Federal Register / Vol. 60, No. 51 / Thursday, March 16, 1995 / Notices 14287

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

notice is given that a food additive

petition (FAP 2A4336) has been filed by

Chemie Research and Manufacturing

Co., Inc., 160 Concord Dr., P.O. Box

181279, Casselberry, FL 32718–1279.

The petition proposes that the food

additive regulations be amended to

provide for the safe use of a glycerin

extract of dried grapefruit seeds and

pulp as an antimicrobial agent in the

processing of fresh or frozen poultry,

fish, or shellfish.

The potential environmental impact

of this action is being reviewed. To

encourage public participation

consistent with regulations promulgated

under the National Environmental

Policy Act (40 CFR 1501.4(b)), the

agency is placing the environmental

assessment submitted with the petition

that is the subject of this notice on

public display at the Dockets

Management Branch (address above) for

public review and comment. Interested

persons may, on or before April 17,

1995, submit to the Dockets

Management Branch (address above)

written comments. Two copies of any

comments are to be submitted, except

that individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. Received

comments may be seen in the office

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

Monday through Friday. FDA will also

place on display any amendments to, or

comments on, the petitioners’s

environmental assessment without

further announcement in the Federal

Register. If, based on its review, the

agency finds that an environmental

impact statement is not required and

this petition results in a regulation, the

notice of availability of the agency’s

finding of no significant impact and the

evidence supporting that finding will be

published with the regulation in the

Federal Register in accordance with 21

CFR 25.40(c).

Dated: March 6, 1995.

Alan M. Rulis,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 95–6428 Filed 3–15–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 94N–0136]

New Monographs and Revisions of

Certain Food Chemicals Codex

Monographs; Opportunity for Public

Comment

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for public comment on

pending changes to certain Food

Chemicals Codex specifications

monographs from the third edition and

its four supplements. New monographs

and additions, revisions, and

corrections to current monographs are

being prepared for certain substances

used as food ingredients, by the

National Academy of Sciences/Institute

of Medicine (NAS/IOM) Committee on

Food Chemicals Codex (the committee).

This material will be published in the

fourth edition of the Food Chemicals

Codex, which is scheduled for release in

March 1996. When the committee

completes its review of the comments,

the agency will announce the

availability of copies of the new and

revised monographs in a future issue of

the Federal Register.

DATES: Written comments by April 17,

1995. The committee advises that

comments received after this date

cannot be considered for the fourth

edition but will be considered for later

supplements.

ADDRESSES: Submit written comments

and supporting data and documentation

to the NAS/IOM Committee on Food

Chemicals Codex, National Academy of

Sciences, 2101 Constitution Ave. NW.,

Washington, DC 20418. Submit written

request for copies of the proposed new

monographs and/or revisions to current

monographs to NAS (address above) or

the Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Fatima N. Johnson, Committee on

Food Chemicals Codex, Food and

Nutrition Board, National Academy

of Sciences, 2101 Constitution Ave.

NW., Washington, DC 20418, 202–

334–2580; or

Paul M. Kuznesof, Center for Food

Safety and Applied Nutrition (HFS–

247), Food and Drug

Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–

3009.

SUPPLEMENTARY INFORMATION: FDA

provides contracts to NAS/IOM to

support the preparation of the Food

Chemicals Codex, which is a

compendium of specifications for

substances used as food ingredients.

Before any specifications are included

in a Food Chemicals Codex publication,

public announcement is made in the

Federal Register.

FDA has previously announced that

the committee was considering new

monographs and monograph revisions

for inclusion in the fourth edition of the

Food Chemicals Codex, which is now

being prepared. In addition, notice and

opportunity for public comment have

been given on policies adopted by the

committee for the fourth edition on lead

and heavy metals specifications (58 FR

38129, July 15, 1993), and on arsenic

specifications (59 FR 11789, March 14,

1994).

