ML20248F563
| ML20248F563 | |
| Person / Time | |
|---|---|
| Issue date: | 02/23/1989 |
| From: | Norry P NRC OFFICE OF ADMINISTRATION (ADM) |
| To: | Beckjord E NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| Shared Package | |
| ML20248F519 | List: |
| References | |
| FOIA-98-86 NUDOCS 9806040333 | |
| Download: ML20248F563 (8) | |
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- WASHINGTON, D. C. 20555 Mle l ' ' ' ~ l FEB 2 3 1989
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MEMORANDUM FOR: Eric S. Beckjord, Director Office of Nuclear Regulatory Research FROM: Patricia G. Norry, Director
, Office of Administration
SUBJECT:
PALLADIUM-103 FOR INTERSTITIAL TREATMENT OF CANCER The Office of Administration concurs on the proposed rule that would amend 10 CFR Part 35 to permit medical licensees to use palladium-103 as a sealed source in seeds for the interstitial treatment of cancer. The proposed rule, developed in response to a petition for *ulemaking (PRM-35-7), would add palladium-103 as a sealed source in seeds to the list of brachytherapy sources approved for use in 10 CFR 35.400. We have enclosed a marked-up copy of the package that presents a number of editorial comments.
If you have any questions concerning this matter, please have a member of your staff contact Michael T. Lesar, Regulatory Publications Branch, ADM (extension 27758).
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./: .c i Patricia n /2.scw G. Norry,Direedor
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l office of Administration
Enclosure:
As stated l
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l NEMORANDUM FOR: Victor Stello, Jr. 7
! Executive Director for Operations j FROM: Eric S. Beckjord, Director Office of Nuclear Regulatory Research l
SUBJECT:
PROPOSED AMENDMENT TO 10 CFR 35.400: ADDING l PALLADIUM-103 FOR INTERSTITIAL TREATMENT OF CANCER (PRM-35-7)
Ex/osnl i.^. tee..d for your signature is a proposed rule (Enclosure A), to be published in the Federal Register, that amends 10 CFR Part 35,
" Medical Use of Byproduct Material." This amendment would add l palladium-103 as a sealed source in seeds to the list of sealed
- sources that may be used in brachytherapy as specified in 10 CFR 35.400.
l BACKGROUND:
A petition for rulemaking was submitted by Theragenics Corporation (PRM-35-7, docketed December 9, 1988) requesting that
' palladium-103 be added to 10 CFR 35.400, "Use of Sources for Brachytherapy." The petitioner stated that, under the present regulation, users of palladium-103 must go through the cumbersome process of amending their licenses before they can use the product and that amending 10 CFR 35.40 would eliminate this cumbersome process. ;,, ./J, m wu .5 vjf ef hc/
Staff review of the petition showed that the addition of palladium-103 to 10 CFR 35.400 would reduce the regulatory burden on medical licensees who plan to use the sealed source. Thus, as compared to the current practice, the proposed change would reduce the burden for both medical licensees and the NRC staff while providing the same level of protection of the public health and safety. The proposed rule would grant the petitioner's request by adding palladium-103 as a sealed source in seeds to the list of approved sources in 10 CFR 35.400.
BACKFIT ANALYSIS:
The staff has determined that c backfit analysis is not required for this proposed rule because the amendment does not constitute I
a backfit as defined in Section 50.109(a)(1). .
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) NOTICES:
A draft regulatory analysis was prepared (Enclosure B).
The appropriate Congressional Committees will be notified j I
l Enclosure
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( l,b, (2 ) (I l . Approved for. Publication The Consission delegated to the EDO (10 CFR E anrai ==d ( the
- authority to develop and promulgate rules as defined in the APA (5 U.S.C. 551 (4)) subject to the limitations in the NRC Hanual Chapter 0103, Organization and Functions, Office of the Executive Director for Operations, paragraphs 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 J use the sealed source.
The propssed 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 as proceeding to issue it.
Date Victor Stello, Jr.
Executive Director for Operations i
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h l NUCLEAR REGULATORY COMMISSION l
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! Palladium-103 for Interstitial Treatment of Cancer l
l AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed rule.
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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 sealed eource in seeds to the list of 5 brachytherapy sources I permitted for use in treatment of cancer. Under current NRC regulations, users must have their licenses amended before they i 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 sealed source. An evaluation of the potential radiation hazards l 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.
l 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 received on or before this date.
l ADDRESSES: Mail written comments to: Secretary, U.S. Nuclear i 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 a and 4:15 p^m weekdays.
Enclosure A
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FOR FURTHER INFORMATION CONTACT: Dr. Anthony N. Tse, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone: (301)492-3797.
SUPPLEMENTARY INFORMATION:
' Petition for Rulemaking l l On November 30, 1988, Theragonics 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 j
the interstitial treatment of cancer to the list of sources permitted in 10 CFR 35.400 for use :.n 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. The petitioner stated that, under current NRC regulations, users of palladium-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. j g , g,y jg In supporting the petition, the petitioner submitted several documents, including a letter from the FDA, a safety evaluation report from the State of Georgia, the package insert, and product literature, j The letter from the FDA stated that, under Section 510 (k)( )
marketing the device (palladium-103 as a sealed source in seeds) )
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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 numbe- of small entities. The proposed rule would l 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 I . O medical use licensees who plan to use the sealed source.
9/The 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 private practice physician as a small entity if the physician's annual gross receipts are $1.0 million or less.
Although some NRC medical use licensees could be considered "small entities," the number that would fall into this category does not constitute a substantial number for purposes of the l Regulatory Flexibility Act. However, the proposed rule would i have a positive economic impact on about 700 licensees. ,
Backfit Analysis i
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 Section 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 f materials, Occupational safety and health, Penalty, Radiation protection, Reporting and recordkeeping requirements.
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For the reasons set out in the preamble and under the 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 propaning to adopt the following amendment to 10 CFR Part 35.
, p evae' l 1. The authority citation for Part 35 erstinus +_ read as follows:
AUTHORITY: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 68 Stat. 1242, as amended (42 U.S.C. 5041).
I For purposes o sec. 223, 68 Stat. 958, as' amended (42 U.S.C. 22 ); il 35.1 , 35.13, 35.20(a) and (b), 35.21(a) and l (b), 35.<2, 35.23, 5.25, 35.27(a), (c) and (d), 35.31(a), 35.49, l 35.50(a) 4 D.,. .51(a)-(c), 35.53(a) and (b), 35.59(a)-(c),
l (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, 4
i 35.404(a), 35.406(a) and (c), 35.410(a),
35.520, 35.605, 35.606, 35.610(a) and (b),35.415, 35.420, 35.500 D l
35.615, 35.620, _
' 35.630(a) and (b), 35.632(a)-(f), 35.638(a)-((), 35.636(a) and (b), 35.641(a) and (b), 35.643(a) and (b), 35.645(a) and (b), 6 35.900, 35.910, 35.920, 35.'930, 35.932, 35.934, 35.940, 35.941, I 35.960, 35.961, 35.970, and 35.971 are issued under sec.
161b, 38 Stat. 948, as amended (42 U.S.C. 2201(b)); and gg 3 .14, 35.21(b), 35.22(b), 35.23(b), 35.27(a) and (c),
i 35 9(b), 35.33(a)-(d), 35.36(b), 35.50(e), 35.51(d), 35.53(c),
.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), /p 35.630(c), 35.632(g), 35.634(j), 35.636(c), 35.641(c), 35.643(c) T 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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l WEEKLY REPORT TO THE COMMISSION 1
OFFICE OF NUCLEAR REGULATORY RESEARCH l
Proposed Rule to be signed by EDO l
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 l response to a petition for rulemaking (PRM-35-7, Theragenics l Corporation, docketed December 9, 1968), unuld add palladium-103 !
as a sealed source in seeds to the list of sources specified in i 10 CFR 35.400. The change would reduce the regulatory burden on '
medical use licensees who plan to u'e the sealed source. i This constitutes notice to the Commission that, in accordance I with the rulemaking authority delegated to the EDO, the EDO has
! signed this proposed r ale 2rf rr^ra=== to fa-==-d it ., so. O'__
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Enclosure D
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April 7, 1989 \
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- IDENTICAL LETTERS TO
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- Chairman John B. Breaux, Senate Subcommittee on Nuclear Regulation cc: Alan K. Simpson Chairman Philip R. Sharp, House Subcommittee on Energy and Power Carlos J. Moorhead cc:
The Honorable Morris K. Udall, Chairman Subcommittee on Energy and the Environment Committee on Interior and Insular Affaire l United States House of Representatives Washington, DC. 20515
Dear Mr. Chairman:
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Enclosed for the information of the subcommittee is a copy of a notice of Proposed Rulemaking to be published in the Federal Reninter. In response to a petition for rulemaking, the Nuclear l Regulatory Commission is proposing to amend its regulations at 10 CFR 35.400 to add palladium-103 as a sealed source in ceeds to the list of brachytherapy sources permitted for use in the interstitial treatment of cancer.
The proposed rule would reduce the regulatory burden on medical use licensees planning to use the sealed source. The proposed 4 rule 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.
The notice will be mailed to medical use licensees and other
! interested individuals for comment. We expect the medical l community will be very interested in the notice.
l Sincerely, ORIGINAL SIG!D BY Eric S. Beckjord, Director j Office of Nuclear Regulatory Recearch l
Enclosure:
Distribution:
Amendment to subj-circ-chron 10 CFR Part 35 EBeckjord, TSpeis, Dross, BMorris, ZRosatoczy, cc: Representative James V. Hansen WLabs, JTelford, ATee RDB d4ng filen M
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OFF.: BDB: R &, RDB DRA B:DRA DN"A:rts DRA:BES NAME: ATs , JTelford WL s ZRosztoczy BMorris DATE: 3/2 / 9 34A/89 3/ "9 3 /e t/89 3/z2/89
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