ML20195G216
| ML20195G216 | |
| Person / Time | |
|---|---|
| Issue date: | 05/21/1999 |
| From: | Cool D NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | NRC |
| Shared Package | |
| ML20195G214 | List: |
| References | |
| NUDOCS 9906150285 | |
| Download: ML20195G216 (20) | |
Text
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!" 'jf NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001
,\ .,,,, / May 21, 1999
, j MEMORANDUM TO: Those on the Attached List FROM: Donald A. Cool, Directo A . -<2 m .b Division of Industrial and .
Medical Nuclear Safety, NM S /
SUBJECT:
DRAFT POLICY AND GUIDANCE DIRECTIVE PG 83-2, REVISION 1, SUPPLEMENT 1, " RENEWAL OF MATERIALS LICENSES" Please review and provide comments on the attached draft supplement to Policy and Guidance Directive (PGD) PG 83-02, Revision 1, " Renewal of Materials Licenses," which provides guidance for the processing of renewal applications for all materials licenses except fuel cycle.
The final document is intended to supersede those parts of PGD 83-02, Revision 1, not associated with fuel cycle licenses.
This draft guidance is part of a licensing streamlining initiative to focus the U.S. Nuclear Regulatory Commission's (NRC's) byproduct, source, and special nuclear material licensing (excluding fuel cycle licenses) renewal resources on applications from licensees whose performance indicates potential programmatic weaknesses and program areas that have '
undergone major changes which could affect radiation safety. Performance indicators provided are used to determine which of the two-tiered review levels is necessary to renew each license.
Management is provided guidelines to determine when licenses (both new licenses and renewals) should be issued for less than 10 years. General guidance is also included to assist reviewers in reducing the number of marginal and protracted interactions needed in bringing -
licensing actions to closure.
l The Regions should provide comments on the attached draft document 30 days from the above i date by e-mail or Fax. i i
Attachment:
Draft PGD 83-02, Rev.1, Supplement 1 CONTACT: Donna-Beth Howe, NMSS/IMNS (301)415-7848 9906150285 990609 PDR ORG NOMA PDR ,
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. MEMORANDUM TO: Thoso on the Attach d List May 21, 1999 FROM: Donald A Cool, Director (orig. signed by Lcamper, for)
Division of Industrial and Medical Nuclear Safety, NMSS
SUBJECT:
DRAFT POLICY AND GUIDANCE DIRECTIVE PG83-2, REVISION 1, SUPPLEMENT 1; RENEWAL OF MATERIALS LICENSES James Lieberman, Director Office of Enforcement George C, Pangburn, Director Division of Nuclear Materials Safety, RI Douglas M. Collins, Director Division of Nuclear Materials Safety, Ril Cynthia D. Pederson, Director Division of Nuclear Materials Safety, Rlli Dwight D. Chamberlain, Director Division of Nuclear Materials Safety, RIV .
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( Policy and Guidance Directive PG 83-2, REV.1 SUPPLEMENT 1 RENEWAL OF' MATERIALS LICENSES !
i Division ofIndustrial and Medical Nuclear Safety .
Office of Nuclear Material Safety and Safeguards l
PREPARED BY: REVIEWED BY:
Donna-Beth Howe, MSIB 5 /99 Frederick C. Combs, IMNS 5/ /99 REVIEWED BY: CONCURRENCE:
Frederick Sturz, MSIB 5/ /99 Larry W. Camper, MSIB 5/ /99 l
APPROVED BY:
Donald A. Cool, IMNS 5/ /99 l
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l OFFICIAL RECORD COPY Table of Contents l
1.0 P u rpo s e . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . .. ..... .. ..1 1 2.0 Guidance . . . . .... . . . .... . .. .. .. . ... .... .. 1 2.1. Determinina Review Status of Acolications for Renewal of Licenses. . . 1 1
2.2. Performance Indicators. . ..... ... . .. . . . 2 2.2.A. Enforcement History . . . . .. . ,, . .. 2 2.2.8. Loss of Material ....... ... . .. ..... .2 2.2.C. Unauthorized Disposal or Release of Material .. . .. ..2 2.2.D. Overexoosure . . . . . ... . .. .. . .. .2 2.3 Comorehensive Reviews . .. . . . .
