ML20149H115

Policy & Guidance Directive (Pgd) 9-11 Rev 2, Technical Assistance Re Matl Licensees (Formerly Pgd 93-2, Fc 84-5 & Fc 90-7), Up

ML20149H115
Person / Time
Issue date:	07/17/1997
From:	Greeves J, Piccone J, Sitek M NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:
Shared Package
ML20149H108	List: ML20149H105 ML20149H115
References
PGD-9-11-01, PGD-9-11-1, NUDOCS 9707240214
Download: ML20149H115 (15)

Text

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1 United States Nuclear Regulatory Commission l

q j Policy and Guidance Directive (PGD) 9-11 l Revision 2 l

V TECHNICAL ASSISTANCE REQUESTS RELATED TO MATERIAL LICENSEES l (formerly PGD 93-2, FC 84-5, and FC 90-7) i e

l Division ofIndustrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards LY '

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LIST OF AFFECTED PAGES Page Revision i 2 ii 2 iii 2 1 2 2 2 3 2 1

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I .l TECHNICAL ASSISTANCE REQUESTS RELATED TO MATERIAL LICENSEES (formerly PGD 93-2, FC 84-5, and FC 90-7)

Table of Contents Eaga 1.0 Purpose . . . . . . . . . . . . ................ ........ ........... ............ 1 2.0 Scope .................. ............ ............... ..... ........-1 3.0 Regional Preparation of TARS . . . . . . . . .. ....... .. . ........ . ....... .1 4.0 Headquarters Processing of TARS . . . . ... . .. . ... .......... ....... .2 5.0 Distribution of TAR Responses . . . . .. ... . .. ........ ..... ... .. ... 2 6.0 TAR Responses for. Generic Use . . .......... . ... .....;..... ... ..... 3 j

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Attachment 1 - Regional Technical Assistance Request Form l

- Attachment 2 - Misadministration TARS Supplement Attachment 3 - Request fnr s 3eated Scurce and Device Evaluation (NRC FORM ;ol)

L Attachment 4 - Technical Assistance Request Transfer Form i l

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PGD 9-11, Revision 2 iii 07/17/97

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TECHNICAL ASSISTANCE REQUESTS RELATED TO MATERIAL LICENSEES 1,0 PURPOSE l

To provide procedures for the preparation and processing of technical assistance requests

- (TARS) related to material and fuel cycle licensees, including misadministrations; sealed ,

source and device evaluations; and issues involving the transportation, storage, and disposal

.l of radioactive material.

4 2.0 SCOPE

, This directive pertains to all TARS submitted by the regions to the Office of Nuclear Material

! Safety and Safeguards (NMSS), including those for misadministrations and sealed source  !

E and device design evaluations.

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. 3.0 . REGIONAL PREPARATION OF TARS 7

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The first attempt to resolve a technical issue should be made at the lowest level of regional l management. If the issue cannot be resolved at this level, then it should be addressed at

, the next highest level of regional management. Only if the issue cannot be resolved at this I level, will it be elevated in the form of a technical assistance requeet and brought to the 1 attention of Headquarters as a possible policy issue.. Attachment 2 provides additional

guidance as to which technical issues related to misadministrations require submittal as

- TARS.

The Regional Division Director will submit all assistance requests, except those for sealed F source and device design evaluations, to the Division of Industrial and Medical Nuclear 1 Safety (IMNS) using the format'shown in Attachment 1. First, the request should be j electronically mailed and then submitted as a hard copy with any needed attachments.

' Electronically submitted versions of the TAR should be sent to the Director, IMNS with a copy -

[ to the IMNS secretary (IMNSMAIL). For information that may not be electronically available -

(e.g. medical consultant's report), indicate in the electronically submitted version; those

attachments to the TAR that could not be sent electronically and that they will be sent with i

! the hard copy of the TAR. The TAR will:

• Conciseiy state the problem or major issue requiring technical assistance from Headquarters.

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• Specifically state the action that is requested from Headquarters.

