Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Rules and Regulations 31397

available for public disclosure before

making the documents available for

inspection.

II. Environmental Impact

The agency has carefully considered

the potential environmental effects of

this action. FDA has concluded that the

action will not have a significant impact

on the human environment, and that an

environmental impact statement is not

required. The agency’s finding of no

significant impact and the evidence

supporting that finding, contained in an

environmental assessment, may be seen

in the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

III. Reference

The following reference has been

placed on display in the Dockets

Management Branch (address above)

and may be seen by interested persons

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

through Friday.

1. Memorandum entitled ‘‘FOAM ADD

10—A terminal no-rinse sanitizer—

Manufactured by Rio Linda Chemical Corp.,’’

dated June 10, 1994.

IV. Filing of Objections

Any person who will be adversely

affected by this regulation may at any

time on or before July 22, 1996 file with

the Dockets Management Branch

(address above) written objections

thereto. Each objection shall be

separately numbered, and each

numbered objection shall specify with

particularity the provisions of the

regulation to which objection is made

and the grounds for the objection. Each

numbered objection on which a hearing

is requested shall specifically so state.

Failure to request a hearing for any

particular objection shall constitute a

waiver of the right to a hearing on that

objection. Each numbered objection for

which a hearing is requested shall

include a detailed description and

analysis of the specific factual

information intended to be presented in

support of the objection in the event

that a hearing is held. Failure to include

such a description and analysis for any

particular objection shall constitute a

waiver of the right to a hearing on the

objection. Three copies of all documents

shall be submitted and shall be

identified with the docket number

found in brackets in the heading of this

document. Any objections received in

response to the regulation may be seen

in the Dockets Management Branch

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

through Friday.

List of Subjects in 21 CFR Part 178

Food additives, Food packaging,

Incorporation by reference.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Director, Center for Food Safety and

Applied Nutrition, 21 CFR part 178 is

amended as follows:

PART 178—INDIRECT FOOD

ADDITIVES: ADJUVANTS,

PRODUCTION AIDS, AND SANITIZERS

1. The authority citation for 21 CFR

part 178 continues to read as follows:

Authority: Secs. 201, 402, 409, 721 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 321, 342, 348, 379e).

2. Section 178.1010 is amended by

adding new paragraphs (b)(46) and

(c)(40) to read as follows:

§ 178.1010 Sanitizing solutions.

* * * * *

(b) * * *

(46) An aqueous solution of chlorine

dioxide and related oxychloro species

generated by acidification of an aqueous

solution of sodium chlorite with a

solution of sodium gluconate, citric

acid, phosphoric acid, and sodium

mono- and

didodecylphenoxybenzenedisulfonate.

In addition to use on food-processing

equipment and utensils, this solution

may be used on dairy-processing

equipment.

* * * * *

(c) * * *

(40) The solution identified in

paragraph (b)(46) of this section shall

provide, when ready for use, at least 100

parts per million and not more than 200

parts per million of chlorine dioxide as

determined by the method developed by

Bio-cide International, Inc., entitled,

‘‘Iodometric Method for the

Determination of Available Chlorine

Dioxide (50–250 ppm Available ClO2),’’

dated June 11, 1987, which is

incorporated by reference in accordance

with 5 U.S.C. 552(a) and 1 CFR part 51.

Copies of this method are available from

the Division of Petition Control, Center

for Food Safety and Applied Nutrition

(HFS–215), Food and Drug

Administration, 200 C St. SW.,

Washington, DC 20204, and may be

examined at the Center for Food Safety

and Applied Nutrition’s Library, Food

and Drug Administration, 200 C St. SW.,

rm. 3321, Washington, DC, or at the

Office of the Federal Register, 800 North

Capitol St. NW., suite 700, Washington,

DC; at least 380 parts per million and

not more than 760 parts per million of

sodium gluconate; and at least 960 parts

per million and not more than 1,920

parts per million of sodium mono- and

didodecylphenoxybenzenedisulfonate.

Other components listed under

paragraph (b)(46) of this section shall be

used in the minimum amount necessary

to produce the intended effect.

* * * * *

Dated: June 7, 1996.

Fred R. Shank,

Director, Center for Food Safety and Applied

Nutrition.

[FR Doc. 96–15726 Filed 6–19–96; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 520

Oral Dosage Form New Animal Drugs;

Neomycin Sulfate Oral Solution

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

Rhone Merieux, Inc. The ANADA

provides for the use of a generic

neomycin sulfate oral solution in

drinking water or in milk for cattle

(excluding veal calves), swine, sheep,

and goats for the treatment and control

of colibacillosis.

EFFECTIVE DATE: June 20, 1996.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary

Medicine (HFV–135), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1643.

