65752 Federal Register / Vol. 62, No. 241 / Tuesday, December 16, 1997 / Rules and Regulations

List of Subjects in 14 CFR Part 39

Air transportation, Aircraft, Aviation

safety, Incorporation by reference,

Safety.

Adoption of the Amendment

Accordingly, pursuant to the

authority delegated to me by the

Administrator, the Federal Aviation

Administration amends part 39 of the

Federal Aviation Regulations (14 CFR

part 39) as follows:

PART 39—AIRWORTHINESS

DIRECTIVES

1. The authority citation for part 39

continues to read as follows:

Authority: 49 U.S.C. 106(g), 40113, 44701.

§ 39.13 [Amended]

2. Section 39.13 is amended by

adding a new airworthiness directive to

read as follows:

97–26–03 Eurocopter Deutschland:

Amendment 39–10246. Docket No. 97–

SW–45–AD.

Applicability: Model MBB–BK 117 A–1, A–

3, A–4, B–1, B–2, and C–1 helicopters,

certificated in any category.

Note 1: This AD applies to each helicopter

identified in the preceding applicability

provision, regardless of whether it has been

modified, altered, or repaired in the area

subject to the requirements of this AD. For

helicopters that have been modified, altered,

or repaired so that the performance of the

requirements of this AD is affected, the

owner/operator must use the authority

provided in paragraph (c) to request approval

from the FAA. This approval may address

either no action, if the current configuration

eliminates the unsafe condition, or different

actions necessary to address the unsafe

condition described in this AD. Such a

request should include an assessment of the

effect of the changed configuration on the

unsafe condition addressed by this AD. In no

case does the presence of any modification,

alteration, or repair remove any helicopter

from the applicability of this AD.

Compliance: Required as indicated, unless

accomplished previously.

To detects cracks in the main rotor mast

flange (flange), which, if not detected, could

result in failure of the flange and subsequent

loss of control of the helicopter, accomplish

the following:

(a) Before further flight, and thereafter at

intervals not to exceed 100 hours time-inservice, visually inspect the flange in the

ribbed area for cracks using a 5-power or

higher magnifying glass in accordance with

paragraphs 2.A.1. and 2.A.2. of the

Accomplishment Instructions in Eurocopter

Deutschland GmbH Alert Service Bulletin

MBB–BK 117 No. ASB–MBB–BK 117–10–

114, dated August 27, 1997.

(b) If a crack is found as a result of the

inspections specified in paragraph (a) of this

AD, remove the cracked main rotor mast and

replace it with an airworthy main rotor mast.

(c) An alternative method of compliance or

adjustment of the compliance time that

provides an acceptable level of safety may be

used if approved by the Manager, Rotorcraft

Standards Staff, Rotorcraft Directorate, FAA.

Operators shall submit their requests through

an FAA Principal Maintenance Inspector,

who may concur or comment and then send

it to the Manager, Rotorcraft Standards Staff.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Rotorcraft Standards Staff.

(d) Special flight permits will not be

issued.

(e) The inspection shall be done in

accordance with Eurocopter Deutschland

GmbH Alert Service Bulletin MBB–BK 117

No. ASB–MBB–BK 117–10–114, dated

August 27, 1997. This incorporation by

reference was approved by the Director of the

Federal Register in accordance with 5 U.S.C.

552(a) and 1 CFR part 51. Copies may be

obtained from American Eurocopter

Corporation, 2701 Forum Drive, Grand

Prairie, Texas 75053–4005, telephone (972)

641–3460, fax (972) 641–3527. Copies may be

inspected at the FAA, Office of Regional

Counsel, Southwest Region, 2601 Meacham

Blvd., Room 663, Fort Worth, Texas 76137;

or at the Office of the Federal Register, 800

North Capitol Street, NW., suite 700,

Washington, DC.

(f) This amendment becomes effective on

December 31, 1997.

Note 3: The subject of this AD is addressed

in Luftahrt-Bundesamt (Germany) AD 97–

276, effective September 25, 1997.

