ML25013A315
| ML25013A315 | |
| Person / Time | |
|---|---|
| Issue date: | 01/13/2025 |
| From: | NRC/NRR/DRO |
| To: | NRC/OCIO |
| Shared Package | |
| ML24366A144 | List: |
| References | |
| OMB-3150-0024, NRC-2025-0011 | |
| Download: ML25013A315 (7) | |
Text
DRAFT SUPPORTING STATEMENT FOR NRC FORM 396, CERTIFICATION OF MEDICAL EXAMINATION BY FACILITY LICENSEE 10 CFR PART 55, SECTIONS 55.23, 55.25, 55.27, 55.31, AND 55.57 (31500024)
EXTENSION DESCRIPTION OF THE INFORMATION COLLECTION U.S. Nuclear Regulatory Commission (NRC) Form 396, Certification of Medical Examination by Facility Licensee is used by an authorized facility licensee and applicant/operator to certify the medical condition of the applicant in accordance with Title 10 of the Code of Federal Regulations (10 CFR) Part 55, Operators' Licenses.
The regulations in 10 CFR Part 55 require facility licensees to certify the medical fitness of the applicant/operator. NRC Form 396 is the mechanism by which NRC is informed of the applicant/operator general health and physical condition.
The information requested includes the applicant/operator identifying information, medical examination information, applicant/operator signature, signature of the certifying representative at the facility, and informing the NRC within 30 days of learning of the diagnosis if a licensee develops a permanent physical or mental condition. Recent changes to the form include the creation of the web-based fillable version of the NRC Form 396, allowing facility licensees to complete the form and submit online.
A.
JUSTIFICATION
- 1.
Need for the Collection of Information This information is needed to determine facility licensees compliance with the regulations in 10 CFR Part 55. Details of these regulations can be found at the end of this supporting statement in Description of Information Collection Requirements.
- 2.
Agency Use and Practical Utility of Information The information assists the Commission in basing its finding upon the certification by facility licensees as detailed on NRC Form 396. NRC Form 396 is the mechanism by which NRC is advised of the information for determining that the applicants or operator licensees medical condition and general health will not adversely affect the performance of assigned operator job duties or cause operational errors endangering public health and safety.
- 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 Submittals application, which is available from the NRC's Electronic Submittals Web page, by Optical Storage Media (OSM) (e.g. CDROM, DVD), by email. The Electronic Submittals application allows electronic transmission of information to the NRC pertaining to licensing actions, associated hearings, and other regulatory matters. The application serves as a secure portal respondents may use to transmit documents to the NRC.
- 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 Not applicable.
- 6.
Consequences to Federal Program or Policy Activities if the Collection Is Not Conducted or Is Conducted Less Frequently Frequency of reporting cannot be discontinued or reduced without violating the NRC licensing requirements as described in 10 CFR 55.31 and 10 CFR 55.57, which would increase the potential for endangering public health and safety.
If the information is not collected, the NRC will not be able to assess and record medical conditions, along with the critical nature of the condition, the permanence, and operational errors the conditions could cause, if any, while operating controls. While the facility is responsible for certifying the medical suitability of an operator, NRC is responsible for assessing an operators medical fitness. Information from this form is sent to a medical expert to review to determine if a conditional license should be issued.
The collection of this information is on an asneeded basis. Collection for this information is the minimum frequency necessary to assure that licensees will continue to conduct programs in a manner that will assure adequate protection of public health and safety.
- 7.
Circumstances which Justify Variation from Office of Management and Budget 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). NRC Form 396 does not include a Privacy Act statement because it is completed by a third party, not the individual. However, once the NRC receives the information on the Form 396, it is covered by NRC System of Records, NRC 16: Facility Operator Licensee Records, published March 19, 2025 (90 FR 12805).
- 11.
Justification for Sensitive Questions The information is required to determine the applicants or operator's medical condition and general health. Without the information the Commission would have no basis for its findings upon the certification by facility licensees. Once the NRC receives the information on the Form 396, it is covered by NRC System of Records, NRC 16: Facility Operator Licensee Records, published March 19, 2025 (90 FR 12805).
- 12.
Estimated Industry Burden and Burden Hour Cost (a)
Reporting Requirements Burden Approximately 1,729 NRC Form 396s are expected to be submitted annually (includes applicants, renewals and notices of disability). The estimated reporting burden is 1.0 hour0 days <br />0 hours <br />0 weeks <br />0 months <br /> per submittal for a total of 1,729 hours0.00844 days <br />0.203 hours <br />0.00121 weeks <br />2.773845e-4 months <br />. At the hourly cost of $317 the total burden cost is $548,093 (See Table 1).
(b)
Recordkeeping Requirements Burden There are 133 facilities that retain the medical documentation for approximately 4,310 applicants, reactor operators and senior reactor operators while they are employed in this capacity (10 CFR 55.27).
Approximately 1,729 facility records require annual NRC Form 396 maintenance. The estimated recordkeeping burden is 0.25 hour2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br /> per record for a total of 432 hours0.005 days <br />0.12 hours <br />7.142857e-4 weeks <br />1.64376e-4 months <br />. At the hourly cost of $317, the total burden cost is $136,944 (See Table 2).
(c)
Total Industry Burden and Cost Total Annual Burden: 2,161 (1,729 Reporting hours plus 432 Recordkeeping hours)
Total Burden Hour Cost: $685,037 (2,161 hours0.00186 days <br />0.0447 hours <br />2.662037e-4 weeks <br />6.12605e-5 months <br /> x $317 per 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 NRC has determined that the records storage cost is approximately proportional to the recordkeeping burden cost. Based on a typical clearance, the recordkeeping storage cost has been estimated to be equal to 0.0004 of the recordkeeping burden. Therefore, the recordkeeping storage cost for this collection is estimated to be $54.77 (432 Recordkeeping hours x $317 x 0.0004).
- 14.
Estimated Annualized Cost to the Federal Government 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. It is estimated that 1,729 NRC Form 396s will be submitted annually during the clearance period. It is also estimated that 622 of these forms will be required to be reviewed by the NRC Contractor Licensed Physician. NRC staff processing per submission is estimated at 0.25 hours2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br />. Total Federal Government cost includes the following:
NRC Contractor Licensed Physician:
622 NRC Forms 396 reviewed annually x $102.49 per form = $63,749.
NRC staff (Headquarters & Regional) processing: 1,729 forms annually submitted x 0.25 hour2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br /> per submittal = 432 hours0.005 days <br />0.12 hours <br />7.142857e-4 weeks <br />1.64376e-4 months <br />. 432 hours0.005 days <br />0.12 hours <br />7.142857e-4 weeks <br />1.64376e-4 months <br /> x $317 per hour =
$136,944.
Total annual cost to the Federal Government is $200,693 ($63,749 + $136,944).
- 15.
Reasons for Change in Burden or Cost The number of total responses has increased from 1,778 in the prior cycle to 1,862 in this cycle. NRC Form 396 is the mechanism by which NRC is advised of the applicant/operator general health and physical condition, and when a facility and/or individual is no longer subject to the requirements of 10 CFR Part 55, they will no longer submit NRC Form 396. Therefore, the increase in projected submissions is due to the increase in licensed individuals, operating reactor plants, and projected license renewals being subject to Part 55 requirements.
Currently, NRC uses the Electronic Information Exchange (EIE), OSM, facsimile, or email to deliver NRC Form 396 and receive the completed medical reviews from the NRC Contractor. The facility licensees submit a scanned pdf version of NRC Form 396 via EIE.
In addition, the fee rate has increased from $288 to $317 per hour.
- 16.
Publication for Statistical Use None.
- 17.
Reason for Not Displaying the Expiration Date The expiration date is displayed on form.
- 18.
Exceptions to the Certification Statement Not applicable.
B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS Not applicable.
TABLE 1 Annual Reporting Burden TABLE 2 Annual Recordkeeping Burden Total Annual Burden:
2,161 hours0.00186 days <br />0.0447 hours <br />2.662037e-4 weeks <br />6.12605e-5 months <br /> (1,729 Reporting hours + 432 Recordkeeping hours)
Total Burden Hour Cost: $685,037 (2,161 hours0.00186 days <br />0.0447 hours <br />2.662037e-4 weeks <br />6.12605e-5 months <br /> x $317/per hour)
Total Responses:
1,862 (1,729 Responses + 133 Recordkeepers)
No. of Respondents Responses per Respondent Total Responses Burden Hours per
Response
Total Annual Burden Hours Cost at
$317 per hour NRC Form 396 133 13 1,729 1.0 1,729
$548,093 Annual Records Requiring Maintenance Hours per Recordkeeping Total Annual Burden Hours Cost at
$317 per hour NRC Form 396 1,729 0.25 432
$136,944
DESCRIPTION OF INFORMATION COLLECTION REQUIREMENTS CONTAINED IN NRC FORM 396, CERTIFICATION OF MEDICAL EXAMINATION BY FACILITY LICENSEE 10 CFR PART 55, SECTIONS 55.23, 55.25, 55.27, 55.31, AND 55.57 (31500024) 10 CFR 55.23 requires that the facility licensee certify the medical fitness of an applicant or licensee by completing and signing NRC Form 396.
10 CFR 55.25 requires the facility licensee to notify the NRC within 30 days of learning of the diagnosis if a licensee develops a permanent physical or mental condition that causes the licensee to fail to meet the requirements of 10 CFR 55.21. For conditions where a conditional license is requested, the facility licensee must provide medical certification on NRC Form 396.
10 CFR 55.27 requires that the facility licensee document and maintain the results of medical qualification data, test results, and each operator's or senior operator's medical history for the duration of the operator's or senior operator's tenure, and to provide the documentation to the Commission upon request.
10 CFR 55.31(a)(6) requires applicants for a license to provide certification by the facility licensee of medical condition and general health on NRC Form 396 to comply with 10 CFR 55.21, 55.23 and 55.33(a)(1).
10 CFR 55.57(a)(6) requires applicants for renewal of a license to provide certification by the facility licensee of medical condition and general health of the applicant on NRC Form 396.
The regulations in 10 CFR Part 55, as described above, require a license applicant (initial, upgrade, reapplication and renewal) to be examined by a licensed physician. In general, the licensed physician uses the guidance provided by the American National Standard for Medical Certification and Monitoring of Personnel Requiring Operator Licenses for Nuclear Power Plants
- ANSI/ANS 3.4 (1983,1996, or 2013) and American National Standard for the Selection and Training of Personnel for Research Reactors (Non-Power) - ANSI/ANS 15.4 (1988 or 2007).
The licensed physician then submits the diagnostic report to the facility licensee. Subsequently, the applicant/operator signs the NRC Form 396 giving permissions to the facility licensee and the NRC, the facility licensee certifies on NRC Form 396 as to the applicants or operators general health and physical condition and then submits NRC Form 396 to the NRC.
In cases where the applicant for an operators license or renewal does not meet the minimum ANSI/ANS medical requirements, the facility licensee submits recommendations for license conditions, removal of license conditions, or revocation of the license with supporting medical evidence for review by the NRC Contractor Medical Review Officer.
In cases where the holder of an operator's license develops a permanent mental or physical condition that causes the individual to fail to meet the requirements of 10 CFR 55.21, the facility licensee is required to notify the NRC, within 30 days of learning of the diagnosis, with their conditional license or revocation recommendations and supporting medical evidence for review by the NRC Contractor Medical Review Officer.
Records required by 10 CFR 55.27 are retained by the facility licensee and provided to the NRC upon request to provide documentation that the applicants and licensed operators are physically and mentally fit.
NRC FORM 396, CERTIFICATION OF MEDICAL EXAMINATION BY FACILITY LICENSEE GUIDANCE DOCUMENTS Title Agencywide Documents Access and Management System (ADAMS)
Accession No.
NUREG1021 Operator Licensing Examination Standards for Power Reactors ML21256A276 NUREG1478 Operator Licensing Examiner Standards for Research and Test Reactors ML072000059