ML20059G786
| ML20059G786 | |
| Person / Time | |
|---|---|
| Issue date: | 10/21/1993 |
| From: | Tse A NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| To: | Lanham D NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM) |
| Shared Package | |
| ML19346D130 | List: |
| References | |
| FRN-58FR39130, RULE-PR-30, RULE-PR-35 AE58-2-001, AE58-2-1, NUDOCS 9311090089 | |
| Download: ML20059G786 (5) | |
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UNITED STATES i
ij NUCLEAR REGULATORY COMMISSION
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WASHINGTON, D C. 2055W1 g
AE58-2 6
MEMORANDUM FOR:
Donald H. Lanham Nuclear Document System (NUDOCS), Mail Stop Pl-37 Office of Information Resource Management FROM:
Anthony N. Tse Regulation Development Branch Division of Regulatory Applications Office of Nuclear Regulatory Research
SUBJECT:
INDEX AND DOCUMENTS FOR REGula. TORY HISTORY FILE OF A FINAL RULE (10 CFR PARTS 30 AND 35) ON EXTENSION OF EXPIRATION DATE OF THE INTERIM FINAL R' LE J
Enclosed are an index and the documents for regt 'atory history file of a final rule. This final rule, entitled " Authorization to Prepare Radiopharmaceutical Reagent Kits and Elute Radiopharmaceutical Generators; Use of Radiopharmaceuticals for Therapy; Extension of Expiration Date," was published on July 22, 1993 (58 FR 39130).
Each document that can be made available to the public document room is marked "PDR" in the upper right-hand corner of the front page.
Documents that cannot be made available to the public are marked "CF" on the frc.nt page. As requested by M. Lesar of ADM in his memorandum dated July 27, 1993, documents marked "CF" are grouped after the documents marked "PDR."
If you have any questions, please call me at 492-3797.
Anthony N. Tse Regulation Development Branch Division of Regulatory Applications Office of Nuclear Regulatory Research
Enclosures:
- 1. Index
- 2. Documents cc (w/ encl. 1):
M. Lesar, ADM l. ll l O
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PDR PR
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b 9311090089 931021
~j 30 58FR39130 PDR
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AE58-2 ENCLOSURE 1 INDFY - REGULATORY HISTORY Final Rule Entitled " Authorization to Prepare Radiopharmaceutical Reagent Kits and Elute Radiopharmaceutical Generators; Use of Radiopharmaceuticals for Therapy; Extension of Expiration Date" DATE FROM TO SUBJECT PDR 07/22/93 FR notice published Final rule (58 FR 39130)
CE 06/17/93 CJHeltemes Off Dirs Off conc request-FR notice 06/24/93 MMalsch CJHeltemes Conc (on conc sheet) 05/24/93 Phorry CJHeltemes Conc 06/25/93 JLieberman ATse Phone conc (on conc sheet) 06/25/93 EHeumann ATse Conc 07/01/93 RBernero CJHeltemes Conc 07/06/93 BStMary ATse Conc 07/08/93 TBeckjord JTaylor Requesting signature 07/09/92 JTaylor Approved for publication 07/12/93 SBahadur DMeyer Forwarding the FR notice
Federal Register /.Vol. 58, No.139 / *Drursday, July
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39130 22, 1993 / Rules and RegulatimE than 5 full days after acquiring the
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animal, not induding the date of
. are acquired from the pound or shelter acquisition and excluding time in orit may be made separately and NUCLEAR REGULATOR transit. nis holding period shall attached to the certification later. If COMMISSION
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include at least one Saturday.The made separately,it must include the provisions of this paragraph apply to:
same information descibing each 10 CFR Parts 30 and 35 r
(1) Each pound or shelter owned and animal as is requimd in the certification. RNO150,AE58 op(erated b a State, county,orcity; A photocopy of the statement willbe Propero Redlopharmaceutical Reagent
- 2) Each vote pound or shelter regarded as a dupliceu original.
Kita and Dute Radiopharmaceutice establish for the purpose ofcaring for (c) %e original certification required Genwators; Use of animals, such as a humane sodety, or
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other organization that is under contract under paragraph (b) of this section shall Radiopharmunch hapn with a State, county, or city, that acmmpany the shipment ofe live dog Nm of ExpiraHon Date operates as a pound or shelter, and. hat or cat to be sold, pmvided, or otherwise AGENCY: Nuclear Regulatory releases animals on a voluntary basis; made available by the dealer.
