Federal Register / Vol. 61, No. 129 / Wednesday, July 3, 1996 / Notices 34849

NADA no. Drug name Sponsor name and address

121–291 ................................... Enflurane liquid (anesthetic) .............................................. Ohmeda, Inc., Pharmaceutical Products Division,

P.O. Box 804, Liberty Corner, NJ 07938–0804.

121–813 ................................... Styrylpyridinium, diethylcarbamazine film-coated tablets Bayer Corp.

133–509 ................................... Pyrantel tartrate Type A medicated articles ...................... Hubbard Milling Co.

Therefore, under authority delegated

to the Commissioner of Food and Drugs

(21 CFR 5.10) and redelegated to the

Center for Veterinary Medicine (21 CFR

5.84), and in accordance with § 514.115

Withdrawal of approval of applications

(21 CFR 514.115), notice is given that

approval of NADA’s 6–462, 10–540, 11–

380, 12–054, 12–103, 12–392, 12–598,

15–161, 15–965, 30–045, 34–394, 35–

263, 45–287, 48–645, 49–555, 91–628,

93–372, 94–402, 95–078, 96–031, 100–

201, 100–356, 100–670, 101–078, 120–

327, 120–670, 121–291, 121–813, and

133–509, and all supplements and

amendments thereto is hereby

withdrawn, effective July 15, 1996.

In a final rule published elsewhere in

this issue of the Federal Register, FDA

is removing 21 CFR 520.500, 520.620a,

520.620b, 520.1520, 520.2022,

520.2160a, 520.2160b, 520.2160c,

520.2160d, 520.2480, 520.2520c,

520.2520d, 522.281, 522.740, 522.2022,

522.2480, 529.810, 558.367, and

558.565, and amending 21 CFR 520.580,

520.622a, 520.622b, 520.2520a, 558.185,

558.485, 558.625, and 558.630 to reflect

the withdrawal of approval of the above

mentioned NADA’s.

Dated: June 3,1996.

Michael J. Blackwell,

Acting Director, Center for Veterinary

Medicine.

[FR Doc. 96–16887 Filed 7–2–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96D–0159]

Compounding of Drugs for Use in

Animals; Compliance Policy Guide;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a Compliance Policy

Guide (CPG) section 608.400 entitled

‘‘Compounding of Drugs for Use in

Animals.’’ The purpose of this CPG is to

provide guidance to FDA’s field and

headquarters staff with regard to the

compounding of animal drugs by

veterinarians and pharmacists for use in

animals. The CPG contains information

that may be useful to industry and the

public. The text of the CPG is included

in this notice. This CPG does not bind

FDA, nor does it create or confer any

rights, privileges, benefits, or

immunities on or for any person.

DATES: Written comments may be

submitted at any time.

ADDRESSES: Submit written requests for

single copies of CPG section 608.400

entitled ‘‘Compounding of Drugs for Use

in Animals’’ to the Industry Information

Staff (HFV–12), Center for Veterinary

Medicine, Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855. Send two selfaddressed adhesive labels to assist that

office in processing your requests.

Submit written comments on CPG

section 608.400 entitled ‘‘Compounding

of Drugs for Use in Animals’’ to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. Two copies of any

comments are to be submitted, except

that individuals may submit one copy.

Requests and comments should be

identified with the docket number

found in brackets in the heading of this

document. A copy of CPG section

608.400 and received comments are

available for public examination in the

Dockets Management Branch between 9

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

Friday.

FOR FURTHER INFORMATION CONTACT:

Richard E. Geyer, Center for Veterinary

Medicine (HFV–200), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855, 301–594–1764.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of CPG

section 608.400 entitled ‘‘Compounding

of Drugs for Use in Animals.’’ The

purpose of this CPG is to provide clear

policy and regulatory guidelines to

FDA’s field and headquarters staff with

regard to the compounding of animal

drugs by veterinarians and pharmacists

for use in animals. It also contains

information that may be useful to

industry and to the public.

The Federal Food, Drug, and Cosmetic

Act (the act) does not distinguish

compounding from manufacturing or

other processing of drugs for use in

animals. However, veterinarians and

pharmacists do manipulate drugs (e.g.,

combine or dilute finished dosage

forms, prepare finished dosage forms

from bulk drug substances, or prepare

injectables from powdered oral dosage

forms) to obtain products that differ

from the starting materials.

