ML20205H621

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

ML20205H621
Person / Time
Issue date:	04/05/1999
From:	Shelton B NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
To:
Shared Package
ML20205H429	List: ML20205H425 ML20205H621
References
OMB-3150-0121, OMB-3150-121, NUDOCS 9904090004
Download: ML20205H621 (7)

Text

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, ,y, t%r"CMWVMr\ Mcuub iIUN AL i buonlicciUIN gg 4 )) ggg [

Pl=se r;id th3 instructions befora compliting this form. For cdditionil forms or assistince in'comKtinithis form, cofitact

{ bour rg;ncy's Pip:rwork Clarenca Offic:r. S:nd two copics of this form, the coll:ction inshument to be review:d, the /

, upporting Stat:mtnt, and any rdditionil documentxtion to: Offica cf inf:rmition cnd Rtgulitory Afftiro, Offica of /

Management and Budge

• Docket Library, Room 10102,72517th Street NW, Washington, DC 20503. - l

1. Agency / Subagency onginating request 2. OMB control number U.S. Nuclear Regulatory Commission g a. 3150-0121 b None

3. Type of information collection (check one) 4 Type of review requested (Check one)

a. New collection g a. Regular c. Delegated

b. Revision of a currently approved collection b. Emergency - Approval requested by (date)-

J c. Extension of a currently approved collection 5 Will this information collection have a significant e' iomic impact on a a Yes l l

d Reinstatement, without change, of a previousti approved substantial r. mber of small entities?

collection for which approval has expired Y D N0 e

co'i$s a$0 0rhhEc approv$afh sehre Reocested y a. Three years from approval date l

f. Existing collection in use without an OMB control number ab n date

b. Other (Specify):

7. Title 10 CFR 81, Standard Specifications for Granting of Patent Licenses I

8 Agency form number (s) (If applicable)

NA 9 Keywords Administrative Practice and Procedure, Inventions and Patents 10 Abstract l

10 CFR 81 establishes the standard specifications for the issuance oflicensees to rights in inventions covered by patents or patent applications invested in the United Sates, as represented by or in the custody of NRC and other patents in w hich NRC has legal rights.

11. Affected puOhC (Mark pnmary win *P*madan others thet appty wrn *C 12. Obhgation to respond gVerk pnmary wtn *P* argt allothers that apply min 'n T a Individuals or households d. Farms a Voluntary l P b Business or othei for-profit e FederalGovernment b ReqJred to obtain or retain benefits l

c. Not-for-profit institutions f State. Local or Tribal GovernmentT c. Mandatory 13 Annual reporting and recordkeeping hour ourden 14 Annual reporting and recordkeeping cost burden onthous. *s of couars: l

. Number of respondents I a Total annualized capital /startup costs I

b. Total annual responses I b Total annual cos's 'O&M)

1. Percentage of these responses c Total annualized cost requested /

collected electronically 0.0  % d current OMB inventory c Totalannualhours requested I d Current OMB inventory e Difference /\ (( /

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O f Explanation of difference f// 2

f. Explanation of difference gram @ange

1. Program change 2 Adjustment

2. Adjustment

15. Purpose of information collection 16 Frequency of recordkeeping or reporting (check allthat apply)

(Mart pnmary wrth *P"and a/I others that apply with *X*)

a Recordkeeping b Third-party disclosure

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T a Application for benefits e. Program planning or management 7 c. Reporting -

b Program evaluation f Research ~] 1 On occasion 2. Weekly ] 's Monthly c General purpose statistics g Regulatory or comphance 4 Quarterly 5 Semi-annually , 6 Annually d Audit 7. Biennially 8 Other(desenbe) 17 Statistucal methoos 18 Agency contact (person who can best answer questoons regardong the l

Does this information collection employ statistical methods?

Name Geraldine R. Fehst Yes No Phone 301-415-1614 OMB 83-1 in's form was oes'9ned og W cms 10/95 9904090004 990405 /s/ Wt PDR ORG EUSOMB PDR

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19.C;rtificrti:n far Prperwark R::ductinn Act Submisciana On behalf of this Federal agency, I certify that the collection ofinformation uicompassed by this request complies with

• 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8 (b)(3), appear at the end of the instructions. The certification is to be made with reference to those regulatoryprovisions as setforth in the mstructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions; (b) It avoids unnecessary duplication; (c) It reduces burden on small entities; (d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents; (e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices; (f) It indicates the retention periods for recordkeeping requirements; (g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3):

(i) Why the information is being collected; (ii) Use ofinformation; (iii) Burden estimate; (iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature of extent of confidentiality; and (vi) Need to display currently valid OMB control number; (h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected (see note in item 19 of the instructions);

(i) It uses effective and efficient statistical survey methodology; and (j) It makes appropriate use ofinformation technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in item 18 of the Supporting Statement.

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Signature of Authonzed Agency Official Date S'Onature Senior Official or desi Date  !

M r T o. helton. NR, le icer. Office of the Chief Information Officer .f, [ff 9 V '

10/95 00A183-1 K

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

EXTENSION Descriotion of the Information Collection Section 81.20(a)(5) Non-exclusive license holders are required to submit periodic reports, at I least annually, on efforts to bring the invention to a point of practical application and the extent to I which license holders continue to make the benefits of the invention reasonably accessible to the public.

Section 81.32(a)(2) NRC inventions may be available for the grant of limited exclusive licenses '

i to responsible applicants who will make its benefits practically applicable c,d, 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 making the invention l publicly accessible and reasonal .y available for the granting of non-exclusive licenses under )

81.20. Under that provision, the i.censee may have a nonexclusive license if the licensee )

I 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 Commission notice to successors of the IMcnsee's business.

