Sponsoring

				organization.

										(3)Clinical trial

				resultsThe database of clinical trial results shall consist of

				not less than the following:

										(A)The trial start

				date and completion date.

										(B)A summary of the

				results of the trial in a standard, non-promotional summary format.

										(C)Summary data

				tables with respect to the primary and secondary outcome measures.

										(D)Information on

				the statistical significance of the results and publications in peer reviewed

				journals relating to the trial, with, when available, an electronic link to the

				journal article.

										(E)A description of

				the process used to review the results of the trial, including a statement

				about whether the results have been peer reviewed by reviewers independent of

				the trial sponsor.

										(F)Safety data

				concerning the trial, including a summary of all adverse events specifying the

				number and type of events.

										(G)Reference

				information to the clinical trial in the clinical registry.

										(d)Registration of

				trials and reporting of results

									(1)Website

				publicationEach principal investigator of a public clinical

				trial or responsible person for a private clinical trial shall register phase

				III clinical trials in accordance with paragraph (2) and report phase III

				clinical trial results in accordance with paragraph (2) with the National

				Library of Medicine of the National Institutes of Health. The National Library

				of Medicine shall make the information available for viewing on the Library's

				Website, www.clinicaltrials.gov. The National Library of Medicine shall

				electronically link each registered clinical trial with its database of results

				and link each database of results with its registered clinical trial.

									(2)Timeline of

				registration

										(A)In

				generalAn entity described in paragraph (1) shall register a

				clinical trial not later than 3 months after the Food and Drug Administration

				has approved the entity’s clinical trial protocol and report clinical trial

				results not later than 3 months after completing the clinical trial, which

				shall be defined as the point where the specified trial duration has been

				surpassed and the analysis of the data is complete or the trial is stopped

				because of vital positive or negative findings, or as the point determined by

				the judgment of the Secretary. All information submitted to the National

				Library of Medicine shall be accurate and updated.

										(B)Loss of

				fundingIn the case in which an entity described in paragraph (1)

				does not register a clinical trial or report on clinical trial results in

				accordance with subparagraph (A), the Secretary may—

											(i)not award a

				grant, contract, cooperative agreements, or any other award to the principal

				investigators of such entity until the principal investigators comply with the

				requirements under subparagraph (A); and

											(ii)in the case of

				an entity that does not receive Federal funding for the clinical trial, fine

				the entity $10,000 a day for a sum not to exceed $2,000,000 until the

				responsible person for the clinical trial complies with the requirements under

				subparagraph (A).

											(C)WaiverThe

				Secretary may waive the requirements of subparagraph (A) upon a written request

				from the responsible person if the Secretary determines that extraordinary

				circumstances justify the waiver and that providing the waiver is in the

				public’s interest or consistent with the protection of public health.

										499H–1.Public

				access requirement for research

								(a)In

				generalThe Secretary shall require all funded investigators,

				whether direct employees of the Department of Health and Human Services or

				recipients of grants, contracts, or other support of the National Institutes of

				Health, the Centers for Disease Control and Prevention, or the Agency for

				Healthcare Research and Quality, to submit to the National Library of Medicine

				of the National Institutes of Health (referred to in this section as the

				National Library of Medicine), upon acceptance for publication

				in a journal or other publication included in the PubMed directory, final

				manuscripts resulting from research in which direct costs are supported in

				whole or in part by the National Institutes of Health, the Centers for Disease

				Control and Prevention, or the Agency for Healthcare Research and

				Quality.

								(b)Public

				availability

									(1)In

				generalThe National Library of Medicine shall include all such

				manuscripts described in subsection (a), after peer review, for display in the

				National Library of Medicine's digital library archive, PubMed Central. The

				copyright holder of a manuscript described in subsection (a) may request the

				author's manuscript be replaced with final published text.

									(2)TimelineA

				manuscript described in subsection (a) shall become publicly available on the

				Internet through PubMed Central not later than 6 months after the date of

				publication of the manuscript.

									(3)Loss of funding

				for failure to submit on timeFailure to submit required

				information under this section to the National Library of Medicine within 6

				months of the date of publication of the manuscript involved shall be

				considered by the Secretary in the context of grant compliance review and may

				result in the loss of public funding for the investigators involved as

				determined appropriate by the agency involved.

