Technology Innovation-Personnel Exchanges, 41468-41472 [2016-14723]
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Federal Register / Vol. 81, No. 123 / Monday, June 27, 2016 / Proposed Rules
Dated: June 22, 2016.
Molly J. Moran,
Acting General Counsel.
Identify the document by docket ID
number and other identifying
information (subject heading, Federal
Register date and page number).
FOR FURTHER INFORMATION CONTACT:
Courtney Silverthorn, via email:
courtney.silverthorn@nist.gov, or by
telephone: 301–975–4189.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2016–15147 Filed 6–24–16; 8:45 am]
BILLING CODE 4910–9X–P
DEPARTMENT OF COMMERCE
National Institutes of Standards and
Technology
I. General Information
15 CFR Part 17
[Docket No.: 160311228–6228–01]
RIN 0693–AB62
Technology Innovation—Personnel
Exchanges
National Institute of Standards
and Technology (NIST), United States
Department of Commerce.
ACTION: Notice of proposed rulemaking.
AGENCY:
NIST is seeking comments on
proposed regulations intended to foster
the exchange of scientific and technical
personnel among academia, industry,
including particularly small businesses,
and Federal laboratories. Such
exchanges are an effective means for
accelerating the transfer of Federal
laboratory technology to benefit the
United States economy. An objective of
this rulemaking is to clarify the
appropriate use of Cooperative Research
and Development Agreement 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to remove outdated regulations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.
When the comment period is
concluded, NIST will analyze the
comments received, incorporate
comments as appropriate, and publish a
final regulation.
DATES: Comments must be received no
later than July 27, 2016.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number: 160311228–6228–01, through
the Federal e-Rulemaking Portal: https://
www.regulations.gov (search using the
docket number). Follow the online
instructions for submitting comments.
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SUMMARY:
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Does this action apply to me?
This proposed rule may be of interest
to you if you are an educational
institution, a company (including a
small business firm), or a nonprofit
institution, that collaborates or would
like to collaborate with Federal
Government employees on technology
research and development of mutual
interest.
II. Background
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.
A. Notice of Proposed Rulemaking
Pursuant to authority delegated to it
by the Secretary of Commerce, NIST is
providing notice to the public of
proposed rulemaking to remove
outdated provisions in part 17 of title 15
of the Code of Federal Regulations (CFR)
regarding the licensing of inventions
owned by the Department, and to revise
part 17 to address the use of personnel
exchange authorities and programs as
authorized under 15 U.S.C. 3712, which
authorizes the establishment of a
program to foster the exchange of
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scientific and technical personnel
among academia, industry, and Federal
laboratories.
Under the Stevenson-Wydler Act,
several mechanisms have been
developed which are being used by
various Federal agencies for exchanging
personnel with the public and private
sectors. The proposed rules will
facilitate agencies’ use of existing
mechanisms, as well as provide for
more integrated programs intended to
expand the exchange of personnel as
authorized under section 3712, in order
to accelerate the transfer of innovative
technologies from Federal laboratories
for the benefit of the United States and
its economy. Some current authorities
relevant to personnel exchange between
Federal laboratories and non-federal
partners are described below.
B. Current Personnel Exchange
Mechanisms
1. Cooperative Research and
Development Agreement—The
Cooperative Research and Development
Agreement (CRADA) is one of the
principal mechanisms used by Federal
laboratories to engage in collaborative
efforts with non-federal partners to
achieve the goals of technology transfer.
It affords discretion to Government
Owned Government Operated (GOGO)
and Government Owned Contractor
Operated (GOCO) laboratories to enter
into collaborative agreements with
many types of organizations. CRADAs
allow one or more Federal laboratories
and one or more non-federal parties (i.e.,
state or local government units;
industrial organizations; public and
private foundations; universities and
other non-profit organizations; and
other individuals who are licensees of
Government-owned inventions) to
collaborate to conduct specified
research and development-related
activities that are consistent with the
laboratory’s mission. Technical
assistance can also be provided to small
businesses. The legal authority for this
personnel exchange mechanism via
mutual collaboration on research and
development projects is 15 U.S.C.
3710a. DOE has recently used the
CRADA authority to enable a pilot
program for public-private
entrepreneurial partnerships between
Federal laboratories and the private
sector for the placement of personnel.
