health & human services; amendment request. · rml policies. dr. hinnebusch replaces dr. byron...

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DEPARfMENfOFHEAL1H&HUMANSERVICES Public Health Service National Institutes of Health FP - 2010 Rocky Mountain Laboratories, NIAID 903 South 4th Street Hamilton, Montana 59840 PHONE: (406) 363-9216 FAX: (406) 363-9336 August 30, 2010 u. S. Nuclear Regulatory Commission Region IV Division of Nuclear Materials Safety, Licensing Branch 611 Ryan Plaza Drive, Suite 400 Arlington, TX 76011-8064 Re: NRC License: 25-0J 203-0 I Docket: 030-05167 Expiration date: May 31, 2015 To Whom it May Concern: Please find enclosed a completed NRC Form 313 license amendment request. Rocky Mountain Laboratories (RML) requests a change to Condition I I. A. of NRC Type A Broad Scope License No. 25-01203-0 I. Dr. Marshall Bloom. RML Associate Director of Scientific Operations, has appointed Dr. Jo Hinnebus h a Chairman of the RML Radiation Safety Committee (RSC). The change was made to be consistent with internal RML policies. Dr. Hinnebusch replaces Dr. Byron Caughey, who will continue to serve as a member of the RML RSC. Provided below are Dr. Hinnebusch's qualifications, training, experience as well as his accessibility to executive management in his position as Chairman of the RML RSC. Dr. Hinnebusch is a Tenured Senior Investigator and a Section Chief of the Plaque Section of the Laboratory of Zoonotic Pathogens (LZP). He supervises a laboratory staffed with 2 post-doctoral fellows, 2 technicians and I senior research fellow. He has access at any time to the Associate Directors of RML and, if need be, to the Director. In September of 1987 Dr. Hinnebusch compl L d a Rauiation Safety cour'e for authorized users presented at the University of Texas Health Science Center. He also has attended authorized user and annual I' freshers our e. at RML. Dr. Hinnebusch has over twenty years of experience working with radioisotopes including 1251, 3H, 14C, 35S and 32P as well as self-shielded irradiators in various applications of biological research. He served as a member of the RML Radiation Safety Committee beginning in 2005 before his appointment as Chairman. Please contact me if you have questions or need additional information. I can be reached at 406-363-9216 or by email at [email protected]. Sincerely, / BaITi Twardoski Radiation Safety Officer Rocky Mountain Laboratories, DIR, NIND, NIH Enclosure: NRC Form 313 c.c. w/enclosure(s): Dr. Joe Hinnebusch (RML LZP Plaque Section Chief) Dr. Marshall Bloom (RML Associate Director, Office of Scientific Operations) Pat Stewart (RML Associate Director, Office of Operations Management) 573592

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DEPARfMENfOFHEAL1H&HUMANSERVICES Public Health Service

National Institutes of Health FP - 2010 Rocky Mountain Laboratories, NIAID 903 South 4th Street Hamilton, Montana 59840 PHONE: (406) 363-9216 FAX: (406) 363-9336

August 30, 2010

u. S. Nuclear Regulatory Commission Region IV Division of Nuclear Materials Safety, Licensing Branch 611 Ryan Plaza Drive, Suite 400 Arlington, TX 76011-8064

Re: NRC License: 25-0J 203-0 I Docket: 030-05167 Expiration date: May 31, 2015

To Whom it May Concern:

Please find enclosed a completed NRC Form 313 license amendment request. Rocky Mountain Laboratories (RML) requests a change to Condition I I. A. of NRC Type A Broad Scope License No. 25-01203-0 I.

Dr. Marshall Bloom. RML Associate Director of Scientific Operations, has appointed Dr. Jo Hinnebus h a Chairman of the RML Radiation Safety Committee (RSC). The change was made to be consistent with internal RML policies. Dr. Hinnebusch replaces Dr. Byron Caughey, who will continue to serve as a member of the RML RSC. Provided below are Dr. Hinnebusch's qualifications, training, experience as well as his accessibility to executive management in his position as Chairman of the RML RSC.

Dr. Hinnebusch is a Tenured Senior Investigator and a Section Chief of the Plaque Section of the Laboratory of Zoonotic Pathogens (LZP). He supervises a laboratory staffed with 2 post-doctoral fellows, 2 technicians and I senior research fellow. He has access at any time to the Associate Directors of RML and, if need be, to the Director.

In September of 1987 Dr. Hinnebusch compl L d a Rauiation Safety cour'e for authorized users presented at the University of Texas Health Science Center. He also has attended authorized user and annual I' freshers our e. at RML. Dr. Hinnebusch has over twenty years of experience working with radioisotopes including 1251, 3H, 14C, 35S and 32P as well as self-shielded irradiators in various applications of biological research. He served as a member of the RML Radiation Safety Committee beginning in 2005 before his appointment as Chairman.

Please contact me if you have questions or need additional information. I can be reached at 406-363-9216 or by email at [email protected].

