ML20150E452
| ML20150E452 | |
| Person / Time | |
|---|---|
| Issue date: | 02/10/1988 |
| From: | Mcdonald W NRC |
| To: | Thompson H NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20150E436 | List: |
| References | |
| FRN-53FR21627, RULE-PR-35 AC69-2-6, NUDOCS 8807150149 | |
| Download: ML20150E452 (7) | |
Text
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HEMORANDUM FOR:
Hugh L. Thompson, Jr., Director Office of Nuclear Material Safety and Safeguards FROM:
William G. Mcdonald, Director Office of Administration and Resources Management
SUBJECT:
DIAGNOSTIC MISADMINISTRATION REPORT FORM The Office of Administration and Resources Management concurs on the final rule that would indicate the form.to be used for reporting diagnostic misadministrations. We have enclosed a marked-up copy of the packege that presents minor' editorial corrections.
If you have any quertions, please have a member of your staff call David L.
Meyer, Chief, Rules and Procedures Branch on extension 27086 or Michael T.
Lesar of his staff on extension 27758.
William G. Mcdonald, Director Office of Administration and Resources Management
Enclosure:
As stated i
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POR MEMORANDUM FOR:
Victor Stello, Jr.
Executive Director for' Operations FROM:
Hugh L. Thompson, Jr., Director Office of Nuclear Material Sefety and Safeguards
SUBJECT:
DIAGNOSTIC MISADMINISTRATION REPORT FORM This is to request your approval of a minor rulemaking to require that medical use licensees submit diagnostic misadministration reports on a special form.
When it approved the revision of 10 CFR Part 35, the Commission. directed that the form be dev-g".
The revised ru"a was aublished without the form number. The Office of Management and Budget 1as approved the form, an NRC form r. umber has been assigned, and the form has been printed.
This rulemaking will require that licensees use the form.
~
The Office of Administrationfc'oncurs/feroaes aa
/ M.,oem nf-in this action and the Office of the General Counsel has no legal objection.
Hugh L. Thompson, Jr., Director Office of Nuc' lear Material Safety and Safeguards DISTRIBUTION:
NRC File Center VLM111er INNS Central File GSjoblom NHSS r/f RECunningham IMA8 r/f SATreby, OGC NLMcElroy PGNorry, ARM yFunches t
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(7590-01]
AC(o9-9 POR NUCLEAR REGULATORY C0fHISSION 10 CFR Part 35 Diagnostic Misadministration Report Form AGENCY:
Nuclear Regulatory Commission.
ACTION:
Final rule.
SUMARY:
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 licensees 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 l
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.
L FOR FURTHER INFORMATION CONTACT:
Norman L. McElroy, Office of Nuclear Materi'al Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Telephone:
(301)492-3417.
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[7590-01)
ACM-1 POR SUPPLEMENTARY INFORMATION:
The NRC amended its regulations for the medical use of byproduct material to requi.e 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 (OM8) 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 t.re amendments dealing with agency practice and 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 thc 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, l
Aaministrative Statements l
l Environmental Impact:
Categorical Exclusion 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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[7590-01)
AcM4 PW Paperwork Reduction Act Statement This final rule amends information collection requirements that are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501 et seq.).
These requirements were approved by the Office of Management and Budget under OMB Number 3150-0140.
/ST [
8JECTS 10 CFR T 35 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.
RfGULATORY T
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 citation 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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[7590-01]
kM-h POR 9 35.33 [ Amended]
2.
I' S 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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"s AcA4 POR DAILY STAFF NOTES OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS On
, 1988, the Executive Director for Operations approved a final rule that amends 10 CFR Part 35, "Medical Use of Byproduct Material," 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, whe.1 the revision was published, neither Office of Management and Budget (OMB) 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 E00, the E00 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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