ML20028H384
| ML20028H384 | |
| Person / Time | |
|---|---|
| Issue date: | 12/04/1990 |
| From: | Cordes J NRC COMMISSION (OCM) |
| To: | |
| References | |
| SECY-90-394, NUDOCS 9101020226 | |
| Download: ML20028H384 (15) | |
Text
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RELEASED TO THE PDR l?
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ADJUDICATORY ISSUE December 4,
1990 SECY-90-394 (Informat. ion)
FOR:
The Commissioners FROM:
John F. Cordes, Jr.
Solicitor
SUBJECT:
LITIGATION REPORT 1990-32 Kerr-McGee Chemical Corporation v. NRC, No. 90-1534 (D.C. Cir. filed November 14, 1990)
On November 14, 1990, the Kerr-McGeo Chemical Corporation filed in the United States Court of Appeals for the District of Columbia circuit a petition for review of three Commission decisions:
(1) the decision to amend the existing Agreement between the NRC and the State of Illinois so as to permit Illinois to assume regulatory authority over uranium and thorium mill tailings, ag_q 55 Fed. Reg. 46591 (1990); (2) the decision to deny Kerr-McGee's motion requesting full adjudicatory hearing before deciding whether'to amend the Agreement with Illinois, CLI-90-09; and (3) the decision denying reconsideration of CLI-90-09, CLI-90-11.
Kerr-McGee seeks an order from the court barring the NRC's relinquishment of regulatory authority contained in the amended agreement with Illinois.
The petitioner's statement of issues to be raised in this lawsuit is to be filed on December 24, 1990.
NRC's Certified Index to the Record is due on January 10, 1991.
No briefing schedule has yet been issued.
CONTACT:
Neil Jensen NOTE:
TO BE MADE PUBLICLY AVAILADLE x21634 IN 10 WORKING DAYS FROM THE DATE OF THIS PAPER 91010202Ee 9Cir.M l
PDR SECY 90-394 PDR D@
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'd 4 The Commissioners
-2 Syncor-International Coro. v. NRC, No. 90-1495 (D.C. Cir., filed October 19, 1990)
This lawsuit socks judicial review of the Commission's " interim final rule" on the preparation and therapeutic uses of
-radiopharmaceuticals.
The Commission's interim final rule relaxes a previous requirement that physicians and pharmacies adhere strictly to the FDA-approved package insert accompanying radiopharmaceuticals.
The Commission's rule requires documentation of each departure from the package _ insert.
The rule was issued immediately, in August-1990, without the usual notice and comment.
Petitioner argues that there was no good cause for avoiding the notice and comment requirement.
Petitioner has suggested ~that the recordkeeping imposed on pharmacies by the rule is overly burdensome.
There have been meetings and i
correspondence between the NRC_ Staff and representatives of petitioner in an effort to clarify the interim rule.
Petitioner also has petitioned the Commission to reconsider the rule.
Contact:
Susan Fonner x21632 Local 1245 v. NRC, No.
(9th Cir., filed-
'Nov. 21, 1990)
A union representing workersRat-the Diablo Canyon.
nuclear power p 27* 'as brought this lawsuit challenging the NRC's denial of their request for an exemption from random drug testing requirements.
Petitioner apparently intends to
-challenge not only-the exemption decision-but also 1
the: constitutionality of.the drug testing
-regulations themselves.
This same petitioner previously brought a district court suit challenging the NRC's_ drug testing rules--(Hiett v.
PG & E).
That suit.was_ dismissed on jurisdictional grounds.
Egg' Litigation Rep. 1990-10, SECY-90-052.
Currently pending.before:the Ninth. Circuit is still-another drug testing suit (Unhoff'v. SMUD),_ this one by workers at the Rancho Seco_ plant, but11n its current posture that
'i
i t
The Commissioners.
case involves a jurisdictional question only.
See Litigation Report 1990-22, SECY-90-177.
Contact:
Charles Mullins x21606 Tcd j ohn F.
Cordes Solicitor
Enclosures:
As stated DISTRIBUTION:
Commissioners OGC OIG GPA REGIONAL OFFICES EDO ASLBP ASLAP SOCY l
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l UNITED STATES COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA CIRCUIT 4
)
KERR-McGEE CHEMICAL CORPORATION
)
)
Petitioner,
)
)
v.
)
Docket No.
)
UNITED STATES OF AMERICA,
)
UNITED STATES NUCLEAR REGULATORY
)
COMMISSION
)
)
Respondents.
)
)
PETITION FOR REVIEW Kerr-McGee Chemical Corporation ("Kerr-McGee")
hereby petitions this Court for review of a decision by the U.S. Nuclear Regulatory Commission ("NRC") to transfer jurisdiction over certain nuclear materials to the State of Illinois'l" State") by means of the amendment to an agreement between the NRC and the State pursuant to Section 274 of the Atomic Energy Act, as amended.
42 U.S.C. S 2021.
The Chairman of the NRC signed the amendment on October 18, 1990, and the amendment, which took effect on November 1, 1990, was published-in the Federal Register on November 5, 1990.
State
-of Illinois (Amendment Number One to the Section 274 Agreement-between the NRC and Illinois), CLI-90-09, NRC (Oct. 17, 1990) (Exhibit 1); 55 Fed. Reg. 46,591 (Nov.
5, 1990) (Exhibit 2).
_ _. _ -. _ _. -. _ _ _ _ _ - - _. _ _.. _ _ _ _ _ _ _.. ~. _.... _..
Kerr-McGee is an affected party because the NRC is using the amendment as a vehicle.to transfer jurisdiction over i
certain nuclear materials at an NRC-licensed facility in West i
Chicago, Illinois, that is owned by Kerr-McGee.
On October 29, 1990, Kerr-McGee filed a petition with the NRC seeking reconsideration of the decision to approve the amendment, but that petition was denied in a Memorandum and Order issued on November 8, 1990.
State of Illinois (Amend-ment Number One to the Section 274 Agreement between the NRC and Illinois), CLI-90-ll, NRC (Nov.
8, 1990)
(Exhibit 3).
This Court has jurisdiction pursuant to 42 U.S.C.
S 2239 and 28 U.S.C. S 2342(4).
Venue is proper in this Court pursuant to 42 U.S.C. S 2343.
The NRC's-decision to transfer jurisdiction to the State through the amended agreement is arbitrary and capri-
~ ious and contrary to' law..
Kerr-McGee prays for the. entry of c
an order barring any transfer to the State of jurisdiction "over materials at Kerr-McGee's West Chicago facility.
Re pectfully submitted,
) /4)
L L
Pb~ter J.