The committee will continue to

provide the opportunity for public

comment on intended changes in

monographs by means of Federal

Register notices before their inclusion

in the fourth edition. If notice of

changes is not provided, the

monographs will be carried into the

fourth edition unchanged from the third

edition or subsequent supplements,

except for minor editorial changes.

Therefore, interested parties are invited

to review all monographs in the third

edition of the Food Chemicals Codex

and its four supplements in preparation

for their inclusion in the fourth edition.

Interested parties should submit all

suggestions with supporting

documentation to the National Academy

of Sciences at the above address.

FDA now gives notice that the

committee is soliciting comments and

information on certain proposed new

monographs and revisions to certain

additional current monographs. These

new monographs and revisions will be

published in the fourth edition of the

Food Chemicals Codex. The proposed

new monographs and revisions to

current monographs may be seen in the

Dockets Management Branch (address

above) between 9 a.m. and 4 p.m.,

Monday through Friday. Copies of the

new monographs and proposed

revisions to current monographs may be

obtained from NAS or the Dockets

Management Branch. Requests for

copies should be identified with the

docket number found in brackets in the

heading of this document, and it should

specify the monographs desired.

FDA emphasizes, however, that it will

not consider adopting and incorporating

any of the committee’s new monographs

or monograph revisions into FDA

regulations without ample opportunity

for public comment. If FDA decides to

propose the adoption of new

monographs and changes that have

received final approval of the

committee, such opportunity for public

comment will be announced in a future

issue of the Federal Register.

The committee invites comments and

suggestions on specifications by all

interested parties on the proposed new

monographs and revisions of current

monographs, that follow:
14288 Federal Register / Vol. 60, No. 51 / Thursday, March 16, 1995 / Notices

I. Proposed New Monographs

Calcium acid pyrophosphate

Carbon dioxide

Dammar gum

Dried yeast

Ferrous lactate

Furcelleran

Gelatin

Glycerol ester of gum rosin

Glycerol ester of partially hydrogenated gum

rosin

Magnesium gluconate

Maltitol syrup

Partially hydrolyzed proteins

Sodium potassium tripolyphosphate

Whey

II. Current Monographs to Which the

Committee Proposes to Make Revisions

Acacia gum (description, heavy metals, lead)

N-Acetyl-L-methionine (specific rotation)

Acid hydrolysates of proteins ([formerly Acid

hydrolyzed proteins] description,

requirements, assay, tests)

Agar (lead)

L-Alanine (specific rotation)

Alginic acid (heavy metals, lead)

Ammonium alginate (heavy metals, lead)

Annatto extracts (identification, heavy

metals, residual solvent, packaging and

storage)

L-Arginine (specific rotation, loss on drying)

L-Arginine monohydrochloride (assay,

specific rotation)

Ascorbic acid (functional use in foods,

identification, tests)

L-Asparagine (loss on drying)

Benzoyl peroxide (heavy metals)

Butadiene-styrene 50/50 rubber (description,

heavy metals, lithium, residual hexane)

Butadiene-styrene 75/25 rubber (description,

heavy metals)

Calcium alginate (ash, heavy metals, lead)

Calcium glycerophosphate (heavy metals)

Calcium lactobionate (numerous changes)

Calcium pantothenate (heavy metals, tests)

Calcium silicate (heavy metals, lead)

Calcium peroxide (heavy metals)

Calcium pantothenate, racemic (heavy

metals)

Calcium phosphate, dibasic (formula weight,

functional use in foods, assay, fluoride,

heavy metals, lead)

Calcium phosphate, monobasic (formula

weight, fluoride, heavy metals, lead,

labeling)

Calcium phosphate, tribasic (synonym,

functional use in foods, fluoride, heavy

metals, lead)

Canola oil (linolenic acid)

Carmine (description, assay)

β-Carotene (description, identification, loss

on drying, melting range, solution in

chloroform)

Cholic acid (assay, heavy metals, specific

rotation)

