ML20132G724

Notice of Pending NRC Action to Submit Info Collection Request to OMB & Solicitation of Public Comment

ML20132G724
Person / Time
Issue date:	01/20/1996
From:	Cranford G NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
To:
References
OMB-3150-0178, OMB-3150-178, NUDOCS 9612270025
Download: ML20132G724 (15)

Text

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[7590-01-P]

NUCLEAR REGULATORY COMMISSION Documents Containing Reporting or Re;ordkeeping Requirements:' Notice of Pending Submittal to the Office of Management and Budget (OMB) Review l

AGENCY:

U. S. Nuclear Regulatory Commission (NRC)

ACTION:

Notice of pending NR, action to submit an information collection request to OMB and solicitation of public comment.

SUMMARY

The NRC is preparing a submittal to OMB for review of continued approval of information collections under the provisions of the Paperwork Reduction Act of 1995(44 U.S.C. Chapter 35).

Information pertaining to the requirement to be submitted:

1.

The title of the information collection: Nuclear Material Events Database (NMED).

2.

Current OMB approval number: 3150-0178 l

i 9612270025 960120 PbH ORO EUSOMB

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3.

How often the collection is required: Agreement States are requested to report events to NRC electronically or by hard copy within one month of notification from an Agreement State licensee that an incident or event involving the industrial, commercial and/or academic use of radioactive byproduct materials, or the use of radioactive materials for medical diagnosis, therapy, or research has occurred. In addition, 1

Agreement States are requested to report events that may pose j

i a significant health and safety hazard to the NRC Headquarters i

l Operations Officer within the next working day of notification i

by an Agreement State licensee.

4.

Who is required or asked to report: Current Agreement States and any State receiving Agreement State status in the future.

i 5.

The number of annual respondents: 29 i

I 6.

The number of hours needed annually to complete the i

a requirement or request: 705 hours0.00816 days <br />0.196 hours <br />0.00117 weeks <br />2.682525e-4 months <br /> (an average of approximately one hour per response) for all existing Agreement States reporting; any new Agreement State would add j

approximately 25 reports per year or 25 burden hours.

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Abstract: NRC regulations require NRC licensees to report incidents and events involving the use of radioactive byproduct material, and source material, such as those involving a radiation overexposure, a leaking or contaminatcJ sealed source, release of excessive contamination of radioactive material, lost or stolen radioactive material, equipment failures, and abandoned welllogging sources. Medical misadministrations are required to.be reported in accordance with 10 CFR 35.33. Agreement State I;censees are also required to report these events and medical misadministrations to their individual Agreement State regulatory authorities under compatible Agreement State regulations. NRC is requesting that the Agreement States voluntarily submit summary information on events and medical misadministrations involving the use of nuclear materials regulated pursuant to the Atomic Energy Act, in a uniform electronic format, for assessment and identification j

of any facility / site specific or generic safety concerns that could f

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have the potential to impact public health and safety; and to evaluate actions necessary to prevent their occurrence at the same or other facilities.

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4 Submit, by (insert date 60 days after publication in the FR), comments that address the following questions:

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1.

Is the proposed collection of information necessary for the NRC to properly perform its functions? Does the information have practical utility?

2.

Is the burden estimate accurate?

3.

Is there a way to enhance the quality, utility, and clarity of the 3

e information to be collected?

4.

How can the burden of the information collection be minimized, including the use of automated collection techniques or other forms of information technology?

t A copy of the draft supporting statement may be viewed free of charge at the NRC Public Document Room, 2120 L Street, NW. (Lower Level), Washington, DC.

Members of the public who are in the Washington, DC, area can access this document via modem on the Public Document Room Bulletin Board (NRC's Advanced Copy Document Library) NRC subsystem at FedWorld, 703-321-3339.

1 Members of the public who are located outside of the Washington, DC, area can dial FedWorld, 1-800-303-9672, or use the FedWorld internet address:

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' fedworld. gov (Telnet). If assistance is needed in accessing the document, please contact the FedWorld help desk at 703-487-4608. Additional assistance in locating the document is available from the NRC Public Document Room, nationally at 1-800-397-4209, or within the Washington, DC, area at 202-634-3273.

