ML20150E449
| ML20150E449 | |
| Person / Time | |
|---|---|
| Issue date: | 05/20/1988 |
| From: | Thompson H NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Stello V NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| Shared Package | |
| ML20150E436 | List: |
| References | |
| FRN-53FR21627, RULE-PR-35 AC69-2-4, NUDOCS 8807150146 | |
| Download: ML20150E449 (11) | |
Text
. _ . - __ .__
E ~1 M(o3-1 PM :
.. MY 8 0198 MEMORANDUM EOR: Victor Stallo, Jr.
Executive Director for Operations FROM: Hugh t.. 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 l use licensees submit diagnostic misadministration reports on a special fom.
When it approved the revision of 10 CFR Part 35, the Commission directed that the fom be developed. The :*evised rule was published without the form number. The Office of Management aad Budget has approved the fom, and a NRC form number has been assigned and printed. This rulemaking will require that' licensees use the fom. .
The Office of Administration and Resources Management concurs in this action dnd the Office of the General Counsel has no legal objection.
M A06ert g Hugh L. Thompson, M tor Office of Nuclear Materi Safety and Safeguards
Enclosure:
, NRC Fom 473 DISTRIBUTION:
NRC File center VLMiller IMNS Central File GSjoblom NMSS r/f RECunningham IMA8 r/f" NLMcElroy SATreby, PGNorry, ARMOGC [AJsr T7,15) ,
JFunches 8807150146 080629
$R S'Jy21627 PDR
.. , [7590-01]
AC A ~9.
POR NUCLEAR REGULATORY COMMISSION 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 licensees must use to meet this report-ing requirement.
4 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 James H. Myers, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Telephone: (301) 492-0635.
FOR FURTHER INFORMATION CONTACT: James H. Myers, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Telephone: (301) 492-0635.
r 1
[7590-01]
ffjh-3.
PDR 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.
This amendment is a minor administrative change to an existing final rule. It merely adds the form number for an NRC form to the codified rule.
The number had been omitted because OMB had not completed its review.
Based on this, good cause txists to find that the notice and public procedure provisions of the Administrative Procedure Act are unnecessary pursuant to the exemptSn provision found in 5 U.S.C. 553(b)(B). Therefore, the amendment is effective epon publication in the Federal Register.
A<ministrative Statements Environmental Impact: Categorical Exclusion The NRC has determined that this regulation is the type of action d
described in categorical exclusion 10 CFR 51.22(c)(3). Therefore, neither an environmental impact statement nor an' environmental assessment has been prepared for this final rule.
2
4- . [7590-01]
ACla94.
PDR Paperwork Reduction Act Statement This final' rule amends information collection requirements that are subject to the Paperwork Rede:
- ion Act of 1980 (44 U.S.C. 3501 et seq.).
These requirements were appron L: .'ie Of fice of Management and Oudget urider CM8 Number 3150-0140.
List of Subjects in 10 CFR Part 35 Byproduct material, Drugs, Health facilities, Health professions, Incorporation by reference, Medical devices, Nuclear it.aterials, Occupa-tional safety and health, F"nalty, Radiation protection, Reporting and _
recordkeeping requirements.
Regulatory Text 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 aniended, and 5 U.S.C. 553 the NRC is adopting the following an,endment 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).
3
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. g (7590-01]
ACW.t.
POR 35.33 [ Amended]
- 2. In % 35.33, paragraph (c) is amended by rernoving footnote I and by inserting "Form NRC 473" in place of "Form NRC " in the second sentence.
- 4. Dated at Rockville, MD, thisd7dd day of b1ctw 1968.
For the Nuclear Regulatory C mission.
.A 0,/af_. -w rel _
V(cGr Steflo, k. /
Executive Director perations -
t e.
4
.. Acca q.
Pok Approved for Publication The Commission has delegated to the ED0 (10 CFR 1.40(c) and (d)) the authority to develop and promulgate rules as defined in the APA (5 U.S.C.
