ML20138F437

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Matls Licensing Package for Amend 3 to License SNM-1996 for Medical College of Pennsylvania.Control:121953
ML20138F437
Person / Time
Site: 07003077
Issue date: 07/12/1995
From: Thompson T
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
To:
References
121953, NUDOCS 9610160224
Download: ML20138F437 (14)
v • d • e


Text

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just w RwletwjaLwAw_wastwAwjstw w w )stw.w w war w w w w w w w w w w w w w w w w w w w w g $R FORM 374 U.S. NUCLEAR REGULATORY COMMISSION PAGE OF PAGES g

MATERIALS LICENSE Amendment No. 03 l

.h g Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93 438), and Tit g

Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,36,39,40, and 70, and in reliance on statements and representations g

g by the licensee, a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byprodu g

f persons authorized to receive it in accordance with the regulations of the appli N

f specified in section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all applicable rule f

N Nuclear Regulatory Commission now or hereafter in effect and to any conditions specified below.

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I N

N E

E N

Licensee N

In accordance with the letter dated E

January 5, 1995, E

N 1 Medical College of Pennsylvania

3. License Number SNM-1996 is amended in E

N and Hahnemann University its entirety to read as follows:

E N

R N 2.3300 Henry Avenue H

N Philadelphia, Pennsylvania 19129

# 4. Expiration Date September 30, 1997 E

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N i),$c$ no, 070-03077/SNM-1656 W

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6. Byproduct, Source, and/or
7. Chemical and/or Physical
8. Maximum Amount that Licensee g

g Special Nuclear Material Form May Possess at Any One ' lime i

g Under This License g

N E

R A. Plutonium (principal A. Sealed source A. 259 milligrams W

W radionuclide Pu-238)

(individual source not to N N

N exceed 250 milligrams) 5 9.

Authorized use X

4 N

N A.

As a component of Corat6mic Model C-101; nuc1' ear-powered cardiac pacemakers for q

N clinical evaluation in accordance with manufacturer's protocol dated November 1, W

N 1975, this authorization includes: follow-up,-explantation,-recovery disposal, but N

not implantation. '

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N g

W g

CONDITIONS N

g Licensed material may be 'used only at the licensee's facilities at 3300 Henry Avenue, W g

10.

g Philadelphia, Pennsylvania, g

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y 11.

A.

The physician responsible for follow-up, explantation, and return to the E

g manufacturer for proper disposal is John Fontaine, M.D.

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B.

The Radiation Safety Officer for this license is Theodore Villafana, Ph.D.

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12. The specified possession limit includes all licensed material possessed by the W

y licensee under this license whether in storage, implanted in patients, or otherwise y

y in use.

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l 13.

The licensee shall report to the U.S. Nuclear Regulatory Commission, Region I, ATTN: Chief, Nuclear Materials Safety Branch, 475 Allendale Road, King of Prussia, y

g Pennsylvania 19406, ATTN: Chief, Nuclear Materials Safety Branch, within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> g

of occurrence, the death of any nuc1sar pacemaker patient, and any adverse reaction g

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and/or malfunction involving a pacemaker system, including the leads.

A written g

report giving details of the adverse reaction and/or malfunction shall be submitted g

g within 30 days.

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FACE 7

OF 2

PAGES Lic;nse numgrr I

I MATERIALS LICENSE SNM-1996 l

l SUPPLEMENTARY SHEET l

l 070-03077/SNM-1656 l

l Amendment No. 03 I

! (Continued)

CONDITIONS I

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14. The licensee shall report to the U.S. Nuclear Regulatory Commission, Region I, ATTN:

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Chief, Nuclear Materials Safety Branch, 475 Allendale Road, King of Prussia, l

Pennsylvania 19406, within 10 days of loss of contact with a nuclear pacemaker I

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patient.

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15. The licensee shall continue patient follow-up and replacement procedures for the l

I nuclear pacemaker during the life of the patient.

Procedures for recovery and i

I authorized disposal of the nuclear pacemaker by return to the manufacturer shall be 1

I followed upon the death of the patien't'. HbG/

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16. Sealed sources or detector iiell's containing licensed maferial shall not be opened or l

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sources removed from source holders or detector cells by,the licensee.

