ML20248F644
| ML20248F644 | |
| Person / Time | |
|---|---|
| Issue date: | 05/28/1998 |
| From: | Beckjord E NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| To: | Stello V NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| Shared Package | |
| ML20248F519 | List: |
| References | |
| FOIA-98-86 NUDOCS 9806040368 | |
| Download: ML20248F644 (15) | |
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UNITED STATES Y.
((g4 3 l g NUCLE AR REGULATORY COMMISSION t i, a j w Asmorow.o. c. rosss .
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Victor Stello, Jr.
MEMORANDUM FOR: Executive Director for Operations ,
Eric S. Beckjord, Director l
FROM: OfficeofNuclearRegulatoryResearc(
SUBJECT:
PROPOSED AMENDMENT TO 10 CFR 35.400IA l PALLADIUM-103 FOR INTEX5T.Valah TREATMENT OF CANCER (PRM-35-7) .. ^
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.oJ J to l 4ttached for your signature is a propor;ed rule (Enclosure A),
Ae published in the Federal Register, that amend ( 10 CFR Part 35,
" Medical Use of Byproduct Material." This amendment would add i
i palladium-103 as a sealed source in seeds to the liet o{
l 35.400. f BACKGROUND: ~
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A petition for rulemaking was submitted by Theragenicsrequesting 1988) that l
Corporation (PRM-35-7, docketed December 9,"Use of Sources for -
( palladium-103 be added to 10 CFR 35.400, i Brachytherapy." The petitionar stated that, under the present regulation, users of palladium-103 must go through the cumbersome !
process of amending their licenses before they can us l
cumbersome process. -
Staff review of the petition showed that the addition of l
palladium-103 to 10 CFR 35.400 would reduce the regulatory Thus, burden f on medical licensees who plan to use the sealed source.the proposed change as
# h compared to the current practice, l NL reduce the burden for both medical licensees and the f -
wh gile ano safety. The proposed rule would grant the petitioner's I
request by adding palladium-103 as a sealed source in seeds to - .
the list of approved sources in 10 CFR 35.400.
.f BACKFIT ANALYSIS:
The staff has determined that a backfit analysis i -
a backfit as defined in Section 50.109(a)(1).
NOTICES: "
A draft regulatory analysis was prepared (Enclosure 9806040368 980528 Y $ 8-86 PDR/;, q f' *
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Staff review of the petition showed that thq addition of palladium-103 to 10 CFR 35.400 would reduce the regulatory.
burden on medical licensees who plan to use the sealed ~
a source. Thus, as compared to the current practice, the proposed change would reduce the burden for both medical l licensees and the NBC ataff while providing the same level of protection of the public health and safety. -
Commenta were requested previously on the draft Fedral Register notice from the cognizant individuals in'NMSS, GPA, OGC, and ADH. Appropriate commenta were incorporated.
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Eric S Beckjord, Director Offic< ef Huclear Regulatory Research
Enclosures:
Hemo to Stello Encis. to the Memo' A. FR Notice -
B. Regulatory Analysia _ _ , ,
C. Draft Congressional letter D. Draft Daily Staff Notes Iten cc (w/encle.):
Cognizant individuals
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Approved for Publication The Commission delegated to the EDO (10 CFR 1.40(c) and (d)) the authority to develop and promulgate rules an defined in the APA (5 U.S.C. 551 (4)) aubjer.t to .the limitations in t_2 HRC Hanual Chapter 0103, Organization a-d Functions, Office of the Executive Director for Operations, pa.agraphs 0213, 038, 039, and 0310.
The enclosed proposed rule, entitled " Palladium-103 for Interstitial Treatment of Cancer," would amend Part 35 to add palladium-103 as a sealed source in seeds to the list of sources specified in 10 CFR 35.400 for brachytherapy. This change would reduce the regulatory burden on medical use licensees who plan to use the sealed source.
