Federal Register / Vol. 65, No. 200 / Monday, October 16, 2000 / Rules and Regulations 61091

Dated: October 6, 2000.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 00–26403 Filed 10–13–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 526 and 556

Intramammary Dosage Form New

Animal Drugs; Pirlimycin

Hydrochloride

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 supplemental new animal

drug application (NADA) filed by

Pharmacia and Upjohn Co. The

supplemental NADA provides for use of

a sterile solution of pirlimycin

hydrochloride for intramammary

treatment of clinical and subclinical

staphylococcal and streptococcal

mastitis in lactating dairy cows, for

reduction in the preslaughter

withdrawal period, and for revision of

the milk discard statement in labeling to

state the milk discard time only (i.e., to

remove reference to the number of

milkings).

DATES: This rule is effective October 16,

2000.

FOR FURTHER INFORMATION CONTACT:

Naba K. Das, Center for Veterinary

Medicine (HFV–130), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–7569.

SUPPLEMENTARY INFORMATION: Pharmacia

and Upjohn Co., 7000 Portage Rd.,

Kalamazoo, MI 49001–0199, filed a

supplemental application to NADA

141–036 that provides for use of

PIRSUE (pirlimycin hydrochloride)

Sterile Solution for intramammary

treatment of clinical and subclinical

mastitis in lactating dairy cattle caused

by Staphylococcus species, such as

Staphylococcus aureus; and

Streptococcus species, such as

Streptococcus agalactiae, Streptococcus

dysgalactiae, and Streptococcus uberis;

for reduction in the preslaughter

withdrawal period from 28 days to 9

days; and for revision of the milk

discard statement in labeling to state the

36-hour milk discard time only (i.e., to

remove reference to the number of

milkings). The supplemental NADA is

approved as of September 7, 2000, and

the regulations are amended in 21 CFR

526.1810 to reflect the approval.

In addition, the regulations are

amended in (21 CFR 556.515) to add the

previously established acceptable daily

intake for total residues of pirlimycin, to

add a tolerance for residues of

pirlimycin in cattle muscle 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.

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

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 360b(c)(2)(F)(iii)), this

approval for food-producing animals

qualifies for 3 years of marketing

exclusivity beginning September 7,

2000, because the application contains

substantial evidence of the effectiveness

of the drug involved, any studies of

animal safety, or, in the case of foodproducing animals, human food safety

studies (other than bioequivalence or

residue studies) required for the

approval and conducted or sponsored

by the applicant. The 3 years of

marketing exclusivity applies only to

the new formulation for which the

supplemental application was

approved.

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.

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 526

Animal drugs.

21 CFR Part 556

Animal drugs, Foods.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under the

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Center for Veterinary Medicine, 21

CFR parts 526 and 556 are amended as

follows:

PART 526—INTRAMAMMARY DOSAGE

FORM

1. The authority citation for 21 CFR

part 526 continues to read as follows:

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

§ 526.1810 [Amended]

2. Section 526.1810 Pirlimycin

hydrochloride aqueous gel is amended

by removing ‘‘aqueous gel’’ from the

section heading, by removing ‘‘(three

milkings)’’ from the first sentence in

paragraph (d)(3), by removing ‘‘28’’ from

the second sentence in paragraph (d)(3)

and by adding in its place ‘‘9’’, and by

removing the third sentence of

paragraph (d)(3).

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:

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

2. Section 556.515 is revised to read

as follows:

§ 556.515 Pirlimycin.

(a) Acceptable daily intake (ADI). The

ADI for total residues of pirlimycin is

0.01 milligrams per kilogram of body

weight per day.

(b) Tolerances—(1) Cattle—(i) Liver

(the target tissue). The tolerance for

parent pirlimycin (the marker residue)

is 0.5 part per million (ppm).

(ii) Muscle. The tolerance for parent

pirlimycin (the marker residue) is 0.3

ppm.

(iii) Milk. The tolerance for parent

pirlimycin (the marker residue in cattle

milk) is 0.4 ppm.

(2) [Reserved]

Dated: October 6, 2000.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 00–26404 Filed 10–13–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Part 1

[TD 8897]

RIN 1545–AQ91

Rules for Property Produced in a

Farming Business; Correction

AGENCY: Internal Revenue Service (IRS),

Treasury.

ACTION: Correction of final regulations.

61092 Federal Register / Vol. 65, No. 200 / Monday, October 16, 2000 / Rules and Regulations

SUMMARY: This document contains

corrections to final regulations relating

to the application of section 263A of the

Internal Revenue Code to property

produced in the trade or business of

farming. This document was published

in the Federal Register on August 21,

2000 (65 FR 50638).

EFFECTIVE DATE: August 21, 2000.

FOR FURTHER INFORMATION CONTACT:

Grant D. Anderson (202) 622–4970 (not

a toll-free number).

SUPPLEMENTARY INFORMATION:

Need for Correction

As published, the final regulations

(TD 8897) contain errors that may prove

to be misleading and are in need of

clarification.

