ML18099A211: Difference between revisions

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| issue date = 04/06/2018
| issue date = 04/06/2018
| title = Letter to Executive Branch Requesting Judgement for Export License Application XMAT443
| title = Letter to Executive Branch Requesting Judgement for Export License Application XMAT443
| author name = Owens J E
| author name = Owens J
| author affiliation = NRC/OIP/ECNP
| author affiliation = NRC/OIP/ECNP
| addressee name = DeLaBarre R
| addressee name = Delabarre R
| addressee affiliation = US Dept of State, Bureau of International Security & Nonproliferation, US Dept of State, Office of Nuclear Energy Safety & Security Affairs
| addressee affiliation = US Dept of State, Bureau of International Security & Nonproliferation, US Dept of State, Office of Nuclear Energy Safety & Security Affairs
| docket = 11006301
| docket = 11006301
| license number = XMAT443
| license number = XMAT443
| contact person = Savoy J M
| contact person = Savoy J
| document type = Letter
| document type = Letter
| page count = 1
| page count = 1
Line 15: Line 15:


=Text=
=Text=
{{#Wiki_filter:*****UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 April 6, 2018 Mr. Robin DeLaBarre Office of Nuclear Energy, Safety & Security Affairs, Room 3320 HST Bureau of International Security& Nonproliferation U.S. Department of State 2201 C Street, NW Washington, D.C. 20520 Dear Mr. DeLaBarre; Enclosed is an application (XMAT443), dated January 30, 2018, received by the U.S. Nuclear Regulatory Commission (NRC), from Vertex Pharmaceuticals Incorporated for the export of 5000 kilograms of deuterium to Shanghi SynTheAII Pharmaceuticals Co., Ltd., in China. Vertex plans to utilize the deuterium compounds to manufacture active pharmaceutical ingredients for use in clinical trials on treatments of cystic fibrosis, In accordance with our mutual understandings documented in August 2016, "Processing applications for licenses for exports of deuterium," we would appreciate receiving your judgement as to whether:* The facts of the proposed export are consistent with non-nuclear end use;* The Executive Branch does not see a need for assurances from the recipient government; and* The proposed export would not be inimical to the common defense and security of the United States.Sincerely, Janice E. Owens, Acting Chief Export Controls and Nonproliferation Branch Office of International Programs  
{{#Wiki_filter:UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001
*****                                            April 6, 2018 Mr. Robin DeLaBarre Office of Nuclear Energy, Safety & Security Affairs, Room 3320 HST Bureau of International Security
    & Nonproliferation U.S. Department of State 2201 C Street, NW Washington, D.C. 20520 Dear Mr. DeLaBarre; Enclosed is an application (XMAT443), dated January 30, 2018, received by the U.S. Nuclear Regulatory Commission (NRC),from Vertex Pharmaceuticals Incorporated for the export of 5000 kilograms of deuterium to Shanghi SynTheAII Pharmaceuticals Co., Ltd., in China. Vertex plans to utilize the deuterium compounds to manufacture active pharmaceutical ingredients for use in clinical trials on treatments of cystic fibrosis, In accordance with our mutual understandings documented in August 2016, "Processing applications for licenses for exports of deuterium," we would appreciate receiving your judgement as to whether:
* The facts of the proposed export are consistent with non-nuclear end use;
* The Executive Branch does not see a need for assurances from the recipient government; and
* The proposed export would not be inimical to the common defense and security of the United States.
Sincerely, Janice E. Owens, Acting Chief Export Controls and Nonproliferation Branch Office of International Programs


==Enclosure:==
==Enclosure:==


Export License Application cc w/enciosure:
Export License Application cc w/enciosure:
K. Strangis, DOE/NNSA J. Norles, DOE/NNSA M. Shoemaker, NRC/NMSS J, Semones, DHS/CBP S. Aguilar, NRC/NMSS M. Chen, DOE/NNSA P. Dessaules, DOE/NMMSS R. Bennett, DHS/CBP S. Clagett, DOC E. Sauls, DTRA}}
K. Strangis, DOE/NNSA                   S. Aguilar, NRC/NMSS                 R. Bennett, DHS/CBP J. Norles, DOE/NNSA                      M. Chen, DOE/NNSA                     S. Clagett, DOC M. Shoemaker, NRC/NMSS                  P. Dessaules, DOE/NMMSS               E. Sauls, DTRA J, Semones, DHS/CBP}}

Latest revision as of 10:54, 21 October 2019

Letter to Executive Branch Requesting Judgement for Export License Application XMAT443
ML18099A211
Person / Time
Site: 11006301
Issue date: 04/06/2018
From: Janice Owens
NRC/OIP/ECNP
To: Delabarre R
US Dept of State, Bureau of International Security & Nonproliferation, US Dept of State, Office of Nuclear Energy Safety & Security Affairs
Savoy J
References
Download: ML18099A211 (1)


Text

UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001

          • April 6, 2018 Mr. Robin DeLaBarre Office of Nuclear Energy, Safety & Security Affairs, Room 3320 HST Bureau of International Security

& Nonproliferation U.S. Department of State 2201 C Street, NW Washington, D.C. 20520 Dear Mr. DeLaBarre; Enclosed is an application (XMAT443), dated January 30, 2018, received by the U.S. Nuclear Regulatory Commission (NRC),from Vertex Pharmaceuticals Incorporated for the export of 5000 kilograms of deuterium to Shanghi SynTheAII Pharmaceuticals Co., Ltd., in China. Vertex plans to utilize the deuterium compounds to manufacture active pharmaceutical ingredients for use in clinical trials on treatments of cystic fibrosis, In accordance with our mutual understandings documented in August 2016, "Processing applications for licenses for exports of deuterium," we would appreciate receiving your judgement as to whether:

  • The facts of the proposed export are consistent with non-nuclear end use;
  • The Executive Branch does not see a need for assurances from the recipient government; and
  • The proposed export would not be inimical to the common defense and security of the United States.

Sincerely, Janice E. Owens, Acting Chief Export Controls and Nonproliferation Branch Office of International Programs

Enclosure:

Export License Application cc w/enciosure:

K. Strangis, DOE/NNSA S. Aguilar, NRC/NMSS R. Bennett, DHS/CBP J. Norles, DOE/NNSA M. Chen, DOE/NNSA S. Clagett, DOC M. Shoemaker, NRC/NMSS P. Dessaules, DOE/NMMSS E. Sauls, DTRA J, Semones, DHS/CBP