31918 Federal Register / Vol. 63, No. 112 /Thursday, June 11, 1998 /Rules and Regulations

been eliminated, the request should include

specific proposed actions to address it.

Compliance: Required within the next 10

hours time-in-service (TIS) after the effective

date of this AD, unless already accomplished.

To prevent in-flight vibrations caused by

the affected airplanes operating at excessive

speeds, which could result in airplane

damage and possible loss of control of the

airplane, accomplish the following:

(a) Fabricate a placard that restricts the

never exceed speed (Vne) to no more than

144 miles per hour (MPH) or 125 knots (KTS)

indicated airspeed (IAS), and install this

placard on the instrument panel within the

pilot’s clear view. The placard should utilize

letters of at least 0.10-inch in height and

contain the following words:

‘‘Never exceed speed, Vne, 144 MPH (125

KTS) IAS’’

(b) Mark a red line on the airspeed

indicator glass at 144 MPH (125 KTS) and

mark a white slippage mark on the outside

surface of the airspeed indicator between the

glass and case.

(c) Insert a copy of this AD into the

Limitations Section of the airplane flight

manual (AFM).

(d) Fabricating and installing the placard as

required by paragraph (a) of this AD and

inserting this AD into the Limitations Section

of the AFM as required by paragraph (c) of

this AD may be performed by the owner/

operator holding at least a private pilot

certificate as authorized by section 43.7 of

the Federal Aviation Regulations (14 CFR

43.7), and must be entered into the aircraft

records showing compliance with this AD in

accordance with section 43.9 of the Federal

Aviation Regulations (14 CFR 43.9).

(e) 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.

(f) An alternative method of compliance or

adjustment of the compliance time that

provides an equivalent level of safety may be

approved by the Manager, Wichita Aircraft

Certification Office (ACO), 1801 Airport

Road, Room 100, Mid-Continent Airport,

Wichita, Kansas 67209. The request shall be

forwarded through an appropriate FAA

Maintenance Inspector, who may add

comments and then send it to the Manager,

Wichita ACO.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Wichita ACO.

(g) Information related to this AD may be

examined at the FAA, Central Region, Office

of the Regional Counsel, Room 1558, 601 E.

12th Street, Kansas City, Missouri.

(h) This amendment becomes effective on

July 7, 1998.

Issued in Kansas City, Missouri, on June 2,

1998.

Ronald K. Rathgeber,

Acting Manager, Small Airplane Directorate,

Aircraft Certification Service.

[FR Doc. 98–15202 Filed 6–10–98; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF COMMERCE

Bureau of Export Administration

15 CFR Part 700

[Docket No. 970827205–8126–02]

RIN 0694–AA02

Defense Priorities and Allocations

System

AGENCY: Bureau of Export

Administration, Commerce.

ACTION: Final rule.

SUMMARY: The Department of Commerce

is issuing this rule to amend the Defense

Priorities and Allocations System

(DPAS) regulation by updating,

modifying and clarifying a number of its

provisions.

In reviewing the current DPAS and in

issuing this rule, the objective has been

to improve DPAS administration and

implementation and make it more

effective and efficient in the post-Cold

War era.

EFFECTIVE DATE: This rule is effective

July 13, 1998.

FOR FURTHER INFORMATION CONTACT:

Richard V. Meyers, DPAS Program

Manager, Office of Strategic Industries

and Economic Security, Room 3876,

U.S. Department of Commerce, 14th

Street and Constitution Avenue, N.W.,

Washington, D.C. 20230; telephone:

(202) 482–3634, FAX: (202) 482–5650,

and E-Mail: rmeyers@bxa.doc.gov.

SUPPLEMENTARY INFORMATION:

Background

On October 1, 1997, the Department

of Commerce published in the Federal

Register (62 FR 51389) a request for

comments on a proposed rule that

would amend the Defense Priorities and

Allocations System (DPAS) regulation

by updating, modifying, and clarifying a

number of its provisions.

Interested parties were requested to

submit comments on the proposed rule

by October 31, 1997. Interested parties

were also requested to provide

comments on any other provision of the

DPAS that may be hindering effective

and efficient administration or

implementation. Of the seven comments

received, only two were from private

sector firms. Based on these comments

and an editorial review of the proposed

rule, several provisions of the proposed

rule are further revised and clarified,

and various editorial changes are made.

Analysis of Comments

No commenters objected to the

proposed rule. Accordingly, the

Department is proceeding with

publication of this final rule with the

changes discussed below.

Public comments were particularly

sought concerning the proposed

revision of three provisions that directly

affect industry operations under the

DPAS. These provisions pertain to: (1)

the time period within which a supplier

must accept or reject a rated order

[§ 700.13(d)(1)]; (2) the order of

precedence to be given by contractors

and suppliers to conflicting rated orders

of equal priority status (§ 700.14); and

(3) the combining by a contractor of

defense rated requirements with

commercial (unrated) requirements on

one purchase order to a supplier

[§ 700.17(d)].

Comments were also sought

concerning (1) a proposal to remove the

controlled materials provisions from

§§ 700.30–700.31 and all other

provisions, references, and supporting

schedules to the program from

throughout the regulation; and (2)

proposals to make various other

jurisdictional, technical, administrative,

and miscellaneous revisions to a

number of DPAS provisions. These

revisions are needed to address changes

to delegated authority, to update and

clarify the text, and to improve

generally the administration,

effectiveness, and efficiency of the

DPAS in support of our nation’s postCold War defense requirements and its

ability to respond fully to a national

security emergency or domestic

emergency preparedness situation.

1. Customer Notification of Acceptance

or Rejection of Rated Orders

Industry has complained about the

difficulty of complying with the

customer notification requirements of

§ 700.13(d)(1). These rules required a

supplier to accept or reject a rated order

in writing within ten (10) working days

after receipt of a DO rated order and

within five (5) working days after

receipt of a DX rated order. Accordingly,

§ 700.13(d)(1) is revised to extend the

time within which a person must accept

or reject a rated order by five (5)

working days to fifteen (15) working

days after receipt of a DO rated order,

and ten (10) working days after receipt

of a DX rated order. No commenter on

the proposed rule objected to this

change.

Also, because of the increasing use by

industry of electronic data interchange

to place contracts and purchase orders,

§ 700.13(d) is revised to reference

specifically the electronic placement,

acceptance, and rejection of rated

orders. However, if the rated order is
Federal Register / Vol. 63, No. 112 /Thursday, June 11, 1998 /Rules and Regulations 31919

rejected, the rule requires that the

reasons for rejection be provided in

writing (not electronically).

