Federal Register / Vol. 60, No. 2 / Wednesday, January 4, 1995 / Rules and Regulations 363

Inc., 2621 North Belt Hwy., St. Joseph,

MO 64506, has filed ANADA 200–008

which provides for use of

oxytetracycline injection as follows:

intramuscular or intravenous use in beef

and nonlactating dairy cattle for the

treatment of pneumonia and shipping

fever associated with Pasteurella spp.

and Hemophilus spp.; infectious bovine

keratoconjunctivitis (pinkeye) caused by

Moraxella bovis; foot rot and diphtheria

caused by Fusobacterium necrophorum;

bacterial enteritis (scours) caused by

Escherichia coli; wooden tongue caused

by Actinobacillus lignieresi;

leptospirosis caused by Leptospira

pomona; and wound infections and

acute metritis caused by strains of

staphylococci and streptococci

organisms sensitive to oxytetracyclineintramuscular use in swine for

treatment of bacterial enteritis (scours,

colibacillosis) caused by E. coli;

pneumonia caused by P. multocida; and

leptospirosis caused by L. pomonaintramuscular use in sows for control of

infectious enteritis (baby pig scours,

colibacillosis) in suckling pigs caused

by E. coli.

Boehringer Ingelheim’s ANADA 200–

008 for oxytetracycline injection (OXY–

TET 200/BIO–MYCIN 200) is approved

as a generic copy of Pfizer’s NADA 113–

232 for oxytetracycline injection

(Liquamycin LA–200). The ANADA is

approved as of November 16, 1994, and

the regulations are amended by revising

§ 522.1660(b) and (c)(2)(iii) (21 CFR

522.1660(b) and (c)(2)(iii)) to reflect the

approval. The basis for approval is

discussed in the freedom of information

summary.

In accordance with the freedom of

information provisions of part 20 (21

CFR part 20) and § 514.11(e)(2)(ii) (21

CFR 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, rm. 1–23, 12420

Parklawn Dr., Rockville, MD 20857,

between 9 a.m. and 4 p.m., Monday

through Friday.

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 522

Animal drugs.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Center for Veterinary Medicine, 21

CFR part 522 is amended as follows:

PART 522—IMPLANTATION OR

INJECTABLE DOSAGE FORM NEW

ANIMAL DRUGS

1. The authority citation for 21 CFR

part 522 continues to read as follows:

Authority: Sec. 512 of the Federal Food,

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

2. Section 522.1660 is amended in

paragraph (b) by adding the phrase

‘‘000010 and’’ before the number

‘‘000069’’, and in paragraph (c)(2)(iii) by

revising the last sentence to read as

follows:

§ 522.1660 Oxytetracycline injection.

* * * * *

(c) * * *

(2) * * *

(iii) * * * Discontinue treatment at

least 42 days prior to slaughter when

provided by 000010 or 28 days prior to

slaughter when provided by 000069.

Dated: December 21, 1994.

Michael J. Blackwell,

Deputy Director, Post-market Surveillance

and Compliance, Center for Veterinary

Medicine.

[FR Doc. 95–163 Filed 1–3–95; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF TRANSPORTATION

Federal Highway Administration

23 CFR Part 655

[FHWA Docket No. 94–33]

RIN 2125–AD45

National Standards for Traffic Control

Devices; Revision of the Manual on

Uniform Traffic Control Devices;

Temporary Traffic Signals

AGENCY: Federal Highway

Administration (FHWA), DOT.

ACTION: Interim final rule with request

for comments.

SUMMARY: This document incorporates

by reference an amendment to Part VI of

the Manual on Uniform Traffic Control

Devices (MUTCD). This amendment is

intended to revise the section of the

MUTCD concerning temporary traffic

signals in order to permit the use of

certain temporary signalling devices

that were inadvertently excluded by an

earlier revision to Part VI. The MUTCD

is recognized as the national standard

for traffic control on all public roads.

Public comments are invited on this

action.

DATES: This interim final rule is

effective January 4, 1995.

Comments must be submitted on or

before March 6, 1995.

Incorporation by reference of the

publications listed in the regulations is

approved by the Director of the Federal

Register as of January 4, 1995.

ADDRESSES: Submit written, signed

comments to FHWA Docket No. 94–33,

Federal Highway Administration, Office

of the Chief Counsel, room 4232, HCC–

10, 400 Seventh Street, SW.,

Washington, DC 20590. All comments

received will be available for

examination at the above address

between 8:30 a.m. and 3:30 p.m., e.t.,

Monday through Friday except Federal

holidays. Those desiring notification of

receipt of comments must include a selfaddressed, stamped postcard.

FOR FURTHER INFORMATION CONTACT: Mr.

