63634 Federal Register / Vol. 62, No. 231 / Tuesday, December 2, 1997 / Rules and Regulations

SUPPLEMENTARY INFORMATION:

Background

The final rule that is the subject of

this correction was intended to provide

policy changes to better meet the needs

of the insured, include the current fresh

market tomato (dollar plan)

endorsement under the Common Crop

Insurance Policy for ease of use and

consistency of terms, and to restrict the

effect of the current fresh market tomato

(dollar plan) endorsement to the 1997

and prior crop years.

Need for Correction

As published, the final regulation

contained a technical error which may

prove to be misleading and is in need

of clarification.

Correction of Publication

Accordingly, the publication on

March 28, 1997, of the final regulation

at 62 FR 14775–14780 is corrected as

follows:

PART 457—[CORRECTED]

§ 457.139 [Corrected]

On page 14780, in the first column, in

§ 457.139, the paragraph following

section 14(b)(4)(ii)(B) is corrected to

read:

‘‘(5) Multiplying the result of section

14(b)(4) by your share.’’

Signed in Washington D.C. on November

25, 1997.

Kenneth D. Ackerman,

Manager, Federal Crop Insurance

Corporation.

[FR Doc. 97–31545 Filed 12–1–97; 8:45 am]

BILLING CODE 3410–08–P

NUCLEAR REGULATORY

COMMISSION

10 CFR Parts 30 and 32

RIN 3150–AF70

Exempt Distribution of a Radioactive

Drug Containing One Microcurie of

Carbon-14 Urea

AGENCY: Nuclear Regulatory

Commission.

ACTION: Final rule.

SUMMARY: The Nuclear Regulatory

Commission (NRC) is amending its

regulations to permit NRC licensees to

distribute a radioactive drug containing

one microcurie of carbon-14 urea to any

person for ‘‘in vivo’’ diagnostic use. The

NRC has determined that the radioactive

component of such a drug in capsule

form presents an insignificant radiation

risk and, therefore, regulatory control of

the drug for radiation safety is not

necessary. This amendment makes the

drug more widely available and reduces

costs to patients, insurers, and the

health care industry. This action grants

a petition for rulemaking (PRM–35–12)

from Tri-Med Specialties, Inc. and

completes action on the petition.

EFFECTIVE DATE: January 2, 1998.

ADDRESS: Copies of the public record,

including the final regulatory analysis

and any public comments received on

the proposed rule, may be examined

and copied for a fee in the

Commission’s Public Document Room

at 2120 L Street, NW. (Lower Level),

Washington, DC.

FOR FURTHER INFORMATION CONTACT: Dr.

Anthony N. Tse, Office of Nuclear

Regulatory Research, U.S. Nuclear

Regulatory Commission, Washington,

DC 20555–0001, telephone (301) 415–

6233 or e-mail at ANT@nrc.gov.

SUPPLEMENTARY INFORMATION:

I. The Petition for Rulemaking.

II. Proposed Rule, Public Comments, and

NRC Responses.

III. Summary of the Final Amendments.

IV. Description of the Final Amendments.

V. Agreement State Compatibility.

VI. Finding of No Significant Environmental

Impact: Availability.

VII. Paperwork Reduction Act Statement.

VIII. Regulatory Analysis.

IX. Regulatory Flexibility Certification.

X. Small Business Regulatory Enforcement

Fairness Act.

XI. Backfit Analysis.

List of Subjects

I. The Petition for Rulemaking

On October 6, 1994, the Commission

docketed a petition for rulemaking

(Docket No. PRM–35–12) from Tri-Med

Specialties, Inc (Tri-Med). In a letter

dated August 23, 1994, Tri-Med

petitioned the NRC to amend its

regulations ‘‘to allow for the general

licensing and/or exemption for the

commercial distribution by licensed

pharmaceutical manufacturers of a

capsule containing one micro-Curie

(μCi) of C–14-urea for in vivo diagnostic

testing.’’ The purpose of this diagnostic

test is to detect the presence of the

bacterium Helicobacter pylori (H.

pylori), a cause of peptic ulcers in

humans.

Following the receipt of the petition,

the NRC published for public comment

a notice of receipt of petition for

rulemaking in the Federal Register on

December 2, 1994 (59 FR 61831). The

comment period closed on February 15,

1995. The NRC received 315 public

comment letters, of which 313

supported the petition (they were

mostly form letters) and 2 letters

opposed the petition.

II. Proposed Rule, Public Comments,

and NRC Responses

A proposed rule was published on

June 16, 1997 (62 FR 32552) that would

permit NRC licensees to distribute

capsules containing one microcurie

C–14 urea to any person for ‘‘in vivo’’

diagnostic use. The public comment

period closed on July 16, 1997.

In the preamble of the proposed rule,

the NRC stated that, because the

capsules present an insignificant

radiological risk to the public and the

environment, the NRC believes the

capsules could be distributed for ‘‘in

vivo’’ diagnostic use to persons exempt

from licensing.

This change makes the drug more

widely available and reduces costs to

patients, insurers, and the health care

industry.

The NRC received seven public

comment letters on the proposed rule:

three from industry, three from State

agencies, and one from a physician

associated with a university medical

facility. Four commenters supported the

rule, one opposed the rule, and two

provided comments but did not

explicitly state whether they supported

or opposed the rule. Public comments

and NRC’s responses are presented

below.

Comment 1: Under the proposed

distribution, the NRC should not be

forbidding research use of this drug by

the same physicians who may use it

clinically. Research use also should be

permitted under this exemption because

the radiological risk for using C–14

capsules is insignificant.

