19184 Federal Register / Vol. 63, No. 74 / Friday, April 17, 1998 /Rules and Regulations

communications received on or before

the closing date for comments will be

considered, and this rule may be

amended in light of the comments

received. Factual information that

supports the commenter’s ideas and

suggestions is extremely helpful in

evaluating the effectiveness of the AD

action and determining whether

additional rulemaking action would be

needed.

Comments are specifically invited on

the overall regulatory, economic,

environmental, and energy aspects of

the rule that might suggest a need to

modify the rule. All comments

submitted will be available, both before

and after the closing date for comments,

in the Rules Docket for examination by

interested persons. A report that

summarizes each FAA-public contact

concerned with the substance of this AD

will be filed in the Rules Docket.

Commenters wishing the FAA to

acknowledge receipt of their comments

submitted in response to this rule must

submit a self-addressed, stamped

postcard on which the following

statement is made: ‘‘Comments to

Docket No. 98–SW–09–AD.’’ The

postcard will be date stamped and

returned to the commenter.

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.

The FAA has determined that this

regulation is an emergency regulation

that must be issued immediately to

correct an unsafe condition in aircraft,

and that it is not a ‘‘significant

regulatory action’’ under Executive

Order 12866. It has been determined

further that this action involves an

emergency regulation under DOT

Regulatory Policies and Procedures (44

FR 11034, February 26, 1979) If it is

determined that this emergency

regulation otherwise would be

significant under DOT Regulatory

Policies and Procedures, a final

regulatory evaluation will be prepared

and placed in the Rules Docket. A copy

of it, if filed, 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 a new airworthiness directive to

read as follows:

98–04–40 Eurocopter France: Amendment

39–10479. Docket No. 98–SW–09–AD.

Applicability: Model SA.315B, SA.316B,

SA.316C, SA.319B, and SE.3160 helicopters,

with main rotor blades, part numbers

3160S11–10000 all dash numbers, 3160S11–

30000 all dash numbers, 3160S11–35000 all

dash numbers, 3160S11–40000 all dash

numbers, 3160S11–45000 all dash numbers,

3160S11–50000 all dash numbers, 3160S11–

55000 all dash numbers, installed,

certificated in any category.

Note 1: This AD applies to each helicopter

identified in the preceding applicability

provision, regardless of whether it has been

modified, altered, or repaired in the area

subject to the requirements of this AD. For

helicopters that have been modified, altered,

or repaired so that the performance of the

requirements of this AD is affected, the

owner/operator must use the authority

provided in paragraph (d) to request approval

from the FAA. This approval may address

either no action, if the current configuration

eliminates the unsafe condition, or different

actions necessary to address the unsafe

condition described in this AD. Such a

request should include an assessment of the

effect of the changed configuration on the

unsafe condition addressed by this AD. In no

case does the presence of any modification,

alteration, or repair remove any helicopter

from the applicability of this AD.

Compliance: Required as indicated, unless

accomplished previously, for helicopters

with main rotor blades (blades) having 400 or

more hours time-in-service (TIS).

To prevent separation of a blade and

subsequent loss of control of the helicopter,

accomplish the following:

(a) Within 25 hours TIS, inspect each blade

spar for cracks using a dye-penetrant method

in accordance with paragraphs CC.1 through

CC.4 of the Operational Procedures in

Eurocopter France Service Telex No. 00055/

0034/98, dated February 3, 1998 (Eurocopter

Service Telex: 316/319 No. 01–64 and 315

No. 01–29).

(b) Within 25 hours TIS, visually inspect

the upper and lower surfaces of each blade

cuff for cracks, especially around the

attachment pins, using a 10-power or higher

magnifying glass.

(c) If a crack is found in a blade spar or

cuff, remove the blade and replace it with an

airworthy blade prior to further flight.

(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, Rotorcraft

Standards Staff, Rotorcraft Directorate, FAA.

