41186 Federal Register / Vol. 63, No. 148 / Monday, August 3, 1998 /Rules and Regulations

and that it is not a ‘‘significant

regulatory action’’ under Executive

Order 12866. It has been determined

further that this action involves an

emergency regulation under DOT

Regulatory Policies and Procedures (44

FR 11034, February 26, 1979). If it is

determined that this emergency

regulation otherwise would be

significant under DOT Regulatory

Policies and Procedures, a final

regulatory evaluation will be prepared

and placed in the Rules Docket. A copy

of it, if filed, may be obtained from the

Rules Docket at the location provided

under the caption ADDRESSES.

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 the following new airworthiness

directive:

98–16–13 Boeing: Amendment 39–10689.

Docket 98–NM–210–AD.

Applicability: Model 747 series airplanes,

line positions 1 through 1157; certificated in

any category.

Note 1: This AD applies to each airplane

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

airplanes that have been modified, altered, or

repaired so that the performance of the

requirements of this AD is affected, the

owner/operator must request approval for an

alternative method of compliance in

accordance with paragraph (c) of this AD.

The request should include an assessment of

the effect of the modification, alteration, or

repair on the unsafe condition addressed by

this AD; and, if the unsafe condition has not

been eliminated, the request should include

specific proposed actions to address it.

Compliance: Required as indicated, unless

accomplished previously.

To prevent accelerated fatigue cracking of

the inner chords of the Body Station (BS)

2598 bulkhead, which could result in

inability of the structure to carry horizontal

stabilizer flight loads, and consequent

reduced controllability of the airplane;

accomplish the following:

(a) Prior to the accumulation of 8,000 total

flight cycles, or within 90 days after the

effective date of this AD, whichever occurs

later, perform a one-time visual inspection

for missing fasteners of the splice fitting of

the forward inner chord of the BS 2598

bulkhead, on the left and right sides of the

airplane, in accordance with Boeing Alert

Service Bulletin 747–53A2423, dated June

11, 1998.

(1) If all fasteners are present, no further

action is required by this AD.

(2) If any fastener is missing, prior to

further flight, accomplish a detailed visual

inspection and a high frequency eddy current

inspection to detect cracking of the forward

and aft inner chords of the BS 2598

bulkhead, on the left and right sides of the

airplane; in accordance with the alert service

bulletin.

(i) If no cracking is detected, prior to

further flight, install the fasteners, in

accordance with the alert service bulletin.

(ii) If any cracking is detected, prior to

further flight, repair the cracking and install

the fasteners, in accordance with Boeing 747

Structural Repair Manual (SRM) 53–10–04,

Figure 72, or Boeing 747SP SRM 53–19–02,

Figure 41; as applicable; or repair in

accordance with a method approved by the

Manager, Seattle Aircraft Certification Office

(ACO), FAA, Transport Airplane Directorate.

(b) Within 10 days after accomplishing the

inspection required by paragraph (a) of this

AD, submit a report of the inspection results

(findings of missing fasteners only) to the

Manager, Seattle Manufacturing Inspection

District Office, FAA, Transport Airplane

Directorate, 2500 East Valley Road, suite C–

2, Renton, Washington 98055–4056; fax (425)

227–1181. Information collection

requirements contained in this regulation

have been approved by the Office of

Management and Budget (OMB) under the

provisions of the Paperwork Reduction Act of

1980 (44 U.S.C. 3501 et seq.) and have been

assigned OMB Control Number 2120–0056.

(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, Seattle

ACO. Operators shall submit their requests

through an appropriate FAA Principal

Maintenance Inspector, who may add

comments and then send it to the Manager,

Seattle ACO.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Seattle ACO.

(d) Special flight permits may be issued in

accordance with sections 21.197 and 21.199

of the Federal Aviation Regulations (14 CFR

21.197 and 21.199) to operate the airplane to

a location where the requirements of this AD

can be accomplished.

(e) Except as provided by paragraph

(a)(2)(ii) of this AD, the actions shall be done

in accordance with Boeing Alert Service

Bulletin 747–53A2423, dated June 11, 1998.

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 Boeing Commercial Airplane Group,

P.O. Box 3707, Seattle, Washington 98124–

2207. Copies may be inspected at the FAA,

Transport Airplane Directorate, 1601 Lind

Avenue, SW., Renton, Washington; or at the

Office of the Federal Register, 800 North

Capitol Street, NW., suite 700, Washington,

DC.