Response: The NRC did not change

the final rule in response to this

comment. A common rule entitled

‘‘Federal Policy for the Protection of

Human Subjects; Notices and Rules’’

was promulgated by 16 Federal agencies

on June 18, 1991 (56 FR 28002) and was

intended to ensure the protection of

human research subjects. This rule was

adopted to implement a

recommendation of the President’s

Commission for the Study of Ethical

Problems in Medicine and Biomedical

and Behavioral Research which was

established on November 9, 1978, by

Public Law 95–622. The Federal Policy

requires that Federal agencies that

conduct, fund, support, or regulate

research involving human subjects

ensure adequate protection of the rights

of the human subjects. The Federal

policy represents a societal

determination that any research

(including research involving

radioactive material) must provide for
Federal Register / Vol. 62, No. 231 / Tuesday, December 2, 1997 / Rules and Regulations 63635

the following minimal protections for

the human subjects: (1) that the research

is approved by an Institutional Review

Board (IRB) and (2) that the human

subject gives informed consent to

participate in the research. Further,

these protections must be provided

regardless of whether or not there is any

risk of consequences (including

radiological consequences). This view is

supported by the fact that during the

public comment period of the common

rule, a commenter suggested that all

minimal risk research be exempt from

the regulations; however, the final rule

did not adopt this comment.

NRC did not participate in the

promulgation of the common rule.

Subsequently, the NRC adopted 10 CFR

35.6 that requires a licensee who

conducts research involving human

subjects using byproduct material to

obtain informed consent from the

human subjects and obtain prior

approval by an IRB. Although the NRC

did not adopt the common rule, the

intention is to follow the essential

requirements of the common rule.

Because the common rule does not

provide an exemption for research

involving minimal risk, the Commission

has determined that such research use

should not be exempt from 10 CFR 35.6.

Comment 2: Two commenters

expressed concerns that the proposed

rule language, ‘‘not exceeding one

microcurie,’’ appeared to indicate that

the upper limit of the radioactivity in a

capsule is exactly one microcurie of

C–14. Both stated that it is not possible

to make the capsules to exactly one

microcurie because of statistical

deviations during the manufacturing

process.

Response: The NRC agrees with the

commenters. The proposed rule did not

intend to limit the radioactivity of C–14

to exactly one microcurie. The final rule

language has been modified to read

‘‘capsules containing one microcurie

C–14 urea (allowing for nominal

variation that may occur during the

manufacturing process).’’

Comment 3: One commenter stated

that, when the total amount of energy

released from complete decay of a

radionuclide is considered, one

microcurie of C–14 has the largest

energy release, because of its long halflife, when compared to one microcurie

of Tc–99m or I–131. The commenter

concluded that, given the insignificant

radiation risk from the diagnostic use of

C–14 urea, the radiation risk from the

diagnostic use of Tc–99m or I–131 also

would be insignificant.

Response: In comparing the hazard

significance of the one microcurie C–14

Urea diagnostic test to the extensive use

of Tc–99m and I–131, the NRC did not

evaluate the dose to the patient because

this dose would be justified for medical

reasons. Justification for retaining some

licensing control on the medical use of

Tc–99m and I–131 while exempting the

one microcurie carbon-14 urea capsules

relies on the relative occupational

hazards to technicians and physicians

administering the radiopharmaceuticals.

Administering an encapsulated

dosage of one microcurie C–14 involves

virtually no occupational dose due to

the low energy beta radiation and

minimal possibility for contamination of

personnel or facilities. On the other

hand dosages of Tc–99m and I–131

entail extracting 10s to 100s of

millicurie amounts, often in liquid form,

from shielded sources of even higher

activity. The possibility of direct

exposure to gamma radiation and the

possibility of contamination requires

that radiation protection measures be in

place to maintain exposure to staff as

low as is reasonably achievable.

Tc–99m and I–131, having relatively

short half-lives, present minimal

environmental hazard. C–14 as urea is

excreted from the patient as carbon

dioxide (CO2) which diffuses into the

atmosphere. Based on a calculation

found in the regulatory analysis for this

rule, the current world inventory of

naturally occurring C–14 results in an

average dose to members of the public

of about 1.25 mrem/yr. A release of 0.6

curies of C–14 from the 600,000 tests

expected to be administered annually,

would result in an additional average

annual dose of 2×10¥7 mrem.

Comparing this estimate to the EPA

Clean Air Act reporting level of 1 mrem/

year, this new test is environmentally

insignificant.

Comment 4: Because of the small

quantity of radioactive material in C–14

capsules, this product may be disposed

of in the general trash. To avoid

unnecessary concern for health risks in

the disposal of the product, labels

should contain a statement that the

product may be disposed of in the

general trash.

Response: In the final rule, the label

requirements include a statement that

the product may be disposed of in

ordinary trash.

Comment 5: The Commenter agrees

that the widespread use of this product

will require uniform regulations and

that Agreement States will need to make

appropriate regulatory provisions to

enable persons to receive the drug for

‘‘in vivo’’ diagnostic use. To avoid

confusing licensees and users, these

changes to NRC and Agreement State

regulations should be made

simultaneously. The commenter urges

that the NRC take action to expedite the

Agreement State regulatory changes.

Response: The NRC has urged the

Agreement States to adopt compatible

changes in their regulations

expeditiously. However, under NRC’s

Adequacy and Compatibility Policy,

Agreement States have up to three years

to change their regulations for

amendments or program requirements

that are items of compatibility.

