Federal Register / Vol. 62, No. 238 / Thursday, December 11, 1997 / Proposed Rules 65235

approximately 1,019 work hours per

airplane to accomplish, at an average

labor rate of $60 per work hour.

Required parts would cost

approximately $20,917 per airplane

($12,888 for all aft door fittings; $8,029

for all forward door fittings). Based on

these figures, the cost impact of the

proposed replacement of this AD on

U.S. operators is estimated to be

$9,436,555, or $82,057 per airplane.

The cost impact figures discussed

above are based on assumptions that no

operator has yet accomplished any of

the current or proposed 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 proposed herein

would 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

proposal would not have sufficient

federalism implications to warrant the

preparation of a Federalism Assessment.

For the reasons discussed above, I

certify that this proposed regulation (1)

is not a ‘‘significant regulatory action’’

under Executive Order 12866; (2) is not

a ‘‘significant rule’’ under the DOT

Regulatory Policies and Procedures (44

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

promulgated, 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 copy of the draft

regulatory evaluation prepared for this

action is contained in the Rules Docket.

A copy of it may be obtained by

contacting the Rules Docket at the

location provided under the caption

ADDRESSES.

List of Subjects in 14 CFR Part 39

Air transportation, Aircraft, Aviation

safety, Safety.

The Proposed Amendment

Accordingly, pursuant to the

authority delegated to me by the

Administrator, the Federal Aviation

Administration proposes to amend 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

removing amendment 39–8500 (58 FR

11190, February 24, 1993), and by

adding a new airworthiness directive

(AD), to read as follows:

Boeing: Docket 97–NM–47–AD. Supersedes

AD 93–02–16, Amendment 39–8500.

Applicability: Model 747 airplanes, line

numbers 1 through 200 inclusive; having

7079–T6 aluminum latch support fittings;

certificated in any category.

Note 1: This AD applies to each airplane

identified in the preceding applicability

provision, regardless of whether it has been

otherwise modified, altered, or repaired in

the area subject to the requirements of this

AD. For airplanes that have been modified,

altered, or repaired so that the performance

of the requirements of this AD is affected, the

owner/operator must request approval for an

alternative method of compliance in

accordance with paragraph (d) of this AD.

The request should include an assessment of

the effect of the modification, alteration, or

repair on the unsafe condition addressed by

this AD; and, if the unsafe condition has not

been eliminated, the request should include

specific proposed actions to address it.

Compliance: Required as indicated, unless

accomplished previously.

To prevent the cargo door from opening

while the airplane is in flight, which could

result in rapid decompression of the airplane,

accomplish the following:

Restatement of the Requirements of AD 93–

02–16

(a) Within 60 days after March 11, 1993

(the effective date of AD 93–02–16,

amendment 39–8500), perform a high

frequency eddy current (HFEC) inspection to

detect cracking on all surfaces of the upper

recess in each 7079–T6 aluminum latch

support fitting of the cargo doorway, in

accordance with Boeing Service Bulletin

747–53A2377, Revision 1, dated January 28,

1993, or Revision 2, dated October 6, 1994.

After the effective date of this AD, only

Revision 2 of the service bulletin shall be

used.

Note 2: Boeing Service Bulletin 747–

53A2377, Revision 2, dated October 6, 1994,

references Boeing Service Bulletin 747–53–

2200, Revision 1, dated November 16, 1979,

as an additional source of service information

for the replacement of these fittings.

(1) If any cracking is found on any fitting,

prior to further flight, replace the cracked

fitting with a new 7075–T73 aluminum latch

support fitting in accordance with Boeing

Service Bulletin 747–53A2377, Revision 1,

dated January 28, 1993, or Revision 2, dated

October 6, 1994. After the effective date of

this AD, only Revision 2 of the service

bulletin shall be used.

(2) If no cracking is found on any fitting,

repeat the HFEC inspection thereafter at

intervals not to exceed 18 months until the

requirements of paragraph (b) of this AD are

accomplished.

New Requirements of This AD

(b) Within 18 months after the effective

date of this AD, replace all 7079–T6

aluminum latch support fittings with new

7075–T73 fittings in accordance with Boeing

Service Bulletin 747–53A2377, Revision 2,

dated October 6, 1994. Replacement of all

latch support fittings constitutes terminating

action for the inspection requirements of this

AD.

(c) As of the effective date of this AD, no

operator shall install any 7079–T6 aluminum

latch support fitting of the cargo door on any

airplane.

