ML20209D116

Request for OMB Review & Supporting Statement Re NRC Form 396, Certification of Medical Exam by Facility Licensee. Estimated Burden of 741 H

ML20209D116
Person / Time
Issue date:	06/21/1999
From:	NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
To:
Shared Package
ML20209C697	List: ML20209C693 ML20209D116
References
OMB-3150-0024, OMB-3150-24, NUDOCS 9907130042
Download: ML20209D116 (9)

Text

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lh .Jne 21,1999

SUMMARY

OF INFORMATION COLLECTION REQUEST

Title:

NRC Form 396, Certification of Medical Examination by Facility Lice see Current Burden /Resoonses: 741 hours0.00858 days <br />0.206 hours <br />0.00123 weeks <br />2.819505e-4 months <br /> /975 responses Prooosed Burden /Resoonses: 730 hours0.00845 days <br />0.203 hours <br />0.00121 weeks <br />2.77765e-4 months <br /> /1116 responses Burden Attributable to Third-Party Collections: 0 l

1 Number of Respondents: 141 l

Frecuency of Response: On occasion and every six years for renewals Reasons for Chanaes in Burden / Responses:

The burden decreased from 741 to 730 hours0.00845 days <br />0.203 hours <br />0.00121 weeks <br />2.77765e-4 months <br /> because of the reestimate of the number of records that will be generated decreased from 4,975 in the previous clearance to 4,864.

Level of Concurrence: j Director Division of Inspection Program Management 0 .

l Office of Nuclear Reactor Regulation l Recordkeepino Reauirements in Accordance with the Retention Periods for Records Rule:

Records retention period is in accordance with established standards. g Search of the Information Reauirements Control Automated System (IRCAS):

IRCAS was searched on May 28,1999. No duplication was found.

Abstract:

NRC Form 396 is used to transmit information to the NRC regarding the medical

condition of applicants for initial or renewal operator licenses and for the maintenance of medical records for all licensed operators. The information is used to determine whether the physical condition and general health of applicants for operator licenses is such that the applicant would not be expected to cause operational errors endangering public health and safety.

cc: B. St. Mary 9907130042 990623 PDR ORG EUSD j - @\

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i NRC FORM 408 U.S. NUCLEAR REGULATORY COMMISSION NRcw ase

, ASSESSMENT OF PROPOSED INFORMATION COLLECTION TO: INFORMATION MANAGEMENT COORDINATOR TITLE OF INFORMATION COLLECTION REQUIREMENT l Debbie McCain, NRR NRC Form 396, Certification of Medical Examination by Facility Licensee

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THE FOLLOWING FACTORS WERE CONSIDERED IN EVALUATING THE PROPOSED l 1NF0RMATION COLLECTION REQU1REMENT. lit the response is not so, check 'No" and explain unde, YES NO

' Remarks. ')

9. The requirement is needed. (It is the best means to achieve a necessary regulatory objective.) X i

2. The requirement has practical utility, i.e., the NRC has the capability to use the information in j X

a timely and useful fashion.

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3. The schedule for imposing the requirement is reasonable. X )

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4. The requirement selected is the least burdensome mcthod of achieving a necessary regulatory objective.

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_ 5. The requirement does not duplicate or overlap requirements imposed by the NRC. X

6. The requirement does not duplicate or overlap requirements imposed by other Government y agencies.

7. The method used to estimate the burden is adequate. X

8. The burden estimates are reasonable when compared with similar requirements previously X

submitted.

9. The methods proposed for collecting or keeping the information are consistent with sound y j records management practices. l l

10. The records retention period is sufficiently definitive and reasonable. X

11. The requirement adequately identifies the records to be maintained and the information to be X

reported. l l

12. NRC administrative support requirements are sufficient to manage the information collection. X

13. The information collection will not cause NRC to exceed its Information Collection Budget. X REMARKS (If an explanation to items 1 through 13 above, reference the remark to the item number)  ;

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l OClO REVIEWER-(Assigned Analyst) l SIGNATURE '

(3 j l DATE 06/22/99 j

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1 Doris J. Curseen e Records Management Branch /OClO j, [,w '# [4 r 2.// v I OCIO APPROVAL-(Branch Level) ] SIGNATURE ,, l DATE

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Brenda Jo. Shelton, NRC Clearance Officer Office of the Chief Information Officer 'f I ' /, .. [- (. h % <

PRINTED ON RECYCLED PAPER NRC FORM 406 (1107) l l

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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 (OMB CLEARANCE NO. 3150-0024)

REVISION DESCRIPTION OF THE INFORMATION COLLECTION 10 CFR 55.23 requires that the facility licensee certify the medical fitness of an applicant or licensee by completing and signing Form NRC 396.

