[Federal Register Volume 60, Number 16 (Wednesday, January 25, 1995)]
[Proposed Rules]
[Pages 4872-4877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-1817]



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NUCLEAR REGULATORY COMMISSION

10 CFR Parts 20 and 35

RIN 3150-AF10


Medical Administration of Radiation and Radioactive Materials

AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule.

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SUMMARY: The Nuclear Regulatory Commission is proposing to amend its 
regulations to clarify that the medical [[Page 4873]] administration of 
radiation or radioactive materials to any individual, even an 
individual not supposed to receive a medical administration, is 
regulated by the NRC's provisions governing the medical use of 
byproduct material rather than the dose limits in the NRC's regulations 
concerning standards for protection against radiation. The proposed 
rule does not represent a change in policy, but is necessary to 
indicate clearly that this is the NRC's policy and to clarify the 
relationship of NRC's regulations.

DATES: The comment period expires April 10, 1995. Comments received 
after this date will be considered if it is practicable to do so, but 
the Commission is able to assure consideration only for comments 
received on or before this date.

ADDRESSES: Send comments to: Secretary, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555. ATTN: Docketing and Service Branch.
    Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland 
between 7:45 am and 4:15 pm on Federal workdays.
    Examine comments received at: The NRC Public Document Room, 2120 L 
Street NW. (Lower Level), Washington, DC.

FOR FURTHER INFORMATION CONTACT: Stephen A. McGuire, Office of Nuclear 
Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 
20555, telephone (301) 415-6204.

SUPPLEMENTARY INFORMATION:

I. Background.
II. Summary of the Proposed Changes.
III. Request for Comment on Notification.
IV. Consistency With the 1979 Medical Policy Statement and 
Coordination With ACMUI.
V. Coordination With and Issue of Compatibility With Agreement 
States.
VI. Finding of No Significant Environmental Impact: Availability.
VII. Paperwork Reduction Act Statement.
VIII. Regulatory Analysis.
IX. Regulatory Flexibility Certification.
X. Backfit Analysis.

I. Background

    Radioactive materials are administered in the practice of medicine 
to roughly 8 to 9 million patients per year for the diagnosis or 
treatment of disease. Occasionally, a radioactive material is 
administered by mistake to an individual for whom it is not intended. 
For the years 1989 and 1990 combined, the NRC is aware of about 200 
cases out of 5 to 6 million administrations performed under NRC license 
in which a diagnostic radiopharmaceutical was administered to the wrong 
individual.
    The misadministration of radiopharmaceuticals is dealt with in NRC 
regulations in 10 CFR part 35, ``Medical Use of Byproduct Material.'' 
As defined in Sec. 35.2, misadministrations include administrations of 
licensed radioactive material or the radiation therefrom to the wrong 
individual, using the wrong radiopharmaceutical, in the wrong amount, 
by the wrong route, or to the wrong treatment site. This proposed rule 
only concerns administrations to the wrong individual.
    An administration to the wrong individual is a misadministration, 
as defined in Sec. 35.2, if it involves: (1) A radiopharmaceutical 
dosage greater than 30 microcuries of either sodium iodide I-125 or I-
131; (2) any therapeutic administration other than sodium iodide I-125 
or I-131; (3) any gamma stereotactic radiosurgery radiation dose; (4) 
any teletherapy dose; (5) any brachytherapy radiation dose; or (6) a 
diagnostic radiopharmaceutical dosage, other than quantities greater 
than 30 microcuries of either sodium iodide I-125 or I-131, when the 
dose to the individual exceeds 5 rems effective dose equivalent or 50 
rems dose equivalent to any individual organ. The practical effect of 
this definition of a misadministration is that some relatively low dose 
diagnostic administrations of radiopharmaceuticals to individuals for 
whom they were not intended are not misadministrations as defined in 
Sec. 35.2.
    If a misadministration occurs, Sec. 35.33 requires that the NRC, 
the referring physician, and the individual receiving the 
administration (or a responsible relative or guardian) be informed of 
the misadministration (unless the referring physician makes a decision 
based on medical judgement that telling the individual or responsible 
relative or guardian would be harmful.) If the dose from a diagnostic 
administration to the wrong individual does not exceed the threshold 
for a misadministration, the administration is not a misadministration 
as defined in Sec. 35.2, and part 35 does not require notification of 
the NRC or the individual.
    Separate from the requirements for misadministrations, 
Sec. 20.1301(a)(1) contains a dose limit for members of the public of 
0.1 rem (1 millisievert). However, the scope of part 20 in Sec. 20.1002 
states that, ``The limits in this Part do not apply to doses due * * * 
to exposure of patients to radiation for the purpose of medical 
diagnosis or therapy. * * *''
    A question arose about the applicability of those words in a 
specific case in which an individual mistakenly received an 
administration of a diagnostic radiopharmaceutical because of an error 
on the part of the physician requesting the test. In that particular 
case the dose to the individual receiving the administration was below 
the threshold for reporting of the misadministration, but above the 0.1 
rem (1 millisievert) dose limit in Sec. 20.1301(a)(1) for a member of 
the public. Was there a violation of Sec. 20.1301(a)(1) or do the words 
in the scope of part 20 exclude this event from being subject to the 
dose limits in part 20? In other words, does the exclusion from the 
part 20 dose limits exclude any medical administration to any 
individual, even an individual not supposed to receive an 
administration?
    The Commission concludes that, in general, the administration of 
radiopharmaceuticals should be regulated by part 35 rather than part 
20. The medical administration of radioactive materials is a very 
special use of radioactive materials that is best dealt with by 
specific regulations covering those administrations. In particular, the 
Commission believes that an administration to any individual is and 
should be subject to the regulations in part 35. This was the 
Commission's intent when the current misadministration requirements 
were adopted in the final rule, ``Quality Management Programs and 
Misadministrations,'' (July 25, 1991; 56 FR 34104) and continues to be 
the Commission's intent.
    In establishing which errors in administration should be under the 
misadministration reporting requirements, the NRC sought to optimize 
the cost effectiveness of the rule by concentrating its regulatory 
requirements on those events with the greatest risk and placing fewer 
requirements on those with relatively low risk, such as most diagnostic 
uses of radiopharmaceuticals. In the final rule on ``Quality Management 
Programs and Misadministrations'' (July 25, 1991; 56 FR 34104), the 
Commission stated that the proposed requirements that would have had 
minimal impact on risk were eliminated to make the final rule more cost 
effective (e.g., deleting the diagnostic components of the proposed 
rule).
    In reaching its conclusion, the Commission recognized that in the 
event of administration of radioactive material to the wrong 
individual, the ability to control the dose to that individual has been 
lost. One cannot decide to terminate the exposure at a certain point to 
prevent exceeding a dose limit. Therefore, the relevant questions are: 
What steps are appropriate to reduce the likelihood of [[Page 4874]] an 
administration to the wrong individual; what corrective actions should 
be taken if the mistake occurs; and what regulatory response is 
appropriate if such a mistake occurs?
    Each of these questions was dealt with in developing the rule on 
quality management programs and misadministrations. The Commission 
considered, in the rulemaking on quality management program and 
misadministrations, what steps should be taken to avoid the 
administration of radioactive materials to an individual not supposed 
to receive the administration. Those steps are contained in Sec. 35.32, 
``Quality management program.'' In adopting those requirements, the 
Commission decided to apply the requirements in Sec. 35.32 only to 
administrations with the potential for relatively high doses and to 
exclude most diagnostic administrations from the requirements. For 
those diagnostic administrations not covered by Sec. 35.32, it was 
considered adequate to rely on the normal and traditional methods and 
techniques that medical care providers use to ensure that medications 
are given to the right individual in the right amount at the right 
time.
    Similarly, the NRC's requirements that licensees take appropriate 
corrective actions in response to a misadministration are contained in 
Sec. 35.32. The specific requirements dealing with corrective actions 
apply to any administration requiring a quality management program.
    With regard to the appropriate regulatory response to mistakes in 
administrations, the Commission decided that violation of the quality 
management program requirements, which apply to the more significant 
administrations, were significant enough that they may result in a 
civil penalty.
    Thus, in the quality management program and misadministrations 
rulemaking, the Commission clearly addressed the issue of when the 
administration of a radioactive material to the wrong individual was 
sufficiently significant to warrant certain actions. Specific 
thresholds were established and codified to reflect the Commission's 
view of a reasonable balance between harm and burden. In particular, 
the Commission concluded that lower thresholds would not significantly 
reduce risk and would divert resources that should be directed toward 
reducing the more serious of those errors. The Commission continues to 
endorse the judgement that it made in that rulemaking.

II. Summary of the Proposed Changes

    To clarify the meaning and intent of part 20, the NRC is proposing 
to amend the scope of part 20, the definitions of public dose and 
occupational dose, and the wording in Sec. 20.1301(a)(1) on public dose 
limit to clarify that the dose limit for individual members of the 
public does not apply to dose contributions from any medical 
administration the individual has received. Thus, the medical 
administration of radioactive materials or radiation to any individual, 
even an individual not supposed to receive an administration, is not 
subject to the public dose limit in Sec. 20.1301(a)(1), but is within 
the scope of part 35.
    The proposed changes in part 20 would replace the word ``patient'' 
with the word ``individual.'' The word ``patient'' has sometimes been 
taken to mean only the individual intended to receive the 
administration. At other times, the view has been that anyone who 
receives a medical procedure is a ``patient.'' Replacing ``patient'' 
with ``individual'' would clarify that the statement refers to anyone 
receiving a medical administration. For consistency, in terminology 
between parts, the word ``patient'' in the definition of 
misadministration in Sec. 35.2, ``Definitions,'' and in certain 
locations in paragraph (a)(2) of Sec. 35.33 would be replaced by the 
word ``individual.''
    In Sec. 20.1002, the phrase ``for the purpose of medical diagnosis 
and therapy'' would be replaced by the phrase ``any medical 
administration the individual has received.'' The existing wording 
raised the question of whether an administration was within the scope 
of part 20 if the administration had no valid medical purpose. The 
proposed wording would make it clear that regardless of the purpose or 
lack of purpose, dose to an individual from any medical administration 
the individual has received is not within the scope of part 20, but is 
within the scope of part 35.
    For the sake of consistency and clarity, the same words would be 
used in Sec. 20.1002, ``Scope,'' in Sec. 20.1003, ``Definitions,'' (in 
the definitions of both public dose and occupational dose), and in 
Sec. 20.1301, ``Dose limits for individual members of the public.'' 
Also for consistency and clarity, the exclusion of dose from background 
radiation and from voluntary participation in medical research programs 
that are now included in Secs. 20.1002 and 20.1003 would be added to 
Sec. 20.1301(a).
    The existing Sec. 20.1301(a) also excludes dose contributions from 
the licensee's disposal of radioactive material into sanitary sewerage. 
That exclusion would not be added to Secs. 20.1002 and 20.1003 because 
the question of dose from sewer disposal of radioactive material is now 
under consideration by the NRC. When that issue is resolved, it is 
intended that the wording concerning dose from sewer disposal will be 
made consistent in Secs. 20.1002, 20.1003, and 20.1301(a).
    Another recently published proposed rule (June 15, 1994; 59 FR 
30724), which deals with criteria for the release of individuals 
administered radioactive material, would also amend Sec. 20.1301(a)(1). 
When that amendment of Sec. 20.1301(a)(1) is published in final form, 
the wording on what is excluded from the dose limit will be inserted in 
Secs. 20.1002 and 20.1003 (in the definitions of public dose and 
occupational dose) so that the same parallelism will exist throughout.
    In addition, another proposed rule (February 3, 1994; 59 FR 5132) 
would amend the definitions of public dose and occupational dose in 10 
CFR part 20. However, that proposed rule would only amend the first 
sentence in the definitions and would not change the wording associated 
with what is excluded from public dose. Therefore, this proposed rule 
and that proposed rule do not conflict.

III. Request for Comment on Notification

    Another question related to the administration of radioactive 
materials to the wrong individual concerns informing the individual of 
the error. Section 35.33 generally requires notification of the 
individual in the case of a misadministration. However, if the dose or 
the amount is less than the misadministration threshold, Sec. 35.33 
does not require that the individual who received an administration of 
a radiopharmaceutical by mistake be notified of the error. One 
fundamental difference in the case in which the wrong individual 
receives the administration is that, unlike the intended patient, who 
it may be argued may have been informed that he or she will be exposed 
to radiation and has thereby implicitly or explicitly consented to the 
procedure, the wrong individual has generally not consented to any 
radiation dose at all. The question then becomes, should part 35 
require that the individual be notified of the error regardless of the 
dose that would be received?
    The Commission was divided on whether the individual should be 
notified. The NRC's Advisory Committee on Medical Uses of Isotopes 
[[Page 4875]] (ACMUI) has assured the NRC that standard medical 
practice is that a physician who becomes aware that a medical procedure 
has been performed on the wrong individual should and almost always 
would notify the individual of the mistake. The current quality 
management program and misadministrations rule does not require the 
physician to notify the individual if the dose or amount is below the 
threshold for a misadministration. The NRC is now seeking comment on 
whether it should continue to rely on standard medical practice below 
the misadministration threshold or whether it is appropriate to impose 
an NRC requirement for notification below the misadministration 
threshold if the administration is to the wrong individual. For 
example, the NRC would like comments on whether a broader notification 
requirement would implicitly impose recordkeeping and procedural 
requirements upon licensees beyond those explicitly set forth in part 
35.

