ML25041A045

OMB 3150-0198, Draft 2025 Supporting Statement, NRC Form 664, General Licensee Registration

ML25041A045
Person / Time
Issue date:	06/05/2025
From:	NRC/NMSS/DMSST
To:
References
OMB 3150-0198
Download: ML25041A045 (4)

Text

1 DRAFT SUPPORTING STATEMENT FOR NRC FORM 664, GENERAL LICENSEE REGISTRATION (3150-0198)

EXTENSION Description of the Information Collection The U.S. Nuclear Regulatory Commission (NRC) requires annual registration of certain radioactive devices issued under Title 10 of the Code of Federal Regulations (10 CFR). The NRC Form 664, General Licensee Registration, is used for the collection of information pertaining to generally licensed devices that are subject to registration under 10 CFR Section 31.5. The annual registration criteria are based on radionuclide and the amount of byproduct material contained in the device at the time of purchase. If a generally licensed device contains one or more of the following isotopes, it is subject to an annual registration: 1) 370 megabecquerel (10 millicurie) cesium-137; 2) 37 megabecquerel (1 millicurie) cobalt-60; 3) 37 megabecquere (1 millicurie) americium-241, or any other transuranic; 4) 3.7 megabecquerel (0.1 millicurie) strontium-90; or 5) 3.7 megabecquerel (0.1 millicurie) radium-226.

The NRC has developed a standard format, NRC Form 664, General Licensee Registration, for general licensees to provide the required information. When sent to the general licensee by the NRC, the form will provide available information to the general licensee and requires the general licensee to verify and update the information as necessary. Essential information to be verified/updated on the form includes: 1) the name, title, email address, and telephone number of the individual responsible for the device; 2) a mailing address and an address of use or storage for the device; and 3) information pertaining to the device such as manufacturers name, device serial number, device model number, and the isotope and activity contained within the device. The registration Form 664 and instructions will be provided by the NRC to all affected general licensees.

A.

JUSTIFICATION

1. Need for and Practical Utility of the Information Collection In the past, general licensees were not contacted by the NRC on a regular basis for information on devices possessed, because of the relatively small radiation risk posed by these devices. However, a number of occurrences involving generally licensed devices suggest better accounting for such devices may be beneficial. For example, one or more cesium gauges were mixed in with scrap metal that was smelted to form steel, and the entire batch of steel was contaminated. There have been other types of incidents involving NRC generally licensed devices; however, lack of accountability remains the most common problem and the predominant concern.

The NRC has concluded that there is a lack of adequate awareness of applicable regulations on the part of the device user and inadequate handling and accounting for these devices. The NRC further concluded that these two problems can be addressed by more frequent and timely contact between the general licensee and

2 NRC in the form of a registration program for the higher risk devices. The NRC Form 664 is used for the collection of information pertaining to the annual registration of certain generally licensed devices.

2.

Agency Use of the Information General licensees subject to the registration criteria under NRC jurisdiction are required to submit information annually to allow the Agency to better track generally licensed devices and so that licensees can be contacted or inspected to ensure that the devices can be identified or tracked even if lost or damaged.

3.

Reduction of Burden Through Information Technology The NRC has issued Guidance for Electronic Submissions to the NRC1 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 process, which is available from the NRC's Electronic Submittals Web page, by Optical Storage Media (e.g. CD-ROM, DVD), by facsimile, or by e-mail. It is estimated that approximately 1 percent of the responses are filed electronically.

Currently NRC scans the form manually or by an automatic batch scanner to upload the information into the general licensing tracking database.

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 Because the majority of the general licensees are small businesses, care was taken to require only the minimum amount of information needed in order to assure that the health and safety of the public is protected. In an effort to simplify the process, licensees will be provided with information from the NRC database for verification and correction, rather than being required to provide all information on a blank form.

It is not possible to further reduce burden on small businesses by reducing the information collection and still adequately track ownership and disposition of the devices. Approximately 30 percent of respondents are estimated to be small businesses.

6.

Consequences to Federal Program or Policy Activities if the Collection is not Conducted or is Conducted Less Frequently Annual reporting is required and essential to assure that devices containing byproduct material are maintained and transferred properly. No reporting would 1 Reference Materials For Electronic Submissions l NRC.gov

3 result in a higher probability of devices being inadvertently discarded and could lead to a diminished level of protection for the health and safety of the public and the environment.

7.

Circumstances Which Justify Variation From OMB Guidelines There is no variation from OMB guidelines.

8.

Consultation Outside the NRC Notice of an opportunity for public comment on the information collection requirements for this clearance package has been published in the Federal Register.

9.

Payment or Gift to Respondents Not applicable.

10.

Confidentiality of Information Confidential and proprietary information is protected in accordance with NRC regulations in Paragraphs 10 CFR 9.17(a) and 10 CFR 2.390(b). However, no information normally considered confidential or proprietary is requested.

11.

Justification for Sensitive Questions This information collection does not request sensitive information.

12.

Estimated Burden and Burden Hour Cost Out of 471 respondents, approximately 373 general licensees are expected to respond to written registration requests from the NRC annually; however, concerted NRC efforts are being made to reach out to the 98 unresponsive registrants; therefore, the burden for these licensees has been included. The average burden per response to these written requests is 20 minutes (or 1/3 hour) for an overall estimated annual burden, assuming all 471 provide a response, of 157 hours0.00182 days <br />0.0436 hours <br />2.595899e-4 weeks <br />5.97385e-5 months <br /> (471 x 1/3 hour), and a cost of approximately $49,769 (157 hours0.00182 days <br />0.0436 hours <br />2.595899e-4 weeks <br />5.97385e-5 months <br /> x $317/hour).

The $317 hourly rate used in the burden estimates is based on the NRCs fee for hourly rates as noted in 10 CFR 170.20 Average cost per professional staff-hour.

For more information on the hourly rate, see the Revision of Fee Schedules, Fee Recovery for Fiscal Year 2024 final rule (89 FR 51789, June 20, 2024).

13.

Estimate of Other Additional Costs There are no additional costs.

14.

Estimated Annualized Cost to the Federal Government

4 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 current estimate of affected licensees, the estimated annualized cost to the Federal Government for registration is as follows:

Mailing a request for verification of devices possessed by general licensees and logging the response into the computerized directory or recording that verification has been received, will take approximately 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> (471 requests at 3 minutes per request) at a cost of $7,608 (24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> x $317 per hour). The annual cost of postage for registered return receipt is approximately $4,710 ($10/package x 471 packages).

The total average cost is $12,318 ($7,608 + $4,710).

15.

Reasons for Changes in Burden or Cost The overall burden estimate for licensees to register generally licensed devices containing radioisotopes on NRC Form 664 has remained stable over the past three years. The number of general licensees increased by only 2% (from 460 to 471). Due to concerted efforts to obtain responses from all licensees, the estimated number of respondents has increased from 409 to 471, resulting in an increase in burden from 136 hours0.00157 days <br />0.0378 hours <br />2.248677e-4 weeks <br />5.1748e-5 months <br /> to 157 hours0.00182 days <br />0.0436 hours <br />2.595899e-4 weeks <br />5.97385e-5 months <br />, an increase of 21 hours2.430556e-4 days <br />0.00583 hours <br />3.472222e-5 weeks <br />7.9905e-6 months <br />.

The rate has increased from $288 per hour to $317 per hour in accordance with 10 CFR Part 170.

16. Publication for Statistical Use None.

17. Reason for Not Displaying the Expiration Date The expiration date will be displayed on the form.

18. Exceptions to the Certification Statement None.

B.

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