ML20209E335

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Transmits State Agreements Program Info (SP-98-092) Re Sealed Source & Device Vendor Workshop to Be Conducted on 990113
ML20209E335
Person / Time
Issue date: 11/20/1998
From: Lohaus P
NRC OFFICE OF STATE PROGRAMS (OSP)
To:
GENERAL, MINNESOTA, STATE OF, OHIO, STATE OF, OKLAHOMA, STATE OF, PENNSYLVANIA, COMMONWEALTH OF, WISCONSIN, STATE OF
Shared Package
ML20209E340 List:
References
SP-98-092, SP-98-92, NUDOCS 9907140207
Download: ML20209E335 (10)
v • d • e


Text

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fr k_ UNITED STATES a ;5 j NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20066-0001

\+....lt November 20, 1998 ALL AGREEMENT STATES MINNESOTA, OHIO, OKLAHOMA, PENNSYLVANIA, AND WISCONSIN TRANSMITTAL OF STATE AGREEMENTS PROGRAM INFORMATION (SP-98 092)

Your attention is invited to the enclosed correspondence which contains:

INCIDENT AND EVENT INFORMATION...........

PROGRAM MANAGEMENT INFORMATION....

TRAINING COURSE INFORMATION................XX SEALED SOURCE AND DEVICE VENDOR WORKSHOP TECHNICAL IN FORMATION.............................

OTH ER I N FO R MATI ON.....................................

Supplementary information: Enclosed is information about a Sealed Source and Device Vendor Workshop to be conducted on January 13,1999. The enclosed sample letter has been sent to NRC and Agreement State licensees who expressed an interest in or participated in the 1997 workshop. The workshop is intended for persons, including those h Agreement States, who are directly or indirectly involved in the preparation and submittal of . plications for safety evaluation of sealed sources or devices (SS&D). The purpose of th: workshop is to identify problems that have been encountered during a review, to discuss process changes being implemented, and to provide information on the appropriate depth and breath of SS&D applications to assure expeditious review and approval Questions and comments from /

participants at the workshop may be used to revise current regulatory guidance for submitting applications as well as the current review process. This workshop is open to all interested individuals, will last one day (8:00 A.M. to 5:00 P.M.), and will be held in the NRC Headquarters )

auditorium in Rockville, Maryland. Interested individuals should respond to the address listed below by December 13,1998, and include the information listed:

U.S. Nuclear Regulatory Commission Office of Nuclear Material Safety and Safeguards ATTN.: Mr. Seung J. Lee (sil@ nrc.aov)

Mail Stop: T8-F5 i Washington, DC 20555 l

. Names of all persons attending.

. Contact name and phone number. l

. Company Name and Address. I I

. Involvement in the application process (vendor, consultant, etc.).

in addition, submittal of suggested topic areas or specific questions (that have general applicability to the application and review process) that persons would like answered during the workshop is encouraged to make the workshop more useful. Following the presentations, there will be a question and answer session where these and other questions may be discussed, as time permits. h3 D Q k

4e SP-98-092 NOV 2 01998 There is no tuition for this workshop, however, Agreement State personnel planning to attend the workshop are responsible for their travel and per diem expenses.

Questions concerning the workshop should be directed to Seung Lee at (301) 415-5787 or Traci Kime at (301) 415-7231.

If you have questions regarding this correspondence, please contact me or the individual named below.

POINT OF CONTACT: James H. Myers TELEPHONE: (301) 415-2328 FAX: (301) 415-3502 INTERNET: JHM@NRC. GOV CriginalSigned By:

PAULH LOHAUS Paul H. Lohaus, Deputy Director Office of State Programs

Enclosure:

As stated 1

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Distribution: I DIR RF (8S296) f DCD (SP03) {

SDroggitis ~ PDR (YES/) {

SLeo, NMSS TKime, NMSS ]

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[Apreement State File' SS&D File *See previous concurrence ,

DOCUMENT NAME: G:\JHM\SP 98092 r/ l T* receive a copy of thle document, Indicate in the bor 'C' a[C4 f wikut ettschment/ent ih #E" = Cop r with attachment / enclosure *N" = No copy I OFFICE - OSP l OS$:d C f/l OEM4 /l NAME JHMyers:gd PHLohdun C RLBangart 'T k DATE 11/17/98* 11/2)/98 11/ 2 (/ /98 OSP FILE CODE:LSP-A-4 f and SP-S-2 j

SP-98 092 20 W There is no tuition for this workshop, however, Agreement State personnel planning to %end the workshop are responsible for their travel and per diem expenses.

