61090 Federal Register / Vol. 65, No. 200 / Monday, October 16, 2000 / Rules and Regulations

Indeed, to avoid any costs, regulated

entities need only comply with the law.

Regulatory Flexibility Act

The Regulatory Flexibility Act of 1980

requires an assessment of the impacts of

proposed and final rule on small

entities. An agency must prepare a

regulatory flexibility analysis that is

consistent with the Regulatory

Flexibility Act (5 U.S.C. 601–612),

unless the agency can certify that a

regulation will not have a significant

economic impact on a substantial

number of small entities. This rule

imposes no substantive burden and

merely amends the existing penalties for

those who engage in prohibited conduct

to reflect statutory changes. The civil

penalties will affect only those who

engage in conduct prohibited by statute

or related regulations. Those who

comply with the law will not be affected

by the civil penalties. Accordingly, the

Office of the Secretary certifies that this

action will not have a significant

economic impact on a substantial

number of small entities.

Paperwork Reduction Act

This final rule imposes no new

reporting or record keeping

requirements necessitating clearance by

OMB.

List of Subjects in 14 CFR Part 383

Administrative practice and

procedure, Penalties.

Accordingly, the Department of

Transportation revises Part 383 of Title

14, as set forth below:

PART 383—CIVIL PENALTIES

Sec.

§ 383.1 Basis and purpose.

§ 383.2 Amount of penalty.

Authority: Secs. 222, 706, 707(b), Pub. L.

106–181, 114 Stat. 61; Pub. L. 101–410, 104

Stat. 890, as amended by sec. 31001, Pub. L.

104–134, 110 Stat. 1321.

§ 383.1 Basis and purpose.

(a) Basis. This part implements the

civil penalty provisions of the Wendell

H. Ford Aviation Investment and

Reform Act for the 21st Century (AIR 21,

Pub. L. 106–181; 114 Stat. 61; April 5,

2000, sections 222, 706, 707(b)), and the

Federal Civil Penalties Inflation

Adjustment Act of 1990 (Pub. L. 101–

410), as amended by the Debt Collection

Improvement Act of 1996 (Pub. L. 104–

134, section 31001). The Debt Collection

Improvement Act requires each agency

head to adjust by regulation each civil

monetary penalty provided by law by

the inflation adjustment described

under section 5 of the Federal Civil

Penalties Inflation Adjustment Act. We

have applied these guidelines to the

civil penalty amounts that were not

affected by AIR 21 and, taking into

account the inflation that has occurred

since the most recent adjustment, have

found that no further adjustment is

warranted as of June 2000.

(b) Purpose. This part states the civil

penalty amounts with respect to

violations of 49 U.S.C. 40127, 41705 and

41712 and other civil penalties provided

in 49 U.S.C. 46301 (a)(1) for violations

covered by this chapter.

§ 383.2 Amount of penalty.

A person is liable to the United States

Government for a civil penalty of not

more than $10,000 for each violation of

49 U.S.C. 41705 and a civil penalty of

not more than $2,500 for each violation

of 49 U.S.C. 40127 or 41712. For other

violations of this chapter within the

scope of 49 U.S.C. 46301, the civil

penalty amount is $1,100.

* * * * *

Issued this 20th day of September, 2000, at

Washington, D.C.

Rodney E. Slater,

Secretary of Transportation.

[FR Doc. 00–26197 Filed 10–13–00; 8:45 am]

BILLING CODE 4910–62–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

Implantation or Injectable Dosage

Form New Animal Drugs; Levamisole

Phosphate Injection

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 Agri

Laboratories, Ltd. The ANADA provides

for use of levamisole phosphate solution

by subcutaneous injection for the

treatment of various species of

gastrointestinal parasites in cattle.

DATES: This rule is effective October 16,

2000.

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: Agri

Laboratories, Ltd., P.O. Box 3103, St.

Joseph, MO 64503, filed ANADA 200–

271 for LEVAMISOLE PHOSPHATE

Injectable Solution, 13.65%. The

ANADA provides for use of levamisole

phosphate solution by subcutaneous

injection for the treatment of various

species of gastrointestinal parasites in

cattle. The ANADA is approved as a

generic copy of Schering-Plough Animal

Health’s NADA 126–742 for

LEVASOLE Injection. ANADA 200–

271 is approved as of September 7,

2000, and the regulations are amended

in 21 CFR 522.1244 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.

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 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.

§ 522.1244 [Amended]

2. Section 522.1244 Levamisole

phosphate injection is amended in

paragraph (b) by removing ‘‘No.

000061’’ and by adding in its place

‘‘Nos. 000061 and 057561’’.

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.