551(4)) subject to the limitations of NRC Hanual Chapter 0103, Organiza-tion anc Functions, Office of the Executive Director for Operations, paragraphs 0213, 038, 039, and 0310.
The enclosed final rule, entitled "Diagnostic Misadministration Report Form," would amend 10 CFR Part 35 to indicate the form to be used for reporting diagnostic misadministrations. This action is intended to inform the public of the development and availability of the form that medical licensees must use to meet this reporting requirement.
This final 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 am proceeding to issue it.
r
),, J MAY 07 1%8 4, ~WM.
(date) "Victor Stello), J .~ ,
Executive' Direc for Operations w
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- 4 OC(d-3. '
POR 1
l NOTES ON MI3 ADMINISTRATION REPORT' FORM: '
5APR88 CONTACTED SAM PETTYJOHN (AEOD) ABOUT "AUTh0RIZED USER" l BLOCK 75 AND AUTHENTICATION STATEMENT id ABSTRACT l SECTION. AEOD HAS NO PROBLEM WITH ADDITION OF THE INFORMATION.
CONTACTED B. MARTIN (ARM) TO SEE IF PROPOSTD ADDITIONS ARE OK.
THEY ARE CHECKING TO SEE IF THE ADDITIONS ARE OK AND ON THE OMB CLEARANCE REINSTATEMENT. FORM Ib UP FOR RENEWAL, PACKAGE HAS BEEN SENT TO OCONNELL (NMSS). SHOULD NOT BE A PROBLEM IN GETTING SMALL ITEMS ADDED TO THE FORM. MARK-UP FORM BEING SENT TO ARM.
RON SMITH (OGC) HAS NO OBJECTIONS TO ADDITIONS.
BOB OCONNELL (NMSS) WILL PROCESS FORM FOR NEW CLEARANCE. GIVEN COPY OF DRAFT FORM FOR HIS USE.
COPY OF DRAFT FORM SENT TO B. REIDLINGER, RV, FOR REV_IEW.
14APR88 CALLED HERB PARKOVER (ARM) TO CHECK ON FORM. ARM HAS AGREED TO PRINT A MINIMUM NUMBER UNTIL CLEARANCE IS GRANTED.
THIS IS TO GET FORM OUT ASAP TO LICENSEES AND AVOID A 3 MONTH DELAY.
SMAY88 CALLED ARM, FORM SENT TO PRINTER ON 19APR88. AWAITING PRINTINC-9MAY88 COPY OF AMENDED FORM GIVEN TO R. E. CUNNINGHAM (NMSS)
FOR REVIEW AND APPROVAL.
10MAY88 APPROVAL FOR AMENDED FORM RECEIVED FROM R. E. CUNNINGHAM (NMSS'
~ .. .. .--
ACM -2.
POR NOTES ON MISADMINISTRATION FORM: 6APR88 l l
THE FOLLOWING INFORMATION AND COMMENT WAS RECEIVED FROM B. REIDLINGER, RV, FOLLOWING DISCUSSION OF THE NEW FORM DURING A REGIONAL CONTERENCE CALL.
- 1. THE FORM DOES NOT INDICATE WHEN IT IS TO BE USED ON THE FORM, IE., 5X PRESCRIBED DOSE, ORGAN DOSE OF 2 REM OR GREATER, OR WHOLE BODY DOSE OF 500 MREM OR ,
GREATER. I l
THE ABOVE INFORMATION IS INCLUDED IN 10CFR35. I
- 2. THE PRECIPITATOR SECTIt'l ONLY ALLOWS ONE PERSON TO j BE IDENTIFIED. WHAT IF THERE ARE MORE7 NEED TO EMPHASIZE THAT NO NAMES ARE REQUIRED. l IT IS THE INTENT OF THE FORM TO IDENTIFY THE MOST LIKELY, SINGLE PRECIPITATOR OF THE EVENT. ADDITIONAL INFORMATION MAY BE SUPPLIED IN THE "ABSTRACT" SECTION ~
OF THE FORM.