Michael E. Robinson, Office of Highway

Safety, (202) 366–0411, or Mr. Wilbert

Baccus, Office of Chief Counsel, (202)

366–0780, Federal Highway

Administration, 400 Seventh Street,

SW., room 3419, Washington, DC 20590.

Office hours are from 7:45 a.m. to 4:15

p.m., e.t., except Federal holidays.

SUPPLEMENTARY INFORMATION: The

MUTCD is available for inspection and

copying as prescribed in 49 CFR Part 7,

appendix D. Part VI of the MUTCD may

be purchased for $16.00 from the

Superintendent of Documents, U. S.

Government Printing Office,

Washington, DC 20402, Stock No. 050–

001–00516–3.

The FHWA both receives and initiates

requests for amendments to the

MUTCD. Each request is assigned an

identification number which indicates,

by Roman numeral, the organizational

part of the MUTCD affected and, by

Arabic numeral, the order in which the

request was received (e.g., Request VIII–

9).

This amendment contains corrections

to Part VI of the MUTCD, Standards and

Guides for Traffic Control for Street and

Highway Construction, Maintenance,

Utility, and Incident Management

Operations. Part VI sets forth principles

and prescribes standards for temporary

traffic control zone operations on streets

and highways in the United States.

Also, part VI addresses the design,

administration, and operation of street

and highway temporary traffic control

plans and projects. Previous Federal

Register actions regarding changes to
364 Federal Register / Vol. 60, No. 2 / Wednesday, January 4, 1995 / Rules and Regulations

part VI are contained in FHWA docket

number 89–1, Notice No. 7, published at

58 FR 6508 on December 10, 1993.

The text change resulting from this

amendment to the MUTCD has been

titled ‘‘1988 MUTCD Revision 4, dated

November 1, 1994.’’ It will be available

from the Government Printing Office

(GPO), Superintendent of Documents,

Washington, D.C. 20402, (202) 783–

3238. Everyone currently appearing on

the FHWA, Office of Highway Safety,

Federal Register mailing list will be

sent a copy.

Discussion of Amendment

Part VI of the MUTCD was revised on

September 3, 1993, and incorporated by

reference in 23 CFR part 655 on

December 10, 1993 (58 FR 64085). As

revised, the last paragraph in section

6F–8c read:

One-way traffic flow requires an all-red

interval of sufficient duration for traffic to

clear the portion of the temporary traffic

control zone controlled by the traffic signals.

To avoid the display of conflicting signals at

each end of the temporary traffic control

zone, traffic signals shall be either hardwired or controlled by radio signals.

The FHWA has since learned that the

last sentence of the section

inadvertently disallowed the use of

certain temporary signaling devices now

in use. While they employ neither hardwiring nor radio signals, these devices

are considered to be as safe and effective

as those devices covered by the

September 3, 1993, version of section

6F–8c. In order to allow the use of such

devices, the last sentence of the

paragraph has been removed and

replaced with the following sentence:

Safeguards shall be incorporated to avoid

the display of conflicting signals at each end

of the temporary traffic control zone.

As revised, the section imposes a

performance standard, and not a design

standard, on all such devices. This

document incorporates the revised Part

VI into 23 CRF part 655. With the

current emphasis on repairing the

Nation’s highways and improving safety

in temporary traffic control zone areas,

an updated and accurate part VI will

better serve the highway community.

Rulemaking Analyses and Notices

The Administrative Procedure Act

(APA), 5 U.S.C. 551 et seq., allows

agencies engaged in rulemaking to

dispense with prior notice and

opportunity for comment when the

agency for good cause finds that such

procedures are impracticable,

unnecessary, or contrary to the public

interest. 5 U.S.C. 553(b)(3)(B).

The FHWA has determined that

providing prior notice to the public on

this action would be contrary to the

public interest. This action will

incorporate by reference into 23 CFR

part 655 a revised version of Part VI of

the MUTCD. The September 3, 1993,

version inadvertently excluded the use

of certain safe and effective traffic

control devices in highway work zones.

This was not the intent of the revision

and therefore Part VI is being revised

again to allow the use of these devices.

Any further delay in revising Part VI

would cause undue economic harm to

those who manufacture and sell the

types of traffic control devices excluded

by the September 1993 language of Part

VI.

Public comment, however, is solicited

on this action. Comments received will

be carefully considered in evaluating

whether any further changes to this

amendment are necessary.

Executive Order 12866 (Regulatory

Planning and Review) and DOT

Regulatory Policies and Procedures

The FHWA has determined that this

document does not constitute a

significant regulatory action within the

meaning of Executive Order 12866, nor

is it significant within the meaning of

Department of Transportation regulatory

policies and procedures. Although this

action will allow the use of alternative

signalling devices not permitted under

the September 3, 1993, version of Part

VI of the MUTCD, the FHWA

anticipates that this action will not

affect the total number of signalling

devices deployed. By permitting public

and private entities to choose from a

wider array of signalling devices, these

entities may be able to make more costeffective choices in the future.

