ML19332C801
| ML19332C801 | |
| Person / Time | |
|---|---|
| Issue date: | 11/21/1989 |
| From: | Tse A NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| To: | Huyer D NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM) |
| Shared Package | |
| ML19324D762 | List: |
| References | |
| FRN-54FR13892, RULE-PR-35, RULE-PRM-35-7 AD11-1-01, AD11-1-1, NUDOCS 8911290014 | |
| Download: ML19332C801 (2) | |
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Il0V 2 1 1999 AD11-1 31.:
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Darlene Huyer, Chief, NUDOCS/IRM FROM:
Anthony N. Tse, RDB/DRA/RES SUBJECP:'
REGUIA' KEY HIS'IORY DOCLMENTS EDR A PROPOSED AMENDENT Copies of the subject documents are enclosed for the proposed amendment,.
~" Palladium-103 for Interstitial Treatment of Cancer," which are to be included-in the NUDOCS. 'Ihis.adsdisit was prepared in response to a petition for rulenuking PRM-35-7. As requested by Michael Tew of the Regulatory 4
Publications Branch / AIM,. the designator "AD11-1" was placed in the upper right-hand corner of each document, including this transmittal memorandum.
Also enclosed for your information is a copy.of the index of the h w nts for the proposed amendment. Please let me know if you have any questions.
I ony N. Tse Regulation Development Branch DRA/RES
Enclosures:
1.
Index 2.
Copies of documents cc (w/ encl.1):
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8911290014 891121 PDR PR 35 54FR13892 PDR
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NOV211919-AD11-1 r
RBATIA'IORY HIS'IORY - INDEX FOR A PROPOSED AMDDENf "PALIADIIM-103 FOR INTERSITTIAL 'IRENDENT OF CANCER" DATE FRCH
'IO SUBJECT i'
i 12/20/88 NMcDonald EBeckjord PRM filed by '1heragenios 1
01/12/89 EBeckjord PNorry Fast-track p wirg 01/19/89 ATse Cognizant Draft sq- = " rule for individuals ocmanent 02/14/89 EBeckjold Office P W rule for office
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Directors concurrence 03/23/89 EBeckjord VStello, Jr.
Prh rule for a; proval l,
Undated NA NA-Federal Register notice 1
Undated ~
NA NA Regulatory Analysis 04/07/89 EBeckjord-
'Cu grassional letters to Cu jsassional Ctannittees Otsumittees 05/08/89
- OLinton, Secretary Public h..e.nt (Only one American comment letter was received)
College of Radiology End
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AGENCY:
Nuclear Regulatory Commission.
- ...lif n 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 i
sealed source in seeds to the list of brachytherapy sources permitted for use in-treatment of cancer.
Under current NRC j
regulations, users must have their licenses amended before they may use palladium-103. The proposed rule, developed in response to a petition for rulemaking (PRM-35-7), would reduce the regulatory burden on medical use licensees who plan to use the l
sealed source.
An evaluation.of the potential radiation hasards 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).
Commente received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given except to comments received on'or before this date.
i ADDRESSES:
Mail written comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Attention:
Docketing and Service Branch.
Deliver comments to One White Flint North, 11555 Rockville Pike, Rockville, Maryland 26852, between 7:30 an and 4:15 pm weekdays.
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Dr. Anthony N. Tse, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission.
-j Washington, DC 20555, telephhne: (301)492-3797.
SUPPLEMENTARY INFORMATION:
Petition for Rulemaking On November 30. 1988. Theragenica Corporation submitted a
petition for rulemaking, PRM-35-7, which was docketed on December 9, 1988.
The petitioner requests 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 sealed sources currently permitted in 10 CFR 35.400 for use in brachytherapy.
A copy of the petition may be obtained from the l
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Regulatory Publications Branch, Division of Freedom of Information and Publications Services, U.S. Nuclear Regulatory Commission, Washincton, DC 20555.
The petitioner enclosed a document from the Food and Drug Administration (FDA) of the Department of Health and Human Services that allows the marketing of palladium-103 as a sealed source in seeds.
The petitioner stated that, under current NRC
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regulations, licensees who are users of palladium-103 must go through the cumbersome process of having their licenses amended L
before'using the product and that amending 10 CFR 35.400 in the manner suggested"would eliminate this cumbersome process.
In supporting the petition, the petitioner submitted several l
documents, including a letter from the FDA, a safety evaluation report from the State of Georgia, the package insert, and product L
literature.
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The letter from the FDA stated that, under Section 510(k) of the Federal Food, Drug, and Cosmetic Act, as amended, marketing 1
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y the device-(palladium-103 as a sealed source in seeds) would be t
l permitted subject to the general controls provisions-of the
. Federal' Food, Drug, and Cosmetic Act until such time as the
-device has been classified as either a Class I, II, or III device under Section G13.
L In March 1986, Theragenics, an " Agreement State" licensee of the state of Georgia, submitted ~information on the radiation.
safety properties of palladium-103 to Georgia in order to obtain L
a " Certificate of Registration."
Such a certificate'is necessary for Theragenics to manufacture and distribute palladium-103 seeds to specific licensees.
The information on these safety properties included the design and construction, prototype I
testing, conditions of normal use, labelling, external radiation levels, solubility in-body fluids, and quality control and assurance.
After reviewing the information and determining the adequacy of the radiation safety properties of the source, the State of Georgia ist,ued a Certificate of Registration to Theragenics on September 22, 1986.
This certificate summarized
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the submitted radiation safety information and specified additional limitations and conditions on the use of the source.
This certificate was amended in-its entirety on June 6, 1988 to include a minor design improvement made by Theragenics.
Following 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 and Device Designs that is maintained by the NRC.
The NRC reviewed the certificate for consistency with other certificates in the Registry and added palladium-103 to the Registry on October 29, 1986, and again in June 1988 to cover the design f
I improvement.
This action, in effect, granted a premarketing l-l approval of the ecaled source and permitted the use of l-palladium-103 provided that the user's license was amendgd to l.
include that sealed source.
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Conclusion i
The NRC-has evaluated the petition and supporting information and proposes to grant the petition.
The NRC has determined that the addition of palladium-103-as a sealed. source in seeds to the list of sealed sources specified in 10.CFR 35.400 would not cause additional risk to hospital personnel or the public because the radiation safety and handling instructions for' palladium-103 are similar to the instructions for the brachytherapy sources currently listed in Section 35.400.
This action would reduce the regulatory burden to the users of palladium-103 seeds-(about 700 potential users) as well as to the NRC staff.
Most users would not have to follow the present requirement of submitting individual license amendment applications in order to be able to use palladium-103 as a sealed source in seeds for the
. interstitial treatment of cancer-(if their license permits the use of any brachytherapy sources specified in 10 CFR 35.400).
A user whose license only permits the use of specified brachytherapy sources would still be required.to submit a license amendment application.
A reduction in the number of license amendment applications would reduce the expenditure of NRC staff resources in reviewing and granting or denying the requested license amendments.
Environmental Impact: Categorical Exclusion The NRC has determined that this proposed regulation is the-type of action described in 10 CFR 51.22(c)(2).
Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this proposed regulation.
Paperwork Reduction Act Statement This proposed rule does not contain a new or amended information collection requirement subject to the Paperwork 4
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L Reduction Act of-1980-(44 U.S.C. 3501 et seq.).
Existing L
requirements were approved'by the Office of Management and Budget, approval number 3150-0010.
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Regulatory Analysis E
The NRC has prepared a draft regulatory analysis on this
! Proposed regulation.
The analysis examines the: costs and-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 l
heading).
The NRC requests public comments on the draft regulatory analysis.
Comments may be submitted to the NRC (See ADDRESSES heading).
Regulatory Flexibility Certification As required by the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b), the Commission certifies that this rule, if adopted, will'not have a significant economic impact on a substantial number of small entities.
The proposed rule would add the use of palladium-103 as a sealed source in seeds in 10 CFR 35.400.
This action would reduce the regulatory burden on medical use licensees planning to use the sealed source because most users would not have to follow the present requirement of submitting a license amendment application in order to use palladium-103 as a sealed source in seeds for the interstitial treatment of cancer (if the license permits the use of any brachytherapy sources specified in 10 CFR 35.400).
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1 Tne NRC has adopted size standards that classify a hospital as a small entity if its annual gross receipts do not exceed $3.5 million, and a privato practice physician as a small entity if q
the physician's annual gross receipts are $1.0 million or less.-
l Although some NRC medical use licensees could be considered "small entities," the number is estimated to be a very small-
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t percentage of the total number of licensees and does not constitute 1a substantial number for purpocos of the Regulatory H
Flexibility Act.
However, the proposed rule would have a positive economic impact on about 700 licensees.
1 Backfit Analysis The NRC has determined that a backfit analysis is not required for this proposed regulation because the amendment does not constitute a backfit as defined in 10 CFR 50.109(a)(1).
List of Subjects in 10 CFR Part 35
. Byproduct material. Drugs, Health facilities, Health professions, Incorporation by reference, Medical devices, Nuclear materials, Occupational safety an'd health, Penalty, Radiation prctection, Reporting and recordkeeping requirements.
I For the. reasons set out in the preamble and under the L
authority of the Atomic Energy Act of 1954, as amended. the Energy Reorganization Act of 1974, as amended, and 5 U.S.C 553,
-the NRC-is proposing to adopt the following amendment to 10 CFR Part 35.
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The authority citationLfor Part 35 is revised to read as follows:
AUTHORITY:
Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 95J, 954, as' amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841).
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.o 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, 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 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),
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),
35.645, and.35.647(c) are issued under sec. 161o, 68 Stat. 950 as amended (42'U.S.C. 2201(o)).
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In 5 35.400, paragraph (g) is added to-read as follows:
l 5 35.400 Use of cources for brachytherapy.
(g) Palladium-103 as a sealed source in seeds for interstitial treatment of cancer.
Ok day of D ted at Rockville,. Maryland, this M-1989.
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For the Nuclear Regulatory Commission.
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/J Victor Ste o
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Executive Directo or Operations.
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