The DOE’s Lawrence Berkeley National
Laboratory provides a virtual home for
entrepreneurial clean-energy researchers
through ‘‘Cyclotron Road,’’ a new
public-private partnership to advance
energy technologies until they can
succeed beyond the laboratory. This
new, competitive opportunity provides
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clean energy researchers with business
mentorship and access to resources and
potential business partners to advance
innovation.
2. Entrepreneur Leave Program
(ELP)—Some Department of Energy
(DOE) GOCO laboratories have a
personnel pathway that permits a
limited number of contractor employees
to take entrepreneurial leave, also
known as Entrepreneurial Separation to
Transfer Technology, for a designated
period of time. Some laboratories offer
the employee assurance of appropriate
resources upon return to restart a
research program, while others offer
continued benefits while the employee
is on leave. These programs are
designed to facilitate commercialization
of technologies developed in a DOE
laboratory. Because these laboratories
are GOCO facilities, the programs are
subject to the policies and procedures of
the contractor organization.
3. Entrepreneur-in-Residence (EIR)—
EIRs are entrepreneurs from outside of
Government who want to use their skills
to benefit the public good. They are
typically mid- to senior-level
professionals and may be academics,
technology entrepreneurs, software
designers, policymakers, business
experts, or non-profit leaders who have
demonstrated a significant record of
innovative achievement in their field.
Funding models differ from agency to
agency, and some flexibility in
authorities can be applied in creating
these programs. Generally, these
programs run through state or non-profit
organizations that recommend or
otherwise place the personnel within
the technology transfer office. NIST
operates its EIR program under the
Partnership Intermediary Agreement
(PIA) authority, 15 U.S.C. 3715. The
program is conducted through a PIA
with the Maryland Technology
Development Corporation, which selects
and funds each EIR. The National
Institutes of Health (NIH) program is
currently conducted through a
contracting mechanism to place EIRs at
several of NIH institutes and centers.
Both programs rely on the expertise of
existing State-based programs with a
shared vision of commercializing
federal technologies and providing
expert support to potentially interested
parties working at these Federal
laboratories. Similarly, the Department
of Homeland Security (DHS) operates a
Loaned Executive Program that is open
to all interested executive-level talent;
DHS makes unpaid temporary
appointments under 5 U.S.C. 3109 to
place private sector consultants at
various DHS laboratories.
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4. Strategic Partnership Projects
(SPP)—This DOE authorization enables
a DOE GOCO laboratory to advise
United States companies or other
agencies and institutions on problems as
to which the laboratory has special
expertise or equipment. Work is
performed under a formal agreement on
a full cost recovery basis if the
assistance requires more than an
incidental amount of time.
Authorization: 48 CFR 970.5217–1—
Work for Others Program. In addition,
the Oak Ridge Institute for Science and
Education (ORISE), a DOE institution
operated under contract on behalf of
DOE, implements a range of education,
training, and workforce development
programs on behalf of DOE and a
number of other Federal sponsors.
Programs provide opportunities for
participants at a broad range of locations
including Federal research laboratories
(including GOCO), agency headquarters
offices, or universities. For example, an
SPP agreement between the United
States Department of Agriculture
(USDA) and ORISE authorizes ORISE to
provide qualified candidates for
research positions and to manage the
appointment process. ORISE-identified
candidates may be selected from a
variety of sources and placed into a
variety of research-related positions.
Appointed candidates placed by ORISE
have ‘‘program participant’’ status and
are not Federal employees.
5. Use of Facilities—Outside entities
such as universities, technology
incubators, private companies, and
individual inventors may be able to use
scientific equipment, specialized rooms,
testing centers, or other unique
experimental property or facilities of the
Federal laboratories, such as DOE’s
designated scientific user facilities
located across the DOE laboratories.
Such facility use is often at the
discretion of the Federal laboratory.
While this provides the opportunity for
outside entities to place personnel at
Government facilities, it does not
typically provide a mechanism for those
personnel to collaborate with
Government personnel (Federal
employees). DOE’s scientific user
facilities are open access, through a
proposal solicitation process, and do
enable collaboration with scientists and
engineers that are employees of the
laboratory contractor.