FDA acknowledges the use of

compounding within certain areas of

veterinary practice. The current state of

veterinary medicine requires products

to treat many conditions in a number of

different species, some of which are

known to have unique physiological

characteristics. While the agency

acknowledges the need for

compounding under certain

circumstances, it is also aware of recent

adverse reactions and animal deaths

caused by compounded drug products

and is concerned about the risks

associated with compounding practices

in veterinary medicine. In addition, the

agency is greatly concerned about

pharmacies that produce large

quantities of unapproved new animal

drugs that are essentially copies of FDAapproved products. These pharmacy

products are actively advertised and

promoted, and sometimes are priced

lower than the approved product. The

firms claim that they are practicing

within the scope of their State licenses.

However, it is apparent that some of

these firms use their pharmacy licenses

to circumvent the entire drug approval

process, and are mass marketing

products that have been produced under

little or no quality control,

manufacturing standards to ensure

purity, potency, and stability.

When the Animal Medicinal Drug Use

Clarification Act of 1994 (AMDUCA) is

implemented and becomes effective, it

will allow compounding from approved

drugs because it will permit the

extralabel use of approved animal and

human drugs. Extralabel use, including

compounding, under AMDUCA will be

subject to conditions specified by the

implementing regulations. The scope of

compounding made legal upon the

effective date of AMDUCA will be

addressed by those regulations.

CPG section 608.400 represents FDA’s

current position and interpretation of

the act. The CPG is intended to provide

clear guidance to FDA field and

headquarters staff and also could
34850 Federal Register / Vol. 61, No. 129 / Wednesday, July 3, 1996 / Notices

1This Update to the Compliance Policy Guides

Manual (March 1995 edition) is a new CPG. This

update will be included in the next printing of the

Compliance Policy Guides Manual. The statements

made in the CPG are not intended to create or

confer any rights, privileges, or benefits on or any

private person, but are intended for internal

guidance.

provide information to the animal

health industry. However, this

document, which is intended merely for

internal FDA guidance, does not bind

FDA, nor does it create or confer any

rights, privileges, benefits, or

immunities on or for any persons. FDA

may reconsider its position at a later

date in light of comments received or

other data or information which comes

to the attention of the agency.

COMPLIANCE POLICY GUIDE 1

CHAPTER - 6

SUB CHAPTER - 600

Sec. 608.400 Compounding of Drugs for

Use in Animals

Background:

The Federal Food, Drug, and Cosmetic Act

(the Act) does not distinguish compounding

from manufacturing or other processing of

drugs for use in animals. However,

veterinarians and pharmacists do manipulate

drugs (e.g., combine or dilute finished dosage

forms, prepare finished dosage forms from

bulk drug substances, or prepare injectables

from powdered oral dosage forms) to obtain

products that differ from the starting

materials.

There is a potential for causing harm to

public health and to animals when drug

products are compounded, distributed, and

used in the absence of adequate and wellcontrolled safety and efficacy data, adherence

to the principles of contemporary

pharmaceutical chemistry and current good

manufacturing practices.

The Agency acknowledges the use of

compounding within certain areas of

veterinary practice. The practice of veterinary

medicine requires products to treat many

conditions in a number of different species,

some of which have unique physiological

characteristics. FDA, other federal, state

agencies, and producer groups encourage

drug sponsors to obtain approvals for all new

animal drugs.

While the Agency acknowledges the use of

compounding under certain circumstances, it

is also aware of adverse reactions and animal

deaths caused by compounded drug products

and is concerned about the risks associated

with compounding practices in veterinary

medicine. An example is the recent death of

cattle due to the presence of endotoxin in a

parenteral product prepared from

spectinomycin approved for oral use. In

addition, the Agency is greatly concerned

about pharmacies that produce large

quantities of unapproved new animal drugs

that are essentially copies of FDA-approved

products. These pharmacy products are

actively advertised and promoted, and

sometimes are priced lower than the

approved product. The firms claim that they

are practicing within the scope of their state

licenses. However, it is apparent that some of

these firms use their pharmacy licenses to

circumvent the entire drug approval process,

and are mass marketing products which have

been produced with little or no quality

control, manufacturing standards to ensure

purity, potency and stability.

The pharmacokinetics and depletion times

for residues from compounded products are

not known and the assigning of

extemporaneous withdrawal times may result

in potentially harmful residues in food.

Excipients and vehicles from unapproved or

unknown origins may pose additional risks.

