36178 Federal Register / Vol. 63, No. 127 /Thursday, July 2, 1998 /Rules and Regulations

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

through Friday.

This final rule contains no collections

of information. Therefore, clearance by

the Office of Management and Budget

under the Paperwork Reduction Act of

1995 is not required.

List of Subjects in 21 CFR Part 178

Food additives, Food packaging.

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: 21 U.S.C. 321, 342, 348, 379e.

2. Section 178.2010 is amended in the

table in paragraph (b) by revising the

entry for ‘‘Phosphorous acid, cyclic

butylethyl propanediol, 2,4,6-tri-tertbutylphenyl ester’’ by adding item ‘‘4.’’

under the heading ‘‘Limitations’’ to read

as follows:

§ 178.2010 Antioxidants and/or stabilizers

for polymers.

* * * * *

(b) * * *

Substances Limitations

* * * * * * *

Phosphorous acid, cyclic butylethyl propanediol, 2,4,6-tri-tertbutylphenyl ester (CAS Reg. No. 161717–32–4), which may contain

not more than 1 percent by weight of triisopropanolamine (CAS Reg.

No. 122–20–3).

For use only:

* * *

4. At levels not to exceed 0.1 percent by weight of olefin polymers

complying with § 177.1520(c) of this chapter, items 2.1, 2.2, 2.3,

3.1(a), 3.1(b), 3.1(c), 3.2 (a), or 3.2(b), having a density not less

than 0.94 grams per cubic centimeter, in contact with foods only of

types III, IV, V, VI–A, VI–C, VII, VIII, and IX identified in Table 1 of

§ 176.170(c) of this chapter, and under conditions of use B through

H as described in Table 2 of § 176.170(c) of this chapter; provided

that the food-contact surface does not exceed 0.003 inch (0.076

mm) in thickness.

* * * * * * *

Dated: June 23, 1998.

L. Robert Lake,

Director, Office of Policy, Planning and

Strategic Initiatives, Center for Food Safety

and Applied Nutrition.

[FR Doc. 98–17544 Filed 7–1–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510 and 520

Animal Drugs, Feeds, and Related

Products; Change of Sponsor

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending the

animal drug regulations to reflect the

change of sponsor for two approved new

animal drug applications (NADA’s) from

Danbury Pharmacal, Inc., to Phoenix

Scientific, Inc.

EFFECTIVE DATE: July 2, 1998.

FOR FURTHER INFORMATION CONTACT:

Thomas J. McKay, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0213.

SUPPLEMENTARY INFORMATION: Danbury

Pharmacal, Inc., 131 West St., Danbury,

CT 06810, has informed FDA that it has

transferred the ownership of and all

rights and interests in the approved

NADA’s 91–818 and 94–170

(phenylbutazone tablets) to Phoenix

Scientific, Inc., 3915 South 48th St.

Terrace, P.O. Box 6457, St. Joseph, MO

64506–0457. The agency is amending 21

CFR 510.600(c)(1) and (c)(2) to remove

the sponsor name for Danbury

Pharmacal, Inc., because the firm no

longer is the holder of any approved

NADA’s. The agency also is amending

21 CFR 520.1720a to reflect the change

of sponsor.

List of Subjects

21 CFR Part 510

Administrative practice and

procedure, Animal drugs, Labeling,

Reporting and recordkeeping

requirements.

21 CFR Parts 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 parts 510 and 520 are amended as

follows:

PART 510—NEW ANIMAL DRUGS

1. The authority citation for 21 CFR

part 510 continues to read as follows:

Authority: 21 U.S.C. 321, 331, 351, 352,

353, 360b, 371, 379e.

§ 510.600 [Amended]

2. Section 510.600 Names, addresses,

and drug labeler codes of sponsors of

approved applications is amended in

the table in paragraph (c)(1) by

removing the entry for ‘‘Danbury

Pharmacal, Inc.’’; and in the table in

paragraph (c)(2) by removing the entry

for ‘‘000591’’.

PART 520—ORAL DOSAGE FORM

NEW ANIMAL DRUGS

3. The authority citation for 21 CFR

part 520 continues to read as follows:

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

§ 520.1720a [Amended]

4. Section 520.1720a Phenylbutazone

tablets and boluses is amended in

paragraph (b)(3) by removing the

numbers ‘‘000591, 000856, 000864, and

015579’’ and adding in their place the

numbers ‘‘000856, 000864, 015579, and

059130’’.
Federal Register / Vol. 63, No. 127 /Thursday, July 2, 1998 /Rules and Regulations 36179

Dated: June 22, 1998.

