Final SS - NRC Form 664

FINAL OMB 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 devices issued under the Code of Federal Regulation (CFR). The NRC Form 664, “General Licensee Registration,” is used for the collection of information pertaining to generally licensed devices which are subject to registration under 10 CFR 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 megabecquerel (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 registration Form 664 and instructions will be provided by the NRC to all affected general licensees.

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 consists of: 1) the name, title, 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 manufacturer’s name, device serial number, device model number, and the isotope and activity contained within the device.

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 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 would be required to submit information periodically which would allow the Agency to better track general 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

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. The NRC issued a regulation on October 10, 2003 (68 FR 58791), consistent with the Government Paperwork Elimination Act, which allows its licensees, vendors, applicants, and members of the public the option to make submissions electronically via CD-ROM, e-mail, special Web-based interface or other means. It is estimated that approximately 1 percent of the potential 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 data base.

4. Effort to Identify Duplication and Use Similar Information

No sources of similar information are available. There is no duplication of requirements. The 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

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.

6. Consequences to Federal Program or Policy Activities if the Collection is not Conducted or is Conducted Less Frequently

Periodic reporting is essential to assure that devices containing byproduct material are maintained and transferred properly. No reporting would 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

Opportunity for public comment on the information collection requirements for this clearance package was published in the Federal Register on August 12, 2015 (80 FR 48349). Nine general licensees that required registration were contacted as part of the public consultation process, via email. The general licensees contacted were: Quantum Composites, Western Sugar, Weatherford, Landmark Alaska Limited, Rohm and Haas Electronic Materials, Elementis Specialties, Justice Corporation, Fabri-Kal, and AMCOL. 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). 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

Approximately 564 general licensees are expected to respond to written registration requests from the NRC annually. The average burden per response to these written requests is 20 minutes for an overall estimated annual burden of 188 hours (564 x 1/3 hour), and a cost of approximately $50,384 (188 x $268/hour).

13. Estimate of Other Additional Costs

There are no additional costs.

14. Estimated Annualized Cost to the Federal Government

Based on the current estimate of affected licensees, the estimated annualized cost to the Federal Government for registration, as a result of the amendment to 10 CFR 31.5(c)(11) 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 28.2 hours (564 requests @ 3 minutes per request). The annual cost would be approximately $7,558 (28.2 hours x $268/hour).

It is estimated that approximately 56 general licensees (10 percent) will call for technical assistance during the annual registration. Approximately 15 minutes of staff time will be required to respond to each of these requests, or 14 hours (56 x 15/60). Approximately 30 minutes of staff time will be required to respond to each of the other 40 technical requests, this number was adjusted to accommodate naturally occurring and accelerator produced radioactive material (NARM) related inquiries, or 20 hours (40 x 30/60), for a total of 34 hours (14 + 20), each year. The annual cost will be approximately $9,112 (34 hours x 268/hour).

The total annual average registration cost to the Federal Government estimated for the next three years is $50,010 ($22,674 + $27,336). Note that this does not include the costs associated with the scanning of the returned registrations, nor the resolutions of those registrations that require significant amount of follow-up or require NRC regional inspections.

This cost is fully recovered through fee assessments to NRC licensees pursuant to 10 CFR Parts 170 and/or 171.

15. Reasons for Changes in Burden or Cost

The change in the overall burden estimate for licensees to register general licensed devices containing radioisotopes on NRC Form 664 has decreased because of a re-estimate of the number of annual responses based on the actual number of responses received during the past 3 years. The number of registration responses are expected to decrease by 69 (from 633 to 564) resulting in a reduction of 23 hours (from 211 hours to 188).

The rate has decreased from $274 per hour to $268 per hour in accordance with

10 CFR Part 170.

The change in annual burden overall estimate for registration of NRC authorized general licensed devices (GLDs) containing radionuclides on NRC Form 664 has decreased by $7,430 (from $57,814 to $50,384) primarily due to a revised number of expected inquiries.

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.