31604 Federal Register / Vol. 63, No. 111 /Wednesday, June 10, 1998 /Rules and Regulations

917, then southeast along State Primary

Highway 917 to the Little Pee Dee River.

Done in Washington, DC, this 4th day of

June 1998.

Charles P. Schwalbe,

Acting Administrator, Animal and Plant

Health Inspection Service.

[FR Doc. 98–15404 Filed 6–9–98; 8:45 am]

BILLING CODE 3410–34–P

NUCLEAR REGULATORY

COMMISSION

10 CFR Part 35

RIN 3150–AF77

License Term for Medical Use Licenses

AGENCY: Nuclear Regulatory

Commission.

ACTION: Final rule.

SUMMARY: The Nuclear Regulatory

Commission is amending its regulations

pertaining to the medical use of

byproduct material to eliminate the 5-

year term limit for medical use licenses.

License terms for licenses issued under

these regulations will be set by policy.

Other materials licenses are issued for

up to 10 years. The NRC will issue some

licenses for shorter terms if warranted

by the individual circumstances of

license applicants. The amendment

reduces the administrative burden of

license renewals on a 5-year cycle for

both NRC and licensees and supports

NRC’s goal of streamlining the licensing

process.

EFFECTIVE DATE: This regulation

becomes effective on July 10, 1998.

FOR FURTHER INFORMATION CONTACT:

Jayne M. McCausland, Office of Nuclear

Material Safety and Safeguards, U.S.

Nuclear Regulatory Commission,

Washington, DC 20555, telephone (301)

415–6219, e-mail JMM2 @ nrc.gov.

SUPPLEMENTARY INFORMATION:

I. Background.

II. Discussion.

III. Statement of Regulatory Action.

IV. Discussion of Public Comments.

V. Agreement State Compatibility.

VI. Environmental Impact: Categorical

Exclusion.

VII. Paperwork Reduction Act Statement.

VIII. Regulatory Analysis.

IX. Regulatory Flexibility Certification.

X. Backfit Analysis.

I. Background

In 1995, the NRC’s Office of Nuclear

Material Safety and Safeguards (NMSS)

initiated a review to determine whether

the license term for materials licenses

could be lengthened so that NRC’s

licensing resources could be redirected

to other areas of the materials program.

At that time, the resources devoted to

renewals constituted over 50 percent of

the total resources expended for

licensing. NMSS undertook this review

as a part of NRC’s ‘‘business process

redesign’’ efforts.

The license renewal process has been

used as an opportunity for the

Commission to review the history of the

licensee’s operating performance (e.g.,

the record on compliance with

regulatory requirements) and the

licensee’s overall materials safety

program. This review is performed to

ascertain if the licensee employs up-todate technology and practices in the

protection of health, safety, and the

environment, and complies with any

new or amended regulations. As part of

a license renewal, the licensee is asked

to provide information on the current

status of its program as well as any

proposed changes in operations (types

and quantities of authorized materials),

personnel (authorized users and

radiation safety officers), facility,

equipment, or applicable procedures.

The renewal process has been perceived

to benefit both the licensee and NRC

because it requires both to take a

comprehensive look at the licensed

operation. However, in practice,

comprehensive program reviews occur

when proposed changes are identified

and requested by licensees as license

amendments rather than during the

license renewal process.

License terms have been reviewed on

numerous occasions since 1967. On

May 12, 1967 (32 FR 7172), the

Commission amended 10 CFR part 40 to

eliminate a 3-year limit on the term of

source material licenses. At that time,

there was no restriction on the term of

byproduct licenses under 10 CFR part

30 or special nuclear material licenses

under 10 CFR part 70. In the notice of

proposed rulemaking associated with

amending 10 CFR part 40, dated

December 22, 1966, NRC indicated that

if the proposed amendment to eliminate

the 3-year restriction were adopted,

licenses would be issued for 5-year

terms, except when the nature of the

applicant’s proposed activities indicated

a need for a shorter license period. At

that time, the Commission believed

there was little justification for granting

licenses under 10 CFR parts 30, 40, and

70 for terms of less than 5 years, in view

of the cumulative experience up to that

time and the means available to NRC to

suspend, revoke, or modify such

licenses if public health and safety or

environment so required.