10 CFR 55.25 requires the facility licensee to notify the NRC within 30 days if a licensee develops a permanent physical or mental condition that causes the licensee to fail to meet the requirements of 55.21. For conditions where a conditional license is requested, the facility licensee must provide medical certification on Form NRC 396.

10 CFR 55.27 requires that the facility licensee document and maintain the results of medical qualifications data, test results, and each operators or senior operators medical history for the duration of the operators or senior operators 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 Form 396 to comnly with 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 Form NRC 396.

10 CFR Parts 26 and 73 specify fitness-for-duty and safeguards requirements that licensed operators must meet. In addition to the medical examination certification, NRC Form 396 requires certification that the applicant has been found to meet the fitness for-duty and j safeguards requirements.

The clearance revision request does not amend the information collection requirements, but does increase the burden due to an increase of NRC Form 396's being reviewed annually by the NRC Consultant Examination Physician, in addition to an increase in his/her hourly fee.

However, the actual time to perform these reviews has decreased by 75 percent.

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2 A. ' JUSTIFICATION

1. Need for and Practical Utility of the Collection of Information -

10 CFR Part 55, " Operators' Licenses," requires an applicant to be examined by a licensed physician who can use guidance provided by ANSI /ANS 3.4-1996:

ANSI /ANS 3.4-1983; and ANSl/ANS 15.4-1988 (Non-Power). The licensed physician submits his/her diagnostic report to the facility licensee. The facility licensee, based on the data provided, certifies on NRC Form 396 whether or not the applicant is fit to be licensed.

In cases where the holder of an operator's or senior 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 so that the individual's license can be revoked.

In cases where the applicant for an operator's license or renewal does not meet the appropriate ANSl/ANS medical requirements, or after recovery from a disabling condition, the facility licensee shall submit supporting medical evidence for review by the NRC consultant examining physician. The NRC and the consultant physician will review such evidence and decide if a conditional license or reinstatement from

~ the disability shall be approved.

Records required by 10 CFR 55.27 are retained and the documentation provided to the NRC upon request to provide assurance that operators and senior operators are physically and mentally fit.

2. Aoency Use of Information The NRC uses the information as part of the basis for determining the fitness of an individual for licensing as a Reactor Operator or Senior Reactor Operator.

3. Reduction of Burden Throuah Information Technoloav There is no legal obstacle to the use of information technology. Moreover, NRC encourages its use; however, at the current time, no information is submitted electronically.

4. Effort to identify Duolication and Use Similar Information This information is available only from facility licensees for each applicant for an operator license, new and renewal, and does not duplicate nor overlap other information collections made by the NRC. The Information Requirements Control Automated System (IRCAS) was searched, and no duplication was found.

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5. Effort to Reduce Small Business Burden This information collection does not involve any small businesses.

6. Consecuences to Federal Prooram or Policy Activities if the Collection is Not Conducted or is Conducted Less Frecuentiv information is to be provided only upon request for issuance of a license, renewal of a !icense (every six years) or upon notification to NRC of disability. Frequency of reporting cannot be reduced without endangering the health and safety of the public.

7. Circumstances which Justify Variation from OMB Guidelines No variations from OMB guidelines.

8. Consultations Outside the NRC Opportunity for public comment will be published in the Federal Reo: ster.

9. Payment or Gift to Respondents Not applicable.

10. Confidentiality of Information NRC 16, Privacy System of Records, specifies confidentiality of these records. ,

These records are limited to those persons whose official duties require such access.