Comminion.
and (d) A dealer who acquires a live dog ACTM, Final rule: Extension of (3) Each research fadlity licensed by or cat from another dealer must obtainexpiration date.
imm that da? r the certiScation
) A dbler sbil not sell, provide, or required by paragraph (b) of this section sUMuARY:
The Nuclear Regulatory make available to any person a live and must attach that certificatam Commission (NRC)is extending the
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random source dog or cat unless the (includmg any previously attached Iration date of the interim final rule dealer provides the recipient of the dogenincade) to the certificatie which re ated to thep aration and or cat with certification that contains he or she provides pursuant to therspeutic use radiopharmaceuticals the following information:
(1)Thename 4ddress,USDAlicense paragraph (b) of this section (a imm August 23,1993, to Decsmber 31, number, and signature of the dealer; photocopy of the original certiScation 1994.The action allows licensees to (2)The name, address USDA license will be deemed a duplicate originalif continue to use byproduct material or registration number, if such number the dealer does not dispose of all of the under the provisions of the interim final exists, and signature of the recipient of dogs or cats in a single trant ctioni.
rule until the NRC completes a related rulemaking to address broaderissues for the dog or cat; (e) A dealer who conipletes, provides, the medical use of byproduct material (3) A description of each dog or cat or receives a certification required (including those issues addressed by the being sold provided, or mele available under paragraph (b) of this section shall Interim final rule).The NRC expects that shallinclude:
keep, maintain, and make available for that this broaderrule would be (i) The spedes and breed or type (for -^
- P fth c mpleted and issued as a finalrule
}3,t mixed breeds, estimate the tw before the end of 1994. This extension dominant breeds or types);
disPositm.n.
(iil The sex; f the expirauon date is necessary to (iii) The date of birth cr. if unknown, (f) A research facility which soquires maintain the relief interim final rule. provided by the then the approximate age; a dealer must obtain the cen16cationany live random source dog ErFECTFVE DATE:
(iv)The color and any distinctive August 23,1993.
marktgs;and required under aragra a men wonuAmmTAct:Dr.
section and sha 1 keep,ph (b) of this maintain, and Anthony N. Tse, OfSce of Nuclerr id ntificat o RegulatoryResearch U of e i al 8
8 Howeve, if the certification is attacEed Regulatory Comnission.S. Nuclear
$ashington, to a certificate provided by a prior d pos don.
8 55 18IeP one (301)492-3797, h
dealer which contains the required description, then only the ofScial (g)1n instances where a research SUPPLEMENTARY WORuATpt:
identification numbers are facility transfers ownership of a live
Background
random source dog or cat acquired from (4)The name and address the person, pound, or shelter from which a dealer to another research fadlity, a On June 5,1989, the American copy of the certification required by College of Nuclear Physidans (ACNP) the do dealer,g or cat was acquired by the and en assurance that the paragraph (b)of this section must and the Society ofNuclear Medicine person, pound, or shelter was notified accompany the dog or cat transferred, (SNM) submitted a petition for rulemaking (PRM-35-9), requesting the that the cat or dog might be used f The research facility to which the dog Commission te amend its regulations to rassarch or educational purposes;or or cat is transferred shall keep, (5) The date the dealer ac maintain, and make available for APHIS permit licensed nuclear pharmacists dog or cat from the person. quired the inspection the copy of the certification and physicians greater fiexibility in the pound. or Preparation and use of shelter referred to in paragraph (b)(4) of for at least 3 years following disposition. radiopha this section; and D*' i" the petition and consulting with the cat from a pound or s;helter, a signed (6)If the dealer acx uired the dog or MJ 3'83-
- i"8t
- E this 1sth dey of U.S. Food and Drug Administration statement by the pound or shelter that Eusaa8 Bramstool.