One commenter objected to the

requirement that a person must

acknowledge acceptance of a rated

order. The primary goal of the DPAS is

to ensure timely delivery of defense

items. Thus, it is most important that

customers receive written or electronic

proof from their suppliers that their

rated orders were accepted for delivery

as required by the order. It should be

noted that this requirement to

acknowledge acceptance of the receipt

of a rated order is an obligation placed

on the recipient of the order, not on the

person placing the order.

2. Precedence of Rated Orders of Equal

Priority Status

Many companies have requested

clarification of the DPAS rules on the

preference to be given to rated orders

which have equal priority status (DX or

DO) when production, delivery or

performance scheduling conflicts or

other problems arise following

acceptance of the rated orders.

Accordingly, § 700.14(c) (Preferential

scheduling) is revised to provide that if

a person finds that delivery or

performance against any accepted rated

orders conflicts with the delivery or

performance against any other accepted

rated orders of equal priority status,

preference shall be given to the

conflicting rated orders in the sequence

in which they are to be delivered or

performed (not to the receipt dates).

However, if the conflicting rated orders

are scheduled to be delivered or

performed on the same day, the person

shall give preference to those orders

which have the earliest receipt dates. If

under these rules, the delivery or

performance conflicts cannot be

resolved, or if the customer objects to

the rescheduling of the rated order,

special priorities assistance should be

requested promptly under §§ 700.50–

700.54.

It should be noted that the proposed

rule specified the receipt dates of the

conflicting rated orders as the criteria

for precedence. Because Department of

Defense (DOD) and an industry

commenter objections, and to

emphasize the importance of timely

delivery against rated orders, the final

rule establishes the delivery or

performance schedule as the criteria for

precedence.

3. Combining Defense Rated

Requirements With Commercial

(Unrated) Requirements

The final rule revises § 700.17(d) (Use

of rated orders) to eliminate the

requirement for a contractor who

combines rated and unrated order

quantities on a purchase order to a

supplier, to attach to the combined

order a separate rated order with the

rated quantities. Many companies have

objected to this separate rated order

requirement and the industry

commenters on the proposed rule

expressed support for its elimination.

The final rule also provides that the

rated quantities in the combined

purchase order must be clearly and

separately identified and that a special

statement must be included on the

combined purchase order to notify the

supplier that the order contains rated

quantities certified for national defense

use and that the provisions of the DPAS

apply only to the rated quantities.

4. National Security Emergency

Preparedness and Removal of the

Controlled Materials Provisions

No commenter objected to removal

from the DPAS of all provisions and

references pertaining to the controlled

materials program. Therefore, the final

rule removes all such provisions and

references, including Schedules II, III,

and IV to part 700.

The final rule also further revises the

text of § 700.30 to clearly state how the

DPAS may be expanded in a national

security emergency to ensure rapid

industrial response and the timely

availability of critical industrial items

and facilities to meet the urgent national

defense or domestic emergency

preparedness requirements of approved

programs.

5. New Approved Programs

Except as discussed below, no

commenter objected to the proposed

addition of two new approved

programs, ‘‘Designated Programs’’ and

‘‘Food Resources (combat rations)’’, and

changing the ‘‘N1’’ Federal Emergency

Management Agency program name to

‘‘Emergency Preparedness Activities’’.

Accordingly, the final rule revises

Schedule 1 to part 700 to title the

Schedule ‘‘Approved Programs and

Delegate Agencies’’; assign the

‘‘Designated Programs’’ program to the

Department of Commerce as Delegate

Agency and identify the program with

the ‘‘H8’’ Program Identification

Symbol; and assign the ‘‘Food Resources

(combat rations)’’ program to the

Department of Defense (DOD) as

Delegate Agency and identify the

program with the ‘‘C1’’ Program

Identification Symbol. At the request of

DOD, the program name ‘‘Designated

Programs’’ is used in this final rule

instead of the name ‘‘Special Projects’’

to avoid confusion over use of this term

for other purposes.

6. Minimum Rated Order Amount

Under the proposed rule, the

minimum rated order amount in

§ 700.17(f) would have increased from

$5000 to $100,000 to conform to the

current simplified Federal Acquisition

Regulation (FAR) small order threshold

of $100,000 (see FAR § 2.101). Although

the private sector commenters

supported this change, DOD objected on

the grounds that too many lower cost

critical defense orders, especially at the

lower-tier levels of the industrial base,

would no longer be priority rated, this

impacting DPAS effectiveness.

However, recognizing the need to

increase the minimum rated order

amount, DOD recommended that this

amount be established at $50,000, or

one half of the FAR Simplified

Acquisition Threshold, which ever

amount is larger, provided that delivery

can be obtained in a timely fashion

without the use of a priority rating. We

have decided to adopt the DOD

recommendation and increase the

minimum rated order amount

accordingly. During the next several

years, we will review the impact of this

revision on the timeliness of defense

procurement and public comment is

invited. If warranted, a further

adjustment of the minimum rated order

amount will be proposed.

7. Other Revisions and Non-Substantive

and Editorial Changes

Several commenters provided

comment on various technical issues

such as the correctness of citations and

definitions; the use of terms such as

‘‘national security emergency’’,

‘‘domestic emergency preparedness’’,

and ‘‘requirements contract’’ and

‘‘calls’’; and the need for a definition of

the term ‘‘industrial resources’’. To

further improve the clarity and

effectiveness of the DPAS, this rule

incorporates these revisions. An

editorial review of the proposed rule

also suggested the need for further

editorial and technical corrections and

these revisions are made in this rule.

8. DPAS Schedule I and the Other DPAS

Schedules

This rule revises DPAS Schedule 1 to

part 700, which lists all Approved

Programs for DPAS support. All other

DPAS Schedules (II through V), which

pertained to the controlled materials

program, are removed.

DPAS Schedule 1 is revised by

changing the term ‘‘Authorized

Program’’ to ‘‘Approved Program’’

wherever it appears in the Schedule and
31920 Federal Register / Vol. 63, No. 112 /Thursday, June 11, 1998 /Rules and Regulations

by making appropriate changes to the

first paragraph of the two paragraph

explanation of the Schedule. This rule

also removes from the Schedule (1) all

program identification symbols and

associated authorized program names

from the Schedule that pertained to the

controlled materials program [‘‘C8—

Controlled materials for Defense

Industrial Supply Center (DISC)’’, ‘‘H2—

Controlled materials producers’’, ‘‘H3—

Further converters (controlled

materials)’’, and ‘‘H4—Distributors of

controlled materials’’]; and (2) the term

‘‘Federal Aviation Administration’’ from

the list of Associated Agencies of the

Department of Defense contained in

footnote 1.

Added to Schedule 1 by this rule are

two new program identification symbols

and associated approved program

names, as follows: ‘‘C1—Food resources

(combat rations)’’ under the ‘‘Defense

Programs’’ heading; and ‘‘H8—

Designated Programs’’, under the ‘‘Other

Defense, Energy and Related Programs’’

heading.

