ML20035H054

Request for OMB Review & Supporting Statement Re 10CFR81, Std Specs for Granting of Patent Licenses. Estimated Respondent Burden Is 1 H

ML20035H054
Person / Time
Issue date:	04/23/1993
From:	Crawford G NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
To:
References
OMB-3150-0120, OMB-3150-120, NUDOCS 9305030041
Download: ML20035H054 (10)

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" Patents, Licenses, License Agreements" 10 CFR 81 establishes the standard specifications for the issuance of licenses to rights j

in inventions covered by patents or patent applications vested in the United States, as represented by the NRC.

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SUPPORTING STATEMENT FOR 10 CFR PART 81 STANDARD SPECIFICATIONS FOR THE GRANTING OF PATENT LICENSES (3150-0121)

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Description of the Information Collection Section 81.20 (a) (5)

Non-exclusive license holders are required to submit periodic reports, at least annually, on efforts to bring. the invention to a point of practical application and the extent to t

which license holders continue to make the benefits of the invention reasonably accessible to the public.

i Section 81. 32 (a) (2)

NRC inventions may be available for the grant of limited exclusive licenses to responsible applicants who will make its benefits 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

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in making the invention publicly accessible and reasonably available for the granting of non-exclusive licenses under S 81.20.

Under that provision, the licensee may have a nonexclusive license if the licensee continues to make the invention publicly accessible.

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 7

Commission notice to successors of the licensee's business.

i Section 81. 32 (a) (9) Exclusive licensees can issue sublicenses only i

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.

l Section 81. 3 2 (a ) (12 )

Before modifying or revoking any license under this subpart, the Commission will mail to the licensee and t

a-.

B 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 sapply to the Government copies of all pleadings and other papers filed in any such suit, as

• ell 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 i

right to surrender the license and be relieved from any further obligation thereunder.

Section 81. 3 2 (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 i

l provide the basis for gianting the requested license.

A.

JUSTIFICATION 1.

Need and Use for the Collection of Information.

NRC inventions may be made available by exclusive (S 81.32) or non-exclusive (S 81.20) license to applicants who will practice the invention and make its benefits reasonably accessible to the public.

In order to determine whether the NRC grants a license or continues it in effect, the NRC needs and uses 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.

Other incidental information is also required. Additional information regarding the applicant's identity, location and ability to develop the invention and use the rights i

which may be granted are required of an applicant for an exclusive license. (S 81.40) Periodic reports are then 2

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i required of licensees to ensure that the license is being used in the manner previously intended. (SS 81.20(a) (5) l and 81. 32 (a) (10) ).

i The NRC needs and uses the information required under S i

81. 3 2 (a) ( 8 )

and S

81. 3 2 (a) (9 )

which covers license extensions, sublicensing assignments and transfers; under j

S 81. 32 (a) (10) for review by the NRC patent counsel to determine the advisability of extending the term of a license, to keep track of any transfer of the license, and to ensure the licensee's continued qualification for the exclusive license; under S

81. 32 (a) (12 )

on modifications and revocations; under S 81.32 (a) (13) on patent infringement suits; under S

81. 32 (a) (14 )

on surrendering licenses to allow the NRC to perform its license monitoring functions, to permit revision or revocation of the license when appropriate, to be kept informed of any litigation concerning the licensed patent, and to maintain the agency's licensing records.

l The application for an exclusive or non-exclusive license (S 81.40) is reviewed by the NRC patent counsel to i

determine whether a license may be granted and whether it should be granted to the applicant as requested.

i Failure to collect this information would prevent the NRC from insuring that NRC patents are properly issued under l

license to and used by the licensee as authorized by i

section 156 of the Atomic Energy Act of 1954, as amended.

i 2.

Reduction of Burden Throuch Inforn.ation Technoloov.

The sporadic nature and extremely small potential frequency of submissions prohibits the efficient use of information technology.

However, there are no legal or i

administrative obstacles to its use if so desired by any i

respondent-3.

Ef fort to Identify Duplication. The requirement to submit l

reports pursuant to SS 81.20 and 81.32 does not duplicate or overlap other information collections by the NRC or other Government agencies.

Some of the information required in an application for a license (S 81.40) may be available as a result of other Government collections of information.

For example, an applicant for an exclusive or non-exclusive license may be identified in other Government records as a small business or a minority business enterprise.

However, the remainder of the information to be collected is unique to the NRC patent and its licensed use.

4.

Ef fort to Use Similar Information. The information needed to determine if the NRC should grant or continue a l

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P license is not collected by any other Government agency in a readily usable form.

5.

Effort to Reduce Small Business Burden. Currently there are no applicants or exclusive /non-exclusive licensees.

6.

Consecuences of Less Freauent Collection. The collection

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frequency contained in these requirements is deemed the minimum necessary to achieve the objectives of the requirements.

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7.

Circumstances Which Justify Variation from OMB l

Guidelines.

The requirements under SS 81.20, 81.32, i

and 81.40 conform to the OMB Guidelines in 5 CFR 1320.6.

l 8.

Consultations Outside the NRC.

There has been no consultation with parties outside the NRC on these requirements since the publication of this rule on March 20, 1973.

9.

Confidentiality of Information.

The NRC provides no pledge of confidentiality for these collections of information.

10.

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

11.

Estimated Annualized Cost to the Federal Government.

Currently, it is anticipated that no reports will be submitted under these requirements and, therefore, there i

is a zero burden on the Government.

However, if reports l

were submitted, the following costs are anticipated:

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a. It takes the NRC patent counsel approximately 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br />

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to review a report submitted pursuant to S 81.20.

At-

$123 per professional staff hours, total annual cost to the NRC could be $492.00.

b. It takes the NRC patent counsel approximately 5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> to review information supporting a

request for an l

extended license period (S

81. 32 ( a) ( 2 ) ) ; 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> to review a license assignment or transfer notice (S

81. 3 2 ( a) (8) ; 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br /> to review a copy of any sublicense a

or assignment (S 81.32 (a) (9) ) ; 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> to review a i

practical application progress report (S 81. 32 (a) (10)) ;

2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> to prepare and give written notice to the licensee about the intention to modify or revoke the license (S 81.32(a)(12)); up to 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br />, depending on the complexity of the

case, to review court pleadings

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(S 81. 31(a) (13) ) ; and 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> to review a licensee's surrendered license (S 81.32 (a) (14)).

At

$123 per l

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l professional staf f hour, total annual cost to the NRC could be $2,952.00.

c. It takes the patent counsel approximately 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> to review an application (5

81.40).

At

$123 per l

professional staff hour, total annual cost to the NRC is i

estimated to be $492.00.

5 d.

Total annual cost to the NRC for all of these requirements is estimated to be $3,936.00 per respondent.

12.

Estimate of Burden.

As under paragraph 11 ' above, no reports are anticipated under these requirements.

If they were submitted, the total anticipated burden and costs to a respondent are 35 hours4.050926e-4 days <br />0.00972 hours <br />5.787037e-5 weeks <br />1.33175e-5 months <br /> or $4,305.

Burden and costs are broken out as follows-i a.

The estimated annual burden each for--

licensees under 5 81.20 is estimated to be 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br />; l

licensees under 5 81.32 (a) (2) is estimated to be 5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br />; licensees under 5 81.32 (a) (8) is estimated to l

be 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br />; 4

licensees under 5 81.32 (a) (9) is estimated to be 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br />; licensees under 9 81.32 (a) (10) is estimated to be 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br />; licensees under 5 81.32 (a) (12) is estimated to be 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br />; licensees under 5 81.32 (a) (13) is estimated to be 9 hours1.041667e-4 days <br />0.0025 hours <br />1.488095e-5 weeks <br />3.4245e-6 months <br />; licensees under S 81.32 (a) (14) is estimated to be 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br />; and l

licensees under 5 81.40 is estimated to be 6

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hours.

b.

The estimated annual cost per respondent to respond to the collection for-- '

i licensees under 5 81.20 is estimated to be

$246.00; licensees under S 81.32(a) (2) is estimated to

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be $615.00.

licensees under S 81.32 (a) (8) is estimated to be $246.00; j

licensees under S 81.32(a) (9) is estimated to be $369.00; I

licensees under S 81.32 (a) (10) is estimated'to I

be $246.00; licensees under S 81.32 (a) (12) is estimated to be $246.00; licensees under S 81.32 (a) (13) is estimated to be $1107.00; i

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i licensees under S 81.32 (a) (14) is estimated to be 492.00; and licensees under S 81.40 is estimated to be

$738.00.

13.

Reasons for Chance in Burden. This renewal represents no increase in the burden on potential respondents.

Since no submittals were made, nor are anticipated, the actual burden is anticipated to be zero.

14.

Publication for Statistical Use.

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

i B.

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

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6

i i

NUCLEAR REGULATORY COMMISSION i

Documents Containing Reporting or Recordkeeping Requirements:

Office of Management and Budget (OMB) Review f

i AGENCY:

Nuclear Regulatory Commission (NRC)

ACTION:

Notice of the OMB review of information collection

SUMMARY

The NRC has recently submitted to OMB for review the i

following proposal for the collection of information l

under the provisions of Paperwork Reduction Act t

i t

(44 U.S.C.

Chapter 35).

l 1.

Type of submission, new, revision, or extension:-

l Extension.

2.

The title of the information collection:

10 CFR Part 81--Standard Specifications for the f

Granting of Patent Licenses 3.

The form number if applicable:

Not applicable 4.

How often the collection is required:

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Applications for licenses are submitted once.

Other reports are submitted annually or as other i

events require.

5.

Who will be required or asked to report:

I Applicants for and holders of NRC licenses f

to NRC inventions f

6.

An estimate of the number of responses:

Zero 7.

An estimate of the total number of hours needed j

i to complete the requirement or request:

Zero I

I f

j t

8.

An indication of whether Section 3504(h),

Pub.

L.96-511 applies:

Not applicable 9.

Abstract:

10 CFR Part 81 establishes the standard specifications for the issuance of licenses to rights in inventions covered by patents or patent applications vested in the United States, as represented by or in the custody of the Commission and other patents in which the Commission has legal rights.

Copies of the submittal may be inspected or obtained for a fee from the NRC Public Document Room, 2120 L Street, Lower Level, N.W.,

Washington, D.C.

20555.

Comments and questions should be directed to the OMB reviewer:

Ronald Minsk Of fice of Inf ormation and Regulatory Af f airs (3150-0121)

NEOB-3019 office of Management and Budget Washington, D.C.

20503 Comments can also be submitted by telephone at (202) 395-3084.

The NRC Clearance Officer is Brenda J.

Shelton, (301) 492-8132.

Dated at Bethesda, Maryland thi O day of 1993.

L/

/

F the Nuclear Regulatory Commission

/ A, i

l

---,y 7

' Gerald F. Cranford, Deqygnated Sepior i

Official for Information Resources Management i

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