ML20217Q166
| ML20217Q166 | |
| Person / Time | |
|---|---|
| Issue date: | 07/06/1989 |
| From: | Tse A NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| To: | Steven Baggett, Bolling L, Donna-Beth Howe NRC OFFICE OF GOVERNMENTAL & PUBLIC AFFAIRS (GPA), NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20217P754 | List: |
| References | |
| FOIA-98-86, RULE-PRM-35-7 NUDOCS 9804100324 | |
| Download: ML20217Q166 (7) | |
Text
- g UNITED STATES 8 ,
-o NUCLEAR REGULATORY COMMISSION
{ WASHINGTON. D. C. 20555 ,
\,e...+.e at . . , _
MEMEANDEM FOR: S. M LL,l@lSS t D. B. Howe,IGGSS L. Bollirg, GPA S. Gagner, GPA M. TwGuiscidld, OGC M. Tamar, AIM PPIM: A. Tse, IRA /RES
SUBJECT:
REVIDi OF IRAFT FINAL AMENIMENT OtMCERtGNG PALIADIIM-103 (PRM-35-7)
Encicoed is a ocpy of the draft Federal Register rrtice containirg the final' amendment to add palladium-103 as a sealed source in Ma to 10 CER 35.400.
Please rwiew the FR notice and provide any tvunants to me by July 21, 1989.
'this amendment was prepared in response to a Alli:lon ehenitted by '1heragenios (PRM-35-7). A s t-- ==-' amendment was published on April 6,1989 for a 30-day public tvunant period (54 FR 13892). One ocenent letter was received. 'Ihe ccanent letter, subnitted by the American College of Radiology, supported the petition. Copies of the p - ==' amendment and the ev=nant letter are also '
enc 1ceed for your information.
[
[ l Anthony N. Tse Regulation Development ararxt IRA /RES
Enclosures:
- 1. Draft FR notice ;
l
- 2. Proposed amendment !
- 3. Public mm.=ut letter 1
1 l l i
9804100324 980407 F PDR FOIA ,
THOMPSON 98-86 PDR v
v M $ $ 1989
[7590-01)
NUCIEAR REGUIA'IG0f CGHISSION 10 CFR Part 35 Palladium-103 for Interstitial Treatment of Onnoer AGENCY: Nuclear Regulatory h i mlen.
i ACTION: Final rule.
SLEMARY: 'Ihe Nuclear Regulatory h4=ico (NRC) is amending its regulations governing the dm1 uses of byproduct material to add palladium-103 as a sealed source ir amwim to the list of brachytherapy sources permitted for use -
in treatment of cancer. 'Ihis amendment, prtmulgated in respcose to a petition for rulemaking (HM-35-7), will reduce the regulatory burden en w im1 use-lice:1 sees who plan to use the sealed source.' An evaluation of the potential ;
radiation hazards to hospital personnel and the public showed that there would be minimal risk if the sealed source is used in accordance with the manufacturer's radiation safety and handling instructions.
EmDCTIVE IATE: (Insert the date of pubMcation)
FtR FURINER INfURt%TICH CONTACT: Dr. Anthony N. Tse, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory h4= ion, Washington DC 20555, i
telephone (301)492-3797. 1 SUPPIDENIARY INFOR% TION:
Petition for Rulemaking l On November 30,1988, 'Iheragenics Cbrporation sutznittai a petition for rulemaking, PRM-35-7, which was docketed cm C+: J-r 9,1988. 'Ihe petiticner requested that the NRC amend its regulations to add palladium-103 as a sealed source in =aarla for the interstitial treatment of cancer to the list of sealed sources currently permitted in 10 CFR 35.400 for use in bradlytherapy. 'Ibe i
k
( ,
petitioner stated that, under current NRC regulations, licensees who are users )
. of palladiunr-103 nust go through the nm**rscane process of having their licenses amended before using the product ard that amending 10 CFR 35.400 in the manner suggested would eliminate this n=**w process.
In supporting the petition, the petitioner sutanitted several drrinnants,
- including a letter from the FDA, a safety evaluation swt fran the State of Georgia, the =r4=:= insert, and product literature.
'Ihm lettar fran the FIA stated that, under Section 510(k) of the Federal Food, Drug, and Cosmetic Act, as amended, marketing the device ( =11M4um-103 I as a sealed scures in seeds) wculd be permitted subject to the general
- Luis provisions of the Federal Food, . Drug, and Cosmetic Act until suds time as the device has been classified as either a cla== I, II, or III device urder Section 513.
In March 1986, 'Iheragenics, an "Acp senent State" licensee of the state of I
i Georgia, subnitted information on the radiation safety rguias of palladium-103 to Georgia in order to obtain a " Certificate of Registration."
Such a certificate is rw=amary for 'Iheragenics to manufacture and distribute
!*1 w ium-103 seeds to specific licensees. 'Ihe information on these safety rgdes included the design and --Loction, juMype testing, ocnditions of normal use, labellirg, external radiation levels, solubility in body fluids, and quality w ikul and assurance. After reviewing the information and determining the W=ey of the radiatics) safety reties of the source, j ~ the State of Georgia issued a certificate of Registration to 'Iheragenics an f Selts=**r 22, 1986. 'Ihis certificate sinunarized the submitted radiation i safety information and specified additional limitations and conditions an the l use of the source. 'Ihis certificate was amended in its entirety on June 6, l,
1988, to include a minor design lev-su made by 'Iheragonics.
~
Following its determination that the radiation safety r g uies of the ]
source are adequate, the State of Georgia sent NRC a copy of the certificate to include in the Registry of Source arxl Device Designs that is maintained by the NRC. 'Ihe NRC reviewed the certificate for consistency with other 1
certificates in the Registry and M ad !=11=dium-103 to the Registry on j Octcher 29, 1986, and again in June 1988 to cover the design lugn.wi --it.
'Ihis action, in effect, granted a prenarketing approval of the sealed source and permitted the use of palladium-103 provided the user's license was amended to include that sealed sauros.
I 2
i
-u
- g-Fu--:-i Amendment and Public Ozanent After ocnsidering the petiticm, the NRC published a po;;-:S amendment granting the petition for a 30-day public ocxument period (54 FR 13892, April 6, 1989). One ocenent letter was received. 'Ihe erwmant letter, sutnitted by a medical professional organization, %t ed the petition. 'Ihe
-l letter stated that "this would indeed alleviate burdensana current NRC regulations that regaire users to amard their licenses before using .
palladium-103."
Ctmclusion i
Following cmsideration of the petition and the rvumant letter, the NRC has deternhed that the addition of pd3adium-103 as a sealed source in seeds to the list of sealed sources specified in 5 35.400 will not cause addii t onal risk to hospital personnel or the public because the radiation safety and i
handling instructions for palladium-103 are similar to the instructions for .
" the brachytherapy scuroes currently listed in i 35.400. 'Ihis action will .
reduce the regulatory burden to the users of y11=diuer-103 seeds (about 700 potential users) as well as to the NRC staff. Mcst users will not have to follow the r ed, requirement of sutsaitting indivirhm1 license amendment applications;in order to be able to use pa11=dium-103 as a sealed source in seeds for the interstitial treataant of cancer (if their license permits the
. use of any bradlytherapy sources specified in' E 3'5.400) . A user whose license ,
j only permits the use of specified brachytherapy scuroes will still be required to sutadt a licanoe amendment application. A reduction in the number of license amendment applications will reduce the expenditure of NRC staff resources in reviewing and granting or denying the requested license
! amendments. 'Ihus, the NRC is amending i 35.400 to add palladiue103 as a
!~ sealed source in seeds for the interstitial treatment of cancer.
Envirmeental T=nar+: Categorical Exclusion 1 l
'Ihe NRC has determined that this final amendment is the type of action described in 10 CFR 51.22(c)(2). 'Iberefore, neither an envirmanital 4=ae+
' statement nor an environmental =-===nt has been prepared for this amendment..
3 I
( ~,
f- *:
.i !
l l Paperwork Reduction Act Statement l
'Ihis final amendment does not contain any new or amended information collection requirements subject to the Paperwork PMv+1on Act of 1980 (44 U.S.C. 3501 et seq.) . Existing requirements wert approved by the Office of j ;'. +, it and Budget, approval raanbar 3150-0010.
Regulatory Analysis
'Iha NRC has prepared a regulatory analysis on this amendment. ' Die analysis examines the costs and benefits of the alternatives considered by the NRC.
l Interested persons may examine a copy of the regulatory analysis at the NRC Public mmentr Rom, 2120 L Street, NW, I4wer Inval, Washington, DC. Single copies of the regulatory analysis may be att: sir.ed frtsa Dr. Anthony N. Tse (See
! ADWESSES banMng) .
l .
l Regulatory Flexibility Certificaticn -
l .
