81_FR_73229 81 FR 73024 - Technology Innovation-Personnel Exchanges

81 FR 73024 - Technology Innovation-Personnel Exchanges

DEPARTMENT OF COMMERCE
National Institute of Standards and Technology

Federal Register Volume 81, Issue 205 (October 24, 2016)

Page Range73024-73026
FR Document2016-25355

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 Another objective of this rulemaking is to remove outdated regulations addressing the licensing of inventions owned by the Department of Commerce.

Federal Register, Volume 81 Issue 205 (Monday, October 24, 2016)
[Federal Register Volume 81, Number 205 (Monday, October 24, 2016)]
[Rules and Regulations]
[Pages 73024-73026]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-25355]



[[Page 73024]]

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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Another objective of this rulemaking is to remove outdated regulations 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

[[Page 73025]]

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

[[Page 73026]]

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]
 BILLING CODE 3510-13-P



                                                73024            Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Rules and Regulations

                                                DEPARTMENT OF COMMERCE                                  innovations are made available to                     agreement (as defined in 35 U.S.C.
                                                                                                        industry and the public is to encourage               201(b)) between a Federal laboratory
                                                National Institutes of Standards and                    frequent interactions among Federal                   and a contractor shall not preclude a
                                                Technology                                              laboratories, academic institutions, and              CRADA with that contractor, where the
                                                                                                        industry, including small businesses.                 Federal laboratory director makes a
                                                15 CFR Part 17                                             The final rule clarifies the appropriate           determination that the technical subject
                                                                                                        use of CRADA authority under 15 U.S.C.                matter of the funding agreement is
                                                [Docket No.: 160311228–6788–02]
                                                                                                        3710a for personnel exchanges where a                 sufficiently distinct from that of the
                                                RIN 0693–AB62                                           Federal laboratory has an existing                    CRADA. Paragraph (a) also provides that
                                                                                                        relationship with the potential partner               a contractor which is a collaborating
                                                Technology Innovation—Personnel                         through another legal mechanism, such                 party shall in no event transfer funds to
                                                Exchanges                                               as a grant or cooperative agreement. The              a Federal laboratory under a CRADA
                                                AGENCY:  National Institute of Standards                final rule also promotes the use of                   using funds awarded to the contractor
                                                and Technology (NIST), United States                    existing authorities to implement                     by that laboratory.
                                                Department of Commerce.                                 personnel exchange programs at Federal                   Paragraph (b) of § 17.3 provides that a
                                                ACTION: Final rule.
                                                                                                        Laboratories: (1) By utilizing the                    Federal laboratory may exchange
                                                                                                        existing CRADA authority to transfer                  personnel with a contractor under a
                                                SUMMARY:    This final rule clarifies the               personnel to and from a Federal                       CRADA where the determination
                                                appropriate use of Cooperative Research                 laboratory for joint research projects or             required under paragraph (a) cannot be
                                                and Development Agreement (CRADA)                       the development of existing laboratory                made, provided that the CRADA
                                                authority by a Federal laboratory for                   technology; and (2) by utilizing the                  includes at least one collaborating party
                                                personnel exchanges where the Federal                   General Services Administration                       in addition to the Federal laboratory and
                                                laboratory has an existing relationship                 (GSA)’s Presidential Innovation Fellows               that contractor. In that circumstance, the
                                                with the potential partner through                      program to offer Federal laboratories                 Federal laboratory shall not provide
                                                another legal mechanism, as well as in                  additional options for implementing                   services, property, or other resources to
                                                the context of joint research projects or               Entrepreneur-In-Residence programs.                   that contractor under the CRADA, and
                                                the development of existing laboratory                     The final rule also provides for the               if any individual terms of that
                                                technology, and through use of the                      deletion of all existing provisions in                contractor’s funding agreement conflict
