Federal Register / Vol. 60, No. 31 / Wednesday, February 15, 1995 / Rules and Regulations 8545

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 Number 94–NM–216–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.

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. App. 1354(a), 1421

and 1423; 49 U.S.C. 106(g); and 14 CFR

11.89.

§ 39.13 [Amended]

2. Section 39.13 is amended by

adding the following new airworthiness

directive:

95–02–11 McDonnell Douglas: Amendment

39–9130. Docket 94–NM–216–AD.

Applicability: Model DC–9–87 (MD–87)

series airplanes having factory serial numbers

(FSN) 49605 through 49612 inclusive, 49614,

53009 through 53011 inclusive, 53336,

53337, 53340, and 53348; 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

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 use the authority

provided in paragraph (b) 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 airplane from

the applicability of this AD.

Compliance: Required as indicated, unless

accomplished previously.

To prevent severe damage to the airframe

in the event of a fire, accomplish the

following:

(a) Within 12 months after the effective

date of this AD, perform a visual inspection

to detect chafing or arcing damage to the

wiring of the aft right coatroom, the

intercostal, and the recirculation duct

assembly near longeron 5 (between stations

Y=1078.000 and Y=1098.000), in accordance

with McDonnell Douglas MD–80 Service

Bulletin 24–151, dated September 29, 1994.

(1) If no damage is found, prior to further

flight, modify the wiring installation for the

aft right coatroom (reference paragraph 1.C.,

Condition I, of the service bulletin) in

accordance with the procedures described in

the service bulletin.

(2) If any damage is found, prior to further

flight, modify the wiring installation for the

aft right coatroom (reference paragraph 1.C.,

Condition II, of the service bulletin) in

accordance with the procedures described in

the service bulletin.

(b) 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, Los

Angeles ACO. Operators shall submit their

requests through an appropriate FAA

Principal Maintenance Inspector, who may

add comments and then send it to the

Manager, Los Angeles ACO.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Los Angeles ACO.

(c) Special flight permits may be issued in

accordance with §§ 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.

(d) The inspection and modification shall

be done in accordance with McDonnell

Douglas MD–80 Serivce Bulletin 24–151,

dated September 29, 1994. 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

McDonnell Douglas Corporation, P.O. Box

1771, Long Beach, California 90801–1771,

Attention: Business Unit Manager, Technical

Administrative Support, Dept. L51, M.C. 2–

98. Copies may be inspected at the FAA,

Transport Airplane Directorate, 1601 Lind

Avenue, SW., Renton, Washington; or at the

FAA, Transport Airplane Directorate, Los

Angeles Aircraft Certification Office, 3960

Paramount Boulevard, Lakewood, California;

or at the Office of the Federal Register, 800

North Capitol Street NW., suite 700,

Washington, DC.

(e) This amendment becomes effective on

March 2, 1995.

Issued in Renton, Washington, on January

24, 1995.

Darrell M. Pederson,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 95–2177 Filed 2–14–95; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 91F–0271]

Indirect Food Additives: Adjuvants,

Production Aids, and Sanitizers

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

food additive regulations to provide for

the safe use of β, 3(or 4)-

bis(octadecylthio)cyclohexylethane as

an antioxidant for general use in

polymeric food-contact articles. This

action is in response to a petition filed

by Atochem North America, Inc.

DATES: Effective February 15, 1995;

written objections and requests for a

hearing by March 17, 1995.
8546 Federal Register / Vol. 60, No. 31 / Wednesday, February 15, 1995 / Rules and Regulations

ADDRESSES: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Vir

Anand, Center for Food Safety and

Applied Nutrition (HFS–216), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–254–9500.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

August 8, 1991 (56 FR 37712), FDA

announced that a food additive petition

(FAP 1B4274) had been filed by

Atochem North America, Inc., c/o 1150

17th St. NW., Washington, DC 20036

(presently, 1001 G St. NW, suite 500

West, Washington, DC 20001). The

petition proposed that the food additive

regulations be amended in § 176.170

Components of paper and paperboard

in contact with aqueous and fatty foods

(21 CFR 176.170) to provide for the safe

use of β, 3(or 4)-

bis(octadecylthio)cyclohexylethane as

an antioxidant in polymeric articles

intended for food-contact uses. The

agency reviewed the nomenclature of

the additive and has determined that to

ensure unambiguous identification of

the compound, a synonym compatible

with the Chemical Abstract Service

nomenclature, namely, 1-[(beta-

(octadecylthio)ethyl]-3(or 4)-

(octadecylthio)cyclohexane, should be

included in this final rule.