(FDA), the NRC determined that some It met the requirements of paragraph (a) Assistant saaerary. Marlering andinspectaon Issues raised in the petition needed to Serdces.
be resolved expeditiously.
of this section. This statement must at least describe the animals by their IFR Loc. 93-17439 Filed 7-21-93; 8:
Subsequently, on August 23,1990 (55 45 aml offidal USDA identiScation numbers. It eaa coac n u FR 34513),the Commission published may be incorporated within the an interim final rule in the Federal certification if the dealer makes the legister to allow medical use licensees, certification at the time that the animals under certain conditions and limitations, to use therapeutic radiopharmaceuticals forindications
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Federal Rgister / Vol. 5E, No.139 / Thursday, July 2.2,1993 / Rules and Rgulations 39132 and methods af ariministration not -
from August 23,1993, to December 31, the relief from restrictions povidedly listedin 6 FDA-appmred paciage 1994. This emansion is necessarylo the interim finalinle untilIhe ebctive inserrs. in addt: ion, the intarim final allow medica use ficassees to continue date of the broader rule.
rule allowsmahesi use hmnsees and to usebyproduct maasid under1he The alternative to this extension is to commeminbaclaarpharmedes to prodsions of the teterksImalrule until maintain fhe existing wbGm date.
depast from thememnactunts the bionderruleIs ebdiva.
instructitms for preparing tiragnos6c Urrder 6dsinternattve,6e prtyrisions in radiopharmaceuticaisusing 3,c,j,, yg,,,g y,,4 hs We d expire m radionuclide generators and reegent Ro6ophanaceutMsfor hsupy August 23.1993, aswotdd the relief from nM-s pmvided byte kits, pros 3ded abat the k====F foUtrw The NRCis extending the expiration interim fimide.
the directions ofa phymniam arribrw=1 date inr,W Mij of&is settien W NRC concludes that this user. N NRC annap6sd the interim from August 23,19!rs,toOma 31, extension is justiSad to cantinue to final rule toeliminate r=,w, 199L nis w=h js nams.sary se allow licensaas touse bypmdud recordleeping seqummaan related to allow medical use licensees to continue material underthe parisians d1he thepreparation and use d to use byproduct material under the interim finai rnie tatIl the broader mle radropharmacruivals {sr FR 455f.6, Provisions af ahe laterim.finalinte.until is effective.
Odober 2,2902). b ta4mm final rw the brosdar mileis eff9 dive.
I Nb% CertiScstin will expire os August 23,1993 unk Also, theNRC is @r5 the word it is extended
" method"mifh the ward "ma* Win As required by the Regulatory bNRC has publi6hed forarmme.t Paragraph M12dfhis wNnn to conscs Flexibihty Act of 1950. 5 IJ.S.C. LD5(bl.
a broader proposed rule in response e a t}pegraphical snar.
the Commissim art 1Ees that this mie FRM-35-9 {58 f223396 hine 27 29G3) does nothaec a signincant economic Ein M W % noel imped on a substantial smmber of small that would resolve the 1Eues tais$d in Exc um6ea the petition, including theissues entities. Thrs rsde afsacts rnedical use addressed by the interim final rule. Ee The NRChas determinad that this licensees including someprivate Commission intsnds to lace the final ruleis the type of adlon described {racticephysnans.Sameof these provisions of fheinterim nalrEle with in categwical exclusion 10 CFR canyees wouldbe considered small the provisions of this binarhr rule. The 51.22(cM2L hrefwe, neither an entities im aer the N5tC's siee stand ards NRC expects that this broader rule will environmentalimpact statementnor,an puhhsbedin the Federal Register on be promulgated and diective before the environmental assessment hasbeen November 5.1991255 TR 5S672).His 6 3d cf 1994.
prepared forthis fina1 rule.
rule extends the expiration date of the The Pruposed Eule and Public Paperwork Mdas Act Statement interim fmalnieImen August 23,1993' Comment to December 31.1994.The extension This EneNie does not contain a new allowslicensees to continue to use The NRC proposed to extend the or amended information collecten byproduct material under the provisions exp; ration date of theinterim finalrule requirement subject to the Paperwork of the interim final rule until the NRC frem August 23,1993,to December 31 Reduction Act of 1980 (44 U.S C. 3502 completes a reisted rulemaking to 19M (38 FR 26938,M67 fi,1993). A 3f. et seg L Existing requirements were addressbroader issues for the medical c:v public comment period expnvd on approved by the Office of Management use of byproduct material (including Ide 7,1993. Comments were reorived and Budget under uppmvalnumbers those issues addressed by the interim fmt thn.e respondents. All three 3150-ocr1D and 315thtm7.
final rulet"herefore, for the reasons co rmenters strpported, whhout modifications,the ped extensian Regulatory Analysis Provided above.Ihis rqe does not have a signiLcant economic impact on a of the erpirttion tlate of the in*erim In August 1990, the NRC substantial number of small entities.
f d rul
implemented an Interim FinalRule Discussion of the Final Enle allowing been mes to depart Iram Ja1 the Baekfit Analysia manufactuser's instnictions for The NRC has deterrained that the IWeause no suggestions were made to Pn' Paring diagnostic backfit rule,10 CFR 50.109, does not 1
rnod.fy the propard rule, the regulaterv radiopharmosutimls and (b)the apply to this finalrule because this tat in the fmai mio is the same as the ~ Package insert instruaions regardmg amendment does not impose t
prcposed rule.
use of radiopharmamuticals for thermpy. requirements on existing nuclear power h effective pened for the rukisimm reactor licensees. brefore,a backfit Section 30.3f Terms and Conditions of August 23, W90. to August 23,1993.
analysis was not prepared for this final k N e3
- The NRCis extending the expiration rule.
The NRCis extending the expiration date from Augud E3,291,toDecember dhte in parapeph {iM2)cf this section 31,1994. This edmeairm allows t;,g i
from Auptst 23, t 993, to Dowmber II, licensees to cmWwrtae to tree byproduct 10 CFBParf 30 1994. This extension is neawary de insterial med-the ymm2stans af the allow crummercial wcisar rescies to interim fias.1 rule smtil ebew as an Byproinct awaenahCriminal continue to prepare bypr uct materist effective fired ruleis a salmand penahmos.Cevemuneetcentracts, under the provisions of the interim final mlemking in respanse to the ACMP-Intergovernmentd relations, hetepes, rde until the broeder rule is e%ctive.
SNM petition acacidass bemdarissues Nuclear materials. Radiation protection.
Reporting and re=Akeqping Section 35.200 Use oI M"
liada.phnrrnaceuticals. Genmtors, and mabrial(mciudegthoselasuas requirements.
A stentKitsforfmagir;gand addneand by the en seri:n fines sule}; h 10 CMPutt 35 umb n Studies NRC expeds that this hmaaritile Byproduct materiel,Onmmel w3nid be currr$stad and shethe beface penalties Drugs, Health'faciltties, ih NRCis extendingibe arpretian the end of 1996. His extenminn of the liealth professicas Med2caldevices.
7 in raragraph (c)(1) of this section expiration dateis me==y to cautinue Nuclear meterials.Occupationabsiety i
39132 Federal Register / Vol. 58, No.139 I hursday, July 32. 1993 / Rules and Keenistiono and health. Radiation prokction, depart from the manufacturer's Westmghouse Plants". NUREG-1432 Reporting and recordkmeping instructions for eluting generators and
" Standard Technical SpeciEcstions, requirementa.
preparing reagent kits for which the Combustion Engineering Plants".
For the reasons ret out in the Food and Drug Administration (FDA)
NUREG-1433." Standard Technical preamble and under the authority of the has approved a "New Drug Speci5mtiona, General Electric Plants.
Atomic Energy Act of 1954, as amended. Application" (NDA), by following the BWR/4". NUREG-1434, " Standard directions of an authoriz.ed user Technical SpeciScations, General the Energy Reorganization Act of 1974.
as amended and 5 U.S.C. 552 and 553, physician.
Electric Plants, BWR/6".
the NRCis adopting the following These improved STS were the result amendments to 10 CFR parts 30 and 35.
5.In 5 35.300 paragraph (b)(1)is of extensive technical meetings and revised to read follows:
discussions amonE the NRC staff.
APPUCABILTTY TO DOMESTIC i 35.300 Use of resopharmeceuticate for industry owners groups, vendors, and the Nuclear Management and Resources UCENSING OF BYPRODUCT 1herePF Council (NUMARC).The improved STS MATERIAL (b)(1) From August 23,1990,to were developed based on the criteria in -
1.The authority citation for Part 30 December 31.1994, a licensee may the interim Policy Statement published continues to rsed as follows:
depan from the package insed in February 1987.%e Policy Statement Anthertry: Seca. 81, 82.161,182,183.186, instructions regarding indications or now reflects modi $ cations result'ng 6a Stat. ess. 04s. 953,954. s55. as amended. methods of administration for a from public comments on the interim ecc. 234. as Stat. 444, as amended (42 U.S C radiopharmaceutical for which the Food Policy Statement and from the 2n t. 2112. 2201,2232,2233. 2236,2282);
and Drug Administration (FDA) has experienm gained in developing the occs. 201. as amended. 202. 206. as Stet.
approved a "New Drug Application" improved STS.lmplementation of the 12 as amen 1244,1246 (42 U.SE (NDA), provided that the authorized Policy Statement through user physician has prepared a written implementation of the improved STS is Section 30.7 also usued under Pub. L e5-directive as required by 5 35.32(c).
expected to produce an improvement in sol, sec.10. s2 Stat. 2951 (42 U.Sc sasil.
the safety of nuclear power plants Section so.34tbl also tuuod under sec.164 68 Stat. 954. as amended (42 U.SC 2234).
Deted at Rockville, Marytand, this 9th day through the use of more operator-Section 30 61 also issued under sec.187. 68 of July,1993, oriented Tecl nical Speci$ cat;ons, Stat. B55 (42 U.Sc 22371 For the Nuclear Regulatory thminion.
improved Technical Speci$ cation
- 2. In $ 30.34, parapsph (i)(1)is laams M. Taylor, Bases, reduced action statement revised to read as fouows:
Irecutin Direcrarfor Opemtions.
induced plant transients. and more
[FR Doc. 93-17463 Filed 7-21-03; 8:45 aml efficient use of NRC and industry iM Terms and condh oMoomea.
resources. no Policy Statement is not a eue eoog w regulation and does not establish (i)(1) From August 23,1990,to binding requirements or limit the scope December 31.1994, each hcensee 10 CFR Part 50 of safety issues for case-specific eluting generators and processing
. djudication*
a radioactive material with diagnostic Final Policy Statement on Technical reagent lits for which the Food and Speelfications improvements for EFFECTNE DATE: July 22.1993.
Dmg Administration (FDA) has Nuclear Power Reactora ADDRESSES: cop es of NUREGs-1430 l
approved a New Drug A plication,,
AGENCY: Nuclear Regulatory 1431.1432.1433. and 1434 may be (NDA).may depart from i e Comminion.
Purchased from the Superintendent of manufacturer's elution and preparation Documents. U.S. Government Printing instructions (for radiophannamuticals ACT>oW: Final policy statement.
Office. P.O. Box 37082. Washington. DC authorized for use ursuant to 10 CFR SUWMARY:his statement presents the 20013-7082. Copies are also available 35.200)' revided t at the licensee Pobey of the Nuclear Regulatory from the National Technical lnformation follows t e directions of an authorized Comm,ulon (NRC) with respect to the Service. 52B5 Port Royal Road.
user physician.
scope and purpose of Technical SpringSeld.VA 22161. A copy is also Specifications for nuclear power plants evallable for public inspection and/or uired by 10 CFR 50.36. It copying at the NRC Public Document as re"lishes a specific set of objective Room. 2120 L Street NW.. Lower level PART 35-4/EDICAL USE OF estab BYPRODUCT MATERIAL criteria as guidance for determining of the Gelman Building. Washington.
3.The authority citation for part 35 which regulatory requirements and DC.ne NUREGs can also be accessed continues to read as follows:
operating restrictions should be through the NRC electronic bulletin
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included in Technical Speci6 cations. It board system. Details of how to use this Authority: Secs. et.161.182.183. sa Stat.
935.548. 953,954 as amended (42 U.S C encourages licensees to implement a system were published in the Federal 2111. 2201. 2232. 2233); sec. 201,88 Stat.
voluptary program to update their Register on November 25.1992 (57 FR 1242.as amended (42 U.SE ss411 Technical Spectfications to %
55602).
o nsistent with improved vendor-
- 4. In 5 35.200 tragraph (c)(1)is specific Standard Technical FOR FURTHER INFORMAT>ON CONT ACT:
revised to read as follows,'
SpeciScotions (STS) issued by the NRC Nanette V. Gilles. Technical l 35.200 use of rad:opharmaceuticata, in September 1992.The improved STS Specifications Branch. Division of ponerators, and respont uts for knag6ng were published as the following NRC Operating Reactor Support. Office of and locanzation studies-Reports: NUREG-1430,** Standard Nuclear Reactor Regulation. U.S.
Technical Specifications. Babcock and Nuclear Regulatory Commission.
(c)(1) From August 23.1990, to Wilcox Plants". NURL1431, WashinEton. DC 20555, telephone (3C1)
December 31.1994, a licensee may
" Standard Technical Specifications.
504-1180.
4 e
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