As required by the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b),
i ' the h4== ion ~ certifies that this amendment does not have a significant econcznic inpact on a substantial number of small entities. 'Ihis amendment adds the use of p=11aMum-103 as a sealed source in seeds in 10 CER 35.400.
l
'Ihis action will reduce the regulatory burden cm wimi use licensees l l plannirs to use the sealed source by eliminating the requirunent of submitting !
a license amendment application. l 1'
Backfit Analysis !
i
'Ihe NRC has determined that a bpMkfit analysis is not required for this j amendment haranaa the action does not constitute a backfit as defined in 10 CFR 50.109(a) (1) .
List of Subjects in 10 CFR Part 35 Byproduct unteri;1, Drugs, Health facilities, Health professicals, Irmg tion by refe anoe, Medical devices, Nuclear materials, %=tional 4
.c .
l safety and health, Penalty, Radiation protaction, Reporting and recordkeeping zu pirements.
Pbr the reasons set out in the y,Mle and under the authority of the Aranic Energy Act of 1954, as amended, the Energy hap-dzation Act of 1974, .
as amended, and 5 U.S.C 552 and 553,.the NRC is adopting the following amendment to 10 CER Part 35.
i
- 1. 'Jhe authority citation for Part 35 is revised to read as follows: )
AUDERITY: Secs. 81,' 161, 182, 183, 68 Stat. 935, 948, 953, 954, as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat.1242, as amended.(42 U.S.C. 5841). i l
For the purposes of sec. 223, 68 Stat. 958, as amended (42 U.S.C. 2273);
55 35.11, 35.13, 35.20(a) and (b), 35.21(a)' and (b), 35.22, 35.23, 35.25, 4 35.27(a)'- (c) and (d), 35.31(a)', 35.49, 35.50(a)-(d), 35.51(a)-(c), 35.53(a)
! and (b), 35.59(a)-(c), (e) (3' , ' (g) . and (h), 35.60, 35.61, 35.70(a)-(f), 35.75, 35.80(a)-(e), 35.90, 35.92(a), 35.120, 35.200(b), 35.204(a) and (b), 35.205, 35.220, 35.310(a), 35.315, 35.320, 35.400, 35.404(a), 35.406(a) and (c), j 35.410(a), 35.415, 35.420, 35.500, 35.520, 35.605, 35.606, 35.610(a) and (b),
! . 35.615, 35.620, 35.630(a) and (b), 35.632(a)-(f), 35.634(a)-(e), 35.636(a) and (b), 35.641(a) and (b), 35.643(a) and (b), 35.645(a) and (b), 35.900, 35.910, 35.920, 35.930, 35.932, 35.934, 35.940, 35.941, 35.950, 35.960, 35.961, 35.970, and 35.971 are i=M under sec.161b, 68 Stat. 948, as amended (42 U.S.C. 2201(b)); and il 35.14, 35.21(b), 35.12(d , 35.23(b), 35.27(a) and (c),
35.29(b), 35.33(a)-(d), 35.36(b), 35.50(e), 3's.51M), 35.53(c), 35.59(d) and l
(e)(2), 35.59(g) and (i), 35.70(g), 35.80(f), 35.92(.::), 35.204(c), 35.310(b),
~
.35.315(b), 35.404(b), 35.406(b) and (d), 35.410(b), 35.415(b), 35.610(c),
35.615(d) (4), 35.630(c), 35.632(g), 35.634(f), 35.636(c), 35.641(c),
35.643(c), 35.645, and 35.647(c) are 4 = M under sec. 161o, 68 Stat. 950 as amended (42 U.S.C. 2201(o)) .
1
. 5
/
- 2. In 5 35.400, pai r ;ti (g) is W to read as fo11cus-f i 35.400 Use of sources for brachytherapy.
(g) 14L11adium-103 as a sealed source in seeds for interstitial treatment of cancer.
1 day of j Dated at Rockville, Maryland, this l i
, 1989.
I Ybr the Nuclear Regulatory hinnion.
i Victor Ste11o, Jr., .
Executive Director for Operations.
l l
I l
t 6