§ 638.
(e)
Definitions
For the purpose of this section—
(1)
the term “extramural budget” means the sum of the total obligations minus amounts obligated for such activities by employees of the agency in or through Government-owned, Government-operated facilities, except that for the Department of Energy it shall not include amounts obligated for atomic energy defense programs solely for weapons activities or for naval reactor programs, and except that for the Agency for International Development it shall not include amounts obligated solely for general institutional support of international research centers or for grants to foreign countries;
(2)
the term “Federal agency” means an executive agency as defined in
section 105 of title 5 or a military department as defined in section 102 of such title, except that it does not include any agency within the Intelligence Community (as the term is defined in section 3.4(f) of Executive Order 12333 or its successor orders);
(3)
the term “funding agreement” means any contract, grant, or cooperative agreement entered into between any Federal agency and any small business for the performance of experimental, developmental, or research work funded in whole or in part by the Federal Government;
(4)
the term “Small Business Innovation Research Program” or “SBIR” means a program under which a portion of a Federal agency’s research or research and development effort is reserved for award to small business concerns through a uniform process having—
(A)
a first phase for determining, insofar as possible, the scientific and technical merit and feasibility of ideas that appear to have commercial potential, as described in subparagraph (B), submitted pursuant to SBIR program solicitations;
(B)
a second phase, which shall not include any invitation, pre-screening, or pre-selection process for eligibility for Phase II, that will further develop proposals which meet particular program needs, in which awards shall be made based on the scientific and technical merit and feasibility of the proposals, as evidenced by the first phase, considering, among other things, the proposal’s commercial potential, as evidenced by—
(i)
the small business concern’s record of successfully commercializing SBIR or other research;
(ii)
the existence of second phase funding commitments from private sector or non-SBIR funding sources;
(iii)
the existence of third phase, follow-on commitments for the subject of the research; and
(iv)
the presence of other indicators of the commercial potential of the idea; and
(C)
where appropriate, a third phase for work that derives from, extends, or completes efforts made under prior funding agreements under the SBIR program—
(i)
in which commercial applications of SBIR-funded research or research and development are funded by non-Federal sources of capital or, for products or services intended for use by the Federal Government, by follow-on non-SBIR Federal funding awards; or
(ii)
for which awards from non-SBIR Federal funding sources are used for the continuation of research or research and development that has been competitively selected using peer review or merit-based selection procedures;
(5)
the term “research” or “research and development” means any activity which is (A) a systematic, intensive study directed toward greater knowledge or understanding of the subject studied; (B) a systematic study directed specifically toward applying new knowledge to meet a recognized need; or (C) a systematic application of knowledge toward the production of useful materials, devices, and systems or methods, including design, development, and improvement of prototypes and new processes to meet specific requirements;
(6)
the term “Small Business Technology Transfer Program” or “STTR” means a program under which a portion of a Federal agency’s extramural research or research and development effort is reserved for award to small business concerns for cooperative research and development through a uniform process having—
(A)
a first phase, to determine, to the extent possible, the scientific, technical, and commercial merit and feasibility of ideas submitted pursuant to STTR program solicitations;
(B)
a second phase, which shall not include any invitation, pre-screening, or pre-selection process for eligibility for Phase II, that will further develop proposals that meet particular program needs, in which awards shall be made based on the scientific, technical, and commercial merit and feasibility of the idea, as evidenced by the first phase and by other relevant information; and
(C)
where appropriate, a third phase for work that derives from, extends, or completes efforts made under prior funding agreements under the STTR program—
(i)
in which commercial applications of STTR-funded research or research and development are funded by non-Federal sources of capital or, for products or services intended for use by the Federal Government, by follow-on non-STTR Federal funding awards; and
(ii)
for which awards from non-STTR Federal funding sources are used for the continuation of research or research and development that has been competitively selected using peer review or scientific review criteria;
(7)
the term “cooperative research and development” means research or research and development conducted jointly by a small business concern and a research institution in which not less than 40 percent of the work is performed by the small business concern, and not less than 30 percent of the work is performed by the research institution;
(8)
the term “research institution” means a nonprofit institution, as defined in section 3703(5)
1
See References in Text note below.
of this title, and includes federally funded research and development centers, as identified by the National Scientific Foundation in accordance with the governmentwide Federal Acquisition Regulation issued in accordance with
section 1303(a)(1) of title 41 (or any successor regulation thereto);
(9)
the term “commercial applications” shall not be construed to exclude testing and evaluation of products, services, or technologies for use in technical or weapons systems, and further, awards for testing and evaluation of products, services, or technologies for use in technical or weapons systems may be made in either Phase II or Phase III of the Small Business Innovation Research Program and of the Small Business Technology Transfer Program, as defined in this subsection;
(10)
the term “commercialization” means—
(A)
the process of developing products, processes, technologies, or services; and
(B)
the production and delivery (whether by the originating party or by others) of products, processes, technologies, or services for sale to or use by the Federal Government or commercial markets;
(11)
the term “Phase I” means—
(A)
with respect to the SBIR program, the first phase described in paragraph (4)(A); and
(B)
with respect to the STTR program, the first phase described in paragraph (6)(A);
(12)
the term “Phase II” means—
(A)
with respect to the SBIR program, the second phase described in paragraph (4)(B); and
(B)
with respect to the STTR program, the second phase described in paragraph (6)(B);
(13)
the term “Phase III” means—
(A)
with respect to the SBIR program, the third phase described in paragraph (4)(C); and
(B)
with respect to the STTR program, the third phase described in paragraph (6)(C);
(14)
the term “senior procurement executive” means an official designated under
section 1702(c) of title 41 as the senior procurement executive of a Federal agency participating in a SBIR or STTR program;
(15)
the term “covered individual” means an individual who—
(A)
contributes in a substantive, meaningful way to the scientific development or execution of a research and development project proposed to be carried out with a research and development award from a Federal research agency; and
(B)
is designated as a covered individual by the Federal research agency concerned;
(16)
the term “foreign affiliation” means a funded or unfunded academic, professional, or institutional appointment or position with a foreign government or government-owned entity, whether full-time, part-time, or voluntary (including adjunct, visiting, or honorary);
(17)
the term “foreign country of concern” means the People’s Republic of China, the Democratic People’s Republic of Korea, the Russian Federation, the Islamic Republic of Iran, or any other country determined to be a country of concern by the Secretary of State;
(19)
the term “federally funded award” means a Phase I, Phase II (including a Phase II award under subsection (cc)), or Phase III SBIR or STTR award made using a funding agreement; and
(20)
the term “agency acquisition workforce” means the employees of a Federal agency that have procurement or acquisition responsibilities, including—
(o)
Federal agency STTR authority
Each Federal agency required to establish an STTR program in accordance with subsection (n) and regulations issued under this chapter, shall—
(1)
unilaterally determine categories of projects to be included in its STTR program;
(2)
issue STTR solicitations in accordance with a schedule determined cooperatively with the Administration;
(3)
unilaterally determine research topics within the agency’s STTR solicitations, giving special consideration to broad research topics and to topics that further 1 or more critical technologies, as identified—
(A)
by the National Critical Technologies Panel (or its successor) in reports required under section 6683 1 of title 42; or
(B)
by the Secretary of Defense, in accordance with section 2522 1 of title 10;
(4)
(A)
unilaterally receive and evaluate proposals resulting from STTR solicitations; and
(B)
make a final decision on each proposal submitted under the STTR program—
(i)
not later than 1 year after the date on which the applicable solicitation closes, if with respect to the National Institutes of Health or the National Science Foundation, or 90 days after the date on which the applicable solicitation closes, if with respect to any other participating agency; or
(ii)
if the Administrator authorizes an extension for a solicitation, not later than 90 days after the date that would be applicable to the agency under clause (i);
(5)
unilaterally select awardees for its STTR funding agreements and inform each awardee under such an agreement, to the extent possible, of the expenses of the awardee that will be allowable under the funding agreement;
(6)
administer its own STTR funding agreements (or delegate such administration to another agency);
(7)
make payments to recipients of STTR funding agreements on the basis of progress toward or completion of the funding agreement requirements and, in all cases, make payment to recipients under such agreements in full, subject to audit, on or before the last day of the 12-month period beginning on the date of the completion of such requirements;
(8)
include, as part of its annual performance plan as required by subsections (a) and (b) of
