ML20248F588
| ML20248F588 | |
| Person / Time | |
|---|---|
| Issue date: | 07/21/1989 |
| From: | Meyer D NRC OFFICE OF ADMINISTRATION (ADM) |
| To: | Tse A NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| Shared Package | |
| ML20248F519 | List: |
| References | |
| FOIA-98-86 NUDOCS 9806040342 | |
| Download: ML20248F588 (4) | |
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MEMORANDUM FOR: Anthony N. Tse Office of Nuclear Regulatory Research FROM: '
David L. Meyer, Chief Regulatory Publications Branch Division of Freedom of~Informe, tion and Publications Services Office of Administration
SUBJECT:
REVIEW OF THE FINAL RULE ON ,
PALLADIUM-103 FOR INTERSTITIAL . l TREATMENT OF CANCER {
The Regulatory Publications Branch has reviewed the final rule that would amend 10 CFR Part 35 by adding palladium-103 as a sealed source in seeds to the list of brachytherapy sources permitted for use in treatment of cancer. We have made an adjustment to the amendatory language necessary to comply with OFR publication requirements. We have enclosed a marked-up copy of the final rule that presents our comments. The changes should be made prior to the rule's submission to the Office of the Executive Director for Operations for signature.
We have forwarded a copy of the final rule to the Records and Reports Management Branch, IRM, for their comment and concurrence concerning the paperwork management aspects of this rulemaking action.
In order to assist you in preparing the list of documents centrally relevant to this final rule that is required by NRC's regulatory history procedures, you should place the designator "AD11-2" in the upper right-hand corner of each document concerning the rule that you forward to the Nuclear Document System.
If you have any questions concerning this matter, please call Betty K. Golden, Regulatory Publications Branch, ADM (extension 24268).
J .) 1.W David L. Meyer, Chief Regulatory Publications Branch Division of Freedom of Information and Publications Services Office of Administration
Enclosure:
As stated i l
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l 9806040342 980528 i PDR FOIA e THOMPSON 98-86 PDR 4 vy-vi v v -
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NOCIEAR REXIJIA'ICRY O2MISSIN C i i
10 CFR Part 35 l J
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Pm11Mium-103 for Interstitial Trea of Cancer l ,
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AGENCY: Nuclear Regulatory n-imion. 1 AcrION: Final rule.
EUMARY: 'Ihe Nuclear Regulatory hi-ion (NRC) is amending its regulations the nurgirm1. uses of byproduct material to add P11Mium-103 as a ;
ed source in seeds to the list of brachytherapy sources permitted for use 3
t: ment of cancer. 'Ihis amendment, promulgated in response to a petition f rulenaking (PRM-35-7), will IMv'a the regulatory burden mi =*iir a1 use - -
licensees who plan to use the sealed source. An evaluation of the potential radiation hazards to hospital ;=w .el and the public showed that there would be minimal risk if the sealed source is used in armrdance with the mornfacturer's radiation safety and handling instructions.
EFFECIIVE DNIE: (Insert the date of publication)
PCR IUtIHIR INPWMNTION CINEACT: Dr. Anthony N. Tse', Office of Nuclear Rogulatory Researd), U.S. Nuclear Regulat 'y & - i m ion, Washington DC 20135, telephcne (301)492-3797.
i l 53PPUMENIARY INPWMNTION:
I4rtition for Rulemaking On Nov==nhar 30,1988, 'Iheragenics Cuy.uation submitted a petition for rul-iri,1g, PIM-35-7, which was docketed on nacwnhor 9,1988. 'Ihe petitioner requested that the NRC amend its regulations to add pa11Mium-103 as a sealed source in p=wwkt for the interstitial treatment of cancer to the list of sealed sources currently permitted in 10 CFR 35.400 for use in brachytherapy. 'Ihe
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petitioner stated that, urder current NRC regulations, licensees who are users of pa11arihme-103 m st go through the cumberscne puc.(:rmis of having their licenses amerded b fore using the product and that amending 10 CTR 35.400 in the manner syyyanted would eliminate this cumberscue process.
In aqporting the petition, the petiticner subnitted several ennarits, including a letter from the ETA, a safety evaluation report frm the State of Georgia, the par + arm insert, and product literature.
'Ihe letter from the FIA stated that, under Section 510(k) of the Federal Pbod, Drug, and N natic Act, as amended, marketing the device (pa11adium-103 h as a sealed source in aaaria) would be permitted subject to the general ccritrols provisions of the Federal Pbod, Drug, ard hnatic Act until such time as the device has been classified as either a class I, II, or III device under Sectimi 513.
In March 1986, Theragenics, an "Ntai .-nt. State" licensee
. the , state 9 Georgia, subnite.ed information on the radiat.;:. afety propert es of pa11mdium-103 to Georgia in order to obtain a " Certificate of 16mryint an."
Such a certificate is r= -mn for Theragenics to marnfacture and distribute pa11adium-103 maaria to specific licensees. The information on these safety swt.ies included the design and w=Loction, rvi.ctype testing, conditions of normal use,1mhp111Dg, external radiation levels, solubility in body fluids, and quality vuuk ul and assurance. After revieviry the information and determining the adarracy of the radiation safety pauperdes of the source, the State of Georgia 4===ri a certificate of Registration to Thr.tispides on Septanber 22, 1986. This certificate sunmarized the submitted radiation safety information ard specified additional limitations and cxniitions en the use of the source. This certificate was amended in its entirety on June 6, 1988, to include a mircr design improvement made by 7heragenics.
Ibliowing its determination that the radiation safety s veerdes of the source are adarriate, the State of Georgia sent NRC a copy of the certificate to include in the Registry of Source and Device Designs that is maintained by the NRC. The NRC reviewed the certificate for consistency with other
- certificates in the Registry and ariciari pa11adium-103 to the Registry cm 0-ta-E 29,1986, ard again in Jtine , to , er the design improvement.
This action, in effect, granted a ' approval of the sealed source ard permitted the use of palladi 103)provid the user's license was amended to include that sealed source. l /
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safety and health, Penalty, Radiation protection, Reportirq and miukeepirq retirements.
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Ptr the reasons set out in the preamble and under the authority of the
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Atmic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C 552 and 553, the NRC is Whig the dilowing ,,,
amendment to 10 CFR Part 35. . /
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- 1. 1ha authority citation for Part 35 is revise lt read as follows:
AUDG TIT: Seas. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, as l amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat.1242, as amended (42 U.S.C. 5841) .
For the ptLposes of sec. 223, 68 Stat. 258, as amended (42 U.S.C. 2273);
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il 35.11, 35.13, 35.20(a) and (b), 35.21(a) and (b), 35.22, 35.23, 35.25, 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)(1), (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),
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==d under sec.161b, 68 Stat. 948, as amended (42 U.S.C. 2201(b)); and il 35.14, 35.21(b), 35.22(b), 35.23(b), 35.27(a) and (c),
35.29(b), 35.33(a)-(d), 35.36(b), 35.50(e), 35.51(d), 35.53(c), 35.59(d) and I
(e)(2), 35.59(g) and (i), 35.70(g), 35.80(f), 35.92(b), 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 L _=d under sec.161o, 68 Stat. 950 as amended (42 U.S.C. 2201(o)) .
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'# 'o,,, UNITED STATES
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1 NDERANIIM MR: SM M.,J . s,p r f ~
D. B. Howe,IMSS
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L. Ibilirg, GPA .~ ,I S. Gagner, GPA If >
M. Rothschild, CGC M. Tmt , AIN
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PRM: A. Tse, IRA /RES i
SUBJECT:
REVIEW OF IRAFT FDEL AMDOENT CNCERNING 7 PAIZADRM-103 (PRM-35-7)
Enclosed is a copy of the draft Federal Reaister notice ocntainirs the final amendment to add palladium-103 as a sealed source in seeds to 10 M 35. 400 '
Please review the FR notice and provide any coments to me J111y 21, .
'this amendment was prepared in response t, a petition y 'Iheragenics (HM-35-7). A sq-M amendmenu vas pub.ished on April 6,1989 far a 30-day public u ::ut period (54 FR 13892). Or,e coment letter was received. 'Ihe crumpnt letter, subnitted by the American College of Radiology, supported the petition. Cbpies of the proposed enwd=.ut and the u.--:=it letter are also enclosed for your information.
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A %. N. Tse Regulation Development Branch DWRES
Enclosures:
- 1. Draft FR notice
- 2. PW_ sg&dist:ut
- 3. Public m uunt letter Sfh-
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A petitioner stated that, under current NRC regulations, licensees who are users of pa11Mi tas-103 Eaast go throtxp the n=*=reme process of having their licenses amended before using the product and that amending 10 CFR 35.400 in the menner suggested would elindnate this n=*== process.
In supporting the petitim, the petitioner sutznitted several <h==sts, including a letter fran the FDh, a safety evaluation wr=1 from the State of Georgia, the package laimert, and product literature.
1he letter fran the FDA stated that, under Section 510(k) of the Federal Food, Drug, and Cosmetic Act, as amended, marketing the devios (palladitan-103 as a sealed sauros in seeds) would be permitted subject to the general controls provisions of the Federal Food, Drug, and chametic Act until sus time as the device has been classified as either a class I, II, or III device under Section 513.
In Mardt 1986,1heragenics, an " Agreement State" licensee of the state of Georgia, sukanitted information on the radiation safety pgdes of palladium-103 to Georgia rder to cbtain a " Certificate of Registration."
Such a certificate id,--r = g for Sheragonics to manufacture and distribute
. !=11Mi ne-103 t to specifi ' licensees. The information on these safety r% ties ir /
b the desi and w.koction, prototype testing, conditions
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ofnormaluse,/1=h=1\ing, radiatim levels, solubility in body I
fluids, and quality m a.w and assuranos. After reviewing the informatim
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and determining the WM of the radiation safety rgdes of the source, the State of [ issued a certificate of Registratim to Sheragenics on Sepe=*=r 22, 986. This certificate mamarized the sutanitted radiation safety information and specified additional limitations and ocruiltions on the use of ina source. This certificate was amended in its entirety on June 6, 1988, to include a minor design inprovesnant made by 1heragonica.
Pcilowing its determination that the radiation safety puru11es of the source are adequate, the State of Georgia sent NRC a copy of the certificate to include in the Registry of Source and Device Designs that is maintained by the NIC. The NRC reviewed the certificate for consistency with other certificates in the Hagistry and mMM palladium-103 to the Registzy on October 29, 1986, and again in June 1988 to cover the design improvement.
1his actim, in effect, granted a prumarketing approval of the sealed source and permitted the use of pa11Mium-103 provided the user's licanoe was amended to include that sealed source. ;
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