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:
Federal Register / Vol. 61, No. 120 / Thursday, June 20, 1996 / Rules and Regulations 31399

§ 520.1484 Neomycin sulfate soluble

powder.

* * * * *

(c) * * *

(3) * * * Discontinue treatment

prior to slaughter as follows: For

sponsor 059130—cattle and goats, 30

days; swine and sheep, 20 days; for

sponsors 000009, 000069, 050604—

cattle (not for use in veal calves), 1 day;

sheep, 2 days; swine and goats, 3 days.

PART 556—TOLERANCES FOR

RESIDUES OF NEW ANIMAL DRUGS

IN FOOD

3. The authority citation for 21 CFR

part 556 continues to read as follows:

Authority: Secs. 402, 512, 701 of the

Federal Food, Drug, and Cosmetic Act (21

U.S.C. 342, 360b, 371).

4. Section 556.430 is revised to read

as follows:

§ 556.430 Neomycin.

A tolerance of 7.2 parts per million

(ppm) is established for residues of

parent neomycin (marker residue) in

uncooked edible kidney (target tissue),

7.2 ppm in fat, 3.6 ppm in liver, 1.2

ppm in muscle of cattle, swine, sheep,

and goats. A tolerance of 0.15 ppm is

established for neomycin in milk.

Dated: May 31, 1996.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 96–15724 Filed 6–19–96; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Bureau of Alcohol, Tobacco and

Firearms

27 CFR Parts 17, 19, 70, 170, 194, 197,

and 250

[T.D. ATF–379; Re Notice Nos. 634, 649,

748, and 758]

RIN 1512–AA20

Taxpaid Distilled Spirits Used in

Manufacturing Products Unfit for

Beverage Use (73R–24P)

AGENCY: Bureau of Alcohol, Tobacco

and Firearms (ATF), Department of the

Treasury.

ACTION: Final rule, Treasury decision.

SUMMARY: This final rule amends and

recodifies the regulations on taxpaid

distilled spirits used to manufacture

nonbeverage products. The regulations

formerly in 27 CFR part 197 (Drawback

on Distilled Spirits Used in

Manufacturing Nonbeverage Products)

are recodified as a new part, designated

27 CFR part 17. In conjunction with the

recodification, a number of changes to

the drawback regulations have been

made. Further, the regulations formerly

in 27 CFR part 170, subpart U

(Manufacture and Sale of Certain

Compounds, Preparations, and Products

Containing Alcohol) have been

distributed between 27 CFR part 19 and

the new part 17; and conforming

amendments have been made in 27 CFR

parts 70, 194, and 250. Significant

changes from prior regulations are

discussed below under SUPPLEMENTARY

INFORMATION.

EFFECTIVE DATE: This Treasury decision

is effective on August 19, 1996.

FOR FURTHER INFORMATION CONTACT:

Steve Simon, Wine, Beer, and Spirits

Regulations Branch, Bureau of Alcohol,

Tobacco and Firearms, 650

Massachusetts Avenue NW,

Washington, DC 20226; (202) 927–8210.

SUPPLEMENTARY INFORMATION:

Notices of Proposed Rulemaking

On July 29, 1987, ATF published

Notice No. 634 in the Federal Register

(52 FR 28286). That notice proposed the

recodification of regulations concerning

nonbeverage drawback, including

changes from the former regulations (27

CFR part 197). Public comment was

requested concerning the proposed

changes. A 90-day comment period was

provided, which ended on October 27,

1987. In response to Notice No. 634,

ATF received four written public

comments. In addition, some review

comments were received from ATF

personnel after the publication of Notice

No. 634.

On December 8, 1987, ATF solicited

additional public comments regarding

the nonbeverage drawback regulations.

On that date, ATF published Notice No.

649 (52 FR 46628), which requested

comments specifically relating to

drawback on nonbeverage products

brought into the U.S. from Puerto Rico

or the Virgin Islands. In conjunction, the

comment period for Notice No. 634 was

extended until January 8, 1988. No

additional comments concerning Notice

No. 634 were received pursuant to that

extension.

On August 31, 1992, ATF decided to

republish the proposed recodification

and amendment of 27 CFR part 197.

Notice No. 748 was published in the

Federal Register (57 FR 39536). Because

more than 4 years had elapsed since the

end of the previous comment periods,

the proposed regulations were

republished in their entirety, with some

additional changes, so that anyone else

who wished to comment on them would

have an opportunity to do so.

Notice No. 748 prescribed a 30-day

comment period, which was scheduled

to end on September 30, 1992. On

September 14, 1992, ATF was asked to

extend this comment period for an

additional 90 days. ATF partially

granted this request. On October 1,

1992, Notice No. 758 (57 FR 45357)

extended the comment period for Notice

No. 748 by an additional 30 days, until

October 30, 1992. The full 90-day

extension (as requested) was not

granted, because most of the same

regulatory issues had been previously

aired for public comment during a

sufficient length of time. Subsequent to

the official ending of the comment

period, comments that were received

while it was still practicable to consider

them were given consideration.

In response to Notices No. 748 and

758, comments were received by letter,

telephone, and personal visit from a

total of twelve persons representing

eleven entities (nine industry members

and two industry groups). These

comments are discussed carefully

below, following the discussion of

comments submitted previously under

Notice No. 634.

Public Comments on Notice No. 634

Comments relating to Notice No. 634

were received from four correspondents:

1. One commenter proposed that

§ 17.183 be liberalized to allow

manufacturers to sell or transport

byproducts from which alcohol may be

recovered, without removing the alcohol

or adding an appropriate substance to

prevent the recovery of residual alcohol.

The commenter was concerned

particularly about economic loss from

an inability to process ‘‘spent’’ vanilla

beans for food use applications.

ATF did not adopt this comment,

because potable alcohol recovered from

a nonbeverage manufacturer’s

byproduct would have been previously

subject to drawback; thus less than 10%

of the tax would remain paid. The

possible recovery of such potable

alcohol by unknown persons would

present an unacceptable jeopardy to the

revenue. Subject to formula approval

and/or approval of an alternative

procedure under § 17.3, ATF could

allow byproducts containing

recoverable alcohol to be subjected to

additional processing, on the

manufacturer’s premises, for food use

applications.

The basis for § 17.183 in this final rule

is ATF Ruling 81–8, 1981–4 QB 24. That

ruling provided a liberalized procedure

for the disposition of spent vanilla

beans, whereby they could be treated

with any substance that the

manufacturer deemed adequate to make