Federal Register / Vol. 63, No. 103 / Friday, May 29, 1998 /Rules and Regulations 29351

individual’s record, the Privacy Act

Officer, or, for records maintained by

the Inspector General, the Inspector

General, shall clearly note any portion

of the record which is disputed and

shall provide copies of the statement

and, if the Commission deems it

appropriate, copies of a concise

statement of the reasons of the

Commission for not making the

amendments requested, to persons or

other agencies to whom the disputed

record has been disclosed.

§ 201.31 Fees.

(a) The Commission shall not charge

any fee for the cost of searching for and

reviewing an individual’s records.

(b) Reproduction, duplication or

copying of records by the Commission

shall be at the rate of $0.10 per page.

There shall be no charge, however,

when the total amount does not exceed

$25.00.

§ 201.32 Specific exemptions.

(a) Pursuant to 5 U.S.C. 552a(k)(2),

and in order to protect the effectiveness

of Inspector General investigations by

preventing individuals who may be the

subject of an investigation from

obtaining access to the records and thus

obtaining the opportunity to conceal or

destroy evidence or to intimidate

witnesses, records contained in the

system titled Office of Inspector General

Investigative Files (General), insofar as

they include investigatory material

compiled for law enforcement purposes,

shall be exempt from this subpart and

from subsections (c)(3), (d), (e)(1),

(e)(4)(G), (H), and (I) and (f) of the

Privacy Act. However, if any individual

is denied any right, privilege, or benefit

to which he is otherwise entitled to

under Federal law due to the

maintenance of this material, such

material shall be provided to such

individual except to the extent that the

disclosure of such material would reveal

the identity of a source who furnished

information to government investigators

under an express promise that the

identity of the source would be held in

confidence.

(b) Pursuant to 5 U.S.C. 552a(j)(2), and

in order to protect the confidentiality

and integrity of Inspector General

investigations by preventing individuals

who may be the subject of an

investigation from obtaining access to

the records and thus obtaining the

opportunity to conceal or destroy

evidence or to intimidate witnesses,

records maintained in the Office of

Inspector General Investigative Files

(Criminal), insofar as they contain

information pertaining to the

enforcement of criminal laws, shall be

exempt from this subpart and from the

Privacy Act, except that subsections (b),

(c)(1) and (2), (e)(4)(A) through (F),

(e)(6), (7), (9), (10), and (11) and (i) shall

still apply to these records.

(c) Pursuant to 5 U.S.C. 552a(k)(1), (5)

and (6), records contained in the system

entitled ‘‘Personnel Security

Investigative Files’’ have been exempted

from subsections (c)(3), (d), (e)(1),

(e)(1)(G) through (I) and (f) of the

Privacy Act. Pursuant to section

552a(k)(1) of the Privacy Act, the

Commission exempts records that

contain properly classified information

that pertains to national defense or

foreign policy and is obtained from

other systems of records or another

Federal agency. Application of

exemption (k)(1) may be necessary to

preclude the data subject’s access to and

amendment of such classified

information under 5 U.S.C. 552a(d). All

information about individuals in these

records that meets the criteria stated in

5 U.S.C. 552a(k)(5) is also exempted

because this system contains

investigatory material compiled solely

for determining suitability, eligibility,

and qualifications for Federal civilian

employment, Federal contracts or access

to classified information. To the extent

that the disclosure of such material

would reveal the identity of a source

who furnished information to the

Government under an express promise

that the identity of the source would be

held in confidence, or, prior to

September 27, 1975, under an implied

promise that the identity of the source

would be held in confidence, the

application of exemption (k)(5) will be

required to honor such a promise

should an individual request access to

the accounting of disclosure, or access

to or amendment of the record, that

would reveal the identity of a

confidential source. All information in

these records that meets the criteria

stated in 5 U.S.C. 552a(k)(6) is also

exempt because portions of a case file

record may relate to testing and

examining material used solely to

determine individual qualifications for

appointment or promotion in the

Federal service. Access to or

amendment of this information by the

data subject would compromise the

objectivity and fairness of the testing or

examining process.

§ 201.33 Employee conduct.

The Privacy Act Officer shall establish

rules of conduct for persons involved in

the design, development, operation, or

maintenance of any system of records,

or in maintaining any record, and

periodically instruct each such person

with respect to such rules and the

requirements of the Privacy Act

including the penalties for

noncompliance.

PARTS 201 AND 205—[AMENDED]

8. In addition to the amendments set

forth above, in 19 CFR parts 201 and

205 remove the words ‘‘Special

Representative for Trade Negotiations’’

and add, in their place, the words

‘‘United States Trade Representative’’ in

the following places:

a. Section 201.7(b); and

b. Section 205.3(a)(1), (a)(2), (b) and

(d).

By order of the Commission.

Issued: May 22, 1998.

Donna R. Koehnke,

Secretary.