Section 81.32(a)(9) Exclusive licensees can issue sublicenses only upon Commissior 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. I 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.

Section 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 n.odified 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

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2 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 finaljudgment 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(aM14) 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.

A. JUSTIFICATION

1. Need For and Practical Utility of the Collection of Information.

NRC needs the information requested to determine whether NRC inventions should be made available to applicants desiring to practice the iavention and to make its benefits reasonably accessible to the public. The application for an exclusive or non-exclusive license (@81.40) is reviewed by the NRC patent counsel to determine whether a license may be granted and whether it should be granted to the applicant as requested. Failure to collect this information would prevent the NRC from insuring that NRC patents are properly issued under license to and used by the licensee as authorized by Section 156 of the Atomic Energy Act of 1954. as amended.

2. Aaency Use of Information. In order to determine whether the NRC grants a license or continues it in effect, either as an exclusive license ( 81.32) or a non-exclusive license

(@81.20), 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 incidentalinformation is also required. Additionalinformation regarding the applicant's identity, location and ability to develop the invention and use the rights which may be granted are required of an applicar't for an exclusive license (@ 81.40). Periodic reports are then required of licensees to ensure that the license is being used in the manner previously intended (@@ 81.20(a)(5) and 81.32(a)(10)).

The NRC needs and uses the information required under 9 81.32(a)(8) and @ 81.32(a)(9)  !

which covers license extensions, sublicensing assignments and transfers; under @ l 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

@ 81.32(a)(12) on modifications and revocations; under 81.32(a)(13) on patent infringement suits; under @ 81.32(a)(14) on surrendering licenses to allow the NRC to I

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erform its license monitoring functions, to permit revision or revocation of the license copropriate, to be kept informed of any litigation concerning the licensed patent,

a. maintain the agency's licensing records.

3. Recuction of Buiden Throuah Information Technoloav. The sporadic nature and extremely small potential frequency of submissions prohibits the efficient use of information to+nology. However, there are no legal or administrative obstacles to its use if so de ..sd by any respondent.

4. Effort to identify Duplication and Use Similar Information. The requirement to submit reports pursuant to 81.20 and 81.32 does not duplicate or overlap other information I collections by the NRC or other Government agencies. Some of the information required in an application for a license (@ 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. The information needed to determine if the NRC should grant or continue a 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 to Federal Proaram or Policy Activities if the Collection is Not Conducted or is Conducted Less Freauentiv. The collection frequency contained in these  ;

requirements is deemed the minimum necessary to achieve the objectives of the requirements.

7. Circumstances Which Justifv Variation from OMB Guidelines. The requirements under

@@ 81.20,81.32, and 81.40 conform to the OMB Guidelines in 5 CFR 1320.6.

8. Consultations Outside the NRC. An opportunity to comment on the information collection contained in Part 81 was published in the _ Federal Reaister on January 7,1999 at 64 Federal Register 1032. No comments were received. l I

9. Payment or Gift to Respondents. Not applicable.

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10. Confidentiality of Information. The NRC provides no pledge of confidentiality for these collections of information. f l

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

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12. Estimated Burden and Burden Hour Cost. As under paragraph 14 below, no reports are l

j anticipated under these requirements. If they were submitted, the total anticipated l 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 $4,235 (at $121 per hour). Burden and l

costs are broken out as follows:

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a. The estimated annual burden per response for--

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licensees under S 81.20 is estimated to be 2 hour2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br />s: I licensees under S 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 />; i licensees under S 81.32(a)(8) is estimated to be 2 hour2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br />s:  !

licensees under @ 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 S 81.32(a)(10) is estimated to be 2 hour2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br />s:

ficensees under S 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 S 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 licensees under @ 81.40 is estimated to be 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br />.

b. The estimated annual cost per response for-- l licensees under S 81.20 is estimated to be $240.00; licensees under S 81.32(a)(2) is estimated to be 5600.00; licensees under @ 81.32(a)(8) is estimated to be $240.00; licensees under S 81.32(a)(9) it estimated to be $360.00; l licensees under 81.32(a)(10) is estimated to be $240.00; licensees under S 81.32(a)(12) is estimated to be $240.00; licensees under @ 81.32(a)(13)is estimated to be $1.080.00; licensees under S 81.32(a)(14)is estimated to be 480.00; and licensees under S 81.40 is estimated to be $720.00.

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

'. 4. Estimated Annualized Cost to the Federal Government.

Currently, it is anticipated that no reports will be submitted under these requirements and, therefore, there is no burden to the Government. However, if reports were submitted, the following costs are anticipated:

a. It takes the NRC patent counsel approximate 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> to review a report submitted pursuant to $81.20. At $121 per professional staff hours, total annual cost to the NRC could be $484.00

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 extended license period (@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 ( 81.32(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 or assignment (S81.32(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 practical application progress report (S81.32(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 ( 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 rev'sw court pleadings (S81.31(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 (581.32(a)(14)).

At $121 per professional staff hour, total annual cost to the NRC could be $2904.00.

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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 (@81.40).

At $121 per professional staff hour, total annual cost to the NRC is estimated to be

$484.00.

d. Total annual cost to the NRC for all of these requirements is estimated to be $3,882 per respondent.

This cost is fully recovered by fees charged to NRC licensees pursuant to 10 CFR Parts 170 and/or 171.

15. Reasons for Chanae in Burden or Cost. 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.

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

17. Reason for Not Displavino the Exoiration Date. The requirement will be contained in a regulation. Amending the Code of Federal Regulations to display information that, in an annual publication, could become obsolete would be unduly burdensome and too difficult to keep current.

18. Exceptions to the Certification Statement. None.

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