Finally, this rule revises (1) the

‘‘Other Energy Programs’’ heading in

Schedule 1 to read: ‘‘Domestic Energy

Programs’’; (2) the ‘‘F3’’ program name

‘‘Construction and Maintenance’’ to

read: ‘‘Construction, repair, and

maintenance’’; and (3) the ‘‘N1’’

program name ‘‘Approved civil defense

programs’’ to read ‘‘Emergency

Preparedness Activities’’.

9. Appendices

There are a number of documents

required to support the effective and

efficient implementation and

administration of the DPAS regulation.

These documents include (1)

Delegations of Authority from the

Department of Commerce to the

Departments of Defense and Energy,

General Services Administration, and

the Federal Emergency Management

Agency (Delegate Agencies) who use the

DPAS to support their national defense

related procurement; (2) Interagency

Memoranda of Understanding between

the Department of Commerce and

Departments of Agriculture, Energy, and

the Interior pertaining to resource

jurisdiction issues and delegated

authority; (3) Form BXA–999 (formerly

Form ITA–999), used to request Special

Priorities Assistance; (4) Memorandum

of Understanding on Priorities and

Allocations Support Between the

Department of Commerce and the

Canadian Public Works and

Government Services Canada (formerly

the Canadian Department of Supply and

Services); and (5) DPAS Emergency

Delegation 1. These documents, except

for DPAS Emergency Delegation 1, were

previously included in the Code of

Federal Regulations (CFR) as

Appendices I through IV. DPAS

Emergency Delegation 1 would be

implemented if in a catastrophic

national security emergency,

communications with Department of

Commerce headquarters in Washington,

D.C. are severed. All of these documents

have been updated and revised.

Because it is used by the public and

therefore of significant public interest,

Form BXA–999 is redesignated as

Appendix I to part 700 and published

with this rule. Because they are of

limited public interest, the Delegations

of Authority, Interagency Memoranda of

Understanding, Memorandum of

Understanding on Priorities and

Allocations Support Between the

Department of Commerce and the

Canadian Public Works and

Government Services Canada, and

DPAS Emergency Delegation 1, will not

be published with this rule. However,

copies of Appendix I and these other

DPAS documents, designated as

Appendices II through V, respectively,

may be obtained by contacting the

DPAS Program Manager at the

Department of Commerce (see FOR

FURTHER INFORMATION CONTACT section

above). Copies of Appendix I may also

be obtained from any Department of

Defense, Defense Contract Management

Command field office.

Public Rulemaking Docket

The public rulemaking docket

concerning this regulation is maintained

in the Bureau of Export Administration

Freedom of Information Records

Inspection Facility, Room 4525, U.S.

Department of Commerce, 14th Street

and Pennsylvania Avenue, N.W.,

Washington, D.C. 20230. Records in this

facility may be inspected and copied in

accordance with regulations published

in 15 CFR part 4. Information pertaining

to the inspection and copying of records

may be obtained from Ms. Margaret

Cornejo, Freedom of Information

Officer, at the Records Inspection

Facility, or by calling (202) 482–5653.

Rulemaking Requirements

The Department made certain

determinations with respect to the

following rulemaking requirements:

1. Classification under E.O. 12866:

This amendment of the DPAS regulation

has been determined to be ‘‘not

significant’’ for the purpose of Executive

Order 12866.

2. Regulatory Flexibility Act: The

Assistant General Counsel for

Legislation and Regulation certified to

the Chief Counsel for Advocacy, Small

Business Administration, that this

amendment of the DPAS regulation will

not have a significant economic impact

on a substantial number of small

entities. This amendment of the DPAS

merely updates, modifies, or clarifies a

number of provisions to make the DPAS

more effective and efficient in the post

Cold War era. Many of the changes are

made in response to comments and

recommendations received from the

business community, thus ensuring that

the updated DPAS conforms to current

business practices and enabling all

business entities subject to its

requirements to increase the efficiency

of their operations and realize certain

cost savings. In addition, some DPAS

provisions are revised to conform the

regulation to recent statutory and

organizational changes while other

provisions are deleted because they are

obsolete.

Because of the self-administered

nature of the DPAS, there is no way to

accurately estimate the number of

business entities throughout the U.S.

industrial base to whom the DPAS is

applicable. However, it has been

roughly estimated that there are at least

18,000 business entities during any one

year that on at least one or more

occasions must respond to its

requirements. It is also estimated that

given the nature of defense production,

relatively few of these entities are small

entities.

The DPAS regulation has been in

effect since 1984 and is the successor to

priorities and allocations regulations

that were first promulgated in the mid1950s. Thus, most business entities

engaged in defense production under

the DPAS, including small entities, can

and do respond to applicable DPAS

requirements in the ordinary course of

their business with very little, if any,

economic impact. These DPAS

revisions, in and of themselves, impose

no economic impact on any business

entity, including small entities, and will

further reduce whatever minimal

economic impact is associated with

DPAS compliance.

3. Paperwork Reduction Act: The

information collection requirements

imposed by the DPAS regulation were

approved by the Office of Management

and Budget (OMB) under the provisions

of Section 3507 of the Paperwork

Reduction Act of 1980, amended (44

U.S.C. 3501 et seq.) (OMB Control

Number 0694–0053).

Notwithstanding any other provision

of law, no person is required to respond

to nor shall a person be subject to a

penalty for failure to comply with any

DPAS information collection

requirements unless the information
Federal Register / Vol. 63, No. 112 /Thursday, June 11, 1998 /Rules and Regulations 31921

collection displays a currently valid

OMB Control Number.

The collection of information

requirements in the DPAS apply to all

persons who receive priority rated

orders under the DPAS. These

requirements are necessary to support

proper administration of the DPAS and

ensure its effectiveness and efficiency.

The total annual public burden per

respondent for this collection of

information is estimated at 14,477

hours. This estimate includes (a) 11,667

total extra record keeping hours to

create a record of the receipt of a

priority rated order (700,000 priority

rated orders annually × 1 minute per

order); (b) 972 total hours to provide

notice of acceptance of a priority rated

order (699,650 priority rated orders

accepted annually × 5 seconds per

order); (c) 88 total hours to provide

notice of rejection of a priority rated

order (350 priority rated orders rejected

annually × 15 minutes per order); and

(d) 1,750 total hours to provide notice

of delayed delivery against a priority

rated order (7000 total priority rated

orders annually against which delivery

will be delayed × 15 minutes per order).

Send comments regarding this burden

estimate or any other aspect of the data

requirements, including suggestions for

reducing this burden, to Richard V.