                                                General Services Administration’s                       part 17 of title 15 of the Code of Federal            with the terms of the multi-party
                                                Presidential Innovation Fellows                         Regulations (CFR), ‘‘Licensing of                     CRADA, then the funding agreement
                                                program for Federal laboratory                          Government-Owned Inventions in the                    terms will control as applied to that
                                                Entrepreneur-In-Residence programs.                     Custody of the Department of                          contractor and the Federal laboratory
                                                Another objective of this rulemaking is                 Commerce,’’ which are outdated.                       only.
                                                to remove outdated regulations                          Outdated subpart A implemented for                       Paragraph (c) of § 17.3 sets forth a
                                                addressing the licensing of inventions                  the Department of Commerce licensing                  number of factors which may be taken
                                                owned by the Department of Commerce.                    rules found at 41 CFR part 101–4, which               into account in making the ‘‘sufficiently
                                                                                                        were themselves removed at 50 FR                      distinct’’ determination required under
                                                DATES: Effective Date: This rule is
                                                                                                        28402, July 12, 1985. Outdated subpart                paragraph (a), including whether the
                                                effective November 23, 2016.
                                                                                                        B was reserved. Outdated subpart C set                conduct of specified research or
                                                FOR FURTHER INFORMATION CONTACT:                        forth appeal procedures addressed to                  development efforts under the CRADA
                                                Courtney Silverthorn, via email:                        the outdated licensing rules of subpart               would require the contractor to perform
                                                courtney.silverthorn@nist.gov, or by                    A. All subparts are obsolete, and the                 tasks identical to those required under
                                                telephone: 301–975–4189.                                rules governing the licensing of                      the funding agreement; whether existing
                                                SUPPLEMENTARY INFORMATION:                              government-owned inventions are today                 intellectual property to be provided by
                                                   The Stevenson-Wydler Technology                      found in 37 CFR part 404. The heading                 the Federal laboratory or the contractor
                                                Innovation Act of 1980, Public Law 96–                  of part 17 will be revised to read                    under the CRADA is the same as that
                                                480, as amended (codified at title 15 of                ‘‘Personnel Exchanges Between Federal                 provided under, or referenced in, the
                                                the United States Code (U.S.C.), Section                Laboratories and Non-Federal Entities,’’              funding agreement; whether the
                                                3701 et seq.) (the Stevenson-Wydler                     and five new sections are added.                      contractor’s employees performing the
                                                Act), sets forth a national policy to                      Section 17.1, Scope, sets forth the                specified research or development
                                                promote cooperation among academia,                     scope of revised part 17, which is to                 efforts under the CRADA are the same
                                                Federal laboratories, labor, and industry               implement 15 U.S.C. 3712 and clarifies                employees performing the tasks
                                                in order to facilitate the transfer of                  the appropriate use of personnel                      required under the funding agreement;
                                                innovative federal technologies to                      exchanges in relation to Federal                      and whether services, property or other
                                                United States and world markets. In                     laboratory CRADAs under the authority                 resources contemplated by the Federal
                                                furtherance of that policy, the                         of 15 U.S.C. 3710a(a)(1), including                   Laboratory to be provided to the
                                                Administration’s Lab to Market                          CRADAs involving as parties recipients                contractor for the specified research or
                                                initiative seeks to ‘‘significantly                     of Federal funding under grants                       development efforts under the CRADA
                                                accelerate and improve technology                       (including cooperative agreements) and                would materially benefit the contractor
                                                transfer by streamlining administrative                 contracts, which could include National               in the performance of tasks required
                                                processes, facilitating partnerships with               Network for Manufacturing Innovation                  under the funding agreement.
                                                industry, evaluating impact, and                        awardees.                                                Section 17.4, Personnel Exchanges
jstallworth on DSK7TPTVN1PROD with RULES