In March 1978, NMSS conducted a

study (SECY–78–284, ‘‘The License

Renewal Study for parts 30, 40, and 70

Licenses’’) to consider changing the 5-

year renewal period for parts 30, 40, and

70 licenses. The study concluded, in

part, that the NRC should continue its

practice of issuing specific licenses for

5-year terms and should retain an

option to write licenses for shorter

terms, if deemed necessary, for new

types of operations or if circumstances

warranted.

On July 26, 1985 (50 FR 30616), NRC

proposed revising 10 CFR part 35,

‘‘Medical Use of Byproduct Material.’’

The proposed rulemaking indicated that

the Commission had selected a term of

five years for a license. It was believed

that a term shorter than 5 years would

not benefit health and safety because

past experience indicated that medical

programs did not generally change

significantly over that period of time.

The notice also indicated that a longer

term may occasionally result in

unintentional abandonment of the

license. On October 16, 1986 (51 FR

36932), NRC issued the final rule that

consolidated and clarified radiation

safety requirements related to the

medical use of byproduct materials, and

included a license term of 5 years.

On June 19, 1990 (55 FR 24948), the

Commission announced that the license

term for major operating fuel cycle

licensees (i.e., licenses issued pursuant

to 10 CFR parts 40 or 70) would be

increased from a 5-year term to a 10-

year term at the next renewal of the

affected licenses. This change enabled

NRC resources to be used to improve the

licensing and inspection programs. The

bases for this change were that major

operating fuel cycle facilities had

become stable in terms of significant

changes to their licenses and operations

and that licensees would be required to

update the safety demonstration

sections of their licenses every 2 years.

On July 2, 1996, the Commission

approved the NRC staff’s proposal to

extend the license term for uranium

recovery facilities from 5 years to 10

years. Extending the license term

reduces the administrative burden

associated with the license renewal

process for both the NRC staff and the

uranium recovery licensees. Also, the

extension reduces licensee fees, makes

the license term for these facilities more

commensurate with the level of risk,

and supports NRC’s goal of streamlining

the licensing process. Licensees were

informed of the extensions in July 1996.

On February 6, 1997 (62 FR 5656), the

Commission gave notice that the license

term for materials licenses issued

pursuant to 10 CFR parts 30, 40, or 70

would be increased from a 5-year term

to up to a 10-year term at the next

renewal of the affected licenses.

However, whereas the 10-year term for
Federal Register / Vol. 63, No. 111 /Wednesday, June 10, 1998 /Rules and Regulations 31605

other licenses was set by this policy, the

term for licenses issued pursuant to 10

CFR part 35 was established by

regulation at 5 years.

On July 31, 1997 (62 FR 40975), the

NRC published a proposed rule to revise

10 CFR part 35 to eliminate the 5-year

term limit in 10 CFR 35.18 for medical

use licenses. The term for medical

licenses could then be set by policy for

up to 10 years. The NRC could issue a

license for a shorter term, depending on

the individual circumstances of the

license applicant. The public comment

period closed on October 14, 1997. A

summary of the public comments is

provided in Section IV, below.

II. Discussion

The change described above (i.e.,

increasing the license term for materials

licenses issued under 10 CFR parts 30,

40, and 70 to up to 10 years) has created

an inconsistency between the license

terms for medical use and nonmedical

use materials licenses. NRC believes

that the license duration period for

medical use licenses may also be

extended without adverse impacts on

public health and safety, such as

increases in the unintentional

abandonment of licensed material or

decreases in the licensees’ attention to

licensed activities, for the following

reasons:

(1) Licensees would continue to be

required to adhere to the regulations

and their license conditions, and to

apply for license amendments for

certain proposed changes to their

programs;

(2) No changes in either the frequency

or elements of the medical inspection

program are being proposed;

(3) NRC would continue to be in a

position to identify, by inspection or

other means, violations of its regulations

or the license conditions that affect

public health and safety, and to take

appropriate enforcement actions;

(4) Cases of abandonment of NRC

licenses would be identified through

nonpayment of the annual licensing fees

and regional NRC office follow-up;

(5) The NRC staff would continue to

make licensees aware of health and

safety issues through the issuance of

generic communications (such as

information notices, generic letters,

bulletins, and the NMSS Licensee

Newsletter); and

(6) NRC is moving to a more

performance-based regulatory approach,

where emphasis is placed on the

licensee’s execution of commitments

rather than on rereview of the details of

the licensee’s program.

III. Statement of Regulatory Action

The NRC is revising part 35 to

eliminate the 5-year term limit in 10

CFR 35.18 for medical use licenses so

that the term for medical use licenses

will be set by policy.

IV. Discussion of Public Comments

Five letters of public comment were

received on the proposed rule.

Comments were received from National

Physics Consultants, Ltd., the American

Association of Clinical

Endocrinologists, the Mayo Clinic, the

University of Cincinnati, and the

American Hospital Association.

All commenters fully supported the

proposed amendment to eliminate the

reference to the 5-year term limit for

medical use licenses in 10 CFR 35.18. In

addition, the commenters endorsed the

change in license terms for licenses

issued pursuant to part 35, to be set by

policy for as many as 10 years, as are the

license terms for other material licenses.

In general, commenters disparaged

the license renewal process, on a 5-year

frequency, as requiring a significant

expenditure of time and fees with

minimal benefit, and supported NRC’s

proposal to eliminate this requirement,

citing a reduction of staff time and costs

for both the NRC and individual

licensees with no decrease in public

health and safety. Commenters

recognized that the NRC may issue some

licenses for shorter terms if warranted

by the individual circumstances of

license applicants.

One commenter stated that routine

license reviews by the local Radiation

Safety Committee will ensure operation

of a radiation safety program that

protects public health and safety.

Another commenter indicated that

because the NRC is in contact with the

licensees on an ongoing basis, any

changes in operations, personnel,

facility, equipment, or applicable

procedures are identified during the

inspection and license amendment

process.

One of the commenters agreed that

the radiation safety programs at most

medical facilities are very stable and

pointed out that significant changes in

the radiation safety program require

license amendments.

Another commenter recommended

that NRC extend the license term for

medical use licenses from 5 years to 10

years as soon as possible to reduce the

license fees and achieve further cost

savings. This commenter expressed

support for the NRC’s ‘‘business process

redesign’’ efforts to reduce both the

administrative burden of license

renewals and license fees. According to

the commenter, this will allow that

organization’s members to redirect their

resources to support and implement

NRC’s initiative to move to a more

performance-based regulatory approach.

V. Agreement States Compatibility

This rulemaking will be a matter of

compatibility between the NRC and the

Agreement States. Compatibility

Category D has been assigned to the

changes in 10 CFR 35.18. Category D

means the provisions are not required

for purposes of compatibility. No

problems have been identified regarding

Agreement State compatibility

implementation of this rule change.

VI. Environmental Impact: Categorical

Exclusion

The Commission has determined that

this final rule is the type of action

described in categorical exclusion 10

CFR 51.22(c)(3)(i) for amendments to

Part 35 that relate to renewals of

licenses. Therefore, neither an

environmental statement nor an

environmental assessment has been

prepared for this final regulation.

VII. Paperwork Reduction Act

Statement

This final rule reduces the burden for

both medical licensees and the NRC

because license terms for Part 35

licensees could be established by policy,

for as many as 10 years, as is the case

for other materials licensees. However,

the reduced burden from less frequent

license renewal will not be realized in

the near future because the affected

licenses are operating under a 5-year

extension of current licenses granted in

1995. The impact of that one-time

extension is addressed in the current

supporting statement for NRC Form 313,

‘‘Application for Material License,’’

which was approved by the Office of

Management and Budget (OMB) under

OMB Clearance No. 3150–0120 and

which expires on July 31, 1999. The

data on reduced burden from extension

of the license term for all material

licenses and from other actions taken to

streamline the licensing process will be

included in the request for renewal of

the information collection requirements

on NRC Form 313 in 1999. This is

appropriate because the next OMB

clearance extension will cover 1999–

2002, when the medical licenses

currently under the 5-year extension

will expire and will be affected by this

rulemaking. Send comments on any

aspect of this information collection,

including suggestions for further

reducing the burden, to the Information

and Records Management Branch (T–

6F33), U.S. Nuclear Regulatory
31606 Federal Register / Vol. 63, No. 111 /Wednesday, June 10, 1998 /Rules and Regulations

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–

0014), Office of Management and

Budget, Washington, DC 20503.

Public Protection Notification

If a document used to impose an

information collection does not display

a currently valid OMB control number,

the NRC may not conduct or sponsor,

and a person is not required to respond

to, the information collection.

VIII. Regulatory Analysis

Problem

The current rule requirement,

regarding the term of medical licenses,

is codified in 10 CFR 35.18 and states

that ‘‘The Commission shall issue a

license for the medical use of byproduct

material for a term of five years.’’ The

license term of other materials licenses,

as established by Commission policy, is

up to 10 years. There is an

inconsistency as to duration and

manner of specifying the license terms

of medical use licenses and all other

materials licenses. Based on the above,

the following options were considered.

Alternative Approaches

1. Take no Action: Maintain the

requirement that licenses issued

pursuant to Part 35 would be issued for

5 years.

This option would continue the

inconsistencies between medical

licenses and all other materials licenses

as to the duration and specification of

license terms. Terms for medical use

licenses are established in codified

regulations, whereas the term for other

materials licenses is now set by policy.

Also, this option would result in

disparities in the duration of the term

for materials licenses. Medical use

licenses would continue to be issued for

5-year terms whereas the duration of the

term for other materials licenses is up to

10 years.

2. Revise 10 CFR 35.18: Revise the

regulations to delete any reference to the

license term for licenses issued

pursuant to part 35.

This option would result in

consistency between how license terms

for medical licenses and all other

materials licenses are established and in

the duration of these licenses.

Commission decisions regarding the

duration of a materials license could

therefore apply uniformly to all types of

materials licenses. After final

rulemaking action to revise 10 CFR

35.18, the license term for licenses

issued pursuant to part 35 would be set

by the already established policy for as

many as 10 years.

Value and Impact

The license renewal process is

resource-intensive for both the licensee

and NRC. At the time of license

renewal, licensees submit to NRC any

changes in operations, personnel,

facility, equipment, or applicable

procedures. Because NRC is in contact

with the licensees on an ongoing basis,

many of these changes are identified

during the inspection and license

amendment process. Therefore, the

rulemaking to remove the 5-year license

term for medical use of byproduct

material would not change the health

and safety requirements imposed on

licensees.

By removing the reference to the 5-

year term in 10 CFR 35.18 and, with the

Commission’s February 1997 extension

of the license term for as many as 10

years for all materials licenses issued

pursuant to parts 30, 40, and 70, there

is a reduction in the regulatory burden

for approximately 1,900 NRC licensees

that use byproduct material for medical

procedures. Estimated savings are based

on the assumption that these licensees

would only be required to submit a

renewal application every 10 years as

opposed to every 5 years, resulting, on

average, in a savings of 190 applications

per year. However, offsetting these

savings, medical licensees may need to

submit an average of one additional

amendment during the 10-year period to

account for changes in operations that

would have routinely been addressed

when the license was renewed on a 5-

year cycle. Assuming that a typical

license renewal application and typical

amendment involves 19 hours and 4

hours of licensee professional effort,

respectively, there would be a net

savings per licensee of 15 hours. Based

on an industry professional labor rate of

$125 per hour, the annual industry-wide

savings would approximate $356,000.

Over a 30-year time frame, based on a

7-percent real discount rate, the present

worth savings to industry would

approximate $4.4 million.

Similarly, this rulemaking is also cost

effective for the NRC because fewer

resources would be required to review

and process renewal applications. On

average, it takes approximately 14 hours

of NRC professional time to renew a

medical license and 4 hours to review

and issue a license amendment. This

means a net savings to the NRC of 10

hours per licensee. Assuming an NRC

labor rate of $125 per hour, and on

average, 190 applications per year, the

annual NRC savings would equal

$237,000. The 30-year present worth

savings to the NRC would approximate

$2.9 million.

Conclusion

This rulemaking, to remove the 5-year

license term for medical use of

byproduct material, is promulgated so

the term for medical licenses will be

consistent with that of other materials

licenses (set by policy to be as many as

10 years). The extension will reduce the

administrative burden of license

renewals for both NRC and licensees

and will support NRC’s goal of

streamlining the licensing process

without any reduction in health and

safety. NRC may issue some licenses for

shorter terms if warranted by the

individual circumstances of license

applicants.

Decisional Rationale

Based on the desire to reduce burden

whenever it is possible to do so without

reducing protection of public health and

safety, to maintain consistency among

license terms for materials licensees,

and the cost effectiveness of longer

license terms, the NRC is amending 10

CFR part 35 to eliminate the 5-year term

limit for medical use licenses and allow

the license term to be set by policy, as

is the case for other materials licenses.

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

will not have a significant economic

impact on a substantial number of small

entities. By removing the reference to

the 5-year license term in 10 CFR 35.18,

the duration of medical use licenses will

be set by policy, resulting in a reduction

in the regulatory burden for NRC

medical use licensees.

X. Backfit Analysis

The NRC has determined that the

backfit rule, 10 CFR 50.109, does not

apply to this final rule and, therefore,

that a backfit analysis is not required for

this final rule because the amendment

does not involve any provision that

would impose backfits as defined in 10

CFR 50.109(a)(1).

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.
Federal Register / Vol. 63, No. 111 /Wednesday, June 10, 1998 /Rules and Regulations 31607

List of Subjects in 10 CFR Part 35

Byproduct material, Criminal

penalties, Drugs, Health facilities,

Health professions, Medical devices,

Nuclear materials, Occupational safety

and health, Radiation protection,

Reporting and recordkeeping

requirements.

For the reasons set out in the

preamble and under the authority of the

Atomic Energy Act of 1954, as amended,

the Energy Reorganization Act of 1974,

as amended, and 5 U.S.C. 552 and 553,

the NRC is adopting the following

amendment to 10 CFR part 35.

PART 35—MEDICAL USE OF

BYPRODUCT MATERIAL

1. The authority citation for part 35

continues to read as follows:

Authority: Secs. 81, 161, 182, 183, 68 Stat.

935, 948, 953, 954, as amended (42 U.S.C.

2111, 2201, 2232, 2233); sec. 201, 88 Stat.

1242, as amended (42 U.S.C. 5841).

2. The introductory text of § 35.18 is

revised to read as follows:

§ 35.18 License issuance.

The Commission shall issue a license

for the medical use of byproduct

material if:

* * * * *

Dated at Rockville, Md., this 20th day of

May 1998.

For the Nuclear Regulatory Commission.

L. Joseph Callan,

Executive Director for Operations.

[FR Doc. 98–15400 Filed 6–9–98; 8:45 am]

BILLING CODE 7590–01–P

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. 98–NM–97–AD; Amendment

39–10582; AD 98–12–28]

RIN 2120–AA64

Airworthiness Directives; CASA Model

C–212 Series Airplanes

AGENCY: Federal Aviation

Administration, DOT.

ACTION: Final rule.

SUMMARY: This amendment adopts a

new airworthiness directive (AD),

applicable to all CASA Model C–212

series airplanes, that requires repetitive

inspections for cracking in the false spar

of the wing, and repair, if necessary.

This amendment is prompted by

issuance of mandatory continuing

airworthiness information by a foreign

civil airworthiness authority. The

actions specified by this AD are

intended to detect and correct cracking

in the false spar, which could result in

reduced structural integrity of the wing.

