Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 / Notices 26193

Application No. Drug Applicant

ANDA 81–242 FOLEX PFS (Methotrexate Sodium Injection, USP) 25

mg/mL

Do.

ANDA 83–187 Afaxin (brand of vitamin A Palmitate) Sanofi Pharmaceuticals, Inc.

ANDA 83–237 Diphenhydarmine Hydrochloride Elixir USP Purepac Pharmaceutical Co.

ANDA 83–278 Propoxyphene Hydrochloride Capsules USP, 65 mg Do.

ANDA 83–856 ESTRATAB (Esterified Estrogens Tablets, USP) 1.25

mg

Solvay Pharmaceuticals, Inc., 901 Sawyer Rd., Marietta, GA 30062.

ANDA 83–921 Elixophyllin (Theophylline Soft Gelatin Capsules, 200

mg)

Forest Laboratories, Inc., 909 Third Ave., New York,

NY 10022–4731.

ANDA 84–003 Quinidine Sulfate Tablets USP, 200 mg Purepac Pharmaceutical Co.

ANDA 85–545 Elixophyllin (Theophylline Soft Gelatin Capsules, 100

mg)

Forest Laboratories, Inc.

ANDA 86–826 Elixophyllin SR (Theophylline Extended-Release Capsules, USP) 125 mg and 250 mgDo.

ANDA 87–999 Spironolactone and Hydrochlorothiazide Tablets USP,

25 mg/25 mg

Purepac Pharmaceutical Co.

ANDA 89–284 Procainamide Hydrochloride Extended-Release Tablets USP, 500 mgInvamed, Inc.

ANDA 89–463 Promethazine Hydrochloride Injection USP, 25 mg/mL Marsam Pharmaceuticals, Inc.

ANDA 89–477 Promethazine Hycrochloride Injection USP, 50 mg/mL Do.

ANDA 89–501 Phenytoin Sodium Injection USP, 50 mg/mL, 2 mL

(ampul)

Do.

ANDA 89–511 Codaphen (Acetaminophen and Codeine Phosphate

Tablets USP) 500 mg/15 mg

Roxane Laboratories, Inc.

ANDA 89–512 Codaphen (Acetaminophen and Codeine Phosphate

Tablets USP) 500 mg/30 mg

Do.

ANDA 89–513 Codaphen (Acetaminophen and Codeine Phosphate

Tablets USP) 500 mg/60 mg

Do.

ANDA 89–563 Chlorpromazine Hydrochloride Injection USP, 25 mg/

mL

Marsam Pharmaceuticals, Inc.

ANDA 89–675 Prochlorperazine Edisylate Injection USP, 5 mg/mL Do.

ANDA 89–779 Phenytoin Sodium Injection USP, 50 mg/mL, 2 mL and

5 mL (vials)

Do.

ANDA 89–849 Methocarbamol Injection USP, 100 mg/mL Do.

Therefore, under section 505(e) of the

Federal Food, Drug, and Cosmetic Act

(21 U.S.C. 355(e)) and under authority

delegated to the Director, Center for

Drug Evaluation and Research (21 CFR

5.82), approval of the applications listed

in the table in this document, and all

amendments and supplements thereto,

is hereby withdrawn, effective June 11,

1998.

Dated: April 28, 1998.

Janet Woodcock,

Director, Center for Drug Evaluation and

Research.

[FR Doc. 98–12613 Filed 5–11–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98F–0196]

Alltech Biotechnology Center; Filing of

Food Additive Petition (Animal Use)-

Selenium Yeast

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Alltech Biotechnology Center has

filed a petition proposing that the food

additive regulations be amended to

provide for the safe use of selenium

yeast as a source of selenium in animal

feeds.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Nelson S. Chou, Center for Veterinary

Medicine (HFV–228), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–827–0161.

SUPPLEMENTARY INFORMATION: Under

section 409 (b)(5) of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C.

348(b)(5)), notice is given that a food

additive petition (FAP 2238) has been

filed by Alltech Biotechnology Center,

3031 Catnip Hill Pike, Nicholasville, KY

40356. The petition proposes to amend

the food additive regulations in part 573

Food Additives Permitted in the Feed

and Drinking Water of Animals (21 CFR

part 573) to provide for the safe use of

selenium yeast as a source of selenium

in animal feeds.

The agency has determined under 21

CFR 25.32(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.

Dated: April 24, 1998.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 98–12611 Filed 5–11–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 96F–0341]

MacMillan Bloedel, Ltd.; Withdrawal of

Food Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.
26194 Federal Register / Vol. 63, No. 91 /Tuesday, May 12, 1998 / Notices

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

withdrawal, without prejudice to a

future filing, of a food additive petition

(FAP 6B4517) proposing that the food

additive regulations be amended to

provide for the safe use of diethylene

glycol as a component of a pulp

bleaching medium used in the

manufacture of paper and paperboard

intended for use in contact with food.