The proposed rule does not constitute a significant question of policy, nor does it amend regulations contained in 10 CFR Parts 7, 8, or 9 Subpart C concerning matters of policy. I, therefore, find that this rule is within the scope of my rulemaking authority and am proceeding to issue it. __
Date V$ctor Stello, Jr.
E.xecutive Director for Operations G 6
Q509-01) u 1
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HDCLEAR REGULATORY COMMISSION II 10 CFR Part 35 7
l Palladium-103 for Interstitial Treatment of Cance'r
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AGENCY: Nuclear Regulatory Commissicn. -f p
ACTION: Proposed rule.
SUMMARY
- The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations governing the medical uses of byproduct material. The proposed regulation would add palladium-103 as a l
sealed source in seeds to the list of brachytherapy sources permitted for use in treatment of cancer. Under current NRC
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regulat' ions, users must have their licenses amended before they may use palladium-103. The proposed rule, developed in response - ~ ~
to a petition for ruleraking (PRM-35-7), would reduce the regulatory burden on medical use licensees who plan to use the I
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.
DATE: Comment period expires (30 days from the date of .
publication in the Federal Register). Comments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given except to comments j received on or before this date.
(;, ADDRESSES: Hail written comments to: Secretary, U.S. Nuclear h
Regulatory Commission, Washington, DC 20555, Attention:
" Docketing and Service Branch. Deliver comments to One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852, between 7:30 a.m. and 4:15 p.m. weekdays.
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- Enclosure A 1 l
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FOR FURTHER INFORMATION CONTACT: Dr. Anthony H. Tse, Office of Huclear Regulatory Research, U.S. Nuclear Regulatory Commission,-
Washington, DC 20555, telephone: (301)492-3797.
SUPPLEMENTARY INFORMATION: W-Petition for Rulemaking On November 30, 1988. Theragenics Corporation submitted a petition for rulemaking, PRM-35-7, which was docketed'on December 9, 1988. The petitioner requesta that the NRC amend its regulations to add palladium-103 as a sealed source in seeds for the interstitial treatment of cancer to the list of sources
/ permitted in 10 CFR 35.400 for use in brachytherapy. A copy of the petition may be obtained from the. Regulatory Publications Branch, Division of Freedom of Information and Publications _ _ . .
Services, U.S. Nuclear Regulatory Commission, Washington, DC 20555.
The petitioner enclosed a document from the Food and Drug Administration (FDA) of the Department of Health and Human Services that allows palladium-103.as a sealed source in seeds to be marketed. e.ptti .oner stated that, under current HRC biegulations e d 'i pai bium-103 must go through the cumbersome process of having their licenses amended before using the product and that amending 10 CFR 35.400 would eliminate this cumbersome process.
In supporting the petition, the petitioner submitted several documents, including a' letter from the FDA, a safety evaluation v,.s report from the State of Georgia._the package insert, an roduct .
literature.
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V The letter from the FDA stated that, under Section 510 (k)
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marketing the device (palladium-103 as a sealed source in seeds) o.P, e s '
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would be permitted subject the general controla provisions of the Federal Food, Drug, and osmetic Act until such t 'e as the I
/ device has been c sifi Section 513 l
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In March 1986',*Th ted information on the g
radiation safety properties of palladium-103 to the State of The information on these safety properties-included the l t 7 Georg l
design and construction, prototype testing, conditions of normal use,' labelling, external radiation levels, solubility in body fluida, and quality control and assurance. After reviewing the I
information and determining the adequacy of the radiation safety properties of the source, the State of Georgia issued a i Certificate of Registration to Theragenics on September 22, 1986.
This certificate summarized the submitted radiation safety i information and specified additional limitations and conditions l q on the use of the source. This certificate was amended in its l l -
kntirety on June 6, 1988 to include a minor design improvement '
made by Theragenica.