IV. Consistency With the 1979 Medical Policy Statement and 
Coordination With ACMUI

    On February 9, 1979 (44 FR 8242), the NRC published a Statement of 
General Policy on the Regulation of the Medical Uses of Radioisotopes. 
The first statement of the policy states, ``The NRC will continue to 
regulate the medical uses of radioisotopes as necessary to provide for 
the radiation safety of workers and the general public.'' The proposed 
rule is consistent with this statement because it continues to provide 
for administrations of radioactive materials to be regulated under 10 
CFR part 35. The proposed rule further clarifies that additional 
regulations are not considered necessary.
    The second statement of the policy states, ``The NRC will regulate 
the radiation safety of patients where justified by the risk to 
patients and where voluntary standards, or compliance with these 
standards, are inadequate.'' The proposed rule is consistent with the 
statement because it clarifies that existing requirements concerning 
misadministrations continue to be concentrated on administrations 
having the greatest risk significance.
    The third statement of the policy states, ``The NRC will minimize 
intrusion into medical judgements affecting patients and into other 
areas traditionally considered to be a part of the practice of 
medicine.'' The proposed rule is consistent with this statement because 
it limits its specific regulatory requirements for notification to the 
most serious errors in administration and minimizes requirements on 
errors in administrations that have less risk significance.
    Thus, the proposed rule is considered to be consistent with the 
1979 medical policy statement.
    The subject of this proposed rule was discussed with the NRC's 
Advisory Committee on Medical Uses of Isotopes (ACMUI) on May 19, 1994. 
The ACMUI agreed that medical administrations, including those to an 
individual not supposed to receive an administration, should be 
regulated by part 35 rather than part 20. The ACMUI stated that 
notification of an individual of an error in administration below the 
misadministration threshold is the current practice and should not be 
regulated.

V. Coordination With and Issue of Compatibility for Agreement 
States

    This proposed rulemaking was discussed with representatives of 
Agreement States at a meeting, ``Organization of Agreement State 
Managers Workshop and Public Meeting on Rulemaking,'' in Herndon, VA, 
on July 12, 1994. There was some concern that the NRC approach was 
different from how State regulations address inadvertent x-ray 
exposures, but no strong opposition. The proposed rule was revised to 
address the concerns of the States and then discussed at a subsequent 
meeting of the Agreement States in Portland, ME, on October 24, 1994. 
The States were polled on how they regulated an administration to the 
wrong individual, and it was found that they would regulate the 
administration the same way as in this proposed rule.
    The NRC believes that the proposed modification of part 20 should 
be a Division 1 matter of compatibility consistent with past practice 
of requiring basic definitions to be uniform for effective 
communication of basic radiation concepts. The Commission specifically 
requests comments on whether the proposed modification to part 20 
should be made a Division 1 matter of compatibility.

VI. Finding of No Significant Environmental Impact

    The NRC has determined under the National Environmental Policy Act 
of 1969, as amended, and the Commission's regulations in subpart A of 
part 51, that this rule, if adopted, would not be a major Federal 
action significantly affecting the quality of the human environment. 
Therefore, an environmental impact statement is not required.
    The NRC has not prepared a separate environmental assessment. The 
following discussion constitutes the assessment. The proposed rule 
would not change the NRC's requirements concerning the administration 
of radiation and radioactive materials. Those requirements are and 
would continue to be contained in part 35 of the NRC's regulations. 
When the potential ambiguity concerning application of part 20 and part 
35 requirements was recognized, the Commission specifically informed 
the staff of its view that the proper interpretation was that the more 
specific part 35 requirements should govern all medical administrations 
and directed that action be taken to remove from the regulations any 
ambiguity on this issue. The staff has, accordingly, not interpreted 
Sec. 20.1301(a)(1) as applying to any medical administrations, but has 
proceeded with this rulemaking to remove any ambiguity in the 
regulations. The proposed rule would merely amend part 20 to make it 
clear that part 20 does not address medical administrations. Thus, the 
proposed rule, if adopted, would clarify the NRC's requirements rather 
than change them, and there would be no environmental impact.