section 1115 of title 31, a section on its STTR program, which section shall describe whether or not the Federal agency complied with the requirements of subsection (n) for the year covered by that plan and include a justification for failure to comply (if applicable),,
3 and shall submit such section to the Committee on Small Business of the Senate, and the Committee on Science and the Committee on Small Business of the House of Representatives;
(9)
collect annually, and maintain in a common format in accordance with the simplified reporting requirements under subsection (v), such information from applicants and awardees as is necessary to assess the STTR program outputs and outcomes, including information necessary to maintain the database described in subsection (k), including—
(A)
whether an applicant or awardee—
(i)
has venture capital, hedge fund, or private equity firm investment or is majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms and, if so—
(I)
the amount of venture capital, hedge fund, or private equity firm investment that the applicant or awardee has received as of the date of the application or award, as applicable; and
(II)
the amount of additional capital that the applicant or awardee has invested in the STTR technology;
(ii)
has an investor that—
(I)
is an individual who is not a citizen of the United States or a lawful permanent resident of the United States and, if so, the name of any such individual; or
(II)
is a person that is not an individual and is not organized under the laws of a State or the United States and, if so, the name of any such person;
(iii)
is owned by a woman or has a woman as a principal investigator; 2
(iv)
is owned by a socially or economically disadvantaged individual or has a socially or economically disadvantaged individual as a principal investigator; 2
(v)
is a faculty member or a student of an institution of higher education, as that term is defined in
section 1001 of title 20; or
(vi)
is located in a State in which the total value of contracts awarded to small business concerns under all STTR programs is less than the total value of contracts awarded to small business concerns in a majority of other States, as determined by the Administrator in biennial fiscal years, beginning with fiscal year 2008, based on the most recent statistics compiled by the Administrator;
(B)
if an awardee receives an award in an amount that is more than the award guidelines under this section, a statement from the agency that justifies the award amount; and
(C)
data with respect to the Federal and State Technology Partnership Program (FAST Program);
(10)
submit an annual report on the STTR program to the Administration and the Office of Science and Technology Policy;
(11)
adopt the agreement developed by the Administrator under subsection (w) as the agency’s model agreement for allocating between small business concerns and research institutions intellectual property rights and rights, if any, to carry out follow-on research, development, or commercialization;
(12)
develop, in consultation with the Office of Federal Procurement Policy and the Office of Government Ethics, procedures to ensure that federally funded research and development centers (as defined in subsection (e)(8)) that participate in STTR agreements—
(A)
are free from organizational conflicts of interests relative to the STTR program;
(B)
do not use privileged information gained through work performed for an STTR agency or private access to STTR agency personnel in the development of an STTR proposal; and
(C)
use outside peer review, as appropriate;
(13)
not later than July 31, 1993, develop procedures for assessing the commercial merit and feasibility of STTR proposals, as evidenced by—
(A)
the small business concern’s record of successfully commercializing STTR or other research;
(B)
the existence of Phase II funding commitments from private sector or non-STTR funding sources;
(C)
the existence of Phase III follow-on commitments for the subject of the research; and
(D)
the presence of other indicators of the commercial potential of the idea;
(14)
implement an outreach program to research institutions and small business concerns for the purpose of enhancing its STTR program, in conjunction with any such outreach done for purposes of the SBIR program;
(15)
provide for and fully implement the tenets of Executive Order No. 13329 (Encouraging Innovation in Manufacturing);
(16)
provide timely notice to the Administrator of any case or controversy before any Federal judicial or administrative tribunal concerning the STTR program of the Federal agency;
(17)
require each small business concern submitting a proposal or application for a federally funded award to disclose in the proposal or application—
(A)
the identity of all owners and covered individuals of the small business concern who are a party to any foreign talent recruitment program of any foreign country of concern, including the People’s Republic of China;
(B)
the existence of any joint venture or subsidiary of the small business concern that is based in, funded by, or has a foreign affiliation with any foreign country of concern, including the People’s Republic of China;
(C)
any current or pending contractual or financial obligation or other agreement specific to a business arrangement, or joint venture-like arrangement with an enterprise owned by a foreign state or any foreign entity;
(D)
whether the small business concern is wholly owned in the People’s Republic of China or another foreign country;
(E)
the percentage, if any, of venture capital or institutional investment by an entity that has a general partner or individual holding a leadership role in such entity who has a foreign affiliation with any foreign country of concern, including the People’s Republic of China;
(F)
any technology licensing or intellectual property sales to a foreign country of concern, including the People’s Republic of China, during the 5-year period preceding submission of the proposal; and
(G)
any foreign business entity, offshore entity, or entity outside the United States related to the small business concern;
(18)
after reviewing the disclosures of a small business concern under paragraph (17), and if determined appropriate by the head of such Federal agency, request such small business concern to provide true copies of any contractual or financial obligation or other agreement specific to a business arrangement, or joint-venture like arrangement with an enterprise owned by a foreign state or any foreign entity in effect during the 5-year period preceding submission of the proposal with respect to which such small business concern made such disclosures;
(19)
evaluate whether a small business concern presents a security risk for any reason, through measures including—
(A)
the due diligence process required under subsection (vv);
(B)
disclosures submitted under this subsection; or
(C)
coordination with the intelligence community, as defined in
section 3003 of title 50, Federal law enforcement, and other counterintelligence capabilities of the Federal Government;
(20)
not make an award under the STTR program of the Federal agency to a small business concern if the head of the Federal agency determines that the small business concern submitting the proposal or application—
(A)
has an owner or covered individual that is party to a malign foreign talent recruitment program;
(B)
has a business entity, parent company, or subsidiary located in the People’s Republic of China or another foreign country of concern;
(C)
has an owner or covered individual that has a foreign affiliation with a research institution located in the People’s Republic of China or another foreign country of concern;
(D)
has a foreign risk connecting the small business concern to an entity, including any affiliates of the entity, or individual on—
(i)
the UFLPA Entity List maintained by the Department of Homeland Security;
(ii)
the Non-SDN Chinese Military-Industrial Complex Companies List of the Office of Foreign Assets Control maintained by the Department of the Treasury;
(iii)
the Section 889 Prohibition List established under section 889 of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 ([Public Law 115–232]; [132 Stat. 1917]) and maintained by the Department of Defense;
(iv)
the list of Chinese Military companies required under section 1260H of the William M. (Mac) Thornberry National Defense Authorization Act for Fiscal Year 2021 (
10 U.S.C. 113 note) and maintained by the Department of Defense;
(v)
the Military End User List maintained by the Bureau of Industry and Security of the Department of Commerce;
(vi)
the Entity List maintained by the Bureau of Industry and Security of the Department of Commerce;
(vii)
the List of Equipment and Services maintained by the Federal Communications Commission; or
(viii)
the Withhold Release Orders and Findings List maintained by U.S. Customs and Border Protection;
(E)
has a security risk with a primary source that is classified; or
(F)
has a security risk that the Federal agency determines warrants a denial;
(21)
provide for—
(A)
a process under which, upon making an award decision to deny an application on the basis of a determination under paragraph (20), or upon making a determination under paragraph (20) that a small business concern has a security risk described in that paragraph, the Federal agency provides to the small business concern, as appropriate pursuant to the discretion of the Federal agency and in a manner that does not compromise security, a notification—
(i)
advising the small business concern of such determination; and
(ii)
identifying the basis for such determination; and
(B)
a policy that clarifies that receipt of an award decision denying an application does not prohibit the small business concern from being eligible for an award in a subsequent award cycle;
(22)
require a small business concern receiving an award under its STTR program to repay all amounts received from the Federal agency under the award if—
(A)
the small business concern makes a material misstatement that the Federal agency determines poses a risk to national security; or
(B)
there is a change in ownership, change to entity structure, or other substantial change in circumstances of the small business concern that the Federal agency determines poses a risk to national security; and
(23)
require a small business concern receiving an award under its STTR program to regularly report to the Federal agency and the Administration throughout the duration of the award on—
(A)
any change to a disclosure required under subparagraphs (A) through (G) of paragraph (17);
(B)
any material misstatement made under paragraph (22)(A); and
(C)
any change described in paragraph (22)(B).
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