Sincerely, /

i~---r-~~ BaITi Twardoski Radiation Safety Officer Rocky Mountain Laboratories, DIR, NIND, NIH

Enclosure: NRC Form 313

c.c. w/enclosure(s): Dr. Joe Hinnebusch (RML LZP Plaque Section Chief) Dr. Marshall Bloom (RML Associate Director, Office of Scientific Operations) Pat Stewart (RML Associate Director, Office of Operations Management)

573592

APPROVED BY OMB: NO. 3150-0120 EXPIRES: 3/31/2012 (3-2009) NRC FORM 313 U.S. NUCLEAR REGULATORY COMMISSION

Estimated burden per response to comply with this mandatory collection request: 4.3 10 CFR 30. 32, 33, hours. Submittal of the application is necessary to determine that the applicant is 34, 35, 36. 39, and 40 qualified and that adequate procedures exist to protect the public health and safety.

Send comments regarding burden estimate to the Records and FOINPrivacy Services Branch (T-5 F53), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by internet e-mail to [email protected], and to the Desk Officer, Office of Information and RegUlatory Affairs, NEOB-10202, (3150-0120), Office of Management and Budget, Washington, DC 20503. If a means used to impose an information collection does not display a currently valid OMB control number, the NRC may not conduct or sponsor, and a person is not required to respond to, the information collection.

APPLICATION FOR MATERIALS LICENSE

INSTRUCTIONS: SEE THE APPROPRIATE LICENSE APPLICATION GUIDE FOR DETAILED INSTRlCTIONS FOR COMPLETING APPLICATION. SEND TWO COPIES OF THE ENTIRE COMPLETED APPLICATION TO THE NRC OFFICE SPECIFIEC BELOW.

APPLICATION FOR DISTRIBUTION OF EXEMPT PRODUCTS FILE APPLICATIONS WITH: IF YOU ARE LOCATED IN:

ILLINOIS, INDIANA, IOWA, MICHIGAN, MINNESOTA, MISSOURI, OHIO, OR WISCONSIN, SEf() OFFICE OF FEDERAL & STATE MATERIALS AND ENVIRONMENTAL MANAGEMENT PROGRAMS APPLICATIONS TO:

DIVISION OF MATERIALS SAFETY AND STATE AGREEMENTS U.S. NUCLEAR REGULATORY COMMISSION WASHINGTON, DC 20555-0001

MATERIALS LICENSING BRANCH U.S. NUCLEAR REGULATORY COMMISSION, REGION III

ALL OTHER PERSONS FILE APPLICATIONS AS FOLLOWS: 2443 WARRENVILLE ROAD, SUITE 210 LISLE, IL 60532-4352

IF YOU ARE LOCATED IN:

ALASKA, ARIZONA, ARKANSAS, CALIFORNIA, COLORADO, HAWAII, IDAHO, KANSAS,

KENTUCKY, MAINE, MARYLAND, MASSACHUSETTS, NEW HAMPSHIRE, NEW JERSEY, ALABAMA, CONNECTICUT, DELAWARE, DISTRICT OF COLUMBIA, FLORIDA, GEORGIA,

LOUISIANA, MISSISSIPPI, MONTANA, NEBRASKA, NEVADA, NEW MEXICO, NORTH

NEW YORK, NORTH CAROLINA, PENNSYLVANIA, PUERTO RICO, RHODE ISLAND, SOUTH DAKOTA, OKLAHOMA, OREGON, PACIFIC TRUST TERRITORIES, SOUTH DAKOTA, TEXAS, UTAH, WASHINGTON, OR WYOMING, SEND APPLICATIONS TO: CAROLINA, TENNESSEE, VERMONT, VIRGINIA, VIRGIN ISLANDS, OR WEST VIRGINIA,

SEND APPLICATIONS TO:

LICENSING ASSISTANCE TEAM NUCLEAR MATERIALS LICENSING BRANCH DIVISION OF NUCLEAR MATERIALS SAFETY U.S. NUCLEAR REGULATORY COMMISSION, REGION IV U.S. NUCLEAR REGULATORY COMMISSION, REGION I 612 E. LAMAR BOULEVARD, SUITE 400 475 ALLENDALE ROAD ARLINGTON, TX 76011-4125 KING OF PRUSSIA, PA 19406-1415

PERSONS LOCATED IN AGREEMENT STATES SEND APPLICATIONS TO THE U.S. NUCLEAR REGULATORY COMMISSION ONLY IF THEY WISH TO POSSESS AND USE LICENSED MATERIAL IN STATES SUBJECT TO U.S.NUCLEAR REGULATORY COMMISSION JURISDICTIONS.

1. THIS IS AN APPLICATION FOR (Check appropriate item) 2. NAME AND MAILING ADDRESS OF APPLICANT (Include ZIP code)

C A. NEW LICENSE Department of Health and Human Services National Institutes of Health, NIAID AMENDMENT TO LICENSE NUMBER [Z B. 25-01203-01 Rocky Mountain Laboratories

C RENEWAL OF LICENSE NUMBER C 903 South 4th Street D 4. NAME OF PERSON TO BE CONTACTED ABOUT THIS APPLICATION 3 ADDRESS WHERE LICENSED MATERIAL WILL BE USED OR POSSESSED

Rocky Mountain Laboratories Barri Twardoski, Radiation Safety Officer

903 South 4th Street TELEPHONE NUMBER

Hamilton, MT 59840

(406) 363-9216

SUBMIT ITEMS 5 THROUGH 11 ON 8-1/2 X 11" PAPER. THE TYPE AND SCOPE OF 'INFORMATION TO BE PROVIDED IS DESCRIBED IN THE LICENSE APPLICATION GUIDE . ..- ­5. RADIOACTIVE MATERIAL

a. Element and mass number: b. chemical and/or physical form; and c. maiximum amount 6. PURPOSE(S) FOR WHICH LICENSED MATERIAL WILL BE USED. which will be possessed at anyone lime.

t- ­7. INDIVIDUAL(S) RESPONSIBLE FOR RADIATION SAFETY PROGRAM AND THEIR

8 TRAINING FOR INDIVIDUALS WORKING IN OR FREQUENTING RESTRICTED AREAS. TRAINING EXPERIENCE.

-9. FACILITIES AND EQUIPMENT. 10. RADIATION SAFETY PROGRAM.

12. LICENSE FEES (See 10 CFR 170 and SectIon 170.31) 11 WASTE MANAGEMENT.

FEE CATEGORY 3E,3L IAMOUNT $ 0.00ENCLOSED

13. CERTIFICATION. (Must ba completed by applicant) THE APPLICANT UNDERSTANDS THAT ALL STATEMENTS AND REPRESENTATIONS MADE IN THIS APPLICATION ARE BINDING UPON THE APPLICANT.

THE APPLICANT AND ANY OFFICIAL EXECUTING THIS CERTIFICATION ON BEHALF OF THE APPLICANT, NAMED IN ITEM 2, CERTIFY THAT THIS APPLICATION IS PREPARED IN CONFORMITY WITH TITLE 10, CODE OF FEDERAL REGULATIONS, PARTS 30, 32, 33. 34, 35. 36, 39, AND 40, AND THAT ALL INFORMATION CONTANED HEREIN IS TRUE AND CORRECT TO THE BEST OF THEIR KNOWLEDGE AND BELIEF.

WARNING: 18 U.S.C. SECTION 1001 ACT OF JUNE 25,194862 STAT. 749 MAKES IT A C~~~~FENSE TO MAKE A WILLFULLY FALSE STATEMENT OR REPRESENTATION TO I- ANY DEPARTMENT OR AGENCY OF THE UNITED STATES AS TO ANY MATTER WITHIN I .S I CTION. ~ Yrc-CERTIFYING OFFICER -- TYPED/PRINTED NAME AND TITLE -r IGN TUI E ~L -, 1 IDB!

Pat Stewart, RML Associate Director I Ou IfV'! flJ.-- ~ 1C;i['/) ()

'-+- J.~ .5-\-p IAJf11 p"!1 TYPE OF FEE

FOR NRC liSE C \ILY COMMENTS = CHECK NUMBER IFEE LOG IFEE CATEGORY l:MOUNT RECEIVED

APPROVED BY 5 7 3 5 9 2DATE

NRC FORM 313 (3-2009) PRINTED ON RECYCLED PAPER

/tJ-o/- 20ft)

This is to acknowledge the receipt of your letter/application dated DATE

J ' Jt) -~ () 10, and to inform you that the initial processing, which includes an administrative review, has been performed.

There were no administrative omissions. Your application will be assigned to a technical reviewer. Please note that the technical review may identify other omissions or require additional information.

D Please provide to this office within 30 days of your receipt of this card:

The action you requested is normally processed within q0 days.

D A copy of your action has been forwarded to our License Fee & Accounts Receivable Branch, who will contact you separately if there is a fee issue involved.

Your action has been assiqned Mail Control Number 5'" 7 -3 ~9,( When calling to inquire about this action, please refer to this mail control number. You may call me at (817) 860-8103.

Sincerely,

NRC FORM 532 (RIV) Licensing Assistant (10-2010)

-----------------

BETWEEN:

Accounts Receivable/Payable and

Regional Licensing Branches

License Fee Worksheet - License Fee Transmittal

A. REGION

1. APPLICATION ATTACHED

ApplicanVLicensee: HEALTH & HUMAN SERVICES, DEPT. OF

Received Date: 09/07/2010 Docket Number: 3005167

Mail Control Number: 573592 License Number: 25-01203-01

Action Type: Amendment

2. FEE ATTACHED

Amount:

Check No.:

3. COMMENTS

Signed:

Date:

B. LICENSE FEE MANAGEMENT BRANCH (Check when milestone 03 is entered

1. Fee Category and Amount:

2. Correct Fee Paid. Application may be processed for:

Amendment:

Renewal:

License:

3. OTHER

[ FOR ARPB USE] INFORMATION FROM LTS

Program Code: 03610

Status Code: Pending Amendment Fee Category: 3E 3L 4A Exp. Date: Fee Comments: Decom Fin Assur Reqd: Y

Signed:

Date:

9/27/2010 R1201021