Choline chloride (heavy metals, lead)

Choline bitartrate (heavy metals, lead)

Copper gluconate (identification)

Corn oil (Unhydrogenated) (identification)

L-Cysteine Monohydrochloride (specific

rotation)

L-Cystine (loss on drying)

Desoxycholic acid (assay, heavy metals)

Dexpanthenol (identification)

Dextrose (chloride)

Dimethylpolysiloxane (identification)

Enzyme preparations (numerous changes)

FD & C Blue No. 1 (description,

identification, mercury, subsidiary

colors)

FD & C Blue No. 2 (description,

identification, subsidiary and isomeric

colors)

FD & C Green No. 3 (description,

identification, subsidiary colors)

FD & C Red No. 3 (description, mercury,

uncombined intermediates and products

of side reactions)

FD & C Red No. 40 (mercury)

FD & C Yellow No. 5 (description, ether

extracts, subsidiary colors, uncombined

intermediates and products of side

reactions)

FD & C Yellow No. 6 (description, subsidiary

colors, total color, uncombined

intermediates and products of side

reactions)

Ferric phosphate (lead)

Ferric pyrophosphate (lead)

Ferrous gluconate (identification, assay, lead)

Ferrous fumarate (lead)

Gellan gum (ash, heavy metals)

L-Glutamic acid (residue on ignition, loss on

drying, specific rotation)

L-Glutamic acid hydrochloride (assay)

L-Glutamine (identification, assay, loss on

drying)

Glycerin (identification; assay; acrolein,

glucose, and ammonium compounds)

Glycerol ester of wood rosin (heavy metals,

lead)

Glycerol ester of polymerized rosin (heavy

metals, lead)

Glycerol ester of partially dimerized rosin

(heavy metals, lead)

Glycerol ester of tall oil rosin (heavy metals,

lead)

Glycerol ester of partially hydrogenated

wood rosin (heavy metals, lead)

Glyceryl-lacto esters of fatty acids (name

change)

Glycine (assay, loss on drying)

Grape skin extract (assay, arsenic, sulfur

dioxide, packaging and storage)

Guar gum (acid-insoluble matter,

galactomannans, lead, loss on drying,

protein)

Gum Ghatti (heavy metals, lead)

High-fructose corn syrup (assay, lead, total

solids, labeling)

L-Histidine (specific rotation)

L-Histidine monohydrochloride (assay, loss

on drying)

Hydroxylated lecithin (heavy metals)

Invert sugar (total solids)

L-Isoleucine (specific rotation)

Karaya gum (heavy metals, insoluble matter,

lead, loss on drying)

Kelp (heavy metals)

Lanolin, anhydrous (heavy metals)

Lecithin (heavy metals)

L-Leucine (loss on drying)

Limestone, ground (heavy metals, mercury)

Locust (carob) bean gum (lead)

L-Lysine monohydrochloride (specific

rotation, assay)

Magnesium stearate (assay, heavy metals)

Magnesium silicate (description, heavy

metals)

Manganese gluconate (numerous changes)

Manganese sulfate (heavy metals)

Manganese glycerophosphate (identification,

assay, heavy metals)

Manganese hypophosphite (heavy metals)

Mannitol (identification, assay, heavy metals,

melting range, specific rotation)

Masticatory substances, natural (heavy

metals)

DL-Methionine (assay, loss on drying)

L-Methionine (assay, heavy metals specific

rotation)

Methyl ester of rosin, partially hydrogenated

(heavy metals)

Methyl formate (delete monograph from the

Food Chemicals Codex)

Mineral oil, white (sulfur compounds)

Monoglyceride citrate (description)

Monopotassium L-Glutamate (loss on drying)

Niacinamide (identification, heavy metals)

Paraffin, synthetic (heavy metals)

Pectins (umerous changes)

Pentaerythritol ester of partially

hydrogenated wood rosin (heavy metals)