9 FoTT6 wing its determination that the radiation safety properties of the source are adequate, theStateoffeorgia sent
/HRC a copy of the certificate to include in the eFatry e f
. [ Source and Device Designs. The HRC reviewed the certificate for ,
consistency with other certificates in the Registry and added khl, palladium-103 to the Registry on October 29, 1986, and again in %-$4 I June 1988 to cover the design improvement. This action, in l effect, granted s h arketing approval of the sealed source;anda W uewtd permit he use of palladium-103 provided that the user's license was amended to include W aealed source. g' I
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Conclusion -
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- (/ /The HRC has Wire!
examined the petition and su%ddMW pporting information ar.d proposes to grant the petition. The cddition of palladium-103 as a sealed source in seeds to the list of sealed
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N ci FE]35.400 would not.cause additi This act would risk to hospital personnel c r the public
/feduce the regulatory burden' to the' users a out 0 lice ces (As well as to the NRC staff. Most users would not have t u ndividual license amendment 3 i theJr ce se perm t eu of any brachytherapy source specified in 10 CFR 35.400).
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However, some users would ,still be required to submit license amendments (if their license only permits the use of specified brachytherapy sources). Tht-NRC .i.a f f ' e e f for4re drev ie w nd the license amen ments, would aiso-be reduced,-
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2 Environmental Impact: Categorical Exclusion L y [
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NRC has determined that this propose egulation is t e type of action dascribed in 10 CFR 51.22L{c1(2) @ J Therefore, l either an environmental impact statement nor an environmental l l assessment has been prepared for this proposed regulation.
Paperwork Reduction Act Statement y) l This proposed rule ces not contain a new or amended
( 'y ' b i formation collection requirement subject to the Paperwork
. eduction Act of 1980 ( .S.C. 3501 et seq.). Existing requirements were approved by the Office of Hanagement and l
i Budget, approval number 3150-0010.
! Regulatory Analysis I
The NBC has prepared a draft regulatory analysis on this proposed regulation. The analysis examines the costs and g
benefits of the alternatives considered by the NRC. The draft regulatory analysis is available.for inspection in the NRC Public Document Room, 2120 L Street, Lower Level, NW, Washington, DC.
Single copies of the draft regulatory analysis may be obtained .
from Dr. Anthony N. Tse (See FOR FURTHER INFORMATION CONTACT heading).
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l The NRC requests public comments on the draft regulatory -
l analysia. Comments may be submitted to the NRC (See ADDRESSES -
heading). .
,- Regulatory Flexibility Certification f- -
As required by the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b), the Commission certifies that this rule, if ,
I fopted, will not have a significant economic impact on a edebstantial. of emall entities. The proposed rule would
[n %e -use a adium-103 as a sealed source in seeds in 10 J CFR 35.400. This action would reduce the regulatory burden on E,
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l edical use 11 N to use the sealed source. -4 s The NRC has adopted size standards that classify a hospital as a small entity if its annual gross receipts do not exceed $3.5 i
l million, and a private practice physician as a small entity if l
the physician's annucl gross receipts are $1.0 million or less.
W Although some NRC medical use licensees could be considered "small entities," the number that would fall into this category l
, does not constitute a substantial number for purposes of the Regulatory Flexibility Act. However, the proposed rule would l
Ihave a positive economic impact on about 700 licensees. ~
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s Backfit Analysis l l
The NRC has determined that a backfit analysis is not required E*
fconstitute a backfit as defined h b 0.109(a)(1).orthisprop List of Subjects in 10 CFR Part 35 Byproduct material, Drugs, Health facilities, Health Professions, Incorporation by reference, Medical devices, Nuclear materials, Occupational safety and health, Penalty, Radiation protection, Reporting and recordkeeping requirements.
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D509-01) ;
For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended, the En.ergy Reorganization Act of 1974, as amended, and 5 U.S.C'553, the NBC is proposing to adopt the following amendment to 10 CFR Part 35.
- 1. The authority citation for Part 35 continues to read as follows: , .
AUTHORITY:
Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, sec. 201, 68 954, as amended (42 U.S.C. 2111, 2201, 2232, 2233);
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Stat. 1242 as amended (42 U.S.C. 5841).
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 _ _ , ,
I (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), 35.633(a)-(i), 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 issued under sec.
161b, 68 Stat. 948, as amended (42 U.S.C. 2201(b)); and 55 35.14, 35.21(b), 35.22(b), 35.23(b), 35.27(a) and (c),
?9 35.29(b), 35.33(a)-(d), 35.36(b), 35.50(e), 35.51(d), 35.53(c),
35.59(d) and (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(j), 35,636(c), 35.641(c), 35.643,(c), ,
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161o, 68 Stat. 950 as 35.645, and 35.647(c) are issued under aec.
amended (42 U.S.C. 2201(o';;. j i
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- 2. In 535.400, paragraph (g) is added to read as follows: .
g 35.400 Use of sources for brachytherapy. ,
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a s s e e -
(g) Palladium-103 as a sealed source in seeds for interstitial i
treatment of cancer.
Dated at Rockville, Maryland, this day of
, 1989.
For the Nuclear Regulatory Commission.
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Victor Stello, Jr. 1 Executive Director for Operations l
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- 2. In s35.400, paragraph (g) is added to read as follows:
i 35.400 Use of sources for brachytherapy. '
s e a e a ..
(g) Palladium-103 as a sealed source in seeds for interstitial treatment of cancer.
Dated at Rockville, Maryland, this day of
. 1989. , ,
i For the Nuclear Regulatory Commission.
Victor Stello, Jr.
Executive Director for Operations E00 VStello l
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W RBernero HDenton WParler PHorry Bkqkjord {
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0FF: B/DRA NAME: ' se/Telford RD WLahs A bhES ZRosztoczy NfR BMorris 6' is .
DATE: /89 2/9/89 2/l3/89 2/13/89 2/gq 89 (1:pM1
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.T f "A REGULATORY ANALYSIS -
10 CFR PART 35 .
PALLADIUM-103 FOR INTERSTITIAL TREATMENT OF CANCER
- 1. STATEMENT OF PROBLEM l
In 10 CFR 35.400, "Use of Sources for Brachytherapy," the regulation lists specific radioactive sealed sources that may be used for treatment of cancer in brachytherapy. In
, December 1988, the NRC received a petition for rulemaking filed by Theragenica Corporation dated November 30, 1988 (docketed PRM-35-7) to amend 10 CFR 35.400.
The petitioner requested that the NRC amend its regulations to add palladium-103 as a sealed source in seeds for interstitial treatment of cancer to the lirt of sources specified in 10 CFR 35.400. The petitioner stated that, under the present regulation, users of palladium-103 must go through the cumbersome process of amenains their licenses before they can use the product and that amending 10 CFR - - - -
l 35.400 would eliminate this cumbersome process.
l l 2. OBJECTIVES l HRC's objectives are to protect the health and safety of l workers and the public in the licensing of byproduct
, materials for medical unca. The State of Georgia performed l safety evaluations of the use of palladium-103 and issued a Certificate of Registration. Subsequently, the NRC reviewed the certificate for consistency with other certificates in the Registry of Source and Device Designs and added .
palladium-103 to the Registry. This action, in effect, granted a presarketing approval of the source and would permit the use of the source provided that the user's license was amended to include the source.
- 3. ALTERNATIVES pj There are only two alternatives:
(1) Maintain status quo, i.e., before using palladium-103, a potential user must first apply for and obtain a license amendment permitting the use; and (2) Auend 10 CFR 35.400 to include palladium-103 as a -
sealed source in seeds for interstitial treatment of cancer.
Enclosure B
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- 4. CONSEQUENCES ,
. r In terms of the'public health and safet'y, both alternatives would permit the use of palladium-103 as a sealed source in needs for brachytherapy, thus, there would be essentially no' difference between the two alternatives. -
In terms of cost, alternative 2 would be less burdensome for both the medical use licensees and the NRC. Alternative 2, if adopted, would eliminate the amendment application process for most licensees who plan to use the sealed source and the review and approval process for the NRC.
- 5. DECISION RATIONALE Since Alternative 2 would result in less burden to the medical use licensees and the NRC staff while providing the same level of protection of the public health and safety,
, the NRC proposes to adopt this alternative.
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- 6. IMPLEMENTATION Implementation' involves adding palladium:103 as~a sealed source in seeds for interstitial treatment of cancer in 10 ----
CFR 35.400.
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< (Identical letters o sent
/ ) 3 to other Subcommittees) .
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The Honorable John B. Breaux,: Chairman .
Subcommittee on Nuclear Regulation '
Committee on Environment and Public Works ' ^
l United States Senate Washington, DC. 2051 .'s Chairman:
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Dear Mr p Enclosed for the formation of the subcommittee is a copy of a l
notice of Proposed Rulemaking to be published in the Federal I
Register. response to a petition for rulemaking, the Nuclear
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Regulatory Commission in proposing to amend its regulations (W M '0 6%
pers se-of-paHirdium4M-eselet source--in-seede&r htef ethial -trea6nce.r hTheproposedrule'wouldreducetheregulatoryburdenonmedical --
ge licensees chloh- play use the sealed sourcep The notice will be mailed to medical use licensees and other interested individuals for comment. We expect the medical community will be very interested in the notice.
Sincerely, ,
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Eric S. Beckjord, Director .
Office of Nuclear regulatory Research
Enclosure:
Federal Register notice cc: Senator Alan K. Simpson
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Enclosure C 1
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WEEKLY REPORT TO THE COMMISSION - -
OFFICE OF NUCLEAR REGULATORY RESEARCH Proposed Rule to be signed by EDO l
On , the Executive Director for Operations approved a proposed rule that would amend 10 CFR 35.400, "Use of Sources for Brachytherapy." This amendment, developed in response to a petition for rulemaking (PRM-35-7, Theragenics -
Corporation, docketed December 9, 1988), would add palladium-103 as a sealed source in seeds to the list of sources specified in 10 CFR 35.400. The change would reduce the regulatory burden on medical use licensees who plan to use the sealed source.
This constitutes notice to the Commission that, in accordance with the rulemaking authority delegated to the EDO, the EDO has signed this propospd rule and proposes to forward it to the Office of the Federal Register for publicati6n.
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Enclosure D
__ ___________________-_a
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- 1 l 0 N (td l M e 61989 -
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r ME2ORANIIM FOR: 'Baggett, MeS /
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. Bolling,
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. Gagner, GPA
. Rothschild, OGC e
. Tamar, AIMf h)
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l FRCE: A. Tse, IIUVRES l
SUBJECT:
REVIEW OF IRAFT FINAL AMENINENT CI2K2RNING I PAIIAD11M-103 (PRM-35-7)
Enclosed is a copy of the draft Federal Reaister notice containirxJ the final siisalirsit to add palladium-103 as a sealed source in seeds to 10 CFR 35.400. !
Please review the FR notice and provide any % sits to me by July 21, 1989. I i
This arendment was prepared in response to a petition subnitted by Theragenics (HM-35-7). A proposed ari=:Inhaait was published on April 6, 1989 for a 30-day public ocanment period (54 ER 13892). One m u uit letter was received. The m sit letter, subnitted by the American Cbilege of Radiology, supported the petition. Copies of the proposed aireA=uit arx1 the wi==uit letter are also enclosed for your information.
Anthony N. Tse l Regulation Development Branch j IRA /RES
Enclosures:
- 1. Draft FR notice
- 2. Proposed airsahmuit
- 3. Public connent letter Informatica in 15!: rc::rd was detetoj OISIRIBUTICE: (w/ encl.) in acccrdanca wituhe Freedcm of Information 4 subjhmire / Act, exempuens b RDB % < pg gg((,
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NAME: ATse JIblford DATE: 6/28/8 7/la/89 OFFICIAL REXDRD CDPY i
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NUCEAR REDUIATORY O2 MISSION 10 CFR Part 35 l
l Palladium-103 for Interstitial tment of Cancer l AGENCY: Nuclear Regulatory rw-iemim. '
AcrIm: Final rule.
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S W MARY: The Nuclear Regulatory b-idian (NRC) is amending its regulations governing the mariimi uses of material to add palladium-103 as a ed source in naark to, list of brachytherapy sources permitted for use L in treatment of cancer. 'lhis amendment, promulgated in respcisiidi to a petition for rulenaking (PRM-35-7), will r=+m the regulatory burden on wim1 use lioeneses 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 miniumi risk if the sealed source is used in accordance with the marefar+=er's radiation safety and handling instructions.
l DTmrIVE DATE: (Insert the date of publication) l l
KR FURIHER INFmMATICH CDNIACT: Dr. Anthony N. 'Ihe, Office of Nuclear Regulatory Daaaad, U.S. Nuclear Regulatory rW=i== ion, Washington DC 20555, l telglarait (301)492-3797.
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SUPPUMENIARY INFWMATIW:
l Petition for Rulemaking l
On Novanhar 30,1988, 'Iheragenics Corporation subnitted a petition for I l
rulemaking, PRM-35-7, whicts was docketed on nammhar 9,1988. She petitioner l rwyw*ed that the NRC amend its regulations to add palladium-103 as a sealed source in aaark 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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O petitioner stated that, under current NRC regulaticris, licensees who are users of palladium-103 mast go through the otunbaracune prmaan of having their lioenees amended before using the product and that amending 10 CFR 35.400 in '
the manner suggestad w:x21d eliminate this mmhamans prmana.
In supporting the petition, the petitioner submitted several h= wits, including a letter fran the FIR, a safety evaluation n r n.L frtan the Stata of Georgia, the package insert, and product literature.
1he letter frtan the F1R stated that, under car +4rwt 510(k) of the Federal Food, Drug, and Cbeastic Act, as amended, ==* Mig the device (palladium-103 as a sealed source in seeds) would be permitted subject to the general controls provisicris of the Federal Faad, Drug, and Cbematic Act until sucts time as the device has been clammified as either a clama I, II, or III device under Section 513.
In Martti 1986, Theragenics, an " Agreement State" licensee of the state of Georgia, m*=itted information an the rad 2.ation safety r urut.ies of palladium-103 to Georgia in order to obtain a " Certificate of Registration."
Sucts a certificate is r=====7y for Theraganics to annufacture and distribute
=11ariium-103 seeds to specific licensees. She information on these safety reties included the design and --Loction, puustype testing, canditions of normal use, labelling, external radiation levels, solubility in body fluids, and quality w ikul and assurance. After reviewing the information and determining the Wwy of the radiation safety ruraties of the source, the State of Georgia immu=1 a Certificate of Registration to Theragenics on Seg#mhar 22, 1986. 'D1is certificate annarized the submitted radiation safety infonnation and specified addit!% limitations ard canditicais n the use of the source. 1his certificate was amended in its entirety on June 6, 1988, to include a minor design improvunent made by 1heraganics.
Pblioving its determination that the radiation safety rgdes of the source are ariaryiate, the State of Georgia sent NRC a copy of the certificate to include in the Registry of Source and Devios Designs that is maintained by the NRC. The NRC revieund the certificate for cxxisistency with other omrtificates in the Registry and atWri palladium-103 to the Registry on October 29,1986, arx1 again in June 1988 to cover the design ing.awi_ L.
This acticrt, in effect, granted a prenarketing approval of the sealed source and permitted the use of p=11arifum-103 provided the user's license was amended to include tint sealed source.
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Proposed ArminismuiL and Public C-writ After ocalsiderirg the petition, the NRC published a pu si amendment grantisq the petition for a 30-day public m.out period (54 FR 13892, l April 6,1989) . One ==ust letter was received. 'Ihe tv=mant letter, submitted by a madir al professional organization, 9=mrted the petition. 'Ibe letter stated that "this would indeed alleviate burdenscats current NRC regulaticris that require users to amend their licenses before using na11adium-103." l l
Ct:riclusion l
Ibliowirq ocnsideration of the petition and the ocumnent letter, the NRC l has derarmined that the addition of pa11adium-103 as a sealed source in =aada to the list of sealed sources specified in 5 35.400 will not cause additional risk to hospital personnel or the public un== the radiation safety and handling instructions for palladium-103 are similar to the instructions for the brachytherapy sources currently listed in 5 35.400. 'Ihis action will rwhm the regulatory burden to the users of pa11adium-103 seeds (about 700 potential users) as well as to the NRC staff. Most users will not have to follow the present requim-mit of subnitting individual license er==miu=uit applications in order to be able to use pa11adium-103 as a sealed source in I
seeds for the interstitial treatment of cancer (if their license permits the use of any bradlytherapy scuroes specified in 5 35.400). A user whose license l cnly permits the use of pecified bracWrapy sources will still be required to submit a license arw.r.lminit application. A reduction in the p uhpr of license amendment applications will rwtm the expenditure of NRC staff raumves in reviewing and granting or denying the requested license j amendments. 'Ihus, the NRC is amending i 35.400 to add palladium-103 as a sealed source in aaada for the interstitial treatment of cancer.
Envim.=adal T==+: Categorical Exclusion
'Ihe NRC has determined that this final amendment is the type of action daar,-ibed in 10 CFR 51.22(c) (2) . Tnerefore, neither an envim===sutl inpact statanent nor an envim===iuml aaaaammarit has been prepared for this er==alu uit.
3
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-rx Reducum Ace Statemene .
l
'Ihis final es=2mi=:ut does rot contain any new or amended information collection requirements subject to the Paperwork Pdv+1cn Act of 1980 (44 ~
U.S.C. 3501 et seq.) . Existing requis.=u.=1Li were approved by the offim'b ,
Marap=.: it and Budget, approval number 31504)010. '
]~ -
i Regulatory Analysis
% FOR 6 % , b d l
'Ihe NRC has prepared a regulatory analysis cm this amendment. 'Ihe anal examines the costs and benefits of the alternatives considered by the NDC.
Interested p=u.esis may examine a copy of the regulatory analysis at the NRC Public Maant Rocan, 2120 L Street, NW, Iower Isvel, Washington, DC. Single I copies of the regulatory anal may be obtained frun Dr. Anthony N. Tse (See baa. iing) .
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Regulatory Flexibility Certification As requized by the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b) wi==im certifies that this amendment does not have a significant 7ev.csic iW cn a substantial number of amall e adds the use of m11Mium-103 as a sealed source in amada in 10 CER 35 00.
'Ihis action will IMm the regulatory burden on nadim_1 use 110== --
planning to use the sealed source by eliminating the requis.=== sit of I a license amendment applintion. '~
Backfit Analysis '
{
'Ibe NRC has Wamined that a backfit analysis is not required for this amerdment hamnaa the action does not aanstitute a backfit as defined in 10 CER 50.109(a) (1) .
List of Subjects in 10 CFR Part 35 Byproduct material, Drugs, Health facilities, Health professions, Irmgation by reference, Madim_1 devices, Nuclear materials, Wetional 4
safety and health, Penalty, Radiation protection, ReportincJ and recordkaaping rupirements.
For the reasons set out in the preamble and under the authority of the Atcanic 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 adopting tho'following amendment to 10 CFR Part 35.
1 l 1. 'Ihm authority citatial for Part 35 is revised to read as follows:
- i AUDERITY
- Seas. 81,161,182,183, 68 Stat. 935, 9/8, 953, 954, as j amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat.1242, as amended (42 U.S.C. 5841) .
For the purposes of sec. d3, 68 btat. 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, 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),
j 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 d under sec. 161b, 68 Stat. 948, as amended (42 U.S.C. 2201(b)); and 55 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 (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.M5, and 35.647(c) are 4=w=1 under sec.161o, 68 Stat. 950 as amended (42 U.S.C. 2201(o)).
5
- 2. In 5 35.400, pa%14 (g) is a& Sed to read as follows:
E 35.400 Use of sources for bradlytharapy.
