Federal Register / Vol. 61, No. 113 / Tuesday, June 11, 1996 / Rules and Regulations 29481

paragraph (b) by removing ‘‘No.

053501’’ and adding in its place ‘‘Nos.

053501 and 059130’’ and by removing

paragraph (d).

Dated: May 28, 1996.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 96–14644 Filed 6–10–96; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 558

New Animal Drugs for Use in Animal

Feeds; Semduramicin With Bacitracin

Methylene Disalicylate and Roxarsone

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect

approval of a new animal drug

application (NADA) filed by Pfizer, Inc.

The NADA provides for using approved

single ingredient Type A medicated

articles to make combination drug Type

C medicated broiler chicken feeds

containing semduramicin with

bacitracin methylene disalicylate and

roxarsone. The Type C medicated feed

is used for prevention of coccidiosis and

for improved feed efficiency.

EFFECTIVE DATE: June 11, 1996.

FOR FURTHER INFORMATION CONTACT:

James F. McCormack, Center for

Veterinary Medicine (HFV–128), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–594–

1607.

SUPPLEMENTARY INFORMATION: Pfizer,

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

10017, filed NADA 141–058, which

provides for combining approved Type

A medicated articles containing Aviax

(semduramicin sodium) with BMD

(bacitracin methylene disalicylate) and

3–Nitro (roxarsone) to make

combination drug Type C medicated

broiler chicken feeds containing 22.7

grams (g) of semduramicin, 10 to 50 g

of bacitracin methylene disalicylate, and

45.4 g of roxarsone per ton. The Type

C medicated feed is used for the

prevention of coccidiosis caused by

Eimeria acervulina, E. brunetti, E.

maxima, E. mivati/E. miti, E. necatrix,

and E. tenella, including some field

strains of E. tenella that are more

susceptible to semduramicin combined

with roxarsone than semduramicin

alone, and for improved feed efficiency

in broiler chickens. The NADA is

approved as of June 11, 1996, and the

regulations are amended by adding new

21 CFR 558.555(b)(2) to reflect the

approval. The basis for approval is

discussed in the freedom of information

summary.

Roxarsone is a Category II drug which,

as provided in 21 CFR 558.4, requires an

approved medicated feed application

(Form FDA 1900) for making a Type C

medicated feed. Therefore, making a

Type C medicated feed containing

semduramicin, bacitracin methylene

disalicylate, and roxarsone requires an

approved Form FDA 1900.

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.

Under section 512(c)(2)(F)(ii) of the

Federal Food, Drug, and Cosmetic Act

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

approval qualifies for 3 years marketing

exclusivity beginning June 11, 1996,

because the application contains reports

of new clinical or field investigations

(other than bioequivalence or residue

studies) essential to the approval of the

application and conducted or sponsored

by the applicant.

The agency has determined under 21

CFR 25.24(d)(1)(ii) 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 in 21 CFR Part 558

Animal drugs, Animal feeds.

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 558 is amended as follows:

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

1. The authority citation for 21 CFR

part 558 continues to read as follows:

Authority: Secs. 512, 701 of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

360b, 371).

2. Section 558.555 is amended by

adding new paragraph (b)(2) to read as

follows:

§ 558.555 Semduramicin.

* * * * *

(b) * * *

(2) Amount. Semduramicin 22.7

grams with bacitracin methylene

disalicylate 10 to 50 grams and

roxarsone 45.4 grams per ton.

(i) Indications for use. For the

prevention of coccidiosis caused by

Eimeria acervulina, E. brunetti, E.

maxima, E. mivati/E. mitis, E. necatrix,

and E. tenella, including some field

strains of E. tenella that are more

susceptible to semduramicin combined

with roxarsone than semduramicin

alone, and for improved feed efficiency.

(ii) Limitations. Feed continuously as

sole ration. Use feed within 2 weeks of

production. Withdraw 5 days before

slaughter. Do not feed to laying hens.

Use as sole source of organic arsenic.

Poultry should have access to drinking

water at all times. Drug overdosage or

lack of water intake may result in leg

weakness or paralysis.

Dated: May 28, 1996.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 96–14650 Filed 6–10–96; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF DEFENSE

DEPARTMENT OF TRANSPORTATION

Coast Guard

DEPARTMENT OF VETERANS

AFFAIRS

38 CFR Part 21

RIN 2900–AI04

Montgomery GI Bill—Selected

Reserve: Miscellaneous

AGENCIES: Department of Defense,

Department of Transportation (Coast

Guard), and Department of Veterans

Affairs.

ACTION: Final rule.

SUMMARY: This document amends

regulations concerning the Montgomery

GI Bill—Selected Reserve program. It

removes provisions that are obsolete,

duplicative, or otherwise unnecessary. It

also makes changes for purposes of

clarification.

EFFECTIVE DATE: June 11, 1996.

FOR FURTHER INFORMATION CONTACT: June

C. Schaeffer, Assistant Director for

Policy and Program Administration,

Education Service, Veterans Benefits

Administration, Department of Veterans

Affairs, 202–273–7187.

SUPPLEMENTARY INFORMATION: The

regulations governing the Montgomery

GI Bill—Selected Reserve program are

found in 38 CFR, Part 21, Subpart L (see
29482 Federal Register / Vol. 61, No. 113 / Tuesday, June 11, 1996 / Rules and Regulations

38 CFR 21.7500 through 21.7810). This

document amends these regulations as

discussed below.

Section 21.7639(a) contained

provisions for reducing educational

assistance for reservists due to excessive

absences. Due to a statutory change,

these provisions applied only to

absences occurring prior to December

18, 1989. Consequently, this paragraph

is unnecessary and is removed.

Section 21.7639(e) provided that in

certain instances a reservist’s monthly

payment would be reduced if he or she

enrolled in a course offered by a

combination of on-campus training and

independent study. Because of a

statutory change, there no longer is a

basis for reducing monthly payments for

such enrollments. Therefore, that

paragraph is removed.

In addition, § 21.7639(f)(1) discussed

payment for independent study begun

before July 1, 1993. The reservists

affected by that paragraph have been

paid. Accordingly, it is unnecessary and

is removed.

Section 21.7640(b) is amended to

reflect organizational changes

previously made within the Department

of Veterans Affairs (VA).

Section 21.7645 is removed because it

is no longer necessary. VA recently

revised § 21.4145 so that it applies to

VA’s work-study programs in all the

education programs VA administers.

There is no need for a separate

regulation restating work-study

provisions for participants in the

Montgomery GI Bill—Selected Reserve

program.

Section 21.7652 is amended to

remove an obsolete reference and to

correct a typographical error.

Section 21.7672 contained many

provisions concerning course

measurement for courses begun before

July 1, 1993. Those provisions are no

longer needed because the reservists in

those courses already have been paid for

their training. This document amends

the course measurement provisions

accordingly.

Section 21.7801 is amended to reflect

organizational changes previously made

within VA.

Section 21.7810 is removed.

Paragraph (a) was duplicative of

provisions concerning civil rights

matters in 38 CFR Parts 18, 18a, and

18b. Paragraph (b) merely concerned the

applicability of provisions that were

removed by another Federal Register

document.

This document also makes changes

for clarification to some of the sections

referred to above and to other sections

in Subpart L.

This document removes provisions

that are obsolete, duplicative, or without

substantive effect and makes changes for

clarification. This document makes no

substantive changes. Accordingly, there

is a basis for dispensing with prior

notice and comment and delayed

effective date provisions of 5 U.S.C. 552

and 553.

The Secretary of Veterans Affairs, the

Secretary of Defense, and the

Commandant of the Coast Guard hereby

certify that this final rule will not have

a significant economic impact on a

substantial number of small entities as

they are defined in the Regulatory

Flexibility Act, 5 U.S.C. 601–612. This

final rule makes no substantive changes.

Pursuant to 5 U.S.C. 605(b), this final

rule, therefore, is exempt from the

initial and final regulatory flexibility

analyses requirements of §§ 603 and

604.

There is no Catalog of Federal

Domestic Assistance number for the

program affected by these regulations.

List of Subjects in 38 CFR Part 21

Administrative practice and

procedure, Armed forces, Civil rights,

Claims, Colleges and universities,

Conflict of interests, Defense

Department, Education, Employment,

Grant programs-education, Grant

programs-veterans, Health care, Loan

programs-education, Loan programsveterans, Manpower training programs,

Reporting and recordkeeping

requirements, Schools, Travel and

transportation expenses, Veterans,

Vocational education, Vocational

rehabilitation.

Approved: May 22, 1996.

Jesse Brown,

Secretary of Veterans Affairs.

Approved: May 29, 1996.

Al H. Bemis,

Deputy Assistant Secretary of Defense for

Reserve Affairs (M&P).

Approved: May 31, 1996.

R. M. Larrabee,

Rear Admiral, U.S. Coast Guard, Director of

Reserve and Training.

For the reasons set out in the

preamble, 38 CFR part 21 (subpart L) is

amended as set forth below.

PART 21—VOCATIONAL

REHABILITATION AND EDUCATION

Subpart L—Educational Assistance for

Members of the Selected Reserve

1. The authority citation for 38 CFR

part 21, subpart L is revised to read as

follows:

Authority: 10 U.S.C. ch. 1606; 38 U.S.C.