DATES: Effective July 15, 1998.

The incorporation by reference of

certain publications listed in the

regulations is approved by the Director

of the Federal Register as of July 15,

1998.

ADDRESSES: The service information

referenced in this AD may be obtained

from Construcciones Aeronauticas, S.A.,

Getafe, Madrid, Spain. This information

may be examined at the Federal

Aviation Administration (FAA),

Transport Airplane Directorate, Rules

Docket, 1601 Lind Avenue, SW.,

Renton, Washington; or at the Office of

the Federal Register, 800 North Capitol

Street, NW., suite 700, Washington, DC.

FOR FURTHER INFORMATION CONTACT:

Norman B. Martenson, Manager,

International Branch, ANM–116, FAA,

Transport Airplane Directorate, 1601

Lind Avenue, SW., Renton, Washington

98055–4056; telephone (425) 227–2110;

fax (425) 227–1149.

SUPPLEMENTARY INFORMATION: A

proposal to amend part 39 of the Federal

Aviation Regulations (14 CFR part 39) to

include an airworthiness directive (AD)

that is applicable to all CASA Model C–

212 series airplanes was published in

the Federal Register on April 9, 1998

(63 FR 17341). That action proposed to

require repetitive inspections for

cracking in the false spar of the wing,

and repair, if necessary.

Comments

Interested persons have been afforded

an opportunity to participate in the

making of this amendment. No

comments were submitted in response

to the proposal or the FAA’s

determination of the cost to the public.

Conclusion

The FAA has determined that air

safety and the public interest require the

adoption of the rule as proposed.

Cost Impact

The FAA estimates that 41 airplanes

of U.S. registry will be affected by this

AD, that it will take approximately 30

work hours per airplane to accomplish

the required inspection, and that the

average labor rate is $60 per work hour.

Based on these figures, the cost impact

of the inspection required by this AD on

U.S. operators is estimated to be

$73,800, or $1,800 per airplane, per

inspection cycle.

The cost impact figure discussed

above is based on assumptions that no

operator has yet accomplished any of

the requirements of this AD action, and

that no operator would accomplish

those actions in the future if this AD

were not adopted.

Regulatory Impact

The regulations adopted herein will

not have substantial direct effects on the

States, on the relationship between the

national government and the States, or

on the distribution of power and

responsibilities among the various

levels of government. Therefore, in

accordance with Executive Order 12612,

it is determined that this final rule does

not have sufficient federalism

implications to warrant the preparation

of a Federalism Assessment.

For the reasons discussed above, I

certify that this action (1) is not a

‘‘significant regulatory action’’ under

Executive Order 12866; (2) is not a

‘‘significant rule’’ under DOT

Regulatory Policies and Procedures (44

FR 11034, February 26, 1979); and (3)

will not have a significant economic

impact, positive or negative, on a

substantial number of small entities

under the criteria of the Regulatory

Flexibility Act. A final evaluation has

been prepared for this action and it is

contained in the Rules Docket. A copy

of it may be obtained from the Rules

Docket at the location provided under

the caption ADDRESSES.

List of Subjects in 14 CFR Part 39

Air transportation, Aircraft, Aviation

safety, Incorporation by reference,

Safety.

Adoption of the Amendment

Accordingly, pursuant to the

authority delegated to me by the

Administrator, the Federal Aviation

Administration amends part 39 of the

Federal Aviation Regulations (14 CFR

part 39) as follows:

PART 39—AIRWORTHINESS

DIRECTIVES

1. The authority citation for part 39

continues to read as follows:

Authority: 49 U.S.C. 106(g), 40113, 44701.

§ 39.13 [Amended]

2. Section 39.13 is amended by

adding the following new airworthiness

directive:

98–12–28 Construcciones Aeronauticas, S.A.

(CASA): Amendment 39–10582. Docket

98-NM–97-AD.

Applicability: All Model C–212 series

airplanes, certificated in any category.

Note 1: This AD applies to each airplane

identified in the preceding applicability

provision, regardless of whether it has been

modified, altered, or repaired in the area