(d) An alternative method of compliance or

adjustment of the compliance time that

provides an acceptable level of safety may be

used if approved by the Manager, Seattle

Aircraft Certification Office (ACO), FAA,

Transport Airplane Directorate. Operators

shall submit their requests through an

appropriate FAA Principal Maintenance

Inspector, who may add comments and then

send it to the Manager, Seattle ACO.

Note 3: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Seattle ACO.

(e) Special flight permits may be issued in

accordance with sections 21.197 and 21.199

of the Federal Aviation Regulations (14 CFR

21.197 and 21.199) to operate the airplane to

a location where the requirements of this AD

can be accomplished.

Issued in Renton, Washington, on

December 5, 1997.

John J. Hickey,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 97–32427 Filed 12–10–97; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1020

[Docket No. 97N–0427]

RIN 0910–ZA06

Diagnostic X-Ray Equipment

Performance Standard; Request for

Comments and Information

AGENCY: Food and Drug Administration,

HHS.

ACTION: Advance notice of proposed

rulemaking.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

intention to propose amendments to the

performance standard for diagnostic xray systems and their major

components. The agency is taking this

action to address changes in the

technology and use of radiographic and

fluoroscopic systems. The agency is

issuing this advance notice of proposed

rulemaking (ANPRM) in accordance

with its policy of early public disclosure

of rulemaking activities. The FDA is
65236 Federal Register / Vol. 62, No. 238 / Thursday, December 11, 1997 / Proposed Rules

soliciting comments and information

from interested persons concerning the

subject matter of the proposed

amendments.

DATES: Submit written comments on the

proposed amendments by March 11,

1998.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857. See the

SUPPLEMENTARY INFORMATION

section for electronic access to the

summary of concepts for amendments

and a summary of the April 8 through

9, 1997, meeting of the Technical

Electronic Product Radiation Safety

Standards Committee (TEPRSSC).

Submit written requests for single

copies of the Diagnostic X-Ray

Equipment Performance Standard to the

Division of Small Manufacturers

Assistance (DSMA), Center for Devices

and Radiological Health (HFZ–220),

Food and Drug Administration, 1350

Piccard Dr., Rockville, MD 20850. Send

two self-addressed adhesive labels to

assist that office in processing your

request or fax your request to 301–443–

8818.

FOR FURTHER INFORMATION CONTACT:

Thomas B. Shope, Center for Devices

and Radiological Health (HFZ–140),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–443–3314, ext. 32.

SUPPLEMENTARY INFORMATION:

I. Background

FDA, under authority conferred by the

Public Health Service Act as amended

by the Radiation Control for Health and

Safety Act (RCHSA) of 1968 (Pub. L. 90–

602 (21 U.S.C. 360hh–360ss)),

administers an electronic product

radiation control program to protect the

public health and safety. This authority

provides for the development and

administration of radiation safety

performance standards for electronic

products.

In order for mandatory performance

standards to achieve intended public

health protection, attention must be

given to keeping the requirements of

standards updated and appropriate. A

number of technological developments

have been or will be implemented for

radiographic and fluoroscopic x-ray

systems that are not addressed by the

performance standard or that present

problems in the application of the

requirements of the current standard.

FDA is developing proposed

amendments to the performance

standard for radiographic and

fluoroscopic systems that take into

account new technology, clarify certain

provisions, and address additional

requirements that may be determined to

be necessary to provide for adequate

radiation safety of these systems.

On October 16 and 17, 1992, the

American College of Radiology and FDA

sponsored a workshop on fluoroscopy to

develop strategies for improvement in

performance, safety and control of

fluoroscopic equipment. Physicians,

physicists, State and Federal

government regulators, and fluoroscopic

equipment manufacturers attended the

workshop. They discussed and made

recommendations for different ways to

approach fluoroscopic radiation safety

issues and concerns, including

regulatory solutions.

In the Federal Register of May 19,

1994 (59 FR 26402), FDA published a

final rule effective May 19, 1995,

amending performance requirements for

fluoroscopic systems to address the

immediate concern of preventing

unlimited exposure rates during the

high-level control mode of fluoroscopic

system operation. The TEPRSSC

discussed the status of standards for

fluoroscopic systems and new clinical

uses during a meeting held on April 9

through 10, 1996. TEPRSSC is a

permanent statutory advisory committee

established by statute that FDA must

consult prior to issuing standards under

the RCHSA.

At a meeting of the TEPRSSC held on

April 8 through 9, 1997, FDA presented

general concepts for amendments to the

performance standard for radiographic

and fluoroscopic systems.