Operators shall submit their requests through

an FAA Principal Maintenance Inspector,

who may concur or comment and then send

it to the Manager, Rotorcraft Standards Staff.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Rotorcraft Standards Staff.

(e) Special flight permits will not be

issued.

(f) The inspection shall be done in

accordance with paragraphs CC.1 through

CC.4 of the Operational Procedures in

Eurocopter France Service Telex No. 00055/

0034/98, dated February 3, 1998 (Eurocopter

Service Telex: 316/319 No. 01–64 and 315

No. 01–29). This incorporation by reference

was approved by the Director of the Federal

Register in accordance with 5 U.S.C. 552(a)

and 1 CFR part 51. Copies may be obtained

from American Eurocopter Corporation, 2701

Forum Drive, Grand Prairie, Texas 75053–

4005, telephone (972) 641–3460, fax (972)

641–3527. Copies may be inspected at the

FAA, Office of the Regional Counsel,

Southwest Region, 2601 Meacham Blvd.,

Room 663, Fort Worth, Texas; or at the Office

of the Federal Register, 800 North Capitol

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

(g) This amendment becomes effective on

May 4, 1998, to all persons except those

persons to whom it was made immediately

effective by Priority Letter AD 98–04–40,

issued February 12, 1998, which contained

the requirements of this amendment.

Note 3: The subject of this AD is addressed

in Direction Generale De L’Aviation Civile

(France) AD 98–088–055(A) and 98–089–

038(A), dated February 25, 1998.

Issued in Fort Worth, Texas, on April 3,

1998.

Henry A. Armstrong,

Manager, Rotorcraft Directorate, Aircraft

Certification Service.

[FR Doc. 98–10175 Filed 4–16–98; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

New Animal Drugs For Use In Animal

Feeds; Bacitracin Zinc; Technical

Amendment

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; technical

amendment.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulation for use of

bacitracin zinc Type A medicated

articles to make Type C medicated feeds
Federal Register / Vol. 63, No. 74 / Friday, April 17, 1998 /Rules and Regulations 19185

in combination with other drugs to

include certain other drugs that have

been approved elsewhere in the animal

drug regulations. This action is being

taken to ensure the accuracy and

consistency of the regulation because

the cross-references were not updated at

the time the combination drug uses

were approved.

EFFECTIVE DATE: April 17, 1998.

FOR FURTHER INFORMATION CONTACT:

David L. Gordon, Center for Veterinary

Medicine (HFV–6), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1739.

SUPPLEMENTARY INFORMATION: In

§ 558.78(d)(3) (21 CFR 558.78(d)(3))

FDA codified a list of combinations in

which bacitracin zinc is approved for

use with certain drugs that have been

approved elsewhere in 21 CFR part 558.

Several cross-references to approved

combination drug uses were not

included in that list. Section

558.78(d)(3) is amended to add those

cross-references.

List of Subjects in 21 CFR Part 558

Animal drugs, Animal feeds.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Center for Veterinary Medicine, 21

CFR part 558 is amended as follows:

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

1. The authority citation for 21 CFR

part 558 continues to read as follows:

Authority: 21 U.S.C. 360b, 371.

2. Section 558.78 is amended by

revising paragraph (d)(3) to read as

follows:

§ 558.78 Bacitracin zinc.

* * * * *

(d) * * *

(3) Bacitracin zinc may be used as

approved in combination as follows:

(i) Amprolium as in § 558.55.

(ii) Amprolium and roxarsone as in

§ 558.55.

(iii) Amprolium and ethopabate as in

§ 558.58.

(iv) Amprolium and ethopabate with

roxarsone as in § 558.58.

(v) Carbarsone as in § 558.120.

(vi) Clopidol as in § 558.175.

(vii) Clopidol and roxarsone as in

§ 558.175.

(viii) Decoquinate as in § 558.195.

(ix) Decoquinate and roxarsone as in

§ 558.195.