									499H–2.Informatics

				training and workforce development

								(a)In

				generalThe Director of NIH shall develop a multi-faceted

				approach to increasing the number of persons trained in clinical bioinformatics

				by implementing appropriate programs, including the programs described in

				subsection (b).

								(b)ProgramsThe

				programs under this subsection are the following:

									(1)K–12 science

				programThe National Library of Medicine of the National

				Institutes of Health shall develop with the National Science Foundation a

				kindergarten through grade 12 clinical informatics education curriculum that

				shall include an assessment component. The National Library of Medicine shall

				award not more than 500 schools each $30,000 to implement the

				curriculum.

									(2)Undergraduate

				degree programs in bioinformaticsThe National Library of

				Medicine of the National Institutes of Health shall—

										(A)award grants to

				academic health centers and graduate training programs to collaborate with an

				undergraduate institution of higher education’s department of biology,

				chemistry, or computer science to develop curricula leading to a bachelor’s

				degree in bioinformatics; and

										(B)encourage

				grantees to form an inter-institutional consortium.

										(3)Increasing the

				number of NIH bioinformatics graduate training programsThe

				National Library of Medicine of the National Institutes of Health shall

				increase the number of bioinformatics graduate training programs through

				funding existing graduate training programs of the National Institutes of

				Health to meet the expanding needs for training and outreach to the biomedical

				community. The programs shall focus on the skills needed to apply

				bioinformatics methods specifically to problems of human health and disease.

				The Director of NIH shall hire 12 individuals with a doctorate in molecular

				biology and expertise in training and developing educational programs to assist

				in carrying out the programs under this paragraph.

									(4)Centers of

				excellence in clinical bioinformaticsThe National Library of

				Medicine of the National Institutes of Health, through the Center, shall

				establish Centers of Excellence in Clinical Bioinformatics that shall have

				state-of-the-art computational methods and tools applicable to human disease

				prevention, diagnosis, and treatment. The Centers of Excellence in Clinical

				Bioinformatics shall provide graduate student and postdoctoral support, through

				distinguished faculty, in order to contribute to the highest level of training

				in the bioinformatics workforce pipeline.

									(c)Authorization

				of appropriationsThere is authorized to be appropriated, from

				the acceleration fund of the Director of Cures described in section

				499B(b)(2)(B)(i), to carry out this section $50,000,000 for fiscal year 2007

				and each succeeding fiscal year of which—

									(1)$15,000,000 is

				authorized to be appropriated for fiscal year 2007 and each succeeding fiscal

				year to carry out subsection (b)(1); and

									(2)$2,000,000 is

				authorized to be appropriated to carry out subsection (b)(3).

									499H–3.National

				Library of Medicine expansion of facilities

								(a)Sense of

				congressIt is the sense of Congress that Congress should make

				special effort to fund the expansion of facilities of the National Library of

				Medicine of the National Institutes of Health. These facilities are essential

				to the National Library of Medicine being able to fulfill its many informatics

				functions, which include providing essential informational resources to

				scientists worldwide and advancing the underpinning of much of the National

				Institutes of Health conducted biomedical research.

								(b)ReportThe

				Director shall request that the Institute of Medicine of the National Academies

				report to Congress on the impact of not providing funding for the expansion of

				facilities described in subsection (a).

								7Research

				Tools

							499I.NIH research

				tool inventory

								(a)Annual

				reviewThe Director of NIH shall direct the head of each

				institute and center of the National Institutes of Health to perform an annual

				review of the institute or center's research tool inventory for the specific

				purpose of enabling each institute or center to understand the research tool

				distribution, frequency of use, intellectual property status, and utility. Each

				institute and center of the National Institutes of Health shall describe in the

				institute or center's annual review the type and quantity of research tools the

				institute or center desires to obtain to better fulfill the institute or

				center's research and development goals.

								(b)DatabaseThe

				Director of Cures shall—

									(1)enter the

				information obtained from the annual review under subsection (a) into an

				electronic research tool database; and

									(2)use such database

				to oversee the prioritization and funding of new projects to fulfill pressing

				needs and promising technologies.

									499I–1.Exceptions

				to tool guidelinesThe

				Director of Cures may advise the Office of Technology Transfer of the Center to

				provide exceptions to prohibitions against patenting and licensing research

				tools under some circumstances of customized contracts when exclusive or

				non-exclusive licensing provides the swiftest and most efficacious final

				development of an important health care

				technology.

							.

			(b)Conforming

			 amendmentSection 401(b)(1) of the Public Health Service Act (42

			 U.S.C. 281(b)(1)) is amended by adding at the end the following:

					(S)The American

				Center for

				Cures.

					.


116 S2502 RS: American Security Drone Act of 2019
U.S. Senate
2019-09-18
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

IICalendar No. 547116th CONGRESS2d SessionS. 2502[Report No. 116–268]IN THE SENATE OF THE UNITED STATESSeptember 18, 2019Mr. Scott of Florida (for himself, Mr. Cotton, Mr. Hawley, Mr. Rubio, Mr. Murphy, Mr. Blumenthal, and Mrs. Blackburn) introduced the following bill; which was read twice and referred to the Committee on Homeland Security and Governmental AffairsSeptember 15, 2020Reported by Mr. Johnson, with an amendmentStrike out all after the enacting clause and insert the part printed in italicA BILLTo ban the Federal procurement of certain drones and other unmanned aircraft systems, and for other
 purposes.1.Short titleThis Act may be cited as the American Security Drone Act of 2019.2.DefinitionsIn this Act:(1)Covered foreign entitythe term covered foreign entity means—(A)a covered entity (as determined by the Secretary of Commerce);(B)any entity that is subject to extrajudicial direction from a foreign government, as determined by the Director of National Intelligence;(C)any entity the Secretary of Homeland Security, in coordination with the Director of National Intelligence, the Secretary of Defense, and the Secretary of State, determines poses a national security risk;(D)any entity subject to influence or control by the Government of the People Republic of China or the Communist Party of the People’s Republic of China, as determined by the Secretary of Homeland Security; and(E)any subsidiary or affiliate of an entity described in subparagraphs (A) through (D).(2)Covered unmanned aircraftThe term covered unmanned aircraft means an unmanned aircraft system and any related services and equipment.3.Ban on procurement of foreign off-the-shelf drones and unmanned aircraft systems(a)In generalExcept as provided under subsections (b) and (c), the head of an executive agency may not procure any commercial off-the-shelf drone or covered unmanned aircraft system manufactured or assembled by a covered foreign entity, including any Original Equipment Manufacturer flight controllers, radios, data transmission devices, cameras, or gimbals manufactured in a covered foreign country or by an entity domiciled in a covered foreign country.(b)ExemptionThe Secretary of Homeland Security and the Secretary of Defense are exempt from the restriction under subsection (a) if the operation or procurement—(1)is for the purposes of training, testing, or analysis for—(A)Counter-UAS surrogate intelligence;(B)electronic warfare; or(C)information warfare operations; and(2)is required in the national interest of the United States.(c)WaiverThe head of an executive agency may waive the prohibition under subsection (a) on a case-by-case basis with the approval of the Secretary of Homeland Security or the Secretary of Defense and notification to Congress.4.Prohibition on operation of foreign commercial off-the-shelf drones and small unmanned aircraft
 systems(a)Prohibition(1)In generalBeginning not later than 180 days after the date of the enactment of this Act, no Federal department or agency may operate a commercial off-the-shelf drone or covered unmanned aircraft system manufactured or assembled by a covered foreign entity.(2)Phase-in period for existing contractsThe prohibition under paragraph (1) shall not apply, during the 1-year period beginning on the date of the enactment of this Act, to commercial off-the-shelf drones and covered unmanned aircraft systems procured through a contract entered into before the date of the enactment of this Act.(b)ExemptionThe Secretary of Homeland Security and the Secretary of Defense are exempt from the restriction under subsection (a) if the operation or procurement—(1)is for the purposes of training, testing, or analysis for—(A)Counter-UAS surrogate intelligence;(B)electronic warfare; or(C)information warfare operations; and(2)is required in the national interest of the United States.(c)WaiverThe head of an executive agency may waive the prohibition under subsection (a) on a case-by-case basis with the approval of the Secretary of Homeland Security or the Secretary of Defense and notification to Congress.(d)RegulationsNot later than 180 days after the date of the enactment of this Act, the Secretary of Homeland Security shall prescribe regulations to implement this section.5.Prohibition on use of Federal funds for purchases and operation of commercial off-the-shelf drones
			 and unmanned
 aircraft systems from ChinaNo Federal funds awarded through a contract, grant, or cooperative agreement or otherwise made available may be used to purchase a commercial off-the-shelf drone or covered unmanned aircraft system, or a system to counter unmanned aircraft systems, that is manufactured or assembled by a covered foreign entity or in connection with the operation of such a drone or system.6.Comptroller General reportNot later than 90 days after the date of the enactment of this Act, the Comptroller General of the United States shall submit to Congress a report on the amount of commercial off-the-shelf drones and covered unmanned aircraft systems procured by Federal departments and agencies from covered foreign entities.1.Short titleThis Act may be cited as the American Security Drone Act of 2020.2.DefinitionsIn this Act:(1)Covered foreign entityThe term covered foreign entity means—(A)a covered entity designated by the Secretary of Commerce;(B)an entity included on the Consolidated Screening List;(C)any entity that is subject to extrajudicial direction from a foreign government, as determined by the Secretary of Homeland Security; (D)any entity the Secretary of Homeland Security, in coordination with the Director of National Intelligence and the Secretary of Defense, determines poses a national security risk;(E)any entity domiciled in the People's Republic of China or subject to influence or control by the Government of the People Republic of China or the Communist Party of the People’s Republic of China, as determined by the Secretary of Homeland Security; or(F)any subsidiary or affiliate of an entity described in subparagraphs (A) through (D).(2)Covered unmanned aircraft systemThe term covered unmanned aircraft system has the meaning given the term unmanned aircraft system in section 44801 of title 49, United States Code. 3.Prohibition on procurement of covered unmanned aircraft systems from covered foreign entities(a)In generalExcept as provided under subsections (b) and (c), the head of an executive agency may not procure any covered unmanned aircraft system that are manufactured or assembled by a covered foreign entity, which includes associated elements (consisting of communication links and the components that control the unmanned aircraft) that are required for the operator to operate safely and efficiently in the national airspace system.(b)ExemptionThe Secretary of Homeland Security, the Secretary of Defense, and the Attorney General are exempt from the restriction under subsection (a) if the operation or procurement—(1)is for the sole purposes of research, evaluation, training, testing, or analysis for—(A)electronic warfare; (B)information warfare operations; (C)development of UAS or counter-UAS technology; (D)counterterrorism or counterintelligence activities; or(E)Federal criminal investigations, including forensic examinations; and(2)is required in the national interest of the United States.(c)WaiverThe head of an executive agency may waive the prohibition under subsection (a) on a case-by-case basis with the approval of the Secretary of Homeland Security or the Secretary of Defense and notification to Congress.4.Prohibition on operation of covered  unmanned aircraft
 systems from covered foreign entities(a)Prohibition(1)In generalBeginning on the date that is 2 years after the date of the enactment of this Act, no Federal department or agency may operate a covered unmanned aircraft system manufactured or assembled by a covered foreign entity.(2)Applicability to contracted servicesThe prohibition under paragraph (1) applies to any covered unmanned aircraft systems that are being used by any executive agency through the method of contracting for the services of covered unmanned aircraft systems. (b)ExemptionThe Secretary of Homeland Security, the Secretary of Defense, and the Attorney General are exempt from the restriction under subsection (a) if the operation or procurement—(1)is for the sole purposes of research, evaluation, training, testing, or analysis for—(A)electronic warfare; (B)information warfare operations;(C)development of UAS or counter-UAS technology;(D)counterterrorism or counterintelligence activities; or(E)Federal criminal investigations, including forensic examinations; and (2)is required in the national interest of the United States.(c)WaiverThe head of an executive agency may waive the prohibition under subsection (a) on a case-by-case basis with the approval of the Secretary of Homeland Security or the Secretary of Defense and notification to Congress.(d)Regulations and guidanceNot later than 180 days after the date of the enactment of this Act, the Secretary of Homeland Security shall prescribe regulations or guidance to implement this section.5.Prohibition on use of Federal funds for purchases and operation of covered unmanned
 aircraft systems from covered foreign entities(a)In generalBeginning on the date that is 2 years after the date of the enactment of this Act, except as provided in subsection (b), no Federal funds awarded through a contract, grant, or cooperative agreement, or otherwise made available may be used—(1)to purchase a covered unmanned aircraft system, or a system to counter unmanned aircraft systems, that is manufactured or assembled by a covered foreign entity; or(2) in connection with the operation of such a drone or unmanned aircraft system.(b)ExemptionA Federal department or agency is exempt from the restriction under subsection (a) if—(1)the contract, grant or cooperative agreement was awarded prior to the date of the enactment of the bill; or(2) the operation or procurement is for the sole purposes of research, evaluation, training, testing, or analysis, as determined by the Secretary of Homeland Security, the Secretary of Defense, or the Attorney General, for— (A)electronic warfare; (B)information warfare operations;(C)development of UAS or counter-UAS technology;(D)counterterrorism or counterintelligence activities; or(E)Federal criminal investigations, including forensic examinations; and (3)is required in the national interest of the United States.(c)RegulationsNot later than 180 days after the date of the enactment of this Act, the Federal Acquisition Regulatory Council shall prescribe regulations or guidance, as necessary, to implement the requirements of this section pertaining to Federal contracts. 6.Prohibition on use of Government-issued Purchase Cards to purchase covered unmanned aircraft systems from covered foreign entitiesEffective immediately, Government-issued Purchase Cards may not be used to procure any covered unmanned aircraft system from a covered foreign entity.7.Management of existing inventories of covered unmanned aircraft systems from covered foreign entities(a)In general Effective immediately, all executive agencies must account for existing inventories of covered unmanned aircraft systems manufactured or assembled by a covered foreign entity in their personal property accounting systems, regardless of the original procurement cost, or the purpose of procurement due to the special monitoring and accounting measures necessary to track the items' capabilities. (b)Classified trackingDue to the sensitive nature of missions and operations conducted by the United States Government, inventory data related to covered unmanned aircraft systems manufactured or assembled by a covered foreign entity may be tracked at a classified level.(c)ExceptionsThe Department of Defense and Department of Homeland Security may exclude from the full inventory process, covered unmanned aircraft systems that are deemed expendable due to mission risk such as recovery issues or that are one-time-use covered unmanned aircraft due to requirements and low cost.8.Comptroller General reportNot later than 275 days after the date of the enactment of this Act, the Comptroller General of the United States shall submit to Congress a report on the amount of commercial off-the-shelf drones and covered unmanned aircraft systems procured by Federal departments and agencies from covered foreign entities.9.Government-wide policy for procurement of unmanned aircraft systems(a)In generalNot later than 180 days after the date of the enactment of this Act, the Director of the Office of Management and Budget, in coordination with the Department of Homeland Security, Department of Transportation, the Department of Justice, and other Departments as determined by the Director of the Office of Management and Budget, and in consultation with the National Institute of Standards and Technology, shall establish a government-wide policy for the procurement of UAS—(1)for non-Department of Defense and non-intelligence community operations; and(2)through grants and cooperative agreements entered into with non-Federal entities. (b)Information securityThe policy developed under subsection (a) shall include the following specifications, which to the extent practicable, shall be based on industry standards and technical guidance from the National Institute of Standards and Technology, to address the risks associated with processing, storing and transmitting Federal information in a UAS:(1)Protections to ensure controlled access of UAS.