ML20137M423

Request for OMB Review & Supporting Statement Re Nuclear Matl Events Database.Estimated Respondent Burden Is 725 H

ML20137M423
Person / Time
Issue date:	04/04/1997
From:	Cranford G NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
To:
Shared Package
ML20137M387	List: ML20137M381 ML20137M423
References
OMB-3150-0178, OMB-3150-178, NUDOCS 9704080083
Download: ML20137M423 (11)

Text

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PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of thin form, the collection instrument to be reviewed, the Supporting Statement, and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Dudget, Docket Ubrary, Room 10102,72517th Street NW, Washington, DC 20603

1. Agency Subagency onginating request J OMB control number U.S. Nuclear Regulatory Commission X a. 3150-0178 b.None

3. Type of information collection (check onel 4. Type of review requested (check onef _

a. New collection X a. Regular submission c. Delegated

b. Revision of a currently approved collection b. Emergency - Approval requested by (date):

c. Extension of a currently approved collection 5. Will this information collection have n ,,y,,

_ significant economic impact on a

d. risinstatement, without change, of a previously approved substantial number of smail entities? x b.No collection for which approval has emptred

e. Reinstatement, with change, of a previously approved X a. Three years from approval date collect on for which approvat has expired N 4"'d ***'

f 6' ex'piration date b. Other (Specify):

I . Existing enllection in use without an OMU control number

. Titi.

Nuclear Material Events Database

8. Agency form number (s) (i/apphcable/

N.A.

9. Keywords Nuclear mt terial, occupational safety and health, inter 0overnmental relations, health f acilities, drugs 1

10. Aostract The A0reement States are requested to voluntarily participate in a monthly automated collection (which may include the NMED data screen and replaces NRC Forms 565 and 566) of licenseo data on the occurrence of  ;

incidents and events involving the use of radioactive byproduct material, such as medical )

misadministrations, radiation overexposures, etc.

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11 Af fetted pubhc IMare whwary s with *P' onut an erhus ther nWy with *x*) 12. obhgetion to respond ta*nre smmary wtth *P' n, ort en euhare ther aspry wtth M*) l

e. Individuais or householde d. raime P e. voluntary l

b. tbsiness or other for profit e rederal oovernment b. Required to obtain or retain benefits l

c Not for profit instituticos P f. Stata. Local. or inhal oovernment c. Mandatory

13. Annual reporting and recorcheeping hour burden 14. Annual reporting and recordbeeping cost burden fin rinmwwls et donars/

a Number of respondents 30 e. Total annualised capatel/startup cocts o b total annual responses i 740 b. Total ennual costs lo&M) 0

1. Percentage of these responses c, total annualised cost requested o collected electronically 35  % d. Current OMB inventory o

c. Total annual hours requested 725 s. oifference o

d. Current OMS inventory 1050 f. f.mplenation of difference

e. Difference (225) 1. Program change

f. Isplanation of difference 2. Adjustment i

1. Program change (225)

2. Ad iustment

16. Purpose of information collection 16 rroquency of recordkeeping or reportin (Check all thaf apply)

(Mark primary with *P' entf oil richer het apply with *X*) a Recordb eeping b Thurd party disclosure

a. Apphcation for benehts o. Program planning or management X c. fleporting x b. Program evaluation f. ltesearch X 1. on occasion 2. Weekly X 3. Monthly

c. oeneral purpose statistics p g Regulatory or compliance 4. ouarterly 6. some annually 6. Annually d Audit L Dimelly 8. other (descnbe)

17. Statistical methods 9g Agency contact Iperson who con har ensw gue&ns reg @g the content of this submissbon) oOes this Informattori colleClion employ atglistaCal methods?

Nome: Patricia M. Larkins Yea h No Phona: (301)415 2309 9704090083 970404 '0**

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19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, I certify that the collection ofinformation =-  ; ri by this request complies with ~

$ CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8(b)(3), appear at the end of the instructions The artijlcation is to be neade with reference to those regulatoryprovisionr as setforth in the instructions.

