63720 Federal Register / Vol. 60, No. 238 / Tuesday, December 12, 1995 / Notices

that compared to conventional, ethylene

glycol-based antifreeze (‘‘EG

antifreeze’’), Sierra and other PG

antifreezes are safer for the environment

generally. According to the complaint,

although respondents had a reasonable

basis that Sierra and other PG

antifreezes, compared to EG antifreeze,

are less toxic, and therefore safer for that

part of the environment that is

composed of humans, pets, and wildlife

that may accidentally ingest it,

respondents did not substantiate their

claim that Sierra and other PG

antifreezes are safer for the environment

generally (e.g., the air, water, soil,

plants, or aquatic life). The complaint

also alleges that respondents

represented without adequate

substantiation that Sierra and other PG

antifreezes are absolutely safe for the

environment after ordinary use and that

because Sierra and other PG antifreezes

are biodegradable, they are absolutely

safe for the environment after ordinary

use. The complaint states that one

reason these claims are unsubstantiated

is that used antifreeze, whether EG or

PG-based, may contain lead and/or

other substances that are hazardous to

the environment.

Furthermore, the complaint charges

that the respondents represented

without adequate substantiation that

Sierra and other PG antifreezes are

absolutely safe for people and pets. The

complaint also charges that respondents

claimed without adequate

substantiation that because Sierra and

other PG antifreezes contain PG—an

ingredient designated by the Food and

Drug Administration as ‘‘generally

recognized as safe’’ and which is found

in foods, drugs, cosmetics, and pet

foods—they are absolutely safe for

people and pets. According to the

complaint, although respondents had a

reasonable basis that Sierra and other

PG antifreezes are safer than EG

antifreeze, respondents lacked

substantiation for the claim that they are

absolutely safe.

In addition, the complaint alleges that

the respondents made the

unsubstantiated representation that

compared to conventional, EG

antifreeze, Sierra provides superior

automotive protection from freezing

temperatures, boil-overs, and corrosion.

Finally, the complaint charges that

the respondents falsely and without

adequate substantiation represented that

Sierra antifreeze and its plastic

container are recyclable. In fact, the

complaint alleges, while both Sierra and

its container are capable of being

recycled, the vast majority of consumers

cannot recycle either of them because

there are few collection facilities

nationwide that accept PG antifreeze or

high-density polyethylene plastic

antifreeze containers for recycling.

The proposed consent order contains

provisions designed to remedy the

violations charged and to prevent the

respondents from engaging in similar

acts and practices in the future.

Part I of the proposed order requires

the respondents to cease and desist from

representing that any antifreeze,

coolant, or deicer product will not harm

the environment, is less harmful to the

environment than other products, or

offers any environmental benefit, unless

the respondents possess competent and

reliable evidence, which when

appropriate must be competent and

reliable scientific evidence, that

substantiates the representation.

Part II of the proposed order requires

the respondents to cease and desist from

making any representation about the

safety or relative safety for humans or

animals of any antifreeze, coolant, or

deicer product, unless they possess

competent and reliable scientific

evidence that substantiates the

representation.

Part III of the proposed order requires

that the respondents print the following

two statements on the back of containers

of all PG antifreeze or coolant products:

‘‘CAUTIONARY INFORMATION: This

Product MAY BE HARMFUL IF

SWALLOWED. STORE SAFELY AWAY

FROM CHILDREN AND PETS. Do not

store in open or unlabeled containers’’

and ‘‘Clean up any leaks or spills.’’ On

the front of all such containers the

following must be disclosed: ‘‘See Back

Panel for CAUTIONARY

INFORMATION.’’ Part III also specifies

the manner in which these disclosures

must be made.

Part IV of the proposed order requires

the respondents to cease and desist from

making any representation about the

level of vehicular engine protection

provided by any antifreeze, coolant, or

deicer product, unless the respondents

possess competent and reliable

scientific evidence that substantiates the

representation.

Part V of the proposed order requires

that the respondents cease and desist

from misrepresenting the extent to

which any antifreeze, coolant, or deicer

product or its package is capable of

being recycled or the extent to which

recycling collection programs are

available.

Part VI of the proposed order provides

that, for up to 100 days after the service

of the order, respondents may continue

to ship products from existing stock in

containers with nonconforming

labeling.

The proposed order also requires the

respondents to maintain materials relied

upon to substantiate the claims covered

by the order, to distribute copies of the

order to certain company officials, to

notify the Commission of any changes

in corporate structure that might affect

compliance with the order, and to file

one or more reports detailing

compliance with the order. The order

also contains a provision stating that it

will terminate after twenty (20) years

absent the filing of a complaint against

respondents alleging a violation of the

order.

The purpose of this analysis is to

facilitate public comment on the

proposed order. It is not intended to

constitute an official interpretation of

the agreement and proposed order or to

modify in any way their terms.

[FR Doc. 95–30216 Filed 12–11–95 8:45 am]

BILLING CODE 6750–01–M

GENERAL ACCOUNTING OFFICE

Federal Accounting Standards

Advisory Board

AGENCY: General Accounting Office.

ACTION: Cancellation of December 14

meeting.

SUMMARY: Pursuant to section 10(a)(2) of

the Federal Advisory Committee Act

(Pub. L. No. 92–463), as amended,

notice is hereby given that the

previously announced December 14

meeting of the Federal Accounting

Standards Advisory Board has been

canceled. Agenda issues planned for the

December meeting will be discussed at

the January 25 meeting, which will be

duly announced in a later edition of the

Federal Register.

FOR FURTHER INFORMATION CONTACT:

Ronald S. Young, Executive Staff

Director, 750 First St., N.E., Room 1001,

Washington, D.C. 20002, or call (202)

512–7350.

