Federal Register / Vol. 62, No. 25 / Thursday, February 6, 1997 / Rules and Regulations 5525

(collections of information) imposed by

an agency. Upon approval of a

collection of information, OMB shall

assign an OMB control number and an

expiration date. Respondents subject to

the filing requirements of this Rule shall

not be penalized for failing to respond

to these collections of information

unless the collections of information

display valid OMB control numbers.

The cost estimates for complying with

the Internet protocols for transmission

of the business practice standards were

included in the FERC–549C information

collection costs estimates in Order No.

587. OMB has approved the information

collection under FERC–549C, Standards

for Business Practices of Interstate

Natural Gas Pipelines, (OMB Control

No. 1902–0174), through September 30,

1999.

The adoption of the Internet protocols

by this rule will create a more efficient

communication medium for conducting

business with interstate pipelines and

reduce the burdens created by the

disparity in log-on and other procedures

among the pipeline’s EBBs. The

information collection requirements in

this final rule will be reported directly

to the industry users and later be subject

to audit by the Commission. The

implementation of these data

requirements will help the Commission

carry out its responsibilities under the

Natural Gas Act and coincide with the

current regulatory environment which

the Commission instituted under Order

No. 636 and the restructuring of the

natural gas industry.

Interested persons may obtain

information on the reporting

requirements by contacting the Federal

Energy Regulatory Commission, 888

First Street N.E., Washington, DC 20426

[Attention: Michael Miller, Information

Services Division, (202) 208–1415] or

the Office of Management and Budget

[Attention: Desk Officer for the Federal

Energy Regulatory Commission (202)

395–3087].

VII. Effective Date

These regulations are effective March

10, 1997. The Commission has

determined, with the concurrence of the

Administrator of the Office of

Information and Regulatory Affairs of

OMB, that this rule is not a ‘‘major rule’’

as defined in section 351 of the Small

Business Regulatory Enforcement

Fairness Act of 1996. The incorporation

by reference of certain publications

listed in the regulations is approved by

the Director of the Federal Register as of

March 10, 1997.

List of Subjects in 18 CFR Part 284

Continental shelf, Incorporation by

reference, Natural gas, Reporting and

recordkeeping requirements.

By the Commission.

Lois D. Cashell,

Secretary.

In consideration of the foregoing, the

Commission amends Part 284, Chapter I,

Title 18, Code of Federal Regulations, as

set forth below.

PART 284—CERTAIN SALES AND

TRANSPORTATION OF NATURAL GAS

UNDER THE NATURAL GAS POLICY

ACT OF 1978 AND RELATED

AUTHORITIES

1. The authority citation for Part 284

continues to read as follows:

Authority: 15 U.S.C. 717–717w, 3301–

3432; 42 U.S.C 7101–7532; 43 U.S.C. 1331–

1356.

2. In § 284.10, paragraph(b)(1)(iv) is

redesignated (b)(1)(v), and new

paragraph (b)(1)(iv) is added to read as

follows:

§ 284.10 Standards for Pipeline Business

Operations and Communications.

* * * * *

(b) * * *

(1) * * *

(iv) Electronic Delivery Mechanism

Related Standards, Principles 4.1.1

through 4.1.15 and Standards 4.3.1

through 4.3.4 and 4.3.7 through 4.3.15

(Version 1.0, October 24, 1996); and

* * * * *

[FR Doc. 97–2931 Filed 2–5–97; 8:45 am]

BILLING CODE 6717–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Amoxicillin Bolus and Soluble Powder

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to codify two

previously approved supplemental new

animal drug applications (NADA’s) filed

by Pfizer, Inc. The supplemental

NADA’s provide for the use of

amoxicillin boluses and soluble powder

in preruminating calves including veal

calves.

EFFECTIVE DATE: February 6, 1997.

FOR FURTHER INFORMATION CONTACT:

Dianne T. McRae, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1623.

SUPPLEMENTARY INFORMATION: Pfizer,

Inc., 235 East 42d St., New York, NY

10017, is sponsor of NADA 55–087

Amoxi-Bol (amoxicillin trihydrate)

bolus and NADA 55–088 Amoxi-Sol

(amoxicillin trihydrate) soluble powder

which provide for treatment of bacterial

enteritis when due to susceptible

Escherichia coli in preruminating calves

including veal calves. Use is by or on

the order of a licensed veterinarian.

These supplemental NADA’s were

approved on October 7, 1993, but the

regulations were inadvertently not

amended at that time to reflect these

approvals. The regulations are now

being amended in §§ 520.88d(d) and

520.88e(d) (21 CFR 520.88d(d) and

520.88e(d)) to reflect the approvals. In

addition, the term ‘‘nonruminating’’ is

being changed to ‘‘preruminating’’ to

better describe the type of animal being

treated.

The supplemental approvals provided

for further clarification of the class of

animals indicated for treatment. No

additional safety or effectiveness data

were required. Therefore, a freedom of

information (FOI) summary is not

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: Sec. 512 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 360b).

