ML20236H922

Ack Receipt of NRC Form 483 Dtd 980622,as Condition of General License Under 10CFR31.11 Authorizing in-vitro Testing W/Byproduct Matl Under General License

ML20236H922
Person / Time
Issue date:	07/02/1998
From:	Kime T NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Bradford W AFFILIATION NOT ASSIGNED
References
SSD, NUDOCS 9807070417
Download: ML20236H922 (2)

Text

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July 2,1998

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University Medical Specialties ATTN: William P.' Bradford, Director.

9045 U.S. 31 Berrien Springs, MI 49103

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Dear Mr. Bradford:

This' letter verifies'the receipt of the completed NRC Form 483 dated June 22,1998. This form is a_ condition of the general license under 10 CFR 31.11 authorizing in-vitro testing 'with byproduct material under general license.

The form has been assigned registration number 9144.- When making changes to any of the information on the form, please reference the registration number and address the -

4 correspondence to Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555.

i If you have any questions or need further assistance, please contact me at (301) 415-8140.

i Sincerely. -

M

. Traci Kime, Acting Registration Specialist'-

Materials Safety Branch

. Division of Industrial and Medical Nuclear Safety..

Office of Nuclear Material Safety.

' and Safeguards I

DISTRIBUTION

. SBaggett '-

IMNS r/f-

'NEO3 d b E DOCUMENT NAME: a.\\bradford.483

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eP NRC FORM 483 U. S. NUCLEAR REGULATORY COMMISSION APPROVED B7 OMB: NO. 31504o38

. EXPIRES: 6-30-99 Ose).

Esemated burden per response = comply with thes mandatory informaten cohereon,equest 7 mmuass. The validened reentration eenes os endence

' REGISTRATION CERTIFICATE -In vitro TESTING

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~ WITH BYPRODUCT MATERIAL UNDER C ""e',n,"0"l* woe,;,e n! o""c"2EE "e'. M c

Oll Ten",l'0.ll.l"e".oc""Ea&. "f"et noi."oni",m'"e GENERAL LICENSE 1.

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..sepon o - or i, ehon onies. n sheploys e cur,enny vehd oms consol number.

Section 31.11 of 10 CFR 31 estabbehes a general license authorizing physicians, clinical laboratories, baarh, and veterinarians in the practme of volonnery medicme to poseees certain e:nell quantibes of byproduct rnatorial for b Wtro clinical or laboratory tests not invoMng the internal or external i

administrobon of the byproduct meterial or the rartionan therefrom to human beings or animais Possession of byproduct enatorial under 10 CFR 31.11 is not authortzed until the physician, clinical laboratory, hospital, or veterierten in the practice of volonnery medidne, has filad NRC Form 483 and received from the Comminoson a voidated copy of NRC Form 483 with a registrahon number

1. NAME AND ADDRESS OF APPUCANT (See ineinic00n 3.8. below)

2. APPUCATION (Check one txm only)

. M N / VER 5 i f[ //t 0 f.c 4 L f[stiga>Lg i hweby apply fw a registradon nurnber pursuant to 10 CFR 31, Section 31.11, for use of tn. product metenets for#

3f A. Myself, e duly licensed physician authortred to disperse drugs in

,SCAfdE At S() A 145, /H [ 9 9to 2

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X B. The above-named clinicallaboratory TELEPMoNE NUMeER (hedum Area Cam)

C. The above named hospital.

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o. vs in,,,n in ine,,c.co o, vowinen, med, cine 3.

BtSTRUCTIONS:

4. REGISTRATION REGISTRATION NUMBER:

Medical, Academic and Commercial Use i

Division of industrial and Medical Nucieer Seisty

1. ge 880ug 9144 n

Seist Branch (T-8 FS)

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Office of Nucieer Material Safety and Safeguards y

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' U.S. Nuclear Regulatory Commiselon g

j U.S. 1:uclear ReguAatory 1

WeeNngton, DC 2056EM)001 Comiisnion (At NRC, a regletrolion number wil be seeigned and a vahdeted copy

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of NRC Form 483 wil be retumed.)

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B. In the bou above, print or type the name, address (including ZIP Code), and telephone ruimber of the registrant phyacien, cunical Of this Whthf Ms.,M, thisspaceblendfMJmberlobe

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laboratory, hospital, or veterinerten in the pnotice of veternary seeigned by NRC. Jf this is a change of hibrmeelon hem a preWously medmine for whom W for wNch ins registrodon form is Ned.

sognefwod gwwref #conse, hciude yourregloire6on number)

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s. If piece of use is dNforent from address hated above, gh complete address

s. CERTIFICATION i herebycertify that l

Af AR informehon in ins repletrobon cutmcote is true and complete.

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B. The regletrant has appropriate redlebon meneurine instruments to cany out the tests for which byproduct metwiel wW be used under the genwel Hoenee of 10 CFR 31.11;- The toets wHI be performed only by personnel competent in the use of the instruments and in the handling of the

'a byproduct meterials l

C.

I understand that Commisalon regulations require that any change in the information fumiehed by a repstrant on this registration cwtifmete be reported to the Olrector of Nuclear Meterial Safety and Sefeguards within 30 days from the effective date of such change

-D 1 have read and understand the provisions of Sechon 31.11 of NRC regulebons 10 CFR 31 (reprinted on the reverse side of this form); and I understand that the registrant is required to comply with those prov;sions as to su byproduct material which he receives, acquires, possesses, uses, or transfers under the general license for which this Registrohon Certificate is filed with the U.S. Nuclear Reguistory Commission PRINTED OR TYPED NAME AND TITLE OF APPLICANT SIGN URE OF APPLICANT DATE LANt VE A 51

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Un a cca n D,su esog WARNING: - FALSE STATEMENTS IN THIS CERTIFICATE MAY BE SUBJECT TO CML AND/OR CRIMINAL PENALTIES. NRC REGULATIONS REQUIRE THAT SUBMISSIONS TO THE NRC BE COMPLETE AND ACCURATE IN ALL MATERIAL RESPECTS.16 U.S.C. SECTION 1001 MAKES IT A CRIMINAL OFFENSE TO MAKE A WILLFULLY FALSE STATEMENT OR REPRESENTATION TO ANY DEPARTMENT OR AGENCY OF THE UNITED STATES AS TO ANY MATTER WITHIN ITS JLIRISDICTION.

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'uncronM e teasi b.

REGISTRANT'S COPY p

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i CONDITIONS AND LIMITATIONS OF GENERAL LICENSE 10 CFR 31.11 I

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{ '31.11 General ficense for'use of ' byproduct mateda's for cetain in selenium 75, and/or iron 59 in excen of 200 microcurie

. vitto clinical or laborausry tetting.

(2) The epneral Ucensatt shah store the byproduct materief, until

, uwd, in the erigin6> shWping container of in a cor.rainer providing (a) A gene <el liter se is hereby issued to any physicia% veterinar)an equiwlent radiation protection.

kn the pract. ice of vetHinary rnardicine, clinical labora:ory or hospital to (3) The gmarel UcenWe shsh use the byproduct nuterlot only ior t' e uses autnorized by paragraph tu) of his sectien.

receive, acquire, possess, transfer, or use, for any of the foHovvirig stated r

t tests, in accordan,ce with the provisions of pangraphs (b), (c), (di, le),

(4) The genera! Ilcer,see shal not transfer the byproduct material and (f) of this section, the following byproduct matPri6ls in prepDCk-except hy transfer to a person authnr!1ed to receive it by 8 license pursuant to this chapter rer from an Agreerpent State,3 nor t ransfer the aged unitti byproduct materia! in any manner other than in the unopened, labeled (1) Jodinr:425, in units not exceedmg 10 microcuries each,for use in m vitro clinical or laboratory tes!s not involving internal or external '

shipping container as received from the suppiler, administratbn of byproduct material, or the fadiation therefrom, to (5) The general licensee shau dispose of the Mocit lodina 125 refe,ence or re:lbratlon sources described in paragraph (a)(7) of this buman beings or animals.

section as required by @ 20.301 of this chapter.

(2) 'jodine-131,-in units not exceeding 10 rpicrocuries each for use In in vitro clir:ical or laboratory tests not invoivhg letemal w external id) The generat licensee shall not receive, acquire, possen, or use administration of byproduct material or the. radiation therefrorn, byproduct material pursuant to paragraph (a) of this section; e

. to hurnen beings or animals.

(1) Except as prepackaged units which are laoeled iri accordance (3) Carbott 14, in units not exceeding 10 microcteries each for use with the provisions of a spec,fic licanse issued under the provisions of in in vitro ciiracal or laboratory tests not involving Internal or enternal 32 71 of this cf ap*er er m accorda ce with the provisions of a n

, surninistration of byproduct materiaf, of the radiation therefrom, specific license hsued by'an Agreement State that authorizes manufac.

s ture and distribution of lodineM75, iodine,131, carbon 14, hydrogen 3 to human beings or animals.

(4) Hydrogen 3 (tritium); in units not exceeding 60 microcuries (tritium), se:emum 75, iron 59 or Mock ladine-125 foi retribution to.

tech for uve in in vitro chnical er laboratory tests not involving internal persons genera 4y Hcensed by the Agreement State.

or external adrninistration of byproduct material, or the radiation (2) Unless the following statement, or a substantially similaf theref rom, to human besngs or animais ttatement which contains the information called for in the following

'(5) iron 69,in units not eacced,ng 20 microcuries each for use in in statement, appears on a tabel afhmed to each prepackaged unit or vitro 1ctinicst or laboratory tests not involving internal or external appears in a leahet or Srochure which accorapanies the package $

administration of byproduct rnateriet, or the radiation therefrom, to This radioactive materia! may t.e received, acquired, posessed, and human beirsgs or animals.

used cnly by physicians, vetennarians in the practice of vetednary (6) Selenium-76, in units not exceeding 10 microcuries each for use medicine, cuncal taboretories or hosoitals and only for in vitro clinical H in vitro clinical or laboratory tests not invofving internal or external or labora:ory tests not bvolwng internal or external administration of administration of byproduct material, or the rediation therefrom.

the matedal or the radiation therefrom, to human beings or animals, to human beings or animats its receipt, acymsition, ponession, use, and transfer are subject to the (7) Mock. lodine 725 reference or cabbration sources, in units not regulations and a general Heense of t e U.SJ Nuclear Reguhrtory Com-h exceeding 0.05 microcurie 'of iodine-129 and 0.005 microcurie of mission or of a State with which the Commission has entered into an americium-24) each tor use in in vitro clinical or labor.,cory tests not agreement for the eserche uf regulatory authority.

' invoMng internal or extemal administration of byproduct material, or the radiation there+ rom, to human beings or animals.*

4 (b) ' A ' person shall not receive, acquire; possess, use of' transfer byproduct materlat under'the general license established by paragraph

- Name of manuf acturer (a) of this 'section unless that person:

- (1) Has filed 'NRC Form 483, "Retstration Certif Kate-In Vitro -

(e) The registrant possessing or using byproduct materials under the Testing with Byproduct Material Under General License," with the general license cf paragraph (u).of this section shah report in writing to Director of Nuclear Materlat Safety and Safeguards, U.S. Nuctor the Director of Nuclear Material Safety anct Safeguards tny changes Regulatory Commission, Washington, D.C. 20555, and received from in the M+ormation turnnhed by him in the " Registration Certibcate--tr the Commission a vahdated copy of NRC Form 483 with registration Vitro Testing with Byproduct Mater at Under General License," NRC number assigned; or Form 483 The report shall be furnished within 30 days atter the

'(2) Has a incense that author!zes the medical use of byproduct effective date of sLch change 3 materialthat was issued under Part 35 of th!s chapter.

D) Any person using byproduct meterial pursuant to the general (c) A persch v.ho' receives, acquires, ' possesses or uses byproduct hcense of paragraph (a) of this svtlon is exempt from the regylrements

, ' material purs$ent to the generat license estabi:shed by paragraph (a) of of Parts 19, 20 and 21 of this chapter with respect to byproduct this section shall comply with the following:

materials covered by that generaf HCense, except that such persons fil.The generat licensee shaf t not possess et any one time, pursuant using the Mock todine-125 described in paragraph (a)(7) of this section to'the gene'rai license in paragraph (a) of th!s section, at any one loca-

^ shMI comply with' the provisions of $ 20.301,20.402 end 20.433 o+

tion of storage or use, a total amount of lodine 125, iodine 131 this chapter; NOTES

, - 1 A State to wh,1ch certain regulatory authority over radioactive material has been transferred by formal agreement, pursuant to section 274 of the

. Atomic Energy Act of 1954, as amended.

' ? Materia! generally licensed under this section prior to January 19,1975 may bear labels authorized by the regulations in effect on January 1,

.1975.

3 A new tripticate set of this Flegistration Ce tificate, NRC Form 433, may be usad to report any change of information furnished by a registrant

' es required by j 3131(e).

M 1arger quahtities or other f >rms of byproduct material than those speelfled in the general Ucense of 10 CF R 31.11 a n required, an "AppHea-tion for Byproduct Mateda! Ucense," NRC Form 313 should be fi:ed to obtain a specific byproduct material licensa. Copies of apphcation and registration forms may be obtained from the Medicaf, Academic and Commercial Use Safety Branch (GH3), Division of Industrial and Medical Nuclear Safety, United States Nuclear Regulatory Commission, Washington, DC 20555.

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