6. Visiting Scientist Programs—These
are arrangements allowing industry
personnel to work for limited periods of
time, usually 6–12 months, in a GOCO
laboratory. Depending on the program,
costs can be borne by the GOCO
laboratory or by the organization
sending the personnel, and intellectual
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property arrangements can be addressed
in exchange agreements. Because these
laboratories are GOCO facilities, they
are subject to the policies and
procedures of the contractor
organization. DOE’s national
laboratories operated as GOCOs and
NIH (e.g., Frederick National Laboratory
for Cancer Research) currently offer
visiting scientist opportunities.
7. Educational Partnership
Agreements (EPAs)—These agreements
are entered into between the
Department of Defense (Defense) and
educational institutions, including
colleges, universities, and local
education agencies, to encourage and
enhance the study of scientific
disciplines. Under an EPA, a Defense
laboratory director may make laboratory
personnel available to teach science
courses or to assist in the development
of science courses and materials for the
institution; provide for sabbatical
opportunities for faculty and internship
opportunities for students of the
institution; involve faculty and students
of the institution in Defense laboratory
projects, cooperate with the institution
in developing a program under which
students may be given academic credit
for work on Defense laboratory projects;
provide academic and career advice to
students of the institution; loan Defense
laboratory equipment to the institution
for any purpose and duration in support
of such agreement; and transfer
commonly used surplus computer or
other scientific equipment to the
institution. EPAs are authorized by 10
U.S.C. 2194.
8. Co-Locations—The USDA has a
number of laboratories that are colocated on University campuses, which
fosters a high level of scientific
exchange between the USDA scientists
and their university collaborators.
C. Proposed Regulation Implementing
15 U.S.C. 3712 Personnel Exchanges
The regulation proposed by NIST to
implement 15 U.S.C. 3712, in
consultation jointly with the
Department of Energy and the National
Science Foundation, is intended to
accomplish two main objectives. The
first objective is to clarify 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 second
objective is to increase the use of
existing authorities to implement
personnel exchange programs at Federal
Laboratories: (1) By utilizing the
existing CRADA authority to transfer
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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.
Under the proposed rule, 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, would be deleted. 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 would be revised to read
‘‘Personnel Exchanges Between Federal
Laboratories and Non-Federal Entities,’’
and five new sections would be added.
Section 17.1, Scope, sets forth the
scope of revised part 17, which is to
implement 15 U.S.C. 3712 and to clarify
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 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 reimburse a
Federal agency under a CRADA using
funds awarded to the contractor by that
agency.
Paragraph (b) of section 17.3 provides
that a Federal laboratory may exchange
personnel with a contractor under a
CRADA where the determination
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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 section 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 Agency, 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
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
or former employee who is an inventor.
Paragraph (a)(2) also provides that
funding may be provided by the nonfederal 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
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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,’’ 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.
In exchanging personnel with a
collaborating party under a CRADA, as
in any other exercise of the CRADA
authority, a Federal Agency 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 Agency, provides that a
Federal Agency 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 an Agency will
engage with the General Services
Administration (GSA) to transfer
funding for exchanged personnel and to
select and place Entrepreneurs-InResidence 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.
III. Request for Comments
NIST requests comments on this
proposed rule to encourage the
exchange of personnel among Federal
laboratories, State, local, and tribal
governments, academia and industry,
including small businesses. NIST is
requesting ideas and comments about
ways in which an integrated program
might be developed. We have included
some questions that you might consider
as you develop your comments.
1. Personnel exchanges commonly
occur in the course of CRADAs
involving Federal laboratories and
collaborating parties. Are there ways to
further promote personnel exchanges
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involving CRADAs? Are there ways to
use the CRADA authority to develop a
more integrated personnel exchange
program? Are there other mechanisms
that you find effective and/or easier to
use that should be included in this
regulation?
2. Do the proposed regulations
facilitate the exchange of personnel
between Federal laboratories and
academia and industry? Are there
additional mechanisms that should be
incorporated in this regulation?
When submitting comments,
remember to:
i. Identify the document by docket ID
number and other identifying
information (subject heading, Federal
Register date and page number).
ii. Please organize your comments by
referencing the specific question you are
responding to or the relevant section
number in the proposed regulatory text.
iii. Explain why you agree or disagree;
suggest alternatives and substitute
language for your requested changes.
iv. Describe any assumptions and
provide any technical information and/
or data that you used.
v. Provide specific examples to
illustrate your concerns and suggest
alternatives.
vi. Explain your views as clearly as
possible.
vii. Comments that contain profanity,
vulgarity, threats, or other inappropriate
language will not be considered.
viii. Make sure to submit your
comments by the comment period
deadline identified.
