ML15335A487

Scheduling Order

ML15335A487
Person / Time
Site:	SHINE Medical Technologies
Issue date:	12/01/2015
From:	Vietti-Cook A L NRC/SECY
To:
SECY RAS
References
50-608-CP, Mandatory Hearing 2, RAS 28594
Download: ML15335A487 (6)

Text

UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION In the Matter of SHINE MEDICAL TECHNOLOGIES, INC. Docket No. 50-608-CP (Medical Radioisotope Production Facility)

SCHEDULING ORDER On October 27, 2015, the Commission issued a notice that it would convene an evidentiary hearing at its Rockville, Maryland headquarters on December 15, 2015, pursuant to section 189a. of the Atomic Energy Act of 1954, as amended, to receive testimony and exhibits in the captioned proceeding.

1 Today's Scheduling Order, issued pursuant to my authority under 10 C.F.R. § 2.346(a), (d), and (j), provides details covering matters such as the identification and swearing-in of witnesses, the process for admitting evidence, and the format of presentations. Identification of Witnesses. To expedite the proceeding, all witnesses will be identified and sworn in at the beginning of the hearing. As a result, all witnesses should be present in the hearing room at that time. Witnesses should remain available for the entirety of the hearing. Presentation Slides. Sets of presentation slides for each panel shall be served using the agency's e-filing system (see 10 C.F.R. § 2.304(g)), and also shall be transmitted via e-mail to Hearing.Docket@nrc.gov, no later than December 8, 2015. Format and Time Allocations. The order of presentation panels and time allocations are reflected in the Scheduling Note for this proceeding, which will be transmitted separately.

1 See SHINE Medical Technologies, Inc.; Notice of Hearing, 80 Fed. Reg. 67,435 (Nov. 2, 2015). Panelists should assume that the Commission is familiar with the content of their written testimony, including written responses to pre-hearing questions. Admission of Evidence. Exhibits for this proceeding will be admitted after the witnesses are identified and sworn and before the panel presentations begin. To facilitate this process, no later than December 8, 2015, the NRC Staff and SHINE Medical Technologies, Inc. each shall pre-file all of the exhibits they intend to propose for admission into evidence at the hearing and provide to the Secretary a table listing these exhibits.

2 The table should be formatted as follows: Exhibit Number Panel Number/

Sponsoring Witness(es) Document Description/Title 3

All exhibits should be pre-filed in accordance with the requirements of our e-filing rules, at 10 C.F.R. § 2.304(g). Other than witness lists, any documents pre-filed in advance of this Scheduling Order should be re-filed as exhibits. Only one copy of each item of documentary material should be offered as evidence in connection with this mandatory hearing, so the parties should coordinate as necessary. The Staff should include the construction permit application in 2 Any pre-filed exhibit that contains confidential or sensitive information should be filed separately in the agency's e-filing system using the "non-public submission" filing option and should include appropriate page markings.

3 The parties should include an ADAMS accession number to the extent one is available for the document (or portion of the document) that will be proffered. For any exhibit having a confidential/sensitive status that would preclude public disclosure, the listing information should

be set forth in bold type. its list of exhibits. Panel presentation slides should be included and identified as exhibits, and will be admitted into the record of the proceeding. In cases of exhibits that are testimony, the sponsoring witness (or witnesses) shall provide a written certification, as part of the filing submitting the exhibit table, containing the following information: that the identified testimony was prepared by the witness (or under the witness's direction); that the written testimony is true and correct to the best of the witness's information, knowledge, and belief; and that the witness adopts the identified testimony as his or her sworn testimony in the proceeding.

4 Exhibits will be admitted at the hearing based on the exhibit tables and associated certifications, as applicable; the list of exhibits and any certifications will not be read aloud at the hearing. SHINE and the Staff will be offered the opportunity at the oral hearing to provide corrections, amendments, and additions to testimony or exhibits, or to object to the admission of particular exhibits, during the process of admitting exhibits. The exhibit tables and certifications will become part of the record of the proceeding.

5 4 This certification may be notarized, or may be submitted in the form of an unsworn declaration consistent with 28 U.S.C. § 1746.

5 Provided the exhibits are properly pre-filed using the agency's e-filing system, it should not be necessary for the parties to provide the Commission or counsel for the other party with any paper copies of their pre-filed evidentiary materials. Nonetheless, the parties should have available at the hearing one properly marked paper copy of each pre-filed document for use in the event that there are any operational issues. In addition, if a party must submit any new testimony or exhibits at the hearing, or revise any pre-filed testimony or exhibits at the hearing, that party must provide at that time a properly marked electronic copy of any such documents, along with enough properly marked paper copies of any such documents for distribution to counsel for the other party, all Commission members (two copies each), and the Secretary of the Commission (three copies). Exhibits should be labeled and numbered consecutively beginning with exhibit number one, formatted as "NRC-001," "NRC-002," or "SHN-001," "SHN-002," etc. Exhibit numbers should be placed in the upper right hand corner of the first page of the exhibit. A separate cover sheet should be used for an exhibit only if there is no space on the first page of the exhibit into which the number can be legibly placed.

6 Multi-page exhibits should be numbered consecutively so that they can be readily referred to at the evidentiary hearing. Post-hearing Responses to Follow-up Questions. If, at the hearing, Commissioners ask any questions that cannot be fully answered at the hearing itself, or expressly pose follow-up questions to be answered in writing, the Staff and SHINE, as appropriate, may file supplemental responses to such questions no later than December 30, 2015, unless the Commission at the hearing sets a different deadline for responses.

6 If a party needs to provide a revised version of a previously pre-filed ex hibit, the exhibit should be re-filed with "-R" following the numbering sequence. For example, if exhibit NRC-005 must be revised, the revised exhibit would be labeled NRC-005-R. If this exhibit must again be revised, it would be labeled NRC-005-R2. If a party needs to break a document into several segments to ensure it does not exceed the agency's guidance on recommended file size for submissions (see NRC, Guidance for Electronic Submissions to the NRC, Rev. 6.1, at 15-16 (May 27, 2011) (ADAMS accession no. ML13031A056)), each of the segments should be labeled by adding a letter directly following the exhibit number to reflect the relationship of each part of the exhibit to the other parts. For example, if NRC Staff exhibit NRC-005 must be submitted in multiple parts, each portion should be assigned a different exhibit number:

NRC-005A, NRC-005B, NRC-005C, etc. General Information. The Office of the Secretary of the Commission will contact the parties regarding logistics related to the hearing.

IT IS SO ORDERED.

For the Commission

NRC SEAL /RA/ ___________________________ Annette L. Vietti-Cook Secretary of the Commission

Dated at Rockville, Maryland, this 1 st day of December, 2015.

UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION In the Matter of ) )

SHINE Medical Technologies, Inc. ) Docket No. 50-608-CP

) (Mandatory Hearing) ) CERTIFICATE OF SERVICE

I hereby certify that copies of the foregoing SCHEDULING ORDER have been served upon the following persons by the Electronic Information Exchange.

U.S. Nuclear Regulatory Commission Office of Commission Appellate Adjudication

Mail Stop: O-7H4 Washington, DC 20555-0001 E-mail: ocaamail@nrc.gov U.S. Nuclear Regulatory Commission Office of the Secretary of the Commission

Mail Stop: O-16C1 Washington, DC 20555-0001 Hearing Docket E-mail: hearingdocket@nrc.gov

Morgan, Lewis & Bockius, LLP

1111 Pennsylvania Ave., NW Washington, DC 20004 Counsel for the Applicant Paul M. Bessette, Esq.

Stephen J. Burdick, Esq.

Andrea N. Threet, Esq.

Mary Freeze, Assistant Audrea Salters, Legal Secretary

E-mail:

pbessette@morganlewis.com sburdick@morganlewis.com andrea.threet@morganlewis.com mfreeze@morganlewis.com asalters@morganlewis.com U.S. Nuclear Regulatory Commission Office of the General Counsel Mail Stop - O-15 D21 Washington, DC 20555-0001 Mitzi A. Young, Esq.

Catherine E. Kanatas, Esq.

Edward L. Williamson, Esq.

E-mail: mitzi.young@nrc.gov catherine.kanatas@nrc.gov edward.williamson@nrc.gov

OGC Mail Center : OGCMailCenter@nrc.gov

[Original signed by Clara Sola ]

Office of the Secretary of the Commission Dated at Rockville, Maryland this 1 st day of December, 2015 UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION In the Matter of SHINE MEDICAL TECHNOLOGIES, INC. Docket No. 50-608-CP (Medical Radioisotope Production Facility)

SCHEDULING ORDER On October 27, 2015, the Commission issued a notice that it would convene an evidentiary hearing at its Rockville, Maryland headquarters on December 15, 2015, pursuant to section 189a. of the Atomic Energy Act of 1954, as amended, to receive testimony and exhibits in the captioned proceeding.

1 Today's Scheduling Order, issued pursuant to my authority under 10 C.F.R. § 2.346(a), (d), and (j), provides details covering matters such as the identification and swearing-in of witnesses, the process for admitting evidence, and the format of presentations. Identification of Witnesses. To expedite the proceeding, all witnesses will be identified and sworn in at the beginning of the hearing. As a result, all witnesses should be present in the hearing room at that time. Witnesses should remain available for the entirety of the hearing. Presentation Slides. Sets of presentation slides for each panel shall be served using the agency's e-filing system (see 10 C.F.R. § 2.304(g)), and also shall be transmitted via e-mail to Hearing.Docket@nrc.gov, no later than December 8, 2015. Format and Time Allocations. The order of presentation panels and time allocations are reflected in the Scheduling Note for this proceeding, which will be transmitted separately.

1 See SHINE Medical Technologies, Inc.; Notice of Hearing, 80 Fed. Reg. 67,435 (Nov. 2, 2015). Panelists should assume that the Commission is familiar with the content of their written testimony, including written responses to pre-hearing questions. Admission of Evidence. Exhibits for this proceeding will be admitted after the witnesses are identified and sworn and before the panel presentations begin. To facilitate this process, no later than December 8, 2015, the NRC Staff and SHINE Medical Technologies, Inc. each shall pre-file all of the exhibits they intend to propose for admission into evidence at the hearing and provide to the Secretary a table listing these exhibits.

2 The table should be formatted as follows: Exhibit Number Panel Number/

Sponsoring Witness(es) Document Description/Title 3

All exhibits should be pre-filed in accordance with the requirements of our e-filing rules, at 10 C.F.R. § 2.304(g). Other than witness lists, any documents pre-filed in advance of this Scheduling Order should be re-filed as exhibits. Only one copy of each item of documentary material should be offered as evidence in connection with this mandatory hearing, so the parties should coordinate as necessary. The Staff should include the construction permit application in 2 Any pre-filed exhibit that contains confidential or sensitive information should be filed separately in the agency's e-filing system using the "non-public submission" filing option and should include appropriate page markings.

3 The parties should include an ADAMS accession number to the extent one is available for the document (or portion of the document) that will be proffered. For any exhibit having a confidential/sensitive status that would preclude public disclosure, the listing information should

be set forth in bold type. its list of exhibits. Panel presentation slides should be included and identified as exhibits, and will be admitted into the record of the proceeding. In cases of exhibits that are testimony, the sponsoring witness (or witnesses) shall provide a written certification, as part of the filing submitting the exhibit table, containing the following information: that the identified testimony was prepared by the witness (or under the witness's direction); that the written testimony is true and correct to the best of the witness's information, knowledge, and belief; and that the witness adopts the identified testimony as his or her sworn testimony in the proceeding.

4 Exhibits will be admitted at the hearing based on the exhibit tables and associated certifications, as applicable; the list of exhibits and any certifications will not be read aloud at the hearing. SHINE and the Staff will be offered the opportunity at the oral hearing to provide corrections, amendments, and additions to testimony or exhibits, or to object to the admission of particular exhibits, during the process of admitting exhibits. The exhibit tables and certifications will become part of the record of the proceeding.

5 4 This certification may be notarized, or may be submitted in the form of an unsworn declaration consistent with 28 U.S.C. § 1746.