(f) This amendment becomes effective on

August 18, 1998.

Issued in Renton, Washington, on July 27,

1998.

S.R. Miller,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 98–20679 Filed 7–31–98; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF COMMERCE

Bureau of the Census

15 CFR Part 30

[Docket No. 980331081–8171–02]

RIN 0607–AA22

Foreign Trade Statistics Regulations;

Reporting the Value of Foreign Military

Sales Shipments

AGENCY: Bureau of the Census,

Commerce.

ACTION: Final rule.

SUMMARY: The Bureau of the Census

(Census Bureau) is amending the

Foreign Trade Statistics Regulations

(FTSR) by adding a section requiring

exporters or their designated agents to

include a foreign military sales indicator

code on the Shipper’s Export

Declaration (SED) Form, Automated

Export System (AES) Record Layout,

and Automated Export Reporting

Program (AERP) Record Layout. This

will apply whenever a commercial

exporter is shipping goods or reporting

the repair of military equipment under

provisions of the Foreign Military Sales

(FMS) program. The Census Bureau is

taking this action to assist the Bureau of

Economic Analysis (BEA), Department

of Commerce, in improving the accuracy

and reliability of data collected on the

value of exports made under the FMS

program. Exports under the FMS

program are a component of the U.S.

balance of payments accounts and of the

U.S. Gross Domestic Product (GDP). The

Census Bureau is also taking this action

to assist both the Census Bureau and

BEA in improving the accuracy and

reliability of estimates presented in the

Department of Commerce’s monthly

release ‘‘U.S. International Trade in

Goods and Services.’’ The BEA has

reviewed and approved this proposed

rulemaking. The Department of

Treasury concurs with the provisions

contained in this final rule.
Federal Register / Vol. 63, No. 148 / Monday, August 3, 1998 /Rules and Regulations 41187

DATES: Effective: September 1, 1998.

Compliance date: Electronic filers will

have until November 1, 1998, to

implement program changes to meet

this requirement.

FOR FURTHER INFORMATION CONTACT: C.

Harvey Monk, Jr., Chief, Foreign Trade

Division, Bureau of the Census, Room

2104, Federal Building 3, Washington,

D.C. 20233–6700, by telephone on (301)

457–2255 or by fax on (301) 457–2645.

SUPPLEMENTARY INFORMATION:

Background

The FMS program is authorized under

the provisions of the Arms Export

Control Act of 1976 (Pub. L. 90–629, as

amended) and predecessor legislation.

Under this program, goods and services

are transferred directly to foreign

governments and international

organizations by the U.S. Department of

Defense (DOD). The delivery is recorded

by the DOD at the time ownership is

transferred to the foreign government or

international organization. This

recording is consistent with balance of

payments accounting principles. The

transfer may be made abroad, in the

United States for shipment abroad, or

for use in the United States. In the latter

case, although the goods physically

remain in the United States (for

example, equipment to train foreign

personnel), ownership is transferred to

a foreign government. Transfers also

may be made from stocks at U.S.

military installations abroad. The SEDs

are not required for FMS transactions by

DOD agencies; SEDs are required by

commercial exporters, but these SEDs

do not separately identify FMS

transactions.

Program Requirements

The DOD submits quarterly reports to

the BEA under provisions of the Office

of Management and Budget’s (OMB)

Statistical Policy Directive No. 19,

‘‘Reports of the Department of

Commerce on International

Transactions.’’ These reports contain

details of FMS deliveries by broad

product category, by country of

destination, and by military agency

(Army, Navy, Air Force, and other DOD

agencies). The reports include deliveries

carried out by both DOD and

commercial exporters. The BEA

prepares estimates of FMS deliveries

based on these reports for the quarterly

balance of payments accounts.

The DOD also submits monthly

reports to the Census Bureau that

contain detailed statistics on military

assistance (Foreign Aid/Grant Aid)

shipments made from the United States

by the DOD and shipments made under

the FMS program by the military

agencies. These monthly reports are

furnished to the Census Bureau in lieu

of the SED in order to facilitate

shipments of material under Grant Aid

and FMS auspices. However, these

reports do not cover FMS deliveries by

commercial exporters, which comprise a

significant share of FMS deliveries.