Meyers at the address given in the FOR

FURTHER INFORMATION CONTACT section

above, or to the Office of Information

and Regulatory Affairs, Office of

Management and Budget, New

Executive Office Building, 725 17th

Street, N.W., Room 10235, Washington,

D.C. 20503; Attn.: Desk Officer for the

Bureau of Export Administration

4. E.O. 12612: This amendment of the

DPAS regulation does not contain

policies with Federalism implications

sufficient to warrant preparation of a

Federalism assessment under E.O.

12612.

List of Subjects in 15 CFR Part 700

Administrative practice and

procedure, Business and industry,

Government contracts, National defense,

Reporting and recordkeeping

requirements, Strategic and critical

materials.

For the reasons stated in the

preamble, part 700 of Subchapter A,

National Security Industrial Base

Regulations (15 CFR part 700), is

amended as follows:

PART 700—[AMENDED]

1. The authority citation for 15 CFR

part 700 is revised to read as follows:

Authority: Titles I and VII of the Defense

Production Act of 1950, as amended (50

U.S.C. app. 2061 et seq.), Title VI of the

Robert T. Stafford Disaster Relief and

Emergency Assistance Act (42 U.S.C. 5195 et

seq.), and Executive Order 12919, 59 FR

29525, 3 CFR, 1994 Comp., p. 901; Section

18 of the Selective Service Act of 1948 (50

U.S.C. App. 468), 10 U.S.C. 2538, 50 U.S.C.

82, and Executive Order 12742, 56 FR 1079,

3 CFR, 1991 Comp., p. 309; and Executive

Order 12656, 53 FR 226, 3 CFR, 1988 Comp.,

p. 585.

2. Section 700.1 is amended:

a. By revising the phrase ‘‘materials

and facilities’’ to read ‘‘materials,

services, and facilities’’, and revising the

phrase ‘‘materials and equipment’’ to

read ‘‘materials, equipment, and

services’’, in paragraph (a);

b. By revising paragraph (b);

c. By redesignating paragraph (c) as

paragraph (e); and

d. By adding new paragraphs (c) and

(d); as follows:

§ 700.1 Purpose of this regulation.

* * * * *

(b) Section 18 of the Selective Service

Act of 1948 (50 U.S.C. app. 468)

(Selective Service Act) authorizes the

President to place an order with a

supplier for any articles or materials

required for the exclusive use of the

U.S. armed forces whenever the

President determines that in the interest

of national security, prompt delivery of

the articles and materials is required.

The supplier must give precedence to

the order so as to deliver the articles or

materials in a required time period. 10

U.S.C. 2538, and 50 U.S.C. 82, provide

similar authority specifically for

Department of Defense procurement, but

only in time of war or when war is

imminent.

(c) Section 602(b) of the Robert T.

Stafford Disaster Relief and Emergency

Assistance Act (42 U.S.C. 5195a(b))

provides that the terms ‘‘national

defense’’ and ‘‘defense’’ as used in the

Defense Production Act includes

‘‘emergency preparedness activities’’

conducted pursuant to Title VI of the

Stafford Act. The definition of ‘‘national

defense’’ in Section 702(13) of the

Defense Production Act provides that

this term includes ‘‘emergency

preparedness activities’’ conducted

pursuant to Title VI of the Stafford Act.

(d) The Defense Priorities and

Allocations System (DPAS) regulation

implements the priorities and

allocations authority of the Defense

Production Act and as this authority

pertains to Title VI of the Stafford Act,

and the priorities authority of the

Selective Service Act and related

statutes, all with respect to industrial

resources. The DPAS ensures the timely

availability of industrial resources for

approved programs and provides an

operating system to support rapid

industrial response to a national

emergency.

* * * * *

3. Section 700.2 is amended by

revising paragraphs (a) and (b), and by

revising the phrase ‘‘Appendix I’’ to

read ‘‘Appendix II’’ in paragraph (c); as

follows:

§ 700.2 Introduction.

(a) Certain national defense and

energy programs (including emergency

preparedness activities) are approved

for priorities and allocations support.

For example, military aircraft

production, ammunition, and certain

programs which maximize domestic

energy supplies are ‘‘approved

programs.’’ A complete list of currently

approved programs is provided at

Schedule 1 to this part.

(b) The Department of Commerce

administers the DPAS to ensure the

timely delivery of industrial items to

meet approved program requirements.

* * * * *

§ 700.3 [Amended]

4. Section 700.3(a) is amended by

revising the term ‘‘authorized program’’

to read ‘‘approved program’’.

5. Section 700.4 is revised to read as

follows:

§ 700.4 Priorities and allocations in a

national emergency.

(a) In the event of a national

emergency, special rules may be

established as needed to supplement

this part, thus ensuring rapid industrial

response and the timely availability of

critical industrial items and facilities to

meet the urgent national defense

requirements, including domestic

emergency preparedness requirements,

of approved programs.

(b) The special rules established in

response to the emergency may include

provisions for the taking of certain

emergency official actions and the

allocation of critical and scarce

materials and facilities.

§ 700.7 [Amended]

6. Section 700.7(a) is amended by

adding the phrase ‘‘and the Selective

Service Act and related statutes’’

following the phrase ‘‘the Defense

Production Act’’.

7. Section 700.8 is amended:

a. By removing the following

definitions: ‘‘Authorized program’’,

‘‘Controlled materials’’, ‘‘Controlled

materials suppliers’’, ‘‘Distributors of

controlled materials’’, ‘‘Further

conversion’’, ‘‘Lead time’’, and

‘‘Minimum mill quantity’’;

b. By amending the definition of

‘‘Delegate Agency’’, by revising the term
31922 Federal Register / Vol. 63, No. 112 /Thursday, June 11, 1998 /Rules and Regulations

‘‘authorized programs’’ to read

‘‘approved programs’’;

c. By amending the definition of

‘‘Official action’’, by adding the phrase

‘‘, the Selective Service Act and related

statutes,’’ following the phrase ‘‘the

Defense Production Act’’;

d. By amending the definition of

‘‘Rated order’’, by revising the term

‘‘authorized program’’ to read

‘‘approved program’’; and

e. By revising the introductory

sentence after the section heading,

revising the definition of ‘‘person’’, and

adding new definitions of ‘‘approved

program’’, ‘‘industrial resources’’, and

‘‘Selective Service Act and related

statutes’’ to read as follows:

§ 700.8 Definitions.

In addition to the definitions

provided in Section 702 of the Defense

Production Act (excepting the definition

of ‘‘industrial resources’’) and Section

602(a) of the Stafford Act, the following

definitions pertain to all sections of this

part:

Approved program—a program

determined as necessary or appropriate

for priorities and allocations support to

promote the national defense by the

Secretary of Defense, the Secretary of

Energy, or the Director, Federal

Emergency Management Agency, under

the authority of the Defense Production

Act, the Stafford Act, and Executive

Order 12919, or the Selective Service

Act and related statutes and Executive

Order 12742.

