ML20150E459
| ML20150E459 | |
| Person / Time | |
|---|---|
| Issue date: | 02/05/1988 |
| From: | Mcelroy N NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Lesar M, Rich Smith NRC, NRC OFFICE OF THE GENERAL COUNSEL (OGC) |
| Shared Package | |
| ML20150E436 | List: |
| References | |
| FRN-53FR21627, RULE-PR-35 AC69-2-7, NUDOCS 8807150151 | |
| Download: ML20150E459 (1) | |
Text
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M-1 POR ROUTING AND TRANSMITTAL SLIP 5FEB88 TO: RON SMITH, OGC MIKE LESAR, ARM "PLEASE PROVIDE OFFICE CONCURRENCE ON THE ENCLOSED RULE REGARDING DIAGNOSTIC MISADMINISTRATION REPORTS" l
l N. L. MCELROY, NMSS 23417 l
878004 00CKETED USHRC RULESORR:ADM
& PROCEDURES BR 88 RB -5 P 3:25 ,
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MEMORANDUM FOR: Victor Stello, Jr.
Executive Director for Operations FROM: Hugh L. Thompson, Jr., Director Office of Nuclear Material Safety and Safeguards
SUBJECT:
DIAGNOSTIC MISADMINISTRATION REPORT FORM This is to request your approval of a minor rulemaking to require that medical uso licensees submit diagnostic inisadministration reports on a special form.
When it approved the revision of 10 CFR Part 35, the Comission directed that the form be developed. The revised rule was sublished without the form number. The Office of Management and Budget 1as approved the form, an NRC form number has been assigned, and the form has been printed. This rulemaking will require that licensees use the form. , , ,
The Office of Administration concurs in this action and the Office of the General Counsel has no legal objection.
Hugh L. Thompson, Jr., Directc.-
i Office of Nuclear Material Saf>!ty l and Safeguards l-l DISTRIBUTION:
i NRC File Center VLM111er INNS Central File GSjoblom NHSS r/f RECunningham IMAB r/f SATreby, OGC l NLHcElroy PGNorry, ARM JFunches I
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AlfoT-2 PDR NUCLEAR REGULATORY COMilSSION 10 CFR Part 35 Diagnostic Misadministration Report Form AGENCY: Nuclear Regulatory Commission.
ACTION: Final rule.
SUMMARY
- The Nuclear Regulatory Commission (NRC) is amending its regulations for the medical use of byproduct material to indicate the form to be used for reporting diagnostic misadministrations. This action is intended to inform the public of the development and avail-ability of the form that medical iicensees must use to meet this report-ing requirement.
EFFECTIVE DATE: (upon publication in the FR)
ADDRESSES: A copy of Form NRC 473 may be examined at the Commission's Public Document Room at 1717 H Street NW., Washington, DC. Single copies are available from Norman L. McElroy, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Telephone: (301)492-3417.
FOR FURTHER INFORMATION CONTACT: Norman L. McElroy, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Telephone: (301)492-3417.
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AClA-9 POR SUPPLEMENTARY INFORMATION:
The NRC amended its regulations for the medical use of byproduct material to require licensees to report certain diagnostic misadmin-istrations to the NRC on a special NRC form. This matter was discussed in the final rule revising 10 CFR Part 35 (51 FR 36932, October 16, 1986).
The NRC staff has developed the form, and the Office of Management and Budget (OMB) has approved its use. The NRC is amending its regula-tions to insert the form number in the regulatory text. A copy of the form will be mailed to NRC medical use licensees.
Because these are amendments dealing with agency practice and
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procedures, the notice and comment provisions of the Administrative Procedure Act do not apply pursuant to 5 U.S.C. 533(b)(A). The amend-ments are effective upon publication in the Federal Register. Good cause exists to dispense with the usual 30-day delay in the effective date because the amendments are of a minor and administrative nature dealing with the identification of the form to be used in meeting a previously approved reporting requirement.
Administrative Statements Environmental Impact: Categorical Exclusion
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The NRC has determined that this regulation is the type of action described in categorical exclusion 10 CFR 51.22(c)(3) and (c)(14).
Therefore, neither an environmental impact statement nor an environ-mental. assessment has been prepared.
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e ANT 4 POR Paperwork Reduction Act Statement l
This final rule amends information collection requirements that are I subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.), i These requirements were approved by the Office of Management and Budget under OMB Number 3150-0140.
LIST OF SUBJECTS IN 10 CFR PART 35
%,\ '%s Byproduct material, Drugs, Health devices, Health professions, Incorporation by reference, Medical devices, Nuclear materials, Occupa-tional safety and health, Penalty, Radiation protection, Reporting and ~
recordkeeping requirements.
REGULATORY TEXT 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 adopting the following amendments to 10 CFR Part 35.
, PART 35--MEDICAL USE OF BYPRODUCT MATERIAL
, 1. The authority cita- i for Part 35 continues to read as follows:
AUTHORITY: Sec. 161, 68 Stat. 948, as amended (42 U.S.C. 2201);
sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841).
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Ac (,91 PDR S 35.33 [ Amended]
- 2. In 6 35.33, paragraph (c) is amended by removing footnote 1 and by inserting "Form NRC 473" in place of "Form NRC " in the second sentence.
Dated at Bethesda, MD, this day of , 1988.
For the Nuclear Regulatory Commission.
Victor J. Stello, Jr.
Executive Director for Operations. ._
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= +> . AOo9-T 0AILY STAFF NOTES OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS On , 1908, the Executive Director for Operations approved a final rule that amends 10 CFR Part 35, "Medical Use of Byproduct Matarial." to require that diagnostic misadministrations be reported on NRC Form 473. This requirement was approved by the Commission in the final revision of 10 CFR Part 35. However, when the revision was published, neither Office of Management and Budget (OM8) approval nor the NRC form number had been obtained. OMB approval and -
design of the form are now complete and the requirement to use the form can now be imposed. A copy of the rulemaking and the form will be mailed to affected licensees.
This constitutes notice to the Commission that, in accordance, with the rulemaking authority delegated to the EDO, the EDO has received this final rule and proposes to forward it on to the Office of the Secretary for FR publication, unless otherwise directed by the Commission.
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