The committee recommended that

FDA pursue development of the

amendments in the areas discussed in

section II of this notice.

A transcript of the TEPRSSC April 8

through 9, 1997, meeting may be

ordered from Miller Reporting Co., Inc.,

507 C St. NE., Washington, DC 20002,

202–546–6666 or FAX 202–546–1502.

Individuals or organizations wishing

to receive copies of draft amendments or

related documents distributed for

review during the development of these

amendments may have their names

placed on the mailing list by writing to:

Office of Science and Technology (HFZ–

140), Center for Devices and

Radiological Health, Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, FAX 301–443–

9101, e-mail: TBS@CDRH.FDA.GOV.

II. Concepts for Amendments to the

Standard

FDA has identified the following nine

areas as candidates for amendments to

accommodate changes in technology

and clinical use of radiographic and

fluoroscopic systems. The discussion

below each concept is not intended to

indicate the specific content of the

proposed amendment to be developed,

but is meant only to describe the need

and FDA’s proposed approach. The

specific regulatory changes or proposed

standards will be included in a future

proposed rule. Comments received in

response to this notice will be used to

develop the proposed amendments.

FDA requests comments on the

following conceptual changes:

1. Conversion to the International

System of Units (SI) quantities and units

for the entire standard. This proposal is

to amend all sections of the performance

standard for diagnostic x-ray systems to

use the radiation quantity ‘‘air kerma’’

in place of the quantity ‘‘exposure’’ and

to change the units to the SI.

2. Clarification of applicability of

requirements to technological

developments, such as digital imaging,

digital recording and solid-state x-ray

imagers. The current organization and

structure of the standard assumes the

presence of an x-ray image intensifier as

the basis for many of the requirements

for fluoroscopic systems. This

assumption may be inappropriate for

digital fluoroscopy systems that may use

new types of digital image receptors.

Such systems may not have an image

intensifier tube. The structure of the

radiographic section of the standard is

based on radiographic film as the image

receptor and revisions are needed to

incorporate technological developments

in that area. It would be desirable to the

extent possible to use terminology

consistent with usage adopted by the

International Electrotechnical

Commission (IEC).

3. Amendment to incorporate draft

Compliance Policy Guide on

Information to be Provided to Users (21

CFR 1020.30(h)). This proposal would

amend the requirements on the content

of information that must be provided to

users to include specific information on

the air kerma rate for certain

fluoroscopic modes of operation. This

amendment would incorporate into the

standard a draft Compliance Policy

Guide that has been developed, but not

yet issued, and is intended to interpret

§ 1020.30(h) for certain ‘‘unique’’ modes

of fluoroscopic system operation.

4. Amendment to add requirements

for minimum half-value layer (HVL) for

systems designed for interventional

radiology (§ 1020.30(m)). This proposal

would increase the minimum half-value

layer requirements for fluoroscopic

systems designed for interventional

radiology. Such a requirement will

require definition of a ‘‘fluoroscopic

system designed for interventional
Federal Register / Vol. 62, No. 238 / Thursday, December 11, 1997 / Proposed Rules 65237

fluoroscopy.’’ As a concept for

discussion, fluoroscopic systems

designed for interventional radiology

might be defined as systems that permit

the beam axis to be positioned at an

angle relative to the normal to the table

top. Systems in which the x-ray beam

direction is fixed with respect to the

plane of the tabletop, such as

conventional radiographic/ fluoroscopic

systems, would not be included in this

definition.

5. Amendment to require improved xray field limitation (21 CFR

1020.32(b)(2)(v)). This proposal would

require improved limitation of the x-ray

field for fluoroscopic equipment to

match the actual area of the image

receptor being used for image capture,

thereby reducing the amount of nonuseful beam striking the patient.

6. Amendment to clarify the

requirements for the minimum sourceskin distance for small, mobile, or

portable mini C-arm systems

(§ 1020.32(g)). This amendment would

address numerous requested and

granted variances for fluoroscopic

systems that have limited source-image

receptor distances. The amendment

would specify the conditions under

which a shorter-than-standard sourceskin distance is permitted and would

obviate the need for continued variances

from the standard.

7. Amendment to require indication

of cumulative exposure time on

fluoroscopic systems (§ 1020.32(h)). The

proposed amendment would require the

means to indicate the cumulative time

of fluoroscopic irradiation of a patient

during an examination or procedure.

