ML17360A056: Difference between revisions
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| issue date = 12/22/2017 | | issue date = 12/22/2017 | ||
| title = Letter to J. Fiore Part 71 Quality Assurance Program Approval Biennial Change Report | | title = Letter to J. Fiore Part 71 Quality Assurance Program Approval Biennial Change Report | ||
| author name = Silva P | | author name = Silva P | ||
| author affiliation = NRC/NMSS/DSFM/IOB | | author affiliation = NRC/NMSS/DSFM/IOB | ||
| addressee name = Fiore J | | addressee name = Fiore J | ||
| Line 9: | Line 9: | ||
| docket = 07100642 | | docket = 07100642 | ||
| license number = | | license number = | ||
| contact person = Tapp J | | contact person = Tapp J | ||
| document type = Letter | | document type = Letter | ||
| page count = 2 | | page count = 2 | ||
| Line 15: | Line 15: | ||
=Text= | =Text= | ||
{{#Wiki_filter:December 22, 2017 | {{#Wiki_filter:December 22, 2017 Ms. Jeanne Fiore Vice President of Regulatory Affairs and Compliance Pharmalucence, Inc. | ||
29 Dunham Road Billerica, MA 01821 | |||
Ms. Jeanne Fiore Vice President of Regulatory Affairs and Compliance Pharmalucence, Inc. 29 Dunham Road | |||
Billerica, MA 01821 | |||
==SUBJECT:== | ==SUBJECT:== | ||
PART 71 QUALITY ASSURANCE PROGRAM APPROVAL BIENNIAL CHANGE REPORT | PART 71 QUALITY ASSURANCE PROGRAM APPROVAL BIENNIAL CHANGE REPORT | ||
==Dear Ms. Fiore:== | ==Dear Ms. Fiore:== | ||
In August of 2015, the U.S. Nuclear Regulatory Commission (NRC) issued a letter (Agencywide Documents Access and Management System (ADAMS) Accession No. ML15245A269) describing changes made to Title 10 of the Code of Federal Regulations (10 CFR), Part 71 regulations. Among the changes described was a new regulation, 10 CFR 71.106, that requires changes to your Part 71 quality assurance program that do not reduce commitments be submitted to the NRC every 24-months. The reporting period started on the date your revised Form 311 was approved, which was in August of 2015. | In August of 2015, the U.S. Nuclear Regulatory Commission (NRC) issued a letter (Agencywide Documents Access and Management System (ADAMS) Accession No. ML15245A269) describing changes made to Title 10 of the Code of Federal Regulations (10 CFR), Part 71 regulations. Among the changes described was a new regulation, 10 CFR 71.106, that requires changes to your Part 71 quality assurance program that do not reduce commitments be submitted to the NRC every 24-months. The reporting period started on the date your revised Form 311 was approved, which was in August of 2015. | ||
As of the date of this letter, the NRC has not received a biennial change report as required by 10 CFR 71.106. Please submit the required report by January 31, 2018, and in accordance with the requirements in 10 CFR 71.1(a). Additional action could be taken, as necessary, during a future inspection of your program. Please note that if you did not make any changes to your quality assurance program in the preceding 24-month period, you are required to report that no changes were made. | As of the date of this letter, the NRC has not received a biennial change report as required by 10 CFR 71.106. Please submit the required report by January 31, 2018, and in accordance with the requirements in 10 CFR 71.1(a). Additional action could be taken, as necessary, during a future inspection of your program. Please note that if you did not make any changes to your quality assurance program in the preceding 24-month period, you are required to report that no changes were made. | ||
If you wish to amend your quality assurance program approval and have determined it reduces commitments, or terminate your approval, please request it in writing. | |||
If you wish to amend your quality assurance program approval and have determined it reduces commitments, or terminate your approval, please request it in writing. | If you have any questions, please contact me at 301-415-7399 or Jeremy Tapp at 301-415-8047. | ||
Sincerely, | |||
If you have any questions, please contact me at 301-415-7399 or Jeremy Tapp at 301-415-8047. | /RA Jon Woodfield Acting for/ | ||
Patricia Silva, Chief Inspections and Operations Branch Division of Spent Fuel Management Office of Nuclear Material Safety and Safeguards Docket No.: 71-0642 | |||
Sincerely, | |||
Patricia Silva, Chief Inspections and Operations Branch Division of Spent Fuel Management Office of Nuclear Material Safety and Safeguards | |||
Docket No.: | |||
ML17360A056 OFC: DSFM | ML17360A056 OFC: DSFM DSFM DSFM NAME: JTapp SFigueroa (by email) JWoodfield for PSilva DATE: 12/21/17 12/21/17 12/22/17}} | ||
Latest revision as of 07:47, 22 October 2019
| ML17360A056 | |
| Person / Time | |
|---|---|
| Site: | 07100642 |
| Issue date: | 12/22/2017 |
| From: | Patricia Silva NRC/NMSS/DSFM/IOB |
| To: | Fiore J Pharmalucence |
| Tapp J | |
| References | |
| Download: ML17360A056 (2) | |
Text
December 22, 2017 Ms. Jeanne Fiore Vice President of Regulatory Affairs and Compliance Pharmalucence, Inc.
29 Dunham Road Billerica, MA 01821
SUBJECT:
PART 71 QUALITY ASSURANCE PROGRAM APPROVAL BIENNIAL CHANGE REPORT
Dear Ms. Fiore:
In August of 2015, the U.S. Nuclear Regulatory Commission (NRC) issued a letter (Agencywide Documents Access and Management System (ADAMS) Accession No. ML15245A269) describing changes made to Title 10 of the Code of Federal Regulations (10 CFR), Part 71 regulations. Among the changes described was a new regulation, 10 CFR 71.106, that requires changes to your Part 71 quality assurance program that do not reduce commitments be submitted to the NRC every 24-months. The reporting period started on the date your revised Form 311 was approved, which was in August of 2015.
As of the date of this letter, the NRC has not received a biennial change report as required by 10 CFR 71.106. Please submit the required report by January 31, 2018, and in accordance with the requirements in 10 CFR 71.1(a). Additional action could be taken, as necessary, during a future inspection of your program. Please note that if you did not make any changes to your quality assurance program in the preceding 24-month period, you are required to report that no changes were made.
If you wish to amend your quality assurance program approval and have determined it reduces commitments, or terminate your approval, please request it in writing.
If you have any questions, please contact me at 301-415-7399 or Jeremy Tapp at 301-415-8047.
Sincerely,
/RA Jon Woodfield Acting for/
Patricia Silva, Chief Inspections and Operations Branch Division of Spent Fuel Management Office of Nuclear Material Safety and Safeguards Docket No.: 71-0642
ML17360A056 OFC: DSFM DSFM DSFM NAME: JTapp SFigueroa (by email) JWoodfield for PSilva DATE: 12/21/17 12/21/17 12/22/17