                                                opening federal research and                               Section 17.2, Definitions, provides                from a Federal Laboratory, provides in
                                                development (R&D) assets as a platform                  definitions for certain terms used in this            paragraph (a)(1) that a Federal
                                                for innovation and economic growth.’’                   part.                                                 laboratory may exchange its personnel
                                                (Lab to Market: Cross Agency Priority                      Section 17.3, Exchange of Federal                  with a collaborating party under a
                                                Goal Quarterly Progress Update, Fiscal                  Laboratory Personnel with Recipients of               CRADA where no invention currently
                                                Year 2015 Quarter 4). One proven                        Federal Funding, provides in paragraph                exists. Under paragraph (a)(2), a Federal
                                                method to ensure that federal                           (a) that the existence of a funding                   laboratory may exchange personnel with


                                           VerDate Sep<11>2014   14:53 Oct 21, 2016   Jkt 241001   PO 00000   Frm 00010   Fmt 4700   Sfmt 4700   E:\FR\FM\24OCR1.SGM   24OCR1


                                                                 Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Rules and Regulations                                            73025

                                                a non-Federal collaborating party for the               technologies, and providing technical                 certification was published in the
                                                purposes of developing or                               consulting to facilitate readying a                   proposed rule and is not repeated here.
                                                commercializing an invention in which                   technology for commercialization by an                No comments were received regarding
                                                the Federal government has an                           outside entity.                                       this certification. As a result, a
                                                ownership interest, including an                                                                              regulatory flexibility analysis was not
                                                                                                        Response to Comments                                  required and none was prepared.
                                                invention made by an employee or
                                                former employee while in the                               During the proposed rule comment
                                                                                                        period, NIST received one written                     Paperwork Reduction Act
                                                employment or service of the Federal
                                                government, and such personnel                          comment that noted that the changes                     This final rule contains no new
                                                exchanged may include such employee                     likely posed no additional burden to                  collection of information subject to the
                                                who is an inventor. Paragraph (a)(2) also               universities, but requested additional                Paperwork Reduction Act, 44 U.S.C.
                                                provides that funding may be provided                   time to provide comments due to the                   3501 et seq.
                                                by the non-federal collaborating party to               academic schedule of university staff.                National Environmental Policy Act
                                                the Federal laboratory for the                             Discussion: NIST appreciates the
                                                                                                        interest of the academic community in                   This rule will not significantly affect
                                                participation of the Federal employee in
                                                                                                        the rule. It is anticipated that these                the quality of the human environment.
                                                developing or commercializing an
                                                                                                        clarifications will strengthen the ability            Therefore, an environmental assessment
                                                invention, including costs for salary and
                                                                                                        of Federal laboratories and partners                  or Environmental Impact Statement is
                                                other expenses, such as benefits and
                                                                                                        through other agreements to work                      not required to be prepared under the
                                                travel. Consistent with guidance in the
                                                                                                        together with a third party, often a                  National Environmental Policy Act of
                                                Office of Legal Counsel’s Memorandum
                                                                                                        university, to support economic                       1969.
                                                for Gary Davis, Acting Director, Office of
                                                Government Ethics, September 7, 2000,                   development and commercialization in                  List of Subjects in 15 CFR Part 17
                                                ‘‘Application of 18 U.S.C. 209 to                       the United States. NIST conducted                       Federal employees, Inventions and
                                                Employee-Inventors Who Receive                          extensive outreach to multiple groups                 patents, Laboratories, Research and
                                                Outside Royalty Payments,’’ 1 paragraph                 that support universities to note the                 development, Science and technology,
                                                (a)(2) also sets forth that royalties from              availability of the proposed rulemaking,              Technology transfer.
                                                inventions received through a license                   and provided a link to the proposed
                                                agreement negotiated with the Federal                   rulemaking to the National Academies                  Kent Rochford,
                                                laboratory and paid by the laboratory to                of Science Government-University-                     Associate Director for Laboratory Programs,
                                                an inventor who is a Federal employee                   Industry Research Roundtable, which                   National Institute of Standards and
                                                are considered Federal compensation.                    was distributed to their mailing list. We             Technology.
                                                Paragraph (a)(3) provides that where an                 believe, as noted within the comment,                   For the reasons stated in the
                                                employee leaves Federal service in                      that these changes are clarifications and             preamble, the National Institute of
                                                order to receive salary or other                        that the lack of substantive comments                 Standards and Technology revises 15
                                                compensation from a non-Federal                         from academia, as well as industry, is                CFR part 17 as follows:
                                                organization, a Federal laboratory may                  indicative of a lack of specific concerns
                                                use reinstatement authority in                          rather than a lack of time and therefore              PART 17—PERSONNEL EXCHANGES
                                                accordance with 5 CFR 315.401, or other                 do not believe an extended comment                    BETWEEN FEDERAL LABORATORIES
                                                applicable authorities, to rehire the                   period is warranted.                                  AND NON-FEDERAL ENTITIES
                                                former Federal employee at the                          Changes From the Proposed Rule                        Sec.
                                                conclusion of the exchange.                                                                                   17.1  Scope.
                                                   In exchanging personnel with a                         The final rule contains no substantive              17.2  Definitions.
                                                collaborating party under a CRADA, as                   changes from the proposed rule.                       17.3  Exchange of Federal laboratory
                                                in any other exercise of the CRADA                      Classification                                            personnel with recipients of Federal
                                                authority, a Federal Laboratory should                                                                            funding.
                                                take into account the provisions of 15                    NIST has determined that the final                  17.4 Personnel exchanges from a Federal
                                                                                                        rule is consistent with the Stevenson-                    laboratory.
                                                U.S.C. 3710a(c)(3) regarding standards                                                                        17.5 Personnel exchanges to a Federal
                                                of conduct for its employees for                        Wydler Act of 1980 and its amendments
                                                                                                        and other applicable law.                                 laboratory.
                                                resolving potential conflicts of interest.
                                                   Section 17.5, Personnel Exchanges to                                                                         Authority: 15 U.S.C. 3712.
                                                                                                        Executive Order 12866
                                                a Federal laboratory, provides that a                                                                         § 17.1   Scope.
                                                Federal laboratory may provide funds                      This final rule was determined to be
                                                                                                        not significant for purposes of Executive               (a) The Stevenson-Wydler Technology
                                                for non-federal personnel exchanged in                                                                        Innovation Act of 1980, Public Law 96–
                                                order to bring into a Federal laboratory                Order 12866.
                                                                                                                                                              480, as amended (codified at title 15 of
                                                outside personnel with expertise in                     Executive Order 13132                                 the United States Code (U.S.C.), section
                                                scientific commercialization through the                                                                      3701 et seq.) (the Stevenson-Wydler
                                                                                                          This final rule does not contain
                                                Presidential Innovation Fellows                                                                               Act), sets forth a national policy to
                                                                                                        policies with Federalism implications as
                                                program, and that a laboratory will                                                                           renew, expand, and strengthen
                                                                                                        defined in Executive Order 13132.
                                                engage with the General Services                                                                              cooperation among academia, Federal
                                                Administration (GSA) to transfer                        Regulatory Flexibility Act                            laboratories, labor, and industry, in
                                                funding for exchanged personnel and to                    The Chief Counsel for Regulation of                 forms including personnel exchanges
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                                                select and place Entrepreneurs-In-                      the Department of Commerce certified                  (15 U.S.C. 3701(3)). One proven method
                                                Residence at the laboratory for the                     to the Chief Counsel for Advocacy of the              to ensure that Federal innovations are
                                                purposes of evaluating the laboratory’s                 Small Business Administration during                  passed to industry and the public is to
                                                  1 https://www.oge.gov/web/oge.nsf/
                                                                                                        the proposed rule stage that this action              encourage frequent interactions among
                                                Legal%20Interpretation/
                                                                                                        would not have a significant economic                 Federal laboratories, academic
                                                604EE82C4CA3404A85257EF200502488/$FILE/op-              impact on a substantial number of small               institutions, and industry, including
                                                olc-v024-p0170_0.pdf?open.                              entities. The factual basis for the                   both large and small businesses. In