8. Amendment to require provision of

‘‘last-image-hold’’ feature on

fluoroscopic systems (§ 1020.32(j)). This

amendment would require that all

fluoroscopic x-ray systems be provided

with a means to continuously display

the last image acquired following

termination of any exposure period.

9. Amendment to require indication

of air kerma rate and cumulative air

kerma on fluoroscopic systems

(§ 1020.32(k)). The proposed

amendment would require the means to

display to the fluoroscopist at the

fluoroscopist’s working position the

cumulative air kerma and the air kerma

rate (air kerma per unit time) at which

air kerma accrues during irradiation of

a patient in an examination or

procedure.

III. Electronic Access

The summary of concepts for

amendments entitled ‘‘Concepts for

Proposed Amendments to the

Performance Standard for Diagnostic Xray Systems, August 1, 1997,’’ may be

accessed at the CDRH Home Page on the

World Wide Web. It is available on the

Topic Index page at: http://

www.fda.gov/cdrh/topindx under

‘‘Fluoroscopy’’. A text-only version of

the CDRH site is also available from a

computer or VT–100 compatible

terminal by dialing 800–222–0185

(terminal settings are 8/1/N). Once the

modem answers, press Enter several

times and then select menu choice 1:

FDA BULLETIN BOARD SERVICE.

From there, follow instructions for

logging in, and at the BBS TOPICS

PAGE, arrow down to the FDA Home

Page (do not select the first CDRH

entry). Then select Medical Devices and

Radiological Health. From there, select

CENTER FOR DEVICES AND

RADIOLOGICAL HEALTH for general

information, or arrow down for specific

topics.

The document may also be obtained

by fax by calling the CDRH Facts-OnDemand (FOD) system at 800–899–0381

or 301–827–0111 from a touch-tone

telephone. At the first voice prompt

press 1 to access DSMA Facts, at the

second voice prompt press 2, and then

enter the document number 591

followed by the pound sign (#). Then

follow the remaining voice prompts to

complete your request.

A summary of the TEPRSSC April 8

through 9, 1997, meeting is available on

the CDRH Home Page at the same

address given above for the concepts for

amendments document.

IV. Comments

Interested persons may, on or before

March 11, 1998, submit to the Dockets

Management Branch (address above)

written comments regarding this

proposed amendment. Two copies of

any comments are to be submitted,

except that individuals may submit one

copy. Comments are to be identified

with the docket number found in

brackets in the heading of this

document. Received comments may be

seen in the Dockets Management Branch

between 9 a.m. and 4 p.m., Monday

through Friday.

Interested persons also are invited to

participate in the development of

proposed amendments by submitting

written data, views, or arguments

concerning the subject matter of the

amendments, or related topics suggested

for inclusion in the amendments. In

addition to general comments and

recommendations, respondents are

encouraged to include suggested text for

provisions of the proposed amendments

that reflect their recommended

performance requirements. A statement

of rationale should accompany any such

proposed text. When a determination is

made on the content of the proposed

amendments, they will be published as

notices of proposed rulemaking with

opportunity given for public comment.

Information and comments are

specifically invited on the following

topics:

1. For concepts 4 through 9 in section

II of this document, recommendation for

whether the amendments should be

limited only to equipment designed for

interventional procedures or for all

fluoroscopic systems. If only for

interventional systems, how should

‘‘interventional fluoroscopic systems’’

be defined?

2. The desirability and technical

feasibility of amendments of the type

described in section II of this document.

3. Recommended performance

requirements to be included in the

proposed amendments, including

attendant methods and conditions of

measurement.

4. Suggestions and supporting data for

other amendments to the performance

standard for radiographic or

fluoroscopic equipment, including

moving towards more outcome-based

performance standards, which may be

needed to provide for adequate

radiation safety.

5. The possible environmental impact

of this action, including factors such as

radiation exposure reduction or

prevention and economic consequences

in relation to expected benefits (costbenefit relationship), and the

anticipated costs of providing such

features or meeting the requirements.

6. Any additional terms or definitions

that are needed to better specify the

intent or meaning of the regulations as

they apply to the equipment.

This ANPRM is issued under 21

U.S.C. 321 and under the authority of

the Commissioner of Food and Drugs.

Dated: October 29, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–32462 Filed 12–10–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Fish and Wildlife Service

50 CFR Part 17

RIN 1018–AE45

Endangered and Threatened Wildlife

and Plants; Proposed Revision of

Special Regulations for the Gray Wolf

AGENCY: Fish and Wildlife Service,

Interior.