This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

45635 

Vol. 73, No. 152 

Wednesday, August 6, 2008 

NUCLEAR REGULATORY 

COMMISSION 

10 CFR Part 35 

RIN 3150–AI26 

[NRC–2008–0071] 

Medical Use of Byproduct Material— 

Amendments/Medical Event 

Definitions 

AGENCY: Nuclear Regulatory 

Commission. 

ACTION: Proposed rule. 

SUMMARY: The Nuclear Regulatory 

Commission (NRC) is proposing to 

amend its regulations that govern 

medical use of byproduct material 

related to reporting and notifications of 

medical events (MEs) to clarify 

requirements for permanent implant 

brachytherapy. The proposed 

amendments would change the criteria 

for defining an ME for permanent 

implant brachytherapy from dose-based 

to activity-based; add a requirement to 

report, as an ME, any administration 

requiring a written directive (WD) if a 

WD was not prepared; clarify 

requirements for WDs for permanent 

implant brachytherapy; and make 

certain administrative and clarification 

changes. 

These amendments regarding 

permanent implant brachytherapy are 

being proposed in response to several 

incidents involving therapeutic use of 

byproduct material. The proposed 

changes are based in part on 

recommendations from NRC’s Advisory 

Committee on the Medical Use of 

Isotopes (ACMUI) and the NRC’s 

Medical Radiation Safety Team. This 

proposed rule would affect all medical 

licensees that perform procedures using 

byproduct material that require 

completion of a WD. 

DATES: The comment period expires 

October 20, 2008. Comments received 

after this date will be considered if it is 

practical to do so, but the NRC is able 

to assure consideration only for 

comments received on or before this 

date. 

ADDRESSES: Please include the following 

number RIN 3150–AI26 in the subject 

line of your comments. Comments on 

rulemakings submitted in writing or in 

electronic form will be made available 

to the public in their entirety on the 

NRC’s Web site in the Agencywide 

Documents Access and Management 

System (ADAMS) and at http:// 

www.regulations.gov. Personal 

information, such as your name, 

address, telephone number, e-mail 

address, etc., will not be removed from 

your submission. You may submit 

comments by any one of the following 

methods. 

Electronically: Via the Federal 

eRulemaking Portal (Docket ID NRC– 

2008–0071) and follow instructions for 

submitting comments. Address 

questions about this docket to Carol 

Gallagher 301–415–5905; e-mail 

Carol.Gallagher@nrc.gov. 

Mail comments to: Secretary, U.S. 

Nuclear Regulatory Commission, 

Washington, DC 20555–0001, ATTN: 

Rulemakings and Adjudications Staff. 

E-mail comments to: 

Rulemaking.Comments@nrc.gov. If you 

do not receive a reply e-mail confirming 

that we have received your comments, 

contact us directly at 301–415–1966. 

Hand deliver comments to: 11555 

Rockville Pike, Rockville, Maryland 

20852, between 7:30 a.m. and 4:15 p.m. 

Federal workdays. (Telephone 301–415– 

1966). 

Fax comments to: Secretary, U.S. 

Nuclear Regulatory Commission at 301– 

415–1101. 

You may submit comments on the 

information collections by the methods 

indicated in the Paperwork Reduction 

Act Statement. 

Publicly available documents related 

to this rulemaking may be viewed 

electronically on the public computers 

located at the NRC’s Public Document 

Room (PDR), Room O–1 F21, One White 

Flint North, 11555 Rockville Pike, 

Rockville, Maryland. The PDR 

reproduction contractor will copy 

documents for a fee. 

Publicly available documents created 

or received at the NRC after November 

1, 1999, are available electronically at 

the NRC’s Electronic Reading Room at 

http://www.nrc.gov/reading-rm/ 

adams.html. From this site, the public 

can gain entry into ADAMS, which 

provides text and image files of NRC’s 

public documents. If you do not have 

access to ADAMS or if there are 

problems in accessing the documents 

located in ADAMS, contact the PDR 

Reference staff at 1–800–397–4209, 301– 

415–4737 or by e-mail to 

pdr.resource@nrc.gov. 

FOR FURTHER INFORMATION CONTACT: 

Edward M. Lohr, Office of Federal and 

State Materials and Environmental 

Management Programs, U.S. Nuclear 

Regulatory Commission, Washington, 

DC 20555–0001, telephone 301–415– 

0253, e-mail, Edward.Lohr@nrc.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

II. Discussion 

A. What Action Is the NRC Taking? 

B. Who Would This Action Affect? 

C. What Steps Did NRC Take To Involve 

the Public in This Proposed Rulemaking? 

D. Why Change the ME Criteria for 

Permanent Implant Brachytherapy? 

E. Would All MEs for Permanent Implant 

Brachtheryapy Be Assessed in Terms of 

Activity? 

F. Why Add an ME Criterion for Failure To 

Prepare a WD When Required? 

G. Can the Authorized User (AU) Modify 

the Preimplantation WD During the 

Administration of Brachythrapy? 

H. Where Does the 20 Percent Deviation 

From the Preimplantation WD Originate? 

I. Would One Sealed Source Implanted 

Beyond the 3 cm Boundary Constitute an 

ME? 

J. What Are the New Information 

Requirements for a Brachytherapy WD? 

K. Has NRC Prepared a Cost-Benefit 

Analysis of the Proposed Actions? 

L. Has NRC Evaluated the Paperwork 

Burden to Licensees? 

M. What Should I Consider as I Prepare My 

Comments to NRC? 

III. Discussion of Proposed Amendments by 

Section 

IV. Criminal Penalties 

V. Agreement State Compatibility 

VI. Plain Language 

VII. Voluntary Consensus Standards 

VIII. Environmental Impact: Categorical 

Exclusion 

IX. Paperwork Reduction Act Statement 

X. Regulatory Analysis 

XI. Regulatory Flexibility Certification 

XII. Backfit Analysis 

I. Background 

MEs are events that meet the criteria 

in 10 CFR 35.3045(a) or (b). These 

events are incidents in which the end 

result of a medical use of radioactive 

material is significantly different from 

what was planned. The ME could be a 

result of an error in calculating or 


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45636 Federal Register / Vol. 73, No. 152 / Wednesday, August 6, 2008 / Proposed Rules 

delivering a radiation dose, 

administering the wrong radionuclide or 

the wrong amount of the correct 

radionuclide, or other factors that are 

described in 10 CFR 35.3045. 

Medical licensees are required to 

report MEs to the NRC and to notify the 

referring physician and the individual 

who is the subject of the ME so that: (1) 

NRC is aware of the events that led to 

the unplanned outcome, to determine 

what actions, if any, need to be taken to 

prevent recurrence; (2) other medical 

use licensees can be made aware of 

generic problems that result in MEs; and 

(3) patients and their physicians can 

make timely decisions regarding 

remedial and prospective health care. 

For all medical uses, the variance 

criterion threshold for licensee 

submission of an ME report is an 

administered total dose (or dosage) that 

differs from the prescribed dose (or 

dosage), as defined in the WD, by more 

than 20 percent. The basis for this ME 

criterion reporting threshold is that 

variances of this magnitude may reflect 

quality assurance (QA) problems with 

the licensees’ programs and also have 

the potential to result in harm to the 

patient. This 20 percent criterion, and 

others relating to reporting of MEs, 

appears in 10 CFR 35.3045. 10 CFR 

35.40 establishes the requirements for a 

WD. 

Several medical use events in 2003 

involving therapeutic use of byproduct 

material, as well as advice from ACMUI, 

prompted the NRC to reconsider the 

appropriateness and adequacy of the 

regulations for MEs and WDs with 

regard to use of byproduct material that 

require completion of a WD. These 

medical use events included the 

implantation of brachytherapy sources 

in the wrong treatment site by several 

licensees. Other medical use events 

were not reportable as MEs because a 

WD was not prepared for use of 

byproduct material when a WD was 

required, and under current regulations 

such events are not reportable as MEs. 