* * * * *

Industrial resources—all materials,

services, and facilities, including

construction materials, the authority for

which has not been delegated to other

agencies under Executive Order 12919.

This term also includes the term ‘‘item’’

as defined and used in this part.

* * * * *

Person—any individual, corporation,

partnership, association, or any other

organized group of persons, or legal

successor or representative thereof; or

any authorized State or local

government or agency thereof; and for

purposes of administration of this part,

includes the United States Government

and any authorized foreign government

or agency thereof, delegated authority as

provided in this part.

* * * * *

Selective Service Act and related

statutes—Section 18 of the Selective

Service Act of 1948 (50 U.S.C. app. 468),

10 U.S.C. 2538, and 50 U.S.C. 82.

* * * * *

Stafford Act—Title VI (Emergency

Preparedness) of the Robert T. Stafford

Disaster Relief and Emergency

Assistance Act, as amended (42 U.S.C.

5195 et seq.).

8. Section 700.10 is amended:

a. By revising paragraph (a); and

b. By revising the phrase ‘‘Office of

Industrial Resource Administration’’ to

read ‘‘Office of Strategic Industries and

Economic Security’’, by revising the

phrase ‘‘authorized programs’’ to read

‘‘approved programs’’, and by revising

the phrase ‘‘Appendix I’’ to read

‘‘Appendix II’’, in paragraph (b); as

follows:

§ 700.10 Delegation of authority.

(a) The priorities and allocations

authorities of the President under Title

I of the Defense Production Act with

respect to industrial resources have

been delegated to the Secretary of

Commerce under Executive Order 12919

of June 3, 1994 (59 FR 29525). The

priorities authorities of the President

under the Selective Service Act and

related statutes with respect to

industrial resources have also been

delegated to the Secretary of Commerce

under Executive Order 12742 of January

8, 1991 (56 FR 1079).

* * * * *

§ 700.11 [Amended]

9. Section 700.11(b) is amended by

revising the term ‘‘authorized program’’

to read ‘‘approved program’’, and

revising the term ‘‘authorized programs’’

to read ‘‘approved programs’’.

10. Section 700.12 is amended by

revising paragraphs (b) and (c) to read

as follows:

§ 700.12 Elements of a rated order.

* * * * *

(b) A required delivery date or dates.

The words ‘‘immediately’’ or ‘‘as soon

as possible’’ do not constitute a delivery

date. A ‘‘requirements contract’’, ‘‘basic

ordering agreement’’, ‘‘prime vendor

contract’’, or similar procurement

document bearing a priority rating may

contain no specific delivery date or

dates and may provide for the

furnishing of items from time-to-time or

within a stated period against specific

purchase orders, such as ‘‘calls’’,

‘‘requisitions’’, and ‘‘delivery orders’’.

These purchase orders must specify a

required delivery date or dates and are

to be considered as rated as of the date

of their receipt by the supplier and not

as of the date of the original

procurement document;

(c) The written signature on a

manually placed order, or the digital

signature or name on an electronically

placed order, of an individual

authorized to sign rated orders for the

person placing the order. The signature

or use of the name certifies that the

rated order is authorized under this part

and that the requirements of this part

are being followed; and

* * * * *

11. Section 700.13 is amended:

a. By adding a new paragraph (b)(4);

b. By removing paragraphs (c)(5),

(c)(6), and (c)(7);

c. By redesignating paragraph (c)(8) as

paragraph (c)(5) and amending

redesignated paragraph (c)(5) by adding

the phrase ‘‘or the Selective Service Act

and related statutes’’ following the

phrase ‘‘the Defense Production Act’’;

d. By revising paragraph (d); and

e. By adding an OMB control number;

as follows:

§ 700.13 Acceptance and rejection of rated

orders.

* * * * *

(b) Mandatory rejection. * * *

(4) If a person is unable to fill all the

rated orders of equal priority status

received on the same day, the person

must accept, based upon the earliest

delivery dates, only those orders which

can be filled, and reject the other orders.

For example, a person must accept order

A requiring delivery on December 15

before accepting order B requiring

delivery on December 31. However, the

person must offer to accept the rejected

orders based on the earliest delivery

dates otherwise possible.

* * * * *

(d) Customer notification

requirements. (1) A person must accept

or reject a rated order in writing or

electronically within fifteen (15)

working days after receipt of a DO rated

order and within ten (10) working days

after receipt of a DX rated order. If the

order is rejected, the person must give

reasons in writing (not electronically)

for the rejection.

(2) If a person has accepted a rated

order and subsequently finds that

shipment or performance will be

delayed, the person must notify the

customer immediately, give the reasons

for the delay, and advise of a new

shipment or performance date. If

notification is given verbally, written or

electronic confirmation must be

provided within five (5) working days.

(The information collection requirements in

paragraphs (d)(1) and (d)(2) are approved by

the Office of Management and Budget under

OMB control number 0694–0053.)

12. Section 700.14 is amended by

revising paragraph (c) to read as follows:

§ 700.14 Preferential scheduling.

* * * * *

(c) Conflicting rated orders. (1) If a

person finds that delivery or

performance against any accepted rated
Federal Register / Vol. 63, No. 112 /Thursday, June 11, 1998 /Rules and Regulations 31923

orders conflicts with the delivery or

performance against other accepted

rated orders of equal priority status, the

person shall give preference to the

conflicting orders in the sequence in

which they are to be delivered or

performed (not to the receipt dates). If

the conflicting rated orders are

scheduled to be delivered or performed

on the same day, the person shall give

preference to those orders which have

the earliest receipt dates.

(2) If a person is unable to resolve

rated order delivery or performance

conflicts under this section, the person

should promptly seek special priorities

assistance as provided in §§ 700.50

through 700.54. If the person’s customer

objects to the rescheduling of delivery

or performance of a rated order, the

customer should promptly seek special

priorities assistance as provided in

§§ 700.50 through 700.54. For any rated

order against which delivery or

performance will be delayed, the person

must notify the customer as provided in

§ 700.13(d)(2).

* * * * *

13. Section 700.17 is amended:

a. By removing the parenthetical

phrase ‘‘(except as provided in

§ 700.31(d)—Controlled materials

program identification symbols)’’ in

paragraph (b)(2);

b. By removing the parenthetical

phrase ‘‘(not applicable to controlled

materials producers)’’ in paragraph

(b)(3);

c. By removing the phrase found at

the end of the paragraph, ‘‘, except as

provided in § 700.31(d) (Controlled

materials program identification

symbols)’’, in paragraph (c).

d. By revising paragraph (d)(1);

e. By redesignating paragraph (d)(2) as

(d)(3);

f. By adding a new paragraph (d)(2);

and

g. By revising paragraph (f); as

follows:

§ 700.17 Use of rated orders.

