ML20247L523
| ML20247L523 | |
| Person / Time | |
|---|---|
| Issue date: | 05/11/1998 |
| From: | Lohaus P NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | Allen K ILLINOIS, STATE OF |
| References | |
| NUDOCS 9805220434 | |
| Download: ML20247L523 (4) | |
Text
__
4 L%Y 111933 Ms. Kathy Allen Senior Project Manager Illinois Department of Nuclear Safety 1035 Outer Park Drive Spring:ield,IL 62704
Dear Ms. Allen:
As requested, we have reviewed the proposed regulations (Subpart A: General Provisions, Section 330.40 License Exemption - Radioactive Materials Other Than Source Material),
emergency rule effective March 18,1998. The regulations were reviewed by comparison to the equivalent NRC regulations in 10 CFR Part 30.21. We also discussed our review of the regulations with you on May 6,1998.
As a result of our review we have no comments. Under our current procedure, a finding that a State regulation meets the compatibility and health and safety categories of the equivalent NRC regulation may only be made based on a review of the final State regulation. However, we have determined that if your proposed regulations were adopted without significant change, they would meet the compatibility and health and safety categories established in OSP Internal Procedure B.7.
We request tha'. when the proposed regulations are adopted and published as final regulations, a copy of the "as published" regulations ce provided to us for review. As requested in our All Agreement States Letter SP-96-027, "Reauest to Highliaht Chances to Aareement State Regulations Submitted to NRC for Compatibility Review" (March 1,1996), please highlight the final changes and send one copy in a computer readable format, if possible.
If you have any questions regarding the compatibility the health and safety categories, or the NRC regulations used in the review, please contact me or Lloyd Bolling of my staff at (301) 415-2322.
Sincerely, Originals'gned By Pit 0HARD L BANGART C23C Paul H. Lohaus, Deputy Director n qu3 Office of State Programs Ls ;
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6 S N Distribution:
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- PHLo6ays, RLBangart*/ O DATE 05/% /98 05/ d/98 05/Q/98 9805220434 980511 OSP FILE CODE: SP-AG-8 PDR STPRG ESGIL PDR u-____________
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,j NUCLEAR REGULATORY COMMISSION
't WASHINGTON, D.C. 20066 4001
% *****#o May 11, 1998 Ms. Kathy Allen Senior Project Manager Illinois Department of Nuclear Safety 1035 Outer Park Drive 1
Springfield,IL 62704
Dear Ms. Allen:
As requested, we have reviewed the proposed regulations (Subpart A: General Provisions, i
Section 330.40 License Exemption - Radioactive Materials Other Than Source Material),
1 emergency rule effective March 18,1998. The regulations were reviewed by comparison to the equivalent NRC regulations in 10 CFR Part 30.21. We also discussed our review of the regulations with you on May 6,1998.
As a result of our review we have no comments. Under our current procedure, a finding that a State regulation meets the compatibility and health and safety categories of the equivalent NRC regulation may only be made based on a review of the final State regulation. However, we have determined that if your proposed regulations were adopted without significant change, they would meet the compatibility and hedth and safety categories established in OSP Intemal Procedura B.7.
We request that when the proposed regulations are adopted and published as final regulations, a copy of the "as published" regulations be provided to us for review. As requested in our All Agreement States Letter SP-96-027, "Reauest to Hiahlicht Chanaes to Aareement State j
Regulations Submitted to NRC for Compatibility Review" (March 1,1996), please highlight the final changes arid send one copy in a computer readable format, if possible.
If you have any questions regarding the compatibility the health and safety categories, or the NRC regulations used in the review, please contact me or Lloyd Bolling of my staff at (301) 415-2322.
Sincerely, h lmd L ba-ad.
ic Paul H. Lohaus, Deputy Direct [
Office of State Programs
30.21(r) 3031 PART 30
- RULES OF GENERAL APPLICAE!LITY TO DOMESTIC LICENSING...
$ 30.21 Radioactive drug: Capsules IICENSES containing carbon 14 uros for "in vivo.,
$ 30.31 Types oflicenses.
(
diagnostic use for humans.
Licenses for byproduct material are of
> (a) Except as provided in paragraphs (b) and (c) of this section, any person is E! two types: General and specific. Specific g licenses are issued to named persons upon exempt from the requirements for a license set forth in Section 81 of the Act E applications filed pursuant to the regula-
$ ons in this part and Parts 32 36, 39.
ti and from the regulations in this part and Generallicenses are effectfve without the part 35 of this chapter provided that filing of applications with the Com-such person receives, possesses, uses, mission or the issuance of licensing transfers, owns, or acquires capsules containing 37 kBq (1p Cl) carbon-14 documents to particular persons, urea (allowing for nominal variation g that may occur during the
- ""'act"'in8 Process) each, for "In 5 *ivo" diagnostic use for humans.
v (b) Any person who desires to use the g capsules for research involving human subjects shall apply for and receive a specific license pursuant to part 35 of this chapter.
(c) Any person who desires to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution such capsules shall apply for and receive a specific license pursuant to S 32.21 of this chapter.
(d) Nothing in this section relieves persons from complying with applicable FDA, other Federal, and State I
requirements governing receipt, I
administration, and use of drugs.
30-8a December 31,1997 (next page is 30-9)
i l
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TASK DESCRIPTION - REVIEW ILLINOIS REGULATION-EXEMPT DISTRIBUTION OF A
~~~~~~~~~~~~~~~~
RADIOACTIVE DRUG CONTAINING ONE MICROCURIE OF C-14 REQUESTING OFF. - IL REQUESTER - ALLEN WITS -
0 FYP - N
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PROG.- LAB PERSON -
STAFF LEAD - LAB PROG. AREA -
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PROJECT STATUS -
IL DUE DATE: 5/22/98
~~~~~~~~~~~~~.
PLANNED ACC.
-N LEVEL CODE -
1
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l I
STATE OF ILLINOIS DEPARTMENT OF NUCLEAR SAFFTY 1035 OUTER PARK DRIVE SPRINGFIELD, ILLINOIS 62704 Jim lhlgar 217-785-9900 Thomas W. Orteiger Gos ernor 2 l 7-782-6133 (TDD)
Director April 22,1998 Mr. Richard Bangart Nuclear Regulatory Commission i
Office of State Programs Mail Stop 03H20 Washington, D.C. 20555 l
Dear Mr. Bangart:
Enclosed with this letter is a copy of proposed revisions to the Illinois Department of Nuclear Safety's regulations regarding licensing ofradioactive material (32 Ill. Adm. Code 330). The proposed revision incorporates changes to allow the receipt and use of exempt quantities of C-14 urea forin-vivo diagnostic use.
Please be advised that the Department issued an emergency rule effective March 18,1998 to allow the immediate use of this material in Illinois. The Department is seeking a finding of
" Compatible" for the proposed rule language, which mirrors the emergency rule language.
Ifyou have any questions or concerns, you may contact me at 217-785-9931, or Rob Holtsclaw as listed in the enclosed mle text. Comments on the proposed rule must be received by May 22,1998.
Sincerely, Kathy Al n Senior Project Manager
Enclosure:
Excerpts from Illinois Register cc: Jim Lynch, Region III i-
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