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Federal Register / Vol. 73, No. 123 / Wednesday, June 25, 2008 / Rules and Regulations 35913
material at NARA, call 2027416030, or go yielding transformational results with In section 296.22, the order of the
to: http://www.archives.gov/federal-register/ far-ranging or wide-ranging award criteria found in paragraphs (d)
cfr/ibr-locations.html. implications; addresses areas of critical and (e) was revised to be consistent with
Issued in Kansas City, Missouri, on June national need that support, promote, the order of the evaluation criteria
13, 2008. and accelerate innovation in the United found in section 296.21.
David R. Showers, States and is within NIST's areas of In paragraph 296.21(b)(1), the first
Acting Manager, Small Airplane Directorate, technical competence; and is too novel sentence was corrected by adding the
Aircraft Certification Service. or spans too diverse a range of word ``knowledge'' after ``United States
[FR Doc. E814106 Filed 62408; 8:45 am] disciplines to fare well in the traditional science and technology'' to be
BILLING CODE 491013P peer review process. Section 3012(f) of consistent with newly redesignated
the America COMPETES Act requires paragraph 296.22(e).
the NIST Director to promulgate
Summary of Public Comments Received
DEPARTMENT OF COMMERCE regulations implementing the TIP.
NIST published a notice of proposed by NIST in Response to the May 7,
rulemaking with a request for public 2008, Proposed Regulations, and NIST's
National Institute of Standards and Response to Those Comments
Technology comments in the Federal Register on
March 7, 2008 (46 FR 12305) to seek NIST received five responses to the
15 CFR Part 296 public comment on proposed request for comments. Two responses
regulations implementing TIP, which were from for-profit companies. One
[Docket No.: 071106659871602] included policies and procedures for the response was from a United States
RIN 0693AB59 award of financial assistance (grants Senator. One response was from an
and/or cooperative agreements) under individual. One response was from an
Technology Innovation Program TIP. The notice specifically sought industry association. A detailed analysis
comment on how NIST should of the comments follows.
AGENCY: National Institute of Standards determine if ``reasonable and thorough
and Technology, United States efforts have been made to secure General Comments
Department of Commerce. funding from alternative funding Comment: One commenter expressed
ACTION: Final rule. sources and no other alternative funding personal views about NIST.
sources are reasonably available.'' In Response: This comment is outside
SUMMARY: The Deputy Director of the
addition, the Federal Register notice the scope of this rulemaking.
National Institute of Standards and Comment: One commenter stated that
Technology (NIST), United States informed the public that NIST was
revising the heading of Subchapter K of they found it difficult to understand
Department of Commerce, issues a final how NIST staff will identify areas that
rule to implement the Technology its regulations to accurately reflect the
current contents of that subchapter. demand government attention. Another
Innovation Program (TIP). This rule commenter highlighted their industry's
The comment period closed on April
prescribes the policies and procedures commitment to high-risk, high-reward
21, 2008.
for the award of financial assistance In response to the comment received research, including a few example of
(grants and/or cooperative agreements) regarding the ownership of invention their work to transform some of the
under TIP. rights in the course of a bankruptcy or Nation's major societal challenges. The
DATES: This rule is effective on June 25, dissolution, and also to correct the commenter further stated that the
2008. following typographical errors and examples provided amplify that their
FOR FURTHER INFORMATION CONTACT: inconsistencies and clarify terminology specific industry should be considered
Barbara Lambis, National Institute of found in the proposed rule, NIST makes as an area of critical national need.