FOR FURTHER INFORMATION CONTACT:

Andrew J. Zajac, Center for Food Safety

and Applied Nutrition (HFS–215), Food

and Drug Administration, 200 Ct. SW.,

Washington, DC 20204, 202–418–3095.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

September 30, 1996 (61 FR 51118), FDA

announced that a food additive petition

(FAP 6B4517) had been filed by

MacMillan Bloedel, Ltd., c/o Camplong

& Associates, Inc., P.O. Box 238,

Schomberg, Ontario L0G 1T0, Canada.

The filing notice stated that the petition

proposed to amend the food additive

regulations in § 176.170 Components of

paper and paperboard in contact with

aqueous and fatty foods (21 CFR

176.170) to provide for the safe use of

diethylene glycol as a pulp bleaching

agent for paper and paperboard

intended for use in contact with food.

Upon further review, FDA has

determined that the petition proposed

the use of diethylene glycol as a

component of a pulp bleaching medium

used in the manufacture of food-contact

paper and paperboard. MacMillan

Bloedel, Ltd. has now withdrawn the

petition without prejudice to a future

filing (21 CFR 171.7).

Dated: April 10, 1998.

Laura M. Tarantino,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 98–12541 Filed 5–11–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98F–0195]

Vanetta S.p.A.; Filing of Food Additive

Petition (Animal Use) Menadione

Nicotinamide Bisulfite

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Vanetta S.p.A. has filed a petition

to allow the use of menadione

nicotinamide bisulfite in swine diets as

a source of vitamin K activity and

niacin.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Michaela G. Alewynse, Center for

Veterinary Medicine (HFV–228), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–827–

6657.

SUPPLEMENTARY INFORMATION: Under the

Federal Food, Drug, and Cosmetic Act

(sec. 409(b)(5) 21 U.S.C. 348(b)(5)),

notice is given that a food additive

petition (FAP 2239) has been filed by

Vanetta S.p.A., Via Alzia Trento 10,

Milano, Corsico, Italy. The petition

proposes to amend the food additive

regulations in part 573 Food Additives

Permitted in the Feed and Drinking

Water of Animals (21 CFR part 573) to

provide for use of menadione

nicotinamide bisulfite in swine diets as

a source of vitamin K activity and

niacin.

The agency has determined under 21

CFR 25.32 that this action is of the 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.

Dated: April 24, 1998.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 98–12540 Filed 5–11–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Food Advisory Committee; Notice of

Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). The meeting will be open to the

public.

Name of Committee: Food Advisory

Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.

Date and Time: The meeting will be

held on June 15 and 16, 1998, 8 a.m. to

6 p.m.; and June 17, 1998, 8 a.m. to 1

p.m..

Location: Sheraton Reston Hotel,

Grand Ballroom, 11810 Sunrise Valley

Dr., Reston, VA.

Contact: Lynn A. Larsen, Center for

Food Safety and Applied Nutrition

(HFS–5), 202–205–4727, or Catherine

M. DeRoever (HFS–22), 202–205–4251,

FAX 202–205–4970, Food and Drug

Administration, 200 C St. SW.,

Washington, DC 20204, or FDA

Advisory Committee Information Line,

1–800–741–8138 (301–443–0572 in the

Washington, DC area), code 10564.

Please call the Information Line for upto-date information on this meeting.

Agenda: The committee will receive

and undertake a scientific discussion

about new data that have become

available regarding the food additive

olestra.

In the Federal Register of January 30,

1996 (61 FR 3118), FDA approved

olestra for use as a food additive to

replace conventional fats in

prepackaged savory snacks. Olestra is a

sucrose polyester formed with long

chain fatty acids. The agency

determined, based on its evaluation of

the evidence in the record at that time,

that there is a reasonable certainty that

no harm will result from the use of

olestra in savory snacks. At the time of

approval, the petitioner, Proctor and

Gamble Co. (P&G), agreed to perform

additional studies of olestra exposure

(both amounts consumed and patterns

of consumption) and the effects of

olestra consumption. P&G also agreed to

provide FDA with access to all data and

reports of those studies as such

information became available. At the

time of olestra’s approval, FDA

committed to review all data received

from P&G’s studies, as well as any other

new data that bear on the safe use of this

additive, and present such information

to the committee within 30 months of

the approval.

Committee discussion will focus on

data gathered from passive surveillance

of complaints attributed to olestra

consumption; the active surveillance of

populations consuming savory snacks,

including olestra snacks; any additional

new data that have become available

that bear on the safety of olestra (such

as data and information on the health

significance of carotenoids); and various

other studies submitted by P&G (e.g.,

rechallenge, home consumption, and

acute consumption test). The committee

will consider whether these newly

developed data are consistent with the

original safety decision or whether the

new data contradict FDA’s original

determination that there is a reasonable

certainty of no harm from the use of