Pentaerythritol ester of wood rosin (heavy

metals)

Petroleum wax (synonym, description,

identification, functional use in foods,

heavy metals, lead, ultraviolet

absorbance, packaging and storage)

Petroleum wax, synthetic (synonym,

description, heavy metals, lead,

ultraviolet absorbance)

DL-Phenylalanine (loss on drying)

L-Phenylalanine (loss on drying, specific

rotation)

Polyisobutylene (heavy metals)

Polypropylene glycol (residue on ignition)

Potassium alginate (ash, heavy metals, lead,

loss on drying)

Potassium chloride (description, assay)

Potassium gluconate (identification, loss on

drying)

Potassium glycerophosphate (identification)

L-Proline (description, specific rotation)

Propylene glycol (identification, acidity,

heavy metals)

Pyridoxine hydrochloride (assay, heavy

metals)

Riboflavin 5’-phosphate sodium (assay, free

riboflavin, riboflavin diphosphate)

Riboflavin (description, specific rotation)

L-Serine (specific rotation)

Sodium acid pyrophosphate (assay, heavy

metals, lead)

Sodium alginate (ash, heavy metals, lead,

loss on drying)

Sodium aluminosilicate (lead)

Sodium aluminum phosphate, acidic (assay,

heavy metals, lead)

Sodium chloride (heavy metals)

Sodium erythorbate (heavy metals, lead)

Sodium gluconate (identification, assay)

Sodium magnesium aluminosilicate (lead)

Sodium phosphate, tribasic (description)

Sodium polyphosphates, glassy (description)

Sorbitan monostearate (identification, assay)

Sorbitol (identification, chloride, heavy

metals, lead, sulfate)

Sorbitol solution (identification, chloride,

heavy metals, lead, reducing sugars,

sulfate)

Soybean oil (unhydrogenated) (identification)

Spice oleoresins (heavy metals; oleoresin

paprika: additional requirements)

Sucrose (calculation formula for invert sugar)
Federal Register / Vol. 60, No. 51 / Thursday, March 16, 1995 / Notices 14289

Sunflower oil (unhydrogenated)

(identification)

Talc (description, identification, extractable

fluoride)

Tannic acid (definition, heavy metals, loss on

drying)

Terpene resin, natural (heavy metals)

Terpene resin, synthetic (heavy metals)

Thiamine mononitrate (assay)

Thiamine hydrochloride (assay)

L-Threonine (specific rotation)

DL-α-Tocopherol (lead, heavy metals)

d-α-Tocopherol concentrate (description,

heavy metals, lead)

Tocopherols concentrate, mixed (description,

heavy metals, lead)

DL-α-Tocopheryl acetate (lead, heavy metals)

d-α-Tocopheryl acetate (heavy metals, lead)

d-α-Tocopheryl acetate concentrate

(description, heavy metals, lead)

d-α-Tocopheryl acid succinate (heavy metals,

lead)

Tragacanth (heavy metals, lead)

L-Tryptophan (description, specific rotation)

L-Tyrosine (specific rotation)

L-Valine (specific rotation)

Vitamin B12 (identification, assay)

Vitamin D2 (identification)

Vitamin D3 (identification)

Xanthan gum (ash, heavy metals)

Xylitol (lead)

Yeast extract ([formerly Autolyzed yeast

extract] description, requirements, assay,

other tests)

Zinc gluconate (numerous changes)

Interested persons may, on or before

April 17, 1995, submit to NAS (address

above) written comments regarding the

monographs listed in this notice. Those

wishing to make comments are

encouraged to submit supporting data

and documentation with their

comments. Two copies of any comments

are to be submitted. Comments and

supporting data or documentation are to

be identified with the docket number

found in brackets in the heading of this

document and should include a

statement that it is in response to this

Federal Register notice. NAS will

forward a copy of each comment to the

Dockets Management Branch (address

above). Received comments may be seen

in the Dockets Management Branch

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

through Friday.