Standards and Technology, Mail Stop the following changes from the Response: As indicated in the March
4700, Gaithersburg, MD 208998600, proposed rule: 7, 2008 Federal Register notice, in
telephone number (301) 9754447, In the Table of Contents, the titles of determining which areas of critical
e-mail barbara.lambis@nist.gov. section 296.11 and the title of Subpart national need will be addressed in a
C were revised to be consistent with the competition, TIP may solicit input from
Background
titles of that section and subpart within within NIST, from the TIP Advisory
The America Creating Opportunities the body of the rule. The title of section Board, and from the public. TIP may
to Meaningfully Promote Excellence in 296.20 in both the Table of Contents and engage experts in scientific and
Technology, Education, and Science the body of the rule was changed to be technology policy to ensure that the
(COMPETES) Act, Public Law 11069, consistent with the capitalization format areas of critical national need that will
was enacted on August 9, 2007, to used in the remainder of the rule. be considered are those that entail
invest in innovation through research In paragraphs 296.2(f) and (z), the significant societal challenges that are
and development and to improve the definitions of critical national need and not already being addressed by others
competitiveness of the United States. societal challenge, respectively, the and could be addressed through high-
Section 3012 of the COMPETES Act word ``demands'' was changed to risk, high-reward research. Specific
established TIP for the purpose of ``justifies'' to better characterize the societal challenges within selected areas
assisting United States businesses and government's role in responding to of critical national need will be the
institutions of higher education or other societal challenges. focus of TIP funding.
organizations, such as national In paragraph 296.4(c), the second Comment: One commenter raised a
laboratories and nonprofit research sentence was corrected to reflect the fact question about a business review
institutions, to support, promote, and that the referenced Procurement indicating that the new legislation
accelerate innovation in the United Standards are in part 14 of subtitle A of appears to remove the impetus and need
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States through high-risk, high-reward title 15. to commercialize to capture the
research in areas of critical national Paragraph 296.11(b)(4) was revised to economic value potentially created.
need. High-risk, high-reward research is clarify under what situations that Response: The TIP legislation does
research that has the potential for paragraph applies. not include a commercialization
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35914 Federal Register / Vol. 73, No. 123 / Wednesday, June 25, 2008 / Rules and Regulations
element; therefore, business review is from the project, including intellectual number of states might respond to this
not required. property developed by the members by creating specific matching funds for
Comment: One commenter stated that themselves and intellectual property their companies, it could create an
a representative of their industry should created by contractors, will be owned. unnecessary burden on numerous
be on the TIP Advisory Board. The decisions of the joint venture will underserved regions and benefit those
Response: This comment is outside be implemented through the contracts. that already have significant technology-
the scope of this rulemaking. based business infrastructures.
Comment: One commenter Comments on the Selection Process
Response: The 50% cost sharing
recommended that NIST clarify the Comment: Two commenters requirement is statutorily mandated and
ownership of invention rights in the recommended that the reviewers cannot be changed in the rule.
course of a bankruptcy or dissolution. demonstrate proven technical and Comment: One commenter indicated
Specifically, the commenter suggested industry sector expertise in the research that meeting ``the second 50% of the
that in the course of a bankruptcy or proposed in order to effectively award evaluation criteria relating to
dissolution of a joint venture, the last scarce funds to appropriate and demonstrating the potential magnitude
participant in a joint venture would deserving applicants. of transformational results upon the
determine whether to retain ownership Response: NIST intends to use Nation's capabilities in an area, the
or transfer a patent for an invention qualified reviewers with requisite in- mechanism and timing for the
developed with TIP funds. The depth knowledge to evaluate proposals. translational effects to be useful to the
commenter provided an example where Comment: One commenter
a company in bankruptcy could Nation, and demonstrating the capacity
recommended that their specific
continue to exist and run its day-to-day and commitment of each award
industry be represented on the TIP
operations and therefore, should be able participant to enable or advance the
Evaluation Panel and that the
to opt to retain or transfer such a patent transformation seems somewhat
Evaluation Panel members have in-
for a TIP funded invention. improbable and potentially impossible.''
depth knowledge of their specific
Response: The TIP statute requires private industry sector. Response: TIP was established to fund
that intellectual property developed by Response: The composition and research and development projects that
a joint venture from assistance provided requisite expertise of the TIP Evaluation will address areas of critical national
by TIP ``shall not be transferred or Panel will depend on the area(s) of need that demand government attention
passed, except to a participant in the critical national need selected for each because the magnitude of the problem is
joint venture, until the expiration of the competition. NIST intends to use large and the societal challenges that
first patent obtained in connection with qualified individuals to serve on the need to be overcome are not being
such intellectual property.'' (15 U.S.C. Evaluation Panel with requisite in-depth addressed, but could be addressed
278n(e)(1)). Section 296.11(b)(4) of the knowledge to evaluate proposals. through high-risk, high-reward research.