.3 2.4. Limited Reviews . .
.. .3 2.4.A. Administrative items . . . .. .. 3 2.4.B. Proaram Manaaement . . .. 3 1
2.4.C. Eauipment and Facilities . . .. .. . . . 4 2.4.D. Environmenta' Assessments . . ... .. . 4 2.4.E. Unreviewed Recuests . ... . . .. .. .. . . . 4 2.4.F. Chance in Control . . . . .. ... .. ... .. . .. .. .4 2.4.G. Maior Areas ..... . .. . .. .. . .. . 4 2.5. Establishina License exoiration. dates ... ... ....... .. .. .. .5 2.5.A. New Technoloav . . . . . . . .... . . . .... . . ... 5 2.5.B. Enforcement History . ...... . ...... .. ..... .. . . .5 2.5.C. Comorehensive Review . . ...... ... .. .. .... 5 2.5.0. Other . . ....... .... .. . .. .. ... ... . . .5 l
2.6. Reviewer Guidance . ..... . ........ ... . .... ... . ... 6 2.6.A. NUREG-1556 serica . . . . . . .. . . ... ... .... ... 6 l
2.6.B. Technical Assistance Reauest (TAR) Data Base . . . . . . . . . . ... 6 2.6.C. Interaction with NRC Inspectors . ....... .. ...... .......6 2.6.D. Meetinos and Visits . . . . . . . . . . . . .. .. ..... .. . .7 2.6.E. Simotify Communications . . . . . . . . . . . . . . . . . . . . . . . . . . ....7 l 2.6.F. Reauest for Information . . . . . . . . . . . . . . . . . . . . . . ....7 L 2.6.G. . Custom License Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 3.0 Resources . . . . . . . . . . . . : . . . . . . . . . . . . . . . . . . . . . . ........... .... .8 1
f DRAFT PGD 83-2, REV 1, SUP.1. i 1
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ATTACHMENTS . ,
NOTICE OF EXPlRATION LETTER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .'
PERFORMANCE AND LIMITED REVIEW CHECKLIST , . . . . . . . . . . . . . . . . . . 2.1
. . . .... 3.1 LIMITED REVIEW ITEMS ........ . ..... ... .. .
LICENSE TERMS OF LESS THAN 10 YEARS . .. . . ..... ..... . 4.1
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t DRAFT PGD 83-2, REV 1 SUP 1.' ii
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- 1.0 . Purpose The O*f ce of Nuclear Material Safety and Safeguards (NMSS) is revising its materials (excluding fuel cycle) licensing renewal review guidance to focus resources on applications from licensees whose performance indicates potential programmatic weaknesses and on program areas that have undergone major changes that could affect radiation safety. Performance .
Indicators are provided to determine the level of review necessary to renew the license. A two
- tiered license renewal system'is being introduced. Guidance is provided to assist staff in determining when licenses should be issued for less than 10 years. General guidance is
. included to address improved information sources, communication techniques, and licensing
. tools needed to bring licensing actions to closure.
The Guidance Consolidation' Project initiated in 1996 resulted in a series of volumes, in the
. NUREG 1556 series, providing specific and consistent guidance for licensees and the U.S.
Nuclear Regulatory Commission (NRC) staff to use in submitting license applications and reviewing the applications, respectively. Licensee use of this guidance should result in better and more complete submissions. Both licensee and reviewer use will enable NRC to spend less resources in reviewing renewals. This guidance should decrease the number of marginal and protracted interactions with licensees, make it easier to void unsupported licensing requests, and use license conditions or other techniques to bring actions to closure.
2.0 Guidance .
When reviewing renewals except fuel cycle renewals, the guidance in this Directive shall be applied. This guidance assumes that renewal applications will be filed and reviewed in )
accordance with the guidance set forth in the NUREG-1556 series and that major program changes will be carefully identified by the applicants. 4 Section 2.1 de' scribes how to determine the review status of the renewal.. The performance
- indicators in Section 2.2 are the basis for identifying those licensees whose radioactive materials
. use program will need a comprehensive review. Section 2.3 describes the comprehensive review that will be used for renewals submitted by licensees triggering any of the performance indicators in Section 2.2. Section 2.4 describes the limited review that will be used for renewals submitted by licensees not triggering any of the Section 2.2 performance indicators. Guidance
'in Section 2.5 will be used to identify those licensees that will receive renewal of less than 10 years.: Section 2.6_ describes general guidance, for reviewers, that should improve communications with licensees, decrease the number of marginal and protracted interactions with licensees, make it easier to void unsupported licensing requests, and use license conditions or other techniques to bring actions to closure. All licensees will be sent a standard " Notice of License Expiration" letter (Attachment 1).
