ML20217Q304
| ML20217Q304 | |
| Person / Time | |
|---|---|
| Issue date: | 11/21/1989 |
| From: | Tse A NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| To: | Bridget Curran AMERICAN ASSOCIATION OF PHYSICISTS IN MEDICINE |
| Shared Package | |
| ML20217P754 | List: |
| References | |
| FOIA-98-86 NUDOCS 9804100382 | |
| Download: ML20217Q304 (9) | |
Text
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UNITED STATES g
NUCLEAR REGULATORY COMMISSION E'
- y WASHINGTON,0. C. 20555
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NOV 21 pgeg I
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i Mr Bruce curran, niitor Newsletter ican kwriation of Itysicists in Medicine Medical Physics Division New Ergland Medical Center, MS 246 l
750 Washington Street ~
Boston, MA 02117
Dear Mr. C11rran:
Based on our recent telephone ccawersation, enclosed for your informtion is a l
copy of a Federal Register notice (54 FR 41819, October 12, 1989). 'Ihe notice contains a final rule published by the NRC maning the use of palladicxn-103 as a sealed source in seeds for brachytherapy.
I Hope this information is useful to members of your association.
Sincerely,
)
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thony N. Tse Regulation Development Branch Office of Nuclear Regulatory Research
Enclosure:
FR notice oc
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Dr F. Khan, President r
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NUCLEAR REGULATORY COMMISSION 10 CFR PART 35 (Docket No. PRM-35-7}
Theragenics Corporation; Receipt of Petition for Rulemaking Nuclear Regulatory Commission.
AGENCY:
ACTION:
Petition for rulemaking:
Notico of roccipt.
The Commission is publishing for public comment a notice
SUMMARY
- 1988, roccipt of a petition for rulemaking dated November 30, of which was filed with the Commission by Theragenics Corporation.
198T'.
The petition was docketed by the Commission on December 9, i
The petitioner requests and has been assigned Docket No. PRM-35-7.
the Commist. ion amend its regulations concerning the medical that use of byproduct material to add palladium-103 as a scaled source in seeds for interstitial treatment of cancor to the list of The petitioner requests sources approved for use in brachytherapy.
I so that cach potential user of the scaled source this amendment have to obtain a license amendment permitting use of the would not scaled source.
Submit comments by (60 days after publication in the Federal DATE:
Comments received af*cr this date will be considered if Register).
r s 1
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2 it is practical to do so but the Commission is able to assure consideration.only for comments roccived on or before this date.
Submit written comments to the Secretary of the ADDRESSES:
DC Nuclear Regulatory Commission, Washington, Commission, U.S.
20555, Attention: Docketing and Service Branch.
For a copy of the, petition, write the Regulatory Publications
.i Branch, Division of Freedom of Information and Publications U.S.
Services, Of fice of Administration and Resources fianagement, DC 20555.
Nuclear Regulatory Commission, Washington, l
The petition and copics of comments received may be inspected 2120 L Street and copied for a fee at the NRC Public Document Room, NW., Washington, DC.
IMichael T.
Lesar, Acting Chief, FOR FURTHER INFORMATION CONTACT:
Rules Review Section,' Regulatory Publications Branch, Division of Freedom of Information and Publications Services, Office of U.S.
Nuc1 car Regulatory Administration and Resources Management, Commission, Washington, DC 20555, Telephone: 301-492-8926 or Toll Free: 800-368-5642.
SUPPLEMENTARY INFORMATION:
has established The Nuclear Regulatory Commission (NRC) f in regulate the medical use of byproduct material provisions that 10 CFR Part 35.
Under these provisions, medical licensecs arc l
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l it is practical to do so but the Commission is abic to assure consideration only for comments roccived on or before this date.
ADDRESSES:
Submit written comments to the Secretary of the Commission, U S. Nuclear Regulatory Commission, Washington, DC 20555, Attention: Docketing and Servico Branch.
For a copy of thc. petition, write the Regulatory Publications Branch, Division of Freedom of Information and Publications Services, Office of Administration and Resources Management, U.S.
Nuclear Regulatory Commission, Washington, DC 20555.
The petition and copies of comments received may be inspected and copied for a fee at the NRC Public Document Room, 2120 L Street NW.,
Washington, DC.
i FOR FURTHER INFORMATION CONTACT:
Michael T.
Lesar, Acting Chief, Rules Review Section, Regulatory Publications Branch, Division of Freedom of Information and Publications Services, Office of Administration and Resources Management, U.S.
Nuclear Regulatory Commission, Washington, DC 20555, Telephone: 301-492-8926 or Toll Free: 800-368-5642.
I SUPPLEMENTARY INFORMATION:
The Nuclear Regulatory Commission (NRC) has established provisions that regulate the medical use of byproduct material in 10 CFR Part 35.
Under these provisions, medical licensees are i
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permitted to use small, radioactive, scaled sources to treat cancer.
These scaled sources are designed to be implanted directly into a tumor area or applied on the surface of an area to be treated.
This procedure is known as brachytherapy.
The list of scaled k
sources approved for use in brachytherapy is set out in 10 CFR 35.400.
The petitioner, requests that the NRC amend 10 CFR 35.400 to add palladium-103 as a scaled source in seeds for the inteistitial treatment of cancor to the list of scaled sources approved for use in brachytherapy The petitioner manufactures and markets a scaled brachytherapy source dnsigned for the interstitial treatment of cancer.
The scaled source cc: cists of a titanium tube scaled at both ends with laser wclded end cups.
The tube encloses two palladium-103 plated graphite pcilots and a lead x-ray marker to identify the position of the implanted seeds on a radiograph.
Palladium-103 cmits soft, therapeutic, ionizing x-rays that interact with the tissue to be treated.
Palladium-103 has a 17 day half-life and decays by electron capture with the emission of characteristic x-rays of 20-23 kcV and Auget electrons.
Ph* >-
a h n OI hCd_by.- tha-Lit a n i um -wa 1 L-o f-the-ca psua oc.-
plan rnnn aro The petitioner requests this amendment so that cach medical licensee that intends to use palladium-103 as a scaled source for the interstitial treatment of cancer may do so without having t o request (,nobta a specif.ic amendment to the 1icense au t har i :. i ng the mcdical use of byproduct material.
The inclusion of
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4 palladium-103 in the list of scaled sources approved for brachytherapy use in 10 CFR 35.400 would climinate the need for licenscos to obtain a licenso amendment.
According to the petitioner, this would benefit both the petitioner and any potential user by climinating the delay and expense involved in amending a license.
Dated at Rockville, Maryland, this th day of 1988.
For the Nuclear Regulatory Commission.
Samuel J. Chilk, Secretary of the Comminsion.
I
<,e PAFT 36 e STATEMENTS OF CONSIDERATION assessment and the finding of no that a backfit analysis is not required for Reguletery Commissiorr. Washington DC eipalficant impact are available from this rule because these amendments do 20555 telephone (302)ess-87pr.
Alan K. Roecklein. USNRC. Washington, not involve any provisions which would suPPLats888TARY NepombsADest DC 20555. [301) 492-3740.
Impose backfits as defined in 10 CFR l
Papetwork Reduction Act Statement Sa W aX1b hhM%
The final rule does not contain a new Ilst of Subjects in 10 CFR Part gg On November 30,198LTheragonies.
or amended information collection Byleoduct material. Drugs. Health Corporation subenieted a petition fer, requirement subject to the Paperwork facilitier Health professions.
rulemaking PRM-36-F which woe, Reduction Act of 1980 (44 U.S.C. 3501 et incorporation by reference Medical docketed on December 9,1986.no-seq.). Existing requirements were devices. Nuclear matarials, petitionerTequested that the NRC approved by the Office of Management Occupational safety aad health. Penalty.
amend its regulations to edel palladians.
and Budget, approval number 3150e0.
Re on p tection. Iteporting and 13[ud esode orthe m
Regulatory Analysis For the reasons set out in the of sealed sources currently permissed ha The Commission has prepared a preamble and under the authority of the 10 CFR 356400 for use in brachytherapy.
regulatory analysis on this regulation.
Atomic Energy Act of 1954. as amended.
D'pe inlan one ed that, undercarsunt.
The analysis examines the costs and the Energy Reorganization Act of1974 RC e one, iconeem who est "b'dium103 must 30 through benefits of the alternatives considered as amended, and 5 U.S.C. 553. the NRC "se o h'
by the Commission. The analysis is is adopting the folk; wing amendment to gig,,],,,,,7before as available for inspection in the NRC 10 CFR Part 35.
Public Document Room.1717 H Street product and that amendtarioCFR 35.400in the-mar suggested woeld.
N W., Washington. DC.
53 FR 43419 eliminadie cumbersoWrocese, 9
and o e aerosol only 88 1 rooms kept at negative pressure will pe tiener I
e g,,,c,,,,,,7ygg.s puolic Document including a letter from the PDA e safety frrYrc$1 licensees and will Ro m;otherunornomenclature evaluation report from the State of me avoid depriving patients of a necessary O*"
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See Part 1 Statements of Conalderation r
ac n ubi c r rker The letter from the FDA stated that, health and safet/ will result.
under section 510(k) of the Federal Fbod.
54 FR 41819 Drug, and Cosmetic Act. as===ndad Regulatory Mexib'lity Certifkation Published 10/t2/69 marketing the device (palladium-108 as As required by ite Regulatory Effective 10/12/89 a sealed source in seeds) wouldbe Flexibility Act of 1980. 5 U.S.C. 805(b).
10 CFR Part 35 permitted subject to the general controle the Commission cer'ifies that this rule provisions of the FederalFood Drug..
will faot have a signifh. ant economic RIN 3150-AC11 and Cosmetic Act until such time as the impact on a substantia) number of smal!
device has been classified as eithee a ntities. The rule removes a restriction Palladium 103 for interstitial Class I. H or HI device under section imposed on many of the NRC's 2.500 Treatment of Canc.w 513. Class I devices require general i
medicallicensees that administer controla. that is, registration and good AGENcv: Nuclear Regulatory manufacturing practices. Class H radioactive aerosols by inhalation for Commission.
diagnostic purposes. The NRC has devices require performance standarda edopted size standards that classify e ActoN: Final rule.
In addition to general controls. Clasa1H hospita1 as a sma11 entity iiits annuai device 8 requite prior FDA approvalof a suwuAny:The Nuclear Regulatory Pro. Market Approvalapplication, gross receipts do not exceed $3.5 million. and a private practice physician Commission (NRC)is amendingits performance standards, end general as a small entity if the physician a regulations governmg the medical uses controls. In January 1988 tS3 FR 1564),
annual gross receipts are $1 million or of byproduct matedal to add palladium.
FDA classified radionuclide 103 as a sealed source in seeds to the brachytherapy scarces as Class U less (50 FR 50241: December 9.1985).
Although some NRC medicallicensees list of brachytherapy sources permitted devices. Thia pernuts Theragen6cs to for use in the trestment of cancer. Under continue marketing the palladium-101 could be considered small entitles, the current NRC regulations, users must seeds.
[1 er th have their licenses amended before they In March 1988.Theragenics, an 8
d substantial number for purposes of the use palladi n 03.This amendment.
Agreement State
- licensee of the State Regulato Flexibility Act' pr malgated in response to a petition for uf Georgia. submitted information on the The eff et of the regulation is to rulemsbng WRM-35-7). will reduce the radiation safety properties of palledlem>
remove a restriction applicable to the reg at rpurden mr m@al use administration of radioactive aerosols.
licensees who plan to use the sealed 103 to Georgia,in orderto obtain a This will benefit all medical licensees e urce. An evatuation of the potential Certifieste of Registration." Such a but will provide special benefits for radietion hazards to hospital personnel certificate is necessary for Theragonics to manufacture and distribute t P sh dt t te w d smaller institutions by allowing the m
g alladium 103 seeds to specific continued use of a clinical diagnostic used in accordance with the procedure without imposing the safety properties included the design requirement of constructing additional manugcturer.a radiat2on safety and and construction, prototype testing.
facilities or modifying existing facilities.
handling instructions.
conditions of normal use, labeling, errecTtva paTa: October 12.1989, external rediation levels, solubility in Backfit Analysis ron puenwn mponseano, co,rracn body fluids, and quality control and The NRC has determined that the Dr. Anthony N. Tse. Office of Nuclear assurance. After reviewing the backfit rule.10 CFR 50.109 does not Regulatory Research. U.S. Nucles, information and determining the apply to this final rule, and therefore, adequacy of the radiation safety September 29,1995 35-SC 4
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!8 PART 35 STATEMENTS OF CONSIDERATION properties of the source, the State of review and approval process for the BackBt Analysis Georgia issued a Certificate of NRC.Thus, the NRC is amending The NRC has determmed that a j
Registration to Theregenics on i 35.400 to add palladium.103 as a September 22.1988. Die certificate sealed source in seeds for the interstitial backfit analysis is not required for this l
summarised the submitted radiation treatment of cancer.
amendment because the action does not c ns backfit as delined in 10 CFR safety information and specified EnvironmentalImpact: cgm additional limitations and conditions on Exclusion the use of the source.This certificate List of Subjects in 10 CFR Part 75 was amended in its entirety on June 6.
The NRC has determined that this 1988, to include e minor design final amendment is the type of action Byproduct material. Drugs. Health improvement made by neragenics.
described in 10 CFR 61.22(c)(2).
facilities. Health professions.
Following its determination that the Therefore. neither an environmental Incorporation by reference. Medical l
radiation safety properties of the source impact statement nor an environmental devices. Nuclear materials.
l are adequate, the State of Georgin sent assessment has been prepared for this Occupational safety and health. Penalty.
NRC a copy of the certificate to include amendment.
Radiation protection. Reporting and in the Registry of Source and Device recordkeeping requirements.
operw e uction Act Statement Designs that is maintained by the NRC.
For the reasons set outin the We NRC reviewed the certificate for nis final amendment does not preamble and under the authority of the l
consistency with other certificates in the contain any new or amended Atomic Energy Act of 1954, as amended.
Registry and added palladium-103 to the information collection requirements the Energy Reorganization Act of1974.
Registry on October 29.1988, and again subject to the Paperwork Reduction Act as amended, and 5 U.S.C. 552 and 553, in June 1988 to cover the minoc design of 1980 (44 U.S.C. 3501 et seq.). Existing the NRC is adopting the following improvement. This action, in effect, requirements were approved by the amendment to 10 CFR Part 35.
granted a premarketing approval of the Office of Management and Budget.
sealed source and permitted the use of approval number 3150 0010.
palladium.103. provided the user's Regulatory Analysis license was amended to include that sealed source.
The NRC has prepared a regulatory analysis on this amendment. The Proposed Amendment and Public analysis examines the costs and Comment benefits of the alternatives considered After considering the petition. the by the NRC.The analysis concludes that NRC published a proposed amendment the adoption of the amendment will not granting the petition for a 30. day public increase the nsk to the public health and comment period (54 FR 13892. Apri! 6.
safety but will reduce the cost to the 1909). One comment letter was received.
medical use licensees who plan to use The comment letter, submitted by a palladium-103 seal d sources.
I medical professional organization.
Interested persons may examine a copy supported the petition.The letter stated of the regulatory analysis at the NRC l
that "this would indeed alleviate Public Document Room. 2120 L Street, burdensome current NRC regulations NW. (Lower Level). Washington, DC.
that require users to amend their Single copies of the regulatory analysis licenses before using palladium 103."
may be obtained from Dr. Anthony N.
Tse (See FoR FURTHER INFOmasATION Conclusion CONTACT heading).
The NRC has determined that the addition of palladium-103 as a sealed Regulatory Flexibility Certification source in seeds to the list of sealed As required by the Regulatory sources specified in i 35.400 will not Flexibility Act of1980. 5 U.S.C. 605(b),
cause additional risk to hospital the Commission certifies that this personnel or the public because the amendment does not have a significant radiation safety and handling economic impact on a substantial instructions to be used for palladium.103 number of small entities.This are the same as the instructions used amendment adds the use of palladium-currently for the brachytherapy sources 103 as a sealed source in seeds in to listed in l 35.400. This action will reduce CFR 35.400. This action will reduce the the regulatory burden to the users of regulatory burden on medical use palladium-103 seeds (about 700 potential licensees planning to use the sealed users) as well as to the NRC staff. Most source by eliminating the requirement of users will not have to follow the present submitting a license amendment requirement of submitting individual application.The NRC has adopted size license amendment applications in order standards that classify a hospital as a to use palladium-103 as a sealed source small entity if its ennual gross receipts in seeds for the interstitial treatment of do not exceed $3.5 million, and a private cancer (if their license permits the use of practice physician as a small entity if any brachytherapy sources specified in the physician's annual gross receipts are 135.400). A user whose license only
$1.0 million or less. Although some NRC permits the use of specified medical use licensees could be brachytherapy sources will still be considered "small entities." the number required to submit a license amendment that would fallinto this category does application. But for most licensees this not constitute a substantial number for rule will eliminate the license purposes of the Regulatory Flexibility
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amendment application process and the Act.
l 35-SC-5 September 29,1995 I
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.a 35.320 e
35.406(d)
PART 35 o MEDICAL USE OF BYPRODUCT MATERIAL s
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I 35.320 Possession of survey
$ 35.404 Release of patients or human
$ 35.406 Brachytherapy sources inventory.
Instruments, research subjects treated with temporary (a) Promptly after removing them A licensee authorized to use Implants.
from a patient or a human reseitch byproduct material for (a) !mmediately after removing the subject.a licensee shall return radiopharmaceutical therapy shall have last temporary implant source from a brachytherapy sources to the storage in its possession a portable radiation patient or a human research subject, the area, and count the number returned to detection survey instrument capable of licensee shall make a radiation survey of ensure that all sources taken from the l
detecting dose rates over the range 0.1 the patient or the human research storage area have been returned.
millirem per hour !o 100 millirem per subject with a radiation detection (b) A licensee shall make a record of hour, and a portable radiation survey mstrument to confirm that all brachytherapy source use which must meaaurement survey instrument capable sources have been removed. The include:
of measuring dose rates over the range 1 licensee may not release from (1) The names of the individuals j
millirem per hour to 1000 millirem per g confinement for medical care a patient permitted to handle the sources; hour.
t:: or a human research subject treated by (2) The number and activity of y temporary irnplant until all sources sources removed from storage. the Subpart G-Sources for Brachytherspy
- have been removed.
patient's or the human research (b) A licensee shall retain a record of subject's name and room number. the Iss.aco Une of sources for patient or human research subject time and date they were removed from
surveys for three years. Each record 3 storage. the number and activity of the 2 A licensee shall use the following must include the date of the survey, the $ sources in storage after the removal. and 8 sources in accordance with the name of the patient or the human cc the initials of the individual who E manufacturer's radiation safety and research subject, the dose rate from the % removed the sources from storage:
3 handling instructions:
patient or the human research subject (3) The number and activity of (a) Cesium 137 as a sealed source in expressed as millirem per hour and sources returned to storage. the patient's needles and applicator cells for topical, measured at 1 meter from the patient or or the human research subject's name inierstitial. and intracavitary treatment the human research subject. the survey and room number, the time and date of cancer:
instrument used, and the initials of the they were returned to storage. the (b) Cobalt 60 as a sealed source in individual who made the survey.
number and activity of sources in needles and applicator cells for topical, storage after the return. and the initials interstitial, and intracavitary treatment of the individual who returned the of cancer:
i I
sources to storage.
(c) Cold 198 as a sealed source in (c) Immediately after implanting seeds for interstitial treatment of cancer:
sources in a patient or a human research (d) Iridium-192 as seeds encased in subject the licensee shall make a nylon ribbon for interstitial treatment of radiation survey of the patient or the cancer:
human research subject and the area of (e) Strontium-90 a s a sealed source in use to confirm that no sources have an applicator for treatment of superficial been misplaced. The licensee shall l
eye conditions: and make a record of each survey.
I (f) lodine 125 as a sealed source in seeds for interstitial treatment of cancer.
(-
?E req (d) A licensee shall retain the recor f"
uired in paragraphs (b) and (c) of this j (g) p.elladmm-tuJ n a scaled source g section for three years.
E in seeds for mterstitial treatmirnt of g
gc.encer.
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l 3 5-19 September 29,1995 i
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