Federal Register / Vol. 62, No. 37 / Tuesday, February 25, 1997 / Rules and Regulations 8373

form of Type B feed did not require

reevaluation of the safety or

effectiveness data supporting the NADA

or the submission of any new data.

Therefore, a freedom of information

summary is not required.

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

Federal Food, Drug, and Cosmetic Act

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

approval does not qualify for marketing

exclusivity because the supplement

does not contain substantial evidence of

the effectiveness of the drug involved,

any studies of animal safety, or in the

case of food-producing animals, human

food safety studies (other than

bioequivalence or residue studies),

required for approval of the supplement

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).

§ 558.342 [Amended]

2. Section 558.342 Melengestrol

acetate is amended in paragraph

(c)(5)(ii)(C) by removing the word

‘‘pelleted’’.

Dated: January 31, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–4514 Filed 2–24–97; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 558

New Animal Drugs For Use In Animal

Feeds; Bambermycins

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 supplemental new animal

drug application (NADA) filed by

Hoechst-Roussel Agri-Vet Co. The

supplement provides for using liquid

bambermycins Type B medicated feeds

to make Type C medicated feeds for

cattle fed in confinement for slaughter

for increased rate of weight gain and

improved feed efficiency.

EFFECTIVE DATE: February 25, 1997.

FOR FURTHER INFORMATION CONTACT:

Russell G. Arnold, Center for Veterinary

Medicine (HFV–142), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1674.

SUPPLEMENTARY INFORMATION: HoechstRoussel Agri-Vet Co., Route 202–206,

P.O. Box 2500, Somerville, NJ 08876–

1258, filed supplemental NADA 141–

034 that provides for using 10-gram per

pound (g/lb) Flavomycin

(bambermycins) Type A medicated

articles to make 40 to 800 g/ton liquid

Type B medicated feeds, the liquid Type

B feeds used to make dry Type C

medicated feeds. The Type C feeds

containing 1 to 4 g/ton bambermycins

are for cattle fed in confinement for

slaughter to provide 10 to 20 milligrams

bambermycins per head per day for

increased rate of weight gain and

improved feed efficiency. The

regulations are amended in § 558.95 (21

CFR 558.95) by adding new paragraph

(a)(5), by redesignating paragraph (b) as

paragraph (d), and by revising newly

redesignated paragraph (d)(4)(i)(b) to

reflect the approval.

Furthermore, use of liquid Type B

feeds to make Type C feeds requires

publication of specifications and

expiration information. New § 558.95(b)

is established to reflect the Type B feed

specifications and expiration

information. In the interest of issuing

uniform regulations in the future, new

§ 558.95(c) is also established at this

time and reserved for future use.

Approval of this supplement did not

require submission of additional safety

or efficacy data. A freedom of

information (FOI) summary as in 21

CFR part 20 and 514.11(e)(2)(ii) is not

required. An FOI summary submitted to

support approval of the original

application may be seen in the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857, from 9 a.m. to 4 p.m., Monday

through Friday.

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

Federal Food, Drug, and Cosmetic Act

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

approval for food producing animals

does not qualify for marketing

exclusivity because the supplement

does not contain substantial evidence of

effectiveness of the drug involved, any

studies of animal safety or human food

safety studies (other than

bioequivalence or residue studies)

required for approval of the supplement

and conducted or sponsored by the

applicant.

The agency has determined under 21

CFR 25.24(d)(1)(iii) 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 558.95 is amended by

adding new paragraph (a)(5), by

redesignating paragraph (b) as paragraph

(d), by adding new paragraph (b), by

adding and reserving paragraph (c), and

by adding a new fourth sentence to

newly redesignated paragraph

(d)(4)(i)(b), to read as follows:

§ 558.95 Bambermycins.

(a) * * *

(5) 10 grams of activity per pound to

012799 in § 510.600(c) of this chapter to

make 40 to 800 gram/ton Type B feeds

for use as in paragraph (d)(4)(i) of this

section.

(b) Special considerations. (1)

Bambermycins liquid Type B feeds may

be manufactured from dry

bambermycins Type A articles. The

liquid Type B feeds must have a pH of

3.8 to 7.5, moisture content of 30 to 45

percent.

(2) The expiration date for the liquid

Type B feed is 8 weeks after date of

manufacture. The expiration date for the

dry Type C feed made from the liquid

Type B feed is 1 week after date of

manufacture.

(c) [Reserved]

(d) * * *

(4) * * *

(i) * * *
8374 Federal Register / Vol. 62, No. 37 / Tuesday, February 25, 1997 / Rules and Regulations

(b) * * * Liquid Type B feeds

containing bambermycins may be used

in the preparation of dry complete

ration Type C feeds.

* * * * *

Dated: February 10, 1997.

Robert C. Livingston,

Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 97–4512 Filed 2–24–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Bureau of Alcohol, Tobacco and

Firearms

27 CFR Parts 47 and 55

[T.D. ATF–387]

RIN 1512–AB63

Implementation of Public Law 104–132,

the Antiterrorism and Effective Death

Penalty Act of 1996, Relating to the

Marking of Plastic Explosives for the

Purpose of Detection (96R–029P)

AGENCY: Bureau of Alcohol, Tobacco

and Firearms (ATF), Department of the

Treasury.

ACTION: Temporary rule (Treasury

decision) and request for comments.

SUMMARY: This temporary rule

implements certain provisions of the

Antiterrorism and Effective Death

Penalty Act of 1996 (Pub. L. 104–132).