Because this guidance represents a change in the renewal process, the Integrated Materials
. Performance Evaluation Program will be modified to address this licensing guidance.
DRAFT PGD 83-2, REV 1,' SUP 1.
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2 2.1. Determinina Review Status of Apolications for Renewal of Licenses Each renewal application will be selected for either a comprehensive review or limited review by comparing the licensee's performance against the perfo,mance indicators in Section 2.2.- Thus, the first task for the reviewer is to review the Docket to compare the licensee's performance against these performance indicators. An application submitted by a licensee that demonstrated the presence of one or more of these performance indicators will receive a comprehensive review, as described in Section 2.3. Applications from licensees who do not exhibit any of these performance indicators will receive the limited review described in Section 2.4. The basis for performing either a limited review or a comprehensive review will be documented as described in Attachment 2.
Based on an evaluation of the specific circumstances associated with the presence of a performance indicator, NRC licensing management may, however, decide that a comprehensive review is not warranted. Further, NRC licensing management may have an application from a licensee that does not trigger any of the formal performance indicators but which may exhibit other characteristics warranting a comprehensive review. Such decisions must also be documented in accordance with Attachment 2.
2.2. - Pr rformance Indicators.
' 2.2.A. Enforcement History A licensee that has been subject to escalated enforcement action within 5 years will be considered for a comprehensive review of the renewal application. ;
2.2.B. Loss of Material ,
Any licensee that has lost control of licensed material that is presumed to be in the public domain, and is reportable aM/or resulted in a violation of regulatory . -.. ~
requirements within the 5-year period immediately before the proposed renewal, will be considered for a comprehensive review of their renewal application. ;
1 2.2.C. Unauthorized Disposal or Release of Material 1
If the licensee has been cited with a violation regarding unauthorized disposal or release of material in the last 5-years, management control of licensed activities may be weak and a comprehensive review of the license application is necessary.
2.2.D. Overexoosure if the licensee has been cited with a violation regarding an exposure in excess of regulatory requirements since the last license renewal, management control of DRAFT PGD 83-2, REV 1, SUP 1.
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3 application is necessary. Exposures at issue would include those to members of the public as well as to occupationally exposed individuals.
2.3. Comorehensive Reviews A comprehensive review of a renewal application is the comparison of all material, submitted by the licensee, with the requirements in the appropriate regulations, guidance in NUREG-1556, and guidance supplemented in relevant Technical Assistance Request (TAR) responses. The reviewer is to review the applicant's radiation protection program, facilities, equipment, and personnel in detail and provide additional attention to the aspects of the program that triggered the Section 2.2 performance indicators. The checklist in the appropriate NUREG 1556 volume (s) must be completed with all deficiency findings clearly annotated on the checklist.
Parts of the application that do not conform to, or fail to address, areas in this guidance, are deficiencies which must be resolved before the license is renewed. Reviewers shall apply this guidance to the extent suitable to the licensee's activities and should not apply any standards or criteria that are not contained in this guidance, or for which there is no specific regulatory basis. Reviewers may consider program changes, not contained in f, the guidance, that were motivated by enforcement action. Reviewers should accept licensee procedures or proposals that result in an equivalent level of safety, as described in NRC guidance.
2.4. Limited Reviews A limited review of a renewal application will only evaluate the following areas for conformance to the appropriate sections of the guidance described in Section 8 of the appropriate NUREG 1556 series: - ,
2.4.A. Administrative items Administrative items, including the licensee's name and address and other items, such as the radiation safety officer's name, which appear in the application and vil be listed on the renewed license.
2.4.B. Proaram Manaaement Those portions of the application that address program management, including:
(1) Organizational structure (assure that appropriate elements are presert and are assigned necessary authority and responsibility);
(2) The qualifications of key personnel, such as the radiation safety officer, authorized users, radiographers, well loggers, irradiator DRAFT PGD 83-2, REV 1, SUP 1.
