ML24220A033

Rulemaking - Proposed Rule - NRC Forms 893 and 894 OMB Supporting Statement Risk-Informed, Technology-Inclusive Regulatory Framework for Advanced Reactors (Part 53)

ML24220A033
Person / Time
Issue date:	10/30/2024
From:	NRC/NMSS/DREFS/RRPB
To:
References
NRC-2019-0062, RIN 3150-AK31, Form 893, Form 894, 10 CFR Part 53
Download: ML24220A033 (7)

Text

DRAFT SUPPORTING STATEMENT FOR INFORMATION COLLECTIONS CONTAINED IN RISK INFORMED, TECHNOLOGY-INCLUSIVE REGULATORY FRAMEWORK FOR ADVANCED REACTORS PROPOSED RULE NRC FORMS 893, SINGLE FFD POLICY VIOLATION FORM, AND 894, ANNUAL REPORTING FORM FOR FFD INFORMATION 10 CFR 26.617 (3150-XXXX)

NEW Description of the Information Collection The U.S. Nuclear Regulatory Commission (NRC) is proposing to establish an optional technology-inclusive regulatory framework for use by applicants for new commercial nuclear plant designs. The regulatory requirements developed in this rulemaking would use methods of evaluation, including risk-informed and performance-based methods, that are flexible and practicable for application to a variety of new reactor technologies. The NRCs goals in amending these regulations are to continue to provide reasonable assurance of adequate protection of public health and safety and the common defense and security at reactor sites at which new nuclear reactor designs are deployed to at least the same degree of protection as required for current-generation light-water reactors; protect health and minimize danger to life or property to at least the same degree of protection as required for current-generation light-water reactors; provide greater operational flexibilities where supported by enhanced margins of safety that may be provided in new nuclear designs; and promote regulatory stability, predictability, and clarity.

The proposed rule covers a wide range of topics, including the following that would result in recordkeeping and reporting requirements:

Fitness for duty (FFD),

Physical security, Cybersecurity, Access authorization.

Plant design and analysis,

Siting, Construction and manufacturing, Facility operations,

Programs,

Staffing, Decommissioning, Applications, Licensing basis information, and Quality assurance.

Licensees and other entities that implement FFD programs under proposed 10 CFR Part 26, Subpart M, would be required under proposed 10 CFR 26.617, Recordkeeping and reporting, to submit NRC Form 893 to the NRC following the occurrence of an FFD policy violation, such as a positive result on a drug or alcohol test. These licensees and other entities would also be required to submit an annual report to the NRC on FFD program performance, specifically regarding the performance effectiveness of their FFD program on NRC Form 894. For example, this report would include aggregated drug and alcohol test results and communication of program weaknesses. Both NRC Forms 893 and 894 are new forms, modeled on NRC Forms 890 and 891 (approved under OMB Clearance No. 3150-0146), respectively. However, NRC Forms 893 and 894 are to be used by Part 53 licensees, whereas NRC Forms 890 and 891 are to be used by licensees and other entities under Part 50, Domestic Licensing of Production and Utilization Facilities, or Part 52, Licenses, Certifications, and Approvals for Nuclear Power Plants.

Form 893, 10 CFR Part 26, Subpart M, Single FFD Policy Violation Form, would be used to transmit detailed information to the NRC by a licensee to report a violation of the FFD policy, such as positive drug or alcohol test results for each such occurrence. Information requested includes the name of the principle facility, date of the collection, reason for testing, employment type, labor category, type of test, type of biological specimen, testing cutoffs used, whether the specimen was collected at an offsite facility, whether a point of collection testing and assessment was performed, whether the positive result is a 24-hour reportable event under proposed 10 CFR 26.617 or 26.719(b), whether the collection was refused, whether the collection involved a subversion attempt, detail on management actions taken, and names of the person(s) responsible for the information provided. Other reportable conditions are the identification of potentially disqualifying FFD information and prohibited FFD items, such as chemicals used to subvert a drug test.

Form 894, 10 CFR Part 26, Subpart M, Annual Reporting Form for FFD Information, would be used to transmit detailed information to the NRC by a licensee on drug and alcohol testing program performance. Information requested includes the facility name, the number and types of tests administered, specimen types used, the number of positive, adulterated, substituted, discrepant biomarker, and refusal to test results, the random testing population and rate, information about the laboratories used for testing, the substances tested, special analyses testing results, testing cutoffs used, management actions taken, and person(s) responsible for the information provided.

This supporting statement describes the information collections in NRC Forms 893 and 894 (3150-XXXX). The supporting statements describing recordkeeping and reporting requirements in 10 CFR Part 53 (3150-XXXX), 10 CFR Part 73 (3150-0002), NRC Forms 366, 366A, and 366B (3150-0104), and NRC Form 361 (3150-0238) have been submitted under the respective clearances. Burden associated with 10 CFR Part 26 (3150-0146) and 10 CFR Part 50 (3150-0011) has been submitted under new clearances due to the recent submission of the Part 26 and Part 50 renewals.

A.

JUSTIFICATION

1.

Need for the Collection of Information The information collections would enable effective and efficient regulatory oversight of affected licensees and other entities through the assessment of FFD program performance to maintain public health and safety, promote the common defense and security, and to protect the environment. The NRC would use these information collections to assess licensee and other entity compliance with Part 26 and take corrective actions, as needed. The NRC also would use these information collections to evaluate the effectiveness of the regulations and to take additional actions, as needed, such as issuing guidance or amending Part 26 through rulemaking.

