FINAL support statement patent licenses

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FINAL SUPPORTING STATEMENT FOR

10 CFR PART 81

STANDARD SPECIFICATIONS FOR THE GRANTING OF PATENT LICENSES

(3150-0121)

EXTENSION

Description of the Information Collection

As specified in 10 CFR Part 81, the Nuclear Regulatory Commission (NRC) may grant non-exclusive licenses or limited exclusive licenses to its patented inventions to responsible applicants. Applicants for licenses to NRC inventions are required to provide information which may provide the basis for granting the requested license. In addition, all 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 must submit additional information if they seek to extend their licenses, issue sublicenses, or transfer the licenses. In addition, if requested, exclusive license holders must promptly supply to the Government of the United States copies of all pleadings and other papers filed in any patent infringement lawsuit, as well as evidence from proceedings relating to the licensed patent. (See supplemental information for a description of the specific information collection requirements in 10 CFR Part 81.)

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 invention and to make its benefits reasonably accessible to the public. The application for an exclusive or non-exclusive license 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. Agency Use of Information

In order to determine whether the NRC grants a license or continues it in effect, either as an exclusive license or a non-exclusive license, 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 which may be granted are required of an applicant for an exclusive license. Periodic reports are then required of licensees to ensure that the license is being used in the manner previously intended.

The NRC needs and uses the information on license extensions, sublicensing assignments, and transfers to determine the advisability of extending the term of a license, to keep track of any transfer of the license, and ensure the licensee's continued qualification for the exclusive license. The NRC needs and uses the information on modifications and revocations, patent infringement suits, and surrendering licenses to allow the NRC 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

There are no legal obstacles to reducing the burden associated with this information collection. The NRC encourages respondents to use new automated information technology when it would be beneficial to them. NRC issued a regulation October 10, 2003 (68 FR 58791), consistent with the Government Paperwork Elimination Act, which allows its licensees, vendors, applicants, and members of the pubic the option to make submissions electronically via CD-ROM, e-mail, special Web-based interface, or other means. However, the sporadic nature and extremely small potential frequency of submissions prohibits the efficient use of information technology. It is estimated that less than 1% of the responses are filed electronically.

4. Effort to Identify Duplication and Use Similar Information

No sources of similar information are available. There is no duplication of requirements. NRC has in place an ongoing program to examine all information collections with the goal of eliminating all duplication and/or unnecessary information collections.

5. Effort to Reduce Small Business Burden

Currently there are no applicants or exclusive/non-exclusive licensees.

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.

7. Circumstances Which Justify Variation from OMB Guidelines

Not applicable.

8. Consultations Outside the NRC

Opportunity for public comment on the information collection requirements for this clearance package has been published in the Federal Register on January 31, 2008 (73 FR 5878). 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

No reports are anticipated under these requirements. However, if they were submitted, the total anticipated burden and costs to a respondent are 37 hours or $9,546.00 (at $258 per hour). See Table 1.

13. Estimate of Other Additional Costs

No other additional costs are anticipated.

14. 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:

1. It takes the NRC patent counsel approximate 4 hours to review a report submitted on a nonexclusive license. At $258 per professional staff hour, total annual cost to the NRC could be $1,032.00.

2. It takes the NRC patent counsel approximately 5 hours to review information supporting a request for an extended license period; 2 hours to review a license assignment or transfer notice; 3 hours to review a copy of any sublicense or assignment; 4 hours to review a practical application progress report; 4 hours to prepare and give written notice to the licensee about the intention to modify or revoke the license; up to 4 hours (depending on the complexity of the case) to review court pleadings; and 4 hours to review a licensee’s surrendered license. At $258 per professional staff hour, total annual cost to the NRC could be $6,708.00.

3. It takes the patent counsel approximately 4 hours to review an application. At $258 per professional staff hour, total annual cost to the NRC is estimated to be $1,032.00.

4. Total annual cost to the NRC for all of these requirements is estimated to be $8,772.00 per respondent.

15. Reasons for Change 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. 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 requirement is 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 this collection of information.

TABLE 1

LICENSEE REPORTING BURDEN, 10 CFR PART 81

PATENT LICENSES

Section	Description	Burden Hrs per Response	Annual Cost Per Response
10 CFR 81.20(a)(5)	Reports on nonexclusive licenses	2	$516
10 CFR 81.20(a)(10)	Revocation of nonexclusive licenses	2	$516
10 CFR 81.32(a)(2)	Extensions of exclusive licenses	5	$1,290
10 CFR 81.32(a)(8)	License transfer of exclusive licenses	2	$516
10 CFR 81.32(a)(9)	Sublicenses for exclusive licenses	3	$774
10 CFR 81.32(a)(10)	Reports on exclusive licenses	2	$516
10 CFR 81.32(a)(12)	License revocation/modification of exclusive licenses	2	$516
10 CFR 81.32(a)(13)	Patent lawsuits for exclusive licenses	9	$2,322
10 CFR 81.32(a)(14)	Surrender of exclusive licenses	4	$1,032
10 CFR 81.40	License applications (nonexclusive and exclusive licenses)	6	$1,548
TOTAL		37	$9,546