Rickles l
Richard A. Meserve l
Herbert'Estreicher L
COVINGTON & BURLING 1201 Pennsylvania Avenue, N.W.
l Washington, DC 20044 (202) 662-5576 Attorneys for Kerr-McGee Chemical Corporation November 14, 1990
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%.9 % y b"NW-1 SANFORD N. NATHAN, ESQ.
(A w b, 6 b LEONARD, CARDER, NATHAN, ZUCKERMAN, C
2 ROSS,-CHIN'& REMAR 1188 Franklin Street, Suite 201 3-San Francisco, California 94109 1 Wd N N I(k t
Telephone: (415) 771-6400 gg 4
TOM DALZELL, ESQ,-
5 3063 Citrus Circle OGC-M 4 %
- P.O.
Box 47790
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Walnut Creek, California 94596
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' Telephone: (415) 933-6060 gj 7
THE UNITED STATES 8
COURT OF APPEALS FOR THE NINTH CIRCUIT 9
LOCAL 1245-INTERNATIONAL
)
CASE NUMBER F
10 BROTHERHOOD OF ELECTRICAL
)
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WORKERS,_AFL-CIO and
)
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11 ENGINEERS AND SCIENTISTS OF
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PETITION FOR REVIEW
!c g5 CALIFORNIA, MEBA, AFL-CIO,
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UNITED STATES NUCLEAR
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15 REGULATORY, COMMISSION,
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.jg LOCAL 1245, INTERNATIONAL BROTHERHOOD OF ELECTRICAL WORKERS, dI
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19 AFL-CIO, and ENGINEERS'AND SCIENTISTS OF CALIFORNIA,.:MEBA, AFL-20 CIO,. hereby petitions the court for review of the Order of the i
21-United-States Nuclear. Regulatory-Commission-denying Petitioners'
-22 request for exemption from Respondent's: random drug l testing 23 Program as set-forth in Respondent's regulations (see, _e.g.,jl0 24 CFR 26, 26. 24 (a) (2), etc.).
Petitioners were informed-of 25 Respondent's Order by a letter _ dated-September 24, 1990,'from 26 James G. Partlow, Associate Director for Projects, Office =of 27 Nuclear Reactor Regulation.
Said Order was signed for Respondent 28
_on-September :24, 1990, by James E. Dyer, Acting Project Director, e iu
l 1
Project Directorate V, Division of Reactor Projects-III, IV, V 2 and Special Projects, Office of Nuclear Reactor Regulation.
3 PETITIONERS HEREBY REQUEST that the above-referenced Order 4
ae reviewed and set aside and the RESPONDENT be ordered to 5
3romulgate regulations in compliance with law.
6 7
3ated:
November 21, 1990 LEONARD, CARDER, NATHAN, ZUCKERMAN, ROSS, CHIN & REMAR
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By:
,s SANFORO N. NATHAN, ESQ.,
10 Attorneys for Petitioners y
1188 Franklin Street cI 11 Suite 201
- [e San Francisco, CA 94109 o
hljji 12 (415) 771-6400 85 w20 "1 i:
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20 21 22 23 24 25 26 27 28 NEk m
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PROOF OF SERVICE 2
I, Mark Fielder, hereby testify that I am over 21 years of 3
age, and am not a party to the associated matter.
I hereby swear 4
that on November 21, 1990, I did cause to be served on the 5
following parties:
6 James G.
Partlow Associate Director for Projects 7
office of Nuclear Reactor Regulation U.S. Nuclear Regulatory Commission 8
Washington, DC 20555 9
J.D.
Shiffer, V.P.
Nuclear Power Generation 10 Pacific Gas & Electric 77 Beale St.
y{
11 San Francisco, CA 94106 e
o Ec 25 6
53 12 the following document (s):
5 OEE
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13 PETITION FOR REVIEW
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.51jj 14 by placing a true and correct copy in an addressed, stamped N
[$8 15 envelope and placing such envelope in the U.S. Mail.
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{!Esi 17 Dated:
November 21, 1990 BierBj z
18 Mark Fielder NI
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27 28 gew iu
United States 0wtof Appeals UNITED STATES COURT OF APPEALS For tu Distritt et ColumMa Circuit FOR THE DISTRICT OF COLUMBIA CIRCTED. 0CT 19199 CONSTANCE L DUPRb SYNCOR INTERNATIONAL CORPORATION,
-)
)
CLERK Petitioner,
)
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j 90-1495 NUCLEAR PIGUIATORY COMMISSION,
)
)
and the UNITED STATES OF AMERICA,
)
)
Respondents.
)
3-PETITION FOR REVIEW Syncor International Corporation hereby petitions the Court l
to review and set aside 10 C.F.R. 5 5 30. 34 (1) (1) (i)-(11),
portions of the final order of the Nuclear Regulatory Commission entered on August 23, 1990, in proceeding No. RIN 3150-AD43, which impose requirements upon petitlener in violation of the Atomic Energy Act, the Administrative Procedure Act, and NRC regulations set forth at 10 C.F.R. Part 2.
A copy of the order is attached.
SYNCOR INT ATIONAL CORPORATION
)v Alvin J.
an.
~ Ann K. Pol ck Baker & Hostetler 1050 Connecticut Avenue, N.W.
Suite 1100 Washington, D.C.
20036 (202) 861-1500 Attorneys for Syncor International Corporation 1..
-~
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Federal Realstar / Vol. 55. No.164 { Thursday. August 23, 1990 / Rules and Regulations 34313
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NUCLEAR REOULATORY (Lower Lev el). Washington. DC. Single safety of patients, but also recognites COMMISSION copies of the Regulatory Analysis are that physicians have the pnmary esailable from Dr. Anthony Tse. Office responsibihty for the protection of their 10 CFR Parts 30 and 35 of Nuclear Regulatory Research. U S-patients. NRC regulations are predicated Nuclear Regulatory Commission.
on the assumption that properl) trained R* 3 **N 3
%shington. DC 20555.
and adequately informed physicians will AutForizat;on To Prepare FOR FW8tTHER IN'oeuatioN cowTACT:
make decisions in the best mierest of Radiopharmaceutical Reagent Kite and Dr.Tse see Acontests headir g.
their patients.
Elute Radiopharrraceutical Telephone (301) 492-3797.
Under the Federal Food. Drug and Generators; Use of sVP9t1WtWT ARY INFonM ATION:
Cosmetic Act. as amended. the Food Findiopharmaceuticals for Therapy
- 1. Backgmund and Drug Administration (FDA) regdates drug research and the actwcr: Nuclear Regulatory A. Nuclear Medice manufseturer and sale of drugs.
Com:: union.
Radioactive materis!s ce used in including radiepharmaceuticals FDA Actiow: Intenm final rule with request drugs in the field of nuclear medicine.
has regulated the safety end for comment.
Unigs labeled with radioisotopes are effectis eness of investigational Lnown as radio @arma:cuticels. In radioactive drugs since 1975 when FDA sVWMany:The Nuclear Re8ulatorY diagnc; tic nuclea.t tr.coicine, patients revoked its 1963 exemption of Commiss;on (NRC) is issuir g an interim recene these materials by initction, radioactive drugs from the inhalation, or oral administration.
" investigational New Drug"(IND) final rule amending its regulations related to the preparation and the Physicians use radiation detection regulation.The NRC withdrew from equipment to visualize the distnbution regulating radioactive drug safer) and arrkace I cals.This interim rule f a radioactive drug within the atient.
efficacy to avoid dual Federal I
die l
e11ow s licensees who e1ute generators Using this technology,it is possi le to regulation, but continues to regalate the and prepare reagent kits to depart frnm locate tumors. assess organ function. or radiation safety of workers. patients, the manufacturer's instructions for monitor the effect.veness of a treatment +
and the ublic' An estimated 7 million diagnostic elution and preparation in the package nuclest medicine procedures are Each new drug approved for human insert la part of the Food and Drug performed in this country annually. In use by the FDA, including Administration (FDA) approved therspeutic nucleat medicine, radiopharmaceuticals. has labehng labeling) provided the beensees meet radiopharmaceuticals are administered approved by FDA that includes a certain conditions and limitations. The to treat various medical conditions (e g.,
description of the drug. Its l
Interim rule also permits NRC licensees hyperactive thyroid). An estimated pharmacology,indicatiors for use, usms byproduct materialin a 30,000 therapeutic procedures are contraindica tions, wa rnings, adverse radiopharmaceutical for a therapeutic performed each year, reactions, dosage and adm nistration, use to depart from the package insert and other information. The labehng of regardmg indications and method of B. Regulatory Progmm and Policy certain drugs, including some administration if certain requirements Regardmg Medical Use of Bypeduct radiopharrnaceuticals. includes
[
are met. This amendment is necessary MCI'fic/8 manufacturer's instructions that specify p
to allow health professionals to provide In a policy statement,"Pegulation of the method of preparation. FDA reviews d: agnostic or therapeutic medical results the Medical Uses of Radioisotopes."
and approves the information in the L
not otherwise attainable or to reduce published on February 9.1979 (44 FR labeling to ensure that it accurately 1
tr.edical nsks to particular patients BM1, the NRC stated' reflects the data on safety and because of their rnedicalcondition while (1) iSe NRC will;ontinue to regulate effectiveness on which the drug continuing to protect public health and the medic.et usec
- of radioisotopes as approvalis based. NRC has,in the past, j-safety adequately. The interim rule necessary to provide for the radiation relied primarily on FDA's determination apphes only to radiopharmaceuticals for safety of workers and the general public. of a dru8's safety and effectiveness which the FDA has approved a "New (2) The NRC will regulate the Drug Application"(NDA).
radiation safety of patients where when it is prepared and used accordir's to the approved labehng. which some carts: Effective deter From August 23,
"'f '
NRC regulations refer to as the package I
w o
s and s, or 1990, to August 23,1993.
E "d " 0 ^' "' *" *
"'"N8 compliance wi these standatds. are protec' tion of the public health and Comment closing date:in view of the insdequate.
interim nature of this rulemaking.
(3) The NRC will minimize intrusion
- I'lY' comments will be welcome at any time into medical judgments affecting -
NRC regulations in to CFR 35.200(b) during the three. year period.
patients and into other areas require medical usa licensees to prepare aoomasses: Submit written comments traditionally considered to be a part of radiopharmaceuticsis in accordance thjrectice of medicine.
with the manufacturer s instructions in and sug2estions to the Secretary of the e
j Commission, U.S. Nuclear Regulatory a ne NRC has the authority to regulate the packs e insert (a part of the FDA-Commission Washington, DC 20655, medical use to protect the health and approved abeling).Similar I
Atlention: Docketing and Service requirements am placed on commercia)
Branch. Hand deliver comments to f1555
'-Medial war u denned ta to cru ut mens nuclear pharmacies through NRC license the **"a"I '**3 * ' " 1'd**atmoon conditions. Regulations in 10 CFR 35.300, Rockville Pike Rockville. Maryland, d bmodxi meanet w m"e adieuen meMast =
"Use of Radiophermaceuticals for between 7:45 a.m. and 4:16 p.m. on Wmn beme.ie e t.c.nu inued by a s""
There py " requin, among other things.
a me p um d medic 1= m Federal workdays.
.eco,e.nc, Copies of the regulatory analysia.
Tem'er et the t'niwd suin. the Dumci er" that the licensees compIy with the environmental assessment. and the CAmbie. W 6e CommonwuNh &ne mco?
package inHN IMtrudons MgarMS
-wedeut u
- includa the da a nc ead comments received on this rule ma be is,,,,,,u,=
.r r,4,,ph.n.m,,uc.i.. ihe indications and method of -
c administration for the therapeutic use of enmined at the Commission e Pub ic prunce et nuie., enedicme bvi do.. nei menude la Document Room at 2120 L Street SW.
- o diesno.uc ie it radiopharmaceuticais.
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M314 Federel Regisest / Vol. 55, No.1m / %ursday, August 23. 1990 / Roles end Raratetiers IL Peutlen for Rulemaking Filed bp the prneription by en aothonred user.
scans for patients who bate pelmonney e
America.n Colley of Nuclear Phpiciamo physicura, curreat NRC regulations h)pertension because the tenges of.
. and to Society al Nuclosr Meecies snerely restnct their actvity.The specinc activity and particle On June 8.1969, the NRC deckeled as petitionees bebeve that their concentration sieen a the par.hp -
PRM f ml kt profeseiorsal activities are curtailed by insert would be esceeded.
. dated e5 wh h we file by the hmitations imposed by the NRC on
(:) Licensees are not able to add the American College of Nuclear nuclear phy N and pharmaci.sta.
ascorbic acid as an entioxident to Tc-Ph)sicians and the Society of Nuclear A notxe of receipt of the petition with 99m-D'!TA. Mich wov!d increase Medictne (ACNP-SNM). The ACNP.
a public comment period of 90 days was stab!!!ty and enhance tmege goaltry. -
SNM m composed of oser 1* 000 published in the Fodarat Register on because NRC tcptations do not permit individuals who participate in the September 15.1989 (54 FR 38:39). W departure from the reanufseturer's raedical use of byproduct ma terials.
Federal Register notice set forth the instructions for reconstituttrig reagent Members inctude physicians, petitioners' proposed amendments to 10 Mts.
technolog sts, and nuclear pharmacists.
CFR parts 30,33, and 35. Including the (3) When evaluating potential blood As charactansed by the petitionars, the deletion of the restriction regardmg the transfusions, licensees are not able to I
phnicians supervise the preparation -
preparation of redtopharmacepticels in perform in vivo crossmatching uoms and administratico of I 35 200(b) and the deletion of the potential donar red cells radiolabeled radiopharmaceuticals to diagnose and restriction in i 35.300, with twpect to with Te-Wm because this is not treat patients Also, technologists following the packap insert instructions provided for in the package insert administer radiopharmaceuticals to regardmg indications and method of (4) Ucensees an mot able to un P-32 diagnose and perform clinical adminletration (54 FR 36240) The sodium phosphate to treat prunary procedures under the direction and comment period closed on December 14.
T/.xmboq6emic because this une la supervision of an autbonzed user 1909, and 4e6 comment letters here ben not spec 4fied in the pscLage insert.
physician.8 Nuclear pharmactsts received.
recorstttote radiopharmacecacal kits, Comments were received from many fil. Need for a Rule compound radiopharmaceuticals. and different sources such as borpttals, Informanon submitted by the ACST-dispense radiopharmaceoticals for pharmacies, and medical associates.
SNM in the petitjan for rulesnaking sed rnedical purnoses.
About 60 percent of the letters were obtalried during subaaquent discussions Among otber thugrs.' the pedhoners similar to a form letter written for with licensees andicates that the requested that the NRC amend its
. members of ACNP.SNM. Noe letten requirersaata in i 3s.300(b) redanbng regulaboos at 10 CTR part 35,"Medaal intheated agreement with the petitiac on preparation of radiopharmeanteala Use of Byprodect Meterial" to recogruse all easential points. Fifteen percent of and in I 3s.100 regarding indications their appropriate practxe of medicine the comment letters were similar to e and rmethod of edennistration for and to allow (1) departures froca the forrn letter written for the staff of Syncor therapy procacharas are preventing tr.anufactaarer's instructions for International Corporstloa, also agreeing authoruad user physicians from preperme diagnostic with the assertions in b petillors.
prmiding certain auclear medicine -
radiopharm-*4 and (:) the use of Twenty.6ve t ed the responses clinical procedums. Ucanoe conditions eadiopharmaceuticals for tharapeut.c were lessere other Ladtvidsals, similar to 6 aluso(b) estrently pleasd on inacations and methods of Most letters (99 percent) supooned the commarcial nuclear pharmacies have administration act included in b fetition and seetad that the NitC shoeld the same effect. For name uncommon pockage insert approved by the FDA.-
amend its regulations to relax tan aurrest sheense states or petiant conditions, in The petitioners stated that, under restruamme on the practice of nuclear order to provide pooper patinal cars. it current NRC regulations, members of the medjcine and nuclear pharmacy.The may be ascessary to depart from the
- petitioning crganLzations believe they esajerity of abese lettem &d not provide FDA. approved laseructions le obtain carmot appropriately praetice thetr
- professions. W pettionen also sieted spac4c seppening totionale. Some chagneens or therspautic medical results comunsolars provided rathmale and -
not o&arwise attainable er lo reduce that authorized user physleians carmot examples of clinical cease ths.t the medical riaka to partscular petisare presenbe certain radiopharmaceuticals cornmentees bebnee demonstrate how because of their medical sandstaen.
or routes of administration for proper the reiesant NRC regulations prevest -
% NRC beheees that comanued patient care, even though they tielieve
- physicians from providing proper ones application of these restrictions they are permitted to do so by the FDA for bit pation h comewnum goverrring b pmperstlan of und by thetr State medical!) censes-
- According to the petiboners, nuclear i
- stened that, ahbosch a licocese may -
radiopharmaceuticals end the pharmacists have been disenfranchised : request an exemption from specine indicatlans and the method of requiremente in the angulations on a admirdstahon for therapestic ase of cs a profeesional entity becsese case-by. case beans, this exemptami radiopharruecseticals would not porosit actmtes that they bebeve see gnaitted b the FDA and by the States are not process is tune censumums and proper patient care to be prounded to -
cerebersome, h comeneeters behew wme patienta.
(
owed ender WC regulations The ~
that a delay in order to obtain NRC Under la 191 Medical Use Po!!ey petititmers etsted that, althoesh a appouses for e partcular departase Brom Statement (44 71t g34L February 9,19"g).
nuclear phermecist is authortaad bY the pechage lasert may. in same cassa, the 1GLC stated that it would regulate State license to prepose
- jeopardine the patient's health.Some the medical mae of byproduct malarial in todopharmaceuticale spes receipt of a exaraplea of chnical cases the order io protact the health and safety of ca===a=rs provided are desenhed wotiara, patieota, and the pubhc. la
%=== he=== *auw=d==r P67mehe*
beisen general. NRC regulatory reruiremenla
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(1) Ucensees are not able to ese Te are odented to ensure that the property '
D'j,lLT *d*** """ *' **
- 99m macroaggregated albeunin wfth high prepared radiopharmaceuticalia -
spectue actinty and low particle admintasered to the sorrect patierrt as menor.w = m.e. ease.e n nec e, in,,un e.,,,d,, nie,
n,,,,,
concentrution so oefety perform leeg prescribed by an anthortred user p
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lti' Federal Register / Vol. 55. No.164 / Thursday. August 23. 1990 / Rulen ed Regulations 34515
\\*
physician Aside frorn the requirements for therapeutic use. prnided a proper the departure, ar.d (3) a brief statement in i 35 Mb) and i 33 ni other record of the departure is made These of the reasons wh) the d*parture from requirements in prt 35 such as the use records will be esammed by the NRC to the manufacturer a metructions would of dose cabbrators are miended to determine whether to entend the mienm obtain medicai results not etherwise ensure that the patient rectnes the period for the rule. make the rule stiamable or would reduce me6 cal prescribed dese. NRC's regulatier.s need permanent. or revise it based on the nsks to particular patients because of to prouJe a balence between adequate nature of reasons for, and frequency of their medical condition. The NRC contro!s and ascidance of undue departures The NRC will provide FDA recognizes that the physician may face mterference in medcal jud ments. The the opportunity to review this sesere time constremis dunr.g an E
high lenel of pubhc health and safety informa tion.
emergency; therefore an exception has protection that accrues from follomrg Because these amendments involve been provided in i 35.200(et Under the the FDA approsed instructions must be rehef from restnettons which if left in esception. a wntien directn e is not balanced with the need to depart from place could base en adierse impct on required before prepanng the those instructions to obtain diagnostic pubhc hes!th and safety. and because ts&opharmaceuticalif an authonzed or therapeutic results not otherwise the NRC has recened and considered user physician determines that the delay attamable of to reduce patient nsk in pubhc comments on the petition for in obtaining a wntren 6tective would some uncommon 6: esse states or rulemakirg good cause exists for leopar&ze the patient's health The patient con 6tions in order to provide omitting the notice of proposed wntten directive together wnh a proper patient care.
rulemakir6 and the pubhc procedures statement of the emergency The d agnostic use of thereon es unnecessary and contrary to determitiation must be prepted with 3 radiopharmaceuticals is. in most cases, the pubhc interest. and for making these working days of the emergency an area of mhetently low rad.ation nsk amendments effectne upon pubbcation administration. The wntten &rectne to patients (Pohe) Statement. 44 FR in the Federal Register without the and a record of the number of ptient 8m. February 9.19*9) Although there customary thirty.da) notice This administrations under each departure are greater risks inherent in the use of intenm rule will te minste 3 yents after must be retained by the beensee for a therapeutic lesels of radioactive drugs the date of publication in the Federal pened of 5 ) ears and made esailable for in hght of the information provided with Register.
NRC inspection, and gathered subsequent to the petition.
IV. Future Agency Action This intenm rule does not address the NRC does not behese that hmiting departures from " Investigational New the therapeutic use of This intenm rule amening 10 CFR Drug" (IND) generator elution radiopharrnaceuticals in all cases to parts 30 and 35 representa only one matructions or IND protocol directions only the mdications and methods of phase of NRC's resolution of the ACNp* for reagent kit preparation because the admmistration specified in the packaF, SNM petition for ruler *aking Dunng the departures may compromise the msert is lustified. Moreos er. as stated in 39 ear period. the NRC rney moify the scientific integrity of the clmical i:s 1979 policy Statement. the NRC intenm rule of take other regulatory traestigabon Therefore. bcensees must recognizes that physicians have the action it deter: runes necessary to protect continue to follow the IND generator pnmary responsibihty for the protection the pubbe health and safety. Based on elution tnstructinns and IND protocol of their patients.The Corninission contmued NRC analysis of the ACNN directions for reagent kit preparation.
beheves that basic decisions concernmg SNM petition, the cornments on petition the 6agnosis and treatment of disesse and on this intenm rule. expenence with Section 33 300 U83 of are a part of the physician patent the implementation of this intenm rule, Rodsophormaceuticols for Theropy relationship and are traditionally and other information. the NRC may For a radiophartnaceutical for which considered to be part of the practice of propose amendments to this rule or to the FDA has approved an NDA. the medicine.
other provisions of10 CFR parts 30 and amendments to i 35.300 would permit a The NRC has made a determination 35 as part of its resolution of all the I censee. under certain ctrcumstances, to that continued apphcation of the sublect issues raised in PRMM use therapeauc radiopharmaceuticals requirements. without exceptions. may V. Discussion for indicauons or a method of adsenely affect the nbbc health and admirustration not specified in the safety because the delivery of proper S'Cfl0^ 33 200 U88 0/
package insert. Specifically, these uses patient care may require,in certain Radiopharmaceuticals. Generefore, and would be permitted if an authonzed user instances. that some Recsent Kiu for /mesmg and physician makes a record of the radiopharmaceuticals be prepared and hhrotion Studies departure which includes the specific admmistered in a manner different from The NRC believes that persons nature of the departure and a bnel that stated in the FDA. approved licensed by the NRC to elute generators statement of the reasons why the instructions.The NRC has reviewed the and prepare reagent kits should not departure would obtait me6 cal results infomistion on t.uclear toedicine clinical always be bound by the requirement not otherwise attalnable or would procedures and believes that adequate spectfied in 10 CFR 35.200(b) to follow reduce medical risks to particular protection of the public health and the manufacturst's ins tructions for patients because of their medical safety can be maintained while, at the rediophmaceuticals for which the FDA condition. A record of the departures name time, proviing proper patent has approved an NDA/fhey should not from indications and method of care. Hence. the NRC is issuing an be bound if they have a wntten direcuve administration and a record of the intenm final rule that permita. on the (es, prescnption) made by an number of pabent administrations under direcuon of an authonted uset authorned user physician directing a each departun must be retained in an physician, departures from the specific departure for a particular auditable form and be available for manufacturer's instructions in patient, or patients. of for a inspectaon for 5 years. If a kit et preparaing ra6opharmaceuticala and radiopharmaceutical, and which generator for a ra6opharmaceutical for departures from package inserts for includes (1) the specific nature of the therapy were approved by FDA (through indication and method of administration departure. (2) a precise description of an NDA). this intenm rule does not i
l l
-~- -
- ~ _. -
[', -
48r30 Pedses! Register / Vol. 58. No.104 / Thitsdsy. August 2.3. 1990 / Role.s and De9 ^ -
authorise departarw froen the nese amendmertts to I 30.M take complying with the requirements of rnanufactorvr's Lrmen#one for elunrq preceder ce os er the teatrictive i 3SR the pr.cretor or preparing b therapy ccrghttcms (ie., on elutwg generators Lit.
and prvparing rsegent kits.for NOA g.7 %
g Section.w.M Terros and Conditio.~s of rad opharmaceuts als)in the Iacertaes of nndirs o!No Significont Ert'i*on:~e:stol t n 33,,
commereal nuclear pharmacaea.
/m; vet: A rollobihty Therefore, those parts of the beenu o
CorrJtere:al nuclear phartnacies are conditions no longer apply dunes the 3 The Commission has determined beensed pursuant to 10 CFR part 30.
> eat period when the tnterim rule ts in under the.*sations! Emironmental Pebc)
' Rules of Generej Applicabihty to effect.This intenm rule does not Act of198R as amended, and the Domeetic Licensing of Byproduct address departures frorm IND generstor Comminion's regdations in subpart A MatenaL* These hcensees are required elution instructions or LND protocol of 10 CFR pan 81 that these t y a heense condition similar to direcuans for reagent kit preparanon.
amendrnents are not a maior Federal I 35.20D(b) to elvte generators and thus beer.saes shall connnue to follow action significantly affectmg the quality prepare reagent kits in accordsom with the LND instruchons, of h human enviroament and therefore the manufacturtr's instructions. The NRC beheves that authonsed wars.