In addition, there is no basis for 

determining whether an ME has 

occurred. 

Another issue identified from these 

medical use events was that criteria for 

MEs for permanent implant 

brachytherapy are dose-based. Under 

current regulations, determining 

whether an ME has occurred for 

permanent implant brachytherapy is not 

done until the dose to the treatment site 

is determined, and often this is not done 

for some time after the procedure. 

ACMUI recommended that the criteria 

for defining most MEs for permanent 

implant brachytherapy be based on 

activity, which allows for a 

determination if an ME has occurred at 

the end of the procedure. Activity-based 

criteria allows for earlier recognition by 

the licensee that an ME has occurred 

and allows corrective actions to be taken 

sooner, resulting in an increase in the 

health and safety of the patient. 

Additionally, because the AU can 

control where the brachytherapy 

sources are implanted, activity-based 

ME criteria would result in fewer 

occurrences of MEs for permanent 

implant brachytherapies. 

ACMUI, in considering the issue of 

defining MEs involving permanent 

implant brachytherapy, concluded that 

the 20 percent variance from the 

prescription criterion in the existing 

rule continued to be appropriate for 

permanent implant brachytherapy if 

both the prescription and the variance 

could be expressed in units of activity, 

rather than in units of dose, because 

there is no suitable clinically used dose 

metric available for judging the 

occurrence of MEs. The NRC staff agrees 

that, for permanent implant 

brachytherapy, total source strength 

(activity-based) is an acceptable 

alternative to total dose (dose-based) for 

the purpose of determining the 

occurrence of most MEs. 

In March 2004, the NRC staff began its 

interactions with the ACMUI on issues 

relating to the adequacy of ME criteria 

for permanent implant brachytherapy. 

ACMUI established a Medical Event 

Subcommittee (MESC) in October 2004 

to develop ACMUI recommendations on 

these issues. In June 2005, ACMUI 

received and approved, with 

modification, the recommendations 

prepared by the MESC. 

The ACMUI recommendations 

included: 

1. For all permanent implants, most 

MEs should be defined in terms of the 

total source strength implanted in the 

treatment site, not in terms of absorbed 

dose. 

2. Any implant in which the total 

source strength implanted in the 

treatment site deviates from the WD by 

more than 20 percent (in either 

direction) should be classified as an ME. 

3. Implants in which more than 20 

percent of the total source strength 

documented in the preimplantation WD 

is implanted in tissue or organs adjacent 

to the treatment site [within 3 

centimeters (cm) (1.2 in.) of the 

treatment site boundary] should be 

classified as MEs. 

4. Implants should be classified as 

MEs if: 

a. Sealed radioactive sources (seeds) 

are implanted in distant [beyond 3 cm 

(1.2 in.) from the treatment site 

boundary] tissue or organs; 

b. The excess dose to the distant 

tissue or organ exceeds 0.5 Sv (50 rem); 

and 

c. The excess dose to the tissue or 

organ is at least 50 percent greater than 

the dose that would have been delivered 

if the seeds had been implanted in the 

correct tissue volume. 

5. An implant is an ME if the dose 

calculations used to determine the total 

source strength documented in the WD, 

to achieve the authorized user’s 

intention for absorbed dose to the 

treatment site, are in error by more than 

20 percent in either direction. 

6. The AU is to complete any 

revisions (to the WD for permanent 

implants) to account for any medically 

necessary plan adaptations before the 

patient is released from licensee control 

after the implantation procedure and 

immediate post-operative period. 

7. Seeds that were correctly implanted 

but subsequently migrated are excluded 

as grounds for any ME. 

ACMUI meetings on these issues were 

noticed in the Federal Register and 

open to the public. Members of the 

public participated in discussions of 

these matters during the meetings. 

Based on the ACMUI and NRC staff 

recommendations, the Commission 

directed the NRC staff in a Staff 

Requirements Memorandum (SRM–

SECY–05–0234, February 15, 2006) to: 

(1) Retain the 20 percent delivered 

dose variation in 10 CFR 35.3045(a) as 

an appropriate threshold for ME 

reporting for all medical use modalities 

except permanent implant 

brachytherapy; and 

(2) Develop a proposed rule to modify 

both the WD requirements in 10 CFR 

35.40 and the ME reporting 

requirements in 10 CFR 35.3045 for 

permanent implant brachytherapy 

medical use to convert from dose-based 

to activity-based. 

II. Discussion 

A. What Action Is the NRC Taking? 

The NRC is proposing to modify 10 

CFR 35.40 and 35.3045 to establish 

separate ME criteria and WD 

requirements for permanent implant 

brachytherapy. This proposed 

amendment would add as an ME a 

criterion for the failure to prepare a WD 

when required. Additionally, the 

proposed rule would make minor 

administrative and clarification 

changes. 

Section 35.3045 would be 

restructured to create separate 

paragraphs specific to ME criteria for 

permanent implant brachytherapy (such 

as seeds and microspheres). Regulations 

for all other uses of byproduct material 


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requiring a WD (such as temporary 

implant brachytherapy and 

radiopharmaceuticals) would be left 

combined. Additionally, minor changes 

would also be made to the language in 

the regulations to accommodate this 

proposed revision. 

B. Who Would This Action Affect? 

This proposed rule would affect all 

NRC and Agreement State medical 

licensees who perform procedures using 

byproduct material that require 

completion of a WD. 

C. What Steps Did NRC Take To Involve 

the Public in This Proposed 

Rulemaking? 

The NRC took several initiatives to 

enhance stakeholder involvement and to 

improve efficiency during the 

rulemaking process. Public input was 

solicited on the preliminary draft rule 

language via http://www.regulations.gov 

(Docket ID # NRC–2008–0071) on 

February 8, 2008, and noticed in the 

Federal Register on February 15, 2008. 

Additionally, the preliminary draft rule 

language and information on how to 

provide input was sent out on the NRC’s 

Medical List Server on February 8, 2008. 

All public input on the preliminary 

draft rule language received was 

considered in formulating this proposed 

rule. 

After consideration of public input on 

the preliminary language, the NRC 

revised the proposed language related to 

information required on a 

preimplantation WD and made other 

clarifications to the proposed 

regulations. The NRC also received 

comments that concerned the technical 

basis for this rulemaking. These 

comments will be considered with all 

other public comments received during 

the comment period on this proposed 

rule. 

In addition, this proposed rule is 

based partly on recommendations from 

ACMUI. The issues were addressed in 

ACMUI’s briefing to the Commissioners 

on March 2, 2004, and discussed in its 

March 2004 meeting. As a result of 

ACMUI’s briefing, the Commission 

directed the NRC staff in SRM–

M040302B, dated March 16, 2004, to 

provide recommendations concerning 

the current ME definition. 

A MESC was established by ACMUI at 

its October 2004 meeting to develop 

recommendations on these issues. 

ACMUI subsequently considered these 

issues: (1) As the principal subject of its 

mid-cycle teleconference in January 

2005 and during a March 2005 

teleconference; (2) during the ACMUI 

spring meeting in April 2005; and (3) as 

the principal subject of a teleconference 

in June 2005. MESC’s recommendations 

were accepted by ACMUI and 

forwarded to the NRC on July 19, 2005. 

ACMUI meetings on these issues were 

noticed in the Federal Register and 

open to the public. Members of the 

public participated in discussions of 

these matters during the meetings. 

D. Why Change the ME Criteria for 

Permanent Implant Brachytherapy? 

Currently, the ME criteria for 

permanent implant brachytherapy are 

dose-based. The proposed rule would 

define ME criteria in terms of the total 

source strength (activity-based) rather 

than dose or dosage (dose-based). This 

change focuses on what the AU can 

control; namely, into which organ or 

treatment site the sources are implanted, 

instead of the absorbed dose 

distribution, over which AU control is 

limited. Additionally, for the most 

commonly practiced forms of imageguided source implantation, definitive 

dose distributions may not be available 

until several weeks after completion of 

the procedure. On the other hand, the 

number of sources implanted in the 

treatment site (and hence total source 

strength) can be assessed before 

releasing the patient from licensee 

control (e.g., via intraoperative imaging 

for prostate implants). 

Criteria for defining an ME for 

permanent implant brachytherapy 

would address situations that are 

specific to permanent implant 

brachytherapy. Currently, the criteria for 

defining an ME for permanent implant 

brachytherapy are incorporated into 

requirements for temporary implant 

brachytherapy and therapeutic use of 

unsealed byproduct materials. 

E. Would All MEs for Permanent 

Implant Brachytherapy Be Assessed in 

Terms of Activity? 

The proposed rule would allow for a 

limited situation in which a dose-based 

criterion is retained in assessing if an 

ME occurred in permanent implant 

brachytherapy. Specifically, prior to 

implantation, an AU prescribes his or 

her treatment intention in units of 

absorbed dose to the treatment site, and 

the intended dose along with the 

corresponding calculated total source 

strength is documented in the 

preimplantation WD. However, an error 

may be made in the calculations used to 

determine the total source strength that 

will deliver the desired dose. As a 

result, although the prescribed total 

source strength is delivered, the 

intended dose to the treatment site is 

not achieved. If an ME were assessed 

solely in terms of whether the correct 

source strength specified in the 

preimplantation WD was implanted, 

treatment planning errors, many of 

which could adversely affect the 

patient’s clinical outcome, would not be 

subject to regulatory oversight. 

Therefore, as recommended by ACMUI, 

the proposed rule would provide in 

§ 35.3045(a)(3) that an administration is 

an ME if an error in the calculations 

used to determine the total source 

strength documented in the 

preimplantation WD results in a 

delivered dose differing by more than 20 

percent from the intended dose to the 

treatment site. 

F. Why Add an ME Criterion for Failure 

To Prepare a WD When Required? 

Under current regulations, a WD must 

be dated and signed by an AU before the 

administration of I–131 sodium iodine 

greater than 1.1 megabecquerels (30 

microcuries), any therapeutic dosage of 

unsealed byproduct material, or any 

therapeutic dose of radiation from 

byproduct material. Prescribed dosage 

and dose are defined differently in 

§ 35.2. 

The NRC has determined that all 

therapeutic and certain diagnostic 

procedures involving radioactive 

material, sealed or unsealed, must have 

WDs to ensure that the health and safety 

of the patient is protected. Unintended 

events have occurred at licensed 

facilities in which therapeutic doses 

requiring a WD have been administered 

to patients without a WD. These 

incidents were not reportable or subject 

to the requirements of the current 

regulations for determining if an ME has 

occurred because a WD was not 

prepared. Under the current regulations, 

if a WD is not prepared for therapeutic 

procedures that prescribe dose or 

dosage, then licensees do not have a 

basis for determining if an ME has 

occurred, nor is there a requirement to 

report such an event as an ME to the 

NRC. Adding a criterion that an incident 

must be reported as an ME if there has 

been a failure to prepare a WD when 

required would ensure that the health 

and safety of medical patients are 

protected. 

G. Can the AU Modify the 

Preimplantation WD During the 

Administration of Brachytherapy? 

No. Making changes to the 

preimplantation WD would constitute 

revising the WD. As is also provided by 

the current regulations, revisions to the 

WD must be made before implantation 

begins. The reason the preimplantation 

WD cannot be changed is that the 

preimplantation WD serves as the basis 

for determining if an ME has occurred. 


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However, the current regulations 

specify that after implantation but 

before completion of the procedure, 

certain information required by the 

regulations must be added to the WD. 

The current regulations do not clearly 

define ‘‘completion of the procedure’’

for permanent implant brachytherapy. 

As a result, there has been confusion as 

to when the required information must 

be added to the WD. The proposed rule 

would clarify that this information must 

be added after administration, but 

before the patient leaves the posttreatment recovery area. 

The requirement in the current 

regulation to document the treatment 

site and nuclide on the WD after 

administration for permanent implant 

brachytherapy would be removed 

because this information is already 

required by the preimplantation WD 

and modifying these two items after the 

procedure has begun would constitute a 

revision of the WD. A requirement for 

the AU to sign the WD after 

administration but before the patient 

leaves the post-treatment recovery area 

would be added to ensure that the 

information added to the WD has been 

reviewed and approved by the AU. This 

change would clarify the intent of the 

current regulation that the AU must 

approve all required information on the 

WD. 

H. Where Does the 20 Percent Deviation 

From the Preimplantation WD 

Originate? 

ACMUI, in its recommendations to 

the NRC, stated that ‘‘any implant in 

which the total source strength 

implanted in the treatment site deviates 

from the written directive by more than 

20 percent (in either direction) should 

be classified as an ME.’’ The rationale 

for this recommendation was that the 

AU should be afforded the option of 

positioning up to 20 percent of the total 

source strength for seed implantation 

into tissue or organs adjacent to the 

treatment site. For example, in treating 

the prostate with permanent implant 

brachytherapy, a small number of 

radioactive seeds need to be placed 2–

10 millimeters outside the prostate in 

order to provide adequate dosimetric 

coverage. In addition, the 20 percent 

latitude also accounts for variations in 

treatment-site definition, difficulties in 

visualizing the target organ by 

intraoperative imaging, and other 

phenomena that contribute to 

uncertainty in estimating the fraction of 

seeds implanted in the treatment site. 

The 20 percent dose threshold is 

comparable to the variation encountered 

in normal medical practice, due mainly 

to the limited control the AU has over 

the positioning of seeds and hence the 

dose delivered by permanent implants. 

Raising the relative absorbed dose 

threshold (e.g., to 50 percent), would 

reduce the number of clinically 

acceptable implants deemed to be MEs, 

but would not take into consideration 

implants that constitute technical errors 

with quality assurance (QA) significance 

that could relate to health issues. 

I. Would One Sealed Source Implanted 

Beyond the 3 cm Boundary Constitute 

an ME? 

Yes, with the exception of sealed 

sources that migrate after implantation, 

a single brachytherapy source implanted 

beyond 3 cm from the outside boundary 

of the treatment site would constitute an 

ME. In its recommendations to the NRC 

(SECY–05–0234, December 27, 2005, 

Enclosure 2), ACMUI distinguished 

between two scenarios for defining MEs 

for implants outside the treatment site. 

The first scenario relates to sealed 

sources permanently implanted in 

tissue or organs adjacent to the 

treatment site. In this case, ACMUI 

recommended that up to 20 percent of 

the total source strength documented in 

the preimplantation WD be allowed in 

the adjacent area before being 

considered an ME. ACMUI concluded 

that ‘‘a 20 percent threshold strikes a 

reasonable balance between permitting 

seed implantation outside of the target 

to boost peripheral doses [a medically 

legitimate objective] and detecting gross 

mispositioning of seeds into an adjacent 

organ rather than the intended treatment 

site.’’ ACMUI recommended that 3 cm 

from the outside boundary of the 

treatment site be used to define the 

adjacent area. 

The second scenario relates to sealed 

sources permanently implanted in 

tissue or organs beyond the adjacent 

area (3 cm) of the treatment site. In this 

case, ACMUI concluded that tissues and 

organs that are more than 3 cm from the 

outside treatment site boundary would 

be considered distant sites and that any 

sealed source implanted beyond the 3 

cm boundary would constitute an ME. 

Both of ACMUI’s recommendations 

have been incorporated into this 

proposed rule. 