4 e identify any attemative actions for the problem / major issue and recommend one of-these alternatives,if appropriate. 'l e ProvideJ the appropriate- background information for the request (e.g., copy 'of application, current license, inspection report, etc.).

e Identify a date when a response to the TAR is required by the region,

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Indicate if enforcement action is being held in abeyance pending response.

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• Identify TARS that have addressed similar issues, by subject and date created.

When submitting a TAR as part of the licensing process, the region shall change the N

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milestone in the License Tracking System'(LTS) to 19 and change the reviewer code to A2 1.

PG'D 9-11, Revision 2 ' 1 07/17/97

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4 l for IMNS When the region receives a final cesponse to the TAR from Headquarters, the L

region shall change the milestone in i TS to 20 and the reviewer code to the regional j reviewer code, i The guidance in attachment 2 should be followed, in addition to the guidance in this section, I

for the preparation of TARS involving medical misadministrations.

Sealed source and device design evaluation TARS should be submitted on NRC Form 567

(Attachment 3). The instruction block located at the top of the form should be followed for the specific details on how and what to submit.

Issues involving the packaging and transportation of radioactive material in accordance with 10 CFR Part 71 and the independent storage of spent nuclear fuelin accordance with 10 CFR Part 72 should be discussed with the cognizant Headquarters technical staff / project manager to determine whether a TAR is required to resolve the issue. Examples of issues for which a TAR should be considered are the interpretation of any of the following: 1) requirements in 10 CFR Parts 71 and 72; 2) any Certificate of Compliance and its associated licensing conditions; 3) any site-specific li:ense and associated licensing cond;tions; ar.d 4) any design, maintenance or operational information in a Safety Analysis Report or Safety Evaluation Report. To ensure consistent regulation of 10 CFR Part 71 and 72 licensees, all policy decisions made involving the above documents should be appropriately documented.

4.0 HEADOUARTERS PROCESSING OF TARS When the hard cooy is received, the Director, IMNS will assign the TAR to an IMNS branch -

or will transfer the TAR to the appropriate NMSS division fc. resolution (Attachment 4). The TAR will be entered into the IMNS Division Ticket Tracking Program (DRAT) as having been received and will be assigned a DRAT number with a due date of ten working days. The responding branch will perform a completeness review of the TAR with a goal of within five working days, but not to exceed ten working days from its assignment to a Headquarters reviewer. The purpose of the review is to ensure that all the information that will be needed by the Headquarters reviewer in preparation for a response is included. TARS that were deemed complete through the completeness review will be assigned a completion due date in DRAT by the appropriate IMNS Section Leader. For those TARS transferred to another division, that division will provide a due date to the IMNS secretary to be entered into DRAT after the completeness review. If the TAR package is incomplete, the region will be notified that additionalinformation is needed in order to respond to the TAR. If Headquarters does not receive the remaining information within ten working days (goal of within five working days, not to exceed ten working days), the TAR package will be retumed to the region for completion of the package and the action will be closed in DRAT.

Typically, the goal to complete TAR responses is within 60 working days from the time all necessary information is received in Headquarters. The lead branch will ccordinate the TAR response with other NMSS divisions and other offices (OGC, OE, etc.) as appropriate. For TARS that involve enforcement related issues, the Director, Office of Enforcement should be on concurrence. Responses may be issued by the Headquarters Branch Chief if they do not involve exemptions or generic issues, otherwise responses will be issued by the appropnate NMSS Division Director. The appropriate regional identifying numbers, including the license number, docket number , and control number will be indicated on the response. In addition, I those TAR responses that are directly related to an event or incident will include the Nuclear l Materials Events Database (NMED) number. A list reflecting the status of open TARS in j DRAT will be transmitted to the regions and the other NMSS Divisions each week from IMNS, which willinclude the title of the TAR, the Control Number, the due date, and the current Headquarters contact.

PGD 9-11, Revision 2 2 07/1'/1,

Prior to management signature, the Headquarters reviewer will e-mail the draft response to the regional reviewer and management (Regional Branch Chief at a minimum) identified on the TAR to confirm that additional clarification is not needed and the region has no specific d concems on the response. This e-mailing will occur after all concurrences, prior to OGC's, have been obtained. If OGC fundamentally etters the TAR response, the ievised draft response will be e mailed to the region before IMNS management signature. The concurrence page of the TAR response will reflect the date of regional coordination. This effort is for informal coordination only and not to obtain formal regional concurrence. The region should respond to the cognizant Headquarters staff with comments, including no s comment, within two working days from the Headquarters e-mail date. If the region has not responded within two working days, the response will be finalized and issued. The purpose of this policy is to avoid additional unnecessary delays. In cases where the regional reviewer is away from the regional office, it is the responsibility of regional management to either review the draft response and provide comments or to contact the Headquarters reviewer (or the reviewer's management) to negotiate an appropnate response date.

Sealed source and device evaluation TARS will be handled by the Sealed Source Safety Section (SSSS). Staff members of SSSS will Jeal directly with the device or scaled source applicant to resolve any deficiencies in the application. Upon completion of the review, SSSS will send a letter, with a copy of the registration cenificate, to the license reviewer and the applicant. The regions will receive a monthly report on the status of all sealed source and device pending cases, independent of the weekly DRAT report on open TARS.

A time line for review of misadministration TAR responses is included in attachment 2.

5.0 DISTRIBUTION OF TAR RESPQRSES A hard copy of the TAR response with all incoming documents normally will be maileu to a single point of contact in RI. Ril, Rill, RIV, WCFO, OSP, TTC, and BPR. The point of contact for the regions shall be the Director, Division of Nuclear Materials Safety, unless oderwise indicated. Further distribution of hard copies will be made by the receiving offices.

An electronic copy of the TAR response, excluding those on sealed source and device evaluations, wiil be sent by e-mail to the same individuals who receive a hard copy (as an advance copy), plus Regional Materials Branch Chiefs, Branch Chiefs in the responding division, contacts in OE and other interested staff. If a division other than IMNS issues the response, the IMNS division secretary should be copied to close the action in DRAT. The DRAT ticket number should be identified on the distribution page to ensure accurate tracking and closure.

If the response grants an exemption or establishes a new policy for generic use (see Section 6.0), the chair of the IMNS Genenc Assessmerit Panel (GAP) will be placed on hard copy distnbution. The chair of GAP is the IMNS Deputy Director.

6.0 TAR RESPONSES FOPuGJNERIC QSE If the TAR response establishes a new policy that other reviewers are authorized to implement without further Headquarters review, the memo transmitting the response is signed by the Director, IMNS and the term " GENERIC USE" will be inserted as a header on i each page of the memo. Responses for generic use will typically include a statement that regional staff may implement the policy without further coordination with Headquarters.

These responses will be reviewed by GAP to determine the need for additional action (e.g.,

rulemaking, generic communication, etc.).

PGD 9-11, Revision 2 3 07/17/97

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4 i Attachment 1 4

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j REGIONAL TECHNICAL ASSISTANCE REQUEST FORM.

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l REGIONAL TECHNICAL ASSISTANCE REQUEST FORM l.

Date: ,

Mail and E Mail to: . Director For E-mail, cc:

Division of Industrial and Medical Nuclear Safety, NMSS IMNS Secretary From: . Director Division of Nuclear Materials Safety, R_.

Licensee: _

l License Number: Docket Number:  ;

Control Number: (if applicable)

Letter dated: (if applicable) ,

Enforcement Action being held in abeyance: () Yes ( ) No i

Suggested change in licensing procedure (enclosed):

E Problem / issue:  ;

6 Action Requested:

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Recommended Action and Alternatives: ( ) Approve or ( ) Reject TARS addressing similar issues (subject and date):

l Background documents (identify those not sent electronically):  ;

Remarks

l Headquarters Reviewer:

Regional Reviewer:

Reviewer Code:

Reviewer Phone Number: ( ) Fax Number: ( )

Request Needed by: //

Att&chment 2 Technical Assistance Requests Regarding Misadministrations l

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' Technical Assistance Requests Regarding Misadministrations The guidance in this attachment to Policy and Guidance Directive (PGD) 9-11 is specific for technical $

1. assistance requests (TARS) for determinations concerning misadministrations. The guidance L presented supersedes the direction to submit all misadministration determinations to Headquarters, ,

as previously specified in PGD FC 90-7, Revision 1: " interpretations of the Medical Misadministration Rule." Additional guidance provided in PGD FC 90-7 addresses such related areas as information collection for a possible misadministration event and is superseded by similar guidance in the following documents: "QM Inspection Procedures: New and Regularly Scheduled Inspections"

' (December 23, 1996); Inspection Manual Chapter 1301, " Response to Radioactive Material ,

j. Incidents that Do Not Require Activation of the NRC Incident Response Plan;" inspection Procedure

87103, " Inspection of Incidents at Nuclear Material Facilities;" and NRC Management Directive 8.10

- "NRC Medical Events Assessment Program" and the associated NRC Handbook 8.10. Therefore,

' PGD FC 90-7 should no longer be used.

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REGIONAL PREPARATION OF TARS '

' A. Cases Requiring Submittal to NRC Headquarters for Determination Events which clearly meet the definition of a misadministration in 10 CFR 35.2, should be  ;

processed by the regions in accordance with established guidance. Cases which do not clearly - i meet the definition of a misadministration must be submitted to NRC Headquarters in the form ' ,

l of a TAR. Examples of. cases that may need to be forwarded are where patient intervention may have caused the misadministration or the wrong treatment site was exposed (e.g. source '

displacement /dislodgement events). All misadministrations involving multiple patients or where

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a generic issue is raised should be referred to Headquarters for review by the Generic Assessment Panel. ,

Questions conceming submittal of specific cases should be directed to the Medical, Academic and Commercial Use Safety Branch (IMAB), either via telephone or electronic communication. i B. Information to Accompany the TAR The guidance provided in Item 3 of this directive should be used for submitting the TAR. The following specific information is required before Headquarters staff can begin work on the TAR:

. Required licensee reports (if applicable), and/or other relevant licensee documents (not including preliminary notifications, moming reports, nor event notifications). ,

e inspection report and/or relevant follow-up information, Draft inspection reports should be forwarded only if the final report is pending

. completion of the TAR or related action. The word " DRAFT" should be clearly indicated and a brief clarification statement provided to indicate that finalization is pending completion of a related action.

If an inspection report will not be generated (e.g. field notes will be used), a summary of the inspection should be provided that includes relevant facts surrounding the misadministration; 7 i

. Identify any outstanding enforcement action which is specific to the misadministration l determination.

i A briefindication of the status of the enforcement action is helpful in establishing priority for the TAR and necessary coordination with the Office of Enforcement; ,

PGD 9-11, Revision 2 A21 07/17/97

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l L, . Medical Consultant's Report  !

If an NRC medical consultant's services were utilized, a final medical consultant's' report L should be provided. If an initial report is provided and further information is expected, the

. TAR submittal should briefly indicate such information. ,

If assistance from a medical consultant was not utilized for the case, the: TAR should ,

provide a brief statement indicating such information. l l . .

C.- Format for submittal The guidance in the second paragraph of item 3.0 of PGD 9-11 should be followed. 1 d

l HEADQUARTERS PROCESSING OF TARS I A .~ Initial Review i

The guidance in item 4.0 of PGD 9-11 will be followed, j B. .Timeline for Review

. To OGC within 30 working days after acceptance review has determined that all information

' has been submitted.

The necessary preparation, review,'and concurrence on the TAR will be completed to-submit the package to the Office of the General Counsel (OGC) within approximately 30 i working days ofits acceptance.  ;

if OGC determines that the TAR package is missing necessary documents, OGC.will request the missing information from IMNS. If IMNS is not able to provide the additional .i' information to OGC within two working days, OGC will retum the TAR package to IMNS for u completion.

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. OGC and IMNS management will meet to discuss the TAR and its response. The regions may participate in these meetings as' appropriate. This meeting will occur at the next '.

regularly scheduled meeting, provided OGC has the document for no less than seven days i prior to the meeting.- The meetings will ':e established on a regular. schedule with the goal '

l of one meeting every two weeks. The meeting may be canceled if, for example, the OGC review is completed prior to the meeting date and no further issues remain to be discussed.

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. Regional Review NRC Headquarters staff will use the procedure in item 4.0 of PGD 9-11. '

. ADDITIONAL ISSUES

! . . Distribution: Refer to item 5.0 of PGD 9-11 I

l-(' . Generic Use TARS: Refer to item 6.0 of PGD 9-11 l

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- PGD 9-11, Revision 2 A2-2 07/17/97 ,

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Attachment 3 i.

j Request for a Sealed Source and Device Evaluation (NRC Form 567) l '

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l PAGE1 I NRC FORM 567 U. S. NUCLEAR REEOLATORY COMMISSION )

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, REQUEST FOR A SEALED SOURCE OR l l

DEVICE EVALUATION )

INSTRUCTIONS: Serrj this request AND a copy of au related letters /apphcahons and drawings to: The Sealed Source Safety Section, ATTN: CNef, OWFN Mall Stop 6 H3. Change the License Tracking Systern maestone to 19 and assign to reviewer code I-5.

NOTE: Retain a copy of tNs request with the application and background files.

rtEQVESIER REGION / LOCATION:

l TELEPHONE NUMBER ll Ull til fV UV R HQ U LFDCB j DATE TYPE OF ACTION REQUESTED (Check as appropriate)

APPLNS NAME SOURCE REVIEW AMENDMENT OF-REGISTRATION SHEET h"JL CONTROL NUMBER (S) NUMEER(S) l DEVICE REVIEW LETTERIAPPUCATION DATE LICENSE NUMBER (S) CUSTOM REVIEW l J

COMMENrs-

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FOR SSSS USE ONLY REVIEWER MODEL NUMBERS NUMBEN A?GGNED DATE RECENED dan. ASSIGNED DATE TO FEES ~

TYPE OF ACTION (Indicate the number of each type) l COMMERCIAL DISTRIBUTION (FORMAL) l USE BY A SINGLE APPLICANT (CUSTOM) l SOURCE (9C) DEVICE (9A) SOURCE (9D) DEVICE (99)

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NEW NEW NEW NEW

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AMENDMENT _

AMENDMENT _

AMENDMENT ] AMENDMENT f j NO SAFETY EVALUATION REQUIRED j LICENSING ACTION REQUIRED IF KNOWN -

NO FEES REQUIRED NO

} OTHER (Specity)

TOTAL NUMBER OF 3 0'ES REVIEW HOURS NUMBER OF DEFICIENCY LETTERS NUMBER OF l l OEFICLENCY CALLS j FOR BILLING PURPOSES ONLY NAME CHANGE ADDRESS CHANGE ~

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ADD TO BILLING REMOVE FROM BILLING FOR FEE USE ONLY j TYPE OF FEE FEE CATEGORY l

] 9A 9B 9C OD AMOUNT RECENED CHECK NUMBER MATANN UPDATED AS REQUIRED

( DATE OF CHECK LOG j MATSYS UPDATED AS REQUIRED APPROVED BY DATE RETURN DATE COMMENTS NRC FORM $67 (843)

ORIGINA1.TO SSSS

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i Attachment 4 l

Technical Assistance Request Transfer Form i

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r Technical Assistance Request Transfer Form

' Date of Transfer: DRAT Number: e Receiving Division Directob.

Date of TAR:

Subject of TAR:

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• 1MNS Division Secretary-Mail Stop: T-8F5

. Phone Number p Email:

Provide the IMNS division secretary with the targeted response completion date.

' include the IMNS division secretary on the distribution list of ;he TAR response.

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! - PGD 9-11, Revision 2 07/17/97 i

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