In order to reconcile the two sets of

data provided by DOD, the Census

Bureau is adding an FMS indicator code

to the SEDs and the electronic

transmissions required from commercial

exporters. The addition of this indicator

code will assure more accurate

identification of FMS transactions in the

goods data reported to the Census

Bureau and will enable the BEA to make

a more accurate estimate of this class of

FMS transactions when it removes them

from the goods data to avoid counting

these transactions twice when it

compiles the balance of payments

accounts. An FMS indicator code on the

SEDs and electronic transmissions from

commercial exporters will permit the

BEA and the Census Bureau to improve

the accuracy and reliability of its

balance of payments and GDP estimates,

as well as the estimates published in the

‘‘U.S. International Trade in Goods and

Services’’ release.

The Census Bureau is amending

Section 30.7(p) of the FTSR to add

paragraph (5) requiring commercial

exporters to identify those exports that

represent FMS deliveries with an ‘‘M’’

indicator code in Item (16) on

Commerce Form 7525–V and in Item

(23) on Commerce Form 7525–V–ALT

(Intermodal) on the paper SEDs, with an

‘‘FS’’ Export Information Code on the

Commodity Line Item Description (CL1)

record on the AES record layout, and

with a ‘‘3’’ indicator code in field 2

(Type) of the AERP record layout for

participants of the AERP.

Response to Comments

The Census Bureau published a

Notice of Proposed Rulemaking and

Request for Comments in the Federal

Register (63 FR 18344) on April 15,

1998. The Bureau of the Census

received three letters commenting on

the proposed rule. All of the comments

received have been addressed and

resolved by the Census Bureau. As a

result of the comments, one revision

was made to the final rule to clarify that

the indicator code also applies to FMS

shipments financed under the Foreign

Military Finance (FMF) Program.

Executive Orders

This rule has been determined to be

not significant for purposes of Executive

Order 12866. This rule does not contain

policies with federalism implications

sufficient to warrant preparation of a

federalism assessment under Executive

Order 12612.

Paperwork Reduction Act

Notwithstanding any other provisions

of law, no person is required to respond

to, nor shall a person be subject to a

penalty for failure to comply with, a

collection of information subject to the

requirements of the Paperwork

Reduction Act (PRA) unless that

collection of information displays a

currently valid OMB control number.

This rule covers collections of

information subject to the provisions of

the PRA, which are cleared by the OMB

under OMB control number 0607–0152.

This rule will not impact the current

response burden requirements as

approved under OMB control number

0607–0152 under provisions of the PRA

of 1995, Public Law 104–13.

List of Subjects in 15 CFR Part 30

Economic statistics, Foreign trade,

Exports, Reporting and recordkeeping

requirements.

For the reasons set out in the

preamble, Part 30 is amended as

follows:

PART 30—FOREIGN TRADE

STATISTICS

1. The authority citation for 15 CFR

part 30 continues to read as follows:

Authority: 5 U.S.C. 301; 13 U.S.C. 301–

307; Reorganization Plan No. 5 of 1950 (3

CFR 1949–1953 Comp., 1004); Department of

Commerce Organization Order No. 35–2A.

August 4, 1975, 40 CFR 42765.

Subpart A—General Requirements—

Exporter

2. Section 30.7 is amended by adding

paragraph (p)(5) to read as follows:

§ 30.7 Information required on Shipper’s

Export Declarations.

* * * * *

(p) * * *

(5) Foreign Military Sales (FMS)

indicator. For any export that represents

the delivery of goods or the repair of

military equipment under provisions of

the FMS program (including those

financed under the Foreign Military

Finance (FMF) Program), an ‘‘M’’

indicator code should be included in

Item (16) on Commerce Form 7525–V

and in Item (23) on Commerce Form

7525–V–ALT (Intermodal) of the paper

SED, with an ‘‘FS’’ Export Information

Code on the Commodity Line Item

Description (CL1) field of the

Automated Export System (AES) record

layout, and a ‘‘3’’ indicator code in field
41188 Federal Register / Vol. 63, No. 148 / Monday, August 3, 1998 /Rules and Regulations

2 (Type) of the Automated Export

Reporting Program (AERP) record

layout. This indicator code should be

used in lieu of the domestic (D) or

foreign (F) indicator code required in

those fields on the SED Form, the AES

record, and the AERP record. The FMS

indicator code will serve to identify

more accurately that segment of U.S.

exports that represent FMS deliveries in

the U.S. export statistics.

* * * * *

Dated: July 16, 1998.

Bradford R. Huther,

Deputy Director, Bureau of the Census.

[FR Doc. 98–20616 Filed 7–31–98; 8:45 am]

BILLING CODE 3510–07–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 510

Animal Drugs, Feeds, and Related

Products; Change of Sponsor

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect the

change of sponsor for an approved new

animal drug application (NADA) from

Ohmeda Pharmaceutical Products

Division, Inc., to Baxter Pharmaceutical

Products, Inc.

EFFECTIVE DATE: August 3, 1998.

FOR FURTHER INFORMATION CONTACT:

Thomas J. McKay, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0213.

SUPPLEMENTARY INFORMATION: Ohmeda

Pharmaceutical Products Division, Inc.,

Liberty Corner, NJ 07938–0804, has

informed FDA that it has transferred the

ownership of, and all rights and

interests in, approved NADA 135–773

(isoflurane) to Baxter Pharmaceutical

Products, Inc., 110 Allen Rd., P.O. Box

804, Liberty Corner, NJ 07938. The new

sponsor will retain the drug labeler code

for Ohmeda, Pharmaceutical Products,

Inc. The agency is amending the

regulations in 21 CFR 510.600(c)(1) and

(c)(2) to reflect the new sponsor name.

List of Subject in 21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

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 510 is amended as follows:

PART 510—NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 510 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352,

353, 360b, 371, 379e.

§ 510.600 [Amended]

2. Section 510.600 Names, addresses,

and drug labeler codes of sponsors of

approved applications is amended in

the table in paragraph (c)(1) by

removing the entry for ‘‘Ohmeda

Pharmaceutical Products Division,

Inc.,’’ and by alphabetically adding an

entry for ‘‘Baxter Pharmaceutical

Products, Inc., 110 Allen Rd., Liberty

Corner, NJ 07938’’; and in the table in

paragraph (c)(2) in the entry for

‘‘010019’’ by removing the sponsor

name ‘‘Ohmeda Pharmaceutical

Products Division, Inc.,’’ and adding in

its place ‘‘Baxter Pharmaceutical

Products, Inc., 110 Allen Rd.,’’.

Dated: July 10, 1998.

Margaret Ann Miller,

Acting Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 98–20531 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 510

Animal Drugs, Feeds, and Related

Products; Change of Sponsor Name

AGENCY: Food and Drug

Administration, HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect the

change of sponsor name from RhonePoulenc Chemicals, Ltd., to Rhodia

Limited.

EFFECTIVE DATE: August 3, 1998.

FOR FURTHER INFORMATION CONTACT:

Thomas J. McKay, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0213.

SUPPLEMENTARY INFORMATION: RhonePoulenc Chemicals, Ltd., P.O. Box 46,

St. Andrews Rd., Avonmouth, Bristol

BS119YF, England, UK, has informed

FDA of a change of sponsor name to

Rhodia, Limited. Accordingly, the

agency is amending 21 CFR

510.600(c)(1) and (c)(2) to reflect the

change of sponsor name.

List of Subjects in 21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

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 510 is amended as follows:

PART 510—NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 510 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352,

353, 360b, 371, 379e.

§ 510.600 [Amended]

2. Section 510.600 Names, addresses,

and drug labeler codes of sponsors of

approved applications is amended in

the table in paragraph (c)(1) by

removing the entry for ‘‘Rhone-Poulenc

Chemicals, Ltd.,’’ and by alphabetically

adding an entry for ‘‘Rhodia Limited’’;

and in the table in paragraph (c)(2) in

the entry for ’’059258’’ by removing the

sponsor name for ‘‘Rhone-Poulenc

Chemicals, Ltd.,’’ and adding in its

place ‘‘Rhodia Limited’’.

Dated: July 10, 1998.

Margaret Ann Miller,

Acting Director, Office of New Animal Drug

EvaluationCenter for Veterinary Medicine.

[FR Doc. 98–20532 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 520

Oral Dosage Form New Animal Drugs;

Milbemycin Oxime Tablets

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

Novartis Animal Health US, Inc. The

supplemental NADA provides for use of

a lower dose of milbemycin oxime in

treating dogs and puppies for the

prevention of heartworm disease.

EFFECTIVE DATE: AUGUST 3, 1998.