11. Justification for Sensitive Questions The facility licensee must certify that an applicant for an NRC operators license meets the facility medical fitness requirements to be licensed as an operator at the facility. The certification involves supplying medicalinformation on applicants. NRC Form 396 also requires certification that applicants meet fitness-for-duty and safeguards requirements for unescorted access to vital areas of a nuclear power plant. This latter certification requires knowledge of an applicant's drug testing results and a facility review of the applicant's criminal history, if any.

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12. Estimated Industry Burden and Costs l

(a) Reoortina Reauirements Approximately 450 new and 500 renewal applicant certifications are expected to be completed by facility licensees annually. Approximately 25 notifications of disability are also expected annually. The estimated l annual reporting burden per applicant is .25 hours2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br />.

450/New Applicants X .25 hours2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br /> = 112.5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> 500/ Renewal Applicants X .?S hours = 125 hours0.00145 days <br />0.0347 hours <br />2.066799e-4 weeks <br />4.75625e-5 months <br /> 25/ Notices of Disability X .25 hours2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br /> = 6.25 hours2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br /> Total annual burden is 975 X .25 hours2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br /> = 243.75 hours8.680556e-4 days <br />0.0208 hours <br />1.240079e-4 weeks <br />2.85375e-5 months <br />.

Recordkeeoina Reauirements (b)

There are 141 facility licensees that shall retain the medical documentation for 4864 reactor operator and senior reactor operators I while they are employed in this capacity (10 CFR 55.27). The facility licensees retain 4864 records annually or an average of 34 records per licensee with an approximate burden of .10 hour1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br /> per record. The total annual burden is 486 hours0.00563 days <br />0.135 hours <br />8.035714e-4 weeks <br />1.84923e-4 months <br /> (34 records per facility licensee x 141 facility licensees x .10 hour1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br /> per record).

(c) Total Industry Cost and Burden 450 New Applicants X .25 hours2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br /> = 112.5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> X $141 = $15,862.50 500 Renewal Applicants X .25 hours2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br /> = 125 hours0.00145 days <br />0.0347 hours <br />2.066799e-4 weeks <br />4.75625e-5 months <br /> X $141 = $17,625 25 Notices of Disability X .25 = 6.25 hours2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br /> x $141= $881.25 4864 Records Retained X .10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br /> = 486.4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> X $141 = $68,582.40 (34 records per facility licensee x 141 facility licensees x .10 hour1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br /> per record)

Total annual industry burden is 730.15 hours1.736111e-4 days <br />0.00417 hours <br />2.480159e-5 weeks <br />5.7075e-6 months <br />. Total annual industry cost is $102,951.15.

13. Estimate of Other Additional Costs None.

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14. Estimated Annualized Cost to the Federal Government Estimate of annual cost to the Federal Government is based on staff experience. It is estimated that 975 certificates (NRC Forms 396) will be submitted annually during the clearance period. Also, it is estimated that 220 of these certificates will be required to be reviewed by the NRC Consultant Physician and would require approximately 15 minutes review each. Total Federal Government cost includes the following:

NRC Consultant Examining Physician: 220 Forms 396 reviewed annually x .25 hours2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br /> each = 55 hours6.365741e-4 days <br />0.0153 hours <br />9.093915e-5 weeks <br />2.09275e-5 months <br /> @ $55/ hour (actual fee) = $3,025.

Initial and final staff review: 975 X .2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> = 195 hours0.00226 days <br />0.0542 hours <br />3.224206e-4 weeks <br />7.41975e-5 months <br /> X $141 = $27,495. i Total annual cost to the government is $30,520.00. This cost is fully recovered by fee assessments to NRC licensees pursuant to 10 CFR Part 171.

15. Reasons for Chanae in Burden or Cost The burden decreased from 741 to 730 hours0.00845 days <br />0.203 hours <br />0.00121 weeks <br />2.77765e-4 months <br /> because the reestimate of the number of records that will be generated decreased from 4,975 in the previous clearance to 4,864.

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16. Publication for Statistical Use This information is not published for statistical use. l

17. Reason for Not Disclavina the Exoiration Date The expiration date is displayed.

18. Exceptions to the Certification Statement None.

B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS Statistical methods are not employed in the collection of information.