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IV. References
1. Federal Laboratory Consortium for
Technology Transfer. (n.d.) Technology
Transfer Mechanisms. Retrieved from
https://www.federallabs.org/education/t2mechanisms/.
2. Federal Laboratory Consortium for
Technology Transfer. (2011). Technology
Transfer Desk Reference. Retrieved from:
https://globals.federallabs.org/pdf/T2_
Desk_Reference.pdf.
3. Kalil, T. and Wong, J. (2015). Lab to
Market: Cross Agency Priority Goal
Quarterly Progress Update, Fiscal Year
2015 Quarter 4. Retrieved from: https://
www.performance.gov/node/3395/view?
view=public#progress-update.
4. Howieson, S.V. et al (2013). Federal
Personnel Exchange Mechanisms.
Retrieved from https://www.ida.org/∼/
media/Corporate/Files/Publications/
STPIPubs/D-4906.ashx.
V. Statutory and Executive Order
Reviews
Executive Order 12866
This rulemaking is a significant
regulatory action under Sections 3(f)(3)
and 3(f)(4) of Executive Order 12866, as
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it raises novel policy issues. This
rulemaking, however, is not an
‘‘economically significant’’ regulatory
action under Section 3(f)(1) of the
Executive Order, as it does not have an
effect on the economy of $100 million
or more in any one year, and it does not
have a material adverse effect on the
economy, a sector of the economy,
productivity, competition, jobs, the
environment, public health or safety, or
State, local, or tribal governments or
communities.
Executive Order 13132
This proposed rule does not contain
policies with Federalism implications as
defined in Executive Order 13132.
Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA)
requires the preparation and availability
for public comment of ‘‘an initial
regulatory flexibility analysis’’ which
will ‘‘describe the impact of the
proposed rule on small entities.’’ (5
U.S.C. 603(a)). Section 605 of the RFA
allows an agency to certify a rule, in lieu
of preparing an analysis, if the proposed
rulemaking is not expected to have a
significant economic impact on a
substantial number of small entities.
The Chief Counsel for Regulation of
the Department of Commerce certified
to the Chief Counsel for Advocacy of the
Small Business Administration (SBA)
that this rule, if adopted, would not
have a significant economic impact on
a substantial number of small entities.
The factual basis for this determination
is as follows:
A description of this proposed rule,
why it is being considered, and the
objectives of this proposed rule are
contained in the preamble and in the
SUMMARY section of the preamble. The
statutory basis for this proposed rule is
provided by 15 U.S.C. 3712. This
proposed rule, if implemented, is not
expected to directly affect any small
entities. Federal agencies that would be
directly affected by this rulemaking are
not small governmental jurisdictions,
small organizations, or small businesses,
as defined by the RFA. 5 U.S.C. 601.
Any requirements imposed by the
proposed rule would be obligatory only
upon Federal agencies. NIST does not
expect the issuance of the proposed rule
to result in any direct impacts to small
entities pursuant to the RFA. Small
entities could potentially benefit from
exchanging personnel with Federal
agencies.
The information provided above
supports a determination that this rule
would not have a significant economic
impact on a substantial number of small
entities. Because this rulemaking, if
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adopted, would directly affect Federal
agencies and not small entities, NIST
concludes the action would not result in
a significant economic impact on a
substantial number of small entities.
Therefore, an initial regulatory
flexibility analysis is not required and
none has been prepared.
Paperwork Reduction Act
This proposed 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 proposed 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.
For the reasons stated in the
preamble, the National Institute of
Standards and Technology proposes to
revise 15 CFR part 17 as follows:
PART 17—PERSONNEL EXCHANGES
BETWEEN FEDERAL LABORATORIES
AND NON-FEDERAL ENTITIES
Sec.
17.1
17.2
17.3
Scope.
Definitions.
Exchange of Federal laboratory
personnel with recipients of Federal
funding.
17.4 Personnel exchanges from a Federal
agency.
17.5 Personnel exchanges to a Federal
agency.
Authority: 15 U.S.C. 3712.
§ 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
accordance with applicable ethics
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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).
§ 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).