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                                                73026            Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Rules and Regulations

                                                accordance with applicable ethics                       efforts where the determination required              collaborating party for the purposes of
                                                regulations and Agency policies,                        under paragraph (a) of this section could             developing or commercializing an
                                                exchanges of personnel between Federal                  not be made, provided that:                           invention in which the Federal
                                                laboratories and outside collaborators                     (i) The CRADA includes at least one                government has an ownership interest,
                                                should be encouraged (15 U.S.C.                         collaborating party in addition to the                including an invention made by an
                                                3702(5)). Models that include Federal                   Federal laboratory and that contractor;               employee or former employee while in
                                                funding, as well as those that are                      and                                                   the employment or service of the
                                                executed without Federal funding, are                      (ii) The Federal laboratory shall not              Federal government, and such
                                                encouraged.                                             provide services, property or other                   personnel exchanged may include such
                                                  (b) This part implements 15 U.S.C.                    resources to that contractor under the                employee who is an inventor.
                                                3712 and provides clarification                         CRADA.
                                                regarding the appropriate use of                           (2) Where a Federal laboratory enters                (i) Funding may be provided under a
                                                personnel exchanges in relation to                      into a CRADA with a contractor under                  CRADA by the non-Federal
                                                Federal laboratory Cooperative Research                 this paragraph (b), the terms of that                 collaborating party to the Federal
                                                and Development Agreements                              contractor’s funding agreement shall                  laboratory for the participation of the
                                                (CRADAs) under the authority of 15                      normally supersede the terms of the                   Federal employee in developing or
                                                U.S.C. 3710a.                                           CRADA, to the extent that any                         commercializing an invention,
                                                  (c) This part is applicable to                        individual terms conflict, as applied to              including costs for salary and other
                                                exchanges of personnel between Federal                  that contractor and the Federal                       expenses, such as benefits and travel.
                                                laboratories and parties to a CRADA                     laboratory only.                                        (ii) Royalties from inventions received
                                                under 15 U.S.C. 3710a(a)(1).                               (c) In making the determination                    through a license agreement negotiated
                                                                                                        required under paragraph (a) of this                  with the Federal laboratory and paid by
                                                § 17.2   Definitions.                                   section, the director of a Federal                    the Federal laboratory to an inventor
                                                  (a) The term funding agreement shall                  laboratory may consider factors
                                                have the meaning according to it under                                                                        who is a Federal employee are
                                                                                                        including the following:
                                                35 U.S.C. 201(b).                                          (1) Whether the conduct of specified               considered Federal compensation.
                                                  (b) The term contractor shall have the                research or development efforts under                   (3) Where an employee leaves Federal
                                                meaning according to it under 35 U.S.C.                 the CRADA would require the                           service in order to receive salary or
                                                201(c).                                                 contractor to perform tasks identical to              other compensation from a non-Federal
                                                  (c) The term Federal laboratory shall                 those required under the funding                      organization, a Federal laboratory may
                                                have the meaning according to it under                  agreement;                                            use reinstatement authority in
                                                15 U.S.C. 3703(4).                                         (2) Whether existing intellectual                  accordance with 5 CFR 315.401, or other
                                                                                                        property to be provided by the Federal                applicable authorities, to rehire the
                                                § 17.3 Exchange of Federal laboratory
                                                                                                        laboratory or the contractor under the                former Federal employee at the
                                                personnel with recipients of Federal
                                                funding.                                                CRADA is the same as that provided                    conclusion of the exchange.
                                                                                                        under, or referenced in, the funding