Authority: Federal Advisory Committee

Act. Pub. L. No. 92–463, Section 10(a)(2), 86

Stat. 770, 774 (1972) (current version at 5

U.S.C. app. section 10(a)(2) (1988); 41 CFR

101–6.1015 (1990).

Dated: December 7, 1995.

Ronald S. Young,

Executive Director.

[FR Doc. 95–30245 Filed 12–11–95; 8:45 am]

BILLING CODE 1610–01–M
Federal Register / Vol. 60, No. 238 / Tuesday, December 12, 1995 / Notices 63721

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 95N–0346]

Akorn, Inc., et al.; Withdrawal of

Approval of NADA’s

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is withdrawing

approval of five new animal drug

applications (NADA’s). Three NADA’s

are held by Akorn, Inc., and one each

is held by Parke-Davis, Division of

Warner-Lambert Co., and Veterinary

Research and Development, Inc. The

firms notified the agency in writing that

the animal drug products were no

longer marketed and requested that

approval of the applications be

withdrawn. In a final rule published

elsewhere in this issue of the Federal

Register, FDA is amending the

regulations by removing the entries

which reflect approval of the NADA’s.

EFFECTIVE DATE: December 22, 1995.

FOR FURTHER INFORMATION CONTACT:

Mohammad I. Sharar, Center for

Veterinary Medicine (HFV–216), Food

and Drug Administration, 7500 Standish

Pl., Rockville, MD 20855, 301–827–

0159.

SUPPLEMENTARY INFORMATION: The

sponsors of the applications listed in the

table in this document have informed

FDA that these animal drug products are

no longer marketed and have requested

that FDA withdraw approval of the

applications.

NADA No. Drug name Sponsor name and address

6–032 ....................................... Diphenylhydantoin sodium capsules ............................. Parke-Davis, Division of Warner-Lambert Co., 201

Tabor Rd., Morris Plains, NJ 07950

12–444 ..................................... Sterile prednisolone suspension ................................... Akorn, Inc., 100 Akorn Dr., Abita Springs, LA 70420

94–978 ..................................... Phenylbutazone injection .............................................. Do.

110–046 ................................... Dexamethasone injection .............................................. Do.

140–904 ................................... Copper disodium edetate injection ................................ Veterinary Research and Development, Inc., P.O. Box

1299, Truckee, CA 95734

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 6–032, 12–444, 94–

978, 110–046, and 140–904 and all

supplements and amendments thereto is

hereby withdrawn, effective December

22, 1995.

In a final rule published elsewhere in

this issue of the Federal Register, FDA

is removing 21 CFR 520.704, 522.514,

and 522.1880, and amending 21 CFR

510.600(c), 522.540, and 522.1720 to

reflect the withdrawal of approval of the

above mentioned NADA’s.

Dated: December 4, 1995.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 95–30122 Filed 12–11–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95D–0370]

Revised Compliance Policy Guides

(CPG’s); Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

revision of two CPG’s. The CPG’s are

being revised because they contain

outdated information and misprinted

regulatory guidance. This action is being

taken to ensure that FDA’s CPG’s

accurately reflect FDA policy and to

limit confusion.

DATES: Effective December 12, 1995.

Written comments may be submitted at

any time.

ADDRESSES: Submit written requests for

single copies of CPG Sec. 545.400

‘‘Pottery (Ceramics); Imported and

Domestic—Cadmium Contamination’’

(CPG 7117.06), and CPG Sec. 545.450

‘‘Pottery (Ceramics); Imported and

Domestic—Lead Contamination’’ (CPG

7117.07) to the Director, Division of

Compliance Policy (HFC–230), Office of

Enforcement, Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857. Send two selfaddressed adhesive labels to assist that

office in processing your requests.

Submit written comments on CPG Sec.

545.400 ‘‘Pottery (Ceramics); Imported

and Domestic—Cadmium

Contamination’’ (CPG 7117.06) and CPG

Sec. 545.450 ‘‘Pottery (Ceramics);

Imported and Domestic—Lead

Contamination’’ (CPG 7117.07) to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr., Rockville

MD, 20857. Requests and comments

should be identified with the docket

number found in brackets in the

heading of this document. A copy of

CPG Sec. 545.400 ‘‘Pottery (Ceramics);

Imported and Domestic—Cadmium

Contamination’’ (CPG 7117.06) and CPG

Sec. 545.450 ‘‘Pottery (Ceramics);

Imported and Domestic—Lead

Contamination’’ (CPG 7117.07) 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:

Ronald C. Varsaci, Center for Food

Safety and Applied Nutrition (HFS–

022), Food and Drug Administration,

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

202–205–4251.

SUPPLEMENTARY INFORMATION: FDA is

revising the following two CPG’s

because they contain outdated

information or misprinted regulatory

guidance: (1) CPG Sec. 545.400 ‘‘Pottery

(Ceramics); Imported and Domestic—

Cadmium Contamination’’ (CPG

7117.06), and (2) CPG Sec. 545.450

‘‘Pottery (Ceramics); Imported and

Domestic—Lead Contamination’’ (CPG

7117.07).

The guidance for flatware and small

hollowware in CPG Sec. 545.400 and for

pitchers in CPG Sec. 545.450 was

mistakenly printed as 0.05 instead of 0.5

microgram/milliliter. The CPG’s are also

being revised to specify current

methodologies in the Official Methods

of Analysis of the Association of Official

Analytical Chemists International

(AOAC) and to include the American

Society for Testing Materials (ASTM)

and Laboratory Information Bulletin

(LIB) methodologies. The CPG provides

guidance on recommending legal

actions and on when entries of potteries

should be detained based on cadmium

or lead contamination. To minimize any

confusion that may exist, FDA has

decided to issue revisions.