These regulations implement the law by

requiring detection agents for plastic

explosives. The temporary rule also

authorizes the use of four specific

detection agents to mark plastic

explosives and provides for the

designation of other detection agents.

The temporary rule will remain in effect

until superseded by final regulations.

In the Proposed Rules section of this

Federal Register, ATF is also issuing a

notice of proposed rulemaking inviting

comments on the temporary rule for a

90-day period following the publication

date of this temporary rule.

DATES: The temporary regulations are

effective April 24, 1997. Comments due

by May 27, 1997.

ADDRESSES: Send written comments to:

Chief, Regulations Branch; Bureau of

Alcohol, Tobacco and Firearms;

Washington, DC 20091–0221.

FOR FURTHER INFORMATION CONTACT:

James P. Ficaretta, Regulations Branch,

Bureau of Alcohol, Tobacco and

Firearms, 650 Massachusetts Avenue,

NW., Washington, DC 20226 (202–927–

8230).

SUPPLEMENTARY INFORMATION:

Background

Public Law 104–132, 110 Stat. 1214,

the Antiterrorism and Effective Death

Penalty Act of 1996 (hereafter, ‘‘the

Act’’) was enacted on April 24, 1996.

Title VI of the Act, ‘‘Implementation of

Plastic Explosives Convention,’’ added

new requirements to the Federal

explosives laws in 18 U.S.C. Chapter 40.

Section 607 of the Act states that, except

as otherwise provided, the amendments

made by Title VI shall take effect 1 year

after the date of enactment, i.e., on April

24, 1997. The stated purpose of Title VI

is to fully implement the Convention on

the Marking of Plastic Explosives for the

Purpose of Detection, Done at Montreal

on 1 March 1991 (hereafter, ‘‘the

Convention’’).

The Convention represents an

important achievement in international

cooperation in response to the threat

posed to the safety and security of

international civil aviation by virtually

undetectable plastic explosives in the

hands of terrorists. Such explosives

were used in the tragic destruction of

Pan Am flight 103 over Lockerbie,

Scotland, in December 1988, and UTA

flight 772 in September 1989.

In the aftermath of these bombings,

the international community moved to

draft a multilateral treaty to ensure that

plastic explosives would thereafter

contain a chemical marking agent to

render them detectable.

The new statutory provisions and the

regulation changes necessitated by the

law are as follows:

(1) Definitions. Section 602 of the Act

added three definitions to section 841 of

title 18, U.S.C. The term ‘‘Convention

on the Marking of Plastic Explosives’’ is

defined in the law to mean the

Convention on the Marking of Plastic

Explosives for the Purpose of Detection,

Done at Montreal on 1 March 1991.

The term ‘‘detection agent’’ is defined

as any one of the following substances

when introduced into a plastic

explosive or formulated in such

explosive as a part of the manufacturing

process in such a manner as to achieve

homogeneous distribution in the

finished explosive:

(1) Ethylene glycol dinitrate (EGDN),

C2H4(NO3)2, molecular weight 152,

when the minimum concentration in the

finished explosive is 0.2 percent by

mass;

(2) 2,3–Dimethyl-2,3-dinitrobutane

(DMNB), C6H12(NO2)2, molecular weight

176, when the minimum concentration

in the finished explosive is 0.1 percent

by mass;

(3) Para-Mononitrotoluene (p-MNT),

C7H7NO2, molecular weight 137, when

the minimum concentration in the

finished explosive is 0.5 percent by

mass;

(4) Ortho-Mononitrotoluene (o-MNT),

C7H77NO2, molecular weight 137, when

the minimum concentration in the

finished explosive is 0.5 percent by

mass; and

(5) any other substance added by the

Secretary of the Treasury by regulation,

after consultation with the Secretary of

State and the Secretary of Defense.

Permitting the Secretary to designate

detection agents other than the four

listed in the statute would facilitate the

use of other substances without the

need for legislation. However, as

specified in the law, only those

substances which have been added to

the table in Part 2 of the Technical

Annex to the Convention on the

Marking of Plastic Explosives may be

designated as approved detection

agents. ATF would have no authority to

issue a regulation adding to the list of

approved detection agents until the

Technical Annex has been so modified.

The last term added to section 841 of

title 18, U.S.C., ‘‘plastic explosive,’’ is

defined as an explosive material in

flexible or elastic sheet form formulated

with one or more high explosives which

in their pure form has a vapor pressure

less than 10–4 Pa at a temperature of 25

°C, is formulated with a binder material,

and is as a mixture malleable or flexible

at normal room temperature. Pursuant

to Part I of the Technical Annex to the

Convention, high explosives include,

but are not restricted to,

cyclotetramethylenetetranitramine

(HMX), pentaerythritol tetranitrate

(PETN), and

cyclotrimethylenetrinitramine (RDX).

The above changes to the regulations

are prescribed in § 55.180.

(2) Requirement of Detection Agents

for Plastic Explosives. The Act amended

the Federal explosives laws in 18 U.S.C.

Chapter 40 by adding new subsections

(l)–(o) to section 842. Section 842(l)

makes it unlawful for any person to

manufacture any plastic explosive that

does not contain a detection agent.

Section 842(m) makes it unlawful for

any person to import or bring into the

U.S. or export from the U.S. any plastic

explosive that does not contain a

detection agent. The provisions of this

section do not apply to the importation

or bringing into the U.S. or the

exportation from the U.S. of any plastic

explosive that was imported or brought

into or manufactured in the U.S. prior

to the date of enactment of the Act by

or on behalf of any agency of the U.S.

performing military or police functions

(including any military reserve

component) or by or on behalf of the