Enclosure:

NRC Form 396 L

NRC FORM 396 U.S. NUCLEAR REGULATORY COMMISSION APPROVED BY OMB: NO. 3150-0024 EXPIRES: MM!DD/YYYY (MM YYYY)

, 10 CFR 55 21,55 23. Estimated burden per retponse to comply with this information collection requet 55 25.55 27. 55 31, 15 minutes NRC requires this informchon to determine that the physcal condition and 55 33,55 57 hetith of operator Icensees is such that the gpphcant would not tre expected to cause operational errors endangenng the pubhc health and safety Send comments regarding CERTIFICATION OF MEDICAL EXAMINATION E"@t ,y " col'ss% "J%n 'g"o,'"'s!T55 cxE %A"n

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BY FAClll"I I ' "uCw '"W' L O " "C "C

'*"'**"'"""""""**"'"'"**"*'Y^""'

N'EOB-10202.' (3150-0000). Omce of ' Management and Budget. Washington,'

20503 If a means used to impose an informaton collection does not display a currently vahd OMB control number, the NRC may not conduct or sponsor, and a person is not reamred to resoond to the information enitection NAME OF APPUCANT FACIUTY FAC1UTY DOCKET NUMBER A. MEDICAL EXAM INFORMATION THIS IS TO CERTIFY THAT THE ABOVE NAMED APPLICANT FOR AN OPERATOR / SENIOR OPERATOR UCENSE HAS BEEN EXAMINED BY A PHYSICIAN AND THAT THE APPUCANT HAS BEEN FOl1ND TO MEET THE SAFEGUARDS AND FITNESS FOR DUTY REQUIREMENTS FOR UCENSED OPERATORS AT THIS FACIUTY PRINTED NnME (of physcian) STATE AND UCENSE NUMBER MOST RECENT MEDICAL EXAMINAT10N DATE BASED ON THE RESULTS OF THE PHYSICAL EXAMINATION. INCLUDING INFORMATION FURNISHED BY THE APPUCANT, THE PHYSICIAN HAS DETERMINED THAT THE APPUCANT'S PHYSICAL CONDITION AND GENERAL HEALTH ARE SUCH THAT THE APPUCANT WOULD NOT BE EXPECTED TO CAUSE OPERATIONAL ERRORS ENDANGERING PUBLIC HEALTH AND SAFETY. ICERTIFY THAT IN REACHING THIS DETERMINATION, THE GUIDANCE CONTAINED IN ANSUANS 3.4-1996, ANSUANS 3 '-

1983, OR ANSUANS 15.4-1988 (N380)WAS FOLLOWED AS ENDORSED BY THE APPLICABLE NRC REGULATORYGUIDE, AND THAT DOCUMENTATION IS AVAILABLE FOR REVIEW BY NRC. IF THE GUIDANCE IN THE APPROPRIATE ANSUANS DOCUMENTIS NOT COMPLIED WITH, AN ACCEPTABLE ALTERNATIVE METHOD,WHICH HAS BEEN APPROVED BY NRC,WAS USED.

ON THE BASIS OF THE RECOMMENDATION OF THE PHYSICIAN,IT IS REQUESTED THATTHE APPLICANT'S OPERATOR LICENSE BE CONDITIONED AS FOLLOWS-1 NO RESTRICTIONS 2 CORRECTIVE LENSES BE WORN WHEN PERFORMING LICENSED DUTIES 3 HEARING AfD BE WORN WHEN PERFORMING LICENSED DUTIES 4 RESTRICTED LICENSE OR EXCEPTION - Provide explanation and attach supportinn rnedical evidence for NRC review 5 RESTRICTION CHANGE FROM PR EVIOUS SUBMITTAL - Provide explanation for restriction channe and attach supportino medical evidence for NRC review 6 INFORMATION ONLY PROPOSED WORDING OF RESTRICTON (Bkch 4 above) GUCANCE USED IN REACHING THis DETERMINAT!ON ANSUANS 3.4 1996 ANSUANS 3.4 1983 ANSUANS 15.4 1988 (NON-POWER)

