29020 Federal Register / Vol. 66, No. 103 / Tuesday, May 29, 2001 / Rules and Regulations

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)(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.

This rule does not meet the definition

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because

it is a rule of ‘‘particular applicability.’’

Therefore, it is not subject to the

congressional review requirements in 5

U.S.C. 801–808.

List of Subject in 21 CFR Part 520

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 520 is amended as follows:

PART 520—ORAL DOSAGE FORM

NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 520 continues to read as follows:

Authority: 21 U.S.C. 360b.

§ 520.1660d [Amended]

2. Section 520.1660d Oxytetracycline

hydrochloride soluble powder is

amended in paragraph (d)(1)(iii)(C) by

removing ‘‘Nos. 000069 and 059130’’

and by adding in its place ‘‘No. 059130

and zero days those products sponsored

by No. 000069’’.

Dated: May 16, 2001.

Claire M. Lathers,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 01–13379 Filed 5–25–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

New Animal Drugs for Use in Animal

Feeds; Lasalocid and Bacitracin Zinc

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 Alpharma,

Inc. The NADA provides for use of

approved lasalocid and bacitracin zinc

Type A medicated articles to make twoway combination drug Type C

medicated feeds used for prevention of

coccidiosis, increased rate of weight

gain, and improved feed efficiency in

broiler chickens.

DATES: This rule is effective May 29,

2001.

FOR FURTHER INFORMATION CONTACT:

Charles J. Andres, Center for Veterinary

Medicine (HFV–128), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–1600.

SUPPLEMENTARY INFORMATION: Alpharma

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

Fort Lee, NJ 07024, filed NADA 141–083

that provides for use of Avatec (90.7

grams per pound (g/lb) lasalocid as

lasalocid sodium) and Baciferm (50 g/

lb bacitracin zinc) Type A medicated

articles to make two-way combination

drug Type C medicated chicken feeds.

The combination Type C medicated

feeds are used for prevention of

coccidiosis caused by Eimeria tenella, E.

necatrix, E. acervulina, E. brunetti, E.

mivati, and E. maxima, and for

increased rate of weight gain and

improved feed efficiency in broiler

chickens. The NADA is approved as of

April 18, 2001, and the regulations are

amended in 21 CFR 558.311 to reflect

the approval. The basis of 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.

FDA has determined under 21 CFR

25.33(a)(2) 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.

This rule does not meet the definition

of ‘‘rule’’ in 5 U.S.C. 804(3)(A) because

it is a rule of ‘‘particular applicability.’’

Therefore, it is not subject to the

congressional review requirements in 5

U.S.C. 801–808.

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

2. Section 558.311 is amended in

paragraph (e)(1) in the table by

redesignating paragraphs (e)(1)(xi)

through (e)(1)(xvi) as paragraphs

(e)(1)(xii) through (e)(1)(xvii),

respectively, and by adding new

paragraph (e)(1)(xi) to read as follows:

§ 558.311 Lasalocid.

* * * * *

(e) * * *

(1) * * *

Lasalocid sodium

activity in grams

per ton

Combination

in grams per

ton

Indications for use Limitations Sponsor

****** *

(xi) 68 (0.0075

pct) to 113

(0.0125 pct).

Bacitracin

zinc 4 to

50.

Broiler chickens. For prevention of coccidiosis caused by Eimeria tenella, E. necatrix,

E. acervulina, E. brunetti, E. mivati, and E.

maxima, and for increased rate of weight

gain and improved feed efficiency.

Feed continuously as sole ration. Bacitracin

zinc and lasalocid sodium as provided by

No. 046573 in § 510.600(c) of this chapter.

046573

****** *

Federal Register / Vol. 66, No. 103 / Tuesday, May 29, 2001 / Rules and Regulations 29021

* * * * *

Dated: May 15, 2001.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 01–13300 Filed 5–25–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF THE TREASURY

Bureau of Alcohol, Tobacco and

Firearms

27 CFR Part 70

[T.D. ATF–450 ]

RIN 1512–AC19

Delegation of Authority

AGENCY: Bureau of Alcohol, Tobacco

and Firearms (ATF), Treasury.

ACTION: Treasury decision, final rule.

SUMMARY: This final rule places most

ATF authorities contained in its

Procedure and Administration

regulations with the ‘‘appropriate ATF

officer’’ and requires that persons file

documents required these regulations

with the ‘‘appropriate ATF officer’’ or in

accordance with the instructions on the

ATF form. Concurrently with this

Treasury Decision, ATF Order 1130.19

is being issued and will be made

available as specified in this rule.

Through this order, the Director has

delegated most of the authorities to the

appropriate ATF officers and specified

the ATF officers with whom

applications, notices and other reports,

which are not ATF forms, are filed. In

addition, this final rule corrects some

typographical errors and updates the

disclosure provisions.

EFFECTIVE DATE: This rule is effective

May 29, 2001.

