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MEMORANDUM EOR: Victor Stallo, Jr.Executive Director

for Operations

FROM: Hugh t.. Thompson, Jr., DirectorOffice 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| use licensees submit diagnostic misadministration reports on a special fom.

When it approved the revision of 10 CFR Part 35, the Commission directed thatthe fom be developed. The :*evised rule was published without the formnumber. The Office of Management aad Budget has approved the fom, and a NRCform number has been assigned and printed. This rulemaking will require that

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licensees use the fom. .

The Office of Administration and Resources Management concurs in this actiondnd the Office of the General Counsel has no legal objection.

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M A06ert gHugh L. Thompson, M torOffice of Nuclear Materi Safety

and SafeguardsEnclosure:NRC Fom 473,

DISTRIBUTION:NRC File center VLMillerIMNS Central File GSjoblomNMSS r/f RECunningham

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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.

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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.

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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.

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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 actiond

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.

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[7590-01]4 - .

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'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).

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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.

Dated at Rockville, MD, thisd7dd day of b1ctw 1968.4.

For the Nuclear Regulatory C mission.

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V(cGr Steflo, k. /Executive Director perations -

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Approved for Publication

The Commission has delegated to the ED0 (10 CFR 1.40(c) and (d)) theauthority 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 ReportForm," would amend 10 CFR Part 35 to indicate the form to be used forreporting diagnostic misadministrations. This action is intended toinform the public of the development and availability of the form thatmedical 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 9Subpart C'concerning matters of policy. I therefore find that thisrule is within the scope of my rulemaking authority and am proceedingto issue it.

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(date) "Victor Stello), J .~ ,

Executive' Direcfor Operations

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|NOTES ON MI3 ADMINISTRATION REPORT' FORM: '

5APR88 CONTACTED SAM PETTYJOHN (AEOD) ABOUT "AUTh0RIZED USER" |

BLOCK 75 AND AUTHENTICATION STATEMENT id ABSTRACT |SECTION. AEOD HAS NO PROBLEM WITH ADDITION OF THEINFORMATION.

CONTACTED B. MARTIN (ARM) TO SEE IF PROPOSTD ADDITIONS ARE OK.THEY ARE CHECKING TO SEE IF THE ADDITIONS ARE OK ANDON THE OMB CLEARANCE REINSTATEMENT. FORM Ib UP FORRENEWAL, PACKAGE HAS BEEN SENT TO OCONNELL(NMSS). SHOULD NOT BE A PROBLEM IN GETTING SMALL ITEMSADDED 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 NEWCLEARANCE. 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 HASAGREED TO PRINT A MINIMUM NUMBER UNTIL CLEARANCE IS GRANTED.THIS IS TO GET FORM OUT ASAP TO LICENSEES AND AVOID A3 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'

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NOTES ON MISADMINISTRATION FORM: 6APR88 ||

THE FOLLOWING INFORMATION AND COMMENT WAS RECEIVED FROMB. REIDLINGER, RV, FOLLOWING DISCUSSION OF THE NEW FORMDURING A REGIONAL CONTERENCE CALL.

1. THE FORM DOES NOT INDICATE WHEN IT IS TO BE USEDON THE FORM, IE., 5X PRESCRIBED DOSE, ORGAN DOSEOF 2 REM OR GREATER, OR WHOLE BODY DOSE OF 500 MREM OR ,

GREATER. IlITHE ABOVE INFORMATION IS INCLUDED IN 10CFR35.

2. THE PRECIPITATOR SECTIt'l ONLY ALLOWS ONE PERSON TO jBE IDENTIFIED. WHAT IF THERE ARE MORE7 NEED TO EMPHASIZETHAT NO NAMES ARE REQUIRED. |

IT IS THE INTENT OF THE FORM TO IDENTIFY THE MOSTLIKELY, SINGLE PRECIPITATOR OF THE EVENT. ADDITIONALINFORMATION MAY BE SUPPLIED IN THE "ABSTRACT" SECTIONOF THE FORM.

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3. IN-THE ABSTRACT SECTION, THERE IS NO CAUTION STATEMENTABOUT NOT IDENTIFYING PATIENTS BY NAME.

10CFR35 IDENTIFIES THIS REQUIREMENT. IF ACCIDENTALLYINCLUDED IN THE REPORT THEY MY EASILY CENSORED FROM THEABSTRACT.

NO COMMENTS FROM THE OTHER REGIONS WERE RECEIVED ON THE FORM.

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SUMMARY OF COMMENTS ON NRC MISADMINISTRATION FORM:

1. QUESTIONS ABOUT FORM: (R. E. CUNNINGHAM, DIRECTOR,NHSS/IMNS)

A. RAVE KATHY BLACK (AEOD) AND REGIONS REVIEWEDFORM?,

YES, FORM DEVELOPED BY N. L. MCELROY AND AEOD.DRAFT FORMS IN THE DRAFT REGULATORY GUIDE WERECIRCULATED TO THE REGIONS FOR COMMENT.

B. WHY ISN'T THERE A SIGNATURE BLOCK WITH A COMMITMENTTHAT THE INFORMATION IS ACCURATE 7

OGC DID NOT FEEL IT WAS NECESSARY AND OTHERINIT|.AL REPORTS DO NOT HAVE THEM AS A RULE.FORM IS ESSENTIALLY AN ADVANCE REPORT AND CANBE FOLLOWED UP BY THE REGIONS IF NECESSARY.

C. WHY ISN'T THE ATTENDING PHYSICIAN LISTED AS A~

POTENTIAL "PRECIPITATOR"?

THE PHRASE "REFERRING PHYSICIAN" AND "ATTENDINGPHYSICIAN" 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 CONCISEAND CONSISTENT MANNER. PREVIOUS REPORTS FROMLICENSERS DID NOT PROVIDE ENOUGH INFORMATIONOR TEE INFORMATION PRESENTED WAS CONFUSING.INFORMATION TO BE COLLECTED ON THIS FORM HAS BEENDERIVED FROM A RETROSPECTIVE ANALYSIS OF PREVIOUSMISADMINISTRATION REPORTS AND INFORMATIONREQUIRED BY 10CFR35. ADDITIONAL INFORMATION MAYBE PROVIDED IN ITEM N 17, ABSTRACT, ON THE FORM.

E. THIS IS ORIENTED TOWARD DIAGNOSIS....IS IT TO BEUSED FOR THERAPY?

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NO. THERAPY MISADMINISTRATIONS ARE TOO FEW IN NUMBERAND TOO COMPLEX TO REPORT USING A CHECK OFF FORMAT.

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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 RECOMMENDEDPARAGRAPH.

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)

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