Section 510(g)(1) of the Act exempts from

the registration requirements licensed

pharmacies which do not compound drugs

except exclusively within the regular course

of their business of dispensing or selling

drugs at retail. Section 510(g)(2) exempts

from the registration requirements licensed

practitioners who manufacture, prepare,

propagate, compound, or process drugs

during the regular course of business of

dispensing drugs at retail. The Act and

regulations do not, however, exempt such

practitioners or pharmacists from the

approval requirements in the new animal

drug provisions of Sections 501(a)(5) and

512. Therefore, compounding allowed under

the Act is limited to the preparation of drug

products which do not meet the definition of

new animal drugs. In the absence of an

approved new animal drug application

(NADA), the compounding of a new animal

drug from any article, including an approved

or unapproved finished human or animal

drug, or a bulk drug, results in an adulterated

new animal drug in violation of section

501(a)(5).

Compounding from Approved Dosage

Form Drugs: When the Animal Medicinal

Drug Use Clarification Act of 1994

(AMDUCA) goes into effect, it will allow the

‘‘extra-label’’ use of approved animal and

human drugs. It will also allow compounding

from those approved drugs. Under AMDUCA

‘‘extra-label’’ use, including compounding,

will be subject to conditions specified by

regulation. AMDUCA will become effective

upon promulgation of the regulations. The

scope of compounding made legal upon the

effective date of AMDUCA will also be

addressed by the regulations. The proposed

regulations were published in the Federal

Register on May 17, 1996. They have no

effect until finalized.

Compounding from Bulk Drugs: Two

Federal Appeals Court decisions, United

States v. Algon Chemical Inc., 879 F.2d 1154

(3d Cir. 1989), United States v. 9/1 Kg.

Containers, 854 F.2d 173 (7th Cir. 1988),

affirmed the FDA position that the Act does

not permit veterinarians to compound

unapproved finished drug products from

bulk drugs, unless the finished drug is not a

new animal drug. The principle established

by the court applies equally to compounding

by pharmacists. However, one of the courts

acknowledged the Agency’s policy that, if the

need is great and the risk small, the Agency

may exercise regulatory discretion with

respect to veterinarians compounding from

approved drugs under Compliance Policy

Guide (CPG) 615.100, Extra-label Use of New

Animal Drugs in Food-Producing Animals.

Definitions:

The Act and accompanying regulations do

not define compounding as different from

other processing of drug compounds.

Bulk drug is an active ingredient (in

unfinished form) intended for manufacture

into finished dosage form drug products

(from United States v. Algon Chemical Inc.,

879 F.2d 1154 (3d Cir. 1989)). See also 21

CFR 207.3(a)(4). Bulk drugs (or ‘‘bulk drug

substances’’) may be supplied in various size

containers and may or may not meet USP

standards.

Compounding is defined, for the purposes

of this CPG, as any manipulation to produce

a dosage form drug other than that

manipulation that is provided for in the

directions for use on the labeling of the

approved drug product, for example, the

reconstitution of a sterile powder with sterile

water for injection.

Compounding ordinarily not subject to

regulatory action, is defined as compounding

by a licensed pharmacist or veterinary

practitioner, when the criteria described in

this document are met, within the confines

of a legitimate practice. However, this

document shall not be construed to bind the

FDA or otherwise constrain its enforcement

discretion. In addition, this document

imposes no new obligations.

Compounding subject to regulatory action,

is defined as compounding by a licensed

pharmacist or other practitioner, when the

criteria described in this document are not

met, even if it is otherwise within the

confines of a legitimate practice.

Compounding outside the confines of a

legitimate pharmacy or veterinary practice,

whether by a pharmacist, veterinarian or

other party, is subject to regulatory action.

‘‘Legitimate practice’’ is defined as follows:

(a) Pharmacist: A person licensed and

operating in conformity with state law, and

dispensing in response to a valid

prescription.

(b) Veterinarian: A person licensed and

operating in conformity with state law, and

prescribing or dispensing in response to a

valid Veterinarian-Client-Patient

Relationship (VCPR.)

Valid Veterinarian-Client-Patient

Relationship (VCPR)

A valid VCPR exists when: (1) the

veterinarian assumes the responsibility for

making medical judgments regarding the

health of the animal(s) and the need for

medical treatment, and the client (owner or

other caretaker) agrees to follow the

instructions of the veterinarian; and (2) the

veterinarian has sufficient knowledge of the

circumstances to initiate at least a general or

preliminary diagnosis of the medical

condition of the animal(s), i.e., the

veterinarian has recently seen and is

personally acquainted with the keeping and

care of the animal(s) by virtue of an

examination of the animal(s), and/or by

medically appropriate and timely visits to the

premises where the animal(s) are kept; and

(3) the practicing veterinarian is readily

available for follow-up in case of adverse

reactions or failure of the regimen of therapy.

Source: American Veterinary Medical

Association.
Federal Register / Vol. 61, No. 129 / Wednesday, July 3, 1996 / Notices 34851

Policy:

Circumstances exist when it may be

necessary for a veterinarian to compound, or

direct for a pharmacist to compound, an

article that will result in an unapproved new

animal drug. There is occasionally a need to

utilize drugs labeled for human use, and

much less commonly, bulk drug substances,

for compounding into an appropriate dosage

form. Some examples of these situations

include: combinations of anesthetic drugs for

titrated administration; preparation of dilute

dosage forms for small, young, or exotic

species patients; and usage of some antidote

preparations. The Agency will exercise

regulatory discretion and ordinarily would

not take regulatory action against violations

of the Act resulting from compounding an

unapproved new animal drug if a

determination is made that, in order to

provide appropriate medical therapy, it is

necessary to compound a new animal drug

when the following conditions are met:

(1) A legitimate medical need is identified

(the health of animals is threatened and

suffering or death would result from failure

to treat the affected animals),

(2) There is a need for an appropriate

dosage regimen for the species, age, size, or

medical condition of the patient, and

(3) There is no marketed approved animal

drug which, when used as labeled or in an

‘‘extra-label’’ manner in conformity with

criteria listed in CPG 615.100, or humanlabel drug, when used in conformity with

criteria listed in CPG 608.100, may treat the

condition diagnosed in the available dosage

form, or there is some other rare extenuating

circumstance. (For example, the approved

drug cannot be obtained in time to treat the

animal(s) in a timely manner, or there is a

medical need for different excipients.)

After making the above determinations, the

following criteria should be met and

precautions observed:

(1) Dispensing by a licensed veterinarian;

or the receipt of a valid prescription of a

licensed veterinarian by a pharmacist.

Dispensing should be within the confines of

a valid veterinarian-client-patient

relationship. Veterinarians should exercise

professional judgment to determine when

compounding requires the services of a

pharmacist. Professional assistance is

appropriate when the complexity of

compounding exceeds the veterinarian’s

knowledge, skill, facilities, or available

equipment.

(2) The veterinarian takes measures to

ensure that:

(a) When used in food-producing animals:

no illegal residues occur; a significantly

extended time period is assigned for drug

withdrawal; and steps are taken to assure that

the assigned time frames are observed;

(b) The safety and efficacy of the

compounded new animal drug is consistent

with current standards of pharmaceutical and

pharmacological practices, e.g., known

incompatibilities are avoided;

(c) Appropriate steps are taken to minimize

risk of personnel exposure to potentially

harmful ingredients in the preparation

process; and

(d) Procedures are instituted to assure that

appropriate patient records for the treated

animals are maintained.

(3) All drugs dispensed to the animal

owner by the veterinarian or a pharmacist,

bear labeling information which is adequate

to assure proper use of the product. The

following label information should be

included:

(a) Name and address of the veterinary

practitioner;

(b) the active ingredient or ingredients;

(c) the date dispensed and the expiration

date, which should not exceed the length of

the prescribed treatment except in cases

where the veterinarian can establish a

rationale for a later expiration date;

(d) directions for use specified by the

practitioner, including the class/species or

identification of the animals; and the dosage,

frequency, route of administration, and

duration of therapy;

(e) cautionary statements specified by the

veterinarian and/or pharmacist (this would

include all appropriate warnings necessary to

ensure safety of human operators handling

the finished drug, especially if there are

potential hazards of exposure to any

components);

(f) the veterinarian’s specified withdrawal/

discard time(s) for meat, milk, eggs, or any

food which might be derived from the treated

animal(s) (while the veterinarian must set the

withdrawal time, the veterinarian in doing so

may use relevant information provided by a

dispensing pharmacist although the

veterinarian retains ultimate responsibility);

(g) if dispensed by a licensed pharmacist,

the name and address of the dispenser, serial

number and date of order or its filing;

(h) if dispensed by a veterinarian, the serial

number; and

(i) any other applicable requirements of

state or federal law.