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4 operators, authorized medical physicist, and authorized nuclear pharmacists; and (3) The licensee's radiation safety audit program.
2.4.C. Eouipment and Facilities Those portions of the application that address equipment and facilities.
2.4.D. Environmental Assessments Those portions of the application that need an environmental assessment because they do not conform to the categorical exclusions in 10 CFR Part 51, 2.4.E. Unreviewed Reouests Any new authorizations, requested by the licensee, that have not been previously reviewed, and any major program elements which require change as a result of the new authorization. These areas should undergo a focused review as opposed to a comprehensive review of the entire application. Some examples of requests that should receive focused reviews are:
4 (1) New broad scope authority, introduction of iodination with millicurie quantities of iodine-131 or iodine-125 requiring major facility j additions or changes; additional research and development 1 activities (human and non-human); additional medical therapy modalities; etc.
(2) Any new high-risk technology uses being added to an existing license, to ensure that the liconsed program can safely manage and use the new technology.-Specific conditions and requirements associated with new technologies may be added to the license. Examples include new license categories for Department of Energy activities converted to commercial facilities; use of intravascular brachytherapy; or Boron Neutron Capture Therapy in humans.
2.4.F. Chance in Control A change in control (ownership) that has resulted in a significant change in key staff members directly responsible for the radiation safety program and which has not been previously reviewed. This condition signals that the new staff may have little operational experience in ostallishing a long-term performance record, in these cases a focused review of the affected areas should be done. NUREG 1556, Volume 15, may be used to assist in change of ownership issues.
DRAFT PGD 83-2, REV 1. SUP 1.
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5 2'.4.G. Maior Agtag A brief overview of the remainder of the application to determine if the major areas discussed in the guidance described in Section 8 of the appropriate NUREG 1556 series are present. If detected, an obvious failure or a deficiency in a significant area should result in a thorough review of that area. A finding that more than one area is not addressed or contains a significant deficiency could result in a comprehensive review of the license application. Change to a comprehensive review should be approved by licensing management and the reason for changing from a limited review to a comprehensive review must be clearly documented on the " Performance And Limited Review Checklist" (see Attachment 2).
2.5. Establishina License exoiration dates' The Commission approved the extension of the terms set by policy for licenses issued under 10 CFR Parts 30 (except Part 35),40, and 70 from 5 to 10 years in 1997, in 1998, final rulemaking was published to set the license term limit for medical use licenses at 10 years: Now all materials licenses have the same license term limit. The Commission's i
actions approved the use of license terms shorter than 10 years on a case-specific !
basis.
Any license issued or renewed after July 10,1998 (when the medical use license term limit was changed to 10 years) should have a 10-year term limit, unless management determines, on a case-by-case basis, that a license should be issued for less than 10 1
years. Some examples of conditions that may result in licenses issued for less than 10 years are:
2.5.A. New Technoloav The license is for a new high-risk technology that the industry, the particular licensee, or NRC has not had extensive experience in using or regulating.
l 2.5.B. Enforcement History The licensee had a Severity Level I,11, or 111 violation because of serious programmatic deficiencies and not isolated events, during the 3-year period immediately before the proposed renewal.
2.5.C. Comorehensive Review e The licensee's renewal received a comprehensive review; or 1 This guidance applies to both new and renewed licenses DRAFT PGD 83-2, REV 1, SUP 1.
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2.5.D. Other Other situations that would warrant increased attention, on a case-specific basis.
Note: Licenses that are in a " possession only for decommissioning" status do not need to be renewed because an expired license remains in effect until terminated by NRC (see 10 CFR 30.36,40.42, or 70.38).
The specific expiration term for a license term shorter than 10 years should be 5 years, unless, on a case-specific basis, another time is more appropriate. NRC management may, however, decide that a license term of 10 years is warranted, based en the evaluation of specific circumstances associated with the above conditions and the licensee's commitments and program improvements made in the renewal submission.
Use Attachment 4 to document the license term, the basis for the decision, and the basis for an exemption, if appropriate.