Dated: March 3, 1995.

L. Robert Lake,

Acting Director, Center for Food Safety and

Applied Nutrition.

[FR Doc. 95–6529 Filed 3–15–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95N–0063]

Dey Laboratories, et al.; Withdrawal of

Approval of 14 Abbreviated New Drug

Applications

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is withdrawing

approval of 14 abbreviated new drug

applications (ANDA’s). The holders of

the ANDA’s notified the agency in

writing that the drug products were no

longer marketed and requested that the

approval of the applications be

withdrawn.

EFFECTIVE DATE: April 17, 1995.

FOR FURTHER INFORMATION CONTACT:

Carolyn C. Harris, Center for Drug

Evaluation and Research (HFD–360),

Food and Drug Administration, 7500

Standish Pl., Rockville, MD 20855, 301–

594–1038.

SUPPLEMENTARY INFORMATION: The

holders of the ANDA’s listed in the table

in this document have informed FDA

that these drug products are no longer

marketed and have requested that FDA

withdraw approval of the applications.

The applicants have also, by their

request, waived their opportunity for a

hearing.

ANDA no. Drug Applicant

70–805 .......... Metaproterenol Sulfate Inhalation Solution, U.S.P., 5% ........................ Dey Laboratories, 2751 Napa Valley Corporate Dr.,

Napa, CA 94558.

80–086 .......... Sulfadiazine Tablets, 167 milligrams (mg) Sulfamerazine Tablets, 167

mg Sulfamethazine Tablets, 167 mg.

Purepac Pharmaceutical, Co., 200 Elmora Ave., Elizabeth, NJ 07207.

80–120 .......... Isoniazid Tablets, 100 mg ...................................................................... Towne, Paulsen & Co., Inc., 14527 South San Pedro

St., Gardena, CA 90248.

80–132 .......... Isoniazid Tablets, U.S.P. ....................................................................... Purepac Pharmaceutical, Co.

80–276 .......... Testosterone Propionate Injection ......................................................... Elkins-Sinn, Inc., 2 Esterbrook Lane, Cherry Hill, NJ

08003–4099.

80–308 .......... Methyltestosterone Buccal Tablets, 10 mg ........................................... Purepac Pharmaceutical, Co.

80–309 .......... Methyltestosterone Tablets, 10 mg ....................................................... Do.

80–310 .......... Methyltestosterone Tablets, 25 mg ....................................................... Do.

80–459 .......... Hyrocortisone Emulsion Cream, 1% ...................................................... Elder Pharmaceuticals, Inc., ICN Plaza, 3300 Highland

Ave., Costa Mesa, CA 92626.

80–475 .......... Methyltestosterone Tablets .................................................................... Purepac Pharmaceuticals, Inc.

80–489 .......... Hydrocortisone Ointment, 0.5% ............................................................. Altana Inc., 60 Baylis Rd., Melville, NY 11747.

80–581 .......... Pyridoxine Hydrochloride Injection U.S.P., 100 mg/milliliter (mL) ......... Elkins-Sinn, Inc.

80–797 .......... Chlorpheniramine Maleate Injection, 10 mg/mL and 100 mg/mL ......... Do.

80–928 .......... Propantheline Bromide Tablets, 15 mg ................................................. Geneva Pharmaceuticals, Inc., 2555 West Midway

Blvd., Broomfield, CO 80038–0446.

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 ANDA’s listed

above, and all amendments and

supplements thereto, is hereby

withdrawn, effective April 17, 1995.

Dated: March 2, 1995.

Murray M. Lumpkin,

Deputy Director, Center for Drug Evaluation

and Research.

[FR Doc. 95–6426 Filed 3-15–95; 8:45 am]

BILLING CODE 4160–01–F

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: This notice announces a

forthcoming meeting of a public

advisory committee of the Food and

Drug Administration (FDA). This notice

also summarizes the procedures for the

meeting and methods by which