2. Section 520.88d is amended by

revising the heading for paragraph (d),

paragraph (d)(2), and the third sentence

in paragraph (d)(3) to read as follows:

§ 520.88d Amoxicillin trihydrate soluble

powder.

* * * * *

(d) Conditions of use. Preruminating

calves including veal calves—

* * * * *

(2) Indications for use. Treatment of

bacterial enteritis when due to

susceptible Escherichia coli in

preruminating calves including veal

calves.
5526 Federal Register / Vol. 62, No. 25 / Thursday, February 6, 1997 / Rules and Regulations

(3) * * * For use in preruminating

calves including veal calves only, not

for use in other animals which are

raised for food production. * * *

3. Section 520.88e is amended by

revising the heading for paragraph (d),

paragraph (d)(2), and the first sentence

in paragraph (d)(3) to read as follows:

§ 520.88e Amoxicillin trihydrate boluses.

* * * * *

(d) Conditions of use. Preruminating

calves including veal calves—

* * * * *

(2) Indications for use. Treatment of

bacterial enteritis when due to

susceptible Escherichia coli in

preruminating calves including veal

calves.

(3) Limitations. For oral use in

preruminating calves including veal

calves only, not for use in other animals

which are raised for food production.

* * *

Dated: January 27, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation Center for Veterinary Medicine

[FR Doc. 97–3015 Filed 2–5–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 522

Implantation or Injectable Dosage

Form New Animal Drugs; Tilmicosin

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 a supplemental new animal

drug application (NADA) filed by

Elanco Animal Health, a Division of Eli

Lilly and Co. The supplemental NADA

provides for subcutaneous use of

tilmicosin phosphate injection for the

control of respiratory disease in cattle at

high risk of developing bovine

respiratory disease (BRD) associated

with Pasteurella haemolytica.

EFFECTIVE DATE: February 6, 1997.

FOR FURTHER INFORMATION CONTACT:

Naba K. Das, Center for Veterinary

Medicine (HFV–133), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1659.

SUPPLEMENTARY INFORMATION: Elanco

Animal Health, a Division of Eli Lilly

and Co., Lilly Corporate Center,

Indianapolis, IN 46285, is sponsor of

NADA 140–929, which provides for the

subcutaneous use of Micotil 300

(tilmicosin phosphate) Injection for the

treatment of cattle with bovine

respiratory disease (BRD) associated

with P. haemolytica. The drug is limited

to use by or on the order of a licensed

veterinarian. The firm filed a

supplemental NADA, which provides

for use of Micotil for the control of

respiratory disease in cattle at high risk

of developing BRD associated with P.

haemolytica. The supplement is

approved as of December 30, 1996, and

21 CFR 522.2471(d)(1)(ii) is amended to

reflect the approval. The basis of

approval is discussed in the freedom of

information summary.

Also, certain limitation statements for

use of the product are revised to reflect

current wording. Section

522.2471(d)(1)(iii) is amended by

revising two sentences.

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)(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 December 30,

1996, because the supplemental

application contains substantial

evidence of the effectiveness of the drug

involved, any studies of animal safety,

or, in the case of food producing

animals, human food safety studies

(other than bioequivalence or residue

studies) required for approval of the

supplement and conducted or

sponsored by the applicant. The 3 years

of marketing exclusivity applies only to

the new claim, control of respiratory

disease in cattle at high risk of

developing BRD associated with P.

haemolytica, for which the the

supplemental application was

approved.

The agency has carefully considered

the potential environmental effects of

this action. FDA has concluded that this

action will not have a significant impact

on the human environment, and that an

environmental impact statement is not

required. The agency’s finding of no

significant impact and the evidence

supporting that finding, contained in an

environmental assessment, may be seen

in the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

List of Subjects

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: Sec. 512 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 360b).

2.Section 522.2471 is amended by

revising paragraph (d)(1)(ii) and the last

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

read as follows:

§ 522.2471 Tilmicosin phosphate injection.

* * * * *

(d) * * *

(1) * * *

(ii) Indications for use. For the

treatment of bovine respiratory disease

(BRD) associated with Pasteurella

haemolytica. For the control of

respiratory disease in cattle at high risk

of developing BRD associated with P.

haemolytica.

(iii) * * * A withdrawal period has

not been established for this product in

preruminating calves. Do not use in

calves to be processed for veal. Do not

slaughter within 28 days of last

treatment. Federal law restricts this drug

to use or on the order of a licensed

veterinarian.

* * * * *

Dated: January 27, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation Center for Veterinary Medicine

[FR Doc. 97–3016 Filed 2–5–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF TRANSPORTATION

Coast Guard

33 CFR Part 165

[COTP San Juan 96–077]

RIN 2115–AA97

Safety Zone Regulations: Southeast

End of Vieques Island, PR

AGENCY: Coast Guard, DOT.

ACTION: Temporary final rule.

SUMMARY: The Coast Guard is

establishing a safety zone on the