Continuing Applicobility of Regulatory an environmentallinpact statement is obtaining raiopharmaoeuticals from A'7"l#'*'"'#
not required. This rntarirn rule amends i
NRC regulations to permit licensees who comrnercial nuclear pharmacy licensees The NRC notes that this intenm rule elute generators and prepare reagent should not be boued by this rsetnction dou ooi relieve beensees from the kits to depart from the manufacturer's J
in the commercirJ onclear pharmacy requirements to compty with other instructions if those feons hase a hcense Therefort, the NRC is amendtog applicable NRC FDA and other Federal written directae inade h an outbonzed 10 CTR 30.M.
- Terms and Con &tma of or State regulations or NRC orders or user physaan that requests a specific Licenses.* to permit actions within the license conditions concermns departure for a panicular patient, or scope of those permitted by the new possession or une of byproduct matarial patients, or for a radiophaittaceutical.
I 35.200(c). For stuations not withm the for medical une or other purpmee as scope of the amended i 30.M. a specified in 10 CFR parts 30. 32. 33, and Thts erective muet provide the specibc nature of the departme, a precise commercial nuclear pharmacy licenaev
- 35. Moreover,if a radioactne bio.ogic desenption of the departura, and the may fue an application to have its recenes a prodvet license approval bcense amended to permit specific (PLA), this mterus rule &ws not reasons wtry & deparntre from the manufacturer's instructsons would departures from the manufacturers authonse deprturm from the InuructJons for identified products.
manafseturere instrucuona fo' obtain tue& cal resuha. diagnosuc or.
therapeubc not otherwise attainable or Under the interim rule commercial prepantg the biotopc. In a6htm Lf a nuclear phannecy heansees would no Lit or geneentor for a ndd reduce medical nsks 4 pnieder l
longer be bound by the requirement in radiopharmaceutical for therapy pahente becanoe of thelt me& cal condition.1he amendinerit does not their beenses to follow the receives an a;+ roved NDA IN laserim l
manufacturse's instructions for a rde dame not anthonse departures (me addam Www fnia IND pm radiopharmaceutical for which the FVA the marsulecturer's a2stnrettone for
- * *I"" *Ch*"' "
P"'*
has approved an NDA if they have a ahseng the generator or prepenne the
",g"*8"" U 78'"
C wntten directive nude by as authurtand therapy kt! Neither of theme approvals user phyadan drecting a specfbc edoes at this ilme end neither le M PM Man departure for a particular patient, or authorized by cuneet requistions.
[',9,"((4*""*[
{d$*5$tn hc' Radiction Safety llesponeibillbn of fellwwtug 16e pochee lmtmstkon g
of the departm. a precies desertption of Medical DWe Lieetween regarding ind ca tjena and method of the departure, and why the deportm NRC medical we kcansea m admirastnrtsoa. The inse n rde does from the snarmiseturer's instructione required by i 35.21 to appoint a not a#ect the anassption in W Cm part would obtetn mediest reenits not Radiation Safety Officer (180) 20 far the intentional aposum of otherwise attainable or would reduce responalble for implementang the panertte le reibatson for the purpose of medical risks to particular patiente licensee's radiation safety gram The me&cel diagnanas and therepy. -
because of their medical conchHon. As licensee le required, the RSO, lo Althoutrh the rule mey cesse some in i 35 200(c). there is en exception to
' ensure that red!atlon safety activilin patients to be exposed to Mgher or the reqtnrement fe. ; niitten directrve are being performed in accordance with lower levels of rechetion than otherwise before preparing the approved pmeedures and regulutory expected. those expoems wooid be radiopharmacetticalin an einergency NnA ds in the daily operathm of given to obtain medscal reso64e not situation if as autbomed oere phyeiden the lloensee's byprodud meteriel otherwise attainable or lo reduce other determines that a delay in obtemms the progre a. Nothing in thle rutemeking rieke lo the pet!ent. It should be noted i
l written dweettee wonld teoperilise the refleves the Keensee from complying that canent reqetremente do not limit patient's health. In tMe case, the with See requirements oM 36.F1.
the redietion dose peeecribed by the commercial nucleat pharmecy licensee In accentense with to CPR 36.22. NRC aptbrtaed user physician for eHhar shall obtein the wrteten directtee fresa moamlinsinution 14eensees are diagacets er
.De oswndmente the euthonced userphysician wifWn 3 vegated to estebitsh e Rediaten Safety would nei reflew frors working days of the preecribed Committee (RSC) to oversee the ese of meeting the regeremenes in W CFR departae.%e dhective meat contain byprodwet malerial.ne defies of the parts 20 and 38 that restrid redletion informatsoa pegardmg Wie einergenc RSC are spedfled in f 38.13(b) and exposure te medical care pereennel in
- and all on,ar regweed icJormenea y include review, on b besie of sedery, the restricted eres or to the generel Licensees eheir keep ttsos, recorde in as of numerees eepoc*e of a Deensee's vee pubas in the unrestocted eres. or ev& table ions and avaflable for of byprodvet meteriel. Noesna in tWe radioactwe efthamt reieeees. M is inspecGon Ier 5 years.
ruh making renevei the licensee from espected that there weeld be no
- ~ <,
g
iI Federal RMerce / Vol n No.164 / "Thrsday. Aurust ?.J.1990 / Rates and Rmelse>cns 3g17 ajnificant change N4rr incerow or the3 do not itnohe an) prmisions that preparatic'n instructions (for o
dectrate,in rad,ahon espotore to the would impose backfds as defined m 10 radiopharmaecuncals authertzed for tise pbhe or to the craironment teerond the CTR 501on(a)(1) pursuant to i 21:00) provided ht:
esposun, currenth resultmg from delaer the dose to the patient y og g (i) N licer soe has a written directne tr.ade by an author red user physician The hrnironinental Assessment and 70 C TR /b ri.to Ho<hna cf L 'upaficant impnt is that directs a specthe departure for a D product resterial Criminal penalt3 particular patier t or patients or for a 3
,o,idable for mtpection at the NRC PubLc Dorement Room at 2130 L Stract Contnment contracts, radiopharmaceutical. and wbch NW,. (twer Les clL W ui hington. DC.
intargournmeNat relath Isotopu.
Includes the specific nature of the Segte cop 4es of the Aumment ute Nuclear materials. Radiation protectinn.
departure, a precise description of the einilable from Dr. Tse (#c aoonessas Reportmg and recordkeeping departure. and a brie.f statement of the hr odmg)-
requiremer.ta.
recons why the departure from the ananufacturer s instructions fnr ID;*ncork Reductivo AtI St::<"r ent
'O 'IN f*
A 0
b P'*Pa!W8
)* redroF erm*Ctuticed This final rule amends inferrtation Dyproduct material Criminal penalt).
- ockl obtein medical results not toller:tton requirements that are subject Drugs. llealth facihtles. }tealth otherwise attainable or would reduce tn the Paperwork Reduction Act of1980 professiens. Incorporation by reference.
medical rrske to particular patients (44 U.S C. 3501 et see ). These hiedical devices. Nuclear rnaterials, ber.ause of their tredical condition.m Occupational safety and health.
licensee shall keep the wntten duective Radiation protection. Reporties and and record of the number of O
of on gerneri e d u it epproval numbers 3150 0010 and 3154-recotS eeping reqv;rements, prescriphons drepemed imder the 0017.
For the reasona set cu in the departure in an auditable form and Pubhc reportirat burden for rtna peramble and under the authonty of the available for inspection for 5 years. or co!!ection ofinfortsation is estimated in Atomic Ene*gy Act of1954. as amended.
(h) An atabonard user physician s verage.05 hout per res ponse, includmg the Energy Reorgamrataan Act ofIg 4.
determines. n accordance wtth the time for rmewmg tretructions.
as amended. and 5 U.S C. 550 and 23.
l 35 00(s). that a delay in prepanns the scurching existing data soorces.
the NRC is adopting the following f*diopharroeceuticalin oroer to make s pthenng and mamlaimag the data amendments to to CFR parts 30 and 35 wntien directive escold jeop.rd.2e the needed, and completirg and rettewing patienre hesith becaame of the emergent the collection of infortnation. Send PART 30--AULIS OF GEh6ERAL nature of the patient a raedical comments regardmg this burden APPUCAStuTY TO DOMESTIC condation. In this casa the hceasee shall estimate or any other aspect of this LicmSWO OF BYPROD"CT obinia the wnstes direc0va mede by the collection of information. Including MATERIAL actbonsed esw phpscaan which WC n
M m
a e
h o
t a s
f" '" 0 N' 8'
N Atangrettant Bnsach 94NBS-77144 U.S.
specified in pasagraph (i)(1)(i) of this Nuclear RequWory Cumaussion.
Aukrier sess at ac. tet Ic, talles, se sachon wahto 3 worijnt a): aLet the d
Washiognan. DC 2053L and to tae Desk SM Bn 94 92 9% 951 as amended. sec.
prescribed departure. Tha Lcensee shall Otheer. O(Goe of Infonnation and
.ex as mat on n amended (c U s C rot.
keep these records in an audaable form Reg 4 story Alfairs. AEOB-Jais(3130 Nm 1, $ $ $g. iga] **
aind m h invecaim for 5 years.
0017 and 31&a-0010). O!nce of
.,nsed d last uso (c UAc nau. sen.
M N ** **""d I" hianagement ano B.uiset. Washinggen.
Sened paragraph (i)(1)of thts sectten are DC 20503..
Section af else i.eund under Pob L es-permitted notwithstanding more ReyalarpryAnc/y.sar sat anc. to. s2 sm assa tu UA.C sasn rootnetire language in hornse condihons Secnoa mMbl ahe luued undet sec. su 6e opleu those licewee conshtierm The Comrninios has prepared a stat. vs4. as amended tu U.st 2:341 specific.ty rebece g 30.3.i(tt regulatory analysis for thane S'C"i 30 et atso issard onder sec.1s'. as (3) NetNng in Ib section reheven the amendments. The anaheis etamines the 5%%#$5C licensee fnim e er phing with other benefits and impacts comaklered by the amended Mt USC std ::m. es Se ses. n eppficab4e NRC, PDA and other Federal sec n a, anM NRC. The regulatory analysie la (cl. (0. Ist med trt sauta) and Ict and as.53 or Sute regolaticma governbg the strailable for inspeclissiat the NRC e,e imamed ender sec. teth, as Seat Ma. as elution of generators and prepetution of f-Pubbe Document Roosa at 2320 L Street erneaded (42 U.sc 2:mibik aad H asA reesent kits.
NW. (Low er Les e11. We sbmgnaa. DC.
30 9. 234(sL Mx aasa.ac.s2. aa.n and Single copies are avallable from Dr.Tse 30386b) and (cJ are tas ad under see, seio, se PetRTS N WatOF (see apoetsees heatftngy stat osa, na senended to U.5 C 22ctiof).
8YPH000CT MATEntAL The Con minton retraets pubhc
- 2. la e aw.34.Parastaph N is addad to comments cm the regulatory arrehvit read as leHe*
3, m _,o g,,y,,, w w partasi, Comments are welcome et arry tune
"'I"d 8end *a (ouossa.
durms the three year pened that the 1 stL34 Terms and consense of teenses.
Aashnessv sees m.1st, es.1ms. as stat intentn finel rule as in effect. Cowsments gn SE SE en as th let 1154 2111.
on the analysis may be evbmbed to the (i)ft)From August 23.1990.to August tapt ass.asas t. c. am as saac ma. a.
NRC as indicated under the Accmassas 23.1993, each hcensee etc6tts generators
- d*4" N 88'4
- hamens, and procaasing radioacth, znatorial g [ g g es u
Back//f Analys/,
N W 8'"'
the food and Drug AdarMtetrsMon asJo tal and m as.rt tal aad !% n :. as **.
n25. 3uf f alde) and $ n*1 (as. nn The NRC has determined that the (FDA)has % J a 'Wew Drwg 3:3e 9 9 4 n ei g y et 35 s3 k H M 7530 teekitt rule. to CFR stLios, does not Appncahon* (NDA) racy depart frorn geHet. Mti. tai med M as as sam. aus epply to these amendmems teacasse the manufacturer's eistian and (aHfk aus. 3SAS (aMak Eat nahek
- (
34518 Fed:ral Register / Vol. 55. No. If>4 / Thursday. August 23. 1990 / Rules and Resulctions 35 i:o 35 200 ib) and te). 35 2041 1 and (bl.
emergency nature of the ratient's 10 CFR PART 110 35.:o5. 35 20 35 300 35 slotal. 35 315.35 3:o-medieal condition. the 35 sac 35 mal 35 ene is) and (cl. 33 410tal-radiopharmaceutical may be prepared r,ig siso. Aos, 35 415. 35 42o 35 500. 35 5:o 35 60L 35 606.
without farst makmg a wntten directive.
35 610 f a) and It t 35 615. 35 6 o. 35 63o (a) a nd (bl. 35 632 te HO. 35 634 la He). 35 636 lal The authonte d user physician shall Export of Components for Use in and it L 35 Mi la) and (t135 643 la) and (b).
make notetion of th. determination in Gas *ous Ottfualon Enrichment Plants:
33 M5 tal and Ib) as 900. 35 elo 35 e:o.
the wntten directive within 3 workmg Cortaction 35 e30 35 932. 35 934. 35 u0 35 Ht. 35 950, days after the preser bed departure.
35 960 35 9c1. 35 o o and 35 rt-are asved (2) The beensee shall keep the wntten actNCv: Nuclear Regulatory unde
- sec.161b 68 Stat 948 as amended (42 directist and a record of the number of Commission' U S C 2:o1(b)) and il 3514 35 21tb)-
patient administrations under the 35 ::(b). 35.:3(b). 35 :7 (a) e ndic). 35.29(bl*
departwe in an auditable form and ACTION: Fmal rule. Correction.
35.3s teHel. 35 36(b). 35 5o(e). 35 51td).
available for inspection for s penod of 5 35 53tc). 33 59 Id) and (e)(2). 35.59 (s) and (1).
suwuamv:In the Federal Register on 35 *0ts) 35 80th,35 92tbl. 35 :oole). 35 204tc).
I. ' ' f8 35 sootb). 35 310(b) 35 315(bl. 35 404(b). 35 400 (3) Nothir.8 in th;s section relieves the July 26,1990 l55 FR 3M491. the Nuclear (b) and Id). 35 410(bl. 35 415(b). 35 tlo(cl.
hcensee from complying with other F.egulatory Commission i880ed a final 35 617elt4). 35 630lc). 35 e,32(pl. 35 634(0, applicable NRC. FDA. and other Federal rule which clarifies the courage of 35 636(cl. 35 Mitc). 35 643(c),35 645. and or State regulations governir:g the epecially designed or prepared nucle.it 35 647(c) are issued under sec.1610. 66 Stat.
elution of generators and preparation of assembhes and components for use in a 950. as amended (42 U.S C. 2201(o)).
reagent kits.
geseous diffusion er nehment plant. As part of the final rule. portions of NRC's
- 4. In ( 35.8. paragraph (b)is revised to
- 6. In l 35 300, the existing text la export regulations were restructured.
read as follows:
designated as paragra[h (a) and a newH weser. the amendments necessary to aragraph (b)is adde to read as follows..
change the references to these 135.8 information con +ction requirementa owe approvst restructured provisions were 1 35.300 Un of radiopharmaceuticata for inadvertently omitted. As a result. parts (b)The approved information nerapy.
of the export licensing regulations now collection requirements contained in this contam erroneous references Th s part appear m 11 35 12.35.13,35.14.
(b)(1) From August 23,1990, to August action is necessary to correct the 35.21,35.22, 35 13.35 27,35.29,35.31.
23.1993, a licensee may depart from the mconsistent references and reDect the 35.33,35 50,35.51,35 53,35 59,35 60, package insert instructions regarding restructured portions of the export 35.61,35.70.35.80, 35 92. 35.200.35.204, indications or method of admmistration regulations.
35.205,35.300.35 310,35.315. 35 404.
for a radiopharmaceutical for which E n te m o a m W 26. M.
35 406. 35 410.35 415.35 606,35.610.
FDA has approved an NDA. provided 35.615,35 630. 35.632, 35 6}4.35.636, that the authonzed user physician com rumTuta wonWanom COM ACT:
35.641. 35 M3. 35M5, and 35 647.
makes a record of the d parture which Eleme O. Hemby. Office of includes the specific nature of the Governmantal and Pubhc Affairs. U.S.
- 5. In 135.200, paragraph (c) is adeled to departure and a brief statement of the Nuclear Regulatory Commission.
read as follows:
reasons why the departure would obtain Washington, DC 20555. telephone 301-rnedical results not otherwise attainable 492-0341, or loanna M. Becker. Cffice of
,,,[,,, h'*
C or would reduce medical nska to the General Counsel. U.S. Nucleer and wmon stuom.
particular patients because of their Regulatory Commission. Washington.
medical condition. Licensees are not DC 20555, telephone 301-493-1740.
(c)(1) From August 23.1990, to August manufacturer, depart from the authorized to
- Instructions for eluting a list of Subjects in 10 CFR Part 110
.'3,IN3, a hcensee may depart from the manufacturer s instructions for eluting generator or prepanns any kit for a h
Administrative practice and generators and prepanng teagent kita radiobarmaceutical for therapy.
(2) e licensee shall obtain this procedure s. Classified information.
for which FDA has approved an NDA'n record within 3 working daye of the Cnminal penalty, Export. Import.
provided that the licensee has a wntte administration and keep th2: record and Incorporation by reference.
directive made by an authonzed user a record of the number of patient Intergovernmental relations, Nuclear physician that directs a specific admirustratiorm under the dedarture in matenals. Nuclear power plants and tffal.
an auditabla form and avail te for reactors. Reporting and recordkeeping ie s or fo a ta opha ac inspection for 5 years.
requirements. Scientific equipment.
and which includes the epecific nature (3) Nathing in this section relieves the For h nuons ut om 6 ee of the departure, a precise description of the departure, and a bnef statement of IIC'"*" f'"" *d*PI in8 *ith oth8' summary and under the authority of the F
manufacturer,hy the departure from the
,"[q
,'n AtoWe Enugy Act om u amenM.
the reasons w i
30 n
a u mission a instructions for the Energy Reorganization Act of 1974, of an INDL and other Federal or State as amended. and 5 U.S.C. 552 and 553.
prepanns the radiopharmaceutical "gul th' f
would obtain medical results not the NRC is adopting the following ediop a a for py.
amendments to 10 CFR part 110.
otherwise attainable or would reduca med2 cal riska to particular patients Dated at Rockville. Maryland, this 17th day because of their medical condition. lf the of August m PART tio.-EXPORT AND IMPORT OF authorized user physician determines Foe the Nuclear Regulatory Commission.
- g. EAR EQUIPMENT AND that a delay in preparing the S*"*ll CMik-MATERIAL radiopharmaceuticalin order to make a surcary o/W Comssion.
written directive would jeopardize the int Doc. 90-19901 Filed 6-22-00t 8.45 aml
- 1. The authority citation for part 110 patient's health because of the ausso coom rees*e continues to read:
_