Questions concerning the workshop should be directed to Seung Lee at (301) 415-5707 or Traci Kime at (301) 415-7231.

If you have questions regarding this correspondence, please contact me or the individual named below.

l POINT OF CONTACT: James H. Myers TELEPHONE: (301) 415-2328 ]'

FAX: (301) 415-3502 INTERNET: @NRC V

)

i -b-Paul H. Lohaus, epu y irector Office of State Programs

Enclosure:

As stated l

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a g &. UNITED STATES g j NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20m50001

+9 . . . . . ,o October 29,1998 l

Dear Sir:

This is to announce that the NRC will be conducting a sealed source and device vendor workshop on January 13,1999. The workshop is intended for persons who are directly or indirectly involved in the preparation and submittal of applications to NRC (applicability to Agreement States as well) for safety evaluation of a sealed source or device containing a sealed source (SS&D). The purpose of the workshop is to identify problems that have been encountered and discuss process changes being implemented, and to provide information on I the appropriate depth and breadth of SSD applications to ensure expeditious review and )

approval. In addition, the workshop will provide applicants and potential applicants the opportunity to ask specific questions concerning the application and review process. Questions and comments from participants of the workshop may be used to revise current regulatory guidance for submitting applications as well as the current review process. Suggested topics include: l

. What sealed sources and devices require a safety evaluation.

.' NUREG-1556, Volume 3.

. NARM material.

  • Foreign manufactured devices and sources.  !

Medical devices and sources (FDA). l

  • Preparation of the application. l

. Proprietary information.

. Applicant's responsibilities.

. Pre-application contact (questions, meeting, etc.).

. Check application for completeness and accuracy.

. Submittal to correct address and offices.

. Other NRC offices (Regional Offices, SFPO)

. The review process.

  • Applicable regulations.

. Deficiency letters, phone calls and meetings.

. Typically missed areas.

  • Time allowed for responses.

Radiation Safety Officer  !

1 e issuance of registration certificates. )

  • Vendor responsibilities after certificate is issued.

. Review certificate and check for completeness and accuracy (contents of a registration certificate).

. Manufacture and distribution in accordance with the registration certificate.

. Amendments.

e incidents.

  • - Part 21 notifications.

e inactive certificates.

. Who uses the registration certificate?

This workshop is open to all interested individuals, will last one day (8:00 AM to 5:00 PM), and will be held in the NRC headquarters auditorium in Rockville, MD. Interested individuals should respond to the address listed below by December 13,1998, and include the information listed:

US Nuclear Regulatory Commission  ;

Office of Nuclear Material Safety and Safeguards  !

ATTN: Mr. Seung J. Lee (sjl@nrc. gov)

Mail Stop: T8-F5 Washington, DC 20555

+ Names of all persons attending.

. Contact name and phone number.

  • Company Name and Address.

e involvement in the application process (vendor, consultant, etc.).

In addition, submittal of suggested topic areas or specific questions (that have general applicability to the application and review process) that persons would like answered during the workshop is encouraged to make the workshop more useful. Following the presentation of the  ;

above topics, there will be a question and answer session where these and other questions may be discussed, as time permits.

Questions concerning the workshop should be directed to me at (301) 415-5787 or Traci Kime at (301) 415-7231.

Sincerely, Seung J. Lee, Mechanical Engineer Materials Safety Branch Division of Industrial and Medical Nuclear Safety, NMSS l

l I

1 Sealed Source and i

Device Vendor Workshop Jan.13,1999 8:00 - 8:15 Introduction and Opening Remarks 8:15 - 8:45 Changes in Review Process 8:45 - 9:30 General Overview of the SS&D Evaluation Process 9:30 - 9:45 Break 9:45 - 12:00 Preparation of the Application I2:00 - 1:00 Lunch 1:00 - 2:15 The Evaluation Process 2:15 - 2:45 Handling of Deficiencies in Applications & Most Common Deficiency 2:45 - 3:00 Break 3:00 - 3:45 Vendor Responsibilities After Certificate Issuance 3:45 - 4:45 Question / Answer Session 4:45 - 5:00 Closing Remarks

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Location: Two White Flint North (TWFN) Building,11545 Rockville Pike, Rockville, Maryland 20852-2738, Auditorium - P2 level Directions: Street Parking available or Ride Metro to White Flint Stop (across street). Enter through TWFN lobby. Proceed left to elevator at end of corridor. Take elevator to P2 level (auditorium). Alternatively, attendees may enter through the rear of the building and follow the security guard's directions to the auditorium.

The following hotels are near the White Flint North complex or near Stations on the Metro's Red Line. Participants must make their own hotel reservations.

Residence Inn Embassy Suites at Chevy Chase Pavilion 7335 Wisconsin Ave. 4300 Military Rd., NW Bethesda, MD - Washington, DC (301) 718-0200 (202) 362-9300 1-800-331-3131 1-800-362-2779 Manor Inn Double Tree Hotel 7740 Wisconsin Ave. 1750 Rockville Pike Bethesda, MD Rockville, MD (on metro line)

(301) 656-2100 (301) 468-1100 1-800-874-0050 1-800-222-8733 Hyatt Hotel Ramada inn One Bethesda Metro Center 1775 Rockville Pike Bethesda, MD (on metro line) Rockville, MD (301) 657-1234 (301) 881-2300.

1-800-233-1234 1-800-255-1775 I

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US NUCLEAR REGULATORY COMMISSION 11555 ROCKVILLE PIKE (ONE WHITE FLINT NORTH) 11545 ROCKVILLE PIKE (TWO WHITE FLINT NORTH)

ROCKVILLE, MD 20852-2738

. SWITCHBOARD: 301-415-7000 DIRECTIONS:

FROM WASHINGTON NATIONAL AIRPORT EXIT AIRPORT ONTO GEORGE WASHINGTON (GW) PARKWAY NORTH TAKE GW PARKWAY 9 MILES TO l-495 NORTH (EXIT TO MARYLAND)

TAKE l-495 4 MILES TO l-270 NORTH TAKE l-270 3 MILES TO MONTROSE ROAD EAST (1ST LOCAL LANE EXIT)

TAKE MONTROSE ROAD 2 MILES TO ROCKVILLE PlKE (RT. 355)

TURN RIGHT ONTO ROCKVILLE PIKE NRC COMPLEX lS 2 BLOCKS ON THE LEFT (AT MARINELLI RD. LIGHT)

FROM WASHINGTON DULLES AIRPORT l

EXIT AIRPORT ON DULLES AIRPORT ACCESS ROAD EAST (TO WASHINGTON)

TAKE ACCESS ROAD 15 MILES TO l-495 NORTH (EXIT TO BALTIMORE)

TAKE l-49510 MILES TO l-270 NORTH TAKE l-270 3 MILES TO MONTROSE ROAD EAST (1ST LOCAL LANE EXIT)

TAKE MONTROSE ROAD 2 MILES TO ROCKVILLE PIKE (RT. 355)

TURN RIGHT ONTO ROCKVILLE PlKE I NRC COMPLEX IS 2 BLOCKS ON THE LEFT (AT MARINELLI RD. LIGHT)

FROM BALTIMORE / WASHINGTON INTERNATIONAL (BWI) AIRPORT EXIT AIRPORT AND FOLLOW SIGNS TO l-95 TAKE l-95 SOUTH 20 MILES TO l-495 WEST (EX11 TO ROCKVILLE)

TAKE l-495 9 MILES TO ROCKVILLE PIKE (RT 355) NORTH (AKA WISCONSIN AVE)

TAKE RT 355 2 MILES NORTH NRC COMPLEX IS 2 BLOCKS ON THE RIGHT, JUST PAST WHITE FLINT MALL (AT MARINELLI RD. LIGHT)

FROM WASHINGTON METRORAll (METRO)

TAKE THE RED LINE TOWARD SHADY GROVE AND EXIT AT THE WHITE FLINT STATION. NRC COMPLEX IS ACROSS THE STREET FROM THE METRO EXIT. l i

SP There is no tuition for this workshop, however, Agree ent State personnel are responsible for the travel and per diem expenses.

Questions concerning the workshop should be dire ed to Seung Lee at (301) 415-5787 or Traci Kime at (301) 415-7231.

If you have questions regarding this corresponde e, please contact me or the individual named below.

POINT OF CONTACT: James H. Myers TELEPHONE: (301) 415-2328 FAX: (301) 415-3502 INTERNET: JHM@NRC. GOV Paul H. Lohaus, Deputy Director Office of State Programs

Enclosure:

As stated Distribution:

DIR RF (8S296) DCD (SP03)

SDroggitis PDR (YES.d SL:0,NMSS TKime, NMSS Agreement State File SS&D File DOCUMENT NAME: G:\JHM\SPXXYY T' receive a copf of this document, indicate in the box: "

= Copy without attachment / enclosure 'E" = Copy with attachment / enclosure "N* m No copy OFFICE OSP _,,l QSP:DD l OSP:D l NAME JHMyers:gd F PHLhhaus RLBangart DATE 11/LT/b8 /11/ /98 11/ /98 OSP FILE CODE: SP-A-4 and SP-S-2

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