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17. The licensee may transport licensed material in accordance)with the provisions o l

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I 10 CFR 71, " Packaging <and Transportation of Radioactive MaterTal."

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18. The licensee shall not receive'or transfer in any s1.ngle transaction one (1) gram or l

l more of plutonium 238 contained in nuclear-powered pacemakers without notifying the I

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Division of Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C.

20555, i

I and, in addition,'co'mpleting and1 distributing OForm NRC-741 as required by i

I Section 70.54 of 10 CFR 70... Wl*

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19. Except as specifically prodthd otherwise int'jtt:lj+hislicense J

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, the' licensee shall conduct l

1 its program in accordance with the statements, representations, and procedures g

I contained in the documents, including any enclosures,' listed.below.

The Nuclear p

l Regulatory Commission's regulations shall govern.unless the; statements, t

i representations, and procedures in the licensee's application and correspondence are I

i morerestrictivethanthefregulations.

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I A.

Letter dated March 31, 1976 y

I B.

Application dated April 10, 1992 I

C.

Two letters dated April 16, 1992 i

D.

Letter dated July 10, 1992 I

i E.

Application dated February 5, 1993 l

l F.

Letter dated January 5, 1995 i

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For the U.S. Nuclear Regulatory Commission I

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Orisinal signed 4:

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Date JUL i 21995 By

'Ibomas K. 'lkmpeen l

1 Nuclear Materials Safety Branch p

I Region I A

%l King of Prussia, Pennsylvania 19406 F

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JUL I 21995 Vincent J. Cristofalo, Ph.D.

Vice Provost for Research 3

Medical College of Pennsylvania and Hahnemann University 2900 Queen Lane Philadelphia, PA 19129 i

Dear Dr. Cristofalo:

This refers to your license amendment request.

Enclosed with this letter is the amended license.

Please review the enclosed document carefully and be sure that you und rstand and fully implement all the conditions incorporated into the amended

, cense.

If there are any errors or questions, please notify the U.S. Nuclear Regulatory Commission, Region I office, the Licensing Assistance Section, (610) 337-5093 or 5239, so that we can provide appropriate corrections and answers.

d Thank you for your cooperation.

Sincerely, Original Signed By:

Francis M. Costello Thomas K. Thompson, Sr. Health Physicist

/

Nuclear Materials Safety Branch Division of Radiation Safety and Safeguards License Nos. 37-07438-15 SNM-1996 Docket Nos.

030-12998 070-03077 Control Nos. 121951 121953

Enclosures:

1. Amendment No. 15 \\37-07438-15
2. Amendment No. 03 \\SNM-1996
4. 10 CFR Parts 2, 19, 20, 30, 35 and 170 0FFICIAL RECORD COPY ML U b

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V. Cristofalo, Ph.D. Medical College of Pennsylvania and Hahnemann University l

DOCUMENT NAME:

R:\\WPS\\MLTR\\3707438.15 To receive e copy of tMe document,indeste in the box: *C* = Copy w/o attach /end

  • E' = Copy w/ attach /end
  • N* = No copy 0FFICE /DRSS/R P M ' lN

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/ TThompson:cmm DATE V 07/11/95 07/

/95 07/

/95 07/

/95 0FFICIAL RECORD COPY 1

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Mf EDICAL

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COLLEGE OF PENNSYLVANIA AND

""*' #' ** M Vice Provost for Research II A'INEMANN UNIVERSITY D10- D307'1 Broad & Vine Phdadelphia PA 19102-1192 2900 Queen lane Philadelphia, PA 19129 Telephone (215) 9914460 January 5, 1995 FAX (215) S431192 Frank Costello Chief, Medical Licensing U.S. Nuclear Regulatory Commission, Region 1 475 Allendale Road King of Prussia, PA 19406-1415 Re NRC License #37-00467-34 (Hahnemann)

NRC License #37-07438-15 (MCP)

Dear Sir / Madam This is a follow up of a previously submitted communication (copy enclosed as addendum A) notifying the NRC of the merger of the Medical College of Pennsylvania (MCP) and Hahnemann University (HU).

In general, the merger will be such that all current licenses will be maintained as is with exception to the named RSO and the institution name.

In accordance with IN89-5, Rev 1 the following information is supplied:

1.

The new name of the licensed organization is the " Medical College of Pennsylvania and Hahnemann University" (MCPHU).

It is composed of the following campuses:

Center City Campus (formerly known as Hahnemann University)

East Falls Campus (formerly known as Medical College of PA)

Campus organization chart is shown as Addendum B.

MCPHU is part of the Allegheny Health, Education and Research Foundation (AHERF) centered in Pittsburgh, Pennsylvania.

AHERF is a non-profit organization.

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.4 mernber of.\\llegherts Health.

EJunation and Resears h ImsnJarion tilcshem tv nct.si H areal

\\ledaal t ol!c;c of nnnahama and Hahnemann l nh erut, l Q l Y

\\fc.h.al(.li,,e of n nnuh am.s at:J Hahnemann I.'nh cruts H.nputal mt m OFFICIAL RECORD COW ML 10

"'""'"#' ""''"' M' I REC'D IN LAS MI9

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l 2.

New Licensee Contacts 1

Radiation Safety Officer:

Theodore Villafana, Ph.D.

Radiation Safety Of fice Medical College of PA and Hahnemann 1

University 3300 Henry Avenue 4'

Philadelphia, PA 19129

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(215) 842-6066 Administrative Officer:

Vincent J. Cristofalo, Ph.D.

Vice Provost for Research Medical College of PA and Hahnemann

)

University 2900 Queen Lane l

Philadelphia, PA 19129

)

l (215) 991-8460 i

Chairman, Radiation j

Safety Committee:

William vanDecker, M.D.

Nuclear Cardiology Division Medical College of PA and Hahnemann University l

3300 Henry Avenue Philadelphia, PA 19129 (215) 842-6990 l

3.

Authorized users will remain as before. Responsibility for all licensed activities will now be under the Office of the Provost of the University. An institutional Radiation Safety Officer is named

]

and will be Theodore Villafana, Ph.D.

Dr. Villafana is currently the RSO for the following NRC Licenses at MCP

]

  1. 37-07438-15 (Broad License)
  1. 37-02562-01 (Medical License)
  1. SNM1996 (Special Nuclear Materials License)

Dr. Villafana will become (pending NRC approval) the institutional

)

RSO covering all licenses of the merged institution.

Mr. Kent Lambert presently the RSO for thw Hahnemann University broad license will become the Center City Campus RSO, reporting to the institutional RSO.

Qualifications and credentials of Dr. Villafana are currently on file under the current MCP licenses. The overall breakdown of administrative authority is submitted.as Addendum C.

4.

Both campus entities in merged organization will continue license activities as previously authorized under current NRC licenses.

5.

Merger between MCP and HU is a totally integrated one with the intent of making it one integral university. Both entities were non-profit organizations as will be the merged entity.

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6.

Planned changes in organization are outlined in item 3 above and in Addendum B.

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There will be one Institutional Radiation Safety Committee with i

representation from both campuses including administrative, nursing and radiation safety personnel as well as representatives of major users.

The new Institutional Radiation Safety Committee will be composed 4

of the following membership as appointed by the Provost of MCPHU William A. VanDocker, M.D., Chair EF Radiologic Sciences Itzhak Fischer, Ph.D.

EF Anatomy ar.d Neurobiology Angelo J. Pinto, Ph.D.

EF Microbiology and Immunology John J. LiPuma, M.D.

EF Pediatrics Bruce Ruggieri, Ph.D.

EF Pathology & Laboratory Med j

Joan M. Mack, M.D.

EF Radiologic Sciences l

Arnold Friedman, M.D.

EF Radiologic Sciences Simindokht Dadparvar, M.D.

CC Radiologic Sciences Seth N. Glick, M.D.

CC Radiologic Sciences Curtis T. Miyamoto, M.D.

CC Radiologic Sciences James F. Conroy, D.O.

CC Medicine Theodore Villafana, Ph.D.

EF Radiation Safety Officer Kent Lambert, M.S.