2.6. Reviewer Guidance ,
2.6.A. NUREG-1556 series Avoid requesting information not identified in the NUREG. Use all available ,
NUREG-1556 tools, including process, criteria, and checklists, to standardize and simplify the review process. .
If the NUREG does not request information thought to be critical to a particular licensing action, this should be identified and shared with Headquarters so that the NUREG can be revised, if necessary, to include the information.
2.6.B. Technical Assistance Reauest (TAR) Data Base.
When guidance is needed, staff should consult the NUREG Web page site on NRC's intranet and then the TAR database, found in Lotus Notes on the Regulatory Product Development Center servers, for existing technical guidance provided by TARS with similar issues. If the guidance exists use it; if not, develop a new TAR. If a TAR response provides new licensing guidance, the response will be added to the electronic NUREG Web page site as an addendum to the appropriate volume of NUREG-1556.
2.6.C. Interaction with NRC Inspector 3 Renewal reviewers are reminded to follow the guidance provided in Policy and Guidance Directive FC-90-1, Revision 1, " Guidelines for Discussions with.
Licensees Prior to issuance of Renewals and Major Amendments to Fuel Cycle and Materials Licensees Authorizing Large Quantities of Hazardous Materials,"
DRAFT PGD 83-2, REV 1, SUP 1.
7 when renewing materials licenses with large amounts of hazardous materials.
FC-90-1, Revision 1, defines large quantities of hazardous radioactive material.
2.6.D. Wetinas and Visits Meet with the licensee before proceeding with complex cases, and use site visits, if necessary. As soon as NRC (i.e., the reviewer and first line supervisor) determines a request involves complex licensing issues, set up a meeting with the applicant to review and discuss the issues. Early licensee /NRC clarification interactions are important for expediting resolution and avoiding protracted correspondence exchanges. Site visits should be used to improve NRC's understanding of the applicant's facilities and program. Policy and Guidance Directive FC 84-09, " Licensing visits for byproduct material licensees," provides additional guidance on site visits.
2.6.E. Simotify Communications Sim?tify licensee-staff interaction by using telephone, E-mail, and Fax. Early dialogue should be established with applicants. Once issues and deficiencies have been identified, use the simplest process available to fully communicate issues to licensees, document the request, and elicit appropriate applicant response. Use the telephone and e-mail to communicate with licensees and reduce reliance on formalletters. The Docket must contain proper documentation of both the information requested by the reviewer (e.g., fax, telephone record, or e-mail) and the applicant's response and commitments (e.g.,
signed fax or letter). Draft documents from the applicant should not be used as ~
the basis for a licensing action.
2.6.F. Reauest for Information ,
Efforts should be directed at improving, reducing, and eliminating reviewers' requests for additionalinformation. Ensure that each requested item for additional information is clear (i.e., provides a description of the deficiency and a statement of what is needed); is essential to protect safety; and is linked to regulatory requirements and NUREG-1556. The goalis to have no rnore than one request for additionalinformation for each application. If a second request is needed, escalate it quickly to NRC and licensee management to resolve open l
issues. If the applicant does not provide adequate information after such a exchange, complete the licensing action that can be completed, inform the licensee of the issues that cannot be approved, and explain why not. Avoid
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multiple rounds of requests for additionalinformation.
2.6.G, Custom License Conditions DRAFT PGD 83-2, REV 1, SUP 1.
8 Utilize custom conditions to reach closure. Whe e simple well-defined policy issues remain unresolved, use custom license conditions, rather than protracted negotiations with the applicant, to achieve closure .
3.0 Fesources This guidance is expected to significantly decrease resource burdens on NRC regional and Headquarters offices.
i DRAFT PGD 83-2, REV 1, SUP 1.
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1 NOTICE OF EXPIRATION LETTER Licensee Name License No. XX-XXXXX-XX
. Address 1 Expiration Date: XX/XX/XXXX Address 2 ' Program Code: XXXX Address 3 Gentlemen: j l
SUBJECT:
NOTICE OF LICENSE EXPlRATION Your U.S. Nuclear Regulatory Commission (NRC) license, specified above, will expire on the j date shown. If you wish to continue your licensed program, you should prepare and submit a renewal application on NRC Form 313, following the instructions in the enclosed volume of NUREG 1556. If the application reflects any significant changes in your licensed program, those changes must be clearly indicated.
You must submit an application for the renewal of your license at least 30 days before the expiration date on the license. If your renewal application is filed at least 30 days before the expiration date, your license will remain in effect until NRC takes final action on your application.
However, if your application is filed less than 30 days before the expiration date, you should contact NRC immediately to see if you will need a temporary extension of the expiration (late. If your license expires, you no longer have a valid license, but you are required to maintain the safety of all licensed materials until your application for a license or request for termination is submitted and approved. Your use of the licensed material after the expiration of your license will subject you to enforcement action.
1 If you do not wish to renew your license, you must dispose of or transfer alllicensed radioactive material in your possession in an authorized manner (see the appropriate requirements in 10 CFR 30.36,40.42, or 70.38); then complete the enclosed Form NRC-314, " Certificate of Disposition of Materials" and return it before the expiration date of your license, with a request that your license be terminate 1 If you cannot dispose of or transfer alllicensed radioactive material in your license before the expiration date, you must request a license renewal, for
- storage-only, of the radioactive material, to avoid enforcement action for violations involving the possession of licensable material without a valid license. Enforcement action may include a substantial monetary civil penalty that could also include daily civil penalties until you achieve compliance.
This notice of your license expiration is sent for your convenience only and does not mean that similar notices will be sent in the future. The responsibility for timely submission of the license renewal remains with the licensee. If you have any questions about this notice or license expiration / renewal, please contact the NRC Regional Office that handles your license.
i Enclosures '
- 1. Form NRC 313
- 2. Form 314
( 3. NUREG -1556, Volume as appropriate
.4 10 CFR Parts as appropriate
- 5. Other appropriate documents-1.1 Attachment 1
2, 4 d MCy jf ',og UNITED STATES ,
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- 3 NUCLEAR REGULATORY COMMISSION e . g WASHINGTON, D.C. 20555 0001
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% Y 9*..*J License No. SNM-1997 MCKAY, JOHN H. Expiration Date: 10/31/97 R. R. #5 Program Code: 22161 STRATFORD, ONTARIO, CN N5A 6S6 Gentlemen:
SUBJECT:
NOTICE OF EXPIRATION Your NRC license specified above will expire on the date shown. This license was issued to authorize your possession of an implanted nuclear-powered United States law requires pacemaker while you are in the United States.
that you be covered by a license whenever you are in the United States with your pacemaker, It would be very helpful to us if fou wculd send a short letter, at least 30 days before the expiration of your license. te;.ing us whether you want discentinte your .1:ense.
to renew your 11:enSe or to terminate Information required for you to renew or terminate your license is enclosed.
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This notice of your license expiration is sent for your convenience and it '
should not be interpreted that similar notices will be sent in the future.
The responsibility for timely submission of an application for license renewal remains with the' licensee. If you have any questions regarding this notice or license expiration / renewal, please contact our Regional Office that handles your license.
Medical. Academic and Commercial
- Use Safety Branch l
Division of Industrial and Medical Nuclear Safety
Enclosures:
- 1. Renewal /Terminat2on Info. for Ir.dividual Pacemaker Licensees
- This will be revised with the next revision of the Li l
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,d MONMOUTH MEDICAL CENTER License No. SNM-1392 300 SECOND AVENUE Expiration Date: 05/31/1999 LONG BRANCH, NJ 07740 Program Code: 22160 Gentlemen:
SUBJECT : NOTICE OF EXPIRATION Your NRC license specified above authorizing use of nuclear-powered pace-makers will expire on the date shown. We want to call your attention to some special conditions on your license and explain how these conditions affect your decision whether to renew the license.
In the United States, anyone who possesses and uses a nuclear pacemaker must be covered by a l'icense. Patients in whom you have implanted pacemakers are covered by the hospital's license; see Condition 11 of your license.
In Conditions 15 and 16 of your license, you are commited to following all for the life of the patient or until the patients with implanted pacemakers pacemaker is removed and returned to the manufacturer for proper disposal.
Follow-up procedures must be in accordance with :he protocol established by Terminatten, renewal, and fee infor-the manufacturer and approved by NRC.
mation is included in the enclosure.
This notice of your license expiration is sent for your convenience and it should not be interpreted that similar notices will be sent in the future.
