Federal Register / Vol. 65, No. 229 / Tuesday, November 28, 2000 / Rules and Regulations 70789

Alternative Methods of Compliance

(e) 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.

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 2: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Seattle ACO.

Special Flight Permits

(f) 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.

Incorporation by Reference

(g) The actions shall be done in accordance

with Boeing Alert Service Bulletin 777–

26A0012, dated May 1, 1997, and Boeing

Alert Service Bulletin 777–26A0009, dated

October 23, 1997.

(1) The incorporation by reference of

Boeing Alert Service Bulletin 777–26A0009,

dated October 23, 1997, is approved by the

Director of the Federal Register in accordance

with 5 U.S.C. 552(a) and 1 CFR part 51.

(2) The incorporation by reference of

Boeing Alert Service Bulletin 777–26A0012,

dated May 1, 1997, was approved previously

by the Director of the Federal Register as of

May 27, 1997 (62 FR 25837, May 12, 1997).

(3) Copies may be obtained from Boeing

Commercial Airplane Group, P.O. Box 3707,

Seattle, Washington 98124–2207. 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.

Effective Date

(h) This amendment becomes effective on

January 2, 2001.

Issued in Renton, Washington, on

November 15, 2000.

Donald L. Riggin,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 00–29799 Filed 11–27–00; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 176

[Docket No. 99F–1719]

Indirect Food Additives: Paper and

Paperboard Components

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 4-(diiodomethylsulfonyl)

toluene as a slimicide in the

manufacture of food-contact paper and

paperboard. This action is in response

to a petition filed by Angus Chemical

Co.

DATES: This rule is effective November

28, 2000. Submit written objections and

requests for a hearing by December 28,

2000.

ADDRESSES: Submit written objections to

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852.

FOR FURTHER INFORMATION CONTACT:

Mark A. Hepp, Center for Food Safety

and Applied Nutrition (HFS–215), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3098.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

June 11, 1999 (64 FR 31593), FDA

announced that a food additive petition

(FAP 9B4668) had been filed by Angus

Chemical Co., c/o Phillip A. Johns,

10900 Silent Wood Pl., North Potomac,

MD 20878–4829. The petition proposed

to amend the food additive regulations

in § 176.300 Slimicides (21 CFR

176.300) to provide for the safe use of

4-(diiodomethylsulfonyl) toluene as a

slimicide in the manufacture of foodcontact paper and paperboard.

FDA has evaluated data in the

petition and other relevant material.

Based on this information, the agency

concludes that: (1) The proposed use of

the additive as a slimicide in the

manufacture of food-contact paper and

paperboard is safe, (2) the additive will

achieve its intended technical effect,

and therefore, (3) the regulations in

§ 176.300 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 rule as announced in the notice of

filing for the petition. No new

information or comments have been

received that would affect the agency’s

previous determination that there is no

significant impact on the human

environment and that an environmental

impact statement is not required.

This final rule contains no collection

of information. Therefore, clearance by

the Office of Management and Budget

under the Paperwork Reduction Act of

1995 is not required.

Any person who will be adversely

affected by this regulation may at any

time file with the Dockets Management

Branch (address above) written

objections by December 28, 2000. 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

are to be submitted and are to 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 176

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 176 is

amended as follows:

PART 176—INDIRECT FOOD

ADDITIVES: PAPER AND

PAPERBOARD COMPONENTS

1. The authority citation for 21 CFR

part 176 continues to read as follows:

Authority: 21 U.S.C. 321, 342, 346, 348,

379e.

2. Section 176.300 is amended in the

table in paragraph (c) by alphabetically

adding an entry under the headings

‘‘List of substances’’ and ‘‘Limitations’’

to read as follows:

70790 Federal Register / Vol. 65, No. 229 / Tuesday, November 28, 2000 / Rules and Regulations

§ 176.300 Slimicides.

* * * * *

(c) * * *

List of substances Limitations

*******

4-(Diiodomethylsulfonyl) toluene (CAS Reg. No. 20018–09–01). At a maximum level of 0.2 pound per ton (100 grams/1,000 kilograms)

of dry weight fiber.

*******

* * * * *

Dated: November 14, 2000.

L. Robert Lake,

Director of Regulations and Policy, Center

for Food Safety and Applied Nutrition.