Correction of Publication

Accordingly, the publication of the

final regulations (TD 8897), which were

the subject of FR Doc. 00–21103, is

corrected as follows:

1. On page 50638, column 3, in the

preamble under the paragraph heading,

‘‘Background’’, line 3, the language

‘‘proposed rulemaking (REG–208151–

91)’’ is corrected to read ‘‘proposed

rulemaking (REG–209316–86)’’.

2. On page 50640, column 3,

paragraph 1, line 14, the language

‘‘I.R.B. (Sept. 5, 2000)) issued’’ is

corrected to read ‘‘I.R.B. 256 (Sept. 5,

2000)) issued’’.

PART 1—[CORRECTED]

§ 1.263A–1 [Corrected]

3. On page 50644, column 2, in

amendatory instruction Par. 5., remove

item designations for items ‘‘1.’’ and

‘‘2.’’ and correctly designate the items

‘‘2.’’ and ‘‘3.’’, respectively. Add new

item ‘‘1.’’ to read as follows:

1. The last sentence of paragraph

(a)(3)(v) is revised.

4. On page 50644, column 2,

§ 1.263A–1, remove the five asterisks

following the section heading and add

the following language for the last

sentence of paragraph (a)(3)(v) to read as

follows:

§ 1.263A–1 Uniform capitalization of costs.

(a) * * *

(3) * * *

(v) * * * See sections 263A(d) and

263A(e) and § 1.263A–4 for rules

relating to taxpayers engaged in a

farming business.

* * * * *

§ 1.263A–4 [Corrected]

5. On page 50644, column 3,

§ 1.263A–4, paragraph (a)(2)(i)(B), line

3, the language ‘‘disbursements method

under section’’ is corrected to read

‘‘disbursements method of accounting

(cash method) under section’’.

6. On page 50648, column 3,

§ 1.263A–4, paragraph (d)(2), line 5 from

the top of the column, the language

‘‘required to use the accrual method’’ is

corrected to read ‘‘required to use an

accrual method’’.

Cynthia E. Grigsby,

Chief, Regulations Unit, Office of Special

Counsel (Modernization & Strategic

Planning).

[FR Doc. 00–25998 Filed 10–13–00; 8:45 am]

BILLING CODE 4830–01–P

DEPARTMENT OF DEFENSE

Department of the Navy

32 CFR Part 706

Certifications and Exemptions Under

the International Regulations for

Preventing Collisions at Sea, 1972

AGENCY: Department of the Navy, DOD.

ACTION: Final rule.

SUMMARY: The Department of the Navy

is amending its certifications and

exemptions under the International

Regulations for Preventing Collisions at

Sea, 1972 (72 COLREGS), to reflect that

the Deputy Assistant Judge Advocate

General of the Navy (Admiralty and

Maritime Law) has determined that USS

Zephyr (PC 8) is a vessel of the Navy

which, due to its special construction

and purpose, cannot fully comply with

certain provisions of the 72 COLREGS

without interfering with its special

function as a naval ship. The intended

effect of this rule is to warn mariners in

waters where 72 COLREGS apply.

EFFECTIVE DATE: June 5, 2000.

FOR FURTHER INFORMATION CONTACT:

Lieutenant Commander Gregg A. Cervi,

JAGC, U.S. Navy, Deputy Assistant

Judge Advocate General (Admiralty and

Maritime Law), Office of the Judge

Advocate General, Washington Navy

Yard, DC 20374–5066, Telephone

number: (202) 685–5040.

SUPPLEMENTARY INFORMATION: Pursuant

to the authority granted in 33 U.S.C.

1605, the Department of the Navy

amends 32 CFR Part 706. This

amendment provides notice that the

Deputy Assistant Judge Advocate

General of the Navy (Admiralty and

Maritime Law), under authority

delegated by the Secretary of the Navy,

has certified that USS Zephyr (PC 8) is

a vessel of the Navy which, due to its

special construction and purpose,

cannot fully comply with the following

specific provisions of 72 COLREGS

without interfering with its special

function as a naval ship: Rule 21(c)

pertaining to the placement of the stern

light as nearly as practicable at the

stern. The Deputy Assistant Judge

Advocate General of the Navy

(Admiralty and Maritime Law) has also

certified that the light involved is

located in closest possible compliance

with the applicable 72 COLREGS

requirements.

Moreover, it has been determined, in

accordance with 32 CFR Parts 296 and

701, that publication of this amendment

for public comment prior to adoption is

impracticable, unnecessary, and

contrary to public interest since it is

based on technical findings that the

placement of lights on this vessel in a

manner differently from that prescribed

herein will adversely affect the vessel’s

ability to perform its military functions.

List of Subjects in 32 CFR Part 706

Marine safety, Navigation (water), and

Vessels.

Accordingly, 32 CFR part 706 is

amended as follows:

PART 706—[AMENDED]

1. The authority citation for 32 CFR

part 706 continues to read as follows:

Authority: 33 U.S.C. 1605.

2. Table 3 of § 706.2 is amended by

revising the entry for USS Zephyr to

read as follows:

§ 706.2 Certifications of the Secretary of

the Navy under Executive Order 11964 and

33 U.S.C. 1605.

* * * * *