Issued in Fort Worth, Texas, on December

5, 1997.

Eric Bries,

Acting Manager, Rotorcraft Directorate,

Aircraft Certification Service.

[FR Doc. 97–32721 Filed 12–15–97; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 524

Ophthalmic and Topical Dosage Form

New Animal Drugs; Doramectin

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 new animal drug

application (NADA) filed by Pfizer, Inc.

The NADA provides for topical use of

doramectin for treatment and control of

certain worm, grub, lice, and mite

infections of cattle.

EFFECTIVE DATE: December 16, 1997.

FOR FURTHER INFORMATION CONTACT:

Estella Z. Jones, Center for Veterinary

Medicine (HFV–135), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1643.

SUPPLEMENTARY INFORMATION: Pfizer,

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

10017–5755, is sponsor of NADA 141–

095 that provides for the use of

Dectomax (doramectin) 0.5 percent

pour-on solution for beef cattle and

female dairy cattle less than 20 months

of age for treatment and control of

gastrointestinal roundworms,

lungworms, eyeworms, grubs, biting and

sucking lice, and mange mites, to

control infections and protect from

reinfection with Cooperia oncophora

and Dictyocaulus viviparus for 21 days,

and Ostertagia ostertagia, C. punctata,

and Oesophagostomum radiatum for 28

days after treatment. The NADA is

approved as of September 16, 1997, and

the regulations are amended by adding

new § 524.770 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, 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)(ii) of the

Federal Food, Drug, and Cosmetic Act

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

approval for food-producing animals

qualifies for 3 years of marketing

exclusivity beginning September 16,

1997, because the NADA contains

substantial evidence of the effectiveness

of the drug involved, 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 and

conducted or sponsored by the

applicant.

The agency has carefully considered

the potential environmental effects of

this action. FDA has concluded that the

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 in 21 CFR Part 524

Animal drugs.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under
Federal Register / Vol. 62, No. 241 / Tuesday, December 16, 1997 / Rules and Regulations 65753

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Center for Veterinary Medicine, 21

CFR part 524 is amended as follows:

PART 524—OPHTHALMIC OR

TOPICAL DOSAGE FORM NEW

ANIMAL DRUGS

1. The authority citation for 21 CFR

part 524 continues to read as follows:

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

2. Section 524.770 is added to read as

follows:

§ 524.770 Doramectin.

(a) Specifications. Each milliliter of

solution contains 5 milligrams of

doramectin.

(b) Sponsor. See 000069 in

§ 510.600(c) of this chapter.

(c) Related tolerances. See § 556.225

of this chapter.

(d) Conditions of use—Cattle—(1)

Amount. 5 milligrams per 10 kilograms

(5 milligrams per 22 pounds).

(2) Indications for use. For treatment

and control of infections of

gastrointestinal roundworms,

lungworms, eyeworms, grubs, biting and

sucking lice, and mange mites, and to

control infections and to protect from

reinfection with Cooperia oncophora

and Dictyocaulus viviparus for 21 days,

and Ostertagia ostertagia, C. punctata,

and Oesophagostomum radiatum for 28

days after treatment.

(3) Limitations. Administer as a single

dose. Do not slaughter cattle within 45

days of latest treatment. Not for use in

female dairy cattle 20 months of age or

older. Do not use in calves to be

processed for veal. Consult your

veterinarian for assistance in the

diagnosis, treatment, and control of

parasitism.

Dated: October 22, 1997.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 97–32807 Filed 12–15–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE INTERIOR

Minerals Management Service

30 CFR Part 206

RIN 1010–AC06

Amendments to Transportation

Allowance Regulations for Federal and

Indian Leases to Specify Allowable

Costs and Related Amendments To

Gas Valuation Regulations

AGENCY: Minerals Management Service,

Interior.

ACTION: Final rulemaking.

SUMMARY: The Minerals Management

Service (MMS) is amending its

regulations governing valuation for

royalty purposes of gas produced from

Federal and Indian leases. The rule

primarily addresses allowances for

transportation of gas. The amendments

clarify the methods by which gas

royalties and deductions for gas

transportation are calculated.