                                                  (a) In accordance with 15 U.S.C.                                                                            § 17.5 Personnel exchanges to a Federal
                                                                                                        agreement;
                                                3710a(b)(3)(A) and 3710a(d)(1), a                          (3) Whether the contractor’s                       laboratory.
                                                Federal laboratory may provide                          employees performing the specified
                                                personnel, services, property, and other                                                                        For exchanges in which a Federal
                                                                                                        research or development efforts under                 laboratory provides funds for the non-
                                                resources to a collaborating party, with                the CRADA are the same employees
                                                or without reimbursement (but not                                                                             federal personnel—
                                                                                                        performing the tasks required under the
                                                funds to non-Federal parties) for the                   funding agreement; and                                  (a) Outside personnel with expertise
                                                conduct of specified research or                           (4) Whether services, property or                  in scientific commercialization may be
                                                development efforts under a CRADA                       other resources contemplated by the                   brought in to a Federal laboratory
                                                which are consistent with the missions                  Federal laboratory to be provided to the              through the Presidential Innovation
                                                of the Federal laboratory. The existence                contractor for the specified research or              Fellows program or related programs
                                                of a funding agreement between a                        development efforts under the CRADA                   (see 5 CFR 213.3102(r)) for
                                                Federal laboratory and a contractor shall               would materially benefit the contractor               Entrepreneur-In-Residence programs or
                                                not preclude the Federal laboratory from                in the performance of tasks required                  similar, related programs run by the
                                                using its authority under 15 U.S.C.                     under the funding agreement.                          General Services Administration (GSA)
                                                3710a to enter into a CRADA with the                                                                          or other Federal Agencies.
                                                contractor as a collaborating party for                 § 17.4 Personnel exchanges from a
                                                the conduct of specified research or                    Federal laboratory.                                     (b) A laboratory may engage with the
                                                development efforts, where the director                   (a) For personnel exchanges in which                GSA or other relevant Agency to transfer
                                                of the Federal laboratory determines                    a Federal laboratory maintains funding                funding for exchanged personnel, and
                                                that the technical subject matter of the                for Federal personnel provided to a                   may work with such agency to select
                                                funding agreement is sufficiently                       collaborating party—                                  and place Entrepreneurs-In-Residence at
                                                distinct from that of the CRADA. In no                    (1) in accordance with 15 U.S.C.                    the laboratory for the purposes of
                                                event shall a contractor which is a                     3710a(b)(3)(A), a Federal laboratory may              evaluating the laboratory’s technologies,
                                                collaborating party transfer funds to a                 exchange personnel with a collaborating               and providing technical consulting to
                                                Federal laboratory under a CRADA                        party for the purposes of specified                   facilitate readying a technology for
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                                                using funds awarded to the contractor                   scientific or technical research towards              commercialization by an outside entity.
                                                by that laboratory.                                     a mutual goal consistent with the
                                                  (b) (1) A Federal laboratory may enter                                                                      Phillip Singerman,
                                                                                                        mission of the Agency, where no
                                                into a CRADA with a contractor as a                     invention currently exists, or                        Associate Director for Innovations and
                                                collaborating party for the purpose of                    (2) in accordance with 15 U.S.C.                    Industry Services.
                                                exchange of personnel for the conduct                   3710a(b)(3)(C), a Federal laboratory may              [FR Doc. 2016–25355 Filed 10–21–16; 8:45 am]
                                                of specified research or development                    exchange personnel with a non-Federal                 BILLING CODE 3510–13–P




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Document Created: 2016-10-21 23:46:33
Document Modified: 2016-10-21 23:46:33
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionRules and Regulations
ActionFinal rule.
ContactCourtney Silverthorn, via email: [email protected], or by telephone: 301-975-4189.
FR Citation81 FR 73024 
RIN Number0693-AB62
CFR AssociatedFederal Employees; Inventions and Patents; Laboratories; Research and Development; Science and Technology and Technology Transfer

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