Federal Register / Vol. 63, No. 127 /Thursday, July 2, 1998 /Rules and Regulations 36179

Dated: June 22, 1998.

Margaret Ann Miller,

Acting Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 98–17542 Filed 7–1–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

New Animal Drugs For Use In Animal

Feeds; Penicillin

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 two supplemental new

animal drug applications (NADA’s), one

filed by Alpharma Inc., the other by

Pfizer, Inc. The supplemental NADA’s

provide for using approved penicillin G

procaine Type A medicated articles to

make Type C medicated chicken,

turkey, pheasant, quail, and swine feeds

used for increased rate of weight gain

and improved feed efficiency.

EFFECTIVE DATE: July 2, 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: Alpharma

Inc., One Executive Dr., P.O. Box 1399,

Fort Lee, NJ 07024, is sponsor of NADA

46–666. Pfizer, Inc., 235 East 42d St.,

New York, NY 10017, is sponsor of

NADA 46–668. The sponsors filed

supplemental NADA’s that provide for

amending the regulations concerning

use of penicillin Type A medicated

articles to make Type B and C

medicated feeds for chickens, turkeys,

pheasants, quail, and swine for

increased rate of weight gain and

improved feed efficiency. The

supplemental NADA’s reflect the results

of the National Academy of Sciences/

National Research Council (NAS/NRC)

Drug Efficacy Study Implementation

(DESI) review of the products’

effectiveness and FDA’s conclusions

based on that review (35 FR 11533, July

17, 1970).

NAS/NRC evaluated these products as

probably effective for faster gain and/or

feed efficiency. FDA concurred with

these findings and concluded that the

appropriate claim should be ‘‘for

increased rate of weight gain and

improved feed efficiency for (under

appropriate conditions of use).’’ The

evaluation concerned only the drug’s

effectiveness and safety to the animal to

which administered, and it did not take

into account the safety for food use of

food derived from drug-treated animals.

Nothing herein will constitute a bar to

further proceedings with respect to

questions of safety of the drugs or their

metabolites as residues in food products

derived from treated animals.

In the Federal Register of August 30,

1977 (42 FR 43772), the then Bureau of

Veterinary Medicine issued a notice of

opportunity for hearing (NOOH) on a

proposal to withdraw approval of

NADA’s for all penicillin-containing

premixes (Type A medicated articles)

intended for subtherapeutic use in

animal feeds. The NOOH was issued in

response to scientific research

suggesting that subtherapeutic use of

such drugs has contributed to the pool

of antibiotic-resistant pathogenic

microorganisms in food animals.

Furthermore, research indicated that the

drug resistance could be transferred to

pathogenic organisms in humans. The

NOOH is still pending and approval of

these supplements to finalize the DESI

review process for penicillin-containing

Type A medicated articles does not

constitute a bar to subsequent action to

withdraw approval on the grounds cited

in the outstanding NOOH.

The supplemental NADA’s are

approved as of April 10, 1998. The

regulations are amended in 21 CFR

558.460 by redesignating paragraphs (b)

and (c) as paragraphs (c) and (d), by

adding new paragraph (b), and by

revising the table in paragraph (d) 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 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, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852, between 9

a.m. and 4 p.m., Monday through

Friday.

The agency has determined under 21

CFR 25.33(a)(3) 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 the

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: 21 U.S.C. 360b, 371.

2. Section 558.460 is amended by

redesignating paragraphs (b) and (c) as

paragraphs (c) and (d), by adding

paragraph (b), and by revising the table

in paragraph (d)(1) to read as follows:

§ 558.460 Penicillin.

* * * * *

(b) Sponsors. Type A medicated

articles: To 000069, 100 grams per

pound. To 046573, 100 and 227 grams

per pound.

* * * * *

(d) * * *

(1) * * *

Penicillin in grams per ton Combination in

grams per ton Indications for use Limitations Sponsor

(i) 2.4 to 50 Chickens, turkeys, and

pheasants; for increased rate of weight

gain and improved

feed efficiency.

Do not feed to poultry

producing eggs for

human consumption.

000069,

046573.

(ii) 5 to 20 Quail; for increased rate

of weight gain and improved feed efficiency.

Quail; not over 5 weeks

of age.

Do.
36180 Federal Register / Vol. 63, No. 127 /Thursday, July 2, 1998 /Rules and Regulations

Penicillin in grams per ton Combination in

grams per ton Indications for use Limitations Sponsor

(iii) 10 to 50 Swine; for increased rate

of weight gain and improved feed efficiency.

Do.

* * * * *

Dated: June 22, 1998.