2.

Agency Use of Information The NRC would use the information submitted in NRC Forms 893 and 894 to:

monitor licensee and other entity compliance with Part 26 requirements to ensure that each FFD program is adequate to protect public health and safety, promote the common defense and security, and protect the environment; be informed of FFD-related performance issues in order to evaluate the need to implement timely regulatory actions to restore compliance, verify corrective actions, implement licensing actions, conduct public outreach, or inspect NRC-licensed activities; and, evaluate the performance of drug and alcohol testing programs through the collection and analysis of annual program performance information to identify trends, lessons learned, and site-specific or industry-wide issues requiring NRC licensing or inspection response, generic communication, or rulemaking.

3.

Reduction of Burden Through Information Technology The NRC has issued Guidance for Electronic Submissions to the NRC, 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 (EIE) process, which is available from the NRC's Electronic Submittals Web page, by Optical Storage Media (OSM) (e.g., CD-ROM, DVD), by facsimile or by e-mail. The Electronic Submissions System ensures that information sent to the NRC is secure and unaltered during transmission. It operates 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> a day, except when it is taken down for scheduled maintenance. The application serves as a secure portal that respondents may use to transmit documents to the NRC.

It is estimated that approximately 99% of the potential responses will be filed electronically.

4.

Efforts 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 The NRC is currently not aware of any known small entities as defined in 10 CFR 2.810 that are planning to apply for a commercial nuclear plant early site permit, construction permit, operating license, manufacturing license, or combined license under Part 53 that would be impacted by this proposed rule.

6.

Consequences to Federal Program or Policy Activities if the Collection is Not Conducted or is Conducted Less Frequently If the information is not collected or collected less frequently, then the NRC would not be able to adequately:

independently monitor licensee and other entity compliance and ensure that each FFD program adequately protects public health and safety, promotes the common defense and security, and protects the environment; verify the scientific accuracy and validity of test results and ensure that the rights of individuals subject to testing are protected; complete timely evaluations of FFD-related performance issues and implement regulatory actions to restore compliance, assess corrective actions, inform the public, and/or propose changes to regulations or guidance; and inform the public in a timely manner on FFD program performance trends, lessons learned, and site-specific or industry-wide issues.

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.

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 No sensitive information is requested. Although the NRC Form 893 submissions detail individual drug and alcohol testing violations, they do not contain any personally identifiable information.

12.

Estimated Burden and Burden Hour Cost The proposed 10 CFR Part 53 rule, specifically 10 CFR 26.617(b)(2), would make reporting on NRC Forms 893 and 894 mandatory for commercial nuclear plants licensed under 10 CFR Part 53. However, as no Part 53 licenses or permits are expected to be issued before or during the clearance period (2025 -

2027), the estimated burden for the clearance is zero.

Section Number of Respondents Responses per Respondent Total Responses Burden per

Response

(hours)

Total Burden Hours 26.617 - Submit Form 893, Single FFD Policy Violation Form 0

3 0

0.5 0

26.617 - Submit Form 894, Annual Reporting Form for FFD Information 0

1 0

106 0

13.

Estimate of other Additional costs No additional costs are anticipated for this form.

14.

Estimated Annualized Cost to the Federal Government Because no Part 53 licensees or permits are expected to be issued before or during the clearance period (2025 - 2027), the estimated cost to the Federal Government is zero.

NRC ACTION No. Actions/

Year Burden Hours/

Action Total Hours 26.617 - Submit Form 893, Single FFD Policy Violation Form 0

0.5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> 0

26.617 - Submit Form 894, Annual Reporting Form for FFD Information 0

12 hours1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br /> 0

15.

Reasons for Change in Burden or Cost The proposed rule would impose new information collections for Part 53 licensees to report to the NRC following the occurrence of an FFD policy violation, such as a positive result on a drug or alcohol test, and to submit an annual report to the NRC on FFD program performance, regarding, in part, results from drug and alcohol testing. No burden is anticipated during the clearance period, but future licensees would incur an annual burden of 0.5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> per single positive test form submitted (NRC Form 893) and 106 hours0.00123 days <br />0.0294 hours <br />1.752645e-4 weeks <br />4.0333e-5 months <br /> to annually prepare and submit NRC Form 894, Annual Reporting Form for FFD Information.

16.

Publication for Statistical Use Not applicable.

17.

Reason for Not Displaying the Expiration Date NRC Forms 893 and 894 display the OMB clearance approval expiration date.

18.

Exceptions to the Certification Statement There are no exceptions.

B.

Collection of Information Employing Statistical Methods The collection of information does not employ statistical methods.

DESCRIPTION OF INFORMATION COLLECTION REQUIREMENTS CONTAINED IN NRC FORMS 893 AND 894 10 CFR 26.617 Section 26.617(b)(2) would require licensees and other entities that implement FFD programs under 10 CFR Part 26, Subpart M, to submit an annual report that must include the FFD program performance data listed in 10 CFR 26.717(b). These licensees or other entities must use NRC-approved forms for the submission of FFD performance data to the NRC. These forms are NRC Forms 893, Single FFD Policy Violation Form, and 894, Annual Reporting Form for FFD Information.