Federal Register / Vol. 63, No. 137 / Friday, July 17, 1998 /Rules and Regulations 38473

1 ‘‘Request for Comments on Proposed Agreement

Between the Government of the United States of

America and the Government of Australia on

Mutual Antitrust Enforcement Assistance,’’ 62 FR

20022 (Apr. 24, 1997) (comment period closed June

9, 1997).

2See International Brotherhood of Teamsters v.

Pen ̃ a, 17 F.3d 1478, 1486 (D.C. Cir. 1994) (APA

foreign affairs exemption and good cause exception

of agency rule); WBEN v. United States, 396 F.2d

601, 616 (2d Cir. 1968) (APA foreign affairs

exemption).

The Commission is also amending Rule

4.10(e) of its Rules, 16 C.F.R. 4.10(e),

which provides that other materials that

are designated confidential by their

submitters may not be disclosed, except

as provided therein, unless the

Commission: (1) determines that they

are neither trade secrets nor confidential

commercial information; and (2)

provides ten days’ pre-disclosure notice

to the submitter. These provisions

implement and expand upon

protections in sections 6(f) and 21 of the

FTC Act, 15 U.S.C. 46(f), 57b–2. The

amendments adopted herein conform

the Commission’s rules to its authority

and obligations under agreements

entered pursuant to the International

Antitrust Enforcement Assistance Act

(‘‘IAEAA’’), 15 U.S.C 6201 et. seq.

The IAEAA authorizes the

Commission and the Department of

Justice (‘‘the agencies’’) to enter into

mutual assistance agreements with

foreign antitrust authorities for the

purpose of providing reciprocal

assistance in antitrust investigations. In

accordance with the IAEAA’s terms, 15

U.S.C. 6206, the agencies have

published for comment the first

proposed IAEAA agreement.1

Pursuant to requests under IAEAA

agreements, the agencies may collect

information on behalf of foreign

antitrust authorities. 15 U.S.C. 6202.

The agencies may also share

information with those authorities,

including both information collected at

their behest and certain information

already in the agencies’ files. As

reflected in these amendments, the

IAEAA expressly authorizes disclosures

of materials notwithstanding sections

6(f) and 21 of the FTC Act. 15 U.S.C.

6205.

The amendments adopted herein will

reconcile the Commission’s rules with

the agency’s obligations to provide

assistance under IAEAA agreements.

Because failure to make these

amendments could impair the

Commission’s ability to meet its

obligations, the amendments are exempt

from notice and comment under the

Administrative Procedure Act by virtue

of the foreign affairs exemption to the

Act. 5 U.S.C. 553(a)(1). They are also

exempt from the notice and comment

requirements of the APA and the

Commission’s rules by virtue of the

good cause exemptions in 5 U.S.C.

553(b)(3) and 16 CFR 1.26(b),

respectively. Except for non-substantive

stylistic changes, the amendments

merely implement agreements that are

themselves subject to public comment,

and comment on the amendments is

therefore unnecessary.2

This action does not entail a

collection of information for purposes of

the Paperwork Reduction Act of 1980,

44 U.S.C. 3501 et seq. It is not subject

to the requirements of the Regulatory

Flexibility Act because it concerns a

foreign affairs function of the United

States. See 5 U.S.C. 601(2), Section

1(a)(2) of E.O. 12291, 46 FR 13193

(1981).

List of Subjects in 16 CFR Part 4

Administrative practice and

procedure, Freedom of Information Act,

Privacy Act, Sunshine Act.

For the reasons set forth in the

preamble, the Federal Trade

Commission amends Title 16, Chapter 1,

Subchapter A of the Code of Federal

Regulations, as follows:

PART 4—MISCELLANEOUS RULES

1. The authority citation for Part 4

continues to read as follows:

Authority: Sec. 6, 38 Stat. 721; 15 U.S.C.

46.

2. Amend § 4.10 by revising

paragraphs (d) and (e) to read as follows:

§ 4.10 Nonpublic material.

* * * * *

(d) Except as provided in paragraphs

(f) or (g) of this section, in § 4.11(b), (c),

or (d), or as contemplated by agreements

under the International Antitrust

Enforcement Assistance Act (15 U.S.C.

6201 et seq.), no material that is marked

or otherwise identified as confidential

and that is within the scope of

§ 4.10(a)(8), and no material within the

scope of § 4.10(a)(9) that is not

otherwise public, will be made

available, without the consent of the

person who produced the material, to

any individual other than a duly

authorized officer or employee of the

Commission or a consultant or

contractor retained by the Commission

who has agreed in writing not to

disclose the information. All other

Commission records may be made

available to a requester under the

procedures set forth in § 4.11 or may be

disclosed by the Commission except

where prohibited by law.

(e) Except as provided in paragraphs

(f) or (g) of this section, in § 4.11(b), (c),

or (d), or as contemplated by agreements

under the International Antitrust

Enforcement Assistance Act (15 U.S.C.

6201 et seq.), material not within the

scope of § 4.10(a)(8) or § 4.10(a)(9) that

is received by the Commission and is

marked or otherwise identified as

confidential may be disclosed only if it

is determined that the material is not

within the scope of § 4.10(a)(2), and the

submitter is provided at least ten days’

notice of the intent to disclose the

material.

* * * * *

By direction of the Commission.

Donald S. Clark,

Secretary.

[FR Doc. 98–19213 Filed 7–16–98; 8:45 am]

BILLING CODE 6750–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Ivermectin Liquid

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 an abbreviated new animal

drug application (ANADA) filed by

Phoenix Scientific, Inc. The ANADA

provides for veterinary prescription use

of ivermectin oral liquid in horses to

treat and control parasites and parasitic

conditions.

EFFECTIVE DATE: July 17, 1998.

FOR FURTHER INFORMATION CONTACT:

Lonnie W. Luther, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0209.

SUPPLEMENTARY INFORMATION: Phoenix

Scientific, Inc., 3915 South 48th St.

Terrace, P.O. Box 6457, St. Joseph, MO

64506–0457, filed ANADA 200–202 that

provides for veterinary prescription use

of PhoenectinTM Liquid (10 milligram

per milliliter (mg/mL) ivermectin oral

liquid) for horses for the treatment and

control of infections of large strongyles

(adult) (Strongylus equinus), (adult and

arterial larval stages) (S. vulgaris), (adult

and migrating tissue stages) (S.

endentatus), (adult) (Triodontophorus

spp.); small strongyles, including those

resistant to some benzimidizole class

compounds (adults and fourth-stage

larvae) (Cyathostomum spp.,
38474 Federal Register / Vol. 63, No. 137 / Friday, July 17, 1998 /Rules and Regulations

Cylicocyclus spp., Cylicodontophorus

spp., (Cylicostephanus spp.), pinworms

(adult and fourth-stage larvae) (Oxyuris

equi); ascarids (third- and fourth-stage

larvae and adults) (Parascaris equorum);

hairworms (adult) (Trichostrongylus

axei); large-mouth stomach worms

(adult) (Habronema muscae); stomach

bots (oral and gastric stages)

(Gastrophilus spp.); lungworms (adults

and forth-stage larvae) (Dictyocaulus

arnfieldi); intestinal threadworms

(adults) (Strongyloides westeri); summer

sores caused by Habronema and

Draschia spp. cutaneous third-stage

larvae; and dermatitis caused by neck

threadworm microfilariae (Onchocerca

spp.).

Approval of ANADA 200–202 for

Phoenix Scientific, Inc.’s, ivermectin

oral liquid is as a generic copy of Merial

Ltd.’s, NADA 140–439 Eqvalan 

(ivermectin) liquid for horses. The

ANADA is approved as of June 5, 1998,

and the regulations are amended in 21

CFR 520.1195(b) 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.

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.

List of Subjects 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.

§ 520.1195 [Amended]

2. Section 520.1195 Ivermectin liquid

is amended in paragraph (b) by

removing ‘‘No. 050604’’ and adding in

its place ‘‘Nos. 050604 and 059130’’.

Dated: July 9, 1998.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 98–19028 Filed 7–16–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Bacitracin Methylene Disalicylate

Soluble

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

Alpharma Inc. The supplemental NADA

provides for using soluble bacitracin

methylene disalicylate (BMD) powder to

make a medicated drinking water for

growing quail for prevention of

ulcerative enteritis.

EFFECTIVE DATE: July 17, 1998.

FOR FURTHER INFORMATION CONTACT:

William T. Flynn, Center for Veterinary

Medicine (HFV–133), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1644.

SUPPLEMENTARY INFORMATION: Alpharma

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

Fort Lee, NJ 07024, filed supplemental

NADA 65–470 that provides for use of

BMD Soluble (BMD soluble powder)

to make a medicated drinking water for

growing quail containing the equivalent

of 400 milligrams of bacitracin per

gallon used for prevention of ulcerative

enteritis due to Clostridium colinum

susceptible to BMD. The supplemental

NADA is approved as of May 27, 1998,

and the regulations in 21 CFR 520.154a

are amended 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(d)(4) 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 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.

2. Section 520.154a is amended in

paragraph (a) by removing the phrase

‘‘paragraph (d)(3)’’ and by adding in its

place the phrase ‘‘paragraphs (d)(3) and

(d)(4)’’ and by adding paragraph (d)(4)

to read as follows:

§ 520.154a Soluble bacitracin methylene

disalicylate.

* * * * *

(d) * * *

(4) Growing quail—(i) Amount. 400

milligrams per gallon in drinking water.

(ii) Indications for use. For prevention

of ulcerative enteritis due to Clostridium

colinum susceptible to bacitracin

methylene disalicylate.

(iii) Limitations. Prepare fresh

solution daily. Use as sole source of

drinking water.

Dated: July 9, 1998.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 98–19026 Filed 7–16–98; 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; Bacitracin Methylene

Disalicylate, Decoquinate, and

Roxarsone

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the