(g) Palladium-103 as a sealed source in seeds for interstitial treatment of Cancer.
Dated at Rockville, Maryland, this day of
, 1989.
For the Nuclear Regulatory h i m imi, I
l l
Victor Stallo, Jr.,
l Doecutive Director for Operatials.
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6
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~g UNITED STATES g NUCLEAR REGULATORY COMMISSION
[ WASHINGTON, D. C. 20555 g p
'*o o o .*
/ $ $ $ }pg MDOMNDLM IVR: S. Baggett, l@t3S ei4 Smites?IGSS$
L. Bollity, GPA S. Gagrer, GPA M. Rothschild, CGC M. Iasar, AIM PBCM: A. Tse, IIM/RES
SUBJECT:
REVIEN OF [RAFP FINAL AMDOENT OCNCERUNG PAIIADRM-103 (PRM-35-7)
Enclosed is a copy of the draft Federal Reaister notice containirg the final aimadTent to add palladium-103 as a sealed source in d to 10 Cm 35.400.
Please review the m notice and provide any h.i.ud.s to me by July 21, 1989.
'Ihis av.=drent was prepared in responce to a petition sutnitted by 7hcragenics (FRM-35-7). A prtposed amerldment was publistd an April 6,1989 fur a 30-day public carament period (54 m 13892). One w = ant letter was received. The wi. wit letter, sulnitted by the American College of Radiology, supported the petition. Copies of the puposed amerriment and tha w=c.rit letter are also erclosed for your information.
2 Anthony N. Tse Regulation Development Branch IP4'RES
Enclosures:
- 1. Draft m notice l
- 2. Proposed amndment
- 3. Public omnent letter 1
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$U$ l U f a f __ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __
) .
petitioner stated that, under carrent NRC regulations, licensees who are users cf pa11aMum-103 nust go through the cumbersome process of having their licenses amended before usirg the product and that amending 10 CFR 35.400 in the manner avryted would eliminate this cumberscane p m.
In supporting the petition, the petitioner submitted several hwants, including a letter frm the FIR, a safety evaluation report from the State of Georgia, the package insert, and product literature.
'Ibe letter frran the FIA stated that, under Secticn 510(k) of the Federal Food, Drug, ard Cosmetic Act, as amended, marketing the device (pa11aMum-103 as a sealed source in ma%) would be permitted subject to the general wi / uls provisions of the Federal Food, Drug, and ch-tic Act until such as the device has been classified as either a Class I, II, or III device 1 r Secticri.5133 /
-Iri~ birch 1986, 'Iberagenics, an "Apw--4t. State" licensee of the state of
(/ ia, subnitted information on the radiation safety properties of I pa11aMum-103 to Georgia in order to obtain a " Certificate of Registration."
s Sucts a certificate is r-en for 'lheragenics to manufacture and distribute
'Ibe information on these safety pa11= Mum-103 seeds to specific licensees. 1 i
rvgrties included the design and web.uction, svL., type testirg, conditions of normal use, labellirg, external radiation levels, solubility in body fluida, and quality control ard assurance. After reviewing the information ard determining the a*=cy of the radiation safety properties of the source, the State of Georgia 1-vi a certificate of Registration to 'Iberagenics on September 22, 1986. 'Ihis certificate snmarized the subnitted radiation safety information and specified additional limitations and canditions on the use of the source. 'Ihis certificate was amended in its entirety an June 6, 1988, to include a minor design improvement made by 'Iheragenics.
l Ybliovirg its determination that the radiation safety properties of the source are adequate, the State of Georgia sent NRC a copy of the certificate to include in the Registry of Source ard Device Designs that is maintained by l
l the NRC. 'Ibe NRC reviewed the certificate for consistency with other certificates in the Registry ard w%vi pa11aMum-103 to the Registry on Oc+r+*r 29, 1986, ard again in June 1988 to cxwer the design improvement.
'Ihis action, in effect, granted a premarketiry apprtual of the sealed source ard permitted the use of palladium-103 provided the user's license was amerded to include that sealed source, r
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