Upon further review of the petition,

the agency noted that the petitioner had

requested use of the additive for general

use in polymers rather than as an

additive for paper and paperboard. In a

notice published in the Federal Register

of September 11, 1991 (56 FR 46323),

FDA amended the filing notice of

August 8, 1991, to state that the

petitioner had requested that the food

additive regulations be amended in

§ 178.2010 Antioxidants and/or

stabilizers for polymers (21 CFR

178.2010) to provide for the use of β,

3(or 4)-

bis(octadecylthio)cyclohexylethane as

an antioxidant for general use in

polymeric food-contact articles.

FDA has evaluated the data in the

petition and other relevant material. The

agency concludes that the proposed use

of the additive is safe and that the

regulations in § 178.2010 should be

amended as set forth below.

In accordance with § 171.1(h) (21 CFR

171.1(h)), the petition and the

documents that FDA considered and

relied upon in reaching its decision to

approve the petition are available for

inspection at the Center for Food Safety

and Applied Nutrition by appointment

with the information contact person

listed above. As provided in 21 CFR

171.1(h), the agency will delete from the

documents any materials that are not

available for public disclosure before

making the documents available for

inspection.

The agency has carefully considered

the potential environmental effects of

this action. FDA has concluded that the

action will not have a significant impact

on the human environment, and that an

environmental impact statement is not

required. The agency’s finding of no

significant impact and the evidence

supporting that finding, contained in an

environmental assessment, may be seen

in the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

Any person who will be adversely

affected by this regulation may at any

time on or before March 17, 1995, file

with the Dockets Management Branch

(address above) written objections

thereto. Each objection shall be

separately numbered, and each

numbered objection shall specify with

particularity the provisions of the

regulation to which objection is made

and the grounds for the objection. Each

numbered objection on which a hearing

is requested shall specifically so state.

Failure to request a hearing for any

particular objection shall constitute a

waiver of the right to a hearing on that

objection. Each numbered objection for

which a hearing is requested shall

include a detailed description and

analysis of the specific factual

information intended to be presented in

support of the objection in the event

that a hearing is held. Failure to include

such a description and analysis for any

particular objection shall constitute a

waiver of the right to a hearing on the

objection. Three copies of all documents

shall be submitted and shall be

identified with the docket number

found in brackets in the heading of this

document. Any objections received in

response to the regulation may be seen

in the Dockets Management Branch

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

through Friday.

List of Subjects in 21 CFR Part 178

Food additives, Food packaging.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Director, Center for Food Safety and

Applied Nutrition, 21 CFR part 178 is

amended as follows:

PART 178—INDIRECT FOOD

ADDITIVES: ADJUVANTS,

PRODUCTION AIDS, AND SANITIZERS

1. The authority citation for 21 CFR

part 178 continues to read as follows:

Authority: Secs. 201, 402, 409, 721 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 321, 342, 348, 379e).

2. Section 178.2010 is amended in the

table in paragraph (b) by alphabetically

adding a new entry under the headings

‘‘Substances’’ and ‘‘Limitations’’ to read

as follows:

§ 178.2010 Antioxidants and/or stabilizers

for polymers.

* * * * *

(b) * * *

Substances Limitations

* * * * * * *

β, 3(or 4)-Bis(octadecylthio)cyclohexylethane (CAS Reg. No. 37625–

75–5); CAS synonym: 1-[(beta-(octadecylthio)ethyl]-3(or 4)-

(octadecylthio)cyclohexane.

For use only:

1. At levels not to exceed 0.3 percent by weight of all polymers for use

in contact with foods of Types I, II, IV-B, VI, VII-B, and VIII under

conditions of use B through H as described in Tables 1 and 2 of

§ 176.170(c) of this chapter.

2. At levels not to exceed 0.3 percent by weight of polyolefins complying with § 177.1520 of this chapter, for use in contact with food of

types III, IV-A, V, VII-A, and IX under conditions of use C through G

as described in Tables 1 and 2 of § 176.170(c) of this chapter.

* * * * * * *
Federal Register / Vol. 60, No. 31 / Wednesday, February 15, 1995 / Rules and Regulations 8547

Dated: February 3, 1995.

Fred R. Shank,

Director, Center for Food Safety and Applied

Nutrition.

[FR Doc. 95–3804 Filed 2–14–95; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 558

New Animal Drugs for Use in Animal

Feeds; Tylosin and Virginiamycin

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to remove those

portions reflecting approval of four new

animal drug applications (NADA’s) held

by Premiere Agri Technologies, Inc. The

NADA’s provide for use of Type A

medicated articles and Type B

medicated feeds containing tylosin and

Type B medicated feeds containing

virginiamycin. In a notice published

elsewhere in this issue of the Federal

Register, FDA is withdrawing approval

of the NADA’s.

EFFECTIVE DATE: February 27, 1995.