OTHER (Specify)

RELATONSHIP OF RESTRICTON TO DtSQUAUFYING CONDITON (Sneffy m6cate how resbehon ws# correct me esquahtymg condihon) I EXPLANATON FOR RESTRICTION CHANGE (8Jach 5 aeove)

8. CERTIFICATION ANY FALSE STATEMENT OR OMISSION IN THIS DOCUMENT, INCLUDING ATTACHMENTS, MAY BE SUBJECT TO civil AND CRIMINAL SANCTIONS. I CERTIFY UNDER PENALTY OF PERJURY THAT THE INFORMATION IN THIS DOCUMENT AND ATTACHMENTS IS TRUE AND CORRECT.

PRINTED NAME AND TITLE (Senor Management Representatrve on Site) l SIGNATURE l DATE l In accordance with 10 CFR 55 5, Communications, this original form shall be submitted to the appropriate NRC office as follows: BY MAIL ADDRESSED TO:

REGIONAL ADMINISTRATOR. REGION I REGIONAL ADMINISTRATOR. REGION 11 REGIONAL ADMINISTRATOR, REGION lli U S NUCLEAR REGULATORY COMMIS$10N U S NUCLEAR REGULATORY COMMISSION U S NUCLEAR REGULATORY COMMISSION 475 ALLENDALE ROAD SAM NUNN ATLANTA FEDERAL CENTER 801 WARRENVILLE RD KING OF PRUSSIA PA 19406-1415 61 FORSYTH STREET S W., SulTE 23T85 USLE, IL 60532-4351 ATLANTA. GA 30303-8931 NON-POWER REGIONAL ADMINISTR4 TOR, REGION IV U.S NUCLEAR REGULATORY COMMISSION U S NUCLEAR REGULATORY COMMISSION U S NUCLEAR REGULATORY COMWSSION OPERATOR UCENSING. HUMAN PERFORMANCE EVENTS ASSESSMENT, GENERIC COMMUNICATIONS 611 RYAN PLAZA DRIVE, SUITE 400 AND PLANT SUPPORT BRANCH. HQ AND NON-POWER REACTORS BRANCH ARUNGTON. TX 760118064 DIVISION OF INSPECTION PROGRAM MANAGEMENT DIVISION OF REGULATORY IMPROVEMENT WASHINGTON. DC 205554001 PROGRAMS WASHINGTON. DC 20555 0001 NRC FORM 396 (MM-YYYY) PRINTED ON RECYCLED PAPER L

cgORM sse u.s. NUCLEAR REGULATORY COMMISSION OMB APPROVAL SECTION UPDATE CHECKLIST OMB CLEARANCE PACKAGE TITLE NRC FORM 396, CERTIFICATION OF MEDICAL EXAMINATION BY FACILITY LICENSEE (3150-0024)

Check the appropriate box:

YES NO TYPE OF CLEARANCE Clearance Extension:

Sections listed in the OCP were compared with those listed in the on-line list of "OMB Approval Sections," and the on-line list was modified as necessary to include the sections listed in the OCP. The clearance extension request was checked to ensure that sections for all final rules that became effective in the '

previous 3 years have been included (or deleted, as appropriate) in the package and that these sections have also been included / deleted in the ,

on-line "OMB Approval Section." Final rules that are expected to become effective in the requested clearance period should also be included in the clearance package, but the on-line dataset should not be modified.

[ Proposed Rule:

The proposed rule adds or deletes section(s) from the on-line current "OMB Approvel Section."

[ A modified "OMB Approval Section" has been included in the proposed rule, or program office staff have been instructed to include such paragraph.

(Do not modify the on-line dataset.)

l C[ Final Rule: l The final rule adds or deletes section(s) from the on-line current "OMB Approval Section."

(( The "OMB Approval Section(s)" in the dataset have been updated to include / delete the affected section(s).

[ An updated "OMB Approval Section" has been included in the final rule.

RMB ANALY T SIGNATURE DATE W  ?

V PRWTED ON REGYCLED PAPER This harm was designed usmg inf orms NRC FORM $39 (101998)