(4) The pharmacist adheres to the National

Association of Boards of Pharmacy Good

Compounding Practices (GCP), or to

equivalent state good compounding practice

regulations, except where provisions conflict

with this CPG. Among other practices,

pharmacists should keep records of

compounding formulas, logs of compounded

items and specific ingredients, record of

assurance of quality of raw materials; and

information on adverse effects and product

failures. Pharmacists should label

compounded products with expiration dates

that do not exceed the prescribed period of

treatment, and with withdrawal times

furnished by the prescribing veterinarian.

Veterinarians and pharmacists who

compound or prescribe compounded

medicaments and pharmacists who

compound medicaments according to these

guidelines criteria set out above would be

considered to be engaged in extemporaneous

compounding not ordinarily subject to

regulatory action.

Regulatory Action Guidance:

Investigations will be conducted in

coordination with state officials as specified

in the October 26, 1995 letter from Associate

Commissioner for Regulatory Affairs (FDA)

and Executive Director, National Boards of

Pharmacy, to state pharmacy and drug

regulatory officials, and FDA officials.

FDA actions based on violative conditions

will be consistent with state laws and

regulations to the extent possible. Deviations

from GCP may be deferred to state authorities

for action.

In general, the agency will place its highest

regulatory priority on compounding products

for use in food animals.

A. The following situations would likely

indicate compounding subject to regulatory

action and the existence of one or more

would ordinarily be of high regulatory

priority.

-Preparation for sale of large quantities of

unapproved new animal drugs on an ongoing

basis and where no valid medical need or

VCPR exists. Compounding very limited

quantities in anticipation of future need is

acceptable provided that a history of past

need can be documented;

-Compounding of medicaments that are

essentially similar to FDA-approved products

except in rare instances where a legitimate

need can be established, for example, to treat

animals on a timely basis or to avoid

problems caused by certain excipients.

-Substitution or recommendation by a

pharmacist of a compounded medicament for

a prescription instead of using an FDAapproved product;

-Compounding from bulk drugs for use in

food animals, with the rare exception of

those medicaments that are permitted to be

compounded by the Center for Veterinary

Medicine (CVM) through compassionate

regulatory discretion or other means (such as

certain antidotes, large volume electrolyte

products and other substances). Because

these items may be revised, an official

contact office at CVM has been designated to

provide current information. That contact

office is HFV–236, Case Guidance Branch,

Division of Compliance, (301) 594–1785.

-Preparation for sale of unapproved new

animal drugs on any scale which employ

fanciful or trade names, colorings or other

additives, or in any way imply that the

products have some unique effectiveness or

composition;

-Advertising, promotion, display, sale, or

other means of marketing, prepared

unapproved new animal drugs; and soliciting

business to compound specific drug

products, product classes or therapeutic

classes of drug products;

-Offering compounded medicaments at

wholesale to other state licensed

veterinarians or pharmacists or other

commercial entities for resale;

-Offering financial incentives such as

rebates and consulting fees; and

-Dispensing of large quantities of

compounded medicaments, where questions

of stability of the finished product would

arise;

-Failing to follow good compounding

practices, including current standards of

pharmaceutical and pharmacological

practices, as described above;

-Labeling a product with an expiration date

that exceeds the prescribed treatment period;

-Labeling a product with a withdrawal time

established by the pharmacist instead of the

veterinarian;

-Dispensing a disproportionate amount of

compounded products out of state. The

primary concern is the difficulty of

maintaining proper relationships, for
34852 Federal Register / Vol. 61, No. 129 / Wednesday, July 3, 1996 / Notices

example, pharmacist/veterinarian/client and

VCPR. Rare instances of specialized

compounding to meet emergency needs

would not be considered disproportionate.

B. The following situations would indicate

excessive risk to public health or to animals,

or an otherwise adverse risk/benefit ratio, of

high regulatory priority:

-Instances where illegal residues occur in

meat, milk, eggs, honey, or aquaculture

products and the residues were caused by the

use of a compounded drug in association

with the violation being investigated;

-Compounding of medicaments for foodproducing animals, especially those used in

lactating dairy animals, which cause a

significant risk of illegal residues because, for

example, withholding times have not been

established by the veterinarian using

adequate scientific information; and

-Preparation of drug products that are

essentially similar to products that have been

removed from the market due to regulatory

concerns, for example, chloramphenicol,

dimetridazole, DES in food animals.

