Federal Register / Vol. 62, No. 165 / Tuesday, August 26, 1997 / Rules and Regulations 45157

SUPPLEMENTARY INFORMATION:

Background

On June 4, 1997, Customs published

in the Federal Register (62 FR 30448)

interim regulations (T.D. 97–45) which

amended § 24.24 of the Customs

Regulations (19 CFR 24.24) to update

the list of ports that process commercial

vessels that transport cargo that are

subject to the Water Resources

Development Act of 1986. That

document contained several

typographical errors in the columns

headed ‘‘Port code, port name and state’’

and ‘‘Port descriptions and notations’’,

both of which may be relied on by

importers in the preparation of

necessary entry documentation. The

errors identified are under the headings

for Delaware, the District of Columbia,

Illinois, Massachusetts, and Michigan,

and consist of incomplete State

abbreviations (for Maryland and

Illinois), incorrect port codes (for East

Chicago and Escanaba), and incomplete

port descriptions (for Delaware and

Massachusetts). Accordingly, this

document corrects those typographical

errors.

Corrections to Publication

The document (FR Doc. 97–14409)

published in the Federal Register (62

FR 30448) on June 4, 1997, is corrected

as follows:

1. On page 30450, under the heading

for ‘‘Delaware’’, in the column headed

‘‘Port descriptions and notations’’, in

the second line the word ‘‘lower’’ is

added after the words ‘‘all points on

the’’;

2. Also on page 30450, under the

heading for ‘‘District of Columbia’’, in

the column headed ‘‘Port code, port

name and state’’, in the first line the

capital letter ‘‘D’’ is removed and the

designation ‘‘MD’’ is added in its place;

3. On page 30451, under the heading

for ‘‘Illinois’’, in the column headed

‘‘Port code, port name and state’’, in the

third line the numbers ‘‘3902’’ are

removed and the numbers ‘‘3904’’ are

added in their place; and in the column

headed ‘‘Port descriptions and

notations’’, in the first line the

designation ‘‘II.’’ is removed and the

designation ‘‘IL’’ is added in its place;

4. Also on page 30451, under the

heading for ‘‘Massachusetts’’, in the

column headed ‘‘Port descriptions and

notations’’, in the second line the word

‘‘River’’ is removed and the word

‘‘Rivers’’ is added in its place; and

5. On page 30452, under the heading

for ‘‘Michigan’’, in the column headed

‘‘Port code, port name and state’’, in the

fifth line the number ‘‘3803’’ is removed

and the number ‘‘3808’’ is added in

their place.

Dated: August 21, 1997.

Harold M. Singer,

Chief, Regulations Branch.

[FR Doc. 97–22639 Filed 8–25–97; 8:45 am]

BILLING CODE 4820–02–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 522

Implantation or Injectable Dosage

Form New Animal Drugs; Gentamicin

Injection; Technical Amendment

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule; technical

amendment.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations for gentamicin

injection. A document which published

in the Federal Register of May 15, 1996

(61 FR 24440), inadvertently resulted in

the 1997 edition of the Code of Federal

Regulations not containing reference to

two gentamicin injection approvals.

This document amends the gentamicin

injection regulations to reflect the

approvals.

EFFECTIVE DATE: August 26, 1997.

FOR FURTHER INFORMATION CONTACT:

David L. Gordon, Center for Veterinary

Medicine (HFV–6), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1739.

SUPPLEMENTARY INFORMATION: In the

Federal Register of May 15, 1996 (61 FR

24440), FDA published a document to

reflect approval of Schering-Plough’s

supplemental NADA 101–862. In

amending the regulations to reflect the

supplemental approval, FDA provided

amendatory instructions which resulted

in two paragraphs inadvertently being

removed. This document reestablishes

those paragraphs in 21 CFR

522.1044(b)(3) and (b)(4).

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: Sec. 512 of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. 360b).

2. Section 522.1044 is amended by

adding paragraphs (b)(3) and (b)(4) to

read as follows:

§ 522.1044 Gentamicin sulfate injection.

* * * * *

(b) * * *

(3) See No. 054273 for use of 50

milligrams-per-milliliter solution in

dogs as in paragraph (d)(5) of this

section.

(4) See No. 050604 for use of 100

milligrams-per-milliliter solution in

chickens as in paragraph (d)(3) of this

section.

* * * * *

Dated: August 18, 1997.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 97–22622 Filed 8–25–97; 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; Polysulfated

Glycosaminoglycan

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 Luitpold

Pharmaceuticals, Inc. The NADA

provides for intramuscular injection of

polysulfated glycosaminoglycan for

dogs for control of signs associated with

noninfectious degenerative and/or

traumatic arthritis of canine synovial

joints.

EFFECTIVE DATE: August 26, 1997.

FOR FURTHER INFORMATION CONTACT:

Ellen M. Buck, Center For Veterinary

Medicine (HFV–114), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1617.

SUPPLEMENTARY INFORMATION: Luitpold

Pharmaceuticals, Inc., Animal Health

Division, 1 Luitpold Dr., Shirley, NY

11967, filed NADA 141–038 that