Accordingly, it is anticipated that the

overall economic impact of this

rulemaking will be minimal, but

positive. For these reasons, the FHWA

has determined that a full regulatory

evaluation is not required.

Regulatory Flexibility Act

In compliance with the Regulatory

Flexibility Act (Pub. L. 96–354, 5 U.S.

C. 601–612), the FHWA has evaluated

the effects of this rule on small entities.

This action will allow a few small

companies to market signalling devices

not allowed under the September 3,

1993, version of Part VI. Based on the

evaluation, the FHWA hereby certifies

that this action will not have a

significant economic impact on a

substantial number of small entities.

The need to further evaluate economic

consequences will be reviewed on the

basis of the comments submitted in

response to this interim final rule.

Executive Order 12612 (Federalism

Assessment)

This action has been analyzed in

accordance with the principles and

criteria contained in Executive Order

12612, and it has been determined that

this action does not have sufficient

federalism implications to warrant the

preparation of a federalism assessment.

The MUTCD is incorporated by

reference in 23 CFR part 655, subpart F,

which requires that changes to the

national standards issued by the FHWA

shall be adopted by the States or other

Federal agencies within two years of

issuance. This proposed amendment is

in keeping with the Secretary of

Transportation’s authority under 23

U.S.C. 109(d) and 315 to promulgate

uniform guidelines to promote the safe

and efficient use of the highway.

Therefore, nothing in this document

would preempt any State laws,

regulations, or requirements.

Executive Order 12372

(Intergovernmental Review)

Catalog of Federal Domestic

Assistance Program Number 20.205,

Highway Planning and Construction.

The regulations implementing Executive

Order 12372 regarding

intergovernmental consultation on

Federal programs and activities apply to

this program.

Paperwork Reduction Act

This action does not contain a

collection of information requirement

for purposes of the Paperwork

Reduction Act of 1980, 44 U.S.C. 3501

et seq.

National Environmental Policy Act

The agency has analyzed this action

for the purpose of the National

Environmental Policy Act of 1969 (42

U.S.C. 4321 et seq.) and has determined

that this action would not have any

effect on the quality of the environment.

Regulation Identification Number

A regulation identification number

(RIN) is assigned to each regulatory

action listed in the Unified Agenda of

Federal Regulations. The Regulatory

Information Service Center publishes

the Unified Agenda in April and

October of each year. The RIN contained

in the heading of this document can be

used to cross reference this action with

the Unified Agenda.

List of Subjects in 23 CFR Part 655

Design standards, Grant programs—

transportation, Highways and roads,

Incorporation by reference, Signs,

Traffic regulations.
Federal Register / Vol. 60, No. 2 / Wednesday, January 4, 1995 / Rules and Regulations 365

The FHWA hereby amends chapter I

of title 23, Code of Federal Regulations,

part 655, as set forth below.

PART 655—TRAFFIC OPERATIONS

1. The authority citation for part 655

continues to read as follows:

Authority: 23 U.S.C. 101(a), 104, 105,

109(d), 114(a), 135, 217, 307, 315, and 402(a);

23 CFR 1.32 and 1204.4; and 49 CFR 1.48(b).

Subpart F—[Amended]

2. In § 655.601, paragraph (a) is

revised to read as follows:

§ 655.601 Purpose.

* * * * *

(a) Manual on Uniform Traffic Control

Devices for Streets and Highways

(MUTCD), FHWA, 1988, including

Revision No. 1 dated January 17, 1990,

Revision No. 2 dated March 17, 1992,

Revision No. 3 dated September 3, 1993,

and Revision No. 4 dated November 1,

1994. This publication is incorporated

by reference in accordance with 5 U.S.C.

552(a) and 1 CFR part 51 and is on file

at the Office of the Federal Register in

Washington, DC. The 1988 MUTCD

Stock No. 050–001–00308–2 and ‘‘1988

MUTCD Revision 3,’’ dated September

3, 1993 (Stock No. 050–001–00316–3),

may be purchased from the

Superintendent of Documents, U.S.

Government Printing Office (GPO),

Washington, DC 20402. The

amendments to the MUTCD, titled

‘‘1988 MUTCD Revision 1,’’ dated

January 17, 1990, ‘‘1988 MUTCD

Revision 2,’’ dated March 17, 1992, and

‘‘1988 MUTCD Revision 4, dated

November 1, 1994,’’ are available from

the Federal Highway Administration,

Office of Highway Safety, HHS–21, 400

Seventh Street SW., Washington, DC

20590. These documents are available

for inspection and copying as prescribed

in 49 CFR part 7, appendix D.

* * * * *

Issued on: December 28, 1994.

Rodney E. Slater,

Federal Highway Administrator.

[FR Doc. 95–86 Filed 1–3–95; 8:45 am]

BILLING CODE 4910–22–P

DEPARTMENT OF EDUCATION

34 CFR Parts 74 and 80

Education Department General

Administrative Regulations; Cost

Principles for Educational Institutions

AGENCY: Department of Education.

ACTION: Announcement regarding

amendments to certain cost principles.

SUMMARY: The Secretary announces

revisions to Office of Management and

Budget (OMB) Circular A–21, ‘‘Cost

Principles for Educational Institutions,’’

which is used by the Department of

Education in administering grant

programs. The preambles to previously

published final rulemaking documents

specified Circular A–21 as amended

through certain dates as the text of the

Circular used for Department of

Education programs. The Secretary

specifies in this document subsequent

OMB amendments to Circular A–21 and

adopts those amendments for grant

programs administered by the

Department.

EFFECTIVE DATE: This notice takes effect

on February 3, 1995.

FOR FURTHER INFORMATION CONTACT:

Glenn Riley, U.S. Department of

Education, 600 Independence Avenue,

SW., room 3636, ROB–3, Washington,

DC 20202–4700. Telephone: (202) 708–

7640. Individuals who use a

telecommunications device for the deaf

(TDD) may call the Federal Information

Relay Service (FIRS) at 1–800–877–8339

between 8 a.m. and 8 p.m., Eastern time,

Monday through Friday.

SUPPLEMENTARY INFORMATION: On July 6,

1994, the Secretary published a revision

to Part 74—Administration of Grants

and Agreements with Institutions of

Higher Education, Hospitals, and Other

Nonprofit Organizations (59 FR 34722).

Also, on March 11, 1988, the Secretary

published a new Part 80—Uniform

Administrative Requirements for Grants

and Cooperative Agreements to State

and Local Governments (53 FR 8071).

These documents established OMB

Circular A–21 as the cost principles

used by the Department of Education for

educational institutions (34 CFR 74.27,

80.22). The preamble to the 1988

document specified all OMB

amendments to Circular A–21 as

amended through December 2, 1986 and

the preamble to the 1994 document all

amendments made by OMB to Circular

A–21 through October 3, 1991. Each of

these preambles adopted for Department

of Education programs the text of A–21

as amended through the dates specified

in those publications.

On July 26, 1993, OMB published

amendments to Circular A–21 at 58 FR

39996. This notice adopts for 34 CFR

part 80 the changes made by OMB on

October 3, 1991 and July 26, 1993, and

adopts for 34 CFR part 74 the changes

made by OMB on July 26, 1993. The

changes adopted in this announcement

bind all recipients of Department grants

and cooperative agreements to the

requirements of Circular A–21 as

amended through July 26, 1993. These

cost principles apply to educational

institutions, except to the extent

program regulations or the Department’s

administrative regulations require a

different outcome.

OMB Circular A–21 was originally

published in the Federal Register on

March 6, 1979, at 44 FR 12368. It has

been amended several times prior to the

amendment made on July 26, 1993, as

follows: On August 3, 1982, at 47 FR

33658, on June 9, 1986, at 51 FR 20908,

on December 2, 1986, at 51 FR 43487,

and on October 3, 1991, at 56 FR 50224.

The circular, as amended, is adopted by

the Department. It is available by calling

the Publications Unit for the Executive

Office of the President at (202) 395–

7332, or by writing the Executive Office

of the President, Publications, room

2200, New Executive Office Building,

725 17th Street, NW., Washington, DC

20503.

Waiver of Notice and Comment

It is the practice of the Secretary to

offer interested parties the opportunity

to comment on proposed actions in

accordance with the Administrative

Procedure Act (5 U.S.C. 553). However,

since an opportunity was previously

provided by OMB for public comment

on the October 1991 changes to the

Circular at 56 FR 22618 on May 15,

1991 and at 56 FR 29530 on June 27,

1991 and, regarding the July 1993

amendments, an opportunity was

previously provided by OMB for public

comment on that amendment to OMB

Circular A–21 (57 FR 58394; December

9, 1992), the Secretary finds that

soliciting further public comment with

respect to adoption of the revised

circular is unnecessary and contrary to

the public interest under 5 U.S.C.

553(b)(B).

(Catalog of Federal Domestic Assistance

Number does not apply.)

Dated: December 1, 1994.

Donald R. Wurtz,

Chief Financial Officer.

[FR Doc. 95–122 Filed 1–3–95; 8:45 am]

BILLING CODE 4000–01–M