FOR FURTHER INFORMATION CONTACT:

Mohammad I. Sharar, Center for

Veterinary Medicine (HFV–216), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–594–

1722.

SUPPLEMENTARY INFORMATION: In a notice

published elsewhere in this issue of the

Federal Register, FDA is withdrawing

approval of the following NADA’s:

NADA

No. Drug name Sponsor nameand address

45–690 . Tylosin Type B

medicated

feeds and

Type A medicated article.

Premiere Agri

Technologies,

Inc., P.O. Box

2508, Fort

Wayne, IN

46801–2508

(former sponsor Henwood

Feed Additives)

97–289 . Tylosin Type B

medicated

feeds and

Type A medicated article.

Do. (Former

sponsor Feed

Specialties

Co., Inc.)

133–361 Virginiamycin

Type B medicated feed.

Do. (Former

sponsor Feed

Specialties

Co., Inc.)

133–839 Virginiamycin

Type B medicated feed.

Do. (Former

sponsor MacPage, Inc.)

The sponsor requested withdrawal of

approval of the NADA’s. This final rule

removes 21 CFR 558.625(b)(11) and

(b)(15) and amends 21 CFR

558.635(b)(2) to reflect the withdrawal

of approval of these NADA’s.

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: Secs. 512, 701 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

360b, 371).

§ 558.625 [Amended]

2. Section 558.625 Tylosin is

amended by removing and reserving

paragraphs (b)(11) and (b)(15).

3. Section 558.635 Virginiamycin is

amended by revising paragraph (b)(2) to

read as follows:

§ 558.635 Virginiamycin

* * * * *

(b) * * *

(2) 2.2 percent activity (10 grams per

pound) to 011490, 016968, and 017790

in § 510.600(c) of this chapter for use as

in paragraphs (f)(1)(iv) and (f)(1)(v) of

this section.

* * * * *

Dated: January 6, 1995.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 95–3802 Filed 2–14–95; 8:45 am]

BILLING CODE 4160–01–F

UNITED STATES INFORMATION

AGENCY

22 CFR Part 514

[Rulemaking No. 110]

Exchange Visitor Program

AGENCY: United States Information

Agency.

ACTION: Final rule.

SUMMARY: The Agency hereby adopts as

final with modifications the interim rule

governing its oversight and

administration of au pair programs. Au

pair programs permit foreign nationals

to enter the United States for a period

of one year for the purpose of residing

with an American host family while

participating directly in the home life of

the family and providing limited child

care services. The foreign national also

attends a United States accredited postsecondary educational institution.

These rules are promulgated pursuant to

Public Law 103–415 which authorizes

the continued operation, until

September 30, 1995, of au pair programs

currently designated by the Agency.

DATES: Effective date: These rules are

effective February 15, 1995.

Applicability dates: With the

exceptions of § 514.31(j) (1) and (4), and

§ 514.31(k), these rules apply to all au

pair placements and operations as of

February 15, 1995. The provisions set

forth at § 514.31(j) (1) and (4) and

§ 514.31(k) shall apply only to au pair

participants placed after date of

publication.

Compliance date: Sponsor

implementation of the provisions set

forth at § 514.31(g) (1) and (2) will not

be expected before March 31, 1995.

FOR FURTHER INFORMATION CONTACT:

Stanley S. Colvin, Assistant General

Counsel, United States Information

Agency, 301 4th Street, SW.,

Washington, DC 20547; Telephone,

(202) 619–6829.

SUPPLEMENTARY INFORMATION: First

begun pursuant to the provisions of the

United States Information and

Educational Exchange Act of 1948

(‘‘Smith-Mundt’’), and subsequently

incorporated into and broadened under

the Fulbright-Hays Act, educational and

cultural exchange activities have, over

the past forty years, exposed millions of

foreign nationals to the United States,

its peoples, cultures, skills, business

techniques, educational institutions,

and way of life. The Fulbright-Hays Act

mandates reciprocal exchange and

Americans traveling abroad have, in

similar fashion, developed an enhanced

awareness of foreign people, their

cultures and societies. Thus, FulbrightHays programs further one of the

Agency’s primary missions: increasing

mutual understanding between

Americans and others through peopleto-people contact. Originally conducted

by the Department of State, oversight of

exchange activities, occurring under the

umbrella of the Exchange Visitor

Program, has been the responsibility of

the Agency since 1978.

The Fulbright-Hays Act sets forth

certain parameters which all exchange

activities must meet. With an eye

towards ensuring that these parameters

were being met and acting in response

to a Congressional request, the General

Accounting Office (‘‘GAO’’) investigated

Agency oversight and administration of

the Exchange Visitor Program and its

attendant utilization of the J visa. In its

report to Congress, dated February 5,

1990 and entitled ‘‘Inappropriate Uses