Comment 6: The NRC should address

this rule in its ongoing effort to revise

10 CFR Part 35 in its entirety. The

commenter believes that (1) this rule

represents a piecemeal effort to respond

to a narrow issue and (2) the issue of

reduced regulation for medical use of C–

14 capsules is applicable to the same

extent for virtually the entire range of

diagnostic radioisotopes.

Response: If this rule is combined

with the overall 10 CFR part 35 revision,

the C–14 capsules would only be

available to authorized user physicians

during the revision period. Thus, the

NRC decided to proceed with this rule

now because the benefits of making this

capsule available to anyone, including

primary-care physicians, outweigh the

benefits of addressing this issue in the

overall revision of 10 CFR part 35.

Comment 7: An appropriate function

of the regulatory regime is to assure that

personnel handling and administering

radioactive drugs meet certain basic

training and qualification requirements.

The proposed exemption would impose

no training or qualification

requirements on users.

Response: The amount of radiation

safety training needed for personnel

depends on the level of radiation risk

associated with the radioactive drug.

Because C–14 capsules present

insignificant radiation risk, radiation

safety training for personnel handling

and administering the capsule is not

necessary, and thus, not required.

Comment 8: If the NRC promulgates

the proposed rule in its present form,

the exemption will divest the

Agreement States of any authority to

regulate this product under a general or

specific license. Had the NRC instead

simply proposed a general license,

Agreement State agencies would retain

the authority to adopt the general

license or continue to require specific

licensing.

Response: In the draft rulemaking

plan, the NRC suggested using the

general license approach. The NRC

received nine comment letters from

Agreement States on the draft

rulemaking plan; three suggested that an

exemption approach would be more

appropriate because it would be less

costly to the Agreement States and their
63636 Federal Register / Vol. 62, No. 231 / Tuesday, December 2, 1997 / Rules and Regulations

licensees than the general license

approach.

Based on these comments, the NRC

chose the exemption approach in the

final rule plan as more cost-effective

than a general license approach. The

final rulemaking plan was revised

accordingly and was provided to the

Agreement States. No Agreement States

expressed opposition to the NRC on the

exemption approach.

Among the seven public comment

letters received on the proposed rule,

two were from Agreement States and

one from a non Agreement State. All

three supported the proposed rule.

Comment 9: The environmental

assessment fails to consider the fact that

another equally noninvasive, but

nonradiological, diagnostic procedure

(such as C–13 test) is available and

provides a comparable alternative to the

C–14 test. The apparent assumption

underlying the environmental

assessment is that in the absence of the

C–14 test, the only alternative for the

detection of H. pylori is invasive

gastroendoscopy.

Response: Because the C–14 urea

capsules are already available to

authorized user physicians, the only

regulatory issue in this rulemaking is

whether the C–14 method should be

made available to individuals who are

not authorized users. The purpose of the

environmental assessment is to consider

and document whether the subject rule

is expected to have any significant

impact to the environment. In this

environment assessment, the NRC has

determined that the environmental

impact is expected to be insignificant

because of the extremely low

radiological hazards associated with the

use of capsules containing one

microcurie C–14 urea. The presence of

an additional non-invasive alternative

procedure does not affect NRC’s

determination of no significant

environmental impact.

Comment 10: NRC’s policy in the past

has been not to exempt byproduct

material that is ingested. Any change in

this policy would be a significant

departure from existing NRC

regulations.

Response: This change is a departure

from existing NRC regulations. In the

statement of consideration for the

proposed rule, under the heading

‘‘Current NRC Regulations on

Exemptions From Licensing,’’ the NRC

stated that, although two broad material

exemptions (§ 30.14, ‘‘Exempt

concentrations,’’ and § 30.18, ‘‘Exempt

quantities’’) exclude the transfer of

byproduct material contained in any

product designed for ingestion or

inhalation by a human being, the C–14

capsules manufactured or prepared as a

radioactive drug can be distributed to

persons exempt from licensing for ‘‘in

vivo’’ diagnostic use because the

capsules present an insignificant

radiological risk to the public and the

environment. This exemption only

applies to the diagnostic use of capsules

containing one microcurie C–14

manufactured or prepared as a

radioactive drug to make a clear

distinction between this radioactive

drug that is intended for ingestion by

humans and other uses of C–14 urea and

byproduct material distributed under

§§ 30.14 and 30.18.

Comment 11: The ACMUI’s (Advisory

Committee on Medical Uses of

Radioisotopes) conclusions that either

an exemption or general license is

appropriate for the C–14 product do not

address the fundamental aspects of

nuclear safety. Its judgment was based

partially on the assumptions: (1) the

product may only be dispensed by

prescription, (2) the product is approved

by the Food and Drug Administration,

and (3) the office/facility using the

product will be subject to Clinical

Laboratory Improvement Amendment

(CLIA) regulation.

Response: The transcript from the

ACMUI meeting shows the Committee

did include radiation safety in its

considerations and did not consider it to

be an issue. Further, as stated in the

supplemental material supporting the

proposed rule, there are no nuclear

safety issues associated with the use of

the C–14 capsules for clinical diagnostic

testing. Therefore, use of either an

exemption or general license is

appropriate.

Comment 12: The exemption

approach does not provide the NRC

with flexibility to impose a limitation

on the amount of C–14 capsules any

physician can possess in an office. In

the event there is a recall of the product,

or a large amount of product becomes

unusable, the NRC will have no control

over the disposal of the product.