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§ 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 reimburse a Federal
agency under a CRADA using funds
awarded to the contractor by that
agency.
(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
VerDate Sep<11>2014
16:32 Jun 24, 2016
Jkt 238001
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.
§ 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
PO 00000
Frm 00007
Fmt 4702
Sfmt 9990
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 or former employee who is an
inventor.
(i) 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.
(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.
§ 17.5 Personnel exchanges to a Federal
agency.
For exchanges in which a Federal
Agency provides funds for the nonfederal personnel—
(a) Outside personnel with expertise
in scientific commercialization may be
brought in to a Federal laboratory
through the Presidential Innovation
Fellows program (see 5 CFR 213.3102(r))
for Entrepreneur-In-Residence programs
or similar, related programs.
(b) An Agency will engage with the
General Services Administration (GSA)
to transfer funding for exchanged
personnel, and will work with GSA to
select and place Entrepreneurs-InResidence 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.
Kent Rochford,
Associate Director for Laboratory Programs.
[FR Doc. 2016–14723 Filed 6–24–16; 8:45 am]
BILLING CODE 3510–13–P
E:\FR\FM\27JNP1.SGM
27JNP1
Agencies
[Federal Register Volume 81, Number 123 (Monday, June 27, 2016)]
[Proposed Rules]
[Pages 41468-41472]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14723]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF COMMERCE
National Institutes of Standards and Technology
15 CFR Part 17
[Docket No.: 160311228-6228-01]
RIN 0693-AB62
Technology Innovation--Personnel Exchanges
AGENCY: National Institute of Standards and Technology (NIST), United
States Department of Commerce.
ACTION: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: NIST is seeking comments on proposed regulations intended to
foster the exchange of scientific and technical personnel among
academia, industry, including particularly small businesses, and
Federal laboratories. Such exchanges are an effective means for
accelerating the transfer of Federal laboratory technology to benefit
the United States economy. An objective of this rulemaking is to
clarify the appropriate use of Cooperative Research and Development
Agreement 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. When the
comment period is concluded, NIST will analyze the comments received,
incorporate comments as appropriate, and publish a final regulation.
DATES: Comments must be received no later than July 27, 2016.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number: 160311228-6228-01, through the Federal e-Rulemaking
Portal: https://www.regulations.gov (search using the docket number).
Follow the online instructions for submitting comments. Identify the
document by docket ID number and other identifying information (subject
heading, Federal Register date and page number).
FOR FURTHER INFORMATION CONTACT: Courtney Silverthorn, via email:
courtney.silverthorn@nist.gov, or by telephone: 301-975-4189.
SUPPLEMENTARY INFORMATION:
I. General Information
Does this action apply to me?
This proposed rule may be of interest to you if you are an
educational institution, a company (including a small business firm),
or a nonprofit institution, that collaborates or would like to
collaborate with Federal Government employees on technology research
and development of mutual interest.
II. Background
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.
A. Notice of Proposed Rulemaking
Pursuant to authority delegated to it by the Secretary of Commerce,
NIST is providing notice to the public of proposed rulemaking to remove
outdated provisions in part 17 of title 15 of the Code of Federal
Regulations (CFR) regarding the licensing of inventions owned by the
Department, and to revise part 17 to address the use of personnel
exchange authorities and programs as authorized under 15 U.S.C. 3712,
which authorizes the establishment of a program to foster the exchange
of scientific and technical personnel among academia, industry, and
Federal laboratories.
Under the Stevenson-Wydler Act, several mechanisms have been
developed which are being used by various Federal agencies for
exchanging personnel with the public and private sectors. The proposed
rules will facilitate agencies' use of existing mechanisms, as well as
provide for more integrated programs intended to expand the exchange of
personnel as authorized under section 3712, in order to accelerate the
transfer of innovative technologies from Federal laboratories for the
benefit of the United States and its economy. Some current authorities
relevant to personnel exchange between Federal laboratories and non-
federal partners are described below.
B. Current Personnel Exchange Mechanisms
1. Cooperative Research and Development Agreement--The Cooperative
Research and Development Agreement (CRADA) is one of the principal
mechanisms used by Federal laboratories to engage in collaborative
efforts with non-federal partners to achieve the goals of technology
transfer. It affords discretion to Government Owned Government Operated
(GOGO) and Government Owned Contractor Operated (GOCO) laboratories to
enter into collaborative agreements with many types of organizations.
CRADAs allow one or more Federal laboratories and one or more non-
federal parties (i.e., state or local government units; industrial
organizations; public and private foundations; universities and other
non-profit organizations; and other individuals who are licensees of
Government-owned inventions) to collaborate to conduct specified
research and development-related activities that are consistent with
the laboratory's mission. Technical assistance can also be provided to
small businesses. The legal authority for this personnel exchange
mechanism via mutual collaboration on research and development projects
is 15 U.S.C. 3710a. DOE has recently used the CRADA authority to enable
a pilot program for public-private entrepreneurial partnerships between
Federal laboratories and the private sector for the placement of
personnel. The DOE's Lawrence Berkeley National Laboratory provides a
virtual home for entrepreneurial clean-energy researchers through
``Cyclotron Road,'' a new public-private partnership to advance energy
technologies until they can succeed beyond the laboratory. This new,
competitive opportunity provides
[[Page 41469]]
clean energy researchers with business mentorship and access to
resources and potential business partners to advance innovation.
2. Entrepreneur Leave Program (ELP)--Some Department of Energy
(DOE) GOCO laboratories have a personnel pathway that permits a limited
number of contractor employees to take entrepreneurial leave, also
known as Entrepreneurial Separation to Transfer Technology, for a
designated period of time. Some laboratories offer the employee
assurance of appropriate resources upon return to restart a research
program, while others offer continued benefits while the employee is on
leave. These programs are designed to facilitate commercialization of
technologies developed in a DOE laboratory. Because these laboratories
are GOCO facilities, the programs are subject to the policies and
procedures of the contractor organization.
3. Entrepreneur-in-Residence (EIR)--EIRs are entrepreneurs from
outside of Government who want to use their skills to benefit the
public good. They are typically mid- to senior-level professionals and
may be academics, technology entrepreneurs, software designers,
policymakers, business experts, or non-profit leaders who have
demonstrated a significant record of innovative achievement in their
field. Funding models differ from agency to agency, and some
flexibility in authorities can be applied in creating these programs.
Generally, these programs run through state or non-profit organizations
that recommend or otherwise place the personnel within the technology
transfer office. NIST operates its EIR program under the Partnership
Intermediary Agreement (PIA) authority, 15 U.S.C. 3715. The program is
conducted through a PIA with the Maryland Technology Development
Corporation, which selects and funds each EIR. The National Institutes
of Health (NIH) program is currently conducted through a contracting
mechanism to place EIRs at several of NIH institutes and centers. Both
programs rely on the expertise of existing State-based programs with a
shared vision of commercializing federal technologies and providing
expert support to potentially interested parties working at these
Federal laboratories. Similarly, the Department of Homeland Security
(DHS) operates a Loaned Executive Program that is open to all
interested executive-level talent; DHS makes unpaid temporary
appointments under 5 U.S.C. 3109 to place private sector consultants at
various DHS laboratories.
4. Strategic Partnership Projects (SPP)--This DOE authorization
enables a DOE GOCO laboratory to advise United States companies or
other agencies and institutions on problems as to which the laboratory
has special expertise or equipment. Work is performed under a formal
agreement on a full cost recovery basis if the assistance requires more
than an incidental amount of time. Authorization: 48 CFR 970.5217-1--
Work for Others Program. In addition, the Oak Ridge Institute for
Science and Education (ORISE), a DOE institution operated under
contract on behalf of DOE, implements a range of education, training,
and workforce development programs on behalf of DOE and a number of
other Federal sponsors. Programs provide opportunities for participants
at a broad range of locations including Federal research laboratories
(including GOCO), agency headquarters offices, or universities. For
example, an SPP agreement between the United States Department of
Agriculture (USDA) and ORISE authorizes ORISE to provide qualified
candidates for research positions and to manage the appointment
process. ORISE-identified candidates may be selected from a variety of
sources and placed into a variety of research-related positions.
Appointed candidates placed by ORISE have ``program participant''
status and are not Federal employees.
5. Use of Facilities--Outside entities such as universities,
technology incubators, private companies, and individual inventors may
be able to use scientific equipment, specialized rooms, testing
centers, or other unique experimental property or facilities of the
Federal laboratories, such as DOE's designated scientific user
facilities located across the DOE laboratories. Such facility use is
often at the discretion of the Federal laboratory. While this provides
the opportunity for outside entities to place personnel at Government
facilities, it does not typically provide a mechanism for those
personnel to collaborate with Government personnel (Federal employees).