(2)Protecting software, firmware, and hardware by ensuring changes to UAS are properly managed, including by ensuring UAS can be updated using a secure, controlled, and configurable mechanism.(3)Cryptographically securing sensitive collected, stored, and transmitted data, including proper handling of privacy data and other controlled unclassified information.(4)Appropriate safeguards necessary to protect sensitive information, including during and after use of UAS.(5)Appropriate data security to ensure that data is not transmitted to or stored in non-approved locations. (6)The ability to opt out of the uploading, downloading, or transmitting of data that is not required by law or regulation and an ability to choose with whom and where information is shared when it is required.(c)RequirementThe policy developed under subsection (a) shall reflect an appropriate risk-based approach to information security related to use of UAS.(d)Revision of acquisition regulationsNot later than 180 days after the date on which the policy required under subsection (a) is issued—(1)the Federal Acquisition Regulatory Council shall revise the Federal Acquisition Regulation, as necessary, to implement the policy; and(2)any Federal department or agency or other Federal entity not subject to, or not subject solely to, the Federal Acquisition Regulation shall revise applicable policy, guidance, or regulations, as necessary, to implement the policy.(e)ExemptionIn developing the policy required under subsection (a), the Director of the Office of Management and Budget shall incorporate an exemption to the policy for the following reasons:(1)In the case of procurement for the purposes of training, testing or analysis for—(A)electronic warfare; or(B)information warfare operations.(2)In the case of researching UAS technology, including testing, evaluation, research, or development of technology to counter UAS.(3)In the case of a head of the procuring department or agency determining, in writing, that no product that complies with the information security requirements described in subsection (b) is capable of fulfilling mission critical performance requirements, and such determination—(A)may not be delegated below the level of the Deputy Secretary of the procuring department or agency;(B)shall specify—(i)the quantity of end items to which the waiver applies, the procurement value of which may not exceed $50,000 per waiver; and(ii)the time period over which the waiver applies, which shall not exceed 3 years;(C)shall be reported to the Office of Management and Budget following issuance of such a determination; and(D)not later than 30 days after the date on which the determination is made, shall be provided to the Committee on Homeland Security and Government Affairs of the Senate and the Committee on Oversight and Reform of the House of Representatives.10.Study(a)Independent studyNot later than 3 years after the date of the enactment of this Act, the Director of the Office of Management and Budget shall seek to enter into a contract with a federally funded research and development center under which the center will conduct a study of—(1)the current and future unmanned aircraft system global and domestic market;(2)the ability of the unmanned aircraft system domestic market to keep pace with technological advancements across the industry;(3)the ability of domestically made unmanned aircraft systems to meet the network security and data protection requirements of the national security enterprise;(4)the extent to which unmanned aircraft system component parts, such as the parts described in section 3(a), are made domestically; and(5)an assessment of the economic impact, including cost, of excluding the use of foreign-made UAS for use across the Federal Government.(b)Submission to OMBUpon completion of the study in subsection (a), the federally funded research and development center shall submit the study to the Director of the Office of Management and Budget.(c)Submission to CongressNot later than 30 days after the date on which the Director of the Office of Management and Budget receives the study under subsection (b), the Director shall submit the study to—(1)the Committee on Homeland Security and Governmental Affairs of the Senate; and(2)the Committee on Homeland Security and the Committee on Oversight and Government Reform of the House of Representatives.11.SunsetSections 3, 4, and 5 shall cease to have effect on the date that is 5 years after the date of the enactment of this Act. September 15, 2020Reported with an amendment