Margaret Ann Miller,

Acting Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 98–17546 Filed 7–1–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Parts 1 and 602

[TD 8775]

RIN 1545–AV79

Election Not to Apply Look-Back

Method in De Minimis Cases

AGENCY: Internal Revenue Service (IRS),

Treasury.

ACTION: Final and temporary

regulations.

SUMMARY: This document contains

regulations explaining how a taxpayer

elects under section 460(b)(6) not to

apply the look-back method to longterm contracts in de minimis cases. The

regulations reflect changes to the law

made by the Taxpayer Relief Act of 1997

and affect manufacturers and

construction contractors whose longterm contracts otherwise are subject to

the look-back method.

DATES: Effective date: These regulations

are effective July 2, 1998.

Applicability date: These regulations

apply to long-term contracts completed

in taxable years ending after August 5,

1997.

FOR FURTHER INFORMATION CONTACT: Leo

F. Nolan II or John M. Aramburu at

(202) 622–4960 (not a toll-free number).

SUPPLEMENTARY INFORMATION:

Paperwork Reduction Act

The collection of information

contained in these final regulations has

been reviewed and approved by the

Office of Management and Budget in

accordance with the Paperwork

Reduction Act (44 U.S.C. 3507) under

control number 1545–1572. Responses

to this collection of information are

required for a taxpayer to elect not to

apply the look-back method to longterm contracts in de minimis cases. An

agency may not conduct or sponsor, and

a person is not required to respond to,

a collection of information unless the

collection of information displays a

valid OMB control number. The

estimated average burden per

respondent is 0.2 hours.

Comments concerning the accuracy of

this burden estimate should be sent to

the Internal Revenue Service, Attn: IRS

Reports Clearance Officer, OP:FS:FP,

Washington, DC 20224, and to the

Office of Management and Budget, Attn:

Desk Officer for the Department of the

Treasury, Office of Information and

Regulatory Affairs, Washington, DC

20503.

Books or records relating to a

collection of information must be

retained as long as their contents may

become material in the administration

of any internal revenue law. Generally,

tax returns and tax return information

are confidential, as required by 26

U.S.C. 6103.

Background

This document contains amendments

to the Income Tax Regulations (26 CFR

part 1). Section 460(b)(6) of the Internal

Revenue Code was added by section

1211 of the Taxpayer Relief Act of 1997,

Public Law 105–34, 111 Stat. 788, 998,

to provide an election not to apply the

look-back method of section 460(b)(2) to

long-term contracts in de minimis cases.

These regulations provide guidance

concerning this new election.

A notice of proposed rulemaking was

published in the Federal Register for

January 13, 1998 (63 FR 1932). No

written comments were received, and

no public hearing was requested or

held. The proposed regulations under

section 460 are adopted by this Treasury

decision with one revision. The final

regulations provide that for long-term

contracts completed in taxable years

ending after August 5, 1997, an election

not to apply the look-back method

under section 460(b)(6) automatically

revokes an election under § 1.460–6(e)

to use the delayed reapplication

method.

Special Analyses

It has been determined that this final

regulation is not a significant regulatory

action as defined in EO 12866.

Therefore, a regulatory assessment is not

required. It also has been determined

that section 553(b) of the Administrative

Procedure Act (5 U.S.C. chapter 5) does

not apply to these regulations.

Moreover, it is hereby certified that the

collection of information in these

regulations will not have a significant

economic impact on a substantial

number of small entities. This

certification is based on the fact that the

time required to prepare and file an

election statement is minimal and will

not have a significant impact on those

small entities that choose to make the

election. In addition, the election need

only be made once by a taxpayer.

Therefore, a Regulatory Flexibility

Analysis under the Regulatory

Flexibility Act (5 U.S.C. chapter 6) is

not required.

Pursuant to section 7805(f) of the

Internal Revenue Code, the notice of

proposed rulemaking preceding these

regulations was submitted to the Chief

Counsel for Advocacy of the Small

Business Administration for comment

on the impact of the proposed

regulations on small business.

Drafting Information

The principal author of these

regulations is Leo F. Nolan II, Office of

Assistant Chief Counsel (Income Tax

and Accounting). However, other

personnel from the IRS and Treasury

Department participated in their

development.

List of Subjects

26 CFR Part 1

Income taxes, Reporting and

recordkeeping requirements.

26 CFR Part 602

Reporting and recordkeeping

requirements.

Adoption of Amendments to the

Regulations

Accordingly, 26 CFR parts 1 and 602

are amended as follows:

PART 1—INCOME TAXES

Paragraph 1. The authority citation

for part 1 is amended by removing the

entry for ‘‘§ 1.460–6T’’ to read in part as

follows: