Federal Register / Vol. 65, No. 213 / Thursday, November 2, 2000 / Proposed Rules 65793

exclusively. Owners of eligible projects

may choose tenant-specific RA or

operating assistance, but may not utilize

both programs in the same project. The

objective of this program is to provide

assistance toward the cost of operating

the project so that rents may be set at

rates that are affordable to very low and

low-income migrant farmworkers.

(1) Project eligibility requirements. To

be eligible for the operating assistance

program, projects must be:

(i) Off-farm labor housing projects

financed under section 514 or section

516 serving migrant farmworkers

exclusively (projects serving both

migrant and year-round farmworker

households are not eligible); and

(ii) Eligible for the Agency’s rental

assistance (RA) program as defined in

paragraph II B of exhibit E of subpart C

of part 1930 of this chapter.

(2) Tenant eligibility requirements. To

be eligible for operating assistance rents,

tenants must meet the RA eligibility

requirements of paragraph II A of

exhibit E of subpart C of part 1930 of

this chapter.

(3) Operating assistance limits. The

amount of operating assistance

requested by the owner must be based

on the project’s actual income and

expenses and must be approved by the

Agency. In no instance may the annual

amount of operating assistance exceed

90 percent of the project’s annual

operating costs.

(4) Owner responsibilities—(i) Request

for operating assistance program.

Owners of off-farm migrant housing

projects may request operating

assistance by submitting a request on a

form provided by the Agency. The

request must include a budget in the

format prescribed by the Agency and

prepared in accordance with Agency

instructions. The budget must include:

(A) Estimated project operating costs,

including authorized expenditures such

as reserve deposits.

(B) Proposed rental rates to generate

sufficient funds for project operating

costs, taking into consideration all other

sources of project income.

(C) Estimated rental income from

tenants, based on a tenant contribution

of 30 percent of the average adjusted

monthly income of migrant farmworker

households in the area. The average

adjusted monthly income of migrant

farmworker households will be

determined as follows:

(1) For existing RHS-financed projects

that have been in operation for at least

one year, owners will use the average

adjusted monthly household income for

each unit-size (1-, 2-, 3-bedroom, etc.)

based on the prior year’s Multi-Family

Tenant File System (MTFS) data.

(2) For new projects, owners will use

the average adjusted monthly household

income for each unit-size, based on the

prior year’s MTFS data for a like-type

property in the same or similar area, as

provided by the Agency. Owners may

request authorization to use other

reliable income data if available.

(D) Estimated operating assistance,

calculated as the difference between

estimated project income and estimated

project operating costs. The annual

amount of operating assistance may not

exceed 90 percent of the annual

operating costs.

(ii) Requesting operating assistance

payments. Each month, owners will

submit a project worksheet for interest

credit and rental or operating assistance

on a form provided by the Agency. The

amount of operating assistance

requested each month will be onetwelfth of the annual amount approved

by the Agency.

(iii) Verifying tenant income

eligibility. Owners are responsible for

verifying tenant income in accordance

with § 1944.182(a). Only very low or

low-income households are eligible for

the operating assistance rents. Incomeeligible households with incomes above

low must pay the full rent.

(iv) Reporting requirements.—(A)

Tenant certification. Owners and

tenants will complete a tenant

certification, on a form provided by the

Agency, to document tenant income and

eligibility. Tenant certification forms

need not be submitted to the Agency but

must be maintained, along with income

verifications, for at least 3 years. The

tenant files must be available for the

Agency’s review upon request. The

owner will use the income information,

along with the project’s actual expense

figures, to complete the next year’s

operating assistance request.

(B) Project worksheet. Each month,

the borrower will submit to the Agency

a project worksheet for interest credit

and rental or operating assistance on a

form provided by the Agency, in

accordance with paragraph XIII C2f (2)

of exhibit B of subpart C of part 1930 of

this chapter.

(C) Budgets. Prior to the beginning of

the project’s fiscal year, owners must

submit an annual planning budget in

accordance with paragraph XIII C2a of

exhibit E of subpart C of part 1930 of

this chapter, on a form provided by the

Agency. The budget must reflect actual

income and expenses for at least 9

months of the current fiscal year and the

proposed income and expenses for the

coming year. Owners must include a

summary report showing the income of

tenants served on a form provided by

the Agency. If warranted by the actual

income of tenants served, a request for

rent change should be included,

following the guidance in paragraph XIII

C2b of exhibit E of subpart C of part

1930 of this chapter. After the first full

year of operation, owners will use the

actual year-end budget figures to make

appropriate adjustments to the amount

of operating assistance requested.

Dated: October 20, 2000.

Jill Long Thompson,

Under Secretary, Rural Development.

[FR Doc. 00–27978 Filed 11–1–00; 8:45 am]

BILLING CODE 3410–XV–U

NUCLEAR REGULATORY

COMMISSION

10 CFR Part 35

RIN 3150–AF74

Medical Use of Byproduct Material—

Speciality Boards and Medical

Speciality Boards: Solicitation

AGENCY: Nuclear Regulatory

Commission.

ACTION: Solicitation.

SUMMARY: The Nuclear Regulatory

Commission (NRC) is beginning a new

process to recognize speciality boards

and medical speciality boards (whose

diplomates would fulfill the training

and experience requirements for an

authorized medical physicist,

authorized nuclear pharmacist,

authorized user, and/or a Radiation

Safety Officer) by listing the boards on

an NRC website instead of including the

names of boards in 10 CFR Part 35,

‘‘Medical Use of Byproduct Material.’’

The NRC is taking this action in

anticipation of a revision to its

regulations governing the medical use of

byproduct material. Any board that is

interested in being recognized by the

NRC should submit a letter certifying

that its certification process would meet

the draft final training and experience

requirements for an authorized medical

physicist, authorized nuclear

pharmacist, authorized user, and/or a

Radiation Safety Officer.

DATES: The solicitation process begins

November 2, 2000.

ADDRESSES: Documents related to the

proposed rule may be examined through

September 22, 2000, at the NRC Public

Document Room and electronically at

http://ruleforum.llnl.gov. Beginning

September 25, 2000, the NRC Public

Document Room will be located at

11555 Rockville Pike, Rockville, MD.

FOR FURTHER INFORMATION CONTACT: Sam

Jones, Office of Nuclear Material Safety

65794 Federal Register / Vol. 65, No. 213 / Thursday, November 2, 2000 / Proposed Rules

and Safeguards, Nuclear Regulatory

Commission, Washington, DC 20555–

0001, (301) 415–6198, e-mail

SZJ@nrc.gov.

SUPPLEMENTARY INFORMATION:

I. Discussion

The NRC is in the final stages of

revising its medical use regulations in

10 CFR Part 35, ‘‘Medical Use of

Byproduct Material.’’ The proposed rule

revising Part 35 was published August

13, 1998 (63 FR 43516). It is anticipated

that the Commission will publish the

final rule in the Federal Register in

Spring 2001 with an effective date 6

months after publication. As part of this

revision, the regulatory text would not

include the names of the specific boards

whose diplomates automatically fulfill

the training and experience

requirements for an authorized medical

physicist, authorized nuclear

pharmacist, authorized user and a

Radiation Safety Officer. Rather, the

NRC will recognize certification boards

that require individuals to complete the

training and experience requirements

specified in the regulatory text. This

change is being made to eliminate the

need for a rulemaking each time a board

is added or deleted. Once recognized,

the board’s name will be placed on the

list of recognized boards to be

maintained on the NRC website. NRC

expects to begin listing the names of

boards on an NRC website prior to the

effective date of the final rule.

This document serves as notification

to all speciality boards of NRC’s intent

to initiate the recognition process

immediately. If any board is interested

in being recognized by the NRC, the

board should submit a letter to Dr.

Donald A. Cool, Director, Office of

Nuclear Material Safety and Safeguards,

Nuclear Regulatory Commission,

Washington, DC 20555–0001. The letter

should list each training and experience

section of the rule for which the board

believes that their diplomates should be

deemed to have met the requirements.

Section II and Section III of the

SUPPLEMENTARY INFORMATION should

assist a board in preparing its letter.

Section II lists all training requirements

for which NRC plans to recognize board

certification as meeting the

requirements. Section III is a copy of the

draft final regulatory text that lists the

training and experience criteria for an

authorized medical physicist,

authorized nuclear pharmacist,

authorized user and a Radiation Safety

Officer.

The board’s letter should clearly state

that an individual must have completed

the training and experience required by

a particular section prior to receiving

board certification. For example, if a

board would like to be recognized under

10 CFR 35.390. ‘‘Training for use of

unsealed byproduct material for which

a written directive is required,’’ the

letter should state: ‘‘(the name of the

organization) has reviewed 10 CFR

35.390 and has determined that our

certification process requires an

individual to meet all the requirements

in paragraph (b) of this section prior to

being certified by our board.’’ The letter

should be dated and signed by the chief

executive of the board.

II. Training Requirements for Which

NRC Plans To Recognize Board

Certification

The following are the titles of the

specific sections in the draft final

regulations that contain the specific

training and experience requirements

for a Radiation Safety Officer, an

authorized medical physicist,

authorized nuclear pharmacist, and

authorized user:

35.50 Training for Radiation Safety Officer.

35.51 Training for an authorized medical

physicist.

35.55 Training for an authorized nuclear

pharmacist.

35.190 Training for uptake, dilution, and

excretion studies.

35.290 Training for imaging and

localization studies.

35.390 Training for use of unsealed

byproduct material for which a written

directive is required.

35.392 Training for the oral administration

of sodium iodide I–131 requiring a

written directive in quantities less than

or equal to 1.22 Gigabecquerels (33

millicuries).

35.394 Training for the oral administration

of sodium iodide I–131 requiring a

written directive in quantities greater

than 1.22 Gigabecquerels (33

millicuries).

35.490 Training for use of manual

brachytherapy sources.

35.491 Training for ophthalmic use of

strontium-90.

35.590 Training for use of sealed sources for

diagnosis.

35.690 Training for use of remote

afterloader units, teletherapy units, and

gamma stereotactic radiosurgery units.

III. Draft Final Regulatory Text—

Training and Experience

This section contains draft final

regulatory text for the sections listed

under section II. This regulatory text is

presented here for use by boards that are

interested in being recognized by NRC.

Section 35.50 Training for Radiation Safety

Officer

Except as provided in § 35.57, the licensee

shall require an individual fulfilling the

responsibilities of the Radiation Safety

Officer as provided in § 35.24 to be an

individual who—

(a) Is certified by a specialty board whose

certification process includes all of the

requirements in paragraph (b) of this section

and whose certification has been recognized

by the Commission or an Agreement State; or

(b)(1) Has completed a structured

educational program consisting of both:

(i) 200 hours of didactic training in the

following areas—

(A) Radiation physics and instrumentation;

(B) Radiation protection;

(C) Mathematics pertaining to the use and

measurement of radioactivity;

(D) Radiation biology; and

(E) Radiation dosimetry; and

(ii) One year of full-time radiation safety

experience under the supervision of the

individual identified as the Radiation Safety

Officer on a Commission or Agreement State

license that authorizes similar type(s) of

use(s) of byproduct material involving the

following—

(A) Shipping, receiving, and performing

related radiation surveys;

(B) Using and performing checks for proper

operation of instruments used to determine

the activity of dosages, survey meters, and

instruments used to measure radionuclides;

(C) Securing and controlling byproduct

material;

(D) Using administrative controls to avoid

mistakes in the administration of byproduct

material;

(E) Using procedures to prevent or

minimize radioactive contamination and

using proper decontamination procedures;

(F) Using emergency procedures to control

byproduct material; and

(G) Disposing of byproduct material; and

(2) Has obtained written certification,

signed by a preceptor Radiation Safety

Officer, that the individual has satisfactorily

completed the requirements in paragraph

(b)(1) of this section and has achieved a level

of radiation safety knowledge sufficient to

function independently as a Radiation Safety

Officer for a medical use licensee; or

(c) Is an authorized user, authorized

medical physicist, or authorized nuclear

pharmacist identified on the licensee’s

license and has experience with the radiation

safety aspects of similar types of use of

byproduct material for which the individual

has Radiation Safety Officer responsibilities.

Section 35.51 Training for an authorized

medical physicist

The licensee shall require the authorized

medical physicist to be an individual who—

(a) Is certified by a specialty board whose

certification process includes all of the

training and experience requirements in

paragraph (b) of this section and whose

certification has been recognized by the

Commission or an Agreement State; or

(b)(1) Holds a master’s or doctor’s degree

in physics, biophysics, radiological physics,

medical physics, or health physics and has

completed 1 year of full-time training in

therapeutic radiological physics and an

additional year of full-time work experience

under the supervision of an individual who

meets the requirements for an authorized

medical physicist at a medical institution

Federal Register / Vol. 65, No. 213 / Thursday, November 2, 2000 / Proposed Rules 65795

that includes the tasks listed in §§ 35.67,

35.433, 35.632, 35.633, 35.635, 35.642,

35.643, 35.645, and 35.652, as applicable;

and

(2) Has obtained written certification that

the individual has satisfactorily completed

the requirements in paragraph (b)(1) of this

section and has achieved a level of

competency sufficient to function

independently as an authorized medical

physicist for each type of therapeutic medical

unit for which the individual is requesting

authorized medical physicist status. The

written certification must be signed by a

preceptor authorized medical physicist who

meets the requirements in § 35.51 or

equivalent Agreement State requirements for

an authorized medical physicist for each type

of therapeutic medical unit for which the

individual is requesting authorized medical

physicist status.

Section 35.55 Training for an authorized

nuclear pharmacist

The licensee shall require the authorized

nuclear pharmacist to be a pharmacist who—

(a) Is certified as a nuclear pharmacist by

a specialty board whose certification process

includes all of the requirements in paragraph

(b) of this section and whose certification has

been recognized by the Commission or an

Agreement State; or

(b)(1) Has completed 700 hours in a

structured educational program consisting of

both:

(i) Didactic training in the following

areas—

(A) Radiation physics and instrumentation;

(B) Radiation protection;

(C) Mathematics pertaining to the use and

measurement of radioactivity;

(D) Chemistry of byproduct material for

medical use; and

(E) Radiation biology; and

(ii) Supervised practical experience in a

nuclear pharmacy involving—

(A) Shipping, receiving, and performing

related radiation surveys;

(B) Using and performing checks for proper

operation of instruments used to determine

the activity of dosages, survey meters, and, if

appropriate, instruments used to measure

alpha- or beta-emitting radionuclides;

(C) Calculating, assaying, and safely

preparing dosages for patients or human

research subjects;

(D) Using administrative controls to avoid

medical events in the administration of

byproduct material; and

(E) Using procedures to prevent or

minimize radioactive contamination and

using proper decontamination procedures;

and

(2) Has obtained written certification,

signed by a preceptor authorized nuclear

pharmacist, that the individual has

satisfactorily completed the requirements in

paragraph (b)(1) of this section and has

achieved a level of competency sufficient to

function independently as an authorized

nuclear pharmacist.

Section 35.190 Training for uptake,

dilution, and excretion studies

Except as provided in § 35.57, the licensee

shall require an authorized user of unsealed

byproduct material for the uses authorized

under § 35.100 to be a physician who—

(a) Is certified by a medical specialty board

whose certification process includes all of

the requirements in paragraph (c) of this

section and whose certification has been

recognized by the Commission or an

Agreement State; or

(b) Is an authorized user under §§ 35.290

or 35.390 or equivalent Agreement State

requirements; or

(c)(1) Has completed 60 hours of training

and experience in basic radionuclide

handling techniques applicable to the

medical use of unsealed byproduct material

for uptake, dilution, and excretion studies;

the training and experience must include—

(i) Classroom and laboratory training in the

following areas—

(A) Radiation physics and instrumentation;

(B) Radiation protection;

(C) Mathematics pertaining to the use and

measurement of radioactivity;

(D) Chemistry of byproduct material for

medical use; and

(E) Radiation biology; and

(ii) Work experience, under the

supervision of an authorized user who meets

the requirements in § 35.190, § 35.290, or

§ 35.390 or equivalent Agreement State

requirements, involving —

(A) Ordering, receiving, and unpacking

radioactive materials safely and performing

the related radiation surveys;

(B) Calibrating instruments used to

determine the activity of dosages and

performing checks for proper operation of

survey meters;

(C) Calculating, measuring, and safely

preparing patient or human research subject

dosages;

(D) Using administrative controls to

prevent a medical event involving the use of

unsealed byproduct material;

(E) Using procedures to contain spilled

byproduct material safely and using proper

decontamination procedures; and

(F) Administering dosages of radioactive

drugs to patients or human research subjects;

and

(2) Has obtained written certification,

signed by a preceptor authorized user who

meets the requirements in §§ 35.190, 35.290,

or 35.390 or equivalent Agreement State

requirements, that the individual has

satisfactorily completed the requirements in

paragraph (c)(1) of this section and has

achieved a level of competency sufficient to

function independently as an authorized user

for the medical uses authorized under

§ 35.100.

Section 35.290 Training for imaging and

localization studies

Except as provided in § 35.57, the licensee

shall require an authorized user of unsealed

byproduct material for the uses authorized

under § 35.200 to be a physician who—

(a) Is certified by a medical specialty board

whose certification process includes all of

the requirements in paragraph (c) of this

section and whose certification has been

recognized by the Commission or an

Agreement State; or

(b) Is an authorized user under § 35.390 or

equivalent Agreement State requirements; or

(c)(1) Has completed 700 hours of training

and experience in basic radionuclide

handling techniques applicable to the

medical use of unsealed byproduct material

for imaging and localization studies; the

training and experience must include, at a

minimum—

(i) Classroom and laboratory training in the

following areas—

(A) Radiation physics and instrumentation;

(B) Radiation protection;

(C) Mathematics pertaining to the use and

measurement of radioactivity;

(D) Chemistry of byproduct material for

medical use;

(E) Radiation biology; and

(ii) Work experience, under the

supervision of an authorized user, who meets

the requirements in §§ 35.290 or 35.390 or

equivalent Agreement State requirements,

involving—

(A) Ordering, receiving, and unpacking

radioactive materials safely and performing

the related radiation surveys;

(B) Calibrating instruments used to

determine the activity of dosages and

performing checks for proper operation of

survey meters;

(C) Calculating, measuring, and safely

preparing patient or human research subject

dosages;

(D) Using administrative controls to

prevent a medical event involving the use of

unsealed byproduct material;

(E) Using procedures to safely contain

spilled radioactive material and using proper

decontamination procedures;

(F) Administering dosages of radioactive

drugs to patients or human research subjects;

and

(G) Eluting generator systems appropriate

for preparation of radioactive drugs for

imaging and localization studies, measuring

and testing the eluate for radionuclidic

purity, and processing the eluate with

reagent kits to prepare labeled radioactive

drugs; and

(2) Has obtained written certification,

signed by a preceptor authorized user who

meets the requirements in §§ 35.290 or

35.390 or equivalent Agreement State

requirements, that the individual has

satisfactorily completed the requirements in

paragraph (c)(1) of this section and has

achieved a level of competency sufficient to

function independently as an authorized user

for the medical uses authorized under

§§ 35.100 and 35.200.

Section 35.390 Training for use of unsealed

byproduct material for which a written

directive is required

Except as provided in § 35.57, the licensee

shall require an authorized user of unsealed

byproduct material for the uses authorized

under § 35.300 to be a physician who—

(a) Is certified by a medical specialty board

whose certification process includes all of

the requirements in paragraph (b) of this

section and whose certification has been

recognized by the Commission or an

Agreement State; or

(b)(1) Has completed 700 hours of training

and experience in basic radionuclide

handling techniques applicable to the

medical use of unsealed byproduct material

65796 Federal Register / Vol. 65, No. 213 / Thursday, November 2, 2000 / Proposed Rules

1Experience with at least 3 cases in Category

(G)(2) also satisfies the requirement in Category

(G)(1).

requiring a written directive; the training and

experience must include—

(i) Classroom and laboratory training in the

following areas—

(A) Radiation physics and instrumentation;

(B) Radiation protection;

(C) Mathematics pertaining to the use and

measurement of radioactivity;

(D) Chemistry of byproduct material for

medical use; and

(E) Radiation biology; and

(ii) Work experience, under the

supervision of an authorized user who meets

the requirements in § 35.390(a), § 35.390(b),

or equivalent Agreement State requirements.