113 HR 5044 IH: End Modern-Day Slavery Act
U.S. House of Representatives
2014-07-09
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

		I
		113th CONGRESS
		2d Session
		H. R. 5044
		IN THE HOUSE OF REPRESENTATIVES

			July 9, 2014
			Mr. Peters of California introduced the following bill; which was referred to the Committee on Foreign Affairs, and in addition to the Committee on the Judiciary, for a period to be subsequently determined by the Speaker, in each case for consideration of such
			 provisions as fall within the jurisdiction of the committee concerned

		A BILL
		To amend the Trafficking Victims Protection Act of 2000 to direct the Interagency Task Force to
			 Monitor and Combat Trafficking to develop a comprehensive action plan to
			 combat human trafficking.

		1.Short titleThis Act may be cited as the End Modern-Day Slavery Act.
		2.Comprehensive action plan to combat human traffickingSection 105(d) of the Trafficking Victims Protection Act of 2000 (22 U.S.C. 7103(d)) is amended—
			(1)by redesignating paragraph (7) as paragraph (8); and
			(2)by inserting after paragraph (6) the following:

					(7)Not later than two years after the date of the enactment of the National Action Plan to Combat
			 Human Trafficking and Modern-Day Slavery Act of 2014, develop a
			 comprehensive plan to combat trafficking in persons, which shall include
			 recommendations for coordination among relevant Federal agencies in order
			 to—
						(A)assist victims of trafficking;
						(B)investigate and prosecute crimes related to trafficking in persons;
						(C)conduct research and collect data related to trafficking in persons;
						(D)train officers and employees of such agencies regarding trafficking in persons;
						(E)engage with nongovernmental entities, which may assist in combating trafficking in persons; and
						(F)implement Federal laws and regulations related to trafficking in persons..


116 SCON 20 IS: Expressing the sense of Congress that the President should posthumously award the Presidential Medal of Freedom to Harry W. Colmery.
U.S. Senate
2019-06-20
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

III116th CONGRESS1st SessionS. CON. RES. 20IN THE SENATE OF THE UNITED STATESJune 20, 2019Mr. Moran (for himself and Mr. Roberts) submitted the following concurrent resolution; which was referred to the Committee on the JudiciaryCONCURRENT RESOLUTIONExpressing the sense of Congress that the President should posthumously award the Presidential
 Medal of Freedom to Harry W. Colmery. Whereas the life of Harry W. Colmery of Topeka, Kansas, was marked by service to the United States and its citizens;Whereas in 1916, Harry Colmery earned a degree in law from the University of Pittsburgh and successfully argued 2 significant cases before the Supreme Court of the United States;Whereas during World War I, Harry Colmery joined the Army Air Service, serving as a first lieutenant during the early stages of military aviation;Whereas after World War I, Harry Colmery actively contributed to the growth of the newly formed American Legion and went on to hold several offices in the Legion and was elected National Commander in 1936;Whereas in 1943, the United States faced the return from World War II of what was to become an active duty force of 15,000,000 soldiers, sailors, airmen, and Marines;Whereas Harry Colmery spearheaded the efforts of the American Legion to develop legislation to ensure that these individuals, who had fought for the democratic ideals of the United States and to preserve freedom, could fully participate in all of the opportunities the United States provided;Whereas in December 1943, during an emergency meeting of the American Legion leadership, Harry Colmery initially drafted the legislation that became the Servicemen's Readjustment Act of 1944, also known as the GI Bill of Rights;Whereas the GI Bill of Rights is credited by veterans' service organizations, economists, and historians as the engine that transformed the postwar United States into a more egalitarian, prosperous, and enlightened Nation poised to lead the world into the 21st century;Whereas since its enactment, the GI Bill of Rights has provided education or training for approximately 7,800,000 individuals, including 2,200,000 in college, 3,400,000 in other schools, 1,400,000 in vocational education, and 690,000 in farm training;Whereas 2,100,000 World War II veterans purchased homes through the GI Bill;Whereas the initial GI Bill has provided education and training to over 800,000 professionals that serve the Nation in specific career fields, including 450,000 engineers, 238,000 teachers, 91,000 scientists, 67,000 doctors, and 22,000 dentists;Whereas in 1945, President Truman established the Presidential Medal of Freedom to recognize notable service during the war, and in 1963, President Kennedy reinstated the medal to honor the achievement of civilians during peacetime;Whereas pursuant to Executive Order 11085 (27 Fed. Reg. 1759), the President may award the Medal of Freedom to any person who has made an especially meritorious contribution to—(1)the security or national interest of the United States;(2)world peace; or(3)other significant public or private endeavors; andWhereas Harry Colmery, noted for his service in the military, in the legal sector, and on behalf of the veterans of the Nation, meets the criteria established for the Presidential Medal of Freedom: Now, therefore, be itThat it is the sense of Congress that the President should posthumously award the Presidential Medal of Freedom to Harry W. Colmery of Topeka, Kansas.