Comments and questions about the information collection requirements may be directed to the NRC Clearance Officer, Brenda Jo Shelton, U.S. Nuclear Regulatory Commission, T-6 F33, Washington, DC. 20555-0001, or by telephone at (301) 415-7233, or by Internet electronic mail at BJS1@NRC. GOV.

Dated at Rockville, Maryland, this.; '- day of v

.,1996.

l For the Nuclear Regulatory Commission j

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l Gerald F. Cranford Designated Senior Official for Information Resources Management l

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fedworld. gov (Telnet). If assistance is needed in accessing the document, please 4

contact the FedWorld help desk at 703-487-4608. Additional assistance in i

locating the document is available from the NRC Public Document Room, nationally at 1-800-397-4209, or within the Washington, DC, area at 202-634-3273.

J Comments and questions about the information collection requirements may j

be directed to the NRC Clearance Officer, Brenda Jo Shelton, U.S. Nuclear j

Regulatory Commission, T-6 F33, Washington, DC. 20555-0001, or by telephone at (301) 415-7233, or by Internet electronic mail at BJS1@NRC. GOV.

l Dated at Rockville, Maryland, this day of

,1996.

1 For the Nuclear Regulatory Commission 4

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Gerald F. Cranford Designated Senior Official for Information Resources Management r.

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

for the CollectSo of Event and Medical Misadm t.stration Reports i

(3150-0'/8)

Revision 'equast Descriotion 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 i

as medical misadministrations, radiation overexposures, environmental releases, contamination, leaking sources, lost sources, equi) ment failure, etc. This information is submitted to the Agreement States ay 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 be reported on a monthly basis using the automated system, which will replace the use of NRC Forms 565 and 566. Agreement States may also choose to submit the report in written form by using a copy of the NMED data screen.

A.

JUSTIFICATION l

1.

Need for and Practical Utility of the Collection of Information, l

The Commission is directed under the Atomic Energy Act of 1954

("the 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 s) ell out a State's role and to provide a statutory basis under w1ich the j

Federal government could relinquish to the States portions of its i

regulatory authority. The 1959 amendments made it possible for the State to license and regulate byproduct, source, and small quantities of special nuclear material. The mechanism for the transfer of NRC's authority to a State is an Agreement signed by i

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, the NRC investigates significant events and abnormal occurrences in i

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.

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Pursuant to Section 274j of the Act, the Commission evaluates 1

Agreement State programs to ensure that each Agreement State has a program that is compatible with NRC's program and to ensure that g?

the State's regulatory program is adequate to protect the public i

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2 health and safety.

In addition, Section 2749 of the Act requires NRC to cooperate with Agreement States in the formulation of standards for protection against hazards of radiation. The information fron 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 29 Agreement States. States regulate from as few as 100 licenses to over 2,000 licenses. Agreement State material licensees include about 4000 medical licensees 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 misadministation 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 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 processing and rekeying information by all parties involved, we are requesting that this information be collected in a standardized format, through electronic transmission into the Nuclear Material Events Database (NMED). The NMED data entry elements have been expanded over those identified in NRC Forms 565 and 566 to respond to i

General Accounting Office and Congress:onal recommendations to 1

provide a complete national set of data that is adecuate to perform long term trend analyses of what occurred, cirect 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 j

565, Event Report, and NRC Form 566, Medical Misadministrations.

1 All events will be reported on a monthly basis, primarily using the new automated system.

In addition, events that could )ose a significant health and safety hazard will be reported ay the Agreement States to the NRC 0)erations Center, within the next working day. of notification by t1eir licensee.

(In accordance with established regulatory

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requirements, licensees report significant events to an Agreement State within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />.)

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Aaency Use of the Information I

The periodic collection of event data from the individual l

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 I

the criteria for an abnormal occurrence. NRC is required to report abnormal occurrences to Congress on an annual 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 l

to NRC, Agreement States, and other material licensees regarding generic or recurring problems, as well as safe operational details and 3rocedures. Specific task forces or working groups may be l

esta)lished to analyze problems and provide lessons learned.

l These 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. 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 >rotection of public health and safety. The NRC also provides feedaack to industry the regulated community and others, in the i

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 Information Technoloav 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 I

collected electronically is approximately 30%. Attachment A l

contains a list of the fields or elements that would be used to collect medical misadministration and incident and event l

information.

