ML20259A487
| ML20259A487 | |
| Person / Time | |
|---|---|
| Issue date: | 09/22/2020 |
| From: | Thi Herrera NRC/NMSS/DMSST |
| To: | Honcharik E Perkin Elmer |
| Herrera T | |
| Shared Package | |
| ML20218A169 | List: |
| References | |
| 20-26 | |
| Download: ML20259A487 (4) | |
Text
UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 September 22, 2020 Ms. Elizabeth Honcharik, Senior Manager Environmental, Health and Safety Radiation Safety Officer PerkinElmer, Inc.
710 Bridgeport Ave, M/S 221 Shelton, CT 06484
SUBJECT:
PERKINELMER, INCORPORATED REQUEST FOR ADDITIONAL INFORMATION
Dear Ms. Honcharik:
This letter is in response to your amendment request dated July 30, 2020, requesting and amendments to your and Sealed Source and Device (SSD) Registration Certificate NR-0536-D-110-B.
We do not have sufficient information to complete the review of your application. In the enclosure to this letter you will find the list of questions and items not addressed in your application.
Please be aware that upon your request, proprietary information submitted to the U.S. Nuclear Regulatory Commission (NRC) may be withheld from public disclosure. To do this, you must follow the procedures in Title 10 of the Code of Federal Regulations (10 CFR) Paragraph 2.390(b) including requesting withholding at the time the information is submitted and complying with the document marking and affidavit requirements set forth in 10 CFR 2.390(b)(1).
We will continue our review upon receipt of this information. If we do not receive your reply within 30 calendar days from the date of this letter, we will consider your application as having been abandoned by you. This action would be without prejudice to the resubmission of another application with the required information.
In accordance with 10 CFR Section 2.390 of the NRCs Agency Rules of Practice and Procedure, a copy of this letter will be available electronically for public inspection in the NRC Public Document Room or from the Publicly Available Records component of NRCs Agencywide Documents Access and Management System (ADAMS). ADAMS is accessible from the NRC Web site at http://www.nrc.gov/reading-rm/adams.html.
E. Honcharik 2
If you have any questions, please contact me at (301) 415-7138, or by e-mail at Tomas.Herrera@nrc.gov.
Sincerely, 9/22/2020 X
Tomas Herrera Team Leader Signed by: Tomas Herrera Tomas Herrera, Team Leader Materials Safety Tribal and Liaison Branch Division of Materials Safety, Security, State, and Tribal Programs Office of Nuclear Material Safety and Safeguards
Enclosure:
Request for Additional Information
E. Honcharik 3
SUBJECT:
PERKINELMER, INCORPORATED REQUEST FOR ADDITIONAL INFORMATION DATED:
September 22, 2020 ADAMS ACCESSION NO.: ML20259A487
- Concurrence Via email OFFICE MSST/MSTB MSST/MSTB MSST/MSTB MSST/MSTB NAME TBrockington THerrera LSepulveda THerrera DATE 9/15/20 9/17/20 9/21/20 9/22/20 OFFICIAL RECORD COPY
Enclosure PerkinElmer, Inc.
AMENDMENT REQUESTS DATED JULY 30, 2020 REQUEST FOR ADDITIONAL INFORMATION The U.S. Nuclear Regulatory Commission (NRC) staff has reviewed the PerkinElmer, Inc.
(PerkinElmer) amendment requests dated July 30, 2020, and determined that additional information is needed. In order to continue with our review, please address the issues listed below. This information is required by Title 10 of the Code of Federal Regulations (10 CFR)
Section 32.210 and described in the relevant guidance document NUREG-1556, Volume 3, Revision 2, titled Applications for Sealed Source and Device Evaluation and Registration.
Description/Construction
- 1.
In your amendment request dated July 30, 2020, drawings of the N6400642 cell assembly were provided. Please provide drawings of the N6400642 cell assembly drawings to include the dimensions and tolerances.
- 2.
We note that there is a change in length in the cylindrical cavity where the foil source is situated. Please discuss whether there are any additional changes, compared to the previously registered ECDs.
- 3.
Please discuss if there were any changes in the assembly methods for the N6400061 or the N6400642 compared to the versions that were previously registered.
- 4.
Please discuss whether there are any tamper resistant measures that would prevent an untrained individual from accessing the radioactive material.
- 5.
We note a change in material for the new ECD from 304 stainless steel to UNS S17400 stainless steel. Please discuss whether there is any potential for corrosion used in the materials of construction for the ECD. Please discuss if UNS S17400 stainless steel has the same properties as 304 stainless steel. In addition, please discuss whether there is any potential for degradation due to the proximity of radioactive material.
Labeling
- 6.
We note that the other registered ECDs were stamped with an individual serial number.
Please confirm that a serial number will be stamped on the N6400061.
Prototype Testing
- 7.
In your amendment request it states that the prototype testing remains the same. It is unclear whether this statement means that the N6400061 was prototype tested. If the N6400061 was tested, please provide the prototype testing results.
If it is PerkinElmers intent to compare it to the previously registered ECDs please explain the rationale and analysis performed to determine that the N6400061 did not require further testing to demonstrate that it would maintain its integrity during normal use and likely accident conditions.