ML20154J739
| ML20154J739 | |
| Person / Time | |
|---|---|
| Issue date: | 10/13/1998 |
| From: | Kime T NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Schwartz F AFFILIATION NOT ASSIGNED |
| References | |
| SSD, NUDOCS 9810150323 | |
| Download: ML20154J739 (3) | |
Text
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October 13,1998 Endocrine Diagnostics, Inc.
ATTN: Dr. Frank L. Schwartz
- 5 Rosemar Circle P.O. Box 4310 Parkersburg,WV 26104
Dear Dr. Schwartz:
This letter verifies the receipt of the completed NRC Form 483 dated September 24,1998. This form is a condition of the generallicense under 10 CFR 31.11 authorizing in-vitro testing with byproduct material under general license.
The form has been assigned registration number 7394. When making changes to any of the information on the form, please reference the registration number and address the correspondence to Director, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear j
Regulatory Commission, Washington, DC 20555.
if you have any questions or need further assistance, please contact me at (301) 415-8140.
Sincerely, Traci Kime, Secretary Materials Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety
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and Safeguards I
DISTRIBUTION:
SBaggett IMNS r/f NEO3 DOCUMENT NAME: a:\\ schwartz.483 l
Te receive e copy of this document, indicate in the bos: "C" = Copy without attachment / enclosure "E' = Cooy with attachment / enclosure "N* = No copy OFFICE MSB l
NAME TKime DATE 10/13/98 l
OFFICIAL RECORD COPY i
9810150323 981013 PDR RC SSD PDR 150018
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-, - - - - _ - - _. ~ _ _. - - -
WRC Form 483 U.S. NUCLE AR R EQ ULATORY COMC]lSSION Acp cved bv ~
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U REGISTR ATION CERTIFICATE-IN VITRO TESTING 3
10 CF R L
WITH BYPRODUCT MATERIAL UNDER GENERAL LICENSE Section 31.11 of 10 CFR 31 establishes a general license authoriiin physicianx cimi:al laboratories, hospitals, and veterinarians in the practice of seterinary medicine to possess certain smalquantities of byproduct material for in Wtro clinical or laboratory tests not involving the internal or external administration of tbc byproduct material or the radiation therefrom to -
)
human beings or animals. Possession of byproduct material udr 10 CFR 31.11 is not authorized until the physician, clinical
. laboratory, hospital, or veterinarian in the practice of veto, nary medicine, has filed NRC Form 483 and received from the Commission a validated copy of NRC Form 483 with registration number.
G 4
Endocrine Diagnostics, Inc.
- 5 Rosemar Circle P.O. Box 4310
- 3. I hereby apply for a registration number pursuant to Parkersburg, W 26104 031.11,10 CRF 31 for use of byproduct materials for (please check one block only)
C a.
Myself, a duly licensed physician authorized to dis-i pense drugs in the practice of medicine.
C b.
The above-narned clinicallaboratory.
O c.
The above-named hospital.
C d.
Veterinarian in the practice of veterinary medicine.
- 4. To be completed by the Nuclear Regulatory Commission.
INSTRUCTIONS
, l. Submit this form in triplicate to:
FORTHE.U.S.NUCLhk"klYiORY 7394 dS gu ds 1$*rs:$a!*e iaIicc$ng$*r$n'"h COMMISSION
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U.S. Nuclear Regulatory Commission 4
Washington, D.C. 20555 g"
o E
- 2. Please print or type the name and address f'
(including rip code) of the registrant physician, o,
o 6
4s.
chnical laboratory, hospital, or seterinarian in the b
practice of veterinary medicine for whom or for St0Veft L. Baggett,***,
10// 3 /98 which this registration form is filed. Position the fif this ss an mitial registration, leave this space blaink - number to be first letter of the address below the left dot and do a signed by NRC. If this is a change ofinformation from a previously not extend the address beyond the right dot. (At registeredgenerallicense, includeyour registration number.)
NRC, a registration number witt be assigned and a validated copy of NRC Form 483 will be returned.)
- 5. If place of useis different from address in Item I, picase give complete address:
- 6. Certification:
I hereby certify that:
a.
Allinformation in this registration certificate is true and coraplete.
i.
b.
The registrant has appropriate radiation measuring instruments to carry out the tests for which byproduct material will be used under the generallicense of 10 CR F 31.11. The tests will be performed only by personnel competent in the use of the instruments and in the handling of f
the byproduct materials.
c.
I understand that Commission regulations require that any change in the information furnished by a registrant on this registration certificate be reported to the Director of Nuclear Material Safety and Safeguards within 30 days from the effective date of such change.
f
- d. ' I have read and understand the provisions of Section 31.11 of NRC regulations 10 CFR 31 (reprinted on the reverse side of this form); and I l.
understand that the registrant is required to comply with those provisions as to all byproduct material which he receives, acquires, possesses, uses, or transfers under the general license for which this Registration Certificate is filed with the Nuclear Regulatory Commission.
l l
l~
Date 9/24/98 sy
/
Frank L. Schwartz, M.D.
Director Printed name and title or position of person filing form r
WARNING-18 U.S.C., Section 1001: Act of June 25,1948; 62 Stat. 749; makes it a criminal offense to make a willfully false statement or l
. representation to any department or agency of the United States as to any matter within its jurisdiction.
cfy CONDITIONS AND LIMITATIONS OF GENER AL UCENSE 10 CFR 31.11 131,11 General beense for use of byproduct materiais license established by paragraph (a) of this section (d) The generalIkensee shall not receive, acquire, until he has filed NRC Form 483, Registration Cer.
possess, or use byproduct material pursuant to for certain in vitro clinical or laboratory tesung.
oficate-in Vitro Testing with Byproduct Material paragraph (as of this section:
(a) A generallicense is hereby issued to any physi-Under General License," with the Director of Nuclear (1) Except as prepackaged units which are labeled j
cian, vetennarian in the practice of veterinary Material Safety and Safeguards, U.S-Nuclear in accordance with the provisions of a specific license medicine, clinical laboratory or hospital to receive.
Regulatory Commission Washington, D.C. 20555, issued under the provtsions of $32.71 of this chapter acquire, possess, transfer, or use, for any of the and received from the Commission a validated copy or in accordance with the provisions of a specific i
following stated tests, in accordance with the provi-of NRC Form 4:3 with reststration number assigned license issued by an Agreement State that authorizes I
sions of paragraphs (b) (c), (d), (e), and tf) of this or until he has been authorized pursuant to 135.14(c) manufacture and distribution of iodine 125, iodine-section, the following byproduct materials in of this chapter to use byproduct material under the 131, carbon 14, hydrogen 3 (tritium), selenium-75, generallicense in this 131.11 The registrant shall fur.
iron 59 or Mock lodine-125 for distribution to per.
prepackaged umes:
(I) lodme-125, in units not exceeding 10 nnh on NRC form 483 the following information and sons generally licensed by the Agreement State.
- microcuries each for use in in vitro clinical or such other information as may be requised by that (2) Unless the following statement, or a substan-laboratory tests not involving internal or externt ad-form:
tially similar statement which contains the informa-ministration of byproduct malenal, or the radiation (1) Name and address of the registrant; tion called for in the following statement, appears on therefrom, to human beings or ammals.
(2) The location of use; and a label af fined to each prepackaged umt or appears in (2) lodine-13), in units not exceeding 10 (3) A statement that the registrant has appropriate a leaflet or brochure w hich accompanies the package:2 microcuries each for use in in vitro clinical or radiation measuring instruments to carry out in vitro This radioactive material may be received, ac-laboratory tests nor involving internal or external ad-clinical or laboratory tests eith byproduct materia's quired, possessed, and used only by physicians, ministration of byproduct material, or the radiation as authorized under the general license in paragraph veterinarians in the practice of veterinary medicine, therefrom, to human bemgs or animals.
(a) of this secuon, and that such tests will be per-clinicallaboratories or hospitals and only for in vitro (3) Carbon 14, in units not exceeding 10 formed only by personnel competent in the use of clinical or laboratory tests not int olving internal or I
microcuries each for use in in vitro clinical or such instruments and in the handling of the byproduct external adounistration of the material or the radia-tion therefrom, to human beings or animals, its 11boratory tests not involving internal or etternal ad-materials.
ministration of byproduct material, or the radiation (c) A person who receives, acquires, possesses or receipt, acquisition, possession, use, and transfer are therefrom, to human bemgs or animals.
uses byproduct material parsuant to the general subject to the regulations and a generallicense of the (4) Hydrogen 3 (tritiumb in units not exceeding 50 license established by paragraph ta) of this section U.S. Nuclear Regulatory Commission or of a State microcuries each for use in in vitro clinical or shall comply with the following:
wiW which the Commission has entered into an agree +
laboratory tests not involving internal or external ad-(1) The generallicensee shall not possess at any one ment for the exercise of regulatory auth ority.
ministration of byproduct matetial, or the radiation time, pursuant to the general license in paragraph (a) therefrom, to human bemgs or ammals, of this section, at any one location of storage or use, a total aniount of iodine 125, iodine 131, selenium 75, Name of manufacturer (5) fron 59, in units not exceeding 20 microcuries and/or iron 59 in excess of 200 microcuries.
each for use in in vitro clinical or laboratory tests not involving internal or external administration of t2) The general licensee shall store the byproduct (e) The registrant possessing or using byproduct i
material, until used, in the original shipping container materials under the generallicense of paragraph (a) of f
byproduct material, or the radiation therefrom, to or in a container providing equivalent radiation pro-this section shal! report in writing to the Director of human beings or animals.
. uclear Material Safety and Safeguards any changes N
I""*
(6) Setemum-75, in units not exceeding 10 (3 The general heensee shall use the byproduct in the mformation furnished by hm, in the "Registra-microcuries each for use in in vitro clinical or material nly f r the uses authorized by paragraph (a) tion Certificate-In Vitro Testing with Byproduct I
laboratory tests not involving internal or external ad-Material Under General License." NRC Form 483.
t s sects n.
ministration of byproduct material, or the radiation N
I N
byproduct material except by transfer to a person ef fective datc of such change.8 therefrom, to human beings or arnimals.
(7) Mock lodme-125 reference or ' calibration authorized to receive it by a license pursuant to this (f) Any person using byproduct material pursuant sources, in unita not exceedmg 0.005 microcurie of chapter or f rom an Agreement State,' nor transfer the to the generallicense of paragraph (a)of this section is iodine 129 and 0.005 microcurie of americium-241 byproduct material in any manner other than in the exempt from the requirements of Parts 19,20 and 21 esch for use in in vitro clinical or laboratory tests not unopened, labeled shipping container as received of this chapter with respect to byproduct materials mvolving internal or enternal administration of from the supplier, covered by that general license, except that such per-6 l
byproduct material, or the radiation therefrom, to (5) The generallicensee shall dispose of the Mock sons using the Mock todine-125 described in human beings or animals.
todme 125 reference or calibration sources decribed paragraph (a)(7) of this section shall comply with the (b) No person shall receive. acquire, possess use or in paragraph (aM7) of this section as required by provisions of $20.301, 20.402 and 20.403 of this j
trr.nsfer byproduct material pursuant to the general 520.301 of this chapter chapter.
NOTES 3 A State to which 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.
2 Material generally licensed under this section prior to January 19, 1973 may bear labels authorized by the regulations in effect on January 1,
- 1975, l
3 A new triplicate set of this Registration Certificate, NRC Form 483, may be used to report any change of informarion furnished by a registrant as r
required by {31.11(c).
If larger quantities or other forms of byproduct material than those specified in the generallicense of 10 CFR 31.11 are required, an "Applica-tion for Byproduct Material License," NRC Forms 3131,313M, or 313R should be filed to obtain a specific byproduct materiallicense. Copies of f
application and registration forths may be obtained from the United States Nuclear Regulatory Commission, Washington, D.C. 20555, Attention:
i Material Licensing Branch, Division of Wel Cycle and Material Safety.
PRIVACY ACT STATEMENT l
I Pursuant to 5 U.S.C. 522a(e)(3), enacted into law by section 3 of the Privacy Act of 1974 (Public Law 93 579), the following statement is fur-(
nished to individuals who supply information to the Nuclear Regulatory Commission on NRC Form 483. This information is maintained in a i
system of records designated as NRC-3 and described at 40 Federal Register 45334 (October 1,1975).
1.
AUTHORITY Sections 81 and 161(b) of the Atomic Energy Act of 1954, as amended (42 U.S.C. 2111 and 2201(b)).
PRINCIPAL PURPOSE (S) The information is evaluated by the NRC staff pursuant to criteria set forth in 10 CFR Parts 30-36 to determine 2.
whether the application conforms to the requirements of the Atomic Energy Act of 1954, as amended, and the regulations of the NRC, for the issuance of a registration certificate authorizing the use of in vitro testing.
ROUTINE USES The information may be used:(a) to provide records to State health departments for their information and use; and (b) to i
3, provide information to Federal State, and local health officials and other persons in the event of incident or exposure for purposes of their in-l' formation, investigation, and protection of the public health and safety. The information may also be disclosed to appropriate Federal, State, or local agencies in the event the information indicates a violation or potential violation of law and in the course of an administrative or judicial 4
proceeding. In addition, this info'mation may be transferred to an appropriate Federal, State, or local agency to the extent relevant and r
necessary for an NRC decision or to an appropriate Federal agency to the extent relevant and necessary for that agency's decision about you.
WHETHER DISCLOSURE IS MANDATORY OR VOLUNTARY AND EFFEhT ON INDIVIDUAL OF NOT PROVIDING INFORMA-4.
TlON It is voluntary that you furnish the requested information. If the requested information is not furnished, however, the registration cer-
. tificate, or amendment thereof, will not be processed.
5, SYSTEM MANAGER (S) AND ADDRESS Director, Division of Fuel Cycle and Material Safety. Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555,
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