J. What Are the New Information 

Requirements for a Brachytherapy WD? 

Information that is required in a WD 

is crucial to ensuring that a patient 

receives the appropriate treatment. 

Therefore, based on recommendations 

from ACMUI, the specific WD 

requirements for permanent implant 

brachytherapy would be changed from 

dose-based to activity-based. 

The permanent implant 

brachytherapy WD requirements would 

include specifying at what point a 

permanent implant brachytherapy 

procedure is considered to be complete. 

ACMUI, in its recommendations to the 

NRC, noted that ‘‘completion of the 

procedure’’ is not currently defined in 

Part 35. 

Requiring the AU to sign the WD after 

administration but before the patient 

leaves the post-treatment area would 

ensure that the information added to the 

WD has been reviewed and approved by 

the AU. This change would clarify the 

intent of the current regulation that the 

AU approve all required information on 

the WD. 

K. Has NRC Prepared a Cost-Benefit 

Analysis of the Proposed Actions? 

The NRC staff has prepared a draft 

Regulatory Analysis for this rulemaking. 

This analysis shows a reduction in cost 

by approximately $5,211 annually from 

this proposed rule. More detailed 

information on this subject is in Section 

XI of this document. 

L. Has NRC Evaluated the Paperwork 

Burden to Licensees? 

This proposed rule would contain 

new or amended information collection 

requirements that are subject to the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). The NRC staff has 

estimated the impact this proposed rule 

would have on reporting and 

recordkeeping requirements of NRC and 

Agreement State licensees. The NRC 

seeks public comment on these 

estimates of reduced burden to licensees 

from the proposed rule. More 

information on this subject is in section 

IX, Paperwork Reduction Act Statement, 

of this document. 

M. What Should I Consider as I Prepare 

My Comments to NRC? 

Commenters may wish to consider the 

following in providing their comments: 

(1) Identify the rulemaking (RIN 

3150–AI26); 

(2) Explain why you agree or disagree; 

suggest alternatives and substitute 

language for your requested changes; 

(3) Describe any assumptions and 

provide any technical information and/ 

or data that you used; 

(4) If you estimate potential costs or 

burdens, explain how you arrived at 

your estimate in sufficient detail to 

allow for it to be reproduced; 

(5) Provide specific examples to 

illustrate your concerns, and suggest 

alternatives; 

(6) Explain your views as clearly as 

possible; 


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(7) Make sure to submit your 

comments by the comment period 

deadline identified; and 

(8) See Section VI of the 

Supplemental Information for the 

request for comments on the use of 

plain language, Section IX for the 

request for comments on the 

information collection, and Section XI 

for the request for comments on the 

draft regulatory analysis. 

III. Discussion of Proposed 

Amendments by Section 

1. Section 35.40 Written Directives 

This section would be amended to 

create specific requirements for a WD 

for permanent implant brachytherapy. 

The section would be restructured to 

accommodate the specific requirements 

for a WD for permanent implant 

brachytherapy. Additionally, there 

would be an administrative change to 

the paragraph numbering. 

2. Section 35.3045 Report and 

Notification of a Medical Event 

This section would be amended to 

separately establish the criteria for MEs 

involving permanent implant 

brachytherapy. The proposed 

amendment would change the 

requirements for defining most MEs for 

permanent implant brachytherapy from 

dose-based to activity-based. A 

requirement would be added to report, 

as an ME, any administration requiring 

a WD if a WD was not prepared. In 

addition, the NRC is proposing to make 

certain administrative and clarification 

changes including an update to reflect 

the new NRC Operations Center phone 

number. 

IV. Criminal Penalties 

For the purpose of section 223 of the 

Atomic Energy Act (AEA), the 

Commission is proposing to amend 10 

CFR Part 35 under one or more of 

sections 161b, 161i, or 161o of the AEA. 

Willful violations of the rule would be 

subject to criminal enforcement. 

V. Agreement State Compatibility 

Under the ‘‘Policy Statement on 

Adequacy and Compatibility of 

Agreement State Programs’’ approved by 

the Commission on June 30, 1997 (62 FR 

46517), specific requirements within 

this rule should be adopted by 

Agreement States for purposes of 

compatibility or because of health and 

safety significance. Implementing 

procedures for the Policy Statement 

establish specific categories which have 

been applied to categorize the 

requirements in Part 32 and 35. A 

Compatibility Category ‘‘A’’ designation 

means the requirement is a basic 

radiation protection standard or deals 

with related definitions, signs, labels, or 

terms necessary for a common 

understanding of radiation protection 

principles. Compatibility Category ‘‘A’’

designated Agreement State 

requirements should be essentially 

identical to those of the NRC. A 

Compatibility Category ‘‘B’’ designation 

means the requirement has significant 

transboundary implications. 

Compatibility Category ‘‘B’’ designated 

Agreement State requirements should be 

essentially identical to those of the NRC. 

A Compatibility Category ‘‘C’’

designation means the essential 

objectives of the requirement should be 

adopted by the State to avoid conflicts, 

duplications, or gaps. The manner in 

which the essential objectives are 

addressed in the Agreement State 

requirement need not be the same as 

NRC provided the essential objectives 

are met. A Compatibility Category ‘‘D’’

designation means the requirement does 

not have to be adopted by an Agreement 

State for purposes of compatibility. The 

Compatibility Category Health & Safety 

(H&S) identifies program elements that 

are not required for purposes of 

compatibility, but have particular health 

and safety significance. States should 

adopt the essential objectives of such 

program elements in order to maintain 

an adequate program. 

SUMMARY OF NRC RULES WITH COMPATIBILITY OR HEALTH AND SAFETY

DESIGNATIONS UNDER THE PROPOSED RULE COVERING 10 CFR 

PART 35 

Section and 

paragraph Section title 

Category C 

§ 35.3045 ....... Report and notification of a 

medical event. 

Category D 

§ 35.40(c) ....... Written directives. 

Category H&S 

§ 35.40(b) ....... Written directives. 

VI. Plain Language 

The Presidential Memorandum ‘‘Plain 

Language in Government Writing’’

published June 10, 1998 (63 FR 31883), 

directed that the Government’s 

documents be in clear and accessible 

language. The NRC requests comments 

on this proposed rule specifically with 

respect to the clarity and effectiveness 

of the language used. Comments should 

be sent to the address listed under the 

ADDRESSES heading. 

VII. Voluntary Consensus Standards 

The National Technology Transfer 

and Advancement Act of 1995 (Pub. L. 

104–113) requires that Federal agencies 

use technical standards that are 

developed or adopted by voluntary 

consensus standards bodies unless the 

use of such a standard is inconsistent 

with applicable law or otherwise 

impractical. In this proposed rule, the 

NRC would amend 10 CFR 35.40 and 

35.3045 to revise the criteria for 

defining MEs and clarify requirements 

for WDs for permanent implant 

brachytherapy. This action does not 

constitute the establishment of a 

standard that establishes generally 

applicable requirements. 

VIII. Environmental Impact: 

Categorical Exclusion 

The NRC has determined that this 

proposed rule is the type of action 

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 proposed rule. 

IX. Paperwork Reduction Act 

Statement 

This proposed rule contains new or 

amended information collection 

requirements that are subject to the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). This proposed rule 

has been submitted to the Office of 

Management and Budget for review and 

approval of the information collection 

requirements. 

Type of submission, new or revision: 

Revision. 

The title of the information collection: 

Part 35 Medical Use of Byproduct 

Material—Amendments/Medical Event 

Definitions. 

The form number if applicable: N/A. 

How often the collection is required: 

As events occur. Historically, the 

number of MEs reported from the NRC 

and Agreement State medical licensees 

have averaged 35 annually. 

Who will be required or asked to 

report: NRC and Agreement State 

medical licensees who perform 

therapeutic procedures using byproduct 

material. 

An estimate of the number of annual 

responses: ¥2 (reduction of one from 

NRC medical licensees and one from 

Agreement State licensees). 

The estimated number of annual 

respondents: ¥2 (reduction of one from 

NRC medical licensees and one from 

Agreement State licensees). 


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An estimate of the total number of 

hours needed annually to complete the 

requirement or request: Reduction of 

¥20.2 hours (10.1 hours per response). 

Abstract: The NRC is proposing to 

amend 10 CFR 35.40 and 35.3045 to 

revise the criteria for defining MEs and 

clarify requirements for WDs for 

permanent implant brachytherapy. The 

proposed amendments would change 

the criteria for defining an ME for 

permanent implant brachytherapy from 

dose-based to activity-based; add a 

requirement to report, as an ME, any 

administration requiring a WD if a WD 

was not prepared; clarify requirements 

for WDs for brachytherapy; and would 

make certain administrative and 

clarification changes. 

These proposed amendments 

regarding permanent implant 

brachytherapy are based in part on 

ACMUI recommendations and on the 

NRC’s Medical Radiation Safety Team 

recommendations in response to several 

incidents involving therapeutic use of 

byproduct material. This proposed rule 

would affect all medical licensees that 

perform therapeutic procedures using 

byproduct material. 

The NRC is seeking public comment 

on the potential impact of the 

information collections contained in 

this proposed rule and on the following 

issues: 

1. Is the proposed information 

collection necessary for the proper 

performance of the functions of the 

NRC, including whether the information 

will have practical utility? 

2. Is the estimate of burden accurate? 

3. Is there a way to enhance the 

quality, utility, and clarity of the 

information to be collected? 

4. How can the burden of the 

information collection be minimized, 

including the use of automated 

collection techniques? 

A copy of the OMB clearance package 

may be viewed free of charge at the NRC 

Public Document Room, One White 

Flint North, 11555 Rockville Pike, Room 

O–1 F21, Rockville, Maryland 20852. 

The OMB clearance package and rule 

are available at the NRC worldwide Web 

site: http://www.nrc.gov/public-involve/ 

doc-comment/omb/index.html for 

60 days after the signature date of this 

notice. 

Send comments on any aspect of 

these proposed information collections, 

including suggestions for reducing the 

burden and on the above issues, by 

September 5, 2008 to the Records and 

FOIA/Privacy Services Branch (T–5 

F52), U.S. Nuclear Regulatory 

Commission, Washington, DC 20555–

0001, or by Internet electronic mail to 

INFOCOLLECTS.RESOURCE@NRC.GOV 

and to the Desk Officer, Nathan J. Frey, 

Office of Information and Regulatory 

Affairs, NEOB–10202, (3150–0010), 

Office of Management and Budget, 

Washington, DC 20503. Comments 

received after this date will be 

considered if it is practical to do so, but 

assurance of consideration cannot be 

given to comments received after this 

date. You may also e-mail comments to 

Nathan_J._Frey@omb.eop.gov or 

comment by telephone at (202) 395–

7345. 

Public Protection Notification 

The NRC may not conduct or sponsor, 

and a person is not required to respond 

to, a request for information or an 

information collection requirement 

unless the requesting document 

displays a currently valid OMB control 

number. 

X. Regulatory Analysis 

The Commission has prepared a draft 

regulatory analysis on this proposed 

regulation and has included it in this 

document. The analysis examines the 

costs and benefits of the alternatives 

considered by the Commission. 

1. Introduction 

The NRC proposes to amend its 

regulations to revise the criteria for 

defining MEs and clarify requirements 

for WDs for permanent implant 

brachytherapy. The rule would amend 

10 CFR 35.40 and 35.3045. The 

proposed amendments would change 

the criteria for defining an ME for 

permanent implant brachytherapy from 

dose-based to activity-based; would add 

a requirement to report, as an ME, any 

administration requiring a WD if a WD 

was not prepared; would clarify 

requirements for WDs for 

brachytherapy, and would make certain 

administrative and clarification 

changes. 

This proposed rule regarding 

permanent implant brachytherapy is 

based in part on the recommendations 

from ACMUI and the NRC’s Medical 

Radiation Safety Team in response to 

several incidents involving 

brachytherapy. The issues raised by 

these incidents were discussed in 

several ACMUI public meetings. Public 

input was solicited during the 

development of the proposed rule 

language. 

Several medical use events involving 

therapeutic use of byproduct material in 

2003, as well as advice from ACMUI, 

prompted the NRC to reconsider the 

appropriateness and adequacy of the 

regulations for MEs and WDs with 

regard to therapeutic use of byproduct 

material. 

1.1 Description of the Proposed Action 

The proposed rule would amend 

§ 35.3045 to change the criteria for 

defining an ME for permanent implant 

brachytherapy in terms of total source 

strength implanted rather than in terms 

of absorbed dose. The proposed rule 

does retain a limited dose-based ME 

criterion as recommended by ACMUI. 

This criterion applies if the calculations 

used to determine the total source 

strength documented in the WD are in 

error by more than 20 percent. As in the 

current regulations, source migration 

would be specifically excluded as 

grounds for treatment-site-accuracy 

MEs. One additional ME criterion 

would be added that would require a 

medical licensee to report, as an ME, 

any administration requiring a WD if a 

WD was not prepared. 

Section 35.40 would be amended to 

clarify requirements for WDs required 

for permanent implant brachytherapy 

for before and after administration. A 

detailed analysis of this amendment is 

included in Section 4 of this Regulatory 

Analysis. 

The proposed rule would also make 

certain administrative and clarification 

changes. These changes include 

updating the phone number for the NRC 

Operations Center, revising the 

numbering of various paragraphs in 

§§ 35.40 and 35.3045, and other minor 

clarifications. 

1.2 Need for the Proposed Action 

The change from a dose-based to an 

activity-based criterion for establishing 

criteria for MEs for permanent 

brachytherapy implants is proposed 

because the current dose-based criteria 

do not adequately address MEs for 

permanent brachytherapy implants. 

Several medical use events involving 

therapeutic use of byproduct material in 

2003, as well as advice from ACMUI, 

prompted the NRC to reconsider the 

appropriateness and adequacy of the 

regulations for MEs and WDs with 

regard to use of byproduct material that 

require completion of a WD. These 

medical use events included the 

implantation of brachytherapy sources 

in the wrong treatment site by several 

licensees. Other medical use events 

were not reportable as MEs because a 

WD was not prepared for use of 

byproduct material when a WD was 

required, and under current regulations 

such events are not reportable as MEs. 

In addition, there is no basis for 

determining whether an ME has 

occurred. 

Another issue identified from these 

medical use events was that criteria for 

MEs for permanent implant 


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brachytherapy are dose-based. Under 

current regulations, determining 

whether an ME had occurred for 

permanent implant brachytherapy was 

not done until the dose to the treatment 

site was determined and often was not 

done for some time after the procedure. 

ACMUI recommended that the criteria 

for defining most MEs for permanent 

implant brachytherapy be based on 

activity which allows for a 

determination if an ME has occurred at 

the end of the procedure. Activity-based 

criteria allow for earlier recognition by 

the licensee that an ME has occurred 

and allow corrective actions to be taken 

sooner, which results in an increase in 

the health and safety of the patient. 

Additionally, because the AU can 

control where the brachytherapy 

sources are implanted, activity-based 

ME criteria would result in less 

occurrences of MEs for permanent 

implant brachytherapies. 

Information required on a WD is 

crucial to ensure that a patient receives 

the appropriate administration. 

Changing from a dose-based to activitybased criteria for defining most MEs for 

permanent implant brachytherapy 

would also entail changing the 

information required in a WD. 

