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:

Federal Register / Vol. 65, No. 229 / Tuesday, November 28, 2000 / Rules and Regulations 70791

Authority: 21 U.S.C. 342, 360b, 371.

2. Section 556.70 is revised to read as

follows:

§ 556.70 Bacitracin.

(a) Acceptable daily intake (ADI). The

ADI for total residues of bacitracin is

0.05 milligram per kilogram of body

weight per day.

(b) Tolerances. The tolerance for

residues of bacitracin from zinc

bacitracin or bacitracin methylene

disalicylate in uncooked edible tissues

of cattle, swine, chickens, turkeys,

pheasants, and quail, and in milk and

eggs is 0.5 part per million.

3. Section 556.592 is added to subpart

B to read as follows:

§ 556.592 Salinomycin.

(a) Acceptable daily intake (ADI). The

ADI for total residues of salinomycin is

0.005 milligram per kilogram of body

weight per day.

(b) [Reserved]

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 558.550 is amended by

adding paragraphs (a)(3), (d)(1)(xx), and

(d)(1)(xxi); by redesignating paragraphs

(d)(3)(ii), (d)(3)(iii), and (d)(3)(iv) as

paragraphs (d)(3)(iv), (d)(3)(vi), and

(d)(3)(vii), respectively; and by adding

paragraphs (d)(3)(ii), (d)(3)(iii), and

(d)(3)(v) to read as follows:

§ 558.550 Salinomycin.

(a) * * *

(3) To 046573 for use as in paragraphs

(d)(1)(xv), (d)(1)(xvi), (d)(1)(xviii)

through (d)(1)(xxi), and (d)(3)(ii)

through (d)(3)(vii) of this section.

* * * * *

(d) * * *

(1) * * *

(xx)(A) Amount per ton. Salinomycin,

40 to 60 grams; and bacitracin

methylene disalicylate, 50 grams.

(B) Indications for use. For the

prevention of coccidiosis caused by

Eimeria 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.

(C) Limitations. Feed continuously as

sole ration. Do not feed to laying

chickens. May be fatal if fed to adult

turkeys or to horses. Salinomycin as

provided by 063238; bacitracin

methylene disalicylate as provided by

046573 in § 510.600(c) in this chapter.

(xxi)(A) Amount per ton.

Salinomycin, 40 to 60 grams; and

bacitracin methylene disalicylate, 100 to

200 grams.

(B) Indications for use. For the

prevention of coccidiosis caused by

Eimeria 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.

(C) Limitations. Feed continuously as

sole ration. To control necrotic enteritis,

start medication at first clinical signs of

disease; vary dosage based on the

severity of infection; administer

continuously for 5 to 7 days or as long

as clinical signs persist, then reduce

bacitracin to prevention level (50 grams

per ton). Do not feed to laying chickens.

May be fatal if fed to adult turkeys or

to horses. Salinomycin as provided by

063238; bacitracin methylene

disalicylate as provided by 046573 in

§ 510.600(c) in this chapter.

* * * * *

(3) * * *

(ii) Amount per ton. Salinomycin, 40

to 60 grams, and bacitracin methylene

disalicylate, 4 to 50 grams.

(A) Indications for use. For the

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.

(B) Limitations. Feed continuously as

sole ration. Discontinue use prior to

sexual maturity. Do not feed to laying

chickens. May be fatal if fed to adult

turkeys or to horses. Salinomycin as

provided by 063238; bacitracin

methylene disalicylate as provided by

046573 in § 510.600(c) of this chapter.

(iii) Amount per ton. Salinomycin, 40

to 60 grams, and bacitracin methylene

disalicylate, 50 grams.

(A) Indications for use. For the

prevention of coccidiosis caused by

Eimeria 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.

(B) Limitations. Feed continuously as

sole ration. Discontinue use prior to

sexual maturity. Do not feed to laying

chickens. May be fatal if fed to adult

turkeys or to horses. Salinomycin as

provided by 063238; bacitracin

methylene disalicylate as provided by

046573 in § 510.600(c) of this chapter.

* * * * *

(v) Amount per ton. Salinomycin, 40

to 60 grams, and bacitracin methylene

disalicylate, 100 to 200 grams.

(A) Indications for use. For the

prevention of coccidiosis caused by

Eimeria 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.

(B) Limitations. Feed continuously as

sole ration. To control necrotic enteritis,

start medication at first clinical signs of

disease; vary dosage based on the

severity of infection; administer

continuously for 5 to 7 days or as long

as clinical signs persist, then reduce

bacitracin to prevention level (50 grams

per ton). Discontinue use prior to sexual

maturity. Do not feed to laying chickens.

May be fatal if fed to adult turkeys or

to horses. Salinomycin as provided by

063238; bacitracin methylene

disalicylate as provided by 046573 in

§ 510.600(c) of this chapter.

* * * * *

Dated: November 6, 2000.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 00–30327 Filed 11–27–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Part 25

[TD 8899]

RIN 1545–AW25

Definition of a Qualified Interest in a

Grantor Retained Annuity Trust and a

Grantor Retained Unitrust; Correction

AGENCY: Internal Revenue Service (IRS),

Treasury.

ACTION: Correction to final regulations.

SUMMARY: This document contains

corrections to final regulations that were

published in the Federal Register on

Tuesday, September 5, 2000 (65 FR

53587), relating to the definition of a

qualified interest under section 2702 of

the Internal Revenue Code.

DATES: This correction is effective

September 5, 2000.

FOR FURTHER INFORMATION CONTACT:

James F. Hogan (202) 622–3090 (not a

toll-free number).