Federal Register / Vol. 63, No. 149 /Tuesday, August 4, 1998 /Rules and Regulations 41419

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Clenbuterol

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 Boehringer

Ingelheim Animal Health, Inc. The

NADA provides for veterinary

prescription use of clenbuterol syrup

(clenbuterol hydrochloride) indicated

for the management of horses affected

with airway obstruction, such as occurs

in chronic obstructive pulmonary

disease (COPD).

EFFECTIVE DATE: August 4, 1998.

FOR FURTHER INFORMATION CONTACT:

Linda M. Wilmot, Center for Veterinary

Medicine (HFV–114), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–0614.

SUPPLEMENTARY INFORMATION:

Boehringer Ingelheim Animal Health,

Inc., 2621 North Belt Highway, St.

Joseph, MO 64506–2002, has filed

NADA 140–973 that provides for

veterinary prescription use of

VENTIPULMIN Syrup (clenbuterol

hydrochloride) indicated for the

management of horses affected with

airway obstruction, such as occurs in

COPD. The NADA is approved as of

May 11, 1998, and the regulations are

amended by adding 21 CFR 520.452 to

reflect the approval. The basis for

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, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857, between

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

Friday.

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

Federal Food, Drug, and Cosmetic Act

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

approval qualifies for 5 years of

marketing exclusivity beginning May

11, 1998, because no active ingredient of

the drug, including any ester or salt of

the active ingredient, has been

previously approved in any other

application filed under section 512(b)(1)

of the act.

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.

List of Subjects in 21 CFR Part 520

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 520 is amended as follows:

PART 520—ORAL DOSAGE FORM

NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 520 continues to read as follows:

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

2. Section 520.452 is added to read as

follows:

§ 520.452 Clenbuterol syrup.

(a) Specifications. Each milliliter

contains 72.5 micrograms of clenbuterol

hydrochloride.

(b) Sponsor. See 000010 in

§ 510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use—(1) Horses—(i)

Amount. Administer orally twice a day

(b.i.d.). Initial dose is 0.5 milliliter per

100 pounds body weight (0.8

micrograms per kilogram) for 3 days (6

treatments). If no improvement,

administer 1 milliliter per 100 pounds

(1.6 micrograms per kilogram) for 3 days

(6 treatments). If no improvement,

administer 1.5 milliliters per 100

pounds (2.4 micrograms per kilogram)

for 3 days (6 treatments). If no

improvement, administer 2.0 milliliters

per 100 pounds (3.2 micrograms per

kilogram) for 3 days (6 treatments). If no

improvement, horse is nonresponder to

clenbuterol and treatment should be

discontinued.

(ii) Indications for use. Indicated for

the management of horses affected with

airway obstruction, such as occurs in

chronic obstructive pulmonary disease

(COPD).

(iii) Limitations. Treat at effective

dose for 30 days. At the end of the 30-

day treatment period, drug should be

withdrawn. If signs return, the 30-day

treatment period may be repeated. If

repeating treatment, the step-wise

dosage schedule should be repeated.

The effect of this drug on breeding

stallions and brood mares has not been

determined. Treatment starting with

dosages higher than the initial dose is

not recommended. Federal law

prohibits the extralabel use of this drug

in food animals. Federal law restricts

this drug to use by or on the order of

a licensed veterinarian.

(2) [Reserved]

Dated: June 30, 1998.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 98–20699 Filed 8–3–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

Implantation or Injectable Dosage

Form New Animal Drugs; Ampicillin

Trihydrate For Sterile Suspension

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 an abbreviated new animal

drug application (ANADA) filed by G. C.

Hanford Manufacturing Co. The

ANADA provides for subcutaneous and/

or intramuscular use of ampicillin

trihydrate sterile powder when

reconstituted as a sterile suspension, for

treatment of dogs, cats, cattle, and

calves including nonruminating (veal)

calves.

EFFECTIVE DATE: August 4, 1998.

FOR FURTHER INFORMATION CONTACT:

Lonnie W. Luther, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0209.

SUPPLEMENTARY INFORMATION: G. C.

Hanford Manufacturing Co., 304 Oneida

St., P.O. Box 1017, Syracuse, NY 13201,

is sponsor of ANADA 200–180 that

provides for the subcutaneous or

intramuscular use of ampicillin

trihydrate sterile powder for

reconstitution as a sterile suspension for

treatment of respiratory, urinary tract,

gastrointestinal, skin, soft-tissue, and

post-surgical infections of dogs and cats,

and intramuscular use for the treatment

of respiratory infections in cattle and

calves including nonruminating (veal)

calves. The drug is limited to use by or

on the order of a licensed veterinarian.

G. C. Hanford Manufacturing Co.’s

ANADA 200–180 is approved as a

generic copy of Fort Dodge Animal

Health’s NADA 55–030 for Polyflex.
41420 Federal Register / Vol. 63, No. 149 /Tuesday, August 4, 1998 /Rules and Regulations

The ANADA is approved as of April 24,

1998, and the regulations in 21 CFR

522.90b(b) are amended 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, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857, between

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

Friday.

The agency has determined under 21

CFR 25.33(a)(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.

List of Subjects in 21 CFR Part 522

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 522 is amended as follows:

PART 522—IMPLANTATION OR

INJECTABLE DOSAGE FORM NEW

ANIMAL DRUGS

1. The authority citation for 21 CFR

part 522 continues to read as follows:

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

2. Section 522.90b is amended by

revising paragraph (b) to read as follows:

§ 522.90b Ampicillin trihydrate for sterile

suspension.

* * * * *

(b) Sponsor. (1) See 000856 in

§ 510.600(c) of this chapter for use of 50,

100, and 250 milligrams per milliliter

ampicillin suspension.

(2) See 010515 in § 510.600(c) of this

chapter for use of 100 and 250

milligrams per milliliter ampicillin

suspension.

* * * * *

Dated: June 30, 1998.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 98–20698 Filed 8–3–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Part 1

[TD 8777]

RIN 1545–AV17

Qualified Nonrecourse Financing

Under Section 465(b)(6)

AGENCY: Internal Revenue Service (IRS),

Treasury.

ACTION: Final regulations.

SUMMARY: This document contains final

regulations on certain issues regarding

qualified nonrecourse financing under

section 465(b)(6). These final

regulations affect individuals and C

corporations for which the stock

ownership requirement of section

542(a)(2) is satisfied. These regulations

provide guidance on certain issues

relating to section 465(b)(6).

DATES: Effective date: These regulations

are effective August 4, 1998.

Applicability dates: See Effective

Dates under Supplementary Information

of the preamble.

FOR FURTHER INFORMATION CONTACT: Jeff

Erickson at (202) 622–3070 (not a tollfree number).

SUPPLEMENTARY INFORMATION:

Background

This document amends 26 CFR part 1

to provide rules regarding qualified

nonrecourse financing under section

465(b)(6). Section 465 limits a

taxpayer’s loss deduction for an activity

to the taxpayer’s amount at risk in the

activity at the close of the taxable year.

A taxpayer’s amount at risk generally

includes the amount of any cash and the

adjusted tax basis of any property

contributed by the taxpayer to the

activity plus any amounts borrowed for

use in the activity to the extent the

taxpayer is personally liable for

repayment. For the activity of holding

real property, section 465(b)(6) provides

that a taxpayer may include as an

amount at risk the taxpayer’s share of

any qualified nonrecourse financing that

is secured by real property used in the

activity of holding real property, even

though the taxpayer is not personally

liable for repayment of the financing.

On August 13, 1997, the IRS

published in the Federal Register (62

FR 43295) a notice of proposed

rulemaking regarding section 465(b)(6).

A number of comments were received

on the proposed regulations. The public

hearing scheduled for December 10,

1997, was canceled because no one

requested to speak. After considering

the written comments, the proposed

regulations are adopted as revised by

this Treasury decision.

Explanation of Provisions

I. Secured by Real Property

A. Proposed Rule

Section 465(b)(6)(A) provides that

qualified nonrecourse financing must be

secured by real property used in the

activity of holding real property. The

proposed regulations provided that a

financing can be a qualified nonrecourse

financing if, in addition to the real

property used in the activity of holding

real property, the financing is secured

by other property that is incidental to

the activity of holding real property

(incidental property).

B. Discussion of Comments

A commentator recommended that

the final regulations clarify the term

incidental property. Another

commentator asked that the IRS and

Treasury define incidental property as

any property with a value of not more

than 15 percent of the value of the real

property held by the borrowing

partnership. A third commentator

explained that real estate partnerships

often hold assets in addition to real

property and incidental property. This

commentator was concerned that only

financings held by partnerships that

own only real estate assets could satisfy

the proposed regulations. Under the

final regulations, if the total gross fair

market value of property that is neither

real property used in the activity of

holding real property nor incidental

property is less than 10 percent of the

total gross fair market value of all the

property securing the financing, such

other property is ignored in determining

whether the financing satisfies the

secured-by-real-property requirement.

Another commentator asked for a

look-through rule for partnerships that

own an interest in another partnership

to determine the character of the assets

securing a qualified nonrecourse

financing. The final regulations adopt

this suggestion by requiring a borrower

(whether or not a partnership) to

determine the character of its assets by

treating itself as owning directly its

proportional share of the assets in any

partnership in which it owns (directly

or indirectly through a chain of

partnerships) an equity interest. If a

borrower pledges a partnership interest

as security for a financing, the

partnership assets attributable to the

borrower’s proportional share of the

partnership’s assets will be treated as

security for the financing.