* * * * *

(d) Combining rated and unrated

orders. (1) A person may combine rated

and unrated order quantities on one

purchase order provided that:

(i) The rated quantities are separately

and clearly identified; and

(ii) The four elements of a rated order,

as required by § 700.12, are included on

the order with the statement required in

§ 700.12(d) modified to read in

substance:

This purchase order contains rated order

quantities certified for national defense use,

and you are required to follow all the

provisions of the Defense Priorities and

Allocations System regulation (15 CFR part

700) only as it pertains to the rated

quantities.

(2) A supplier must accept or reject

the rated portion of the purchase order

as provided in § 700.13 and give

preferential treatment only to the rated

quantities as required by this part. This

part may not be used to give preferential

treatment to the unrated portion of the

order.

* * * * *

(f) A person is not required to place

a priority rating on an order for less than

$50,000, or one half of the Federal

Acquisition Regulation (FAR)

Simplified Acquisition Threshold (see

FAR 2.101), whichever amount is larger,

provided that delivery can be obtained

in a timely fashion without the use of

the priority rating.

14. Section 700.18 is amended:

a. By adding a new paragraph

(a)(2)(v);

b. By revising paragraph (b)(1);

c. By revising the phrase ‘‘Appendix

II’’ to read ‘‘Appendix III’’ in paragraph

(b)(2); and

d. By removing the first item listed,

‘‘communication services’’, and the

parenthetical phrase, ‘‘(as defined in

Schedule III)’’ which follows the item,

‘‘Copper raw materials’’, in paragraph

(b)(3); as follows:

§ 700.18 Limitations on placing rated

orders.

(a) * * *

(2) * * *

(v) Any items related to the

development of chemical or biological

warfare capabilities or the production of

chemical or biological weapons, unless

such development or production has

been authorized by the President or the

Secretary of Defense.

(b) Jurisdictional limitations. (1) The

priorities and allocations authority for

certain items has been delegated under

Executive Orders 12919 and 12742,

other executive order, or Interagency

Memoranda of Understanding to other

agencies. Unless otherwise agreed to by

the concerned agencies, the provisions

of this part are not applicable to these

items which include:

(i) Food resources, food resource

facilities, and the domestic distribution

of farm equipment and commercial

fertilizer (Department of Agriculture—

see Attachment A to DPAS Delegation 1

in Appendix II to part 700 concerning

combat rations);

(ii) All forms of energy, including

radioisotopes, stable isotopes, source

material, and special nuclear material

produced in Government-owned plants

or facilities operated by or for the

Department of Energy (Department of

Energy);

(iii) Health resources (Department of

Health and Human Services);

(iv) All forms of civil transportation

(Department of Transportation);

(v) Water resources (Department of

Defense/U.S. Army Corps of Engineers);

(vi) Communications services

(National Communications System

under Executive Order 12472 of April 3,

1984); and

(vii) Mineral resources and mineral

processing facilities (Department of the

Interior/U.S. Geological Survey—see

Memorandum of Understanding

Between Interior and Commerce in

DPAS Appendix III to part 700).

* * * * *

15. Section 700.21 is amended:

a. By revising paragraph (a);

b. By revising the phrases ‘‘materials

or equipment’’ and ‘‘material or

equipment’’ to read ‘‘materials,

equipment, or services’’ in paragraphs

(b)(2), (c) introductory text, (c)(1)

introductory text, and (d); and

c. By revising the term ‘‘authorized

programs’’ to read ‘‘approved programs’’

in paragraph (f); as follows:

§ 700.21 Application for priority rating

authority.

(a) For projects believed to maximize

domestic energy supplies, a person may

request priority rating authority for

scarce, critical, and essential supplies of

materials, equipment, and services

(related to the production of materials or

equipment, or the installation, repair, or

maintenance of equipment) by

submitting DOE Form PR 437 to the

Department of Energy. Blank

applications and further information

may be obtained from the U.S.

Department of Energy, Office of

Clearance and Support, Field/

Headquarters Support Division,

Forrestal Building, 1000 Independence

Avenue, S.W., Washington, D.C. 20585;

Attn.: PR–132.

* * * * *

16. Subpart F is revisied to read as

follows:

Subpart F—National Emergency

Preparedness and Critical Items

§ 700.30 Priorities and allocations in a

national emergency.

(a) In the event of a national

emergency, special rules may be

established as needed to supplement

this part, thus ensuring rapid industrial

response and the timely availability of

critical industrial items and facilities to

meet the urgent national defense

requirements, including domestic

emergency preparedness requirements,

of approved programs.

(1) Emergency official actions. (i) As

needed, this part may be supplemented
31924 Federal Register / Vol. 63, No. 112 /Thursday, June 11, 1998 /Rules and Regulations

to include additional definitions to

cover civilian emergency preparedness

industrial items, support for essential

civilian programs, and provisions for

the taking of certain emergency official

actions under sections §§ 700.60

through 700.63.

(ii) Emergency official actions may

include:

(A) Controlling inventories of critical

and scarce defense and/or emergency

preparedness items;

(B) Restricting the purchase, use, or

distribution of critical and scarce

defense and/or emergency preparedness

items, or the use of production or

distribution facilities, for non-essential

purposes; and

(C) Converting the production or

distribution of non-essential items to the

production or distribution of critical

and scarce defense and/or emergency

preparedness items.

(2) Allocation of critical and scarce

items and facilities. (i) As needed, this

part may be supplemented to establish

special rules for the allocation of scarce

and critical items and facilities to

ensure the timely availability of these

items and facilities for approved

programs, and to provide for an

equitable and orderly distribution of

requirements for such items among all

suppliers of the items. These rules may

provide for the allocation of individual

items or they may be broad enough to

direct general industrial activity as

required in support of emergency

requirements.

(ii) Allocation rules (i.e., controlled

materials programs) were established in

response to previous periods of national

security emergency such as World War

II and the Korean Conflict. The basic

elements of the controlled materials

programs were the set-aside (the amount

of an item for which a producer or

supplier must reserve order book space

in anticipation of the receipt of rated

orders), the production directive

(requires a producer to supply a specific

quantity, size, shape, and type of an

item within a specific time period), and

the allotment (the maximum quantity of

an item authorized for use in a specific

program or application). These elements

can be used to assure the availability of

any scarce and critical item for

approved programs. Currently, a setaside applies only to metalworking

machines (see § 700.31).