[FR Doc. 00–30328 Filed 11–27–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 556 and 558

New Animal Drugs for Use in Animal

Feeds; Salinomycin and Bacitracin

Methylene Disalicylate

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect

approval of a new animal drug

application (NADA) filed by Alpharma,

Inc. The NADA provides for use of

approved, single-ingredient salinomycin

and bacitracin methylene disalicylate

Type A medicated articles to make twoway combination drug Type C

medicated feeds for broiler, roaster, and

replacement (breeder and layer)

chickens. The Type C medicated feeds

are used for prevention of coccidiosis

and as an aid in the prevention and

control of necrotic enteritis in broiler,

roaster, and replacement (breeder and

layer) chickens; and for prevention of

coccidiosis, increased rate of weight

gain, and improved feed efficiency in

roaster and replacement (breeder and

layer) chickens. Previously established

acceptable daily intakes (ADI’s) for total

residues of bacitracin and salinomycin

are also being codified.

DATES: This rule is effective November

28, 2000.

FOR FURTHER INFORMATION CONTACT:

Charles J. Andres, Center for Veterinary

Medicine (HFV–128), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–1600.

SUPPLEMENTARY INFORMATION: Alpharma,

Inc., One Executive Dr., P.O. Box 1399,

Fort Lee, NJ 07024, filed NADA 141–136

that provides for use of approved BIOCOX (30 or 60 grams per pound (g/lb)

of salinomycin activity) and BMD (10,

25, 30, 40, 50, 60, or 75 g/lb bacitracin

methylene disalicylate) Type A

medicated articles to make combination

drug Type C medicated feeds for use in

broiler, roaster, and replacement

(breeder and layer) chickens. The

combination Type C medicated feeds

containing 40 to 60 g/ton salinomycin

and 4 to 50 g/ton bacitracin methylene

disalicylate are used for prevention of

coccidiosis caused by Eimeria tenella, E.

necatrix, E. acervulina, E. maxima, E.

brunetti, and E. mivati, and for

increased rate of weight gain and

improved feed efficiency in roaster and

replacement (breeder and layer)

chickens. The combination Type C

medicated feeds containing 40 to 60 g/

ton salinomycin and 50 g/ton bacitracin

methylene disalicylate are used for the

prevention of coccidiosis caused by E.

tenella, E. necatrix, E. acervulina, E.

maxima, E. brunetti, and E. mivati, and

as an aid in the prevention of necrotic

enteritis caused or complicated by

Clostridium spp. or other organisms

susceptible to bacitracin in broiler,

roaster, and replacement (breeder and

layer) chickens. The combination Type

C medicated feeds containing 40 to 60

g/ton salinomycin and 100 to 200 g/ton

bacitracin methylene disalicylate are

used for the prevention of coccidiosis

caused by E. tenella, E. necatrix, E.

acervulina, E. maxima, E. brunetti, and

E. mivati, and as an aid in the control

of necrotic enteritis caused or

complicated by Clostridium spp. or

other organisms susceptible to

bacitracin in broiler, roaster, and

replacement (breeder and layer)

chickens. The NADA is approved as of

September 20, 2000, and the regulations

are amended in 21 CFR 558.550 to

reflect the approval. The basis for

approval is discussed in the freedom of

information summary.

In addition, the regulations are

amended in 21 CFR part 556 to add the

previously established ADI’s for total

residues of bacitracin and salinomycin,

and editorially, to reflect current format. In accordance with the freedom of

information provisions of 21 CFR part

20 and 514.11(e)(2)(ii), a summary of

safety and effectiveness data and

information submitted to support

approval of this application may be seen

in the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852, between 9

a.m. and 4 p.m., Monday through

Friday. The agency has determined under 21

CFR 25.33(a)(2) that this action is of a

type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required. This rule does not meet the definition

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because

it is a rule of ‘‘particular applicability.’’

Therefore, it is not subject to the

congressional review requirements in 5

U.S.C. 801–808.

List of Subjects

21 CFR Part 556

Animal drugs, Food.

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 parts 556 and 558 are amended as

follows:

PART 556—TOLERANCES FOR

RESIDUES OF NEW ANIMAL DRUGS

IN FOOD

1. The authority citation for 21 CFR

part 556 continues to read as follows: