Federal Register / Vol. 63, No. 148 / Monday, August 3, 1998 /Rules and Regulations 41191

neither an environmental assessment

nor an environmental impact statement

is required.

List of Subjects

21 CFR Part 522

Animal drugs.

21 CFR Part 556

Animal drugs, Foods.

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 parts 522 and 556 are 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 522.955 is amended by

revising paragraph (d)(1)(i) and the first

four sentences of paragraph (d)(1)(iii) to

read as follows:

§ 522.955 Florfenicol solution.

* * * * *

(d) * * *

(1) * * *

(i) Amount. For intramuscular

injection use 20 milligrams per kilogram

of body weight (3 milliliters per 100

pounds). A second dose should be given

48 hours later. Alternatively, a single

subcutaneous injection of 40 milligrams

per kilogram of body weight (6

milliliters per 100 pounds) may be used.

* * * * *

(iii) Limitations. For intramuscular or

subcutaneous use only. Do not inject

more than 10 milliliters at each site.

Injection should be given in the neck

only. Do not slaughter within 28 days of

last intramuscular treatment or within

38 days of subcutaneous treatment.

* * *

* * * * *

PART 556—TOLERANCES FOR

RESIDUES OF NEW ANIMAL DRUGS

IN FOOD

3. The authority citation for 21 CFR

part 556 continues to read as follows:

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

4. Section 556.283 is revised to read as

follows:

§ 556.283 Florfenicol.

(a) Acceptable daily intake (ADI). The

ADI for total residues of florfenicol is 10

micrograms per kilogram of body weight

per day.

(b) Cattle. A tolerance of 3.7 parts per

million (ppm) for florfenicol amine

(marker residue) in liver (target tissue)

is established. A tolerance of 0.3 ppm

for florfenicol amine in cattle muscle is

established.

Dated: July 10, 1998.

Margaret Ann Miller,

Acting Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 98–20534 Filed 7–31–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

New Animal Drugs For Use In Animal

Feeds; Melengestrol Acetate and

Oxytetracycline

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 two original new animal

drug applications (NADA’s) filed by

Pharmacia & Upjohn Co. The NADA’s

provide for the use of separately

approved Type A medicated articles

containing melengestrol acetate (dry and

liquid form) and oxytetracycline (dry

form) to make dry combination drug

Type C medicated feeds. The Type C

medicated feeds are for heifers fed in

confinement for slaughter for increased

rate of weight gain, improved feed

efficiency, suppression of estrus, and

reduced incidence of liver abscesses.

EFFECTIVE DATE: August 3, 1998.

FOR FURTHER INFORMATION CONTACT: Jack

Caldwell, Center For Veterinary

Medicine (HFV–126), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1638.

SUPPLEMENTARY INFORMATION: Pharmacia

& Upjohn Co., 7000 Portage Rd.,

Kalamazoo, MI 49001–0199, filed

original NADA’s 46–718 and 46–719

that provide for combining separately

approved melengestrol acetate (MGA)

(dry and liquid form) and

oxytetracycline (dry form) Type A

medicated articles to make dry Type C

medicated feeds for heifers fed in

confinement for slaughter for increased

rate of weight gain, improved feed

efficiency, suppression of estrus (heat),

and reduced incidence of liver

abscesses. The NADA’s are approved as

of May 6, 1998, and 21 CFR

558.342(d)(8) and 558.450(d)(3)(iii) are

added to reflect the approvals.

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.

FDA has determined under 21 CFR

25.33(a)(2) 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 558

Animal drugs, Animal feeds.

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 558 is amended as follows:

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

1. The authority citation for 21 CFR

part 558 continues to read as follows:

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

2. Section 558.342 is amended by

adding paragraph (d)(8) to read as

follows:

§ 558.342 Melengestrol acetate.

* * * * *

(d) * * *

(8) Amount. Melengestrol acetate,

0.25 to 0.5 milligram per head per day,

plus oxytetracycline, 75 milligrams per

head per day.

(i) Indications for use. For increased

rate of weight gain, improved feed

efficiency, suppression of estrus (heat),

and reduction of liver condemnation

due to liver abscesses.

(ii) Limitations. Heifers fed in

confinement for slaughter. Add at the

rate of 0.5 to 2.0 pounds per head per

day a medicated feed (liquid or dry)

containing 0.125 to 1.0 milligram of

melengestrol acetate per pound to a feed

containing 6 to 10 grams of

oxytetracycline per ton; or add at the

rate of 0.5 to 2.0 pounds per head per

day a dry medicated feed containing

0.125 to 1.0 milligram of melengestrol

acetate plus 37.5 to 150 milligrams of

oxytetracycline per pound to provide

0.25 to 0.5 milligram of melengestrol

acetate and 75 milligrams of

oxytetracycline per head per day. Liquid

melengestrol acetate may not be mixed
41192 Federal Register / Vol. 63, No. 148 / Monday, August 3, 1998 /Rules and Regulations

with oxytetracycline in a common

liquid feed supplement. Melengestrol

acetate as provided by 000009,

oxytetracycline by 000069, in

§ 510.600(c) of this chapter.

3. Section 558.450 is amended by

adding paragraph (d)(3)(iii) to read as

follows:

§ 558.450 Oxytetracycline.

* * * * *

(d) * * *

(3) * * *

(iii) Melengestrol acetate as in

§ 558.342.

Dated: June 30, 1998.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 98–20535 Filed 7–31–98; 8:45 am]

BILLING CODE 4160–01–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 159

[OPP–60010K; FRL–6016–2]

RIN 2070–AB50

Pesticide Reporting Requirements for

Risk/Benefit Information

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Deferral of compliance date;

amendment to final rule.

SUMMARY: EPA is amending its recent

reporting requirements for risk/benefit

information for pesticides to defer the

compliance date. EPA is taking this

action because it recently published

technical corrections to the final rule as

well as detailed guidance on reporting

procedures. EPA believes that

registrants who are required to comply

with the rule should have time to adjust

their procedures and train personnel to

comply with the rule, the corrections,

and new guidance in their entirety.

Registrants who wish to comply with

the final rule immediately may do so

after notifying the Agency.

DATES: Effective August 3, 1998. The

complaince date for the final rule

amending 40 CFR part 159, issued on

September 19, 1997 at 62 FR 49388 is

deferred from June 16, 1998 until

August 17, 1998.

FOR FURTHER INFORMATION CONTACT: By

mail: Kathryn Bouve, Office of Pesticide

Programs (7502C), U.S. Environmental

Protection Agency, 401 M St., SW,

Washington, DC 20460. Office location,

telephone number, and e-mail address:

Crystal Mall #2, Room 224, 1921

Jefferson Davis Highway, Arlington, VA

22202; (703) 305–5032;

Bouve.Kate@epamail.epa.gov.

SUPPLEMENTARY INFORMATION:

I. Does This Document Apply to You?

You are affected by this action if you

are a pesticide producer who is now or

ever has been the registrant of a

pesticide product. Regulated categories

and entities may include, but is not

limited to:

Category Examples of regulated entities

Industry ..................... Pesticide producers.

This table is not intended to be

exhaustive, but rather provides a guide

for readers regarding entities likely to be

regulated by this action. To determine

whether you or your business is

regulated by this action, you should

carefully examine the applicability

provisions in the rule at 40 CFR

159.152.

II. Background

On September 19, 1997, EPA

published in the Federal Register (62

FR 9388 et seq.) (FRL–5739–1) new

regulations governing the reporting by

pesticide registrants of information

under section 6(a)(2) of the Federal

Insecticide, Fungicide, and Rodenticide

Act (FIFRA). That section requires

registrants to report to EPA additional

factual information in their possession

related to whether a pesticide causes

unreasonable adverse effects in the

environment. Among other things, the

new regulations provided registrants

with detailed instructions on whether,

when, and how to report information in

the possession of the registrant or its

agents. Until the new rule is effective,

registrants are required to comply with

Agency guidance issued in 1979 (44 FR

40716, July 12, 1979).

At the time the regulations were

promulgated, the Agency was sensitive

to the significant need for training and

other implementation issues raised by

the regulations. The Agency therefore

established an effective date for the

regulations of June 16, 1998. At the time

the regulations were published, the

Agency also announced its intention to

provide assistance to registrants in

implementing the regulations. In

addition to providing speakers at

seminars and conferences, the Agency

commenced preparation of guidance

documents to help explain to registrants

their responsibilities under the new

regulations.

On April 3, 1998, the Agency issued

Pesticide Registration (PR) Notice 98–3

which provided guidance to registrants

on a broad range of issues. In addition,

the Agency promulgated a direct final

rule and technical corrections to the

regulations, which were published on

June 19, 1998 in the Federal Register

(63 FR 33580) (FRL–5792–2). The June

1998 document corrects the definition

of registrants which identifies the

parties subject to the regulations,

specifies time frames for reporting

certain types of adverse effects

information, and specifies information

to be submitted to the Agency about

reportable detections of pesticides in

food, feed, and water.

On June 10, 1998, seven pesticide

trade associations requested that the

effective date of the regulation be

deferred for 120 days after issuance of

the technical corrections and other

guidance. The seven trade associations

observed that the new regulations

impose extensive new reporting

obligations on pesticide registrants

which must train numerous individuals

to implement their compliance

programs. Because of Agency delays in

issuing all needed technical corrections

and guidance, the trade associations

believed that registrants did not have

sufficient time to address all

requirements before the effective date of

the regulations.

The Agency has considered the issues

raised by the trade associations and has

determined that, given the timing of the

issuance of the guidance documents and

the technical corrections, it would be

appropriate to defer the compliance date

of the regulations for an additional 60

days in order to allow registrants the

opportunity to incorporate the material

included in the guidance documents

into their training and implementation

programs in an orderly fashion.

Accordingly, the Agency is hereby

extending the adjustment period and

changing the compliance date of the

final rule published at 62 FR 49388,

September 19, 1997 from June 16, 1998,

to August 17, 1998. EPA is also

modifying § 159.159 to reflect this new

date.

While EPA is deferring the

compliance date for the new regulations

for a brief period, EPA is also aware that

some registrants may wish to comply

with the new regulations immediately

rather than continue to comply with the

pre-existing requirements for another 2

months. Any registrant that wishes to

comply with the new regulations

immediately may do so provided that

the registrant first informs the Agency in

writing of its desire to be bound by the

new regulations effective June 16, 1998.

Such notice should be submitted to

Kathryn Bouve, the Agency contact

person, at the address given above