113 HR 3444 IH: Critical Access Hospital Flexibility Act of 2013
U.S. House of Representatives
2013-10-30
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I113th CONGRESS1st SessionH. R. 3444IN THE HOUSE OF REPRESENTATIVESOctober 30, 2013Mr. Walden (for himself and Mr. Kind) introduced the following bill; which was referred to the Committee on Ways and MeansA BILLTo amend title XVIII of the Social Security Act to provide flexibility in the manner in which beds are counted for purposes of determining whether a hospital may be designated as a critical access hospital under the Medicare program.1.Short titleThis Act may be cited as the Critical Access Hospital Flexibility Act of 2013.2.Flexibility in the manner in which beds are counted for purposes of determining whether a hospital may be designated as a critical access hospital under the Medicare program(a)In generalSection 1820(c)(2) of the Social Security Act (42 U.S.C. 1395i–4(c)(2)) is amended—(1)in subparagraph (B)(iii), by inserting subject to subparagraph (F), before provides not more; and(2)by adding at the end the following:(F)Alternative bed number determination(i)20-bed alternativeIn the case of a facility that was designated as a critical access hospital before the date of the enactment of the Critical Access Hospital Flexibility Act of 2013, such facility may satisfy the requirement under subparagraph (B)(iii) by providing inpatient care for a period that does not exceed, as determined on an annual, average basis, 96 hours per patient and by—(I)providing not more than 25 acute care inpatient beds (meeting the standards established by the Secretary under such subparagraph); or(II)providing not more than 20 acute care inpatient beds (as determined on an annual, average basis and meeting any applicable standards established by the Secretary under such subparagraph which do not conflict with this subclause).(ii)Occupied beds onlyIn determining the number of beds for purposes of clause (i) and subparagraph (B)(iii), only beds that are occupied shall be counted..(b)Effective dateThe amendments made by this section take effect on January 1, 2014.


114 SRES 217 ATS: Designating October 8, 2015, as ‘‘National Hydrogen and Fuel Cell Day’’.
U.S. Senate
2015-07-08
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

		III
		114th CONGRESS
		1st Session
		S. RES. 217
		IN THE SENATE OF THE UNITED STATES

			July 8, 2015
			Mr. Blumenthal (for himself, Mr. Graham, Mr. Coons, Ms. Hirono, Mr. Murphy, and Mr. Heinrich) submitted the following resolution; which was referred to the Committee on the Judiciary

		September 29, 2015Committee discharged; considered and agreed toRESOLUTION
		Designating October 8, 2015, as ‘‘National Hydrogen and Fuel Cell Day’’.

 Whereas hydrogen, which has an atomic mass of 1.008, is the most abundant chemical substance in the universe;
 Whereas the United States is a world leader in the development and deployment of fuel cell and hydrogen technologies;
 Whereas hydrogen fuel cells played an instrumental role in the United States space program, helping the United States achieve the mission of landing a man on the moon;
 Whereas private industry, Federal and State governments, national laboratories, and universities continue to improve fuel cell and hydrogen technologies to address our most pressing energy, environmental, and economic issues;
 Whereas fuel cells utilizing hydrogen and hydrogen-rich fuels to generate electricity are clean, efficient, resilient technologies being sold for stationary and backup power, zero-emission light duty motor vehicles and buses, industrial vehicles, and portable power;
 Whereas stationary fuel cells are being placed in service for continuous and backup power to provide business and energy consumers with reliable power in the event of grid outages;
 Whereas stationary fuel cells can help reduce water use compared to traditional power generation technologies;
 Whereas fuel cell electric light duty motor vehicles and buses that utilize hydrogen can completely replicate the experience of internal combustion vehicles including comparable range and refueling times;
 Whereas hydrogen fuel cell industrial vehicles are being deployed at logistical hubs and warehouses across the country and are also being exported to facilities in Europe and Asia;
 Whereas hydrogen is a non-toxic gas that can be derived from a variety of domestically available traditional and renewable resources, including solar, wind, biogas and the abundant supply of natural gas in the United States;
 Whereas hydrogen and fuel cells can store energy to help enhance the grid and maximize opportunities to deploy renewable energy;
 Whereas the United States currently produces and uses more than 11,000,000 metric tons of hydrogen per year; and
 Whereas engineers and safety code and standard professionals have developed consensus-based protocols for safe delivery, handling, and use of hydrogen: Now, therefore, be it

 That the Senate designates October 8, 2015, as National Hydrogen and Fuel Cell Day.