- The following is a summary of the topics, regarding the proposed collection of infomation, that the certification covers: .

(a) It is necessary for the proper performance of agency functions; (b) It avoids unnecessary duplication; ,

(c) It reduces burden on small entities; (d)- It uses plain, coherent, and unambiguous tennmology that is understandable to respondents; (c) Its implementation will be consistent and compatible with current reporting and recordkeeping gh, l It indicates the retention periods for recordkeeping requirements;  ;

. (f)

(g) It informs respondents of the information called for under 5 CFR 1320.8(b)(3): ,

(i) Why the infonnation is being collected; (ii) Use of information; (iii) Burden estimate; (iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and I

(vi) Need to display currently valid OMB control number; (h) It was developed by an office that has planned ac4 allocated resources for the efficient and effective management and use of the information to be collected (see note in Item 19 of the instructions).

(i) It uses effective and efficient statistical survey methodology; and (j) It makes appropriate use ofinformation technology. l s

I If you are unable to certify compliance with any of these pmvisions, identify the item below and explain the reason in .

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Item 18 of the Supporting Statement. (

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SUPPORTING STATEMENT FOR Proposed NRC " Nuclear Material Events Database (NMED)"

for the Collection of Event and Medical Misadministration Reports (3150-0178)

Revision Request Description of the information Collection The Agreement States have been requested to voluntarily participate in an automated collection of Agreement State licensee data on the occurrence of incidents and events involving the use of radioactive byproduct material, such as medical misadministrations, radiation overexposures, environmental releases, contamination, leaking sources, lost sources, equipment failure, etc. This information is submitted to the Agreement States by their licensees through Agreement State regulations that are compatible to NRC regulations, and that require the reporting of incidents and events involving the use of radioactive byproduct materials. Previously this information was collected annually from the Agreement States on NRC Forms 565 and 566. In addition, significant events that could pose a significant health and safety hazard are requested to be orally reported by the Agreement States within the next working day of notification by their licensee. (In accordance with established regulatory requirements, Agreement State licensees report ,

significant events to the Agreement State within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />.) These and other events will l be reported on a monthly basis using the automated system, which will replace the use of i NRC Forms 565 and 566. Agreement States may also chocse to submit the report in written form by using a copy of the NMED data screen.

A. JUSTIFICATION

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

I The Commission is directed under the Atomic Energy Act of 1954 ("the l Act") Sections 274, Sec. 2, Findings, Paragraphs D and E, to protect the public against the hazards of radiation. In 1959, Section 274 of the Atomic Energy Act was enacted to spell out a State's role and to provide a statutory l basis under which the Federal government could relinquish to the States l portions of its regulatory authority. The 1959 amendments made it possible j for the State to license and regulate byproduct, source, and small quantities i of special nuclear material. The mechanism for the transfer of NRC's authority to a State is an Agreement signed by the Governor of the State and the Chairman. These States are known as Agreement States. Pursuant to )

the 1954 "Act" and the Energy Reorganization Act of 1974, as amended, l the NRC investigates significant events and abnormal occurrences in licensed facilities. The Energy Reorganization Act requires NRC to provide to Congress on an annual basis, information on significant events that meet the abnormal occurrence criteria. Pursuant to Section 274j of the Act, the Commission evaluates Agreement State progr:ms to ensure that each Agreement State has a program that is compatible with NRC's program and to ensure that the State's regulatory program is adequate to protect the public health and safety. In addition, Section 274g of the Act requires NRC

to ccoperate with Agreement States in the formulation of standards for protection against hazards of radiation. The information from medical misadministrations and event reports is invaluable in assessing actual Agreement State regulatory experiences.

Responsibility for regulating the 22,000 specifically licensed users of radioactive materials is shared between NRC and the 30 Agreement States.

States regulate from as few as 100 licenses to over 2,000 licenses.

