70662 Federal Register / Vol. 65, No. 228 / Monday, November 27, 2000 / Rules and Regulations

puppies, cats, and kittens that are 4

weeks of age and older and 2 lb of body

weight or greater. The NADA is

approved as of October 20, 2000, and

the regulations are amended in part 520

(21 CFR part 520) by adding § 520.1510

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)(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 October

20, 2000, because no active ingredient

(including any ester or salt of the drug)

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.

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 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 520.1510 is added to read

as follows:

§ 520.1510 Nitenpyram.

(a) Specifications. Each tablet

contains 11.4 or 57 milligrams of

nitenpyram.

(b) Sponsor. See No. 058198 in

§ 510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use—Dogs and

cats—(1) Amount. One tablet given

orally, as needed.

(2) Indications for use. For the

treatment of flea infestations on dogs,

puppies, cats, and kittens 4 weeks of age

and older and 2 pounds of body weight

or greater.

Dated: November 8, 2000.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 00–30047 Filed 11–24–00; 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; Trenbolone

and Estradiol

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 abbreviated

new animal drug application (ANADA)

filed by Ivy Laboratories, Inc. The

supplemental ANADA provides for

adding tylosin tartrate as a local

antibacterial to an approved

subcutaneous cattle ear implant

containing trenbolone and estradiol

used in pasture cattle for increased rate

of weight gain.

DATES: This regulation is effective

November 27, 2000.

FOR FURTHER INFORMATION CONTACT:

Daniel A. Benz, Center for Veterinary

Medicine (HFV–126), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0223.

SUPPLEMENTARY INFORMATION: Ivy

Laboratories, Inc., 8857 Bond St.,

Overland Park, KS 66214, filed

supplemental ANADA 200–221 for

COMPONENT TE–G (trenbolone

acetate/estradiol) with Tylan, a

subcutaneous ear implant containing 40

of milligrams (mg) trenbolone acetate

and 8 mg of estradiol, in 2 pellets, each

pellet containing 20 mg of trenbolone

acetate and 4 mg of estradiol, and an

additional pellet containing 29 mg of

tylosin tartrate as a local antibacterial.

The implants are used in pasture cattle

(slaughter, stocker, and feeder steers and

heifers) for increased rate of weight

gain. The supplemental application is

approved as of September 18, 2000, and

the regulations are amended in 21 CFR

522.2477 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)(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 18,

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 addition of tylosin tartrate to the

implant 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 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.

Federal Register / Vol. 65, No. 228 / Monday, November 27, 2000 / Rules and Regulations 70663

1Multiplying (A) the rehearing range in the

current D.C. guidelines by (B) [the Base Point Score

minus 3 points] (the number of rehearings required

before parole assuming no disciplinary infractions

and ordinary program achievement) produces the

Base Point Range. For example, an inmate with a

Base Point Score of 6 with no disciplinary

infractions and ordinary program achievement at

each hearing would have two rehearing range of 18–

24 months each before the guidelines indicated

parole. This translates to a guideline range of the

Parole Eligibility Date plus 36–48 months. For most

cases, the results under the current system lumps

together certain dissimilar cases; for example, under

the current system, an offender with a case point

score of 5 who has outstanding program

achievement and no disciplinary infractions will

serve the same amount of time as an offender with

ordinary program achievement.

2. Section 522.2477 is amended in the

first sentence of paragraph (b) by

removing ‘‘(d)(3)’’ and by adding in its

place ‘‘(d)(3)(i)(A), (d)(3)(ii), and

(d)(3)(iii)’’; in the second sentence of

paragraph (b) by removing ‘‘(d)(3)’’ and

by adding in its place ‘‘(d)(3)(i)(A),

(d)(3)(i)(B), (d)(3)(ii), and (d)(3)(iii)’’;

and by revising paragraph (d)(3)(i) to

read as follows:

§ 522.2477 Trenbolone acetate and

estradiol.

* * * * *

(d) * * *

(3) * * *

(i) Amount. (A) 40 mg trenbolone

acetate and 8 mg estradiol (one implant

consisting of 2 pellets, each pellet

containing 20 mg trenbolone acetate and

4 mg estradiol) per implant dose.

(B) 40 mg trenbolone acetate and 8 mg

estradiol (one implant consisting of 3

pellets, each of 2 pellets containing 20

mg trenbolone acetate and 4 mg

estradiol, and 1 pellet containing 29 mg

tylosin tartrate) per implant dose.

* * * * *

Dated: October 11, 2000.