501, unless otherwise noted.

2. In § 21.7639, the introductory text

is amended by removing ‘‘of this part’’;

paragraphs (a), (e), and (f)(1) are

removed; paragraphs (b), (c), (d), (f)(2),

(f)(3), (g), (h), (i), (j), and (k) are

redesignated as paragraphs (a), (b), (c),

(d)(1), (d)(2), (e), (f), (g), (h), and (i),

respectively; newly redesignated

paragraph (a)(1) introductory text is

amended by removing ‘‘unless;’’ and

adding, in its place, ‘‘unless’’; newly

redesignated paragraph (a)(1)(ii)(B) is

amended by removing ‘‘veteran or

servicemember’’ and adding, in its

place, ‘‘reservist’’; newly redesignated

paragraph (c)(2)(i) is amended by

removing ‘‘the VA’’ and adding, in its

place, ‘‘VA’’; newly redesignated

paragraph (c)(2)(ii) is amended by

removing ‘‘of this part’’; newly

redesignated paragraph (c)(3)

introductory text is amended by

removing ‘‘(d)(2)(i)’’ and adding, in its

place, ‘‘(c)(2)(i)’’; and newly

redesignated paragraph (c)(3)(ii) is

amended by removing ‘‘(d)(3)(i)’’ and

adding, in its place, ‘‘(c)(3)(i)’’.

§ 21.7640 [Amended]

3. In § 21.7640, paragraph (b)(1) is

amended by removing ‘‘of this part’’

both places it appears; paragraph

(b)(2)(i) is amended by removing

‘‘Vocational Rehabilitation and’’; and

paragraph (b)(2)(ii) is amended by

removing ‘‘Vocational Rehabilitation

and’’ both places it appears.

§ 21.7645 [Removed]

4. Section 21.7645 is removed.

§ 21.7652 [Amended]

5. In § 21.7652, paragraph (c)(2)(ii) is

removed; paragraphs (c)(2)(iii),

(c)(2)(iv), (c)(2)(v), and (c)(2)(vi) are

redesignated as paragraphs (c)(2)(ii),

(c)(2)(iii), (c)(2)(iv), and (c)(2)(v),

respectively; and newly redesignated

paragraph (c)(2)(v) is amended by

removing ‘‘of’’ and adding, in its place,

‘‘or’’.

6. In § 21.7672, paragraphs (a)(3),

(b)(1), (c), (d), and (e) are removed;

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

(b)(5), and (f) are redesignated as

paragraphs (a)(3), (b)(1), (b)(2), (b)(3),

(b)(4), and (c), respectively; newly

redesignated paragraph (b)(1)(i) is

amended by removing ‘‘of this part’’;

newly redesignated paragraph (b)(3) is

amended by removing ‘‘paragraph (f)’’

each time it appears and adding, in its

place, ‘‘paragraph (c)’’; and paragraph

(a)(2), newly redesignated paragraph

(a)(3), and the introductory text of

newly redesignated paragraph (c) are

revised, to read as follows:
Federal Register / Vol. 61, No. 113 / Tuesday, June 11, 1996 / Rules and Regulations 29483

§ 21.7672 Measurement of courses not

leading to a standard college degree.

(a) Overview. * * *

(2) In determining which is the

correct basis for measuring a reservist’s

enrollment, VA will first examine

whether credit-hour measurement is

appropriate, as provided in paragraph

(b) of this section.

(3) If it is not appropriate to measure

a reservist’s enrollment on a credit-hour

basis, VA will measure the enrollment

on a clock-hour basis as described in

paragraph (c) of this section.

(Authority: 10 U.S.C. 16136(b); 38 U.S.C.

3688(b))

* * * * *

(c) Clock-hour measurement. The

provisions of this paragraph apply to all

enrollments in courses not leading to a

standard college degree. If VA

concludes that the courses in which a

reservist is enrolled do not qualify for

credit-hour measurement, VA shall

measure those courses as follows.

(Supervised study shall be excluded

from measurement of all courses to

which this paragraph applies).

* * * * *

§ 21.7801 [Amended]

7. In § 21.7801, paragraph (a) is

amended by removing ‘‘Vocational

Rehabilitation and’’; and by removing

‘‘Chief Benefits Director’’ both places it

appears and adding, in its place, ‘‘Under

Secretary for Benefits’’; and paragraph

(b) is amended by removing ‘‘of this

part’’.

8. In § 21.7802, the introductory text

of paragraph (a) is amended by

removing ‘‘VA facility’’ and adding, in

its place, ‘‘the VA facility of’’; and

paragraph (a)(3) is amended by

removing ‘‘of this part’’, and by

removing ‘‘Chapter’’ and adding, in its

place, ‘‘chapter’’.

