ML20045B176
| ML20045B176 | |
| Person / Time | |
|---|---|
| Issue date: | 06/02/1993 |
| 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 AD69-1-031, AD69-1-27, AD69-1-31, AD69-1-32, NUDOCS 9306160376 | |
| Download: ML20045B176 (7) | |
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UNITED STATES o
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June 2, 1993 OFFICE OF THE SECRETARY MEMORANDUM TO:
James M. Taylor ExecutiveDirhcorfhrOperations FROM:
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SUBJECT:
SECY-93-OSb - PROPOSED AMENDMENTS ON PREPARATION, TRANSFER, AND USE OF BYPRODUCT MATERIAL FOR MEDICAL USE 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:
6/4/93)
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,a 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 Recister notice shoIld tell readers 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.
Attachment:
As stated (Revised to add changes to pages 2 and 3 of proposed FRN) j l
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 9306160376 930602 6
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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)
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k ADDRESSES:
Mail written comments to the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Attention:
Docketing and Service Branch.
Hand deliver comments to 11555 Rockville Pike, Rockville, Maryland, between 7:45 a.m., and 4:15 p.m. on Federal workdays.
Copies of the draft regulatory analysis and any public coments received on the proposed rule may be examined at:
the NRC Public Document Room, 2120 L Street, NW. (Lower Level), Washington, DC.
FOR FURTHER INFORMATION CONTACT: Samuel Z. Jones or Anthony N. Tse, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 492-3738 for Mr. Jones, or (301) 492-3797 for Mr. Tse.
SUPPLEMENTARY INFORMATION:
BACKGROUND The Petition for Rulemaking In early On-Gene-Fr 1989, the American College of Nuclear l
Physicians (ACNP) and the society of Nuclear Medicine (SNM) approached the NRC staff with concerns that the Commission's reculations failed to accommodate the functions and responsibilities of the practice of nuclear charmacy.
At the succestion of the NRC staff, the ACNP and SNM submitted a petition for rulemaking requesting the Commission to amend its regulations to fully recognize the role of licensed nuclear pharmacists and physicians.
On September 15, 1989 (54 FR 38239), the Commission published in the Federal Register a notice of receipt of a petition for rulemaking for public comment (PRM-35-9).
4 During the development of the ACNP-SNM petition, one NRC staff l
member provided substantial assistance in the preparation of the petition, but has not participated in the NRC's resolution of the petition or in the development of this proposed rule.
Another NRC staff member reviewed the petition prior to its formal submittal to the Cc= mission and participated, to a limited some extent at--an z
early stage-in the NRC's resolution of the petition and in the development of the proposed rule.
The Commission, while aware of this backaround, considered the petition on its own merits.
l The NRC reviewed the petition and identified the following issues:
A.
The petitioners requested that authorized users who are physicians (physician authorized users) be given greater flexibility regarding the medical use of radiophamaceuticals containing byproduct material.
l Specifically, the petitioners requested that these physicians be permitted to:
(1) use radiopharmaceuticals to treat diseases that are not listed in the U.S.
Food and Drug Administration (FDA) approved package insert; (2) use methods of administration of radiopharmaceuticals for therapy that are not listed in the package insert; (3) use radiopharmaceuticals other than those for which the FDA has accepted an Investigational New Drug (IND) or an approved New Drug Application (NDA); (4) prepare radiopharmaceuticals using radionuclide generators and reagent kits in a manner other than in accordance with the manufacturer's instructions; (5) compound radiopharmaceuticals as described in r
State or FDA regulations; and (6) compound radiopharmaceuticals whose manufacture and distribution are not regulated by the State or FDA.
B.
The petitioners requested that the NRC recognize the practice of nuclear pharmacy by nuclear pharmacists and the certification of nuclear pharmacists by the Board of Pharmaceutical Specialties.
Specifically, the petitioners requested that nuclear pharmacists be permitted to:
(1) compound 3
h management rule and misadainistrations in 6 35.2 are Division 1 items of compatibility; sl 35.32 and 35.33 are Division 2 items c: 0.>.stibility; 6 35.8 is a Division 4 item of compatibility; and all other <.ctions of Part 35 are Division 3 items of compatibility.
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next gt Finding of No Significant Environmental Impact:
Availability The Comission has determined under the National Environmental Policy i
Act of 1969, as amended, and the Commialon's regulations in Subpart A of 10 CFR Part 51, that the proposed amerdments, 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 t
use byproduct material in the prat.tice 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 L
delivering the byproduct material or radiation from byproduct material to the r
l patient. The draft environmental assessment and finding of no significant impact on which this determination is based is available for inspection at the 47 i
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Insert for page 47 of FRN
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r NRC expects Agreement States to_ adopt rules required to maintain compatibility within 3 years after NRC's rules become effective.
Some Agreement States, faced with administrative and resource constraints, may find the 3 year goal difficult to attain and may prefer that NRC extend flexibility in such cases to allow the States to implement the requirements through license conditions.
Staff requests public comment on permitting Agreement' States. flexibility in this regard, and if permitted, 1
under what conditions.
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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 5 35.50, paragraphs (a), (b)(3), and (e)(2) through (e)(4) are revised to read as follows:
1 35.50 Possession, use, calibration, and check of dose calibrators.
(a) A licensee shall possess and use a dose calibrator to measure the activity of dosages of photon-emitting radionuclides prior to administration to each pat 4 at 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 64