4.

Efforts to Identify Duolication and to Use Similar Information 1

The Information Requirements Control Automated System (IRCAS) was 4

searched and no dualication was found. There is no similar information availaale to the NRC. The information provided through the subject electronic database is not available from any l

other source other than Agreement States.

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5.

Effort to Reduce Small Business Burden l

This voluntary information is requested only from Agreement State regulatory authorities.

6.

Conseauences to Federal Program Activities if the Collection is not Conducted or is Conducted Less Freauently Information on events that could pose a significant health and safety hazard is requested to be orally reported to the NRC 0)erations Center within the next working day of notification to t1e 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, would greatly reduce the usefulness of the asses' ments of nuclear material events that have occurred in the Agreeme i

States, and would impact our responsibility to report abno" ul occurrences to the Congress and the public in a timely mrmr.

7.

Circumstances Which Justify Variation from OMB Guidelines Information on events that could pose a significant health and safety hazard is requested from Agreement States within the next working day of notification by their licensee so that NRC can identify immediately 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 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 )

j 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.

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.

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10.

Justification for Sensitive Questions No sensitive information is requested.

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 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 233 hours0.0027 days <br />0.0647 hours <br />3.852513e-4 weeks <br />8.86565e-5 months <br /> per year to review an estimated 700 events and misadministrations 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 233 hours0.0027 days <br />0.0647 hours <br />3.852513e-4 weeks <br />8.86565e-5 months <br />. The annual cost to the government is estimated as follows:

233 Hours X $120 an hour = $27,960 (professional effort) 2.250 (clerical effort) 50 Hours X $45 an hour

=

TOTAL COST:

$30.210.

Contractor Cost)

Events that occur that could pose a significant health and safety hazard will be orally reported by an Agreement State to the NRC 03erations Center within the next working day of notification by t1eir licensee. The staff estimates that they may receive and process approximately 20 such 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 40 staff hours X $120.00 an hour = $4,800.

TOTAL COST:

$4,800.

(Staff Cost)

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

13.

Estimate of Industry Burden The requested information is collected in the following manner.

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

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i 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 particular frequency; therefore, a particular 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 byaroduct material. Additionally, as the entity with regulatory aut1ority, 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 l

the Agreement State, and the Agreement State's burden to collect this information, exists absent NRC's request for voluntary j

Agreement State participation in the electronic reporting of J

medical misadministration and other incidents and events, and the burden is covered in separate OMB approvals for licensee reporting and Agreement State overview.

The staff estimates that the States receive from their licensees about 700 material event reports annually, and it will take about 4

3/4 (.75) hour for the Agreement State to process the event l

information received from their licensees.

l 29 States X 24 Reports / State = 700 X.75 hour8.680556e-4 days <br />0.0208 hours <br />1.240079e-4 weeks <br />2.85375e-5 months <br /> = 525 burden hours The previous OMB clearance for NRC For.ns 565 and S66 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 700 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:

29 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 /> = 175 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 licensees. The staff estimates that they may report between 12 and 20 significant events, each of which would require between 5 and 15 minutes to report (15 min./rpt. x 20 rpts. = 5 burden hours).

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7 The total burden for Agreement State licensees and Agreement States is (525 + 175 + 5) = 705 total burden hours.

14.

Reason for Chanae 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 700 hours0.0081 days <br />0.194 hours <br />0.00116 weeks <br />2.6635e-4 months <br /> due to the use of an automated, rather than manual, system to collect the data.

15.

Publication 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 number, burden estimate, expiration date and public protection statement as required.

17.

Exceptions to the Certification Statement Not applicable.

18.

Payment or a Gift to Respondents Three Agreement States were provided one 386 Personal Computer each, from NRC retired equi) ment, through a government to government transfer. The t1ree Agreement States had indicated that they would not be able to participate in the electronic collection of event information due to insufficient equipment.

B.

COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL Kc M The collection of information does not employ statistical methods.

Attachment:

As stated

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

EVENT REPORT INVOLVING USE OF NUCLEAR MATERIAL Tt.e Nuclear Metenal Events Database (NMED) contains the official NRC collection of informanon on all non-commercial p,wer reactor incidents and events, including medical misadmmistration, that are required to be reportW by the regulated community of licensees to NRC and tne Agreements States, through NRC and compatible veement State regulations. The following 2 page list contains tho NMED data entry elements necessary to support the collection of consistent information m a standardized format for all nuclear matena, incidents 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 th- -op6 ate stem and makes a choice. The codes have been developed to provide standardizabon and consistency in information, ease of retneval, and to provide a three or four keystroke entry for lengthy information.

GENERAL INFORMATION

2. MEDICAL EVENT INFORMATION (Where applicable)

ISOTOPE, ACTIVITY AND DOSAGE: (te.,10 mci of lodine-A. ORIGIN AL ITEM NO 131; 40 red of Cs-137; 200 pCi of lodine Hippurete)

(State ID\\YRiNol B. FOLLOW UP RPT NO.

a. INTENDED DOSE (Code)

(01, 02, etc.)

C. LICENSEE NAME, CITY AhD Millicuries STATE, ZIP CODE (Code)

Isotope D. LICENSE NO.

Chemical Form E. PROGRAM CODE (License Type)

F. SITE OF EVE..I

b. ACTUAL DOGE (Code)

G. STATE OF EVENT H. LICENSE NO. OF SITE Millicunes

1. WERE OTHET; PARTIES INVOLVED?

Isotope IF SO, IDENTIFY (Provide Chemical Form Name\\ City \\ State):

Study \\ Procedure J. RECIPROCITY (Code)

K. REPORTABLE EVENT (Y\\N):

c. %OVERTRE ATMENT NRCf._j ASL I

d. %UNDERTRE ATMENT L. AEA (Y\\N)

e. FAMILY DOSE M. DATE OF EVENT

f. FETAL DOSE N. TIME OF EVENT

g. DOSE NEWBORN O. TIME ZONE

h. ORG AN (Code) l P. DATE RPTED TO STATE

i. EFFECT ON PATIENT (S) l Q. T:ME REPORTED

j. WHO ADMINISTERED l

R. CONSULT ANT (yin)

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. INVESTIG ATION (Y'N)

m. NO. OF PATIENTS V. EVENT DESCRIPTION (Code)

n. PATIENT \\ RESPONSIBLE RELATIVE NOTIFIED (Y\\N)

W. CAUSE DESCRIPTION (Code)

o. REFERRING PHYSICIAN NOTIFIED (Y\\N)

X. CONTRIBUTING FACTOR (Code)

p. DEMOCP APHICS Y. PRECIPITATING FACTOR (Code) l Z. CORRECTIVE ACTION (Code)

3. OVEREXPOSUhr DATA (Where applicable) l A1. REPORTING REQUIREMENT a NO. OF PERSONS INVOLVED

a. CLASS EVENT TYPE (Code)

b. DOSE RECEIVED tremi

b. NRC 10 CFR (Code)

c. RADIATION SOURCE

c. AGREEMENT STATE COMPATIBLE REGULATION

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

TYPE OF EVENT

a. SYSTEM TYPE

b. MANUF ACTt RER\\ SHIPPER

1. RELEASE OF MATERIAL

c. MODEL NO.

(Where applicable).

d. SERIAL \\lD NO.

e. MANUF ACT. D ATE

a. TYPE OF RELE ASE (Codel

f. ISOTOPE ACTIVITY (Cd (Code)

b. ISOTOPE (Code)

g. ASSAY DATE

c. ACTIVITY (Ci) (Codel

h. LE AK TEST RESULT ( Cd

i. SOURCE CHANGE DATE

m.

2

4. EQUIPMENT WFO. CONT.

j. PROBLEM (Enter date when equipment may have contributed to the event).

5. ABSTRACT (Provide clear concise chronological statement in the form of a mini executive summary of the important facto concering the event. This element is appended to as follow up information is added or when the licensee makes any corrections. It le not deleted and then ter'ritten as now information is obtained include direct cause, any new motorial, any retractions, licensee corrective actions, consultant statemen'.s, civil penalties, significant enforcement actions taken by State.)

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