ML13149A015

Pre-Application Communication and Scheduling for Medical Radioisotope Facilities Intending to Produce Molybdenum-99

ML13149A015
Person / Time
Site:	PROJ0786
Issue date:	05/24/2013
From:	Bigles C I Coqui Radio Pharmaceuticals Corp
To:	Document Control Desk, Office of Nuclear Reactor Regulation
References
RIS 13-003
Download: ML13149A015 (3)

See also: RIS 2013-03

Text

U.S. Nuclear Regulatory

Commission

ATTN: Document Control Desk Washington, DC 20555-0001

May 24, 2013 Project No.: PROJ0786 Subject: NRC REGULATORY

ISSUE SUMMARY 2013-03, PRE-APPLICATION

COMMUNICATION

AND SCHEDULING

FOR MEDICAL RADIOISOTOPE

FACILITIES

INTENDING

TO PRODUCE MOLYBDENUM-99

Coqui Radio Pharmaceuticals

Corp. (Coqui) is providing

the Nuclear Regulatory

Commission (NRC) herein the voluntary

answers to the questions

set forth in the above-mentioned

April 24, 2013 communication.

If you have question or need additional

information, please contact me by telephone

at 787-685-5046

or by email at cbigles@coquipharma.com.

Sincerely, Carmen Irene Bigles Chief Executive

Officer / President Coqui RadioPharmaceuticals

Corp.Enclosure:

As stated Cc: Al Alexander, Senior Project Manager Steven Lynch, Project Manager Mary Adams, Sr. Env. Engineer Amy C. Roma, Hogan Lovells US LLP Alejandro

J. Valderrabano-Wagner

Board of Directors

of Coqui RadioPharmaceuticals

Corp.James Lewis, Lewis and Crawford US LLP

ENCLOSURE

(1)Coqui RadioPharmaceuticals

Corp.Design and Licensing

Submittal

Information

(1) How many applications

will be submitted

to the NRC? What NRC licensing actions will the application(s)

request? What will be the content of the application(s)?

Coqui RadioPharmaceuticals

Corporation (Coqui) anticipates

that it will submit applications

for both a construction

permit and an operating

license in a single submittal

per 10 CFR 2.105(c)for a Medical Isotope Production

Facility (MIPF), which will consist of two production

reactors and a radioisotope

processing

plant for the production

of molybdenum-99.

Coqui intends to submit its Environmental

Report for the requested

licenses prior to submitting

its license application.

(2) Under which part(s) of 10 CFR will the application(s)

request licenses?

In particular, will license applications

be submitted

under 10 CFR Part 50 for consideration

as a production

or utilization

facility or under 10 CFR Part 70 as a processing

facility?

Will an exemption

from any part of the regulations

be sought?Coqui's application

will be submitted

pursuant to 10 CFR Part 50. At this point, Coqui does not anticipate

the need to request any exemptions

from any part of the NRC regulations

when it submits its applications.

Coqui will also request a radioactive

materials

license, which will be requested

in its Part 50 reactor license applications.

(3) What consideration, if any, has been given to the applicability

of other parts of 10 CFR to the application(s)?

For example, a license for possession

of byproduct

material may be necessary

in accordance

with 10 CFR Part 30, "Rules of General Applicability

to Domestic Licensing

of Byproduct

Material." Coqui will also request authority

to possess and use the necessary

radioactive

materials

at the facility when it submits its Part 50 reactor license applications.

(4) When (month and year) will the NRC receive the application(s)

for review?Please provide the licensing

milestones

that have been established

for the development, submission, and review of the application(s).

Coqui intends to submit its Environmental

Report in November 2013 and its construction

permit and operating

license applications

in a single submittal

in March 2014. The Preliminary

Safety Analysis Report will follow NUREG 1537 acceptance

criteria for non-power

reactors.

The submission

date for the application

is subject to timely and successful

placement

of external funds and receipt of all board of director's

approvals.

Based on conversations

with the NRC staff, Coqui anticipates

that the NRC will issue the requested

construction

permit in March 2015 and the requested

operating

license in October 2016.

(5) Has a site been selected for each facility described

in the application(s)?

If so, please describe it.University

of Florida has allocated

a site in Alachua, Florida for the MIPF. In a December 7, 2012 communication

to the NRC, Coquf provided the NRC with the site assessment

for this location.(6) What design will be used for each facility?

What is the current status of the development

of the design(s) (i.e., conceptual, preliminary, or final)? Please provide a schedule for completing

the design(s).

The Coqui reactor is an INVAP reactor design. INVAP is the reactor designer and the general contractor

for the MIPF. The INVAP reactor design is conceptual, the development

of the preliminary

design supporting

the Preliminary

Safety Assessment

is associated

with the availability

of external funds.(7) Are vendors or consultants

assisting

in preparing

the application(s)?

If so, please describe their roles and responsibilities

in the design and licensing activities.

INVAP is the reactor designer and general contractor

for the project. Gresham Smith & Partners domestic design firm. Coqui has also engaged the law firm of Hogan Lovells to provide nuclear regulatory

licensing

counsel.White Papers and Technical

or Topical Reports (1) Are there current plans to submit white papers or technical

or topical reports related to design features, policy resolution, or technical

issues for review and approval?

If so, please describe and provide a schedule for submitting

the anticipated

report(s).

In May 2010, Coqui submitted

a first licensing

strategy document to the NRC about what class of license Coqui intends to apply for. In June 2012, Coqui submitted

a second licensing strategy document to the NRC, which provided for the NRC staff's review a Safety and Licensing

Plan for the technical

portions of the applications

that Coqui prepared with INVAP.Coqul does not anticipate

that it will submit any more white papers.