A supervising authorized user, who meets

the requirements in § 35.390(b), must have

experience in administering dosages in the

same dosage category or categories (i.e.,

§ 35.390(b)(1)(ii)(G)(1), (2), (3), or (4)) as the

individual requesting authorized user status.

The work experience must involve—

(A) Ordering, receiving, and unpacking

radioactive materials safely and performing

the related radiation surveys;

(B) Calibrating instruments used to

determine the activity of dosages, and

performing checks for proper operation of

survey meters;

(C) Calculating, measuring, and safely

preparing patient or human research subject

dosages;

(D) Using administrative controls to

prevent a medical event involving the use of

unsealed byproduct material;

(E) Using procedures to contain spilled

byproduct material safely and using proper

decontamination procedures;

(F) Eluting generator systems, measuring

and testing the eluate for radionuclidic

purity, and processing the eluate with

reagent kits to prepare labeled radioactive

drugs; and

(G) Administering dosages of radioactive

drugs to patients or human research subjects

involving a minimum of three cases in each

of the following categories for which the

individual is requesting authorized user

status—

(1) Oral administration of less than or

equal to 1.22 Gigabecquerels (33 millicuries)

of sodium iodide I-131;

(2) Oral administration of greater than 1.22

Gigabecquerels (33 millicuries) of sodium

iodide I-131 1;

(3) Parenteral administration of any beta

emitter or a photon-emitting radionuclide

with a photon energy less than 150 keV; and/

or

(4) Parenteral administration of any other

radionuclide; and

(2) Has obtained written certification that

the individual has satisfactorily completed

the requirements in paragraph (b)(1) of this

section and has achieved a level of

competency sufficient to function

independently as an authorized user for the

medical uses authorized under § 35.300. The

written certification must be signed by a

preceptor authorized user who meets the

requirements in § 35.390(a), § 35.390(b), or

equivalent Agreement State requirements.

The preceptor authorized user, who meets

the requirements in § 35.390(b), must have

experience in administering dosages in the

same dosage category or categories (i.e.,

§ 35.390(b)(1)(ii)(G)(1), (2), (3), or (4)) as the

individual requesting authorized user status.

Section 35.392 Training for the oral

administration of sodium iodide I-131

requiring a written directive in quantities less

than or equal to 1.22 Gigabecquerels (33

millicuries)

Except as provided in § 35.57, the licensee

shall require an authorized user for the oral

administration of sodium iodide I-131

requiring a written directive in quantities less

than or equal to 1.22 Gigabecquerels (33

millicuries), to be a physician who—

(a) Is certified by a medical specialty board

whose certification process includes all of

the requirements in paragraph (c) of this

section and whose certification has been

recognized by the Commission or an

Agreement State; or

(b) Is an authorized user under § 35.390(a),

§ 35.390(b), for uses listed in

§ 35.390(b)(1)(ii)(G)(1) or (2), § 35.394, or

equivalent Agreement State requirements; or

(c)(1) Has successfully completed 80 hours

of classroom and laboratory training,

applicable to the medical use of sodium

iodide I-131 for procedures requiring a

written directive; the training must include—

(i) Radiation physics and instrumentation;

(ii) Radiation protection;

(iii) Mathematics pertaining to the use and

measurement of radioactivity;

(iv) Chemistry of byproduct material for

medical use; and

(v) Radiation biology; and

(2) Has work experience, under the

supervision of an authorized user who meets

the requirements in § 35.390(a), § 35.390(b),

§ 35.392, § 35.394, or equivalent Agreement

State requirements. A supervising authorized

user who meets the requirements in

§ 35.390(b), must have experience in

administering dosages as specified in

§ 35.390(b)(1)(ii)(G)(1) or (2). The work

experience must involve—

(i) Ordering, receiving, and unpacking

radioactive materials safely and performing

the related radiation surveys;

(ii) Calibrating instruments used to

determine the activity of dosages and

performing checks for proper operation for

survey meters;

(iii) Calculating, measuring, and safely

preparing patient or human research subject

dosages;

(iv) Using administrative controls to

prevent a medical event involving the use of

byproduct material;

(v) Using procedures to contain spilled

byproduct material safely and using proper

decontamination procedures; and

(vi) Administering dosages to patients or

human research subjects, that includes at

least 3 cases involving the oral

administration of less than or equal to 1.22

Gigabecquerels (33 millicuries) of sodium

iodide I-131; and

(3) Has obtained written certification that

the individual has satisfactorily completed

the requirements in paragraphs (c)(1) and

(c)(2) of this section and has achieved a level

of competency sufficient to function

independently as an authorized user for

medical uses authorized under § 35.300. The

written certification must be signed by a

preceptor authorized user who meets the

requirements in § 35.390(a), § 35.390(b), or

equivalent Agreement State requirements. A

preceptor authorized user, who meets the

requirement in § 35.390(b), must have

experience in administering dosages as

specified in § 35.390(b)(1)(ii)(G)(1) or (2).