2. Technical Basis for the Proposed Rule 

For all medical uses, the variance 

criterion threshold for licensee 

submission of an ME report is an 

administered total dose (or dosage) that 

differs from the prescribed dose (or 

dosage), as defined in the WD, by more 

than 20 percent. The basis for this ME 

criterion reporting threshold is that 

variances of this magnitude may reflect 

quality assurance (QA) problems with a 

licensee’s program and also have the 

potential to harm the patient. This 

20 percent criterion, and others relating 

to reporting of MEs, appears in 10 CFR 

35.3045. 10 CFR 35.40 defines the 

requirements for a WD. 

Several medical use events involving 

therapeutic use of byproduct material 

that require completion of a WD in 

2003, as well as advice from the 

ACMUI, prompted the NRC to 

reconsider the appropriateness and 

adequacy of the regulations for MEs and 

WDs. ACMUI, in considering the issue 

of defining MEs involving permanent 

implant brachytherapy, concluded that 

the 20 percent variance from the 

prescription criterion in the existing 

rule continued to be appropriate for 

permanent implant brachytherapy if 

both the prescription and the variance 

could be expressed in units of activity, 

rather than in units of dose, because 

there is no suitable clinically used dose 

metric available for judging the 

occurrence of MEs. The NRC staff 

agreed that, for permanent implant 

brachytherapy, total source strength 

(activity-based) is an acceptable 

alternative to total dose (dose-based) for 

the purpose of determining the 

occurrence of most MEs. 

In March 2004, the NRC staff began its 

interactions with the ACMUI on the 

issues related to the adequacy of ME 

definitions. ACMUI established a MESC 

in October 2004 to develop ACMUI 

recommendations on these issues. In 

June 2005, ACMUI received and 

approved, with modification, the 

recommendations prepared by the 

MESC. ACMUI meetings on these issues 

were noticed in the Federal Register 

and open to the public. Members of the 

public participated in discussions of 

these matters during the meetings. 

Based on the ACMUI and NRC staff 

recommendations, the Commission 

directed the NRC staff in a Staff 

Requirements Memorandum (SRM–

SECY–05–0234, February 15, 2006) to 

(1) retain the 20 percent delivered dose 

variation in 10 CFR 35.3045(a), as an 

appropriate threshold for ME reporting 

for all medical use modalities except 

permanent implant brachytherapy; and 

(2) develop a proposed rule to modify 

both the WD requirements in 10 CFR 

35.40 and the ME reporting 

requirements in 10 CFR 35.3045 for 

permanent implant brachytherapy 

medical use to convert from dose-based 

to activity-based. 

3. Identification of Alternative 

Approaches 

The NRC considered two alternatives 

for the proposed rule: 

Alternative 1: No-Action 

Under this alternative, the 

Commission would make no changes to 

current regulations. This could result in 

the continued delay in recognizing MEs 

related to implant brachytherapy by 

medical licensees. Corrective actions 

based on MEs might not be taken in a 

timely manner which could affect the 

health and safety of patients. 

Alternative 2: Revise the Criteria for 

Defining MEs and Clarify Requirements 

for WDs for Permanent Implant 

Brachytherapy 

This alternative would amend the 

regulations as described in section 1.1 

and 1.2 of this Regulatory Analysis and 

is the preferred alternative for reasons 

stated in section 1.2. 

4. Analysis of Values and Impacts 

This section examines the values 

(benefits) and impacts (costs) expected 

to result from NRC’s proposed rule. 

Report and Notification of a Medical 

Event (§ 35.3045) 

The NRC staff, based on a review of 

historic reporting of MEs, anticipates a 

decrease in reported MEs from the use 

of the new ME criteria for permanent 

implant brachytherapy by 

approximately four per year. This would 

result in a reduction of cost by 

approximately $10,423. 

Based on NRC staff estimates, the 

number of MEs would increase by 

approximately two per year from the 

new reporting requirements when a WD 

is not prepared when required. This 

would result in an increase of cost by 

approximately $5,211. 

The net result is that the proposed 

amendment to § 35.3045 would decrease 

cost to medical licensees by $5,211. 

Written Directives (§ 35.40) 

INFORMATION REQUIRED TO BE DOCUMENTED ON A WRITTEN DIRECTIVE FOR PERMANENT IMPLANT BRACHYTHERAPY

Current regulations Proposed rule change 

(Before Implantation) (Before Implantation *) 

Date &signature of the Authorized User ............................................................................................. Date & signature of the Authorized User 

Treatment site ...................................................................................................................................... Treatment site 

Radionuclide ........................................................................................................................................ Radionuclide 

Dose ..................................................................................................................................................... Intended dose 

Calculated total source strength 

(After Implantation) (After Implantation *) 

Total source strength ........................................................................................................................... Total source strength 

Number of sources implanted ............................................................................................................. Date & signature of the Authorized User 


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INFORMATION REQUIRED TO BE DOCUMENTED ON A WRITTEN DIRECTIVE FOR PERMANENT IMPLANT BRACHYTHERAPY—

Continued 

Current regulations Proposed rule change 

(After Implantation) (After Implantation *) 

Treatment site 

Radionuclide 

* The proposed rule language uses ‘‘administration’’ in lieu of ‘‘implantation.’’

As noted in the table above, the 

information required on a WD for 

permanent implant brachytherapy 

under the proposed rule does not differ 

greatly from the current regulatory 

requirements. The proposed rule would 

add the requirement of documenting the 

calculated total source strength in the 

WD before implantation. Source 

strength must be known before a dose 

can be calculated; therefore this 

requirement is not a new burden on the 

medical licensee. Also, requiring the 

source strength to be documented in the 

WD would be an insignificant change. 

The term ‘‘dose’’ in the current language 

means ‘‘intended dose’’ and is a 

clarification in the proposed rule 

language and would not constitute a 

new requirement. 

Under both the current regulations 

and the proposed rule the WD must be 

completed after implantation. The 

requirement under the proposed rule to 

have the AU sign and date the WD when 

the post implantation information is 

documented would be an insignificant 

change for the medical licensee. 

The result of the proposed 

amendment to § 35.40 is that there 

would be a negligible increase of burden 

or cost to the medical licensees. 

The characteristics, in both the public 

and private sectors that would be 

affected by the proposed rule, are listed 

below. These are called ‘‘attributes,’’

and are based on the list of potential 

attributes provided by NRC in Chapter 

5 of its Regulatory Analysis Technical 

Evaluation Handbook. Only the 

following attributes would be impacted 

by this proposed rule: 

Industry Implementation. The NRC 

anticipates that there would be a 

reduction in the number of MEs 

reported under the new criteria for 

permanent implant brachytherapy and 

an increase in the number of MEs 

reported from the new reporting 

requirement when a WD is not prepared 

when required, resulting in a decrease 

in the total number of MEs reported. 

The change in information required to 

be documented in the WD for 

permanent implant brachytherapy 

would not place any significant 

additional burden on the medical 

licensees. Therefore, the industry would 

have a decrease in expenses from 

implementation of this proposed rule. 

NRC Implementation. NRC would 

incur one-time costs to support 

development of the rule following 

publication in the Federal Register 

through publication of the final rule. 

NRC may also need to revise guidance 

documentation during the 

implementation time period. 

Other Government. Agreement State 

governments may incur a one-time cost 

for adopting this proposed rule, if it 

becomes a final rule, into their State 

regulations governing the use of 

radioactive material. Under the ‘‘Policy 

Statement on Adequacy and 

Compatibility of Agreement State 

Programs’’ approved by the Commission 

on June 30, 1997 (62 FR 46517), specific 

requirements within this rule should be 

adopted by Agreement States for 

purposes of compatibility or because of 

health and safety significance. 