Margaret Ann Miller,

Acting Director, Office of New Animal Drug

Evaluation, Center for Veterinary Medicine.

[FR Doc. 98–17542 Filed 7–1–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 558

New Animal Drugs For Use In Animal

Feeds; Penicillin

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 two supplemental new

animal drug applications (NADA’s), one

filed by Alpharma Inc., the other by

Pfizer, Inc. The supplemental NADA’s

provide for using approved penicillin G

procaine Type A medicated articles to

make Type C medicated chicken,

turkey, pheasant, quail, and swine feeds

used for increased rate of weight gain

and improved feed efficiency.

EFFECTIVE DATE: July 2, 1998.

FOR FURTHER INFORMATION CONTACT:

Dianne T. McRae, Center for Veterinary

Medicine (HFV–102), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1623.

SUPPLEMENTARY INFORMATION: Alpharma

Inc., One Executive Dr., P.O. Box 1399,

Fort Lee, NJ 07024, is sponsor of NADA

46–666. Pfizer, Inc., 235 East 42d St.,

New York, NY 10017, is sponsor of

NADA 46–668. The sponsors filed

supplemental NADA’s that provide for

amending the regulations concerning

use of penicillin Type A medicated

articles to make Type B and C

medicated feeds for chickens, turkeys,

pheasants, quail, and swine for

increased rate of weight gain and

improved feed efficiency. The

supplemental NADA’s reflect the results

of the National Academy of Sciences/

National Research Council (NAS/NRC)

Drug Efficacy Study Implementation

(DESI) review of the products’

effectiveness and FDA’s conclusions

based on that review (35 FR 11533, July

17, 1970).

NAS/NRC evaluated these products as

probably effective for faster gain and/or

feed efficiency. FDA concurred with

these findings and concluded that the

appropriate claim should be ‘‘for

increased rate of weight gain and

improved feed efficiency for (under

appropriate conditions of use).’’ The

evaluation concerned only the drug’s

effectiveness and safety to the animal to

which administered, and it did not take

into account the safety for food use of

food derived from drug-treated animals.

Nothing herein will constitute a bar to

further proceedings with respect to

questions of safety of the drugs or their

metabolites as residues in food products

derived from treated animals.

In the Federal Register of August 30,

1977 (42 FR 43772), the then Bureau of

Veterinary Medicine issued a notice of

opportunity for hearing (NOOH) on a

proposal to withdraw approval of

NADA’s for all penicillin-containing

premixes (Type A medicated articles)

intended for subtherapeutic use in

animal feeds. The NOOH was issued in

response to scientific research

suggesting that subtherapeutic use of

such drugs has contributed to the pool

of antibiotic-resistant pathogenic

microorganisms in food animals.

Furthermore, research indicated that the

drug resistance could be transferred to

pathogenic organisms in humans. The

NOOH is still pending and approval of

these supplements to finalize the DESI

review process for penicillin-containing

Type A medicated articles does not

constitute a bar to subsequent action to

withdraw approval on the grounds cited

in the outstanding NOOH.

The supplemental NADA’s are

approved as of April 10, 1998. The

regulations are amended in 21 CFR

558.460 by redesignating paragraphs (b)

and (c) as paragraphs (c) and (d), by

adding new paragraph (b), and by

revising the table in paragraph (d) 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 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, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852, between 9

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

Friday.

The agency has determined under 21

CFR 25.33(a)(3) 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 558

Animal drugs, Animal feeds.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under the

authority delegated to the Commissioner

of Food and Drugs and redelegated to

the Center for Veterinary Medicine, 21

CFR part 558 is amended as follows:

PART 558—NEW ANIMAL DRUGS FOR

USE IN ANIMAL FEEDS

1. The authority citation for 21 CFR

part 558 continues to read as follows:

Authority: 21 U.S.C. 360b, 371.

2. Section 558.460 is amended by

redesignating paragraphs (b) and (c) as

paragraphs (c) and (d), by adding

paragraph (b), and by revising the table

in paragraph (d)(1) to read as follows:

§ 558.460 Penicillin.

* * * * *

(b) Sponsors. Type A medicated

articles: To 000069, 100 grams per

pound. To 046573, 100 and 227 grams

per pound.

* * * * *

(d) * * *

(1) * * *

Penicillin in grams per ton Combination in

grams per ton Indications for use Limitations Sponsor

(i) 2.4 to 50 Chickens, turkeys, and

pheasants; for increased rate of weight

gain and improved

feed efficiency.

Do not feed to poultry

producing eggs for

human consumption.

000069,

046573.

(ii) 5 to 20 Quail; for increased rate

of weight gain and improved feed efficiency.

Quail; not over 5 weeks

of age.

Do.