Section 35.394 Training for the oral

administration of sodium iodide I-131

requiring a written directive in quantities

greater than 1.22 Gigabecquerels (33

millicuries)

Except as provided in § 35.57, the licensee

shall require an authorized user for the oral

administration of sodium iodide I-131

requiring a written directive in quantities

greater than 1.22 Gigabecquerels (33

millicuries), to be a physician who—

(a) Is certified by a medical specialty board

whose certification process includes all of

the requirements in paragraph (c) of this

section and whose certification has been

recognized by the Commission or an

Agreement State; or

(b) Is an authorized user under § 35.390(a),

§ 35.390(b), for uses listed in

§ 35.390(b)(1)(ii)(G)(2), or equivalent

Agreement State requirements; or

(c)(1) Has successfully completed 80 hours

of classroom and laboratory training,

applicable to the medical use of sodium

iodide I-131 for procedures requiring a

written directive; the training must include—

(i) Radiation physics and instrumentation;

(ii) Radiation protection;

(iii) Mathematics pertaining to the use and

measurement of radioactivity;

(iv) Chemistry of byproduct material for

medical use; and

(v) Radiation biology; and

(2 ) Has work experience, under the

supervision of an authorized user who meets

the requirements in § 35.390(a), § 35.390(b),

§ 35.394, or equivalent Agreement State

requirements. A supervising authorized user,

who meets the requirements in § 35.390(b),

must have experience in administering

dosages as specified in

§ 35.390(b)(1)(ii)(G)(2). The work experience

must involve—

(i) Ordering, receiving, and unpacking

radioactive materials safely and performing

the related radiation surveys;

(ii) Calibrating instruments used to

determine the activity of dosages and

performing checks for proper operation for

survey meters;

(iii) Calculating, measuring, and safely

preparing patient or human research subject

dosages;

(iv) Using administrative controls to

prevent a medical event involving the use of

byproduct material;

(v) Using procedures to contain spilled

byproduct material safely and using proper

decontamination procedures; and

(vi) Administering dosages to patients or

human research subjects, that includes at

least 3 cases involving the oral

administration of greater than 1.22

Gigabecquerels (33 millicuries) of sodium

iodide I-131; and

Federal Register / Vol. 65, No. 213 / Thursday, November 2, 2000 / Proposed Rules 65797

(3) Has obtained written certification that

the individual has satisfactorily completed

the requirements in paragraphs (c)(1) and

(c)(2) of this section and has achieved a level

of competency sufficient to function

independently as an authorized user for

medical uses authorized under § 35.300. The

written certification must be signed by a

preceptor authorized user who meets the

requirements in § 35.390(a), § 35.390(b), or

equivalent Agreement State requirements. A

preceptor authorized user, who meets the

requirements in § 35.390(b), must have

experience in administering dosages as

specified in § 35.390(b)(1)(ii)(G)(2).

Section 35.490 Training for use of manual

brachytherapy sources

Except as provided in § 35.57, the licensee

shall require an authorized user of a manual

brachytherapy source for the uses authorized

under § 35.400 to be a physician who—

(a) Is certified by a medical specialty board

whose certification process includes all of

the requirements in paragraph (b) of this

section and whose certification has been

recognized by the Commission or an

Agreement State; or

(b)(1) Has completed a structured

educational program in basic radionuclide

handling techniques applicable to the use of

manual brachytherapy sources that

includes—

(i) 200 hours of classroom and laboratory

training in the following areas—

(A) Radiation physics and instrumentation;

(B) Radiation protection;

(C) Mathematics pertaining to the use and

measurement of radioactivity; and

(D) Radiation biology; and

(ii) 500 hours of work experience, under

the supervision of an authorized user who

meets the requirements in § 35.490 or

equivalent Agreement State requirements at a

medical institution, involving—

(A) Ordering, receiving, and unpacking

radioactive materials safely and performing

the related radiation surveys;

(B) Checking survey meters for proper

operation;

(C) Preparing, implanting, and removing

brachytherapy sources;

(D) Maintaining running inventories of

material on hand;

(E) Using administrative controls to

prevent a medical event involving the use of

byproduct material;

(F) Using emergency procedures to control

byproduct material; and

(2) Has obtained 3 years of supervised

clinical experience in radiation oncology,

under an authorized user who meets the

requirements in § 35.490 or equivalent

Agreement State requirements, as part of a

formal training program approved by the

Residency Review Committee for Radiation

Oncology of the Accreditation Council for

Graduate Medical Education or the

Committee on Postdoctoral Training of the

American Osteopathic Association. This

experience may be obtained concurrently

with the supervised work experience

required by paragraph (b)(1)(ii) of this

section; and

(3) Has obtained written certification,

signed by a preceptor authorized user who

meets the requirements in § 35.490 or

equivalent Agreement State requirements,

that the individual has satisfactorily

completed the requirements in paragraphs

(b)(1) and (b)(2) of this section and has

achieved a level of competency sufficient to

function independently as an authorized user

of manual brachytherapy sources for the

medical uses authorized under § 35.400.

