65020 Federal Register / Vol. 62, No. 237 / Wednesday, December 10, 1997 / Rules and Regulations

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Lincomycin Soluble Powder

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 I. D.

Russell Co. Laboratories. The ANADA

provides for use of lincomycin

hydrochloride soluble powder to make

medicated drinking water for swine for

the treatment of dysentery (bloody

scours) and broiler chickens for the

control of necrotic enteritis.

EFFECTIVE DATE: December 10, 1997.

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: I. D.

Russell Co. Laboratories, 1301 Iowa

Ave., Longmont, CO 80501, filed

ANADA 200–189 that provides for use

of lincomycin hydrochloride soluble

powder to make medicated drinking

water for swine for the treatment of

dysentery (bloody scours) and broiler

chickens for the control of necrotic

enteritis caused by Clostridium

perfringens susceptible to lincomycin.

Approval of I. D. Russell Co.

Laboratories’ ANADA 200–189

lincomycin hydrochloride soluble

powder is as a generic copy of

Pharmacia & Upjohn’s NADA 111–636

LincomixTM soluble powder. The

ANADA is approved as of November 7,

1997, and the regulations are amended

in 21 CFR 520.1263c(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, 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(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.

§ 520.1263c [Amended]

2. Section 520.1263c Lincomycin

hydrochloride soluble powder is

amended in paragraph (b) by removing

‘‘No. 000009’’ and adding in its place

‘‘Nos. 000009 and 017144’’.

Dated: December 1, 1997.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 97–32217 Filed 12-9-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF DEFENSE

Office of the Secretary

32 CFR Part 320

National Imagery and Mapping Agency

(NIMA) Privacy Program

AGENCY: Department of Defense.

ACTION: Final rule.

SUMMARY: The document is published to

make administrative changes to the

National Imagery and Mapping Agency

(NIMA), formerly know as the Defense

Mapping Agency, Privacy Program rule.

EFFECTIVE DATE: This rule is effective

December 10, 1997.

FOR FURTHER INFORMATION CONTACT: Ms.

M. Flattery, 301–227–2268.

SUPPLEMENTARY INFORMATION:

List of Subjects in 32 CFR Part 320

Privacy program.

Accordingly, 32 CFR part 320 is

amended as follows:

PART 320—NATIONAL IMAGERY AND

MAPPING AGENCY (NIMA) PRIVACY

PROGRAM

1. The authority citation for part 320

continues to read as follows:

Authority: Pub. L. 93–579, 88 Stat. 1986 (5

U.S.C. 552a).

2. The part heading is revised as set

forth above.

§ 320.1 [Amended]

3. In § 320.1, paragraph (a)(1)(i) is

amended by revising ‘‘Defense Mapping

Agency (DMA)’’ to read ‘‘National

Imagery and Mapping Agency (NIMA)’’

and paragraph (a)(2) is amended by

revising ‘‘DMS’’ to read ‘‘NIMA.’’

§ 320.2 [Amended]

4. In § 320.2, the definitions Record

and System or records are amended by

revising ‘‘DMA’’ to read ‘‘NIMA.’’

5. Section 320.3 is amended as

follows:

a. Paragraph (a), paragraph (c)(2), and

paragraph (d) by revising ‘‘DMA’’ to

read ‘‘NIMA’’;

b. Paragraph (b) by revising ‘‘HQ DMA

or at the principal office of DMA

Component (Please refer to the DMA

address list at paragraph (e) of this

section’’ to read ‘‘NIMA General

Counsel Office (refer to the NIMA

address list at paragraph (e) of this

section) or at the NIMA officer’’;

c. Paragraph (c) introductory text by

revising ‘‘Director of the DMA

Component or Staff Office’’ to read

‘‘Office of General Counsel,’’ and after

the word ‘‘section)’’ and ‘‘or NIMA

office’’;

d. Paragraph (e) is revised to read as

follows:

§ 320.3 Procedures for requests for

information pertaining to individual records

in a record system.

* * * * *

(e) NIMA General Counsel address

list.

(1) NIMA Fairfax, Attn: GC, Mail Stop

A–7 NIMA Fairfax, 8613 Lee Highway,

Fairfax, VA 22031–2137.

(2) NIMA Bethesda, Attn: GCM, Mail

Stop D–10, 4600 Sangamore Road,

Bethesda, MD 20816–5003.

(3) NIMA St. Louis, Attn: GCM Mail

Stop L–32, 3200 South Second Street,

St. Louis, MO 63118–3399.

(4) NIMA Navy Yard, Attn: GCM Stop,

N–24, Building 213, Washington, DC

20505–0001.

(5) NIMA Westfields, Attn: GCM,

Room 13F20C, 14675 Lee Road,

Chantilly, VA 20151–1715.

6. Section 320.4 is amended as

follows:

a. Paragraph (a), paragraph (b)

introductory text, paragraph (b)(3),

paragraph (c)(2), and paragraph (d) by

revising ‘‘DMA’’ to read ‘‘NIMA’’;

b. Paragraph (b)(1) is amended by

revising ‘‘Headquarters Defense

Mapping Agency or at the principal