Response: It is not necessary to

impose a possession limit on the

amount of C–14 capsules because the

radiation risk is insignificant. The

earth’s atmosphere contains an

inventory of naturally occurring C–14 of

about 3.8 million curies which is in

addition to the huge inventory of about

240 million curies in the world’s

oceans. The small amount of C–14

released into the atmosphere from the

use of this test would mix with the

global inventory and would have no

impact on public health. The current

world inventory of naturally occurring

C–14 results in an average dose to the

public of about 1.25 mrem per year, and

the release of 0.6 curies of C–14 from

the total of 600,000 tests assumed to be

administered annually would result in

an additional average annual dose of

2 × 10¥7 mrem. In the event that a recall

is necessary, the manufacturer may use

the same process for recalling any other

non-radioactive drugs. If C–14 urea

capsules are returned to the

manufacturers, they will be disposed of

in accordance with the manufacturer’s

possession license. A user, however, can

dispose the C–14 urea capsules as

ordinary trash. Medical users of the C–

14 urea test would be unlikely to

acquire significant quantities of

capsules because they can be ordered

within a few days. Thus, even under a

recall, the impact of disposing of C–14

urea capsules into landfills by the user

would also be insignificant.

Comment 13: It is essential that end

users be adequately informed of the

product’s radioactive characteristics, so

that some form of storage, use, and

disposal precautions can be followed.

Thus, the labeling must be

conspicuously and prominently placed.

The commenter suggested the following:

(1) the phrase ‘‘conspicuously and

prominently’’ in front of the proposed

labeling ‘‘bears the words Radioactive

Material’’ should be added, and (2) the

NRC should require that the radioactive

material legend, ‘‘Radioactive Material,’’

be included on promotional brochures.

Response: Because the radiation risk

from C–14 capsules is insignificant,

regulatory control of the use, storage,

and disposal of the drug for purpose of

radiation safety is not necessary. In fact,

the label accompanying C–14 capsules

is required to indicate that the capsules

may be disposed of by users as ordinary

trash. Paragraph(a)(6) of § 32.21 requires

that applicants submit copies of

prototype labels and brochures for NRC

approval. The NRC will ensure that the

labels meet the requirements of § 32.21a

before they are approved. Since

paragraph (a) of § 32.21a specifies that

the label must be durable and legible,

the use of an additional phrase such as

‘‘conspicuously and prominently’’ is

unnecessary. Promotional brochures are

for information only; manufacturers are

not required to indicate on the

promotional brochures that C–14 is a

radioactive material.

III. Summary of the Final Amendments

Final Amendment to 10 CFR Part 32

The regulations in 10 CFR part 32 are

amended to add new §§ 32.21 and

32.21a, to provide requirements for a

specific license to manufacture, prepare,

process, produce, package, repackage, or

transfer for commercial distribution,
Federal Register / Vol. 62, No. 231 / Tuesday, December 2, 1997 / Rules and Regulations 63637

capsules containing one microcurie of

C–14 urea, as a radioactive drug, to be

distributed to any person for ‘‘in vivo’’

diagnostic use. These requirements are

consistent with the existing

requirements on other items under the

heading ‘‘Exemptions’’ in 10 CFR part

30. The amendment includes a reminder

that licensees distributing the

radioactive drug to persons exempt from

licensing would not be relieved from

other applicable Federal (e.g., FDA) or

State requirements governing the

manufacture and distribution of drugs.

The amendment requires that the

manufacture or preparation of capsules

containing one microcurie of C–14 urea

be prepared by persons who meet the

current NRC regulations to manufacture

and commercially distribute radioactive

drugs. The NRC believes regulatory

control is needed to provide high

confidence that the drug contains one

microcurie of C–14 urea and does not

contain any other radioactive

contaminants.

Final Amendment to 10 CFR Part 30

The NRC has determined that the

drug in capsule form presents an

insignificant radiological safety and

environmental risk, and that it is not

necessary to regulate the use of this drug

for its radioactive component.

Therefore, the NRC can not justify

requiring physicians, or any other

person, to meet NRC training and

experience criteria directed at the safe

use of radioactive drugs, or to become

an ‘‘authorized user.’’ Hence, the

capsules can be distributed to any

person. However, other Federal or State

agencies may limit the receipt and use

of the capsules in accordance with their

own requirements.

The regulations in 10 CFR part 30 are

amended to add a new § 30.21, to permit

any person to receive, possess, use,

transfer, own, or acquire for ‘‘in vivo’’

diagnostic use, capsules containing one

microcurie of C–14 urea without a

license. The final regulation includes a

reminder that persons receiving the

capsules would not be relieved from

other Federal or State law governing

drugs. Further, in accordance with the

NRC’s provisions for research involving

human subjects (10 CFR 35.6), the

exemption permitting receipt and use of

the capsules for ‘‘in vivo’’ diagnostic use

does not extend to use of the capsules

for research involving human subjects.

Any person desiring to use the capsules

for human research would still be

required to submit an application for a

specific license under part 35. The

phrase ‘‘in vivo diagnostic use’’ was

selected to describe the activity

authorized in § 30.21 to differentiate it

from the term ‘‘medical use’’ because:

(1) ‘‘Medical use’’ limits

administration to authorized users; use

of this drug would not be so limited;

and

(2) ‘‘Medical use’’ includes the

administration of the drug to a human

research subject, which would continue

to require a specific license pursuant to

part 35 under this rulemaking.

Effects of the Final Amendments

The final amendments make the drug

available to any person, for ‘‘in vivo’’

diagnostic use, without need for an NRC

or Agreement State license. Because the

receipt and use of the drug are exempt

from NRC licensing, Agreement States

need to make appropriate provisions in

their regulations to recognize the

exempt distribution of the drug, for ‘‘in

vivo’’ diagnostic use. Thus after the

manufacture and distribution of the

drug, the NRC and the Agreement States

will not regulate the use of the drug as

long as its use is for ‘‘in vivo’’ diagnostic

use. This means that, under NRC and

Agreement State regulations, primarycare physicians do not need to be

‘‘authorized users’’ in order to

administer the drug, and do not need to

refer their patients to nuclear medicine

physicians. This should result in cost

savings to patients. Other Federal and

State organizations with responsibilities

for regulating drugs will determine and

regulate who can receive and use the

drug for ‘‘in vivo’’ diagnostic use. NRC

will continue to regulate the use of the

drug for research involving human

subjects under a specific part 35 license.

IV. Description of the Final

Amendments

The final amendments are the same as

the proposed amendments except for

two minor changes. Public comments

suggested that the phrase ‘‘carbon-14

urea capsules not exceeding one

microcurie’’ used in the proposed rule

may be interpreted as an exact limit of

one microcurie per capsule (See

Comment 2 under the heading ‘‘Public

Comment and NRC Responses). The

final rule has been modified and the

phrase ‘‘capsules containing one

microcurie carbon-14 urea (allowing for

nominal variation that may occur during

the manufacturing process)’’ is used.

Another public comment suggested that

labels should contain a statement that

the product may be disposed of in the

general trash. In the final rule, the label

requirements include such a statement.

Manufacturer and Distributors

A new section is added to 10 CFR Part

32 to permit the distribution of the

capsules to persons who are exempt

from licensing.

Section 32.21 Radioactive Drug:

Manufacture, Preparation, or Transfer

for Commercial Distribution of Capsules

Containing one Microcurie Carbon-14

Urea Each for ‘‘in Vivo’’ Diagnostic use

for Humans to Persons Exempt From

Licensing; Requirements for a License

Paragraph (a)

This paragraph establishes the

requirements for approval of a license

application to manufacture, prepare,

process, produce, package, repackage, or

transfer for commercial distribution,

capsules containing one microcurie

carbon-14 urea each for ‘‘in vivo’’

diagnostic use, to persons exempt from

licensing.

Paragraph (a)(1)

This paragraph limits issuance of an

‘‘exempt distribution license’’ for

distribution of the capsules to persons

exempt from licensing to only those

who possess either a NRC or Agreement

State ‘‘specific license’’ for possession

and use of byproduct material.

Paragraph (a)(2)

To assure that the capsules contain

one microcurie of carbon-14 and present

no other radiological risks, this

paragraph requires that the persons

manufacturing and/or commercially

distributing the capsules for ‘‘in vivo’’

diagnostic use must also meet the

requirements of § 32.72(a)(2).

Specifically, these persons must be:

(1) Registered with or licensed by the

FDA as a drug manufacturer; or

(2) Registered with or licensed by a

state agency as a drug manufacturer; or

(3) Licensed as a pharmacy by a State

Board of Pharmacy; or

(4) Operating as a nuclear pharmacy

within a Federal medical institution.

Paragraph (a)(3)

This paragraph requires applicants to

provide evidence that each carbon-14

urea capsule contains one microcurie.

The NRC’s evaluation that the capsules

would result in insignificant radiation

risks was based on the capsules

containing one microcurie of carbon-14

urea. Therefore, applicants must

demonstrate that the activity of each

carbon-14 capsule contains one

microcurie, allowing for nominal

variation that may occur during the

manufacturing process.

Paragraph (a)(4)

This paragraph prohibits carbon-14

urea from being contained in any food,

beverage, cosmetic, drug or other

commodity designed for ingestion or
63638 Federal Register / Vol. 62, No. 231 / Tuesday, December 2, 1997 / Rules and Regulations

inhalation by, or topical application to,

a human being except for the capsules

as described in this section, because

exempt distribution of this drug has

only been evaluated for ‘‘in vivo’’

diagnostic use in the form of a capsule

containing one microcurie of carbon-14

urea. There is no prohibition against the

capsule being combined with food or

beverage at the time of administration so

that the capsule can be ingested by the

patient.

Paragraph (a)(5)

Because the exempt distribution of

this drug has only been evaluated for

‘‘in vivo’’ diagnostic use in the form of

a capsule containing one microcurie of

carbon-14 urea, this paragraph prohibits

incorporation of the capsules into any

manufactured or assembled commodity,

product, or device intended for

commercial distribution. Further,

although the drug is being distributed to

persons exempt from licensing, this

paragraph requires the carbon-14 urea to

be identified as radioactive because the

drug is being used for its radioactive

content; therefore, the end user must be

provided with information that the drug

contains a radioactive material.

Paragraph (a)(6)

As with any product approved for

distribution to persons exempt from

licensing, this paragraph requires

persons who apply for a license to

manufacture or commercially distribute

these capsules to submit copies of

prototype labels or brochures for NRC

approval. This will allow the NRC to

confirm that the labels or brochures

meet the requirements of § 32.21a (a)

and (b).

Paragraph (b)

This paragraph declares that the

regulations do not relieve licensees or

applicants from complying with

applicable FDA, other Federal, and State

requirements governing the manufacture

and distribution of drugs.

Section 32.21a Same: Conditions of

License

This section establishes the

conditions required for a licensee to

commercially distribute the capsules to

persons exempt from licensing.

Paragraph (a)

To inform the end user of the identity

of the radioisotope, the physical and

chemical form, and the dosage of

radioactivity, this paragraph establishes

that the immediate container of each

capsule or capsules must bear a durable,

legible label that:

(1) Identifies the radioisotope, the

physical and chemical form of the

radioisotope, the quantity of

radioactivity contained in each

container at a specific date; and

(2) Bears the words ‘‘Radioactive

Material.’’

The date requirement is consistent

with labeling requirements for other

radioactive drugs with a half life of

greater than 100 days.

Paragraph (b)

This paragraph establishes that,

consistent with the intended use of the

capsules, the label affixed to the

immediate container, or an

accompanying brochure, must:

(1) State that the contents are exempt

from NRC or Agreement State licensing

requirements;

(2) Bear the words ‘‘Radioactive

Material. For ‘‘In Vivo’’ Diagnostic Use

Only. This Material Is Not To Be Used

for Research Involving Human Subjects,

and Must Not Be Introduced into Foods,

Beverages, Cosmetics, or Other Drugs or

Medicinals, or into Products

Manufactured for Commercial

Distribution. This Product May Be

Disposed of in Ordinary Trash.’’

The intent of the requirement set out

in Paragraph (b)(2) is to make clear that

the capsule must remain in the form of

a capsule and is not to be combined

with one of the listed items such as food

or beverages which would result in a

radioactive product other than in the

form of a capsule for commercial

distribution. There is no prohibition

against the capsule being combined

with food or beverage at the time of

administration so that the capsule can

be ingested by the patient. This label

also informs the user that this product

may be disposed of in ordinary trash.

‘‘In Vivo’’ Diagnostic use by Persons

Exempt From Licensing

A new section is added to 10 CFR Part

30 to exempt any person from NRC or

the Agreement State regulations to

receive the drug for ‘‘in vivo’’ diagnostic

use for humans.

Section 30.21 Radioactive Drug:

Capsules Containing one Microcurie of

Carbon-14 Urea for ‘‘in Vivo’’ Diagnostic

use for Humans

Paragraph (a)

This paragraph provides an

exemption to any person from the

requirements for a license to receive,

possess, use, transfer, own, or acquire

capsules containing one microcurie of

carbon-14 urea for ‘‘in vivo’’ diagnostic

purposes. It should be noted that the

‘‘transfer’’ in this paragraph does not

include ‘‘transfer for commercial

distribution,’’ which is covered in

paragraph (c) of this section.

Paragraph (b)

This paragraph establishes that

persons who desire to use the drug for

research involving human subjects must

apply for and receive a specific part 35

license. Such a license would ensure the

protection of the rights of the human

subjects by requiring that the research

be approved by an IRB and that the

human subjects give their informed

consent to participate in the research.

Paragraph (c)

This paragraph specifies that a

specific license is needed to

manufacture, prepare, process, produce,

package, repackage or transfer such

capsules for commercial distribution.

Paragraph (d)

This paragraph declares that the

regulations do not relieve end users

from complying with applicable FDA,

other Federal, or State requirements

governing the receipt, administration,

and use of drugs.

V. Agreement State Compatibility

Under the Atomic Energy Act, certain

regulatory functions are reserved to the

NRC. Among these are the distribution

of products to persons exempt from

licensing, as discussed in 10 CFR part

150. Hence, amendments related to the

manufacture and commercial

distribution of the capsules (10 CFR part

32) is a Division 4 item of compatibility

(Category NRC under the new adequacy

and compatibility policy). However,

amendments related to possession and

use (10 CFR part 30) are a Division 1

item of compatibility (Category B under

the new adequacy and compatibility

policy) because of the need for

nationwide consistency in the use of

products which are widely distributed.

Therefore, the Agreement States will

need to make appropriate provisions in

their regulations to allow any person to

receive capsules containing one

microcurie of carbon-14 urea for ‘‘in

vivo’’ diagnostic use in humans without

need for a license.

VI. Finding of No Significant

Environmental Impact: Availability

The Commission has determined

under the National Environmental

Policy Act of 1969, as amended, and the

Commission’s regulations in Subpart A

of 10 CFR part 51, that the final rule is

not a major Federal action significantly

affecting the quality of the human

environment; therefore, an

environmental impact statement is not
Federal Register / Vol. 62, No. 231 / Tuesday, December 2, 1997 / Rules and Regulations 63639

required. The final rule establishes

requirements for the manufacture and

commercial distribution of carbon-14

urea capsules to persons exempt from

licensing and establishes regulations to

permit any person to receive the

capsules without an NRC license. The

Commission believes that the

radioactive component of this drug

presents an insignificant radiation risk

and, therefore, regulatory control of the

‘‘in vivo’’ diagnostic use of the capsules

for radiation safety is not necessary. It

is expected that this final rule will not

cause any significant increase in

radiation exposure to the public or

radiation release to the environment

beyond the exposures or releases

resulting from the use of the carbon-14

capsules under the current regulations.

Also, it is expected that there will be no

non-radiological impacts. One public

comment on the draft environmental

assessment has been received (See

Comment 9 under the heading

‘‘Proposed Rule, Public Comments, and

NRC Responses’’). The environmental assessment and

finding of no significant impact on

which this determination is based is

available for inspection at the NRC

Public Document Room, 2120 L Street

NW. (Lower Level), Washington, DC.

Single copies of the environmental

assessment and the finding of no

significant impact are available from Dr.

Anthony N. Tse, Office of Nuclear

Regulatory Research, U.S. Nuclear

Regulatory Commission, Washington,

DC 20555–0001, telephone (301) 415–

6233 or e-mail at ANT@nrc.gov.

VII. Paperwork Reduction Act

Statement

This final rule amends information

collection requirements that are subject

to the Paperwork Reduction Act of 1995

(44 U.S.C. 3501 et seq.). These

requirements were approved by the

Office of Management and Budget,

approval numbers 3150–0001, 3150–

0017, and 3150–0120.

The public reporting burden for this

collection of information is estimated to

average 16 hours per response,

including the time for reviewing

instructions, searching existing data

sources, gathering and maintaining the

data needed, and completing and

reviewing the collection of information.

Send comments on any aspect of this

collection of information, including

suggestions for reducing the burden, to

the Information and Records

Management Branch (T–6 F33), U.S.

Nuclear Regulatory Commission,

Washington, DC 20555–0001, or by

Internet electronic mail at

BJS1@NRC.GOV; and to the Desk

Officer, Office of Information and

Regulatory Affairs, NEOB–10202,

(3150–0001, 3150–0017, and 3150–

0120), Office of Management and

Budget, Washington, DC 20503.

Public Protection Notification

The NRC may not conduct or sponsor,

and a person is not required to respond

to, a collection of information unless it

displays a currently valid OMB control

number.

VIII. Regulatory Analysis

The NRC has prepared a regulatory

analysis for the final rule. The analysis

examines the benefits and impacts

considered by the NRC. No public

comments on the draft regulatory

analysis have been received during the

public comment period. The regulatory

analysis is available for inspection at the

NRC Public Document Room, 2120 L

Street NW. (Lower Level), Washington,

DC. Single copies of the regulatory

analysis are available from Dr. Anthony

N. Tse, Office of Nuclear Regulatory

Research, U.S. Nuclear Regulatory

Commission, Washington, DC 20555–

0001, telephone (301) 415–6233 or email at ANT@nrc.gov.

IX. Regulatory Flexibility Certification

As required by the Regulatory

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

the Commission certifies that this rule

does not have a significant economic

impact upon a substantial number of

small entities. The final rule permits

physicians and other health care

providers to use an additional

diagnostic test without having to obtain

an NRC license, thus, would provide

cost savings to patients, insurers, and

the health care industry. The final rule

does not impose any additional

obligations on entities that may fall

within the definition of ‘‘small entities’’

as set forth in Section 601(3) of the

Regulatory Flexibility Act; or within the

definition of ‘‘small business’’ as found

in Section 3 of the Small Business Act,

15 U.S.C. 632; or within the size

standards adopted by the NRC on April

11, 1995 (60 FR 18344).

X. Small Business Regulatory

Enforcement Fairness Act

In accordance with the Small

Business Regulatory Enforcement

Fairness Act of 1996, the NRC has

determined that this action is not ‘‘a

major’’ rule and has verified this

determination with the Office of

Information and Regulatory Affairs,

Office of Management and Budget.

XI. Backfit Analysis

The NRC has determined that the

backfit rule, 10 CFR 50.109, does not

apply to this rule, and therefore, a

backfit analysis is not required because

these amendments do not involve any

provisions that would impose backfits

as defined in 10 CFR 50.109(a)(1).

XII. List of Subjects

10 CFR Part 30

Byproduct material, Criminal

penalties, Government contracts,

Intergovernmental relations, Isotopes,

Nuclear materials, Radiation protection,

Reporting and record keeping

requirements.

10 CFR Part 32

Byproduct material, Criminal

penalties, Labeling, Nuclear materials,

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. 552 and 553,

the NRC is adopting the following

amendments to 10 CFR Parts 30 and 32.

PART 30—RULES OF GENERAL

APPLICABILITY TO DOMESTIC

LICENSING OF BYPRODUCT

MATERIAL

1. The authority citation for part 30

continues to read as follows:

Authority: Secs. 81, 82, 161, 182, 183, 186,

68 Stat. 935, 948, 953, 954, 955, as amended,

sec. 234, 83 Stat. 444, as amended (42 U.S.C.

2111, 2112, 2201, 2232, 2233, 2236, 2282);

secs. 201, as amended, 202, 206, 88 Stat.

1242, as amended, 1244, 1246 (42 U.S.C.

5841, 5842, 5846).

Section 30.7 also issued under Pub. L.

95–601, sec.10, 92 Stat. 2951 as

amended by Pub. L. 102–486, sec. 2902,

106 Stat. 3123, (42 U.S.C. 5851). Section

30.34(b) also issued under sec. 184, 68

Stat. 954, as amended (42 U.S.C. 2234).

Section 30.61 also issued under sec.

187, 68 Stat. 955 (42 U.S.C. 2237).

2. In § 30.8, paragraph (b) is revised to

read as follows:

§ 30.8 Information collection

requirements: OMB approval.

* * * * *

(b) The approved information

collection requirements contained in

this part appear in §§ 30.9, 30.11, 30.15,

30.18, 30.19, 30.20, 30.21, 30.32, 30.34,

30.35, 30.36, 30.37, 30.38, 30.41, 30.50,

30.51, 30.55, appendices A and C to this

part.

* * * * *

3. A new § 30.21 is added under the

undesignated center heading

‘‘Exemptions’’ to read as follows:
63640 Federal Register / Vol. 62, No. 231 / Tuesday, December 2, 1997 / Rules and Regulations

§ 30.21 Radioactive drug: Capsules

containing carbon-14 urea for ‘‘in vivo’’

diagnostic use for humans.

(a) Except as provided in paragraphs

(b) and (c) of this section, any person is

exempt from the requirements for a

license set forth in Section 81 of the Act

and from the regulations in this part and

part 35 of this chapter provided that

such person receives, possesses, uses,

transfers, owns, or acquires capsules

containing 37 kBq (1μ Ci) carbon-14

urea (allowing for nominal variation

that may occur during the

manufacturing process) each, for ‘‘in

vivo’’ diagnostic use for humans.