FOR FURTHER INFORMATION CONTACT:

Robert Ruhf, Regulations Division,

Bureau of Alcohol, Tobacco and

Firearms, 650 Massachusetts Avenue

NW., Washington, DC 20226 (telephone

202–927–8210 or e-mail to

alctob@atfhq.atf.treas.gov).

SUPPLEMENTARY INFORMATION:

Background

Delegations of Authority

Pursuant to Treasury Order 120–01

(formerly 221), dated June 6, 1972, and

120–03, dated November 5, 1990, the

Secretary of the Treasury delegated to

the Director of the Bureau of Alcohol,

Tobacco and Firearms (ATF), the

authority to enforce, among other laws,

the provisions of section 4181 of chapter

32 and chapters 51, 52 and 53 of the

Internal Revenue Code of 1986 (IRC)

and the Federal Alcohol Administration

(FAA) Act. The Director has

subsequently redelegated certain of

these authorities to appropriate

subordinate officers by way of various

means, including by regulation, ATF

delegation orders, regional directives, or

similar delegation documents. As a

result, to ascertain what particular

officer is authorized to perform a

particular function under such

provisions, each of these various

delegation instruments must be

consulted. Similarly, each time a

delegation of authority is revoked or

redelegated, each of the delegation

documents must be reviewed and

amended as necessary.

ATF has determined that this

multiplicity of delegation instruments

complicates and hinders the task of

determining which ATF officer is

authorized to perform a particular

function. ATF also believes these

multiple delegation instruments

exacerbate the administrative burden

associated with maintaining up-to-date

delegations, resulting in an undue delay

in reflecting current authorities.

Accordingly, this final rule rescinds

all authorities of the Director in part 70

that were previously delegated and

places those authorities with the

‘‘appropriate ATF officer.’’ Most of the

authorities of the Director that were not

previously delegated are also placed

with the ‘‘appropriate ATF officer.’’

Along with this final rule, ATF is

publishing ATF Order 1130.19,

Delegation Order—Delegation of the

Director’s Authorities in 27 CFR Part 70,

Procedure and administration, which

delegates certain of these authorities to

the appropriate organizational level.

The effect of these changes is to

consolidate all delegations of authority

in part 70 into one delegation

instrument. This action both simplifies

the process for determining what ATF

officer is authorized to perform a

particular function and facilitates the

updating of delegations in the future. As

a result, delegations of authority will be

reflected in a more timely and userfriendly manner.

In addition, this final rule also

eliminates all references in the

regulations that identify the ATF officer

with whom an ATF form is filed. This

is because ATF forms will indicate the

officer with whom they must be filed.

Similarly, this final rule also amends

part 70 to provide that the submission

of documents other than ATF forms

(such as letterhead applications, notices

and reports) must be filed with the

‘‘appropriate ATF officer’’ identified in

ATF Order 1130.19. These changes will

facilitate the identification of the officer

with whom forms and other required

submissions are filed.

This final rule eliminates all

references to an ATF region, which were

comprised of certain States for ATF

administrative purposes but no longer

exist. Also, this final rule eliminates the

definition of ‘‘delegate’’ in § 70.11 and

the references to ‘‘delegate’’ in § 70.803.

The definition of delegate in § 70.11 is

any officer, employee, or agency of the

Department of the Treasury authorized

by the Secretary of the Treasury

directly, or indirectly by one or more

redelegations of authority, to perform

the function mentioned or described in

the delegation order. To prevent any

misunderstanding or confusion with the

ATF delegation order, ATF Order

1130.19, we are removing this term from

the aforementioned sections of 27 CFR

part 70.

This final rule also makes various

technical amendments to Subpart D—

Administrative and Miscellaneous

Provisions of 27 CFR part 70.

Specifically, a new § 70.3 is added to

recognize the authority of the Director to

delegate regulatory authorities in part 70

and to identify ATF Order 1130.19 as

the instrument reflecting such

delegations. Also, § 70.2 is amended to

provide that the instructions for an ATF

form identify the ATF officer with

whom it must be filed.

ATF has made or will make similar

changes in delegations to all other parts

of Title 27 of the Code of Federal

Regulations through separate

rulemakings.

Typographical and Miscellaneous

Corrections

This final rule removes a sentence

from § 70.438 that refers to an obsolete

ATF publication, corrects references to

other sections of regulations in

§ 70.253(b)(1) and (2) and in § 70.438,

corrects § 70.224 that refers to the

general statute of limitations on

collecting an assessment in accordance

with 26 U.S.C. 6502, and corrects

§ 70.482(e) by raising the amount for

which a Chief Counsel’s opinion need

not be filed for offers-in-compromise in

accordance with 26 U.S.C. 7122(b).

Disclosure Changes

In § 70.802 we have eliminated the

card index record of permits, which is

no longer maintained, and made

appropriate changes to the information

available or provided by ATF because of

the disclosure restrictions of 26 U.S.C.

6103.