Section 35.491 Training for ophthalmic use

of strontium-90

Except as provided in § 35.57, the licensee

shall require the authorized user of

strontium-90 for ophthalmic radiotherapy to

be a physician who—

(a) Is an authorized user under § 35.490 or

equivalent Agreement State requirements; or

(b)(1) Has completed 24 hours of classroom

and laboratory training applicable to the

medical use of strontium-90 for ophthalmic

radiotherapy; the training must include—

(i) Radiation physics and instrumentation;

(ii) Radiation protection;

(iii) Mathematics pertaining to the use and

measurement of radioactivity; and

(iv) Radiation biology; and

(2) Supervised clinical training in

ophthalmic radiotherapy under the

supervision of an authorized user at a

medical institution that includes the use of

strontium-90 for the ophthalmic treatment of

five individuals. This supervised clinical

training must involve—

(i) Examination of each individual to be

treated;

(ii) Calculation of the dose to be

administered;

(iii) Administration of the dose; and

(iv) Follow up and review of each

individual’s case history; and

(3) Has obtained written certification,

signed by a preceptor authorized user who

meets the requirements in § 35.490, § 35.491,

or equivalent Agreement State requirements,

that the individual has satisfactorily

completed the requirements in paragraphs (a)

and (b) of this section and has achieved a

level of competency sufficient to function

independently as an authorized user of

strontium-90 for ophthalmic use.

Section 35.590 Training for use of sealed

sources for diagnosis

Except as provided in § 35.57, the licensee

shall require the authorized user of a

diagnostic sealed source for use in a device

authorized under § 35.500 to be a physician,

dentist, or podiatrist who—

(a) Is certified by a specialty board whose

certification process includes all of the

requirements in paragraph (b) of this section

and whose certification has been recognized

by the Commission or an Agreement State; or

(b) Has had 8 hours of classroom and

laboratory training in basic radionuclide

handling techniques specifically applicable

to the use of the device; the training must

include—

(1) Radiation physics and instrumentation;

(2) Radiation protection;

(3) Mathematics pertaining to the use and

measurement of radioactivity;

(4) Radiation biology; and

(5) Training in the use of the device for the

uses requested.

Section 35.690 Training for use of remote

afterloader units, teletherapy units, and

gamma stereotactic radiosurgery units

Except as provided in § 35.57, the licensee

shall require an authorized user of a sealed

source for a use authorized under § 35.600 to

be a physician who—

(a) Is certified by a medical specialty board

whose certification process includes all of

the requirements in paragraph (b) of this

section and whose certification has been

recognized by the Commission or an

Agreement State; or

(b)(1) Has completed a structured

educational program in basic radionuclide

techniques applicable to the use of a sealed

source in a therapeutic medical unit that

includes—

(i) 200 hours of classroom and laboratory

training in the following areas—

(A) Radiation physics and instrumentation;

(B) Radiation protection;

(C) Mathematics pertaining to the use and

measurement of radioactivity; and

(D) Radiation biology; and

(ii) 500 hours of work experience, under

the supervision of an authorized user who

meets the requirements in § 35.690 or

equivalent Agreement State requirements at a

medical institution, involving—

(A) Reviewing full calibration

measurements and periodic spot-checks;

(B) Preparing treatment plans and

calculating treatment doses and times;

(C) Using administrative controls to

prevent a medical event involving the use of

byproduct material;

(D) Implementing emergency procedures to

be followed in the event of the abnormal

operation of the medical unit or console;

(E) Checking and using survey meters; and

(F) Selecting the proper dose and how it is

to be administered; and

(2) Has completed 3 years of supervised

clinical experience in radiation oncology,

under an authorized user who meets the

requirements in § 35.690 or equivalent

Agreement State requirements, as part of a

formal training program approved by the

Residency Review Committee for Radiation

Oncology of the Accreditation Council for

Graduate Medical Education or the

Committee on Postdoctoral Training of the

American Osteopathic Association. This

experience may be obtained concurrently

with the supervised work experience

required by paragraph (b)(1)(ii) of this

section; and

(3) Has obtained written certification that

the individual has satisfactorily completed

the requirements in paragraphs (b)(1) and

(b)(2) of this section and has achieved a level

of competency sufficient to function

independently as an authorized user of each

type of therapeutic medical unit for which

the individual is requesting authorized user

status. The written certification must be

signed by a preceptor authorized user who

meets the requirements in § 35.690 or

equivalent Agreement State requirements for

an authorized user for each type of

therapeutic medical unit for which the

individual is requesting authorized user

status.

Dated at Rockville, Maryland this 20th day

of October, 2000.

65798 Federal Register / Vol. 65, No. 213 / Thursday, November 2, 2000 / Proposed Rules

For the Nuclear Regulatory Commission.

Josephine M. Piccone,

Acting Director, Division of Industrial and

Medical Nuclear Safety, NMSS.

[FR Doc. 00–27940 Filed 11–1–00; 8:45 am]

BILLING CODE 7590–01–P

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. 99–CE–77–AD]

RIN 2120–AA64

Airworthiness Directives; Pilatus

Aircraft LTD Model PC–6 Airplanes

AGENCY: Federal Aviation

Administration, DOT.

ACTION: Notice of proposed rulemaking

(NPRM).