(b) Any person who desires to use the

capsules for research involving human

subjects shall apply for and receive a

specific license pursuant to part 35 of

this chapter.

(c) Any person who desires to

manufacture, prepare, process, produce,

package, repackage, or transfer for

commercial distribution such capsules

shall apply for and receive a specific

license pursuant to § 32.21 of this

chapter.

(d) Nothing in this section relieves

persons from complying with applicable

FDA, other Federal, and State

requirements governing receipt,

administration, and use of drugs.

PART 32—SPECIFIC DOMESTIC

LICENSES TO MANUFACTURE OR

TRANSFER CERTAIN ITEMS

CONTAINING BYPRODUCT MATERIAL

4. The authority citation for Part 32

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).

5. In § 32.8, paragraph (b) is revised to

read as follows:

§ 32.8 Information collection

requirements: OMB approval.

* * * * *

(b) The approved information

collection requirements contained in

this part appear in §§ 32.11, 32.12,

32.14, 32.15, 32.16, 32.17, 32.18, 32.19,

32.20, 32.21, 32.21a, 32.22, 32.23, 32.25,

32.26, 32.27, 32.29, 32.51, 32.51a, 32.52,

32.53, 32.54, 32.55, 32.56, 32.57, 32.58,

32.61, 32.62, 32.71, 32.72, 32.74, and

32.210.

* * * * *

6. A new § 32.21 is added to read as

follows:

§ 32.21 Radioactive drug: Manufacture,

preparation, or transfer for commercial

distribution of capsules containing carbon14 urea each for ‘‘in vivo’’ diagnostic use

for humans to persons exempt from

licensing; Requirements for a license.

(a) An application for a specific

license to manufacture, prepare,

process, produce, package, repackage, or

transfer for commercial distribution

capsules containing 37 kBq (1μ Ci)

carbon-14 urea (allowing for nominal

variation that may occur during the

manufacturing process) each for ‘‘in

vivo’’ diagnostic use, to persons exempt

from licensing under § 30.21 of this

chapter or the equivalent regulations of

an Agreement State will be approved if:

(1) The applicant satisfies the general

requirements specified in § 30.33 of this

chapter, provided that the requirements

of § 30.33(a)(2) and (3) of this chapter do

not apply to an application for a license

to transfer byproduct material

manufactured, prepared, processed,

produced, packaged, or repackaged

pursuant to a license issued by an

Agreement State;

(2) The applicant meets the

requirements under § 32.72(a)(2) of this

part;

(3) The applicant provides evidence

that each capsule contains 37 kBq (1μ

Ci) carbon-14 urea (allowing for

nominal variation that may occur during

the manufacturing process);

(4) The carbon-14 urea is not

contained in any food, beverage,

cosmetic, drug (except as described in

this section) or other commodity

designed for ingestion or inhalation by,

or topical application to, a human being;

(5) The carbon-14 urea is in the form

of a capsule, identified as radioactive,

and to be used for its radioactive

properties, but is not incorporated into

any manufactured or assembled

commodity, product, or device intended

for commercial distribution; and

(6) The applicant submits copies of

prototype labels and brochures and the

NRC approves these labels and

brochures.

(b) Nothing in this section relieves the

licensee from complying with

applicable FDA, other Federal, and State

requirements governing drugs.

7. A new § 32.21a is added to read as

follows:

§ 32.21a Same: Conditions of license.

Each license issued under § 32.21 of

this part is subject to the following

conditions:

(a) The immediate container of the

capsule(s) must bear a durable, legible

label which:

(1) Identifies the radioisotope, the

physical and chemical form, the

quantity of radioactivity of each capsule

at a specific date; and

(2) Bears the words ‘‘Radioactive

Material.’’

(b) In addition to the labeling

information required by paragraph (a) of

this section, the label affixed to the

immediate container, or an

accompanying brochure also must:

(1) State that the contents are exempt

from NRC or Agreement State licensing

requirements; and

(2) Bear the words ‘‘Radioactive

Material. For ‘‘In Vivo’’ Diagnostic Use

Only. This Material Is Not To Be Used

for Research Involving Human Subjects

and Must Not Be Introduced into Foods,

Beverages, Cosmetics, or Other Drugs or

Medicinals, or into Products

Manufactured for Commercial

Distribution. This Material May Be

Disposed of in Ordinary Trash.’’

Dated at Rockville, Maryland, this 24th day

of November, 1997.

For the Nuclear Regulatory Commission.

John C. Hoyle,

Secretary of the Commission.

[FR Doc. 97–31514 Filed 12–1–97; 8:45 am]

BILLING CODE 7590–01–P

NUCLEAR REGULATORY

COMMISSION

10 CFR Part 73

RIN 3150–AF53

Changes to Nuclear Power Plant

Security Requirements

AGENCY: Nuclear Regulatory

Commission.

ACTION: Final rule.

SUMMARY: The Nuclear Regulatory

Commission (NRC) is revising its

regulations to delete certain security

requirements associated with an

internal threat. This action follows the

NRC’s reconsideration of nuclear power

plant physical security requirements to

identify those requirements that are

marginal to safety, redundant, or no

longer effective. This action will reduce

the regulatory burden on licensees

without compromising physical

protection against radiological sabotage

required for public health and safety.

EFFECTIVE DATE: January 16, 1998.

FOR FURTHER INFORMATION CONTACT: Dr.

Sandra Frattali, Office of Nuclear

Regulatory Research, U.S. Nuclear

Regulatory Commission, Washington,

DC 20555–0001, telephone (301) 415–

6261, e-mail sdf@nrc.gov.