TIP rule contemplates the situation Comment: One commenter asked NIST developed the evaluation criteria
where all members of a joint venture what makes one eligible to participate in contained in the rule to ensure that
cease to exist prior to the expiration of the Evaluation Panel and what is the projects funded by TIP meet the
the first such patent. NIST has revised overall make-up. requirements sets forth in the
section 296.11(b)(4) of the rule to clarify Response: Since the Evaluation authorizing legislation. The TIP
that whenever the last existing Panel(s) will be providing funding Proposal Preparation Kit will provide
participant in a joint venture ceases to recommendations to the Selecting guidance to potential proposers on how
exist prior to the expiration of the first Official, to ensure compliance with the to address the TIP evaluation criteria.
patent obtained in connection with Federal Advisory Committee Act (5 Comments on How NIST Should
intellectual property developed by a U.S.C. App.), all members of the Determine if ``Reasonable and
joint venture from assistance under the Evaluation Panel(s) will be federal Thorough Efforts Have Been Made To
TIP, title to any such patent must be employees. The Evaluation Panel may Secure Funding From Alternative
transferred or passed to a United States request individual technical reviews of Funding Sources and No Other
entity that can commercialize the proposals. The technical reviews will Alternative Funding Sources Are
technology in a timely fashion. generally be conducted by federal Reasonably Available''
Comment: One commenter employees. As stated in the response to
recommended that NIST clarify that the previous comment, the composition Comment: One commenter suggested
contractors and subcontractors who and requisite expertise of the TIP that any criteria set forth regarding the
have contributed to an invention should Evaluation Panel will depend on the demonstration that reasonable and
have ownership rights to the invention area(s) of critical national need selected thorough efforts have been made to
if contractually agreed upon by the for each competition. NIST intends to secure external funding ``does not
participants in the joint venture. use qualified individuals to serve on the require exchange of detailed
Response: The TIP statute specifies: Evaluation Panel with requisite in-depth information that would be deemed to be
``Title to any intellectual property knowledge to evaluate proposals. The confidential by the alternative funding
developed by a joint venture from make-up of the Evaluation Panel will be sources.'' The commenter indicated that
assistance provided under this section discussed in the notice announcing a in some cases, funding sources may
may vest in any participant in the joint competition and request for proposals. deem that even the acknowledgement of
venture, as agreed by the members of consideration of funding is confidential
the joint venture, notwithstanding Comments on the Evaluation Criteria and offerors may not be able to disclose
section 202(a) and (b) of title 35, United Comment: One commenter details about the funding source and
States Code.'' (15 U.S.C. 278n(e)(1)). questioned, how is a proposing entity to would therefore not meet award criteria.
This section of the TIP statute clearly provide a 50% matching, when a major The commenter requested that the
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means that the members of the joint premise of the process is that no government consider the level of
venture must decide and set forth in alternative funding is available to information that can be reasonably
their joint venture agreement how title support these developments? The provided by the offeror depending upon
to all intellectual property that arises commenter further stated that while a the funding source as acceptable.
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Federal Register / Vol. 73, No. 123 / Wednesday, June 25, 2008 / Rules and Regulations 35915
Response: To the extent permitted by that there was no alternative in the Paperwork Reduction Act
law, including the Freedom of budget for the proposed project. Notwithstanding any other provision
Information Act (5 U.S.C. 552), NIST Response: NIST will consider of the law, no person is required to, nor
will protect confidential/proprietary information provided in each proposal shall any person be subject to penalty
information about business operations received to address the award criteria on for failure to comply with, a collection
possessed by any organization and a case by case basis. It would be of information, subject to the
provided to NIST. Proposals are likely premature to speculate on what requirements of the Paperwork
to be less competitive if significant documentation an applicant will submit Reduction Act, unless that collection of
details are omitted due to an to address the applicant's efforts to information displays a currently valid
organization's reluctance to reveal secure alternative funding and whether Office of Management and Budget
confidential/proprietary information. such documentation will be acceptable. (OMB) Control Number.