Agreement State materiallicensees include about 4,000 medicallicensees and about 11,000 other nonreactor licensees. Approximately 65-70 percent of the licensed users of radioactive material are regulated by the Agreement States. Therefore, we could expect a representative proportion of nuclear material event report data, including medical misadministration events, from Agreement State licensees. The reported information will significantly aid in understanding material events and identifying actions necessary to improve the effectiveness of NRC and Agreement State regulatory programs, in 1994 and 1995, all 29 Agreement States voluntarily provided information on material events in various formats from very limited to very detailed information in technical content and substance. To improve the technical information content of event reports, ensure consistency, improve ease of access and retrieval of event information, and reduce duplication of effort in 1 processing and rekeying information by all parties involved, we are l requesting that this information be collected in a standardized format, through electronic transmiss!on into the Nuclear Material Events Database l (NMED). The NMED data entry elements have been expanded over those identified in NRC Forms 565 and 566 to respond to General Accounting Office and Congressional recommendations to provide a complete national set of data that is adequate to perform long-term trend antdyses of what occurred, direct and indirect causes, possible precursors, identify any site specific or generic issues and any effects (long and short-term) as a result of the event, as well as the health and safety significance. The automated NMED system will replace NRC Form 565, Event Report, and NRC Form 566, Medical Misadministrations. All events will be reported on a monthly basis, primarily using the new automated system.

In addition, events that could pose a significant health and safety hazard will be reported by the Agreement States to the NRC Operations Center, within the next working day of notification by their licensee. (In accordance with established regulatory requirements, licensees report significant events tc, an Agreement State within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />.)

2. Aaency Use of the Information The periodic collection of event data provided voluntarily from the individual Agreement States will be assessed both individually and collectively to identify any safety concerns that could have the potential to reduce assurance that the health and safety of the public are adequately protected.

Some significant events may meet the criteria for an abnormal occurrence.

NRC is required to report abnormal occurrences to Congress on a annual

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basis. When incidents related to radiation safety have occurred at material licensees' facilities, the NRC reviews the incident report and assesses the information against other similar operating experiences. These assessments can provide important information to NRC, Agreement States, and other ,

materiallicensees regarding generic or recurring problems, as well as safe I operational details and procedures. Specific task forces or working groups i may be established to analyze problems and provide lessons leamed. These l assessments may also identify generic implications which would indicate a need for NRC to assess any changes necessary in the conduct of the Agreement State Program or any revisions to nuclear material regulations. 1 This information is also used during formal periodic reviews of an Agreement State radiation control program to assess the adequacy of their program to assure the protection of public health and safety. The NRC also provides feedback to industry, the regulated community and others, in the form of technical reports, training programs, video tapes on medical and industrial safety training, etc., on lessons learned in order to improve safety.

3. Reduction of Burden Throuah Informa_ tion Technofoav NRC has worked with the Agreement States through several workshops to develop an efficient and cost effective method for providing the necessary information. The goal of this joint effort has been to develop an events database system that meets the needs of both the NRC and the Agreement States. The national electronic database system will provide the Agreement States with online access to nuclear material event information from NRC and Agreement State licensees. The current percentage of information collected electronically is approximately '35%. Attachment A contains a list of the fields or elements that would be used to collect medical misadministratier, and incident and event information.

4. Efforts to identifv Duolication and to Use Similar Information The Information Requirements Control Automated System (IRCAS) was searched and no duplication was found. There is no similar information available to the NRC. The information provided through the subject electronic database is not available from any other source other than Agreement States.

5. Effort to Reduce Small Business Burden This voluntary information is requested only from Agreement State regulatory authorities.

