Technology Innovation-Personnel Exchanges, 41468-41472 [2016-14723]

Download as PDF 41468 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 Another objective of this rulemaking is to remove outdated regulations addressing the licensing of inventions owned by the Department of Commerce.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: http:// www.regulations.gov (search using the docket number). Follow the online instructions for submitting comments. mstockstill on DSK3G9T082PROD with PROPOSALS SUMMARY: VerDate Sep<11>2014 16:32 Jun 24, 2016 Jkt 238001 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 PO 00000 Frm 00003 Fmt 4702 Sfmt 4702 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 E:\FR\FM\27JNP1.SGM 27JNP1 mstockstill on DSK3G9T082PROD with PROPOSALS Federal Register / Vol. 81, No. 123 / Monday, June 27, 2016 / Proposed Rules 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. VerDate Sep<11>2014 16:32 Jun 24, 2016 Jkt 238001 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 PO 00000 Frm 00004 Fmt 4702 Sfmt 4702 41469 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 E:\FR\FM\27JNP1.SGM 27JNP1 mstockstill on DSK3G9T082PROD with PROPOSALS 41470 Federal Register / Vol. 81, No. 123 / Monday, June 27, 2016 / Proposed Rules 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 VerDate Sep<11>2014 16:32 Jun 24, 2016 Jkt 238001 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 PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 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 E:\FR\FM\27JNP1.SGM 27JNP1 Federal Register / Vol. 81, No. 123 / Monday, June 27, 2016 / Proposed Rules 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. mstockstill on DSK3G9T082PROD with PROPOSALS IV. References 1. Federal Laboratory Consortium for Technology Transfer. (n.d.) Technology Transfer Mechanisms. Retrieved from http://www.federallabs.org/education/t2mechanisms/. 2. Federal Laboratory Consortium for Technology Transfer. (2011). Technology Transfer Desk Reference. Retrieved from: http://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 VerDate Sep<11>2014 16:32 Jun 24, 2016 Jkt 238001 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 PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 41471 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 E:\FR\FM\27JNP1.SGM 27JNP1 41472 Federal Register / Vol. 81, No. 123 / Monday, June 27, 2016 / Proposed Rules 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). mstockstill on DSK3G9T082PROD with PROPOSALS § 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]


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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.

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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: http://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 http://www.federallabs.org/education/t2-mechanisms/.
2. Federal Laboratory Consortium for Technology Transfer. (2011). 
Technology Transfer Desk Reference. Retrieved from: http://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]
 BILLING CODE 3510-13-P