Comment: One commenter suggested The example provided by the This rule does not contain collection
that the regulations require applicants to commenter could be considered along of information requirements subject to
provide evidence that their application with the documentary evidence of any review and approval by OMB under the
has been rejected by at least two funding efforts to secure alternative funding. Paperwork Reduction Act (PRA). The
sources, including one private source, Additional Information TIP Proposal Preparation Kit, which
before they can be considered for federal contains all necessary forms and
funding, and that the application Executive Order 12866 information requirements, was
submitted to NIST must be identical to This rulemaking is a significant submitted to OMB and approved. The
the application rejected twice regulatory action under sections 3(f)(3) OMB Control Number for the
previously. The commenter further and 3(f)(4) of Executive Order 12866, as information collection requirements is
suggests that applicants must it materially alters the budgetary impact 06930050 and will be published in all
demonstrate that they do not have the of a grant program and raises novel Federal Register notices soliciting
necessary financial resources to conduct policy issues. This rulemaking, proposals under the Program.
the research themselves. however, is not an ``economically
Response: Due to the variety of types National Environmental Policy Act
significant'' regulatory action under
of organizations that may apply to TIP section 3(f)(1) of the Executive Order, as This rule will not significantly affect
and the various types of funds available it does not have an effect on the the quality of the human environment.
to different types of organizations and in economy of $100 million or more in any Therefore, an environmental assessment
different sectors, setting a minimum one year, and it does not have a material or Environmental Impact Statement is
number of unsuccessful attempts to adverse effect on the economy, a sector not required to be prepared under the
obtain funding seems to be of the economy, productivity, National Environmental Policy Act of
inappropriate. Rather, NIST will require competition, jobs, the environment, 1969.
that each proposer, including each public health or safety, or State, local,
member of a joint venture, submit List of Subjects in 15 CFR Part 296
or tribal governments or communities.
evidence documenting all of their Business and industry; Grant
unsuccessful attempts to obtain funding Executive Order 13132 programs--science and technology;
for the work described in the proposal, This rule does not contain policies Inventions and patents; Reporting and
including internal funding, funding with Federalism implications as defined recordkeeping requirements; Research;
from external private sources, and other in Executive Order 13132. Science and technology.
funding from government sources Dated: June 16, 2008.
(federal, state and local). Based on all Administrative Procedure Act
James M. Turner,
relevant factors, NIST will determine Pursuant to 5 U.S.C. 553(a)(2), all Deputy Director.
whether the unsuccessful attempts to matters related to agency management
obtain funding documented in each or personnel or to public property, I For the reasons set forth in the
proposal are reasonable and thorough. loans, grants, benefits, or contracts are preamble, Title 15 of the Code of
Comment: One commenter exempt from the rulemaking Federal Regulations is amended as
recommended that NIST consider an requirements of 5 U.S.C. 553, including follows:
applicant's previous efforts to raise the 30-day delay in effectiveness. This Subchapter K--NIST Extramural Programs
funds, such as through public and rule prescribes the policies and I 1. The heading of chapter II,
private financing, to demonstrate procedures for the award of financial subchapter K is revised to read as set
``reasonable and thorough'' efforts to assistance (grants and/or cooperative forth above.
secure alternative funds and to show agreements) under the Technology I 2. In 15 CFR chapter II, subchapter K,
that no other alternative sources are Innovation Program. Because this rule add a new part 296 as follows:
available. The commenter further concerns a grant program, this rule is
recommended that NIST should not subject to the 30-day delay in PART 296--TECHNOLOGY
examine the rationale behind a non-lead effectiveness. Therefore, this final rule INNOVATION PROGRAM
product failing to receive funding, is made effective immediately upon
which would allow companies to satisfy publication. Subpart A--General
the requirement that no other alternative Sec.
sources are reasonably available. The Regulatory Flexibility Act 296.1 Purpose.
commenter provided the example that a Because notice and comment are not 296.2 Definitions.
company could submit as part of their required under 5 U.S.C. 553, or any 296.3 Types of assistance available.
296.4 Limitations on assistance.
proposal an attestation by the other law, the analytical requirements of
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296.5 Eligibility requirements for
company's board, which would usually the Regulatory Flexibility Act (5 U.S.C. companies and joint ventures.
include key investors. Such attestation 601 et seq.) are inapplicable. As such, a 296.6 Valuation of transfers.
would state that the funds raised are for regulatory flexibility analysis is not 296.7 Joint venture registration.
the more advanced lead products and required, and none has been prepared. 296.8 Joint venture agreement.
