Federal Register / Vol. 63, No. 98 /Thursday, May 21, 1998 /Rules and Regulations 27835

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:

98–11–07 Dornier Luftfahrt GmbH:

Amendment 39–10534. Docket 98–NM–

40–AD.

Applicability: Model 328–100 series

airplanes, serial numbers 3005 through 3086

inclusive; 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 request approval for an

alternative method of compliance in

accordance with paragraph (c) 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 ensure replacement of the double

shuttle valves when they have reached their

maximum life limit, accomplish the

following:

(a) Within 30 days after the effective date

of this AD, perform a one-time visual

inspection of the double shuttle valve in the

upper fuselage fairing to determine if the part

number of the valve is labeled correctly, in

accordance with Dornier Service Bulletin

SB–328–27–236, Revision 1, dated November

5, 1997.

(b) If the inspection required by paragraph

(a) of this AD reveals that the installed

double shuttle valve is labeled incorrectly,

prior to further flight, accomplish paragraphs

(b)(1) and (b)(2) of this AD, in accordance

with Dornier Service Bulletin SB–328–27–

236, Revision 1, dated November 5, 1997.

(1) Revise the valve identification label to

correctly identify the part number of the

double shuttle valve, and delete any

reference to operating pressure (i.e., BAR

205).

(2) Verify that the installed valve is within

the limits specified for that particular part

number in accordance with the service

bulletin. If the installed double shuttle valve

is outside the limits, prior to further flight,

replace the double shuttle valve with a new

part.

(c) 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,

International Branch, ANM–116, 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, International Branch,

ANM–116.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the International Branch,

ANM–116.

(d) 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.

(e) The actions shall be done in accordance

with Dornier Service Bulletin SB–328–27–

236, Revision 1, dated November 5, 1997.

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 FAIRCHILD DORNIER, DORNIER

Luftfahrt GmbH, P.O. Box 1103, D–82230

Wessling, Germany. Copies may be inspected

at the FAA, Transport Airplane Directorate,

1601 Lind Avenue, SW., Renton,

Washington; or at the Office of the Federal

Register, 800 North Capitol Street, NW., suite

700, Washington, DC.

Note 3: The subject of this AD is addressed

in German airworthiness directive 1997–321/

2, dated January 15, 1998.

(f) This amendment becomes effective on

June 25, 1998.

Issued in Renton, Washington, on May 13,

1998.

John J. Hickey,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 98–13312 Filed 5–20–98; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 178

[Docket No. 90F–0310]

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 1,11-(3,6,9-

trioxaundecyl)bis-3-

(dodecylthio)propionate as an

antioxidant for can end cements used in

contact with food. This action is in

response to a petition filed by Goodyear

Tire and Rubber Co.

DATES: The regulation is effective May

21, 1998. Submit written objections and

requests for a hearing by June 22, 1998.

ADDRESSES: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Vir

D. Anand, Center for Food Safety and

Applied Nutrition (HFS–215), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3081.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

October 30, 1990 (55 FR 45656), FDA

announced that a food additive petition

(FAP 0B4223) had been filed by

Goodyear Tire and Rubber Co., Akron,

OH 44316–0001 (presently c/o Keller

and Heckman, 1001 G St. NW., suite 500

West, Washington, DC 20001). The

petition proposed to amend the food

additive regulations in § 178.2010

Antioxidants and/or stabilizers for

polymers (21 CFR 178.2010) to provide

for the safe use of 1,11-(3,6,9-

trioxaundecyl)bis-3-

(dodecylthio)propionate as an

antioxidant for can end cements used in

contact with food.

FDA has evaluated data in the

petition and other relevant material.

Based on this information, the agency
27836 Federal Register / Vol. 63, No. 98 /Thursday, May 21, 1998 /Rules and Regulations

concludes that the proposed use of the

additive is safe, that the additive will

achieve its intended technical effect,

and therefore, 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 § 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 June 22, 1998, 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: 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

* * * * * * *

1, 11-(3, 6, 9-Trioxaundecyl) bis-3-(dodecylthio) propionate (CAS Reg.

No. 64253–30–1).

For use only as provided in § 175.300(b)(3)(xxxi) of this chapter at 4.0

parts per 100 parts rubber.

* * * * * * *

Dated: May 11, 1998.

L. Robert Lake,

Director, Office of Policy, Planning and

Strategic Initiatives, Center for Food Safety

and Applied Nutrition.

[FR Doc. 98–13469 Filed 5–20–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 201

[Docket No. 78N–036L]

RIN 0910–AA01

Package Size Limitation for Sodium

Phosphates Oral Solution and Warning

and Direction Statements for Oral and

Rectal Sodium Phosphates for Overthe-Counter Laxative Use

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is issuing a final

rule to limit the container size for

sodium phosphates oral solution

(dibasic sodium phosphate/monobasic

sodium phosphate oral solution) to not

greater than 90 milliliters (mL) (3

ounces (oz)) when used as an over-thecounter (OTC) laxative drug product.

FDA is limiting the container size

because of reports of deaths associated

with an overdosage of sodium

phosphates oral solution when the

product was packaged in a larger-size

container and a larger than intended

dose was ingested inadvertently. The

agency is also requiring warning and

direction statements to inform

consumers that exceeding the

recommended dose of oral and rectal

sodium phosphates products in a 24-

hour period can be harmful. This final

rule is part of the ongoing review of

OTC drug products conducted by FDA.

DATES: The regulation is effective June

22, 1998, however compliance with