VII. Paperwork Reduction Act Statement

    This proposed rule does not contain a new or amended information 
collection requirement subject to the Paperwork Reduction Act of 1980 
(44 U.S.C. 3501 et seq.). Existing requirements were approved by the 
Office of Management and Budget, approval numbers 3150-0014 and 3150-
0010.

VIII. Regulatory Analysis

    The regulatory analysis for this proposed rulemaking is as follows:

1. Alternatives

Alternative 1: Part 20 Regulates Doses to Wrong Individuals

    In this alternative, a medical administration of radiation or 
radioactive material to an individual when no administration is 
intended that results in a total effective dose equivalent greater than 
1 millisievert (0.1 rem) would be a violation of Sec. 20.1301. If the 
event did not meet the threshold definition of a misadministration, NRC 
would receive a notification of the event from the licensee pursuant to 
Sec. 20.2203, ``Reports of exposures, radiation levels, and 
concentrations of radioactive material exceeding the limits'' and the 
individual involved would receive notification of [[Page 4876]] the 
exposure from the licensee pursuant to Sec. 19.13(d), ``Notifications 
and reports to individuals.''
    Under this alternative, notification and recordkeeping requirements 
of 10 CFR parts 19 and 20 would apply to the medical administration of 
radiation or radioactive material to the wrong individual that involves 
a dose to the individual above 1 millisievert (0.1 rem) but less than 
the threshold definition of a misadministration.

Alternative 2: Part 35 Regulates Doses to Wrong Individuals

    In this alternative, the medical administration of radiation or 
radioactive material to any individual would be the exclusive province 
of the regulations in 10 CFR part 35. Section 20.1301 would not be 
applicable. Under this alternative, errors in the administration of 
radiation or radioactive material to individuals would be subject to 
the reporting and notification requirements of 10 CFR part 35 rather 
than the reporting and notification requirements in 10 CFR parts 19 and 
20. This alternative is consistent with the Commission's determination, 
published in the rule on quality management programs and 
misadministrations (July 25, 1991; 56 FR 34104), that licensees should 
direct their resources toward preventing the more serious errors in the 
administration of byproduct material.
    However, there would be no requirement in the event of errors in 
the administration of byproduct material to individuals who were not 
intended to receive any administration for the medical licensee to 
notify either the NRC or the individual of the error unless the error 
meets the threshold definition of a misadministration in Sec. 35.2. In 
general, standard medical practice is that a physician who becomes 
aware that a medical procedure has been performed on the wrong 
individual would notify the individual of the mistake.

Preferred Alternative

    Alternative 2 (Part 35 is controlling) is preferable because it 
maintains the intent of the rulemaking on quality management programs 
and misadministrations by concentrating regulatory requirements on 
those events with the greatest risk and placing fewer requirements on 
those with relatively low risk, such as most diagnostic uses of 
radiopharmaceuticals. Also, this alternative would allow the Commission 
to treat all medical administrations of licensed material consistently 
under the regulations in Part 35.

2. Impact of Proposed Action

    Licensees. There is no anticipated impact on licensees, except that 
licensees will more clearly understand the meanings of the regulations.
    Individuals. There is no anticipated impact on an individual 
because this action will not increase or decrease the error rate for 
administrations of radiation or radioactive material.
    NRC Resources. No NRC resources would be required to implement the 
rule.

IX. Regulatory Flexibility Certification

    As required by the Regulatory Flexibility Act of 1980, 5 U.S.C. 
605(b), the NRC certifies that, if adopted, this proposed rule would 
not have a significant economic impact on a substantial number of small 
entities. The impact of the revised regulation would not be significant 
because the proposed amendment represents a continuation of current 
practice and merely clarifies existing requirements.

X. Backfit Analysis

    The NRC has determined that the backfit rule, Sec. 50.109, does not 
apply to this proposed rule and, therefore, that a backfit analysis is 
not required for this proposed rule, because these amendments do not 
involve any provisions which would impose backfits as defined in 
Sec. 50.109(a)(1).

List of Subjects

10 CFR Part 20

    Byproduct material, Criminal penalties, Licensed material, Nuclear 
materials, Nuclear power plants and reactors, Occupational safety and 
health, Packaging and containers, Radiation protection, Reporting and 
recordkeeping requirements, Special nuclear material, Source material, 
Waste treatment and disposal.