SUPPLEMENTARY INFORMATION: Rhone

Merieux, Inc., 7101 College Blvd.,

Overland Park, KS 66210, filed ANADA

200–153, which provides for the use of

neomycin sulfate oral solution in

drinking water or in milk of cattle

(excluding veal calves), swine, sheep,

and goats for the treatment and control

of colibacillosis (bacterial scours)

caused by Escherichia coli susceptible

to neomycin. ANADA 200–153 is

approved as a generic copy of The

Upjohn Co.’s NADA 11–035. The

ANADA is approved as of May 8, 1996,

and the regulations are amended in 21

CFR 520.1485(b) and (d)(3) 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 part 20 (21
31398 Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Rules and Regulations

CFR part 20) and § 514.11(e)(2)(ii) (21

CFR 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 carefully considered

the potential environmental effects of

this action. FDA has concluded that the

action will not have a significant impact

on the human environment, and that an

environmental impact statement is not

required. The agency’s finding of no

significant impact and the evidence

supporting that finding, contained in an

environmental assessment, may be seen

in the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

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: Sec. 512 of the Federal Food,

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

2. Section 520.1485 is amended by

revising paragraph (b) and the last

sentence of paragraph (d)(3) to read as

follows:

§ 520.1485 Neomycin sulfate oral solution.

* * * * *

(b) Sponsors. See Nos. 000009,

050604, and 059130 in § 510.600(c) of

this chapter.

* * * * *

(d) * * *

(3) * * * Discontinue treatment prior

to slaughter as follows: For sponsors

000009 and 059130: 30 days for cattle

and goats, and 20 days for swine and

sheep; for sponsor 050604: 1 day for

cattle (not for use in veal calves), 2 days

for sheep, and 3 days for swine and

goats.

Dated: June 10, 1996.

Shephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 96–15566 Filed 6–19–96; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Parts 520 and 556

Animal Drugs, Feeds, and Related

Products; Neomycin Sulfate 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 a supplemental new animal

drug application (NADA) filed by The

Upjohn Co. and two supplemental

abbreviated new animal drug

applications (ANADA’s), one filed by

Pfizer, Inc., and the other filed by Rhone

Merieux, Inc. The applications provide

for use of neomycin sulfate soluble

powder in drinking water or in milk for

cattle (excluding veal calves), swine,

sheep, and goats for the treatment and

control of colibacillosis. The

supplements provide for revised

preslaughter withdrawal times

following use of the drug and revised

tolerances for neomycin residues in

edible tissues of treated animals.

EFFECTIVE DATE: June 20, 1996.

FOR FURTHER INFORMATION CONTACT:

Melanie R. Berson, Center for Veterinary

Medicine (HFV–135), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1643.

SUPPLEMENTARY INFORMATION: The

Upjohn Co., Agricultural Division,

Kalamazoo, MI 49001–0199, filed

supplemental NADA 11–315; Pfizer,

Inc., 235 East 42d St., New York, NY

10017, filed supplemental ANADA 200–

046; Rhone Merieux, Inc., 7101 College

Blvd., Overland Park, KS 66210, filed

supplemental ANADA 200–050. The

supplements provide for revised

withdrawal times for use of neomycin

sulfate soluble powder in drinking

water or in milk for cattle (excluding

veal calves), swine, sheep, and goats for

the treatment and control of

colibacillosis (bacterial scours) caused

by Escherichia coli susceptible to

neomycin sulfate. The supplements are

approved as of April 3, 1996, and

§ 520.1484(c)(3) (21 CFR 520.1484(c)(3))

is amended to reflect the approvals. The

basis for approval is discussed in the

freedom of information summary as

indicated below. Also, the firms

sponsored studies which provided data

to support revised tolerances for

residues of neomycin in the edible

tissues of cattle, swine, sheep, and

goats. Based on evaluation of the data as

provided in the General Principles for

Evaluating the Safety of Compounds

Used in Food-Producing Animals

Guidelines, tolerances of 1.2 parts per

million (ppm) in muscle, 3.6 ppm in

liver, and 7.2 ppm in kidney and fat,

and withdrawal times of 1 day for cattle,

2 days for sheep, and 3 days for swine

and goats, are established. The revised

withdrawal times are provided in

§ 520.1484(c)(3). The revised tolerances

for neomycin residues are established in

amended 21 CFR 556.430.

In accordance with the freedom of

information provisions of part 20 (21

CFR part 20) and § 514.11(e)(2)(ii) (21

CFR 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)), these

approvals do not qualify for marketing

exclusivity because the applications do

not contain reports of new clinical or

field investigations (other than

bioequivalence or residue studies) or

new human food safety studies (other

than bioequivalence or residue studies)

essential to the approvals and

conducted or sponsored by the

applicants.

The agency has determined under 21

CFR 25.24(d)(1)(i) 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

21 CFR Part 520

Animal drugs.

21 CFR Part 556

Animal drugs, Foods.

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 parts 520 and 556 are 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: Sec. 512 of the Federal Food,

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

2. Section 520.1484 is amended in

paragraph (c)(3) by revising the last

sentence to read as follows: