ML20045B159
| ML20045B159 | |
| Person / Time | |
|---|---|
| Issue date: | 04/15/1993 |
| From: | Chilk S NRC OFFICE OF THE SECRETARY (SECY) |
| To: | Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| References | |
| FRN-58FR33396, REF-10CFR9.7 AD69-1-025, AD69-1-21, AD69-1-25, NUDOCS 9306160358 | |
| Download: ML20045B159 (5) | |
Text
s RELEASED TO THE PDR m
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NUCLEAR REGULATORY COMMISSION
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,y OFFICE OF THE April 15. 1993 SECRETARY MEMORANDUM FOR:
James M.
Taylor Executive Director for Opepations FROM:
Samuel J.
Chilk, Secreta 7
dfdhMENTSON
SUBJECT:
SECY-93-050 - PROPOSED Al PREPARATION, TRANSFER, A140 USE OF BYPRODUCT MATERIAL FOR MEDICAL USE
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The Commission (with all Commissioners agreeing) has approved publication of the Notice of Proposed Rulemaking enclosed in the subject paper with the changes described below and indicated in the attachment.
(EDO)
(SECY Suspense:
5/21/93)
The format of Table 1 on page 10 of Enclosure 1 is an effective way of summarizing the main points of the ACNP-SNM petition and the NRC's response to those points.
However, several of the entries which describe NRC responses speak of permitting " greater discretion," but do not describe the nature of the discretion, and therefore do not respond directly to the points raised by the petition.
The staff should revise the table to be more clearly responsive to the petition.
The staff should revise the definition of " patient" so as to distinguish between medical patients in the conventional sense and research subjects, which should be referred to as such in the proposed rule.
The Supplementary Information in the Federal Register notice should tell reaJers how they can acquire a copy of the Federal Policy for the Protection of Human Subjects so they can more easily comment on the proposed text of 5 35.6.
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Attachment:
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SECY NOTE:
THIS SRM, SECY-93-050, AND THE VOTE SHEETS OF ALL COMMISSIONERS WILL BE MADE PUBLICLY AVAILABLE 10 WORKING DAYS FROM THE DATE OF THIS SRM
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9306160358 930415 "O
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PDR-10CFR PT9.7 PDR
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cc:
The Chairman Commissioner Rogers Commissioner Curtiss Commissioner Remick Commissioner de Planque OGC OIG Office Directors, Regions, ACRS, ACNW (via E-Mail)
OP, SDBU/CR, ASLBP (via FAX) i
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t management rule and misadministrations in i 35.2 are Division 1 items of compatibility; 19 35.32 and 35.33 are Division 2 items of compatibility;
& 35.8 is a Division 4 item of compatibility; and all other sections of Part 35 are Division 3 items of compatibility.
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Finding of No Significant Environmental Impact:
Availability The Commission has determined under the National Environmental Policy Act of 1969, as amended, and the Commission's regulations in Subpart A of 10 CFR Part 51, that the proposed amendments, if adopted, would not be a major Federal action significantly affecting the quality of the human environment, and therefore an environmental impact statement is not required. The proposed amendments would provide greater flexibility for physician authorized users to use byproduct material in the practice of medicine.
The proposed amendments would also incorporate into the regulations the concept of authorized nuclear pharmacists to permit properly qualified pharmacists to prepare radioactive drugs containing byproduct material in the practice of pharmacy.
The proposed amendments would allow physician authorized users greater discretion to prepare and use radioactive drugs containing byproduct material.
The proposed amendments would also allow authorized nuclear pharmacists greater discretion to prepare radioactive drugs containing byproduct material.
It is expected that there will be no increase in radiation exposure to the public or to the environment beyond the exposures currently resulting from delivering the byproduct material or radiation from byproduct material to the patient. The draft environmental assessment and finding of no significant impact on which this' determination is based is_ available for inspection at the 47
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Insert for page 47 of FRN NRC expects Agreement States to adopt rules required to maintain compatibility within 3 years after NRC's rules l
t become effective.
Some Agreement States, face'd with i
administrative and resource constraints, may find the'3 f
year goal difficult to attain and may prefer,that NRC extend flexibility in such cases to allow the States to
'I implement the requirements through license conditions.
Staff requests public comment on permitting Agreement States flexibility in this regard, and if permitted, under what conditions.
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- 20. Section 35.49 is revised to read as follows:
9 35.49 Suppliers for sealed sources or devices for medical use.
A ' licensee may use for medical use only:
(a) Sealed sources or devices manufactured, labeled, packaged, and distributed in accordance with a license issued pursuant to 10 CFR Part 30 and 32.74 or the equivalent regulations of an Agreement State; or and (b) Teletherapy sources manufactured,og distributed in accordance with a l
license issued pursuant to 10 CFR Part 30 or the equivalent regulations of an Agreement State.
21.
In 9 35.50, paragraphs (a), (b)(3), and (e)(2) through (e)(4) are revised to read as follows:
5 35.50 Possession, use, calibration, and check of dose calibrators.
t (a) A licensee shall possess and use a dose calibrator to measure the i
activity of dosages of photon-emitting radionuclides prior to administration to each patient or human subject.
(b)
(3) Test each dose calibrator for linearity upon installation and at least quarterly thereafter over the range of its use between the ' highest dosage that will be administered to a patient and 1.1 megabecquerels (30 microcuries); and 1
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