ML20056E013
| ML20056E013 | |
| Person / Time | |
|---|---|
| Issue date: | 05/12/1993 |
| From: | Miller V NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | GENERAL |
| Shared Package | |
| ML20056C038 | List: |
| References | |
| NUDOCS 9308190188 | |
| Download: ML20056E013 (4) | |
Text
.
. o n, QUESTION 72 M
'o UNITED ST,JES i
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NUCLEAR REGULATORY COMMISSION l
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WASHINGTON, D. C. 20555 I
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May 12, 1993
-i i
t ALL AGREEMENT STATES i
TRANSMITTAL OF STATE AGREEMENTS PROGRAM INFORMATION (SP-93-056)
Your attention is invited to the attached correspondence which l
contains:
1 INCIDENT AND EVENT INFORMATION......
l t
PROGRAM MANAGEMENT INFORMATION.......
TRAINING COURSE INFORMATION..........
TECHNICAL INFORMATION................
i OTHER INFORMATION....................XX Rule Extension.
Supplementary information:
Enclosed is a copy of the-Federal Reoister Notice proposing to extend the expiration date of the interim final rule related to the preparation and therapeutic use 1
of radiopharmaceuticals from August 23, 1993-to. December 31, 1994. The extension would allow-licensees to continue to use byproduct material under the provisions'of the interim final rule l
until the NRC completes a related rulemaking.
Please note the comment Deriod for the proposed extension ends June 7.
l 1993.
If you have further questions regarding this correspondence, please contact the individual named below.
POINT OF CONTACT:
Jim Myers.
-TELEPHONE:
(301) 504-2328 FAX (301) 504-3502 i
Vandy L. Mill r, ssistant Director for State Agre ents Program t
Office of State Programs',
Enclosure:
As stated 93C8190189 930802 L.PDR STPRG ESGGEN
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I 26938 Toderal Register / Vol. 58, No, e6 /1%ursday, May 8,1993 / Proposed Rules t
suPMasetTARY e#0funA11osc Disensaiess
.j Eack rwomi Section 30.34 Turms andConditions of~
l NUCLEAR REGIR.ATORY 8
COMMtSSION On June 5,1999, the American Naser.
10 CFR Porta 30 and 35 College of NuclearPhysidans (ACNP) b NRC la proposing to extend the F
and the Sodoty of Nuclear Medidne expireuon date in paragroph (i)(1) of
(
RW 3150-AEss (SNM) submitted a peutiot, foe Ltds section frorn Aupst 23,1993, to i
i ruba=h tag (PRh6-35-9), requesting the December 31,1994.Tala extension is Authorization To Proper
- Commission to amend its regulations to proposed to allow commerdal nuclear Redlopharmaceutical Rangent KHa and permit Bcensed nuclear phannadets harmacies to continue to repare Efuta Radiopharmaceutical and physicians greater flexibdity in the yproduct material under t provisions I
Generators; Une of propantloo and use of of theinterim Enalruleuntilthe Rediopharmaceuticale for Therapy; rediopharmaceuticals. AAerreviewing broader rule is effedive.
Extension of Espiretion Date
& petidon and consulting with the 8yI U
an den Acpect: Nuclear Reguletcry op arrn ceu als Generators,and Commission.
AcTest: o
, rul'e: extension of issues raised in the petition needed to R'88'nt LesforImaging and Iocah. otion Studies.
z o
- P rstion ste-k resdved expe&Uously.
i Subsequenuy.on August 23,1990,the
& NRCis proposing to extend the v
sumuny N Nuclear Reguhtory Commission published en interim Enal exp!ntion date in paragraph (c)(1) of Commission (NRC)is proposing to rule la the Federal Register (55 FR this section from August 23,1993,to extend b aspiration date of the interim 34513) to allow mechcal use licensees.
December 31,1994. This extension as Ena! rule related to the preparation and under certain conditions and proposed to allow medical use licensees thuspoutic um of radiopharmaceuticals limitations,to use therapeutic to continue to use byproduct material from August 23,1993,to December 31, radiopharmaceuticah forindications under the provisions of 6 interim final 1994,m proposed artension would and methods of ad= tat *ation not rule untu b broeder rule is effectiva.
allow licenwes to continue to use listed in the FDA-eppmnd packap byproduct snatorial under the provisions inserta. In addition, the interim Enal -
Section 35 300 Use of
^
of the interim firal rule until the NRC ruk allows andim! use W-anci Radiopharmacentrealsfor Thempy l
completes a rehted rulemaking to coenmerds! nuclear pharmados to b NRC is proposing to extend the addreas brander luuse for b medical depart from the manufacturer's expiration date la paragraph (b)(1) of use of byproduct material (including instructions for pnparing diagnostic this section from August 23,1993,to those lesues addressed by the interim radiopharmaceuticals using December 31,1994. This extension is Enal rule).& NRC expects ' hat this radionuclide senerstars and reagent proposed to allow medical use lir=n-broeder rule wculd be complMed and kits, provided~that the licansees follow to continue to use byproduct material issued as a Ena] rule before the and of the directions of a physician authoriud under b pmvistor.s of the interim Anal.
i 1994.His proposed extension of b user.The NRC amended the interim rule until the broader rule is eflodive.
expirstion date is netwasary to maintain Entl rule to eliminate certain Also, the NRCis the word " method
- proposing to replace the relief provided by b interim Enal recordkeeping requirements related to with the word rule.
the preparation and use of methodsin paragraph (b)(1) of this -
i a
nATts:N ranmant period expires radiopharmaceuticals (57 FR 45566, section to correct a typographical error.
June 7,1993. Commants received aEar October 2.1992). & interim final rule EnvironmentalImpact.Cateprical this date will be considered ifit is will expire on August 23,1993 unless gggg,,)**
pracucal to do so, but the Commbton itis extended.
ls able to assure considerstice only for Curmndy, the NRCis working on a h NRC has determined that this comments received on or before this broader proposed rule in response to proposed rule is the type of action date.
PRM-35-9 that would resolve b issues described in cateForical exclusion 10 ADontassa: Mall written comments to raised in the petidon. including the CFR 51.22[c)(2).brefon,neither an the Secretary, U.S. Nuclear Regulatory issues addmased by b interim final environmental impact statement nor an Commission. Washington. DC 20555, rule.He Commission intends to mplace emironmental aanessment has been Attention: Docketing and Service the provisions of the interim Enal rule pmpar'd for this proposed rule.
Branch.
, with the provisions of this broader rule.
Paperwerk Radecties Act Stataanset Hand deliver comments to 11555
, b NRC expects that thh 56-d Rockville Pike. Raciville. Maryland, will be promulgsted and effective before This proposed rule does not contain berwean 7:45 an and 4:15 pm cm
. the end of 1994. Therefore, the NRC is 1 a new or amended information Federal workdays.
proposing to extend b expiration date collection mquimment subject to the Copies of any public *mmments of the interim Enal rule from August 23, ' Pe rwork Reductbn Act of1980 (44 received on the proposed rule may be 1993, to December 31,1994.h U..C. 3501 et seg ). Existing aumMed at:the NRC Public hmt Proposed extension would allcw mquirements were approved by the r
Room. 2120 L Street. NW. (lower licensees to continue to use byproduct Office of Management and Budget under.
Level). Washington. DC.
material under the provisions of the approval numbers 3150-0010 and 3150-I Post Pu8tTMn DdPOMbeaT1088 COfrACTt Dr.
Interim Engl rule until the broeder rulo 0017.
Anthony N. Tse. Office of Nuclear is completed and effectiva.This Regulatory Research U.S. Nuclear Proposed extension is necouary to ReguIstory Commissicn.Wuhington, maintain the rollef from restrictions DC 20555, telephone (301) 492-3797, Provided by b interim Enal rule.
I
[
Regul: tory An:lys3 BackSt Analysis In August 1990,the NRC The NRC has determined that the implemented an interim Enal rule backSt rule.10 CR 50.109 does not PART 35-4tEDICAh USE OF BYPRODUCT MATERIAL d a m (s) de
[jt (ljwig censees e
en doe et 3.The authority citation for part 35 p aring diapostic 12Pm mquirements on axisting
- continun to red as foDows:
nNopharmaceuticals, and (b) the nuclear power ructst licensees.
Authadry: secs. st.161.182. t a3. sa stat.
p:ckege insert instructions regarding Therefore, e beckEt analysis was not s35. 948. 953. rs4. as amended (42 US.C
. use of radiopharmaceuticals for therapy.
Pnpared for this proposed amandmet.
2111. 2201. 2232. 2233h wc 2es, as stat The e!!ective period for the rule is from List of Subjects
- * *** " ***"d*d Ii' U# C * *I' August 23.1990 to August 23.1993.
- 4. In i 35.200. paragraph (c)(1)is The NRC is proposing to extend the' Jo CEPart 30 avised to read as follows:
cxpiration date from August 23.1993 to Byaroduct material.Crimhal y
g__
Dec:mber 31,1994.The proposed pea [ tin. Government contracts, cxt:nsion would allow licensees to Intergovernmental relations. Isotopes.
p n.,,gy,,,ng y w,,, %
arid becalmsbon sewanes.
continue to un byproduct material Nuclur materials. Radiation protection.
under the provisions of the interim Ensi Reporting and recordkeeping
. rule until there is an effective Enal rule requirements.
(c)(1)Trom August 23.1990,to in a related rulemaking in response to December 31.19H. a licensee may 20 ("FR PM 35 depart fmm 6 medmurn's the ACNP-SNM petition to address bro-derissues for the medical use of B roduct material.Cdmind instruc.tions for sluting gennaton and byproduct materid (including thow ga ties, Drugs. Health facilities, h p7, thhMh lth professions. Incorporstion by Drug Administration (FDA)
Issues addnssed by the interim anal has ap gFp Qved aNew ruh) The NRC expects that this broader nfuencs Medicaldevices. Nuclear n (NDA). by owinE the rub would be ce=pleted and effective materit!s. Occupational safety and before the end of 1994. This propowd health. Radistion protection, Raporting directions of an authorianit user extension of the expiration date is and recordkeeping requirementa.
phyncian.
necessary to continue the relief from For the rusons set out in the nstrictions provided by the interim pr3 amble end under the authority of the
- 5. b i 35.300, paragraph (b)(1)is final rule until the eHective date of the Atomic Energy Act of1954.as amended, revised to read as bliows:
broada rule.
6 Ene Rao)anization Act of1974 I m U w of w see The altemative to th!: proposed as amen
, a'n 5 U.S.C. 553. the NRC ext:nsion is to maintain the exf sting is proposing to adopt b foDowing
,,,,,py' cxpiration date Under this alte.mative, amendments to 10 CFR puts 30 and 35.
the provisions in the interim Smal rule (b)(1) From August 23.1990, to would expire on August 23,1993,as PART 3G-4ULES OF GENERAL December 31.1994, a lir-a may would the nlief from restrictions APPUCABlWTY TO DOMESTIC depart fmm the package insart provided by the intnim Enal rule.
UCENSING OF 5YPRODUCT instructions regarding indications or MATERIAL The NRCconcludes that this methods of ar%f tration far a t
propowd extension is tustined to
,,g[,,(
Part 30 radiopharmaceutical for which the Food I
and Drug Arhweiration DA)has continue to aDow licensees to uw d
ows-byproduct esterial under the provisions Anio+T: Sees-si, s2. tet.182.1s3.166 approved a New Drug Application **.
cf the interim Enal rule until the sa stat. 935, s4 s, s53. est, ess, as amended.
(NDA), provided that the authorimod broade rule is eHective.
"c. 234,83 stat 444, as amended (42 US C user physicia has prepared a writtan 2111.2112.2201.2232.2233.2236.2282L directive as required by $ 35.12(a).
Regulatory Flexibility CertiScation secs. 201, as amended. 202. 2o6. Se stat.
As required by the Regulatory 1242, as amended.1244.1246 (42 US.C Deted et RockviDs. Maryland. this 22rd day of A r1.1993.
Flexibility Act of 1960. 5 U.S.C 605(b)*
Sul &&<2 ss45)
P the Commission certiSes thet.if section $o.7 ateo issued um.dsr Pub. t. 95-For the Nuclear Regu! story rwa %
edopted, this proposed rule would not sol.sec 10.s2 stat 2851 (a2 U3n ses4 lames M. Teyler, heve a s;gniScant economic t= pact on section 30 sol dao tae.ned under esc 1H.
'h.m w4ww.
o substetial number of s=aU satities.
sa stat est, as amanded (42 USC 22341 section 30.s1 ateo istued under sec Isr.se IrR Dr. 23-10666 hied 6-6-43: s 45 en:) -
This proposed rule would aHect medical stat. ess (42 US C 223r).
use licensees ineluding some private practice physicians.Some of thne
- 2. In 5 3034 pangnph (t)(1) h Lcenwes would be conaldend small revised to rad as foHows:
satities undu the NRC's size standards.
8 30.34 Terme end eenmone et meennes.
published in the Federal Register on Nov;mber 6,1991 (55 FR 55672).The (I)(1)From August 23.1990,to,
proposed amendments would extend December 31.1994,each licensee 6 cxpiration date of the interim Enal sluting generators and processing iule from August 23.1993,toDecember radioacuve material with diagnostic 31.1994.The proposed extension nagent lits for tahich 6 Food and would aHow licensees to continue to Drug Administration WA) has use byproduct matnial under the approved a *New Drug Application'*,
provisions of the interim final rule until (NDA) may depart from the thiNRC completes a nlated rulemaWg manufacturer's elution and pnparstion to address broaderlasues for the m: dical use of byproduct material instructions (for radiopharmaceuticals authoriad for un pursuant to to CPR (including those issues addrused by the 35.200).
inte-im Ena) rule). Therders, for the follows t$revided that & licensee e directions of an authorized i
reasons provided above.this usn physician.
amendment would not have a j
signiScant economic impact on a substantial number of amaB entities.
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4' TO:
Assistant Director for State Agreements Program l
SUBJECT:
' RESPONSE TO ALL AGREEMENT STATES LETTER
-l (SP-93-056)
~
EXTENSION OF INTERIM RULE:
PART 35 Please check one of the following:
0 We acknowledge receipt of the referenced letter and-i have no comments.
j 0
We acknowledge receipt of the referenced letter and providing comments which are attached.
{Short responses may be. faxed to (301) 504-3502.}
j 0
Other (please explain under comments).
l comments (use additional sheets as appropriate):
j t
i
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Please complete the following information:
Signature:
Name:
Title:
Date:
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-l i
i State Programs
Contact:
Jim Myers State Agreements Letter Number: SP93056.JHM Response Due:
Lune 7, 1993
.PLEASE TYPE OR PRINT YOUR STATE ABREVIATION HERE:
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