(3) In the event that certain critical

items become scarce, and approved

program requirements for these items

cannot be met without creating a

significant dislocation in the civilian

market place so as to create appreciable

hardship, Commerce may establish

special rules under section 101(b) of the

Defense Production Act to control the

general distribution of such items in the

civilian market.

(b) Regional Emergency Coordinators.

(1) If due to a catastrophic national

security emergency event,

communications with Commerce

headquarters in Washington, D.C. are

severed, DPAS Emergency Delegation 1

will provide authority to the Regional

Emergency Coordinators (REC) located

in the Standard Federal Region Council

cities (Boston, New York, Philadelphia,

Atlanta, Dallas, Kansas City, Chicago,

Denver, San Francisco, and Seattle) to

represent the Secretary of Commerce,

and as necessary, act for the Secretary

to carry out the emergency industrial

production and distribution control

functions of Commerce as set forth in

this part, in any supplement thereto, or

other applicable authority. See DPAS

Emergency Delegation 1 for further

information about the authority and

duties of the RECs, and the effective

date of the Delegation.

(2) If DPAS Emergency Delegation 1 is

implemented due to a catastrophic

national security emergency event,

requests for special priorities assistance

under §§ 700.50 through 700.55 should

be filed with the nearest Regional

Emergency Coordinator located in one

of the Standard Federal Region Council

cities as provided in DPAS Delegation 1.

§ 700.41 [Redesignated as § 700.31]

Subpart G—[Removed and Reserved]

17. Section 700.41 is redesignated as

§ 700.31 in Subpart F; and Subpart G is

removed and reserved.

§ 700.50 [Amended]

18. Section 700.50(c) is amended by

revising the term ‘‘ITA–999’’ to read

‘‘BXA–999’’ each of the three times it

appears in the paragraph; by revising

the term ‘‘(OMB control number 0625–

0015)’’ to read ‘‘(OMB control number

0694–0057)’’; by removing the phrase

‘‘, any Commerce District Office’’; and

by revising the phrase ‘‘Appendix III’’ to

read ‘‘Appendix I’’.

19. Section 700.54 is amended by

revising the section heading and the

second sentence of the introductory

text, as follows:

§ 700.54 Instances where assistance may

not be provided.

* * * * *

Examples where assistance may not

be provided include situations when a

person is attempting to:

* * * * *

§ 700.55 [Amended]

20. Section 700.55 is amended:

a. By revising the term ‘‘authorized

programs’’ to read ‘‘approved programs’’

in paragraph (a);

b. By revising the term ‘‘Canadian

Department of Supply and Services’’ to

read ‘‘Canadian Public Works and

Government Services Canada’’ in

paragraphs (b)(2), (b)(3), (b)(4), (b)(5),

and (b)(6); and by revising the phrase

‘‘The Department of Supply and

Services’’ to ‘‘Public Works and

Government Services Canada’’ in

paragraph (b)(5).

c. By revising the term ‘‘ITA–999’’ to

read ‘‘BXA–999’’ in paragraph (b)(6).

21. The phrase ‘‘the Selective Service

Act and related statutes,’’ is added

following the phrase ‘‘the Defense

Production Act,’’ wherever it appears in

the following places:

Sec.

700.70(a)

700.71(a)

700.71(c)(1)

700.71(c)(2)

700.71(c)(3)

700.72(a)

700.73(a)

700.73(b)

700.75

700.80(a)(2)

700.91(d)

§ 700.72 [Amended]

22. Section 700.72(b) is amended by

revising the term ‘‘Assistant General

Counsel for International Trade’’ to read

‘‘Chief Counsel for Export

Administration’’.

23. Section 700.74 is amended:

a. By revising paragraph (a);

b. By removing paragraph (b);

c. By redesignating paragraph (c) as

paragraph (b), and paragraph (d) as

paragraph (c); as follows:

§ 700.74 Violations, penalties, and

remedies.

(a) Willful violation of the provisions

of Title I or Sections 705 or 707 of the

Defense Production Act, the priorities

provisions of the Selective Service Act

and related statutes, this part, or an

official action, is a crime and upon

conviction, a person may be punished

by fine or imprisonment, or both. The

maximum penalty provided by the

Defense Production Act is a $10,000

fine, or one year in prison, or both. The

maximum penalty provided by the

Selective Service Act and related

statutes is a $50,000 fine, or three years

in prison, or both.

* * * * *

24. The term ‘‘Office of Industrial

Resource Administration’’ is revised to

read ‘‘Office of Strategic Industries and

Economic Security’’ in the following

places:
Federal Register / Vol. 63, No. 112 /Thursday, June 11, 1998 /Rules and Regulations 31925

Sec.

700.80(a)

700.80(c)

700.80(d)

700.81(a)

700.81(b)

700.93

25. The phrase ‘‘Assistant Secretary

for Trade Administration’’ is revised to

read ‘‘Assistant Secretary for Export

Administration’’ in the following places:

Sec.

700.80(d)

700.81(a)

700.81(b)

700.81(d)

700.81(e)

700.81(f)

700.81(g)

700.81(h)

§ 700.81 [Amended]

26. Section 700.81(b) is amended by

revising the term ‘‘International Trade

Administration’’ to read ‘‘Bureau of

Export Administration’’.

§ 700.91 [Amended]

27. Section 700.91(a) is amended by

revising the term ‘‘(OMB control

number 0625–0107)’’ to read ‘‘(OMB

control number 0694–0053)’’.

§ 700.93 [Amended]

28. Section 700.93 is amended by

revising the phrase ‘‘telephone: (202)

377–4506’’ to read ‘‘telephone: (202)

482–3634, or FAX: (202) 482–5650’’.

29. Schedule 1 to part 700 is revised,

as follows:

Defense Priorities and Allocations System

SCHEDULE 1 TO PART 700

Approved Programs and Delegate Agencies

The programs listed in this schedule have

been approved for priorities and allocations

support under this part. They have equal

preferential status. The Department of

Commerce has authorized the Delegate

Agencies to use this part in support of those

programs assigned to them, as indicated

below.

Program identification symbol Approved program Delegate agency

Defense programs:

A1 ................................ Aircraft ............................................................................................................................ Department of Defense.1

A2 ................................ Missiles .......................................................................................................................... Do.

A3 ................................ Ships .............................................................................................................................. Do.

A4 ................................ Tank—Automotive ......................................................................................................... Do.

A5 ................................ Weapons ........................................................................................................................ Do.

A6 ................................ Ammunition .................................................................................................................... Do.

A7 ................................ Electronic and communications equipment ................................................................... Do.

B1 ................................ Military building supplies ................................................................................................ Do.

B8 ................................ Production equipment (for defense contractor’s account) ............................................ Do.