(x) Hygromycin B as in § 558.274.

(xi) Hygromycin B and penicillin as in

§ 558.274.

(xii) Lasalocid sodium and roxarsone

as in § 558.311.

(xiii) Monensin as in § 558.355.

(xiv) Monensin and roxarsone as in

§ 558.355.

(xv) Robenidine as in § 558.515.

(xvi) Salinomycin as in § 558.550.

(xvii) Salinomycin and roxarsone as

in § 558.550.

(xviii) Zoalene as in § 558.680.

(xix) Zoalene and arsanilic acid as in

§ 558.680.

(xx) Zoalene and roxarsone as in

§ 558.680.

Dated: March 31, 1998.

Andrew J. Beaulieu,

Deputy Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 98–10251 Filed 4–16–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 814

[Docket No. 98N–0171]

Medical Devices; Humanitarian Use of

Devices

AGENCY: Food and Drug Administration,

HHS.

ACTION: Direct final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

regulations governing humanitarian use

devices. These amendments are being

made to implement provisions of the

Federal Food, Drug, and Cosmetic Act

(the act) as amended by the Food and

Drug Administration Modernization Act

of 1997 (FDAMA). Elsewhere in this

issue of the Federal Register, FDA is

publishing a companion proposed rule,

under FDA’s usual procedures for notice

and comment, to provide a procedural

framework to finalize the rule in the

event the agency receives any

significant adverse comment and

withdraws the direct final rule.

DATES: This rule is effective August 31,

1998. Submit written comments on or

before July 1, 1998. Submit written

comments on the information collection

provisions on or before June 16, 1998.

If FDA receives no significant adverse

comments within the specified

comment period, the agency intends to

publish a document confirming the

effective date of the final rule in the

Federal Register within 30 days after

the comment period on this direct final

rule ends.

ADDRESSES: Submit written comments

on the direct final rule to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Joanne R. Less, Center for Devices and

Radiological Health (HFZ–403), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20857,

301–594–1190.

SUPPLEMENTARY INFORMATION:

I. Background

The Safe Medical Devices Act of 1990

(Pub. L. 101–629) added section 520(m)

to the act (21 U.S.C. 360j(m)). Section

520(m) creates an incentive for the

development of humanitarian use

devices (HUD) for use in the treatment

or diagnosis of diseases or conditions

affecting a small number of individuals.

Section 520(m) authorizes FDA, by

regulation, to exempt a HUD from the

effectiveness requirements of section

514 and 515 of the act (21 U.S.C. 360d

and 360e) (i.e., ‘‘reasonable assurance

that the device is effective’’) provided

that: (1) The device is to be used to treat

or diagnose a disease or condition that

affects fewer than 4,000 individuals in

the United States; (2) the device would

not be available to a person with such

a disease or condition unless the

exemption is granted; (3) no comparable

device (other than a device that has

been granted such an exemption) is

available to treat or diagnose the disease

or condition; and (4) the device will not

expose patients to an unreasonable or

significant risk of illness or injury, and

the probable benefit to health from

using the device outweighs the risk of

injury or illness from its use, taking into

account the probable risks and benefits

of currently available devices to

alternative forms of treatments.

In the Federal Register of June 26,

1996 (61 FR 33232), FDA published a

final rule prescribing the procedures for

submitting humanitarian device

exemption (HDE) applications,

amendments, and supplements;

procedures for obtaining an extension of

the exemption; and the criteria for FDA

review and approval of HDE’s. This rule

amended part 814 (21 CFR part 814) of

FDA’s regulations.

On November 21, 1997, the President

signed into law FDAMA (Pub. L. 105–

115). Section 203 of FDAMA made the

following changes to section 520(m) of

the act:

(1) FDAMA added a new provision to

section 520(m) of the act that requires

FDA to issue an order approving or

denying an HDE within 75 days after

receiving the application.

(2) FDAMA provided for an

exemption from the requirement that a