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6. Consequences to Federal Proaram Activities if the Collection is not Conducted or is Conducted I.ess F eouentiv information on events that could pose a significant health and safety hazard is requested to be orally reported to the NRC Operations Center within the next working day of notification to the Agreement State by an Agreement State licensee. (Under established regulatory requirements, Agreement State licensees will report significant events to the Agreement State within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />.) Additional follow up information on significant events is requested to be provided as it is collected by the States. Some significant events meet the criteria of an abnormal occurrence and are included in NUREG-0090, the NRC annual abnormal occurrence report to Congress, required by the Energy Reorganization Act of 1974. Information on events that do not pose a significant health and safety hazard are collected within one month or 30 days after notification to the Agreement States by a licensee. Collecting information on a less frequent basis could impact public health and Safety,

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would greatly reduce the usefulness of the assessments of nuclear material events that have occurred in the Agreement States, and would impact our responsibility to report abnormal occurrences to the Congress and the public in a timely manner.

7. Circumstances Which Justifv Variation from OMB Guidelines Information on events that could pose a significant health and safety hazard is requested from Agreement States on a voluntary basis, within the next  ;

working day of notification by their licensee so that NRC can identify I immediateiy any health and safety hazard to the public, and offer assistance to the Agreement State in responding to the event. (Under established regulatory requirements these events will be reported by a licensee to the J Agreement State within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> or less.) ,

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8. Consultation Outside the NRC in 1993,1994, and 1995, the Agreement States were consulted and participated in the identification of information to be collected for the Nuclear Material Events Database system. Opportunity to comment was published in the Federal Reaister, December 27,1996 (61 FR 68307). No comments were received.

9. Confidentiality of Information Proprietary information is only generated in a small percentage of Agreement State collections. However, this information will be handled in accordance with NRC regulations in 10 CFR 2.790.

10. Justification for Sensitive Questions No sensitive information is requested.

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11. Estimate of Other Additional Costs None.

12. Estimated Annualized Cost to the Federal Government ,

The following cost is estimated to be incurred by the government in the J

automated processing, coding and information storage activities related to these events and misadministration.

The staff estimates that it would take a contractor an average of about 240 hours0.00278 days <br />0.0667 hours <br />3.968254e-4 weeks <br />9.132e-5 months <br /> per year to review an estimated 720 events and misodministrations forwarded annually by the Agreement States to NRC or 1/3 hour per report.

Automating this effort reduces the government burden from 250 hours0.00289 days <br />0.0694 hours <br />4.133598e-4 weeks <br />9.5125e-5 months <br /> to 240 hours0.00278 days <br />0.0667 hours <br />3.968254e-4 weeks <br />9.132e-5 months <br />. The annual cost to the government is estimated as follows:

240 Hours X $120 an hour = $28,800(professional effort) 50 Hours X $45 an hour = 2,250 (clerical effort)

TOTAL COST: $31,050.

(Contractor Cost) j Events that occur that could pose a significant health and safety hazard will be orally reported by an Agreement State to the NRC Operations Center within the next working day of notification by their licensee. The staff  !

estimates that.they may receive and process approximately 20 such l significant events, each of which would require approximately 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> of staff time.

2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> X 20 significant events = 40 staff hours 4 40 staff hours X $120.00 an hour = $4,800. i l

TOTAL COST: $4,800.

(Staff Cost)

These costs are fully recovered through license fees charged to NRC j licensees pursuant to 10 CFR Part 170 and/or 171.

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13. Estimate of Industrv Burden I l

The requested information is collected in the following manner.  ;

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Agreement State licensees report information to the States and the States in turn will summarize event information received from their licensees and voluntarily enter this information into an electronic " Nuclear Material Event Database (NMED)," on a monthly basis. They will electronically transmit the information to NRC or send it to NRC via PC diskette. Some small Agreement State programs with less than 100 licensees may provide NMED ]

event reports in written form using a hard copy of the NMED data screen. )

Events do not occur with any part% aar frequency; therefore, a particular l 1

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State may report 3-4 events during one month and may not report any information for the following two months.