B9 ................................ Production equipment (Government owned) ................................................................. Do.

C1 ................................ Food resources (combat rations) .................................................................................. Do.

C2 ................................ Department of Defense construction ............................................................................. Do.

C3 ................................ Maintenance, repair, and operating supplies (MRO) for Department of Defense facilities.Do.

C9 ................................ Miscellaneous ................................................................................................................ Do.

International defense programs:

Canada:

D1 ......................... Canadian military programs ........................................................................................... Department of Commerce.

D2 ......................... Canadian production and construction .......................................................................... Do.

D3 ......................... Canadian atomic energy program ................................................................................. Do.

Other Foreign Nations:

G1 ........................ Certain munitions items purchased by foreign governments through domestic commercial channels for export.Department of Commerce.

G2 ........................ Certain direct defense needs of foreign governments other than Canada ................... Do.

G3 ........................ Foreign nations (other than Canada) production and construction .............................. Do.

Co-Production:

J1 ......................... F–16 Co-Production Program ........................................................................................ Departments of Commerce

and Defense.

Atomic energy programs:

E1 ................................ Construction ................................................................................................................... Department of Energy.

E2 ................................ Operations—including maintenance, repair, and operating supplies (MRO) ................ Do.

E3 ................................ Privately owned facilities ............................................................................................... Do.

Domestic energy programs:

F1 ................................ Exploration, production, refining, and transportation ..................................................... Department of Energy.

F2 ................................ Conservation .................................................................................................................. Do.

F3 ................................ Construction, repair, and maintenance ......................................................................... Do.

Other defense, energy, and

related programs:

H1 ................................ Certain combined orders (see section 700.17(c)) ......................................................... Department of Commerce.

H5 ................................ Private domestic production .......................................................................................... Do.

H6 ................................ Private domestic construction ........................................................................................ Do.

H7 ................................ Maintenance, repair, and operating supplies (MRO) .................................................... Do.

H8 ................................ Designated Programs .................................................................................................... Do.

K1 ................................ Federal supply items ..................................................................................................... General Services Administration.

N1 ................................ Emergency preparedness activities ............................................................................... Federal Emergency Management Agency.

1 Department of Defense includes: Armed Services—Army, Navy (including Marines and Coast Guard), and Air Force; Component Agencies,

including Defense Logistics Agency, National Security Agency, Defense Advanced Research Projects Agency, Defense Information Systems

Agency, Defense Nuclear Agency, Defense Mapping Agency, and On-Site Inspection Agency; and Associated Agencies, including Central Intelligence Agency and National Aeronautics and Space Administration.
31926 Federal Register / Vol. 63, No. 112 /Thursday, June 11, 1998 /Rules and Regulations

30. Schedule II to part 700 (Controlled

Materials), Schedule III to part 700

(Technical Definitions of Controlled

Materials Products), Schedule IV to part

700 (Copper Controlled Materials

Producers’ Set-aside Base and

Percentages), and Schedule V to part

700 (Nickel Alloys Controlled Materials

Producers’ Set-aside Base and

Percentages) are removed.

31. Appendix I to part 700 is revised,

as follows:

Defense Priorities and Allocations

System

Appendix 1 to Part 700

Form BXA–999—Request for Special

Priorities Assistance

BILLING CODE 3510–JT–P
Federal Register / Vol. 63, No. 112 /Thursday, June 11, 1998 /Rules and Regulations 31927
31928 Federal Register / Vol. 63, No. 112 /Thursday, June 11, 1998 /Rules and Regulations
Federal Register / Vol. 63, No. 112 /Thursday, June 11, 1998 /Rules and Regulations 31929
31930 Federal Register / Vol. 63, No. 112 /Thursday, June 11, 1998 /Rules and Regulations

BILLING CODE 3510–JT–C 32. Appendix II to part 700:

Interagency Memoranda of

Understanding; Appendix III to part

700: Form ITA–999—Request for
Federal Register / Vol. 63, No. 112 /Thursday, June 11, 1998 /Rules and Regulations 31931

Special Priorities Assistance; and

Appendix IV to part 700: Memorandum

of Understanding on Priorities and

Allocations Support Between the

Department of Commerce and the

Canadian Department of Supply and

Services, are removed.

Issued: June 5, 1998.

Iain S. Baird,

Deputy Assistant Secretary for Export

Administration.

[FR Doc. 98–15410 Filed 6–10–98; 8:45 am]

BILLING CODE 3510–JT–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 524

Ophthalmic and Topical Dosage Form

New Animal Drugs; Gentamicin

Sulfate, Betamethasone Valerate, and

Clotrimazole Ointment

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 an abbreviated new animal

drug application (ANADA) filed by

Med-Pharmex, Inc. The ANADA

provides for the use of gentamicin

sulfate, betamethasone valerate, and

clotrimazole (Tri-Otic ointment) for the

treatment of canine acute and chronic

otitis externa associated with yeast and/

or bacteria susceptible to gentamicin.

EFFECTIVE DATE: June 11, 1998.

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: MedPharmex, Inc., 2727 Thompson Creek

Rd., Pomona, CA 91767, filed ANADA

200–229 that provides for the use of

gentamicin sulfate, betamethasone

valerate, and clotrimazole (Tri-Otic

ointment) for the treatment of canine

acute and chronic otitis externa

associated with yeast and/or bacteria

susceptible to gentamicin.

The ANADA is approved as a generic

copy of Schering Plough Animal Health

Corp.’s NADA 140–896 for OTOMAX

(gentamicin sulfate, betamethasone

valerate, and clotrimazole). ANADA

200–229 is approved as of April 8, 1998,

and the regulations are amended in 21

CFR 524.1044g to reflect the approval.

The basis for approval is discussed in

the freedom of information summary. In

addition, the agency is amending 21

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

a change of sponsor’s name and address.

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.

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.

List of Subjects

21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

21 CFR Part 524

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 parts 510 and 524 are 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.

2. Section 510.600 Names, addresses,

and drug labeler codes of sponsors of

approved applications is amended in

the table in paragraph (c)(1) in the entry

for ‘‘Med-Pharmex, Inc., Biomed

Laboratories’’ and in the table in

paragraph (c)(2) in the entry for

‘‘051259’’ by revising the sponsor name

and address to read as follows:

§ 510.600 Names, addresses, and drug

labeler codes of sponsors of approved

applications.

* * * * *

(c) * * *

(1) * * *

Firm name and address Drug labeler code

* * * * * * *

Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767–

1861

051259

* * * * * * *

(2) * * *

Drug labeler code Firm name and address

* * * * * * *

051259 Med-Pharmex, Inc., 2727 Thompson Creek Rd., Pomona, CA 91767–

1861

* * * * * * *