[FR Doc. 98–14140 Filed 5–28–98; 8:45 am]

BILLING CODE 7020–02–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Milbemycin Oxime Tablet

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

Novartis Animal Health US, Inc. The

supplemental NADA provides for

expanding the indications to include

separate dosage and labeling for use of

milbemycin oxime in cats.

EFFECTIVE DATE: May 29, 1998.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary

Medicine (HFV–110), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1612.

SUPPLEMENTARY INFORMATION: Novartis

Animal Health US, Inc., P.O. Box 26402,

Greensboro, NC 27404–6402, filed

supplemental NADA 140–915 that

provides for oral administration of

Interceptor Flavor Tabs (milbemycin

oxime) tablets to cats 6 weeks of age or

greater and 1.5 pounds of body weight

or greater. The product is currently

approved for the prevention of

heartworm disease in both dogs and

puppies 4 weeks of age or greater. The

supplemental NADA provides for

expanding the indications to include

separate dosage and labeling for use of
29352 Federal Register / Vol. 63, No. 103 / Friday, May 29, 1998 /Rules and Regulations

the product in cats 6 weeks of age or

greater and 1.5 pounds of body weight

or greater. This supplemental NADA

approval provides for 5.75, 11.5, and

23.0 milligram tablets, given orally,

once a month, for the prevention of

heartworm disease caused by Dirofilaria

immitis and the removal of adult

Toxocara cati (roundworm) and

Ancylostoma tubaeforme (hookworm)

infections in cats 6 weeks of age or

greater and 1.5 pounds body weight or

greater. The supplemental NADA is

approved as of April 13, 1998, and the

regulations are amended in 21 CFR

520.1445 by revising paragraph (a) and

the heading of paragraph (c) and by

adding paragraph (d) to reflect the

approval for cats. 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, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857, between

9 a.m. and 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 qualifies for 3 years of

marketing exclusivity beginning April

13, 1998, because the application

contains substantial evidence of

effectiveness of the drug involved and

studies of animal safety required for

approval and conducted or sponsored

by the applicant.

The agency has determined under 21

CFR 25.33(d)(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.

2. Section 520.1445 is amended by

revising paragraph (a) and the heading

of paragraph (c) and by adding

paragraph (d) to read as follows:

§ 520.1445 Milbemycin oxime tablets.

(a) Specifications—(1) Dogs. Each

tablet contains 2.3, 5.75, 11.5, or 23.0

milligrams of milbemycin oxime.

(2) Cats. Each tablet contains 5.75,

11.5, or 23.0 milligrams of milbemycin

oxime.

* * * * *

(c) Conditions of use in dogs. * * *

(d) Conditions of use in cats—(l)

Amount. 0.91 milligram per pound of

body weight (2.0 milligrams per

kilogram).

(2) Indications for use. For prevention

of heartworm disease caused by

Dirofilaria immitis and the removal of

adult Toxocara cati (roundworm) and

Ancylostoma tubaeforme (hookworm)

infections in cats 6 weeks of age or

greater and 1.5 pounds body weight or

greater.

(3) Limitations. Do not use in kittens

less than 6 weeks of age or 1.5 pounds

body weight. Administer once a month.

Federal law restricts this drug to use by

or on the order of a licensed

veterinarian.

Dated: May 11, 1998.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 98–14182 Filed 5–28–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

Implantation or Injectable Dosage

Form New Animal Drugs; Guaifenesin

Injection

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 intravenous use of

guaifenesin injection in horses as a

skeletal muscle relaxant.

EFFECTIVE DATE: May 29, 1998.

FOR FURTHER INFORMATION CONTACT:

Lonnie W. Luther, Center For Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Place,

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 200–230 that

provides for intravenous use of

guaifenesin injection in horses as a

skeletal muscle relaxant.

Approval of Phoenix Scientific, Inc.’s,

ANADA 200–230 for guaifenesin

injection is as a generic copy of Summit

Hill Laboratories’ NADA 48–854 for

Gecolate (guaifenesin) Injection. The

ANADA is approved as of April 8, 1998,

and the regulations are amended in 21

CFR 522.1086(b) to reflect the approval.

The basis of approval is discussed in the

freedom of information summary.

In addition, paragraph (c) is

redesignated as paragraph (d) and

paragraph (c) is reserved.

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, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857, between

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

Friday.

The agency has determined under 21

CFR 25.33(d)(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 522

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 522 is amended as follows:

PART 522—IMPLANTATION OR

INJECTABLE DOSAGE FORM NEW

ANIMAL DRUGS

1. The authority citation for 21 CFR

part 522 continues to read as follows:

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

§ 522.1086 [Amended]

2. Section 522.1086 Guaifenesin

injection is amended in paragraph (b) by

removing ‘‘No. 037990’’ and adding in

its place ‘‘Nos. 037990 and 059130’’, by

redesignating paragraph (c) as paragraph

(d), and by reserving paragraph (c).