[Federal Register Volume 81, Number 205 (Monday, October 24, 2016)]
[Rules and Regulations]
[Pages 73024-73026]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25355]
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DEPARTMENT OF COMMERCE
National Institutes of Standards and Technology
15 CFR Part 17
[Docket No.: 160311228-6788-02]
RIN 0693-AB62
Technology Innovation--Personnel Exchanges
AGENCY: National Institute of Standards and Technology (NIST), United
States Department of Commerce.
ACTION: Final rule.
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SUMMARY: This final rule clarifies the appropriate use of Cooperative
Research and Development Agreement (CRADA) authority by a Federal
laboratory for personnel exchanges where the Federal laboratory has an
existing relationship with the potential partner through another legal
mechanism, as well as in the context of joint research projects or the
development of existing laboratory technology, and through use of the
General Services Administration's Presidential Innovation Fellows
program for Federal laboratory Entrepreneur-In-Residence programs.
Another objective of this rulemaking is to remove outdated regulations
addressing the licensing of inventions owned by the Department of
Commerce.
DATES: Effective Date: This rule is effective November 23, 2016.
FOR FURTHER INFORMATION CONTACT: Courtney Silverthorn, via email:
[email protected], or by telephone: 301-975-4189.
SUPPLEMENTARY INFORMATION:
The Stevenson-Wydler Technology Innovation Act of 1980, Public Law
96-480, as amended (codified at title 15 of the United States Code
(U.S.C.), Section 3701 et seq.) (the Stevenson-Wydler Act), sets forth
a national policy to promote cooperation among academia, Federal
laboratories, labor, and industry in order to facilitate the transfer
of innovative federal technologies to United States and world markets.
In furtherance of that policy, the Administration's Lab to Market
initiative seeks to ``significantly accelerate and improve technology
transfer by streamlining administrative processes, facilitating
partnerships with industry, evaluating impact, and opening federal
research and development (R&D) assets as a platform for innovation and
economic growth.'' (Lab to Market: Cross Agency Priority Goal Quarterly
Progress Update, Fiscal Year 2015 Quarter 4). One proven method to
ensure that federal innovations are made available to industry and the
public is to encourage frequent interactions among Federal
laboratories, academic institutions, and industry, including small
businesses.
The final rule clarifies the appropriate use of CRADA authority
under 15 U.S.C. 3710a for personnel exchanges where a Federal
laboratory has an existing relationship with the potential partner
through another legal mechanism, such as a grant or cooperative
agreement. The final rule also promotes the use of existing authorities
to implement personnel exchange programs at Federal Laboratories: (1)
By utilizing the existing CRADA authority to transfer personnel to and
from a Federal laboratory for joint research projects or the
development of existing laboratory technology; and (2) by utilizing the
General Services Administration (GSA)'s Presidential Innovation Fellows
program to offer Federal laboratories additional options for
implementing Entrepreneur-In-Residence programs.
The final rule also provides for the deletion of all existing
provisions in part 17 of title 15 of the Code of Federal Regulations
(CFR), ``Licensing of Government-Owned Inventions in the Custody of the
Department of Commerce,'' which are outdated. Outdated subpart A
implemented for the Department of Commerce licensing rules found at 41
CFR part 101-4, which were themselves removed at 50 FR 28402, July 12,
1985. Outdated subpart B was reserved. Outdated subpart C set forth
appeal procedures addressed to the outdated licensing rules of subpart
A. All subparts are obsolete, and the rules governing the licensing of
government-owned inventions are today found in 37 CFR part 404. The
heading of part 17 will be revised to read ``Personnel Exchanges
Between Federal Laboratories and Non-Federal Entities,'' and five new
sections are added.
Section 17.1, Scope, sets forth the scope of revised part 17, which
is to implement 15 U.S.C. 3712 and clarifies the appropriate use of
personnel exchanges in relation to Federal laboratory CRADAs under the
authority of 15 U.S.C. 3710a(a)(1), including CRADAs involving as
parties recipients of Federal funding under grants (including
cooperative agreements) and contracts, which could include National
Network for Manufacturing Innovation awardees.
Section 17.2, Definitions, provides definitions for certain terms
used in this part.
Section 17.3, Exchange of Federal Laboratory Personnel with
Recipients of Federal Funding, provides in paragraph (a) that the
existence of a funding agreement (as defined in 35 U.S.C. 201(b))
between a Federal laboratory and a contractor shall not preclude a
CRADA with that contractor, where the Federal laboratory director makes
a determination that the technical subject matter of the funding
agreement is sufficiently distinct from that of the CRADA. Paragraph
(a) also provides that a contractor which is a collaborating party
shall in no event transfer funds to a Federal laboratory under a CRADA
using funds awarded to the contractor by that laboratory.
Paragraph (b) of Sec. 17.3 provides that a Federal laboratory may
exchange personnel with a contractor under a CRADA where the
determination required under paragraph (a) cannot be made, provided
that the CRADA includes at least one collaborating party in addition to
the Federal laboratory and that contractor. In that circumstance, the
Federal laboratory shall not provide services, property, or other
resources to that contractor under the CRADA, and if any individual
terms of that contractor's funding agreement conflict with the terms of
the multi-party CRADA, then the funding agreement terms will control as
applied to that contractor and the Federal laboratory only.
Paragraph (c) of Sec. 17.3 sets forth a number of factors which
may be taken into account in making the ``sufficiently distinct''
determination required under paragraph (a), including whether the
conduct of specified research or development efforts under the CRADA
would require the contractor to perform tasks identical to those
required under the funding agreement; whether existing intellectual
property to be provided by the Federal laboratory or the contractor
under the CRADA is the same as that provided under, or referenced in,
the funding agreement; whether the contractor's employees performing
the specified research or development efforts under the CRADA are the
same employees performing the tasks required under the funding
agreement; and whether services, property or other resources
contemplated by the Federal Laboratory to be provided to the contractor
for the specified research or development efforts under the CRADA would
materially benefit the contractor in the performance of tasks required
under the funding agreement.
Section 17.4, Personnel Exchanges from a Federal Laboratory,
provides in paragraph (a)(1) that a Federal laboratory may exchange its
personnel with a collaborating party under a CRADA where no invention
currently exists. Under paragraph (a)(2), a Federal laboratory may
exchange personnel with
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a non-Federal collaborating party for the purposes of developing or
commercializing an invention in which the Federal government has an
ownership interest, including an invention made by an employee or
former employee while in the employment or service of the Federal
government, and such personnel exchanged may include such employee who
is an inventor. Paragraph (a)(2) also provides that funding may be
provided by the non-federal collaborating party to the Federal
laboratory for the participation of the Federal employee in developing
or commercializing an invention, including costs for salary and other
expenses, such as benefits and travel. Consistent with guidance in the
Office of Legal Counsel's Memorandum for Gary Davis, Acting Director,
Office of Government Ethics, September 7, 2000, ``Application of 18
U.S.C. 209 to Employee-Inventors Who Receive Outside Royalty
Payments,'' \1\ paragraph (a)(2) also sets forth that royalties from
inventions received through a license agreement negotiated with the
Federal laboratory and paid by the laboratory to an inventor who is a
Federal employee are considered Federal compensation. Paragraph (a)(3)
provides that where an employee leaves Federal service in order to
receive salary or other compensation from a non-Federal organization, a
Federal laboratory may use reinstatement authority in accordance with 5
CFR 315.401, or other applicable authorities, to rehire the former
Federal employee at the conclusion of the exchange.
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\1\ https://www.oge.gov/web/oge.nsf/Legal%20Interpretation/
604EE82C4CA3404A85257EF200502488/$FILE/op-olc-v024-p0170_0.pdf?open.
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In exchanging personnel with a collaborating party under a CRADA,
as in any other exercise of the CRADA authority, a Federal Laboratory
should take into account the provisions of 15 U.S.C. 3710a(c)(3)
regarding standards of conduct for its employees for resolving
potential conflicts of interest.
Section 17.5, Personnel Exchanges to a Federal laboratory, provides
that a Federal laboratory may provide funds for non-federal personnel
exchanged in order to bring into a Federal laboratory outside personnel
with expertise in scientific commercialization through the Presidential
Innovation Fellows program, and that a laboratory will engage with the
General Services Administration (GSA) to transfer funding for exchanged
personnel and to select and place Entrepreneurs-In-Residence at the
laboratory for the purposes of evaluating the laboratory's
technologies, and providing technical consulting to facilitate readying
a technology for commercialization by an outside entity.
Response to Comments
During the proposed rule comment period, NIST received one written
comment that noted that the changes likely posed no additional burden
to universities, but requested additional time to provide comments due
to the academic schedule of university staff.
Discussion: NIST appreciates the interest of the academic community
in the rule. It is anticipated that these clarifications will
strengthen the ability of Federal laboratories and partners through
other agreements to work together with a third party, often a
university, to support economic development and commercialization in
the United States. NIST conducted extensive outreach to multiple groups
that support universities to note the availability of the proposed
rulemaking, and provided a link to the proposed rulemaking to the
National Academies of Science Government-University-Industry Research
Roundtable, which was distributed to their mailing list. We believe, as
noted within the comment, that these changes are clarifications and
that the lack of substantive comments from academia, as well as
industry, is indicative of a lack of specific concerns rather than a
lack of time and therefore do not believe an extended comment period is
warranted.
Changes From the Proposed Rule
The final rule contains no substantive changes from the proposed
rule.
Classification
NIST has determined that the final rule is consistent with the
Stevenson-Wydler Act of 1980 and its amendments and other applicable
law.
Executive Order 12866
This final rule was determined to be not significant for purposes
of Executive Order 12866.
Executive Order 13132
This final rule does not contain policies with Federalism
implications as defined in Executive Order 13132.
Regulatory Flexibility Act
The Chief Counsel for Regulation of the Department of Commerce
certified to the Chief Counsel for Advocacy of the Small Business
Administration during the proposed rule stage that this action would
not have a significant economic impact on a substantial number of small
entities. The factual basis for the certification was published in the
proposed rule and is not repeated here. No comments were received
regarding this certification. As a result, a regulatory flexibility
analysis was not required and none was prepared.
Paperwork Reduction Act
This final rule contains no new collection of information subject
to the Paperwork Reduction Act, 44 U.S.C. 3501 et seq.
National Environmental Policy Act
This rule will not significantly affect the quality of the human
environment. Therefore, an environmental assessment or Environmental
Impact Statement is not required to be prepared under the National
Environmental Policy Act of 1969.
List of Subjects in 15 CFR Part 17
Federal employees, Inventions and patents, Laboratories, Research
and development, Science and technology, Technology transfer.
Kent Rochford,
Associate Director for Laboratory Programs, National Institute of
Standards and Technology.
For the reasons stated in the preamble, the National Institute of
Standards and Technology revises 15 CFR part 17 as follows:
PART 17--PERSONNEL EXCHANGES BETWEEN FEDERAL LABORATORIES AND NON-
FEDERAL ENTITIES
Sec.
17.1 Scope.
17.2 Definitions.
17.3 Exchange of Federal laboratory personnel with recipients of
Federal funding.
17.4 Personnel exchanges from a Federal laboratory.
17.5 Personnel exchanges to a Federal laboratory.
Authority: 15 U.S.C. 3712.
Sec. 17.1 Scope.
(a) The Stevenson-Wydler Technology Innovation Act of 1980, Public
Law 96-480, as amended (codified at title 15 of the United States Code
(U.S.C.), section 3701 et seq.) (the Stevenson-Wydler Act), sets forth
a national policy to renew, expand, and strengthen cooperation among
academia, Federal laboratories, labor, and industry, in forms including
personnel exchanges (15 U.S.C. 3701(3)). One proven method to ensure
that Federal innovations are passed to industry and the public is to
encourage frequent interactions among Federal laboratories, academic
institutions, and industry, including both large and small businesses.
In
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accordance with applicable ethics regulations and Agency policies,
exchanges of personnel between Federal laboratories and outside
collaborators should be encouraged (15 U.S.C. 3702(5)). Models that
include Federal funding, as well as those that are executed without
Federal funding, are encouraged.
(b) This part implements 15 U.S.C. 3712 and provides clarification
regarding the appropriate use of personnel exchanges in relation to
Federal laboratory Cooperative Research and Development Agreements
(CRADAs) under the authority of 15 U.S.C. 3710a.
(c) This part is applicable to exchanges of personnel between
Federal laboratories and parties to a CRADA under 15 U.S.C.
3710a(a)(1).
Sec. 17.2 Definitions.
(a) The term funding agreement shall have the meaning according to
it under 35 U.S.C. 201(b).
(b) The term contractor shall have the meaning according to it
under 35 U.S.C. 201(c).
(c) The term Federal laboratory shall have the meaning according to
it under 15 U.S.C. 3703(4).
Sec. 17.3 Exchange of Federal laboratory personnel with recipients of
Federal funding.