CC Center City Campus RSO Allan Chackman EF Rep, Human Resources Susan croushore EF Rep, Hospital Administration Alan Lieber CC Rep, Hospital Administration Vincent J. Cristofalo, Ph.D.

U Vice Provost, Research Pamela S. Callahan U

Assistant Provost, Research Patricia Mee, R.N.

EF Rep, Nursing office To Be Named CC Rep, Nursing Office Monica Dent EF Rep, Surgery Notes EF = East Falls Campus CC = center City Campus U = Medical College of PA and Hahnemann University Administration A subcommittee will be designated at each campus to make recommendations to the institutional committow where all final decisions will reside.

Radiation Safety Committee organization shown in Addendum D.

The Institutional Radiation Safety Committee will report both to the University as well as the medical executive boards of the respective hospitals.

Locations of use will be as specified previously at each campus.

There will be no changes in equipment or operating or emergency procedures.

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7.

There will be no changes in use, possession, location, or storage l

of licensed materials as'specified in current NRC licenses at either campus.

8.

The following NRC license amendments will be required A.

Change Radiation Safety Officer to Theodore V111afana, Ph.D. on the following licenses:

i License #37-00467-34 j

License #SNM1369 i

B.

Change name to Medical College of Pennsylvania and Hahnemann

(.

University / Center City Campus on NRC License #37-00467-34 Change name to Medical College of Pennsylvania and Hahnemann

]

University / East Falls Campus on NRC License #37-07438-15 i

l C.

Change name of Chairman, Radiation Safety Committee, to Dr.

I William A. VanDocker on NRC License #37-00467-34.

Dr.

l VanDecker's credentials are listed under current NRC License

  1. 37-07438-15.

6 9.

The status of all surveillance items and records (e.g.

calibrations, leak tests, surveys,. inventories, and accountability i

requirements) are current and will remain so.

1 l

10.

There will be no decommissioning of any of the current facilities j

or licensed activities. All responsibilities concerning public dose, waste disposal, radioactive spills and license amendments j

have been taken over by the merged MCPHU entity.

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11.

No decommissioning will occur and there is no need for decontamination action at this time.

12.

Refer to item #11.

13..

MCPHU agrees to abide by all commitments and representations previously made to the NRC as indicated on current NRC licenses.

Thcse commitments include full responsibility for all open inspection items and enforcement actions. All liability for either campus will be assumed by the merged MCPHU.

There are no contamination problems at either the Center City or the East Falls Campus sites.

14.

The merged MCPHU is aware of all NRC open items and enforcement actions and assumes all responsibility thereof.

15.

MCPHU agrees to abide by all constraints, conditions, requirements, representations and commitments identified in all existing NRC licenses on all campuses.

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5h At present we intend to continue with the existing multiple NRC licenses.

Our intent, however, is to combine these licenses at a later date after study by our Radiation Safety Office concerning making all procedures uniform between campuses and producing a uniform Radiation Safety Manual.

When ready, authorization for this will be filed with the NRC.

Yours truly, i

/

/

Vincent

. Cristo alo, Ph.D.

Vice P ost for Research cca Donald Kaye, M.D.

President and CEO - Medical College of Pennsylvania and Hahnemann University Hospital Systems Susan croushore Vice President, Operations - Medical College of Pennsylvania Hospital i

Shelley Gebar Executive Director and CEO - Hahnemann University Hospital

^

Al.LEGHENY

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Nancy A. Wynstra HEA1.TH, Dmntve Vict tvecent EDUCATION AND and Generit Counsel t w iiu,trnoni s

RESEARCH FOUNDATION Add Q.% R J

11fth Avenue Place,suito 29n0 i

120 Mfth Avenue PitLsburgh, PA 1 A222 3009 j

Telephone (412) 3594644 100 Wat laurel Avi:nJc October 7,1994 cheltenham,i>A 19oiz.zon i

2 Tetephont (215) 66bl412 I

j j

Ronald Mellamy j

Chief of Nuclear Materials I

j Safety Branch Nuclear Regulatory Commission 475 Allendale Road i

King of Prussia, PA 19406-1415 i

RE:

Consolidation of Hahnemann University and Allegheny Health, Education and Research Foundation I

Please accept this letter as notice that effective July 1,1994, Allegheny Health. Education and Research Foundation became the sole corporate member of Hahnemann University, and the name of Hahnemann University has been changed to The Medical College of Pennsylvania A Hahnemann Univershy.

l The Medical College of Pennsylvania and Hahnemann University is a Pennsylvania nonprofit corporation.

Committees for oversight of nuclear saf'ety will continue within The Medical College of Pennsylvania & Hahnemann University and any changes in membership of committees will be forwarded to the appropriate federal and state offices. In the meantime, if you have any questions, or if specific additional documentation or information is required, please feel free to contact Patricia Koehler, Associate l

General Counsel, at (412) 3594111.

Si,ncerely,

4. w

/.

Nancy A.

ynstra Executive Vice President and s

General Counsel NAW:aaa 1

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Msdical Cell ga Of Psnnsylvania/

Hahnemann University Campus Organization Medical College Of Pennsylvania /

Hahneman University i

Center City Campus East Falls Campus O!

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MCPHU/CC Hahnemann MCPHU/EF EPPI MCP University Hospital Hospital Notes: 1. MCPHU/CC = Medical College of Pennsylvania and Hahnemann University, Center City Campus

2. MCPHU/EF = Medical College of Pennsylvania and Hahnemann University, East Falls Campus

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3. EPPI = Eastem Pennsylvania Psychiatric Institute.

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4. MCP = Medical College of Pennsylvania
5. Distance between Buildings on East Falls Campus is about 3 city blocks

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6. Distance between campuses is about 7 miles. They are connected by

-l limited access highways. Health Physicist to be stationed at each campus "j

M2 dical Collsg3 Of Pannoylvania/

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Hahnemann University Radiation Safety Office Organization Vice Provost Vincent Cristofalo PhD l

L institutional Radiation Safety Officer ej l

Theodore Villafana PhD f

i Center City Campus East Falls Campus

.l Kent Lambert MS, Clinical & Resarch Campuses Campus RSO Theodore Villafana PhD, RSO l

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Rad Safety Rad Safety Rad Safety Administrative Health Health Rad Safety f{!

Tech 1 Tech 2 Tech 3 Coordinator Physicist Physicist Tech 1.0 fte 1.0 fte 1.0 fte 1.0 fte 1.0 fte 0.4 fte 1.0 fte Ol; Note: In addition to the above personnel there is an additional part time radiation safety technician available.(approximately 0.30 FTE) t

M dical Collega Of Pennsylvania /

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Hahnemann University Radiation Safety Committee Organization i

Radiation Safety Committee Chairman William VanDecker MD r-i O'

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Institutional RSO 5

Theodore Villafana PhD 8

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Center City Campus East Falls Campus Sub-Committee Sub-Committee k

Note: The radiation Safety Committee is a university appointed committee,

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responsible administratively to the provost of the university.

it is charged with the responsibility of overseeing all uses of radioactive materials as well as all uses of electronically produced x-rays.

E The sub-committees serve in an advisory capacity only, all final decisions C7 h

will be made by the parent committee.

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INFORMATION FROM LTS BETWEEN:

O LICENSE FEE M AN AGEMENT BRANCH, ARM PROGRAM CODE: 22160 AND-STATUS CODE: 0 I

O REGIONAL LIC ENSING SECTIONS FEE CATEGORY:.EX 7C EXP. DATE: 19970930 FEE COMMENTS: PACEMAKER /37-07433-i O.

DECOM FIN ASSUR RE00: h

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LICENSE see TRANSMITTAt 4.

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AP P LI C AT ION ATT ACHED A P PLIC A N T/ LICh NS EE:

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receive 0 oAre:

950629 00CKET NO:

7003077 CONTROL No.:

121953 O

LICENSE NO.:

SNM-1996 ACTION TYPE:

AMENDMENT O

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CHECK NO.:

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3. COMMENTS h W t%tasi,12.L96L
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LICENS E eEE M ANAGEMENT BRANCH (CHECK VtEN MIL E S 0.

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FEE C ATEGORT AND AMOUNT:

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CORRECT FEE PAID.

APPLIC ATION M AY BE PROCESSED FOR:

AMENDMENT.

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