5 Provided the exhibits are properly pre-filed using the agency's e-filing system, it should not be necessary for the parties to provide the Commission or counsel for the other party with any paper copies of their pre-filed evidentiary materials. Nonetheless, the parties should have available at the hearing one properly marked paper copy of each pre-filed document for use in the event that there are any operational issues. In addition, if a party must submit any new testimony or exhibits at the hearing, or revise any pre-filed testimony or exhibits at the hearing, that party must provide at that time a properly marked electronic copy of any such documents, along with enough properly marked paper copies of any such documents for distribution to counsel for the other party, all Commission members (two copies each), and the Secretary of the Commission (three copies). Exhibits should be labeled and numbered consecutively beginning with exhibit number one, formatted as "NRC-001," "NRC-002," or "SHN-001," "SHN-002," etc. Exhibit numbers should be placed in the upper right hand corner of the first page of the exhibit. A separate cover sheet should be used for an exhibit only if there is no space on the first page of the exhibit into which the number can be legibly placed.

6 Multi-page exhibits should be numbered consecutively so that they can be readily referred to at the evidentiary hearing. Post-hearing Responses to Follow-up Questions. If, at the hearing, Commissioners ask any questions that cannot be fully answered at the hearing itself, or expressly pose follow-up questions to be answered in writing, the Staff and SHINE, as appropriate, may file supplemental responses to such questions no later than December 30, 2015, unless the Commission at the hearing sets a different deadline for responses.

6 If a party needs to provide a revised version of a previously pre-filed ex hibit, the exhibit should be re-filed with "-R" following the numbering sequence. For example, if exhibit NRC-005 must be revised, the revised exhibit would be labeled NRC-005-R. If this exhibit must again be revised, it would be labeled NRC-005-R2. If a party needs to break a document into several segments to ensure it does not exceed the agency's guidance on recommended file size for submissions (see NRC, Guidance for Electronic Submissions to the NRC, Rev. 6.1, at 15-16 (May 27, 2011) (ADAMS accession no. ML13031A056)), each of the segments should be labeled by adding a letter directly following the exhibit number to reflect the relationship of each part of the exhibit to the other parts. For example, if NRC Staff exhibit NRC-005 must be submitted in multiple parts, each portion should be assigned a different exhibit number:

NRC-005A, NRC-005B, NRC-005C, etc. General Information. The Office of the Secretary of the Commission will contact the parties regarding logistics related to the hearing.

IT IS SO ORDERED.

For the Commission

NRC SEAL /RA/ ___________________________ Annette L. Vietti-Cook Secretary of the Commission

Dated at Rockville, Maryland, this 1 st day of December, 2015.

UNITED STATES OF AMERICA NUCLEAR REGULATORY COMMISSION In the Matter of ) )

SHINE Medical Technologies, Inc. ) Docket No. 50-608-CP

) (Mandatory Hearing) ) CERTIFICATE OF SERVICE

I hereby certify that copies of the foregoing SCHEDULING ORDER have been served upon the following persons by the Electronic Information Exchange.

U.S. Nuclear Regulatory Commission Office of Commission Appellate Adjudication

Mail Stop: O-7H4 Washington, DC 20555-0001 E-mail: ocaamail@nrc.gov U.S. Nuclear Regulatory Commission Office of the Secretary of the Commission

Mail Stop: O-16C1 Washington, DC 20555-0001 Hearing Docket E-mail: hearingdocket@nrc.gov

Morgan, Lewis & Bockius, LLP

1111 Pennsylvania Ave., NW Washington, DC 20004 Counsel for the Applicant Paul M. Bessette, Esq.

Stephen J. Burdick, Esq.

Andrea N. Threet, Esq.

Mary Freeze, Assistant Audrea Salters, Legal Secretary

E-mail:

pbessette@morganlewis.com sburdick@morganlewis.com andrea.threet@morganlewis.com mfreeze@morganlewis.com asalters@morganlewis.com U.S. Nuclear Regulatory Commission Office of the General Counsel Mail Stop - O-15 D21 Washington, DC 20555-0001 Mitzi A. Young, Esq.

Catherine E. Kanatas, Esq.

Edward L. Williamson, Esq.

E-mail: mitzi.young@nrc.gov catherine.kanatas@nrc.gov edward.williamson@nrc.gov

OGC Mail Center : OGCMailCenter@nrc.gov

[Original signed by Clara Sola ]

Office of the Secretary of the Commission Dated at Rockville, Maryland this 1 st day of December, 2015