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35916 Federal Register / Vol. 73, No. 123 / Wednesday, June 25, 2008 / Rules and Regulations
296.9 Activities not permitted for joint relationship between the Federal High-risk, high-reward research
ventures. government and the recipient is to means research that:
296.10 Third party in-kind contribution of transfer something of value, such as (1) Has the potential for yielding
research services. money, property, or services to the transformational results with far-ranging
296.11 Intellectual property rights and or wide-ranging implications;
procedures.
recipient to accomplish a public
purpose of support or stimulation (2) Addresses areas of critical national
296.12 Reporting and auditing
requirements. authorized by Federal statute instead of need that support, promote, and
acquiring (by purchase, lease, or barter) accelerate innovation in the United
Subpart B--The Competition Process property or services for the direct States and is within NIST's areas of
296.20 The selection process. benefit or use of the Federal technical competence; and
296.21 Evaluation criteria. government; and substantial (3) Is too novel or spans too diverse
296.22 Award criteria. involvement is anticipated between the a range of disciplines to fare well in the
Subpart C--Dissemination of Program Federal government and the recipient traditional peer-review process.
Results during performance of the contemplated Indirect costs means those costs
activity. incurred for common or joint objectives
296.30 Monitoring and evaluation.
296.31 Dissemination of results. Critical national need means an area that cannot be readily identified with
296.32 Technical and educational services. that justifies government attention activities carried out in support of a
296.33 Annual report. because the magnitude of the problem is particular final objective. A cost may
large and the societal challenges that not be allocated to an award as an
Authority: 15 U.S.C. 278n (Pub. L. 11069
section 3012) need to be overcome are not being indirect cost if any other cost incurred
addressed, but could be addressed for the same purpose in like
Subpart A--General through high-risk, high-reward research. circumstances has been assigned to an
award as a direct cost. Because of
§ 296.1 Purpose. Direct costs means costs that can be
diverse characteristics and accounting
identified readily with activities carried
(a) The purpose of the Technology practices it is not possible to specify the
out in support of a particular final
Innovation Program (TIP) is to assist types of costs which may be classified
objective. A cost may not be allocated to
United States businesses and as indirect costs in all situations.
an award as a direct cost if any other
institutions of higher education or other However, typical examples of indirect
cost incurred for the same purpose in
organizations, such as national costs include general administration
like circumstances has been assigned to
laboratories and nonprofit research expenses, such as the salaries and
an award as an indirect cost. Because of
institutes, to support, promote, and expenses of executive officers,
the diverse characteristics and
accelerate innovation in the United personnel administration, maintenance,
accounting practices of different
States through high-risk, high-reward library expenses, and accounting. NIST
organizations, it is not possible to
research in areas of critical national shall determine the allowability of
specify the types of costs which may be
need within NIST's areas of technical indirect costs in accordance with
classified as direct costs in all
competence. applicable Federal cost principles.
situations. However, typical direct costs Institution of higher education means
(b) The rules in this part prescribe
could include salaries of personnel an educational institution in any State
policies and procedures for the award
working on the TIP project, travel, that--(1) Admits as regular students
and administration of financial
equipment, materials and supplies, only persons having a certificate of
assistance (grants and/or cooperative
subcontracts, and other costs not graduation from a school providing
agreements) under the TIP. While the
categorized in the preceding examples. secondary education, or the recognized
TIP is authorized to enter into grants,
NIST shall determine the allowability of equivalent of such a certificate;
cooperative agreements, and contracts to
direct costs in accordance with (2) Is legally authorized within such
carry out the TIP mission, the rules in
applicable Federal cost principles. State to provide a program of education
this part address only the award of
grants and/or cooperative agreements. Director means the Director of the beyond secondary education;
National Institute of Standards and (3) Provides an educational program
§ 296.2 Definitions. Technology (NIST). for which the institution awards a
Award means Federal financial Eligible company means a small-sized bachelor's degree or provides not less
assistance made under a grant or or medium-sized business or company than a 2-year program that is acceptable
cooperative agreement. that satisfies the ownership and other for full credit toward such a degree;
Business or company means a for- requirements stated in this part. (4) Is a public or other nonprofit
profit organization, including sole Grant means a Federal assistance institution; and
proprietors, partnerships, limited instrument used whenever the principal (5) Is accredited by a nationally
