712 Federal Register / Vol. 66, No. 3 / Thursday, January 4, 2001 / Rules and Regulations

Staphylococcus aureus); upper

respiratory infections such as rhinitis or

pharyngitis (Cpyogenes); blackleg

(Clostridium chauvoei).

(B) As in paragraph (d)(2)(ii)(A) of this

section; and prophylaxis of bovine

shipping fever in 300- to 500-pound

beef calves.

(iii) Limitations. Limit treatment to

two doses. Not for use within 30 days

of slaughter.

3. Section 522.1696b is revised to read

as follows.

§ 522.1696b Penicillin G procaine aqueous

suspension.

(a) Specifications. Each milliliter

contains penicillin G procaine

equivalent to 300,000 units of penicillin

G.

(b) Sponsors. See sponsor numbers in

§ 510.600(c) of this chapter as follows:

(1) Nos. 010515, 053501, and 059130

for use as in paragraph (d) of this

section.

(2) Nos. 000864 and 055529 for use as

in paragraph (d)(2) of this section.

(c) Related tolerances. See § 556.510

of this chapter.

(d) Conditions of use—(1) Dogs and

cats—(i) Amount. 10,000 units per

pound body weight daily by

intramuscular injection at 24-hour

intervals. Continue treatment at least 48

hours after symptoms disappear.

(ii) Indications for use. Treatment of

infections caused by penicillin-sensitive

organisms.

(iii) Limitations. Federal law restricts

this drug to use by or on the order of

a licensed veterinarian.

(2) Cattle, sheep, swine, and horses—

(i) Amount. 3,000 units per pound body

weight (1 milliliter per 100 pounds body

weight) daily by intramuscular

injection.

(A) For Nos. 000864, 010515, 053501,

and 059130: Continue treatment at least

48 hours after symptoms disappear.

(B) For No. 055529: Continue

treatment at least 1 day after symptoms

disappear (usually 2 or 3 days).

(ii) Indications for use. Treatment of

cattle and sheep for bacterial

pneumonia (shipping fever) caused by

Pasteurella multocida; swine for

erysipelas caused by Erysipelothrix

insidiosa; and horses for strangles

caused by Streptococcus equi.

(iii) Limitations. Not for use in horses

intended for food.

(A) For Nos. 000864, 010515, 053501,

and 059130: Do not exceed 7 days of

treatment in nonlactating dairy and beef

cattle, sheep, and swine, or 5 days in

lactating cattle. Milk that has been taken

during treatment and for 48 hours after

the last treatment must not be used for

food. Discontinue treatment for the

following number of days before

slaughter: Nonruminating cattle

(calves)—7, all other cattle—4, sheep—

8, and swine—6.

(B) For No. 055529: Treatment should

not exceed 4 consecutive days. Milk that

has been taken during treatment and for

72 hours after the last treatment must

not be used for food. Discontinue

treatment for the following number of

days before slaughter: Cattle—10,

sheep—9, and swine—7.

Dated: December 12, 2000.

Melanie R. Berson,

Acting Deputy Director, Office of New Animal

Drug Evaluation, Center for Veterinatiy

Medicine.

[FR Doc. 01–72 Filed 1–3–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524

Ophthalmic and Topical Dosage Form

New Animal Drugs; Gentamicin

Sulfate, Mometasone Furoate,

Clotrimazole Otic Suspension

AGENCY: Food and Drug Administration

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 ScheringPlough Animal Health Corp. The NADA

provides for veterinary prescription use

of gentamicin/mometasone/clotrimazole

otic suspension to treat otitis externa in

dogs.

DATES: This rule is effective January 4,

2001.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary

Medicine (HFV–110), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–7540.

SUPPLEMENTARY INFORMATION: ScheringPlough Animal Health Corp., 1095

Morris Ave., Union, NJ 07083, filed

NADA 141–177 that provides for

veterinary prescription use of

MometamaxTM gentamicin sulfate/

mometasone furoate/clotrimazole) Otic

Suspension for the treatment of otitis

externa associated with yeast

(Malassezia pachydermatis) and/or

bacteria susceptible to gentamicin in

dogs. The NADA is approved as of

December 5, 2000, and the regulations

are amended in 21 CFR 524 by adding

§ 524.1044h to reflect the approval. The

basis of approval is discussed in the

freedom of information summary.

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.

Under section 512(c)(2)(F)(ii) of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 360b(c)(2)(F)(ii)),

this approval qualifies for 3 years of

marketing exclusivity beginning

December 5, 2000, because the

application contains substantial

evidence of effectiveness of the drug

involved, or any studies of animal

safety, required for approval of the

application and conducted or sponsored

by the applicant.

The agency has determined under 21

CFR 25.33(d)(1) 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 in 21 CFR Part 524

Animal drugs.

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 524 is amended as follows:

PART 524—OPTHALMIC AND

TOPICAL DOSAGE FORM NEW

ANIMAL DRUGS

1. The authority citation for 21 CFR

part 524 continues to read as follows:

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

2. Section 524.1044h is added to read

as follows:

§ 524.1044h Gentamicin sulfate,

mometasone furoate, clotrimazole otic

suspension.

(a) Specifications. Each gram contains

gentamicin sulfate, United States

Pharmacopeia (USP) equivalent to 3-

milligram (mg) gentamicin base,

mometasone furoate monohydrate

Federal Register / Vol. 66, No. 3 / Thursday, January 4, 2001 / Rules and Regulations 713

equivalent to 1-mg mometasone, and 10

mg clotrimazole, USP.

(b) Sponsor. See No. 000061 in

§ 510.6(c) of this chapter.

(c) Conditions of use— Dogs—(1)

Amount. For dogs weighing less than 30

pounds (lb), instill 4 drops from the 5-

and 30-gram (g) bottle into the ear canal

(2 drops from the 215-g bottle) or, for

dogs weighing 30 lb or more, instill 8

drops from the 5- and 30-g bottle into

the ear canal (4 drops from the 215-g

bottle), twice daily for 7 days.

(2) Indications for use. For the

treatment of otitis externa associated

with yeast (Malassezia pachydermatis)

and/or bacteria susceptible to

gentamicin in dogs.

(3) Limitations. Federal law restricts

this drug to use by or on the order of

a licensed veterinarian.

Dated: December 26, 2000.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 01–140 Filed 1–3–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Part 1

[TD 8919]

RIN 1545–AY57

Guidance on Filing an Application for

a Tentative Carryback Adjustment in a

Consolidated Return Context

AGENCY: Internal Revenue Service (IRS),

Treasury.

ACTION: Temporary regulations.

SUMMARY: This document contains

temporary regulations relating to the

filing of an application for a tentative

carryback adjustment. These temporary

regulations provide guidance to

determine the time for filing such

application by a consolidated group.

This document also contains temporary

regulations relating to the filing of an

application for a tentative carryback

adjustment by certain corporations for

the separate return year created by their

becoming a member of a consolidated

group. These temporary regulations may

affect all consolidated groups. The text

of these temporary regulations also

serves as the text of proposed

regulations set forth in the notice of

proposed rulemaking on this subject in

the Proposed Rules section of this issue

of the Federal Register.

DATES: Effective Date: January 4, 2001.

Applicability Date: For dates of

applicability, see § 1.1502–78T (g)(2)(v)

of these regulations.

FOR FURTHER INFORMATION CONTACT:

Christopher M. Bass or Frances L. Kelly,

(202) 622–7770 (not a toll-free number).

SUPPLEMENTARY INFORMATION:

Background

This document contains temporary

amendments to the Income Tax

Regulations (26 CFR Part 1) under

section 1502 of the Internal Revenue

Code of 1986 (Code). The amendments

provide guidance as to the time for

filing an application for a tentative

carryback adjustment by a consolidated

group. The amendments also extend the

time for filing an application for a

tentative carryback adjustment by

certain corporations for the separate

return year created by their becoming

new members of a consolidated group.

Section 6411(a) requires that an

application for a tentative carryback

adjustment be filed on or after the date

of filing for the return for the taxable

year of the loss (or unused business

credit) from which the carryback results

and within a period of twelve (12)

months after the end of such taxable

year. Section 6411(c) provides that if the

corporation seeking a tentative

carryback adjustment made or was

required to make a consolidated return

for the year in which the loss or credit

arose or for the preceding taxable year

affected by such loss or credit, the

provisions of Section 6411(a) apply only

to such extent and subject to such

conditions, limitations and exceptions

as the Secretary may by regulations

prescribe. Section 1.6411–4 refers

taxpayers to the consolidated return

regulations, specifically § 1.1502–78, for

further rules applicable to consolidated

groups filing for a tentative carryback

adjustment.

Section 1.1502–78(a) addresses the

proper party to file an application for a

tentative carryback adjustment.

However, there is no provision

addressing the time for filing such

application. Section 1.1502–78 does not

currently alter the statutory rule as to

‘‘when’’ the end of a taxable year occurs

for purposes of determining whether the

twelve-month rule of section 6411 has

been satisfied. Under § 1.1502–76, the

due date for the separate return of a new

member is generally extended until the

due date of the return of the

consolidated group. In certain instances,

however, such separate return cannot be

filed before the expiration of the twelvemonth period under section 6411(a).

Thus, a new member may be prevented

from filing an application for a tentative

carryback adjustment.

Section 1.1502–76(b)(1)(i) provides

that the consolidated return must

include the common parent’s items of

income, gain, deduction, loss, and credit

for the entire consolidated year, and

each subsidiary’s items for the portion

of the year for which it is a member.

Items of a corporation for the portion of

the year not included in the

consolidated return must be included in

a separate return (including the

consolidated return of another group).

Thus, the items of a new member of a

consolidated group are included in two

returns: first, the consolidated return for

the period of time it is a member of the

group; and second, a separate return

(including the consolidated return of

another group) for the pre-affiliation

period prior to becoming a member of

the consolidated group. This preaffiliation period is a separate return

year as defined in § 1.1502–1(e).

The tax returns for the periods that

end and begin upon a corporation

becoming (or ceasing to be) a member of

a consolidated group are separate

taxable years for all Federal income tax

purposes. Section 1.1502–76(b)(2)(i).

Although these periods are separate

taxable years, items of income, gain,

deduction, loss, and credit (other than

extraordinary items) may be ratably

allocated between such years if: (1) The

corporation is not required to change its

annual accounting period or its method

of accounting as a result of its change in

status as a member; and (2) a timely

ratable allocation election is made.

Section 1.1502–76(b)(2)(ii)(A). If a

ratable allocation cannot be made (or is

not made), the corporation must close

its books at the close of the day on

which its status as a member changes

and its items of income, gain,

deduction, loss, and credit for the preaffiliation period are included in its

separate return. Section 1.1502–

76(b)(2)(ii).

Section 1.1502–76(c) determines the

time for filing the new member’s

separate return. The provisions of this

section apply only to a corporation

which, immediately prior to becoming a

new member of a group, was the

common parent of another consolidated

group, or was not required to join in the

filing of a consolidated return. Under

§ 1.1502–76(c), the due date of the new

member’s separate return is dependent

upon the filing of the consolidated

group’s tax return. If the consolidated

return for the group has been filed by

the due date for the new member’s

separate return, then the separate return

must be filed no later than the due date

of the consolidated group’s return,