Implementing procedures for the Policy 

Statement establish specific categories 

which have been applied to categorize 

the requirements in Parts 35. The 

proposed rule would amend the 

following sections and paragraphs that 

are covered under the Policy Statement: 

1. § 35.3045, which has a 

Compatibility Category C designation 

under the Policy Statement. A 

Compatibility Category ‘‘C’’ designation 

means the essential objectives of the 

requirement should be adopted by the 

State to avoid conflicts, duplications, or 

gaps. The manner in which the essential 

objectives are addressed in the 

Agreement State requirement need not 

be the same as NRC provided the 

essential objectives are met. 

2. § 35.40(c), which has a 

Compatibility Category D designation 

under the Policy Statement. A 

Compatibility Category ‘‘D’’ designation 

means the requirement does not have to 

be adopted by an Agreement State for 

purposes of compatibility. 

3. § 35.40(b), which has a 

Compatibility Category Health & Safety 

(H&S) designation under the Policy 

Statement. The Compatibility Category 

H&S identifies program elements that 

are not required for purposes of 

compatibility, but have particular health 

and safety significance. States should 

adopt the essential objectives of such 

program elements in order to maintain 

an adequate program. 

Each Agreement State had its own 

unique procedure it must follow to 

amend its State regulations governing 

the use of radioactive material. The NRC 

recognizes that there is a cost for 

Agreement States to amend their State 

regulations to adopt this proposed rule 

if it becomes a final rule. On average 

each State would expend 0.1 FTE to 

amend their State regulation, which, 

based on $76,000 per FTE, would equal 

$7,600 per State. With 34 Agreement 

States, the total cost would be $258,400. 

The Agreement States are required to 

report MEs that occur under their 

license jurisdiction to the NRC. As 

noted in Section 4 of this Regulatory 

Analysis, the proposed amendment to 

§ 35.3045 would decrease the cost to the 

medical licensees and the proposed 

amendment to § 35.40 would have a 

negligible increase of burden or cost to 

the medical licensees. Also, there would 

be no additional burden to the 

Agreement States for licensing or 

inspections. 

Other Considerations. Public 

confidence in NRC may be affected 

positively by the rule. The public may 

have more confidence in NRC’s program 

for protection of patient health and 

safety as a result of clarifying the 

specific criteria for MEs resulting from 

permanent implant brachytherapy. 

5. Decision Rationale and 

Implementation 

The assessment of costs and benefits 

discussed previously leads the NRC to 

the conclusion that the proposed rule, if 

implemented, would not have a 

significant economical impact on 

medical licensees who are performing 

therapeutic procedures using byproduct 

material. The proposed rule would 

make it easier for AUs to determine if 

MEs have occurred, thereby facilitating 

timely reporting and other appropriate 

actions and therefore, increase patient 

health and safety. Requiring licensees to 

report, as an ME, when a WD is not 

prepared when required would increase 


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patient health and safety as well as 

ensure the proper documentation of the 

procedure. 

The revised requirements for a WD for 

permanent implant brachytherapy 

would make determining if an ME has 

occurred during the procedure easier, 

therefore improving the reliability of ME 

recognition and reporting. Requiring the 

AU to sign and date the WD at the end 

of the procedure would ensure that any 

changes made during the procedure 

were authorized by the AU. 

The Commission requests public 

comment on the draft regulatory 

analysis. Comments on the draft 

regulatory analysis may be submitted to 

the NRC as indicated under the 

ADDRESSES heading. 

After publication of this proposed 

rule in the Federal Register and 

consideration and resolution of public 

comments, a final rule will be 

published. 

XI. Regulatory Flexibility Certification 

In accordance with the Regulatory 

Flexibility Act of 1980 (5 U.S.C. 605(b)), 

the Commission certifies that this rule 

would not, if promulgated, have a 

significant economic impact on a 

substantial number of small entities. 

XII. Backfit Analysis 

The NRC has determined that the 

backfit rule (§§ 50.109, 70.76, 72.62, or 

76.76) does not apply to this proposed 

rule because this amendment would not 

involve any provisions that would 

impose backfits as defined in 10 CFR 

Chapter I. Therefore, a backfit analysis 

is not required. 

List of Subjects in 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 part 35. 

PART 35—MEDICAL USE OF 

BYPRODUCT MATERIAL 

1. 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); sec. 1704, 

112 Stat. 2750 (44 U.S.C. 3504 note); sec. 

651(e), Pub. L. 109–58, 119 Stat. 806–810 (42 

U.S.C. 2014, 2021, 2021b, 2111). 

2. In § 35.40, paragraphs (b)(5) and (c) 

are revised, paragraph (b)(6) is 

redesignated as paragraph (b)(7), and a 

new paragraph (b)(6) is added to read as 

follows: 

§ 35.40 Written directives. 

* * * * * 

(b) * * * 

(5) For high dose-rate remote 

afterloading brachytherapy: the 

radionuclide, treatment site, dose per 

fraction, number of fractions, and total 

dose; 

(6) For permanent implant 

brachytherapy: 

(i) Before administration 

(preimplantation): the treatment site, the 

radionuclide, the intended dose to the 

treatment site and other sites as 

necessary, and the corresponding 

calculated total source strength 

required; and 

(ii) After administration but before the 

patient leaves the post-treatment 

recovery area: the total source strength 

implanted, the date, and signature of 

AU; or 

* * * * * 

(c)(1) A written revision to an existing 

written directive may be made if the 

revision is dated and signed by an 

authorized user before the 

administration of the dosage of unsealed 

byproduct material, the brachytherapy 

dose, the gamma stereotactic 

radiosurgery dose, the teletherapy dose, 

or the next fractional dose. 

(2) If, because of the patient’s 

condition, a delay in order to provide a 

written revision to an existing written 

directive would jeopardize the patient’s 

health, an oral revision to an existing 

written directive is acceptable. The oral 

revision must be documented as soon as 

possible in the patient’s record. A 

revised written directive must be signed 

by the authorized user within 48 hours 

of the oral revision. 

* * * * * 

3. In § 35.3045, paragraph (a) and the 

footnote to paragraph (c) are revised to 

read as follows: 

§ 35.3045 Report and notification of a 

medical event. 

(a) A licensee shall report as a 

medical event any administration 

requiring a written directive if a written 

directive was not prepared or any event, 

except for an event that results from 

patient intervention, in which—

(1) The administration of byproduct 

material or radiation from byproduct 

material, except permanent implant 

brachytherapy, results in—

(i) A dose that differs from the 

prescribed dose or dose that would have 

resulted from the prescribed dosage by 

more than 0.05 Sv (5 rem) effective dose 

equivalent, 0.5 Sv (50 rem) to an organ 

or tissue, or 0.5 Sv (50 rem) shallow 

dose equivalent to the skin; and 

(A) The total dose delivered differs 

from the prescribed dose by 20 percent 

or more; 

(B) The total dosage delivered differs 

from the prescribed dosage by 20 

percent or more or falls outside the 

prescribed dosage range; or 

(C) The fractionated dose delivered 

differs from the prescribed dose, for a 

single fraction, by 50 percent or more. 

(ii) A dose that exceeds 0.05 Sv (5 

rem) effective dose equivalent, 0.5 Sv 

(50 rem) to an organ or tissue, or 0.5 Sv 

(50 rem) shallow dose equivalent to the 

skin from any of the following—

(A) An administration of a wrong 

radioactive drug containing byproduct 

material or the wrong radionuclide for 

a brachytherapy procedure; 

(B) An administration of a radioactive 

drug containing byproduct material by 

the wrong route of administration or by 

use of the wrong applicator in a 

brachytherapy procedure; 

(C) An administration of a dose or 

dosage to the wrong individual or 

human research subject; 

(D) An administration of a dose or 

dosage delivered by the wrong mode of 

treatment; or 

(E) A leaking sealed source. 

(iii) A dose to the skin or an organ or 

tissue other than the treatment site that 

exceeds by 0.5 Sv (50 rem) and by 50 

percent or more the dose expected to 

that site if the administration had been 

carried out as specified in the written 

directive. 

(2) The administration of byproduct 

material or radiation from byproduct 

material for permanent implant 

brachytherapy (excluding sources that 

were implanted in the correct site but 

migrated outside the treatment site) 

results in—

(i) The total source strength 

administered differing by 20 percent or 

more from the total source strength 

documented in the preimplantation 

written directive. 

(ii) The total source strength 

administered outside the treatment site 

and within 3 cm (1.2 in) of the boundary 

of the treatment site exceeding 20 

percent of the total source strength 

documented in the preimplantation 

written directive. 

(iii) Brachytherapy source(s) 

implanted beyond 3 cm (1.2 in) from the 

outside boundary of the treatment site, 

except for brachytherapy source(s) at 


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45644 Federal Register / Vol. 73, No. 152 / Wednesday, August 6, 2008 / Proposed Rules 

other sites noted in the preimplantation 

written directive. 

(iv) A dose to the skin or an organ or 

tissue other than the treatment site 

exceeding by 0.5 Sv (50 rem) and by 50 

percent or more the dose expected to 

that site if the administration had been 

carried out as specified in the 

preimplantation written directive. 

(v) A dose that exceeds 0.05 Sv (5 

rem) effective dose equivalent, 0.5 Sv 

(50 rem) to an organ or tissue, or 0.5 Sv 

(50 rem) shallow dose equivalent to the 

skin from any of the following—

(A) An administration of the wrong 

radionuclide; 

(B) An administration by the wrong 

route of administration; 

(C) An administration to the wrong 

individual or human research subject; 

(D) An administration delivered by 

the wrong mode of treatment; or 

(E) A leaking sealed source. 

(3) An error in calculating the total 

source strength for permanent implant 

brachytherapy documented in the 

preimplantation written directive that 

resulted in an administered total source 

strength that delivered a dose differing 

by more than 20 percent from the 

intended dose to the treatment site. 

* * * * * 

(c) * * * 

3The commercial telephone number of the 

NRC Operations Center is (301) 816–5100. 

* * * * * 

Dated at Rockville, Maryland, this 31st day 

of July 2008. 

For the Nuclear Regulatory Commission. 

Annette L. Vietti-Cook, 

Secretary of the Commission. 

[FR Doc. E8–18014 Filed 8–5–08; 8:45 am] 

BILLING CODE 7590–01–P 

DEPARTMENT OF TRANSPORTATION 

Federal Aviation Administration 

14 CFR Part 39 

[Docket No. FAA–2008–0834; Directorate 

Identifier 2007–SW–78–AD] 

RIN 2120–AA64 

Airworthiness Directives; Agusta 

S.p.A. Model A109A and A109A II 

Helicopters 

AGENCY: Federal Aviation 

Administration (FAA), DOT. 

ACTION: Notice of proposed rulemaking 

(NPRM). 

SUMMARY: We propose to adopt a 

superseding airworthiness directive 

(AD) for the specified Agusta S.p.A. 

(Agusta) model helicopters. This 

proposed AD results from a revised 

mandatory continuing airworthiness 

information (MCAI) originated by an 

aviation authority to identify and 

correct an unsafe condition on an 

aviation product. The aviation authority 

of Italy, with which we have a bilateral 

agreement, reports that the previous 

MCAI should not apply to newly 

redesigned and improved tail rotor 

blades. This action proposes the same 

inspection requirements as the current 

AD but would limit the applicability to 

only three part-numbered tail rotor 

blades. The proposed AD would require 

actions that are intended to prevent 

fatigue failure of a tail rotor blade 

(blade), loss of a tail rotor, and 

subsequent loss of control of the 

helicopter. 

DATES: We must receive comments on 

this proposed AD by September 5, 2008. 

ADDRESSES: You may send comments by 

any of the following methods: 

• Federal eRulemaking Portal: Go to 

http://www.regulations.gov. Follow the 

instructions for submitting comments. 

• Fax: 202–493–2251. 

• Mail: U.S. Department of 

Transportation, Docket Operations, M–

30, West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue, SE., 

Washington, DC 20590. 

• Hand Delivery: U.S. Department of 

Transportation, Docket Operations, M–

30, West Building Ground Floor, Room 

W12–140, 1200 New Jersey Avenue, SE., 

Washington, DC 20590, between 9 a.m. 

and 5 p.m., Monday through Friday, 

except Federal holidays. 

You may get the service information 

identified in this AD from Agusta, 

21017 Cascina Costa di Samarate (VA) 

Italy, Via Giovanni Agusta 520, 

telephone 39 (0331) 229111, fax 39 

(0331) 229605–222595. 

Examining the AD Docket: You may 

examine the AD docket on the Internet 

at http://www.regulations.gov, or in 

person at the Docket Operations office 

between 9 a.m. and 5 p.m., Monday 

through Friday, except Federal holidays. 

The AD docket contains this proposed 

AD, the economic evaluation, any 

comments received, and other 

information. The street address for the 

Docket Operations office (telephone 

(800) 647–5527) is in the ADDRESSES

section. Comments will be available in 

the AD docket shortly after receipt. 

FOR FURTHER INFORMATION CONTACT: 

Sharon Miles, Aviation Safety Engineer, 

FAA, Rotorcraft Directorate, Regulations 

and Guidance Group, Fort Worth, Texas 

76193–0111, telephone (817) 222–5122, 

fax (817) 222–5961. 

Comments Invited 

We invite you to send any written 

relevant data, views, or arguments about 

this proposed AD. Send your comments 

to an address listed under the 

ADDRESSES section. Include ‘‘Docket No. 

FAA–2008–0834; Directorate Identifier 

2007–SW–78–AD’’ at the beginning of 

your comments. We specifically invite 

comments on the overall regulatory, 

economic, environmental, and energy 

aspects of this proposed AD. We will 

consider all comments received by the 

closing date and may amend this 

proposed AD based on those comments. 

We will post all comments we 

receive, without change, to http:// 

www.regulations.gov, including any 

personal information you provide. We 

will also post a report summarizing each 

substantive verbal contact we receive 

about this proposed AD. 

Discussion 

Ente Nazionale Per L’Aviazione Civile 

(ENAC), which is the Aviation 

Authority for Italy, has issued an MCAI 

in the form of ENAC AD No. 2006–001, 

Revision 1, dated January 3, 2006 

(referred to after this as ‘‘the MCAI’’), to 

correct an unsafe condition for the 

Italian-certificated product. The aviation 

authority of Italy, with which we have 

a bilateral agreement, reports that this 

MCAI cancels Registro Aeronautico 

Italiano AD 1999–325, which was our 

basis for issuing FAA AD 99–27–12. 

They state that the AD should not apply 

to certain newly redesigned and 

improved blades. You may obtain 

further information by examining the 

MCAI and the service information in the 

AD docket. 

Relevant Service Information 

Agusta has issued Bollettino Tecnico 

No. 109–110, Revision A, dated 

December 12, 2005 (BT). The actions 

described in the MCAI are intended to 

correct the same unsafe condition as 

that identified in the BT. Agusta advises 

that the inspection for cracks should 

only apply to blades, part number (P/N) 

109–0132–02–11/–15/–121 with 400 or 

more flight hours and not to new blade, 

P/N 109–0132–02–125, because it was 

designed and certified with improved 

structural characteristics. The BT 

continues to stress the importance of 

performing a detailed inspection of the 

subject blades for cracks already 

prescribed in Telegraphic Technical 

Bulletin No. 109–5, dated January 27, 

1987. 

FAA’s Determination and Requirements 

of This Proposed AD 

This product has been approved by 

the aviation authority of Italy, and is 


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