10 CFR Part 35

    Byproduct material, Criminal penalties, Drugs, Health facilities, 
Health professions, Medical devices, Nuclear materials, Occupational 
safety and health, Radiation protection, Reporting and recordkeeping 
requirements. 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 amended; and 5 U.S.C. 553; the NRC is 
proposing to adopt the following amendments to 10 CFR parts 20 and 35.

PART 20--STANDARDS FOR PROTECTION AGAINST RADIATION

    1. The authority citation for part 20 continues to read as follows:

    Authority: Secs. 53, 63, 65, 81, 103, 104, 161, 182, 186, 68 
Stat. 930, 933, 935, 936, 937, 948, 953, 955, as amended (42 U.S.C. 
2073, 2093, 2095, 2111, 2133, 2134, 2201, 2232, 2236), secs. 201, as 
amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 
5841, 5842, 5846).

    2. Section 20.1002 is revised to read as follows:


Sec. 20.1002  Scope.

    The regulations in this part apply to persons licensed by the 
Commission to receive, possess, use, transfer, or dispose of byproduct, 
source, or special nuclear material or to operate a production or 
utilization facility under parts 30 through 35, 39, 40, 50, 60, 61, 70, 
or 72 of this chapter. The limits in this part do not apply to doses 
due to background radiation, due to any medical administration the 
individual has received, or due to voluntary participation in medical 
research programs.
    3. In Sec. 20.1003, the definitions of Occupational dose and Public 
dose are revised to read as follows:


Sec. 20.1003  Definitions.

* * * * *
    Occupational dose means the dose received by an individual in a 
restricted area or in the course of employment in which the 
individual's assigned duties involve exposure to radiation and to 
radioactive material from licensed and unlicensed sources of radiation, 
whether in the possession of the licensee or other person. Occupational 
dose does not include dose received from background radiation, from any 
medical administration the individual has received, from voluntary 
participation in medical research programs, or as a member of the 
general public.
* * * * *
    Public dose means the dose received by a member of the public from 
exposure to radiation and to radioactive material released by a 
licensee, or to another source of radiation either within a licensee's 
controlled area or in unrestricted areas. It does not include 
occupational dose or doses received from background radiation, from any 
medical administration the individual has received, or from voluntary 
participation in medical research programs.
* * * * *
    4. In Sec. 20.1301, paragraph (a)(1) is revised to read as follows: 
[[Page 4877]] 


Sec. 20.1301  Dose limits for individual members of the public.

    (a) * * *
    (1) The total effective dose equivalent to individual members of 
the public from the licensed operation does not exceed 0.1 rem (1 mSv) 
in a year, exclusive of the dose contributions from background 
radiation, any medical administration the individual has received, 
voluntary participation in medical research programs, and the 
licensee's disposal of radioactive material into sanitary sewerage in 
accordance with Sec. 20.2003.
* * * * *
    5. The authority citation for part 35 continues to read as follows:

    Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954, 
as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat. 
1242, as amended (42 U.S.C. 5841).

    6. In Sec. 35.2, the definition for misadministration is revised at 
paragraphs (1)(i), (2)(i), (3)(i), (4)(i), (5)(i), (6)(i), and (6)(ii) 
by removing the word ``patient'' and inserting the word ``individual.''
    7. In Sec. 35.33, paragraph (a)(2) is revised to read as follows:


Sec. 35.33  Notifications, reports, and records of misadministrations.

    (a) * * *
    (2) The licensee shall submit a written report to the appropriate 
NRC Regional Office listed in 10 CFR 30.6 within 15 days after 
discovery of the misadministration. The written report must include the 
licensee's name; the prescribing physician's name; a brief description 
of the event; why the event occurred; the effect on the individual; 
what improvements are needed to prevent recurrence; actions taken to 
prevent recurrence; whether the licensee notified the individual, or 
the individual's responsible relative or guardian (this person will be 
subsequently referred to as ``the patient'' in this section), and if 
not, why not, and if the patient was notified, what information was 
provided to the patient. The report must not include the patient's name 
or other information that could lead to identification of the patient.
* * * * *
    Dated at Rockville, Maryland, this 19th day of January, 1995.

    For the Nuclear Regulatory Commission.
John C. Hoyle,
Acting Secretary of the Commission.
[FR Doc. 95-1817 Filed 1-24-95; 8:45 am]
BILLING CODE 7590-01-P