Through formal Agreements with the Governor of a State the NRC relinquishes regulatory authority to the State. As the entity with regulatory authority, Agreement States, through regulations that are compatible to NRC regulations, require their licensees to report events and medical misadministrations involving the use of radioactive byproduct material.  ;

Additionally, as the entity with regulatory authority, the Agreement State radiation control program, generally under the State Department of Health, shoulders the responsibility and burden of collecting nuclear material event information from Agreement State licensees and voluntarily reports this information to NRC. Therefore, the Agreement State licensee's burden to report nuclear material event information to the Agreement State, and the Agreement State's burden to collect this information, exists absent NRC's request for voluntary Agreement State participation in the electronic reporting of medical misadministration and other incidents and events. The burden is covered in separate OMB approvals for licensee reporting and Agreement State review.

The staff estimates that the States receive from their licensees about 720 i material event reports annually. It will take about 3/4 ( 75) hour for the i Agreement State to process the event information received from their l licensee, j 30 States X 24 reports / State X .75 hour8.680556e-4 days <br />0.0208 hours <br />1.240079e-4 weeks <br />2.85375e-5 months <br /> = 540 burden hours Based on historical data and experience during the first four months of a trial program using the NMED system, the additional burden to the Agreement States to enter the event information and electronically transmit it to NRC via the NMED system will be as follows:

30 States X 24 reports / State X .25 hour2.893519e-4 days <br />0.00694 hours <br />4.133598e-5 weeks <br />9.5125e-6 months <br /> = 180 burden hours in addition to the above, the Agreement States voluntarily report events that occur that could pose a significant health and safety hazard orally to the NRC Operations center within the next working day of notification by their licensee. The staff estimates that they may report up to 20 significant events, each of which would require up to 15 minutes to report (15 min./rpt. x 20 rpts. = 5 burden hours).

The total burden for the Agreement States is (540 + 180 + 5) = 725 total burden hours.

The previous OMB clearance for NRC Forms 565 and 566 estimated the burden to be 1050 hours0.0122 days <br />0.292 hours <br />0.00174 weeks <br />3.99525e-4 months <br />. The change from written to electronic reporting reduces the estimated burden to 725 burden hours.

14. Reason for Chance in Burden The burden is estimated to decrease from 1050 hours0.0122 days <br />0.292 hours <br />0.00174 weeks <br />3.99525e-4 months <br /> to 725 hours0.00839 days <br />0.201 hours <br />0.0012 weeks <br />2.758625e-4 months <br /> due to the use of an automated, rather than manual, system to collect the data.

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15. Puolication for Statistical Use This information will not be published for statistical use.

16. Reason for Not Disolavino the Exoiration Date Not applicable. The expiration date is displayed. The database software [

displays the OMB clearance, burden estimate, expiration date and public -!

protection statement as required.

17. Exceotions to the Certification Statement Not applicable.

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18. Payment or a Gift to Resoondents Three Agreement States were provided one 386 Personal Computer each, I from NRC retired equipment, through a government to government transfer. l The three Agreement States had indicated that they would not be able to j participate in the electronic collection of event information due to insufficient l equipment.

B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS The collection of information does not employ statistical methods. j

Attachment:

As stated 4

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DATA ENTRY INFORMATION FOR ATTACHMENT A NUCLEAR MATERIAL EVENTS DATABASE (NMED)

EVENT REPORT INVOLVING USE OF NUCLEAR MATERIAL The Nuclear Material Events Database (NMED) contains the official NRC collection of information on all non-commercial power reactor incidents and events, including medical misadministration, that are required to bc reported by the regulated community of licensees to NRC and the Agreements States, through NRC and compatible Agreement State regulations. The following 2 page list contains the NMED data entry elements necessary to support the collection of consistent information in a standardized format for all nuclear materialincidents and events. Many of the items require only one keystroke for entry. Information has been pre-coded into a master list. The user scrolls through a pick list to the appropriate item and makes a choice. The codes have been developed to provide standardization and consistency in information, ease of retrieval, and to provide a three or four Iceystroke entry for lengthy information.

GENERAL INFORMATION 2. MEDICAL EVENT INFORMATION (Where applicable) g ISOTOPE. ACTIVITY AND DOSAGE: (i.e.,10 mci of Iodine-A. ORIGINAL ITEM NO 131: 40 rad of Cs-137; 200 pCi of lodine Hippurate)

(State ID\YR\No.) ]

B. FOLLOW UP RPT NO. a. INTENDED DOSE (Code) '

(01, 02, etc.)

C. UENSEE NAME. CITY AND Millicuries l STATE, ZIP CODE (Code) Isotope i D. LICENSE NO. Chemical Form l E. PROGRAM CODE (License Type) l F. SITE OF EVENT b. ACTUAL DOSE (Code) l G. STATE OF EVENT l H. LICENSE NO OF SITE Millicuries

1. WERE OTHER PARTIES INVOLVED 7 Isotope IF SO, IDENTIFY (Provide Chemical Form Name\ City \ State): Study \ Procedure J. RECIPROCITY (Code)

K. REPORTABLE EVENT (Y\N): c. %OVERTREATMENT NRCl_f ASl l d. % UNDERTREATMENT L. AEA (Y\N) e. FAMILY DOSE M. DATE OF EVENT f. FETAL DOSE N. TIME OF EVENT g. DOSE NE'NBORN O. TIME 2ONE h ORGAN (Code)

P. DATE RPTED TO STATE i. EFFECT ON PATIENT (S)

Q. TIME REPORTED j. WHO ADM:N!STERED R. CONSULTANT (Y\N) k. DIAGNOSTIC OR THERAPEUTIC (D\T)

S. ABNORMAL OCCURRENCE (Y\N) 1. TREATMENT PLAN AND SCHEDULE--INTENDED AND T. DATE OF THIS REPORT ACTUAL (Include fractionations, where applicable)

U. INVESTIGATION (Y\N) m. NO. OF PATIENTS V. EVENT DESCRIPTION (Code) n. PATIENT \RESPONSIDLE RELATIVE NOTIFIED (Y\N)

W. CAUSE DESCRIPTION (Code) o. REFERRING PHYSICIAN NOTIFIED (Y\N)

X. CONTRIBUTING FACTOR (Codit) p. DEMOGRAPHICS Y. PRECIPITATING FACTOR (Code)

Z. CORRECTIVE ACTION (Code) 3. OVEREXPOFURE DATA (Where applicable)

A1. REPORTING REOJIREMENT

a. NO. 0F PERSONS INVOLVED

a. CLASS EVEld TYPE (Codel b. DOSE RECEIVED (rem)

b. NRC 10 CFR (Code) c. RADIATION SOURCE

c. AGREEMENT STATE COMPATIBLE REGULAllON 4. EQUIPMENT INFO (Enter applicable data for all equipment in use during event-hardware \ software) Choose from code list for SPECIFIC INFORMATION BASED ON a,b.c,d:

a. SYSTEM TYPE

b. MANUFACTURER \ SHIPPER

1. RELEASE OF MATERIAL c. MODEL NO.

(Where applicable), d. SERIAL \fD NO.

e. MANUFACT. DATE

a. TYPE OF RELEASE (Code) f. ISOTOPE ACTIVITY (Ci) (Code)

b. ISOTOPE (Code) g. ASSAY DATE

c. ACTIVITY (Ci) (Code) h. LEAK TEST RESULT ( Ci)

L SOURCE CHANGE DATE

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+ +

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~ 4. EQUIPMENT INFO. CONT.

. j, PftOBLEM (Enter data when - i 1

' ynt may have contributed ,

t ' to the event).' - I,

' 5. N - (Provide ckar concise chronological  ;

. statement in the form of a mini executive summary of the important facts concerning the event. This element is apperwied

- to as follow up info,'metion is added or when the licensee makes J any corrections. It is not deleted arwd then rewritten as new [

information is obtelnedc include direct cause, any new material,.  !

any retractions,' licensee corrective actions, consultant ' -

statements, civil penalties, significant enforcement actions

-taken by State.) - l t

- April 3,1997 l

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