C. The following activities would indicate

compounding subject to regulatory action,

and possibly of high regulatory priority.

However, guidance from CVM should be

solicited to assess the potential public health

threat and/or animal safety (i. e., risk vs

benefits).

-Instances where animals have been

harmed or their safety unnecessarily

compromised, such as compounding a

nonsterile product for parenteral or

ophthalmic administration where a sterile

product is indicated, or other instances of not

adhering to good compounding practices.

-Compounded substances that do not bear

the required label information, including the

name of the authorizing veterinarian, the

active ingredients, directions for use,

cautionary statements, and withdrawal times.

D. The following compounding situations

would not ordinarily be considered for

regulatory action. Appropriate state and local

practice and pharmacy laws must be adhered

to, however.

-Compounding for non-food animals and

minor food animal uses where public health

and animal safety have not been threatened,

and are of great need and small risk. This

would include such common practices as:

veterinarians’ combining agents for

anesthesia, large volume parenterals,

preparing appropriate dosage-forms for the

size of the patient in question, ‘‘animal-side’’

compounding, and other similar common

practices that are widely accepted in the day

to day treatment of animal patients.

-Compounding from bulk drug substances

for use in nonfood animals, including

animals in public and private aquaria, when

animal health is not threatened, and there is

not a significant risk of diversion of the bulk

drugs or compounded drugs for use in food

animals. Bulk drug substances would

ordinarily be expected to be in small

packages that meet or exceed USP standards;

see definition of ‘‘bulk drugs’’ above.

Compounding should be performed in

accordance with current standards of

pharmaceutical practice (including referral to

compendial monographs or established

pharmacy textbooks).

If circumstances exist on a case-by-case

basis that indicate otherwise, the Field

should request guidance from CVM before

considering regulatory action. The preceding

is not intended to be a complete list of

activities relating to compounding; there may

be other factors which are appropriate when

assessing an individual case.

Guidance for Charging Violations:

A warning letter is ordinarily the first

choice of action, when referral to state

authorities is not appropriate. Injunction

would be the usual choice of court action,

although seizure should be considered in the

case of high priority drugs such as

chloramphenicol or DES intended for use in

food animals. Criminal action can be

considered in egregious situations.

Compounded drugs subject to regulatory

action under this policy will ordinarily be

charged as unapproved new animal drugs,

violative under Section 501(a)(5). Deviations

from GCP, if not subject of state action will

ordinarily be charged under Section

501(a)(2)(b). The tissue residue violations are

covered under Section 402(a)(2)(D).

Dated: June 26, 1996.

Gary Dykstra,

Acting Associate Commissioner for

Regulatory Affairs.

[FR Doc. 96–16973 Filed 7–2–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96F–0184]

Life Technologies, Inc.; Filing of Food

Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Life Technologies, Inc., has filed a

petition proposing that the food additive

regulations be amended to provide for a

change in the level of reactants for

sulphopropyl cellulose ion-exchange

resin for the recovery and purification of

proteins for food use.

DATES: Written comments on the

petitioner’s environmental assessment

by August 2, 1996.

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:

Andrew D. Laumbach, Center for Food

Safety and Applied Nutrition (HFS–

217), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3071.

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 6A4500) has been filed by

Life Technologies, Inc., 8400 Helgerman

Ct., Gaithersburg, MD 20874. The

petition proposes to amend the food

additive regulations in § 173.25 Ionexchange resins (21 CFR 173.25) to

provide for a change in the level of the

reactants for sulphopropyl cellulose ionexchange resin for the recovery and

purification of proteins for food use.

The amendment proposes that the

amount of epichlorohydrin plus

propylene oxide employed does not

exceed 250 percent by weight of the

starting quantity of cellulose. The

current regulation provides that the

amount of epichlorohydrin plus

propylene oxide employed does not

exceed 61 percent by weight of the

starting quantity of cellulose.

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

display at the Dockets Management

Branch (address above) for public

review and comment. Interested persons

may, on or before August 2, 1996,

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 public display any

amendments to, or comments on, the

petitioner’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: May 31, 1996.

Alan M. Rulis,

Director, Office of Premarket Approval,

Center for Food Safety and Applied Nutrition.

[FR Doc. 96–16975 Filed 7–2–96; 8:45 am]

BILLING CODE 4160–01–F