SUMMARY: This document proposes to

adopt a new airworthiness directive

(AD) that would apply to all Pilatus

Aircraft LTD (Pilatus) Model PC–6

airplanes that are equipped with a

certain stabilizer trim actuator. The

proposed AD would require you to

inspect the lower lug of the actuator for

cracks, damage, or distortion; verify that

the staked bearing is correctly installed

in the bore of the lug; and repair any

cracked, damaged, or distorted parts and

reassemble any incorrectly installed

staked bearing, as necessary. The

proposed AD is the result of mandatory

continuing airworthiness information

(MCAI) issued by the airworthiness

authority for Switzerland. The actions

specified by the proposed AD are

intended to detect and correct damage,

distortion, or cracks in the lower lug

assembly, which could result in failure

of the lower lug. Such failure could lead

to loss of the stabilizer trim actuator

with consequent loss of control of the

airplane.

DATES: The Federal Aviation

Administration (FAA) must receive any

comments on this proposed rule on or

before December 8, 2000.

ADDRESSES: Submit comments in

triplicate to FAA, Central Region, Office

of the Regional Counsel, Attention:

Rules Docket No. 99–CE–77–AD, 901

Locust, Room 506, Kansas City,

Missouri 64106. Comments may be

inspected at this location between 8

a.m. and 4 p.m., Monday through

Friday, holidays excepted.

Service information that applies to the

proposed AD may be obtained from

Pilatus Aircraft Ltd., Customer Liaison

Manager, CH–6371 Stans, Switzerland;

telephone: +41 41 619 65 09; facsimile:

+41 41 610 33 51. This information also

may be examined at the Rules Docket at

the address above.

FOR FURTHER INFORMATION CONTACT:

Roman T. Gabrys, Aerospace Engineer,

FAA, Small Airplane Directorate, 901

Locust, Room 301, Kansas City,

Missouri 64106; telephone: (816) 329–

4141; facsimile: (816) 329–4090.

SUPPLEMENTARY INFORMATION:

Comments Invited

How Do I Comment on the Proposed

AD?

The FAA invites comments on this

proposed rule. You may submit

whatever written data, views, or

arguments you choose. You need to

include the rule’s docket number and

submit your comments in triplicate to

the address specified under the caption

ADDRESSES. The FAA will consider all

comments received on or before the

closing date. We may amend the

proposed rule in light of comments

received. Factual information that

supports your ideas and suggestions is

extremely helpful in evaluating the

effectiveness of the proposed AD action

and determining whether we need to

take additional rulemaking action.

Are There Any Specific Portions of the

Proposed AD I Should Pay Attention

To?

The FAA specifically invites

comments on the overall regulatory,

economic, environmental, and energy

aspects of the proposed rule that might

suggest a need to modify the rule. You

may examine all comments we receive

before and after the closing date of the

rule in the Rules Docket. We will file a

report in the Rules Docket that

summarizes each FAA contact with the

public that concerns the substantive

parts of the proposed AD.

We are re-examining the writing style

we currently use in regulatory

documents, in response to the

Presidential memorandum of June 1,

1998. That memorandum requires

federal agencies to communicate more

clearly with the public. We are

interested in your comments on whether

the style of this document is clearer, and

any other suggestions you might have to

improve the clarity of FAA

communications that affect you. You

can get more information about the

Presidential memorandum and the plain

language initiative at http://

www.plainlanguage.gov. 

How Can I Be Sure FAA Receives My

Comment?

If you want us to acknowledge the

receipt of your comments, you must

include a self-addressed, stamped

postcard. On the postcard, write

‘‘Comments to Docket No. 99–CE–77–

AD.’’ We will date stamp and mail the

postcard back to you.

Discussion

What Events Have Caused This

Proposed AD?

The Federal Office for Civil Aviation

(FOCA), which is the airworthiness

authority for Switzerland, recently

notified the FAA that an unsafe

condition may exist on all Pilatus Model

PC–6 airplanes that are equipped with

a stabilizer trim actuator, part number

(P/N) 978.73.18.101, 978.73.18.102, or

978.73.18.103 (Electomech P/N EM–

483–1, 483–2, or 483–3). The FOCA

reports an incident of a cracked,

damaged, and distorted lower lug of the

horizontal stabilizer trim actuator.

Analysis of this incident reveals that the

staked bearing was loose, which caused

excessive wear and failure of the

actuator lower lug.

What Are the Consequences If the

Condition Is Not Corrected?

Damage, distortion, or cracks in the

lower lug assembly, if not detected and

corrected, could result in failure of this

part. Such failure could lead to loss of

the stabilizer trim actuator with

consequent loss of control of the

airplane.

Is There Service Information That

Applies to This Subject?

Pilatus has issued Service Bulletin

No. 178, dated September 29, 1999.

What Are the Provisions of This Service

Bulletin?

The service bulletin:

—includes procedures for inspecting the

lower lug of the actuator for cracks,

damage, or distortion, and assuring

that the staked bearing is correctly

installed in the bore of the lug; and

—specifies repairing any cracked,

damaged, or distorted parts, as

necessary, and reassembling any

incorrectly installed staked bearing.

What Action Did the FOCA Take?

The FOCA classified this service

bulletin as mandatory and issued Swiss

AD HB 99–507, dated October 1, 1999,

in order to assure the continued

airworthiness of these airplanes in

Switzerland.