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Federal Register / Vol. 86, No. 1 / Monday, January 4, 2021 / Proposed Rules regulatory requirementthese revisions will all increase the ability for a small entity to more effectively attract outside funding for their inventions. Proposed revisions to 37 CFR 401.9 and 401.15
will clarify the process by which small entities and sole proprietors may request title to their inventions when not otherwise automatically granted title by the funding agreement. While the requirements for small business considerations in licensing have been significantly streamlined, the proposed revision greatly increases the clarity of these requirements while not affecting any of the statutory requirements that a contractor must fulfill with regard to small entities. Finally, revisions to 37
CFR 404.7 will make it easier for small entities to seek exclusive, co-exclusive, or partially exclusive licenses.
The information provided above supports a determination that this proposed rule would not have a significant economic impact on a substantial number of small entities.
Because this rulemaking, if implemented, is not expected to have a significant economic impact on any small entities, 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 37 CFR Parts 401 and 404
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 amend 37 CFR parts 401 and 404 as follows:

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PART 401RIGHTS TO INVENTIONS
MADE BY NONPROFIT
ORGANIZATIONS AND SMALL
BUSINESS FIRMS UNDER
GOVERNMENT GRANTS, CONTRACTS, AND COOPERATIVE
AGREEMENTS
1. The authority citation for 37 CFR
part 401 continues to read as follows:

Authority: 35 U.S.C. 206; DOO 302A.

2. Revise 401.1 to read as follows:

401.1

Scope.

a This part implements 35 U.S.C.
200 through 204 and is applicable to any funding agreement with a nonprofit organization or small business firm as defined by 35 U.S.C. 201, except for an agreement made primarily for educational purposes under 35 U.S.C.
212. This part also applies to any funding agreement with business firms regardless of size in accordance with section 1, paragraph b4 of Executive Order 12591, as amended by Executive Order 12618, unless directed otherwise pursuant to NASA or DOE vesting statutes.
b This regulation supersedes OMB
Circular A124 and shall take precedence over any regulations or other guidance dealing with ownership of inventions made by businesses and nonprofit organizations which are inconsistent with it. Only deviations requested by a contractor and not inconsistent with Chapter 18 of Title 35, United States Code, may be made without approval of the Secretary.
Modifications or tailoring of clauses as authorized by 401.5 or 401.3, when alternate provisions are used under 401.3a1 through 6, are not considered deviations requiring the Secretarys approval.
c This part is not intended to apply to arrangements under which nonprofit organizations, small business firms, or others are allowed to use governmentowned research facilities and normal technical assistance provided to users of those facilities, whether on a reimbursable or nonreimbursable basis.
This part is also not intended to apply to arrangements under which sponsors reimburse the government or facility contractor for the contractor employees time in performing work for the sponsor. Such arrangements are not considered funding agreements as defined at 35 U.S.C. 201b and 401.2a.
3. Amend 401.2 by revising the introductory text and paragraphs k through o to read as follows:

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401.2

39

Definitions.

In addition to the definitions in 35
U.S.C. 201, as used in this part

k The term electronically filed means any submission of information transmitted by an electronic system.
l The term electronic system means a software-based system approved by the agency for the transmission of information.
m The term patent application or application for patent may be the following:
1 A United States provisional application as defined in 37 CFR
1.9a2 and filed under 35 U.S.C.
111b; or 2 A United States nonprovisional application as defined in 37 CFR
1.9a3 and filed under 35 U.S.C.
111a; or 3 A patent application filed in a foreign country or an international patent office; or 4 A patent application filed under the Patent Cooperation Treaty as defined in 37 CFR 1.9b which designates the United States; or 5 An application for a Plant Variety Protection certificate.
n The term initial patent application means, as to a given subject invention:
1 The first United States provisional application as defined in 37 CFR
1.9a2 and filed under 35 U.S.C.
111b; or 2 The first United States nonprovisional application as defined in 37 CFR 1.9a3 and filed under 35
U.S.C. 111a; or 3 The first patent application filed in a foreign country or an international patent office; or 4 The first patent application filed under the Patent Cooperation Treaty as defined in 37 CFR 1.9b which designates the United States; or 5 The first application for a Plant Variety Protection certificate.
o The term statutory period means the one-year period before the effective filing date of a claimed invention in a patent application during which exceptions to prior art exist per 35
U.S.C. 102b as amended by the LeahySmith America Invents Act, Public Law 11229.
401.3

Amended
4. Amend 401.3 as follows:
a. Remove 401.5g and add in its place 401.5f in paragraph c3;
b. Remove of Commerce from the fourth sentence of paragraph f; and c. Remove paragraph g and redesignate paragraphs h and i as paragraphs g and h.

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