DOE's scientific user facilities are open access, through a proposal
solicitation process, and do enable collaboration with scientists and
engineers that are employees of the laboratory contractor.
6. Visiting Scientist Programs--These are arrangements allowing
industry personnel to work for limited periods of time, usually 6-12
months, in a GOCO laboratory. Depending on the program, costs can be
borne by the GOCO laboratory or by the organization sending the
personnel, and intellectual property arrangements can be addressed in
exchange agreements. Because these laboratories are GOCO facilities,
they are subject to the policies and procedures of the contractor
organization. DOE's national laboratories operated as GOCOs and NIH
(e.g., Frederick National Laboratory for Cancer Research) currently
offer visiting scientist opportunities.
7. Educational Partnership Agreements (EPAs)--These agreements are
entered into between the Department of Defense (Defense) and
educational institutions, including colleges, universities, and local
education agencies, to encourage and enhance the study of scientific
disciplines. Under an EPA, a Defense laboratory director may make
laboratory personnel available to teach science courses or to assist in
the development of science courses and materials for the institution;
provide for sabbatical opportunities for faculty and internship
opportunities for students of the institution; involve faculty and
students of the institution in Defense laboratory projects, cooperate
with the institution in developing a program under which students may
be given academic credit for work on Defense laboratory projects;
provide academic and career advice to students of the institution; loan
Defense laboratory equipment to the institution for any purpose and
duration in support of such agreement; and transfer commonly used
surplus computer or other scientific equipment to the institution. EPAs
are authorized by 10 U.S.C. 2194.
8. Co-Locations--The USDA has a number of laboratories that are co-
located on University campuses, which fosters a high level of
scientific exchange between the USDA scientists and their university
collaborators.
C. Proposed Regulation Implementing 15 U.S.C. 3712 Personnel Exchanges
The regulation proposed by NIST to implement 15 U.S.C. 3712, in
consultation jointly with the Department of Energy and the National
Science Foundation, is intended to accomplish two main objectives. The
first objective is to clarify 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 second objective is to increase the use of existing
authorities to implement personnel exchange programs at Federal
Laboratories: (1) By utilizing the existing CRADA authority to transfer
[[Page 41470]]
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.
Under the proposed rule, 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, would be deleted. 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 would be revised to read ``Personnel Exchanges
Between Federal Laboratories and Non-Federal Entities,'' and five new
sections would be added.
Section 17.1, Scope, sets forth the scope of revised part 17, which
is to implement 15 U.S.C. 3712 and to clarify 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 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 reimburse a Federal agency under a CRADA using funds
awarded to the contractor by that agency.
Paragraph (b) of section 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 section 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 Agency, 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 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 or former 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,'' 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.
In exchanging personnel with a collaborating party under a CRADA,
as in any other exercise of the CRADA authority, a Federal Agency
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 Agency, provides
that a Federal Agency 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 an Agency 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.
III. Request for Comments
NIST requests comments on this proposed rule to encourage the
exchange of personnel among Federal laboratories, State, local, and
tribal governments, academia and industry, including small businesses.
NIST is requesting ideas and comments about ways in which an integrated
program might be developed. We have included some questions that you
might consider as you develop your comments.
1. Personnel exchanges commonly occur in the course of CRADAs
involving Federal laboratories and collaborating parties. Are there
ways to further promote personnel exchanges
[[Page 41471]]
involving CRADAs? Are there ways to use the CRADA authority to develop
a more integrated personnel exchange program? Are there other
mechanisms that you find effective and/or easier to use that should be
included in this regulation?
2. Do the proposed regulations facilitate the exchange of personnel
between Federal laboratories and academia and industry? Are there
additional mechanisms that should be incorporated in this regulation?
When submitting comments, remember to:
i. Identify the document by docket ID number and other identifying
information (subject heading, Federal Register date and page number).
ii. Please organize your comments by referencing the specific
question you are responding to or the relevant section number in the
proposed regulatory text.
iii. Explain why you agree or disagree; suggest alternatives and
substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information
and/or data that you used.
v. Provide specific examples to illustrate your concerns and
suggest alternatives.
vi. Explain your views as clearly as possible.
vii. Comments that contain profanity, vulgarity, threats, or other
inappropriate language will not be considered.
viii. Make sure to submit your comments by the comment period
deadline identified.
IV. References
1. Federal Laboratory Consortium for Technology Transfer. (n.d.)
Technology Transfer Mechanisms. Retrieved from https://www.federallabs.org/education/t2-mechanisms/.
2. Federal Laboratory Consortium for Technology Transfer. (2011).
Technology Transfer Desk Reference. Retrieved from: https://globals.federallabs.org/pdf/T2_Desk_Reference.pdf.
3. Kalil, T. and Wong, J. (2015). Lab to Market: Cross Agency
Priority Goal Quarterly Progress Update, Fiscal Year 2015 Quarter 4.
Retrieved from: https://www.performance.gov/node/3395/view?view=public#progress-update.
4. Howieson, S.V. et al (2013). Federal Personnel Exchange
Mechanisms. Retrieved from https://www.ida.org/~/media/Corporate/
Files/Publications/STPIPubs/D-4906.ashx.
V. Statutory and Executive Order Reviews
Executive Order 12866
This rulemaking is a significant regulatory action under Sections
3(f)(3) and 3(f)(4) of Executive Order 12866, as it raises novel policy
issues. This rulemaking, however, is not an ``economically
significant'' regulatory action under Section 3(f)(1) of the Executive
Order, as it does not have an effect on the economy of $100 million or
more in any one year, and it does not have a material adverse effect on
the economy, a sector of the economy, productivity, competition, jobs,
the environment, public health or safety, or State, local, or tribal
governments or communities.
Executive Order 13132
This proposed rule does not contain policies with Federalism
implications as defined in Executive Order 13132.
Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA) requires the preparation and
availability for public comment of ``an initial regulatory flexibility
analysis'' which will ``describe the impact of the proposed rule on
small entities.'' (5 U.S.C. 603(a)). Section 605 of the RFA allows an
agency to certify a rule, in lieu of preparing an analysis, if the
proposed rulemaking is not expected to have a significant economic
impact on a substantial number of small entities.
The Chief Counsel for Regulation of the Department of Commerce
certified to the Chief Counsel for Advocacy of the Small Business
Administration (SBA) that this rule, if adopted, would not have a
significant economic impact on a substantial number of small entities.
The factual basis for this determination is as follows:
A description of this proposed rule, why it is being considered,
and the objectives of this proposed rule are contained in the preamble
and in the SUMMARY section of the preamble. The statutory basis for
this proposed rule is provided by 15 U.S.C. 3712. This proposed rule,
if implemented, is not expected to directly affect any small entities.
Federal agencies that would be directly affected by this rulemaking are
not small governmental jurisdictions, small organizations, or small
businesses, as defined by the RFA. 5 U.S.C. 601. Any requirements
imposed by the proposed rule would be obligatory only upon Federal
agencies. NIST does not expect the issuance of the proposed rule to
result in any direct impacts to small entities pursuant to the RFA.
Small entities could potentially benefit from exchanging personnel with
Federal agencies.
The information provided above supports a determination that this
rule would not have a significant economic impact on a substantial
number of small entities. Because this rulemaking, if adopted, would
directly affect Federal agencies and not small entities, NIST concludes
the action would not result in a significant economic impact on a
substantial number of small entities. Therefore, an initial regulatory
flexibility analysis is not required and none has been prepared.
Paperwork Reduction Act
This proposed 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 proposed 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.
For the reasons stated in the preamble, the National Institute of
Standards and Technology proposes to revise 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 agency.
17.5 Personnel exchanges to a Federal agency.
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 accordance with applicable ethics
[[Page 41472]]
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 reimburse a Federal agency
under a CRADA using funds awarded to the contractor by that agency.
(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 or former employee who is an
inventor.
(i) 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.
(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 agency.
For exchanges in which a Federal Agency 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 (see 5 CFR 213.3102(r)) for
Entrepreneur-In-Residence programs or similar, related programs.
(b) An Agency will engage with the General Services Administration
(GSA) to transfer funding for exchanged personnel, and will work with
GSA 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.
Kent Rochford,
Associate Director for Laboratory Programs.
[FR Doc. 2016-14723 Filed 6-24-16; 8:45 am]
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