liability companies (LLCs), and purpose of the relationship between the recognized accrediting agency or
corporations. Federal government and the recipient is association, or if not so accredited, is an
Contract means a procurement to transfer something of value, such as institution that has been granted
contract under an award or subaward, money, property, or services to the preaccreditation status by such an
and a procurement subcontract under a recipient to accomplish a public agency or association that has been
recipient's or subrecipient's contract. purpose of support or stimulation recognized by the Secretary of
Contractor means the legal entity to authorized by Federal statute instead of Education for the granting of
which a contract is made and which is acquiring (by purchase, lease, or barter) preaccreditation status, and the
accountable to the recipient, property or services for the direct Secretary of Education has determined
subrecipient, or contractor making the benefit or use of the Federal that there is satisfactory assurance that
contract for the use of the funds government; and no substantial the institution will meet the
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provided. involvement is anticipated between the accreditation standards of such an
Cooperative agreement refers to a Federal government and the recipient agency or association within a
Federal assistance instrument used during performance of the contemplated reasonable time (20 U.S.C. 1001). For
whenever the principal purpose of the activity. the purpose of this paragraph (l) only,
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Federal Register / Vol. 73, No. 123 / Wednesday, June 25, 2008 / Rules and Regulations 35917
the term State includes, in addition to working on a TIP project). Third party lower tier subrecipient. The term
the several States of the United States, in-kind contributions include but are includes financial assistance when
the Commonwealth of Puerto Rico, the not limited to equipment, research tools, provided by any legal agreement, even
District of Columbia, Guam, American software, supplies, and/or services. The if the legal agreement is called a
Samoa, the United States Virgin Islands, value of in-kind contributions shall be contract, but does not include
the Commonwealth of the Northern determined in accordance with § 14.23 procurement of goods and services.
Mariana Islands, and the Freely of this title and will be prorated Subrecipient means the legal entity to
Associated States. The term Freely according to the share of total use which a subaward is made and which
Associated States means the Republic of dedicated to the TIP project. NIST shall is accountable to the recipient for the
the Marshall Islands, the Federated determine the allowability of matching use of the funds provided.
States of Micronesia, and the Republic share costs in accordance with Transformational results means
of Palau. applicable Federal cost principles. potential project outcomes that enable
Intellectual property means an Medium-sized business means any disruptive changes over and above
invention patentable under title 35, business that does not qualify as a current methods and strategies.
United States Code, or any patent on small-sized business or a large-sized Transformational results have the
such an invention, or any work for business under the definitions in this potential to radically improve our
which copyright protection is available section. understanding of systems and
under title 17, United States Code. Member means any entity that is technologies, challenging the status quo
Joint venture means a business identified as a joint venture member in of research approaches and
arrangement that: the award and is a signatory on the joint applications.
(1) Includes either: venture agreement required by § 296.8.
(i) At least two separately owned United States owned company means
Nonprofit research institute means a a for-profit organization, including sole
companies that are both substantially nonprofit research and development
involved in the project and both of proprietors, partnerships, limited
entity or association organized under liability companies (LLCs), and
which are contributing to the cost- the laws of any state for the purpose of
sharing required under the TIP statute, corporations, that has a majority
carrying out research and development. ownership by individuals who are
with the lead company of the joint Participant means any entity that is
venture being an eligible company; or citizens of the United States.
identified as a recipient, subrecipient, or
(ii) At least one eligible company and contractor on an award to a joint § 296.3 Types of assistance available.
one institution of higher education or venture under the Program.
other organization, such as a national Subject to the limitations of this
Person will be deemed to include section and § 296.4, assistance under
laboratory, governmental laboratory (not corporations and associations existing
including NIST), or nonprofit research this part is available to eligible
under or authorized by the laws of the companies or joint ventures that request
institute, that are both substantially United States, the laws of any of the
involved in the project and both of either of the following:
Territories, the laws of any State, or the
which are contributing to the cost- (a) Single Company Awards: No
laws of any foreign country.
sharing required under the TIP statute, Program or TIP means the Technology award given to a single company shall
with the lead entity of the joint venture Innovation Program.