Claire M. Lathers,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 00–30049 Filed 11–24–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF JUSTICE

Parole Commission

28 CFR Part 2

Paroling, Recommitting, and

Supervising Federal Prisoners:

Prisoners Serving Sentences Under

the District of Columbia Code

AGENCY: United States Parole

Commission, Justice.

ACTION: Final rule.

SUMMARY: The U.S. Parole Commission

is revising the guidelines that govern its

decisions to grant and deny parole in

the case of prisoners serving sentences

for felony crimes under the District of

Columbia Code. The revised guidelines

convert the rehearing ranges into a

single range indicating the total prison

time that may be served by the inmate,

and authorizes the setting of

presumptive release dates up to 36

months from the date of the parole

hearing. However, the Point Assignment

Table remains the basis upon which the

guidelines are determined. The

Commission is adopting this rule

change to improve understanding by

inmates and the public as to the impact

that the guidelines will have in

individual cases, and to facilitate

successful release planning in advance

of parole.

EFFECTIVE DATE: January 2, 2001.

FOR FURTHER INFORMATION CONTACT:

Office of General Counsel, U.S. Parole

Commission, 5550 Friendship Blvd.,

Chevy Chase, Maryland 20815,

telephone (301) 492–5959. Questions

about this publication are welcome, but

public inquiries concerning individual

cases cannot be answered.

SUPPLEMENTARY INFORMATION: The

Commission has voted to revise 28 CFR

2.80 so as to make the guidelines for

D.C. Code offenders more

understandable to inmates and the

public, fairer and easier to administer.

The revised rule will (1) enhance the

ability of inmates and the public,

including victims of crime, to

understand the guidelines and their

impact in individual cases by allowing

each inmate’s Base Point Score to

determine an overall guideline range

showing the total time the inmate is

expected to serve before release on

parole; (2) provide more information to

inmates as to their actual expected

release dates by authorizing

presumptive release dates up to 36

months from the date of the most recent

parole hearing (contingent upon good

conduct and development of an

adequate release plan); (3) facilitate

release planning by setting such

presumptive release dates; (4) eliminate

anomalies in the current system that

disadvantage inmates whose rehearings

are delayed through no fault of their

own or who are encouraged by staff to

waive parole reconsideration until they

complete institutional programs; and (5)

reduce the maximum allowable time

between parole consideration hearings

from five years to three years (except for

an offense in which death results and

the offender is more than three years

below his or her applicable guideline

range). Moreover, the revised rule

contains a presumptive credit for

‘‘ordinary program achievement,’’

which currently must be determined on

a case-by-case basis, in the guideline

range itself. Hence, inmates will now

receive the benefit of having their

‘‘ordinary program achievement’’ points

credited in advance.

Public comment was received on this

rule in response to the proposals

published at 65 FR 26789 (May 8, 2000).

In general, the comment was favorable

as to the establishing of presumptive

release dates and the general limitation

of continuances to 36 months. However,

there were complaints that the proposed

rule was difficult to understand and

apply. Confusion was, in all likelihood,

caused by the Commission having

published alternative options of the

proposal for public comment. The

Commission believes that the version

adopted herein (Option 2, modified by

increasing the credit for superior

program achievement from 25 percent to

331⁄3 percent) is straightforward and will

be readily understood by prisoners and

their representatives.

Summary of the Final Rule

The revised version of § 2.80

eliminates the Total Point Score from

the Point Assignment Table (i.e., the

system of adding or subtracting points

for post-incarceration factors), and

eliminates the system of determining at

each hearing (based on the Total Point

Score) whether the inmate qualifies for

parole at that time. It substitutes the

following decisionmaking procedure.

Under Step 1, a Base Guideline Range

is determined from the Base Point

Score. There is no change from the Base

Point Score used in § 2.80. The time

expected for the inmate to qualify for

parole (assuming no disciplinary

infractions and ordinary program

achievement) is simply made explicit.1

Under Step 2, the Parole Eligibility Date

is recorded. Under Step 3, a

Disciplinary Guideline Range is

determined (if there are any disciplinary

infractions) based on the time ranges

prescribed at § 2.36. Under Step 4, a

Superior Program Achievement Award

(if superior program achievement is

found) is determined. The Superior

Program Achievement Award is based

on the number of months of superior

program achievement on the inmate’s

prison record (i.e., program achievement

that would have qualified for a twopoint deduction under the current

system that this rule will replace).

Under Step 5, Base Point Guideline

Range, Parole Eligibility Date,

Disciplinary Range, and the Superior

Program Achievement Award are

combined, at the initial hearing, into a