DATE: Effective February 1, 1998.

ADDRESSES: David S. Guzy, Chief, Rules

and Publications Staff, Royalty

Management Program, Minerals

Management Service, P.O. Box 25165,

MS 3021, Denver, Colorado 80225–

0165; courier delivery to Building 85,

Denver Federal Center, Denver,

Colorado 80225, telephone (303) 231–

3432, FAX (303) 231–3385, e-Mail

DavidlGuzy@mms.gov.

FOR FURTHER INFORMATION CONTACT:

David S. Guzy, Chief, Rules and

Publications Staff, Royalty Management

Program, Minerals Management Service,

phone (303) 231–3432, FAX (303) 231–

3385, e-Mail DavidlGuzy@mms.gov.

SUPPLEMENTARY INFORMATION: The

principal authors of this rule are

Theresa Walsh Bayani and Susan

Lupinski, from Royalty Valuation

Division, MMS, Lakewood, Colorado.

I. Background

MMS published a set of rules in 30

CFR part 206 governing gas valuation

and gas transportation calculation

methods to clarify and codify the

departmental policy of granting

deductions for the reasonable actual

costs of transporting gas from a Federal

or Indian lease when the gas is sold at

a market away from the lease (53 FR

1272, January 15, 1988).

Since the 1988 rulemaking, Federal

Energy Regulatory Commission (FERC)

regulatory actions have significantly

affected the gas transportation industry.

Before these changes, gas pipeline

companies served as the primary

merchants in the natural gas industry.

During that environment, pipelines:

• Bought gas at the wellhead,

• Transported the gas, and

• Sold the gas at the city gate to local

distribution companies (LDC).

In the mid-1980’s, FERC began

establishing a competitive gas market,

allowing shippers access to the pipeline

transportation grid. These actions

ensured that willing buyers and sellers

could negotiate their own sales

transactions.

Specifically, starting with the

implementation of FERC Order 436,

FERC began regulating pipelines as

open access transporters and requiring

nondiscriminatory transportation. This

permitted downstream gas users (such

as LDCs and industrial users) to buy gas

directly from gas merchants in the

production area and to ship that gas

through interstate pipelines.

FERC Order 436 and amendments,

plus the elimination of price controls,

created a vigorous spot market.

Producers and marketers, in

competition for the sale of gas to end

users, are now transporting substantial

volumes of gas that they own through

interstate pipelines.

In the early 1990’s, FERC recognized

that pipelines still held an advantage

over competing sellers of gas. Pipelines

held substantial market power and sold

gas bundled with a transportation

service. FERC remedied the inequities

in the gas market by issuing FERC Order

636, effective May 18, 1992. Under the

provisions of this order, FERC:

• Required the separation

(unbundling) of sales and gas

transportation services;

• Enabled the implementation of a

capacity release program; and

• Allowed pipelines to assess

shippers surcharges for services such as

transition costs and FERC’s annual

charges (57 FR 13267, April 16, 1992).

The unbundled costs—previously

embedded in a lump-sum charge—

include:

• Transmission;

• Storage;

• Production; and

• Gathering costs.

Necessity for This Rulemaking

We reviewed our current gas

transportation regulations (30 CFR

206.156 and 206.157 (for Federal

leases), and 206.176 and 206.177 (for

Indian leases) (1996)) and determined

that they provide general authority to

calculate transportation deductions for

cost components resulting from

implementing FERC Order 636 and

previous FERC orders. However, we

have determined that lessees and

royalty payors need specific guidance

and certainty on which components are

deductible as transportation costs from

royalty. This guidance is necessary

because components previously

aggregated and unidentifiable may now

be separately identified in

transportation contracts, and new costs

unique to the FERC Order 636

environment are emerging.

Further, some of the components

reflect non-deductible costs of

marketing rather than transportation.

We believe that without the clarification

provided in this rule, lessees and payors