The responsibiity f or timely submission of ar. application f or license renewal remains with the licensee.
If you have any questions regarding this notice or license expiration / renewal, please contact our Regional Office that handles your license.
Medical, Academic and Commercial Use Safety Branch Division of Industrial and Medical Nuclear Safety
- 1. Termination, Renewal and Fee Info. for Institutional Pacemaker Licensees
- 2. 10 CFR Parts 30, 70 and 170 This will be revised with the next revision of the LTS.
1.3
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PERFORMANCE AND LIMITED REVIEW CHECKLIST .
Licensee:
License or Docket No:
Control No: t The following performance indicators were reviewed:
Conclusion if YES. explain:
_ Performance Ir.dicator Enforcement History YES NO Loss of Material YES NO Unauthorized Disposal or ' YES NO Release of Material
- Overexposure YES NO If any of the above items are checked "YES", perform a Comprehensive Review using the i applicable guidance contained in NUREG 1556. If all boxes are checked "NO," perform a Limited Review. An exception must be approved by a supervisor, documented, and a copy of that documentation must be attached to this document for placement in the docket.
Additional Information or Explanation of Exception .
I Comprehensive Review Limited Review Reviewer / Date Supervittor / Date f
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' LIMITED REVIEW ITEMS'.
. , Licensee: . .
- License or Docket No:
Control No:-
NRC-313.or appropriate equivalent signed and dated by senior licensee representative.-
Place of use is a physical location (i.e., not P.O. Box, etc.)
q RSO and key personnel are appropriately qualified Facilities an'd equipment are adequate.
All uses' qualify for a categorical exclusion in 10 CFR Part 51.-
' Organizational structure conforms with applicable regulations and NUREG 1556
_ guidance2 (appropriate individuals are present and are assigned necessary aut h or it y
& responsibility)
The audit program structure conforms with applicable regulations and NUREG 1556 y guidance2, New authorizations requested by the licensee and any major program elements which require change as a result of the new authorization structure conform with 2
applicable regulations and NUREG 1556 guidance .
Major program changes, new high risk technology programs, and changes in control
- (ownership) normally require on'.y a focused review of the specific changes. If these changes are so extensive that a Comprehensive Review of the entire application is needed, obtain Branch Chief approval before prce4eding. Each of the following three items must be marked
. with NA or a check and the change briefly identified.
Major program change conforms with applicable regulations and NUREG 1556
. guidance2.
New high risk technology program conforms with regulations for similar technologies, guidance provided for similar technologies in NUREG 1556 guidance2, and specific licensing conditions for the new technology.
Use either a check mark to designate a satisfactory response, "NA" to designate not
' applicable or "D" to designate deficiency as appropriate.
'8' Reviewers are reminded licensees have the flex 5ility to provide information equivalent to that requested in NUREG 1556.
3.1 Attachment 3
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Change in Control (Ownership) conforms with applicable regulations and 2
NUREG 1556 guidance . .
A brief overview of the remainder of the application found the major areas discussed in the guidance 2 described in Section 8 of the appropriate NUREG 1556 series are a
present.
An obvious failure or a deficiency in a significant area resulted in a thorougn review of that area.
A Comprehensive Review was conducted and the reason for changing from a Limited Review to a Comprehensive Review is documented on the " Performance and Limited Review Check List."
Appropriate additionalinformation was requested (circle as appropriate: phone log /
e-mail / fax / letter / )
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3.2 Attachment 3 l
i LICENSE TERMS OF LESS THAN 10 YEARS Licensee:
License or Docket No:
Contro! No:
The following conditions were reviewed :
Condition Yes _N_Q Basis for YES New high risk technology without extensive use or i regulation experience by industry, or licensee, or 9
NRC; Enforcement History - Severity Level I,11, or ill violation due to serious programmatic deficiencies and not singular events, in preceding 3-years; Renewal received a Comprehensive Review; ,
t Other If any of the above items are checked "YES", describe the basis above, determine the license term (usually 5 years) and document the determination below. All exceptions must be approved by a supervisor, documented, and a copy of that documentation must be attached to this document for placement in the docket.
Assigned License Term: years l AdditionalInformation or Explanation of Exception ,
i 1
l l
l Reviewer / Date Supervisor / Date 4.1 Attachment 4 i