- 3. IN-THE ABSTRACT SECTION, THERE IS NO CAUTION STATEMENT ABOUT NOT IDENTIFYING PATIENTS BY NAME.
10CFR35 IDENTIFIES THIS REQUIREMENT. IF ACCIDENTALLY INCLUDED IN THE REPORT THEY MY EASILY CENSORED FROM THE ABSTRACT.
NO COMMENTS FROM THE OTHER REGIONS WERE RECEIVED ON THE FORM.
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A CJ A 9.
POR
SUMMARY
OF COMMENTS ON NRC MISADMINISTRATION FORM:
- 1. QUESTIONS ABOUT FORM: (R. E. CUNNINGHAM, DIRECTOR, NHSS/IMNS)
A. RAVE KATHY BLACK (AEOD) AND REGIONS REVIEWED
, FORM?
YES, FORM DEVELOPED BY N. L. MCELROY AND AEOD.
DRAFT FORMS IN THE DRAFT REGULATORY GUIDE WERE CIRCULATED TO THE REGIONS FOR COMMENT.
B. WHY ISN'T THERE A SIGNATURE BLOCK WITH A COMMITMENT THAT THE INFORMATION IS ACCURATE 7 OGC DID NOT FEEL IT WAS NECESSARY AND OTHER INITl.AL REPORTS DO NOT HAVE THEM AS A RULE.
FORM IS ESSENTIALLY AN ADVANCE REPORT AND CAN BE FOLLOWED UP BY THE REGIONS IF NECESSARY.
~
C. WHY ISN'T THE ATTENDING PHYSICIAN LISTED AS A POTENTIAL "PRECIPITATOR"?
THE PHRASE "REFERRING PHYSICIAN" AND "ATTENDING PHYSICIAN" ARE SYN 051YMOUS.
D. MANY BLOCKS ARE TOO SMALL TO WRITE IN THE IN-FORMATION.
THIS FORM IS INTENDED TO REPORT AND CATEGORIZE MISADMINISTRATION REPORT INFORMATION IN A CONCISE AND CONSISTENT MANNER. PREVIOUS REPORTS FROM LICENSERS DID NOT PROVIDE ENOUGH INFORMATION OR TEE INFORMATION PRESENTED WAS CONFUSING.
INFORMATION TO BE COLLECTED ON THIS FORM HAS BEEN DERIVED FROM A RETROSPECTIVE ANALYSIS OF PREVIOUS MISADMINISTRATION REPORTS AND INFORMATION REQUIRED BY 10CFR35. ADDITIONAL INFORMATION MAY BE PROVIDED IN ITEM N 17, ABSTRACT, ON THE FORM.
E. THIS IS ORIENTED TOWARD DIAGNOSIS....IS IT TO BE USED FOR THERAPY?
NO. THERAPY MISADMINISTRATIONS ARE TOO FEW IN NUMBER AND TOO COMPLEX TO REPORT USING A CHECK OFF FORMAT.
i ACM4 y
NOTE TO FILE: 29 MAR 88
SUBJECT:
DIAGNOSTIC HISADMINISTRATION REPORT FORM, 000 COMMENTS DTD 11FEB88, MEETING WITH RON SMITH, OGC, ON 29 MAR 88
- 1. DELETED ONE' PARAGRAPH AND SUBSTITUTED RECOMMENDED PARAGRAPH.
- 2. CHANGE ADOPTED.
- 3. ITEMS LISTED DO NOT APPLY TO THIS RULE, PER M. LESAR, (ARM), REVIEW NOTES AND RECHECK WITH ARM ON 29 MAR 88.
- 4. ITEM CHANGED.
- 5. ITEM CHANGED PER SUGGESTION.
- 6. NOT CHANGED PER SUGGESTION, WILL USE SHORT FORM. _
MYERS (IMAB) e