§ 21.7805 [Amended]

9. Section 21.7805 is amended by

removing ‘‘of this part’’.

§ 21.7810 [Removed]

10. Section 21.7810 is removed.

[FR Doc. 96–14370 Filed 6–10–96; 8:45 am]

BILLING CODE 8320–01–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 52

[PA 52–2–7155; A–1–FRL–5506–8]

Approval and Promulgation of Air

Quality Implementation Plans;

Pennsylvania; Revision of Final Rule

Pertaining to the RACT Determinations

for 5 Texas Eastern Facilities,

Metropolitan Edison—Portland,

Pennsylvania Power—New Castle

Plant, and for International Paper—

Hammermill Division

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Revision of direct final rule.

SUMMARY: On April 9, 1996, EPA

published approval of a State

Implementation Plan (SIP) revision

submitted by Pennsylvania (61 FR

15709) pertaining to reasonably

available control technology (RACT)

requirements for 21 individual

Pennsylvania facilities. EPA is revising

the final rule due to the State’s request

to withdraw any adverse comments.

This revision pertains to five Texas

Eastern Transmission Corporation

facilities, Metropolitan Edison—

Portland Generating Station,

Pennsylvania Power Company—New

Castle Plant, and International Paper—

Hammermill Division into the

Pennsylvania State Implementation

Plan.

EFFECTIVE DATE: June 10, 1996.

FOR FURTHER INFORMATION CONTACT:

Cynthia H. Stahl (215) 597–9337 (or

215–597–2180, after May 20, 1996), or

via e-mail,

stahl.cynthia@epamail@epa.gov.

SUPPLEMENTARY INFORMATION: On April

9, 1996, EPA published approval of a

State Implementation Plan (SIP)

revision submitted by Pennsylvania (61

FR 15709) pertaining to reasonably

available control technology (RACT)

requirements for 21 individual

Pennsylvania facilities. EPA approved

this direct final rulemaking without

prior proposal because the Agency

viewed it as a noncontroversial

amendment and anticipated no adverse

comments. The final rule was published

in the Federal Register with a provision

for a 30 day comment period (61 FR

15709). At the same time, EPA

announced that this final rule would

convert to a proposed rule in the event

that adverse comments were submitted

to EPA within 30 days of publication of

the rule in the Federal Register (61 FR

15744). The final rulemaking action

would be withdrawn by publishing a

document announcing withdrawal of

this action.

Notice of intent to adversely comment

on the Pennsylvania Power—New Castle

plant and International Paper—

Hammermill Division RACT

determinations was submitted to EPA

within the prescribed comment period.

In addition, Pennsylvania Department of

Environmental Protection withdrew its

request for EPA to approve the RACT

determinations for five Texas Eastern

facilities: Bectelsville, Grantville,

Perulack/Leidy, Shermans Dale and

Bernville, and the RACT determination

for Metropolitan Edison—Portland

Generating Station. Therefore, EPA is

revising the April 9, 1996 proposed

rulemaking action (61 FR 15744) and

the final rulemaking action to indicate

that no rulemaking action is being taken

for the five Texas Eastern facilities and

Metropolitan Edison—Portland because

Pennsylvania no longer wants EPA to

approve these RACT determinations

into the Pennsylvania SIP. In addition,

EPA received notice that New York

State Department of Environmental

Conservation intends to submit adverse

comments on the Pennsylvania Power—

New Castle and International Paper—

Hammermill RACT determinations.

Consequently, EPA is revising the April

9, 1996 final rulemaking action only as

it pertains to Pennsylvania Power and

International Paper so that no final

rulemaking action is being taken on

these two sources. Elsewhere in today’s

Federal Register, EPA is reopening the

comment period until June 28, 1996

only as it pertains to the Pennsylvania

Power—New Castle plant and the

International Paper—Hammermill

Division RACT determinations. All

public comments received will be

addressed in a subsequent rulemaking

action based on the proposed rule.

Accordingly, EPA is revising 40 CFR

52.2020 (c)(103) to remove the five

Texas Eastern facilities, Metropolitan

Edison—Portland, Pennsylvania

Power—New Castle and International

Paper—Hammermill Division.

List of Subjects in 40 CFR Part 52

Environmental protection, Air

pollution control, Hydrocarbons,

Incorporation by reference,

Intergovernmental relations, Nitrogen

Dioxide, Ozone, Reporting and

recordkeeping requirements.

Dated: May 9, 1996.

Stanley Laskowski,

Acting Regional Administrator, Region III.

40 CFR part 52 is amended as follows: