Final 2023 Supporting Statement 10 CFR Part 81 (1) Update 1-24

FINAL SUPPORTING STATEMENT
FOR
10 CFR PART 81
STANDARD SPECIFICATIONS FOR THE GRANTING OF PATENT LICENSES
(3150-0121)
EXTENSION
Description of the Information Collection
The Nuclear Regulatory Commission (NRC) may grant licenses to its patented inventions.
Licenses are ordinarily available to all responsible applicants. An applicant may be granted an
exclusive license for a limited time; however, to provide a financial incentive to develop the
technology to a point where it can be practically applied.
All license applicants must report information that includes the nature and type of their
business, the purpose for which the patent will be used, and the location where it will be used.
Applicants who request exclusive use of the patent must report additional information regarding
status; specifically, whether they are a small business, minority-owned, located in a surplus
labor area, or located in a low-income area. Applicants for exclusive licenses must also include
information to justify the need for a financial incentive by describing the time, expenditures, and
all actions that will be necessary to bring the invention to the point where it can be practically
applied. In addition, an applicant must explain how widely the invention is expected to be used
in private industry and the Government.
All patent-license holders must submit periodic reports on efforts to bring the invention to a point
of practical application and the extent to which they are making the benefits of the invention
reasonably accessible to the public. Exclusive license holders who seek to extend their
license’s duration must submit sufficient information to show that the additional time is
necessary to permit the license holder to enter the market and recoup its investment by bringing
the invention to a point where it can be practically applied. If an exclusive license holder initiates
a patent infringement lawsuit, it must promptly submit to the Government of the United States,
upon request, copies of all pleadings, evidence and other filings in the lawsuit.
A.
.

JUSTIFICATION
1.

Need for and Practical Utility of the Collection of Information
The NRC must collect the information to make determinations on whether
to grant, establish terms, or take other actions on the licensing of NRC
patents in accordance with standard specifications in 10 CFR. Part 81.
Failure to collect this information would prevent the NRC from making the
regulatory determinations required under these regulations, which have
been promulgated under the authority of section 156 of the Atomic
Energy Act of 1954, as amended. The regulations which specify the
information required to be submitted by license applicants and licensees
are below.

-2Section 81.20(a)(5) Non-exclusive license holders must submit reports
annually (unless otherwise specified in the license) on efforts to bring the
invention to a point of practical application and the extent to which license
holders continue to make the benefits of the invention reasonably
accessible to the public.
Section 81.20(a)(10) Before revoking or restricting any license granted
pursuant to this subpart, the Commission shall mail to the licensee and
any sublicensee of record, at the last address filed with the Commission,
a written notice of the Commission’s intention to revoke or restrict the
license, and the licensee and any sublicensee shall be allowed 30 days
after the mailing of such notice, or within such period as may be granted
by the Commission, to remedy any breach of any covenant or agreement
as referred to in paragraph(a)(8)(iii) of this section, or to show cause why
the license should not be revoked or restricted.
Section 81.32(a)(2) NRC inventions may be available for the grant of
limited exclusive licenses to responsible applicants who will make the
benefits of these inventions practically applicable and publicly accessible.
The length of the license will be negotiated (but will not exceed 5 years)
and include a period of exclusivity specified in it, which relates to the
period necessary to provide a reasonable incentive for the licensee to
invest the necessary risk capital to make the invention practically
applicable. The license cannot be extended unless the Commission
determines, based on a written submission supported by a factual
showing, that a longer period is necessary to permit the licensee to enter
the market and recoup the investment in bringing the invention to the
point of practical application. The license must also include a terminal
portion that is sufficient to make the invention reasonably available for the
granting of nonexclusive licenses under § 81.20, during which the
licensee may have a nonexclusive license if the licensee continues to
make the invention reasonably accessible to the public.
Section 81.32(a)(8) The license can be extended to wholly owned
subsidiaries of the licensee but cannot be assigned or transferred without
Commission approval, unless assignments are made upon Commission
notice to successors of the licensee's business.
Section 81.32(a)(9) Exclusive licensees can issue sublicenses only upon
Commission approval. Such a sublicense or assignment is subject to the
terms and conditions of the exclusive license, including all rights retained
by the Government, and a copy of each sublicense or assignment must
be provided to the Commission.
Section 81.32(a)(10) A holder of an exclusive license to NRC inventions
must submit periodic reports on efforts to achieve practical application of
the invention and the extent to which a holder continues to make the
benefits of the invention reasonably accessible to the public.

-3Section 81.32(a)(12) Before modifying or revoking any license under this
subpart, the Commission will mail to the licensee and any sublicensee at
the last address filed with the Commission a written notice of the
Commission's intention to modify or revoke the license. The licensee and
any sublicensee is then given 30 days after the notice is mailed, or within
any period granted by the Commission, to remedy any breach of
covenant or agreement in paragraph (a)(11)(iv) of this section or to show
cause why the license should not be modified or revoked.
Section 81.32(a)(13) An exclusive licensee has the right to sue at its own
expense any party who infringes the rights included in the license and the
licensed patent. Upon consent of the Attorney General, the licensee may
join the Government as a complainant in such suit, but without expense to
the Government so that the licensee shall pay costs and any final
judgment or decree that may be rendered against the Government in
such a suit. The Government has an absolute right to intervene in any
such suit at its own expense. Upon request, the licensee is obligated to
promptly supply to the Government copies of all pleadings and other
papers filed in any such suit, as well as evidence from proceedings
relating to the licensed patent. If, as a result of any such litigation, the
patent is declared invalid, the licensee has the right to surrender the
license and be relieved from any further obligation thereunder.
Section 81.32(a)(14) A licensee can surrender the license any time
before termination of the license upon notice to the Commission and
approval of the Commission, but the licensee will not be relieved of the
obligations thereunder without Commission approval.
Section 81.40 Applicants for exclusive and non-exclusive licenses to
NRC inventions are required to provide information which may provide
the basis for granting the requested license.
2.

Agency Use of Information
In order to determine whether to grant a license or to modify or revoke a
license, either as an exclusive license or a non-exclusive license, the
NRC must make regulatory findings that require the collection of
information on invention and patent number; the applicant's identity and
citizenship; the applicant's business; the purpose for which the license is
desired and the field of use in which the applicant intends to practice the
invention; and the geographic area in which the applicant will practice the
invention as well as other incidental information. The NRC may require
additional information regarding the applicant's identity and location, as
well as its ability to develop the invention and use the rights which may be
granted, so that the agency can make the regulatory findings necessary
for an exclusive license. The NRC also requires exclusive licensees to
submit periodic reports containing information on efforts to achieve a
practical application of an invention and make it accessible to the public
so that the agency can determine whether the license should be modified
or revoked.
The NRC requires the information to make the regulatory determinations
required for approval of license extensions, sublicensing assignments,

-4and license transfers. The NRC also requires information to allow the
agency to perform its license monitoring functions, permit revision or
revocation of the license when appropriate, be kept informed of any
litigation concerning the licensed patent and maintain the agency's
licensing records.
3.

Reduction of Burden Through Information Technology
The NRC has issued Guidance for Electronic Submissions to the NRC
which provides direction for the electronic transmission and submittal of
documents to the NRC. Electronic transmission and submittal of
documents can be accomplished via the following avenues: the Electronic
Information Exchange (EIE) process, which is available from the NRC's
“Electronic Submittals” Web page, by Optical Storage Media (OSM) (e.g.,
CD-ROM, DVD), by facsimile or by e-mail. It is currently estimated that
approximately 100% of the potential responses will be filed electronically.
There are no legal obstacles to reducing the burden associated with this
information collection. The NRC encourages respondents to use
information technology when it would be beneficial to them.

4.

Effort to Identify Duplication and Use Similar Information
No sources of similar information are available. There is no duplication of
requirements.

5.

Effort to Reduce Small Business Burden
Currently there are no applicants or exclusive/non-exclusive licensees
and, thus, no anticipated burden on small businesses.

6.

Consequences to Federal Program or Policy Activities if the Collection Is
Not Conducted or Is Conducted Less Frequently
The collection frequency is deemed the minimum necessary to achieve
the objectives of the requirements. Less frequent collection of information
would prevent the NRC from obtaining information necessary to
implement its regulations in 10 CFR Part 81.

7.

Circumstances Which Justify Variation from OMB Guidelines
Not applicable.

-58.

Consultations Outside the NRC
Opportunity for public comment on the information collection
requirements for this clearance package was published in the Federal
Register on September 18, 2023 (88 FR 63981). As no potential
respondents have been identified, the NRC was unable to conduct any
public consultations beyond the publishing of the Federal Register
Notice. No comments were received.

9.

Payment or Gift to Respondents
Not applicable.

10.

Confidentiality of Information
Confidential and proprietary information is protected in accordance with
NRC regulations at 10 CFR 9.17(a) and 10 CFR 2.390(b).

11.

Justification for Sensitive Questions
No questions of a sensitive nature are asked under these requirements.

12.

Estimated Burden and Burden Hour Cost
The NRC estimates that it will receive 3.5 responses from 10
respondents annually under this information collection. The estimated
total annual burden is 10 hours or $3,000 (at $300 per hour). See Table
1.
The $300 hourly rate used in the burden estimates is based on the Nuclear
Regulatory Commission’s fee for hourly rates as noted in 10 CFR 170.20
“Average cost per professional staff-hour.” For more information on the
basis of this rate, see the Revision of Fee Schedules, Fee Recovery for
Fiscal Year 2023 (88 FR 39120, June 15, 2023).

13.

Estimate of Other Additional Costs
No other additional costs are anticipated.

14.

Estimated Annualized Cost to the Federal Government
The staff has developed estimates of annualized costs to the Federal
Government related to the conduct of this collection of information.
These estimates are based on staff experience and subject matter
expertise and include the burden needed to review, analyze, and process
the collected information and any relevant operational expenses.
Based on the estimated number of annual responses received, the
following costs to the Government are anticipated:
Activity
Review a report submitted on a
nonexclusive license

Estimated Review
Time
4 hours

Estimated
Cost
$1,200

-6Review information supporting a
request for an extended license
period
Review a license assignment or
transfer notice
Review a copy of any
sublicense or assignment
Review a practical application
progress report
Prepare and give written notice
to the licensee about the
intention to modify or revoke the
license
Review court pleadings

5 hours

$1,500

2 hours

$600

3 hours

$900

4 hours

$1,200

Subject to
complexity

Review a licensee’s
surrendered license
Review an application
The total annual cost to the NRC for all of these requirements is estimated
to be approximately $5,400.
15.

Reasons for Change in Burden or Cost
This renewal reflects a more accurate estimate, in Table 1, of this
clearance. 10 respondents that comes from the 10 different subparts of
the collection (i.e., it assumes separate respondents for each aspect of
the collection), and the 3.5 responses annually is the average number of
responses that would be expected annually under these collections to
report, given their different frequencies, NRC estimates they were all
active at once and all had only 1 respondent each. This is instead of
treating all the same information collection response activity as part of “1
response” submitted by “1 respondent” in the previous clearance.
There has, however, been an increase in the NRC’s professional hourly
fee rate from $278 to $300.

16.

Publication for Statistical Use
The collections of information under these requirements will not be
published for statistical use.

17.

Reason for Not Displaying the Expiration Date
The recordkeeping and reporting requirements for this information
collection are associated with regulations and are not submitted on
instruments such as forms or surveys. For this reason, there are no data
instruments on which to display an OMB expiration date. Further,
amending the regulatory text of the CFR to display information that, in an
annual publication, could become obsolete would be unduly burdensome
and difficult to keep current.

18.

-7Exceptions to the Certification Statement
None.

B.

COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS
Statistical methods are not used in this collection of information.

-8TABLE 1
LICENSEE REPORTING BURDEN, 10 CFR PART 81
PATENT LICENSES

Section

Description

Respondents

Annual
responses

10 CFR
81.20(a)(5)
10 CFR
81.20(a)(10)
10 CFR
81.32(a)(2)
10 CFR
81.32(a)(8)
10 CFR
81.32(a)(9)
10 CFR
81.32(a)(10)
10 CFR
81.32(a)(12)

Reports on nonexclusive
licenses
Revocation of
nonexclusive licenses
Extensions of exclusive
licenses
License transfer of
exclusive licenses
Sublicenses for
exclusive licenses
Reports on exclusive
licenses
License
revocation/modification
of exclusive licenses
Patent lawsuits for
exclusive licenses
Surrender of exclusive
licenses
License applications
(nonexclusive and
exclusive licenses)

1

10 CFR
81.32(a)(13)
10 CFR
81.32(a)(14)
10 CFR 81.40
TOTAL

Total
burden

Cost at
$300/hr

1

Burden
per
response
2

2.0

$600

1

0.2

2

0.4

$120

1

0.2

5

1.0

$300

1

0.2

2

0.4

$120

1

0.2

3

0.6

$180

1

1

2

2.0

$600

1

0.2

2

0.4

$120

1

0.1

9

0.9

$270

1

0.2

4

0.8

$240

1

0.2

6

1.2

$360

10

3.5

9.7

$2,910