(a) In accordance with 15 U.S.C. 3710a(b)(3)(A) and 3710a(d)(1), a
Federal laboratory may provide personnel, services, property, and other
resources to a collaborating party, with or without reimbursement (but
not funds to non-Federal parties) for the conduct of specified research
or development efforts under a CRADA which are consistent with the
missions of the Federal laboratory. The existence of a funding
agreement between a Federal laboratory and a contractor shall not
preclude the Federal laboratory from using its authority under 15
U.S.C. 3710a to enter into a CRADA with the contractor as a
collaborating party for the conduct of specified research or
development efforts, where the director of the Federal laboratory
determines that the technical subject matter of the funding agreement
is sufficiently distinct from that of the CRADA. In no event shall a
contractor which is a collaborating party transfer funds to a Federal
laboratory under a CRADA using funds awarded to the contractor by that
laboratory.
(b) (1) A Federal laboratory may enter into a CRADA with a
contractor as a collaborating party for the purpose of exchange of
personnel for the conduct of specified research or development efforts
where the determination required under paragraph (a) of this section
could not be made, provided that:
(i) The CRADA includes at least one collaborating party in addition
to the Federal laboratory and that contractor; and
(ii) The Federal laboratory shall not provide services, property or
other resources to that contractor under the CRADA.
(2) Where a Federal laboratory enters into a CRADA with a
contractor under this paragraph (b), the terms of that contractor's
funding agreement shall normally supersede the terms of the CRADA, to
the extent that any individual terms conflict, as applied to that
contractor and the Federal laboratory only.
(c) In making the determination required under paragraph (a) of
this section, the director of a Federal laboratory may consider factors
including the following:
(1) Whether the conduct of specified research or development
efforts under the CRADA would require the contractor to perform tasks
identical to those required under the funding agreement;
(2) Whether existing intellectual property to be provided by the
Federal laboratory or the contractor under the CRADA is the same as
that provided under, or referenced in, the funding agreement;
(3) Whether the contractor's employees performing the specified
research or development efforts under the CRADA are the same employees
performing the tasks required under the funding agreement; and
(4) Whether services, property or other resources contemplated by
the Federal laboratory to be provided to the contractor for the
specified research or development efforts under the CRADA would
materially benefit the contractor in the performance of tasks required
under the funding agreement.
Sec. 17.4 Personnel exchanges from a Federal laboratory.
(a) For personnel exchanges in which a Federal laboratory maintains
funding for Federal personnel provided to a collaborating party--
(1) in accordance with 15 U.S.C. 3710a(b)(3)(A), a Federal
laboratory may exchange personnel with a collaborating party for the
purposes of specified scientific or technical research towards a mutual
goal consistent with the mission of the Agency, where no invention
currently exists, or
(2) in accordance with 15 U.S.C. 3710a(b)(3)(C), a Federal
laboratory may exchange personnel with a non-Federal collaborating
party for the purposes of developing or commercializing an invention in
which the Federal government has an ownership interest, including an
invention made by an employee or former employee while in the
employment or service of the Federal government, and such personnel
exchanged may include such employee who is an inventor.
(i) Funding may be provided under a CRADA by the non-Federal
collaborating party to the Federal laboratory for the participation of
the Federal employee in developing or commercializing an invention,
including costs for salary and other expenses, such as benefits and
travel.
(ii) Royalties from inventions received through a license agreement
negotiated with the Federal laboratory and paid by the Federal
laboratory to an inventor who is a Federal employee are considered
Federal compensation.
(3) Where an employee leaves Federal service in order to receive
salary or other compensation from a non-Federal organization, a Federal
laboratory may use reinstatement authority in accordance with 5 CFR
315.401, or other applicable authorities, to rehire the former Federal
employee at the conclusion of the exchange.
Sec. 17.5 Personnel exchanges to a Federal laboratory.
For exchanges in which a Federal laboratory provides funds for the
non-federal personnel--
(a) Outside personnel with expertise in scientific
commercialization may be brought in to a Federal laboratory through the
Presidential Innovation Fellows program or related programs (see 5 CFR
213.3102(r)) for Entrepreneur-In-Residence programs or similar, related
programs run by the General Services Administration (GSA) or other
Federal Agencies.
(b) A laboratory may engage with the GSA or other relevant Agency
to transfer funding for exchanged personnel, and may work with such
agency to select and place Entrepreneurs-In-Residence at the laboratory
for the purposes of evaluating the laboratory's technologies, and
providing technical consulting to facilitate readying a technology for
commercialization by an outside entity.
Phillip Singerman,
Associate Director for Innovations and Industry Services.
[FR Doc. 2016-25355 Filed 10-21-16; 8:45 am]
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