19070 Federal Register / Vol. 60, No. 72 / Friday, April 14, 1995 / Notices

incorporating the definitions established

in the Clean Air Act Amendments of

1990. Class I substances currently listed

under the Act include CFCs, halons,

carbon tetrachloride, 1,1,1-

trichloroethane, methyl bromide, and

hydrobromofluorocarbons. Class II

substances currently consist of HCFCs.

Part I of the proposed order requires

the respondent to cease and desist from

representing that any product

containing any Class I or Class II ozonedepleting substance ‘‘contains no

chlorofluorocarbons’’ or ‘‘contains no

CFC’s’’ or representing, in any manner,

that any such product will not deplete,

destroy, or otherwise adversely affect

ozone in the upper atmosphere or

otherwise harm the atmosphere.

Under the Clean Air Act

Amendments, the EPA has authority to

add new chemicals to the Class I and

Class II lists. Thus, the order’s

definitions of Class I and Class II ozonedepleting substances include these and

any other substances that may be added

to the lists. If additional substances are

added to the Class I or II lists, Part I of

the order becomes applicable to claims

made for products containing those

substances after the substances are

added to the lists.

Part II of the proposed order provides

that if the respondent represents in

advertising or labeling that any aerosol

product offers any environmental

benefit, it must have a reasonable basis

consisting of competent and reliable

evidence, which when appropriate must

be competent and reliable scientific

evidence, that substantiates the claims.

The proposed order also requires the

respondent 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.

Benjamin I. Berman,

Acting Secretary.

[FR Doc. 95–9265 Filed 4–13–95; 8:45 am]

BILLING CODE 6750–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

Agency Information Collection Under

OMB Review

Title: Evaluation of the National Head

Start/Public School Early Childhood

Transition Demonstration Project.

OMB No.: 0980–0240.

Description: This is a series of

standardized instruments and interview

forms for use with children, parents,

teachers, and principals participating in

the national evaluation of the Head

Start/Public School Early Transition

demonstration program. The evaluation

is designed to determine the impact of

the demonstration project on the

participating children, families and

schools.

Respondents: Individuals or

households, and State Government.

Estimate of total annual reporting and

recordkeeping burden:

Respondents: 26,364.

Number of Responses per

Respondent: 1.

Total Annual Responses: 26,364.

Average Burden per Response: 1.26.

Estimated Annual Burden: 33,288.

Additional Information: Copies of the

request for approval may be obtained

from Bob Sargis of the Office of

Information Resource Management,

ACF, by calling (202) 690–7275.

OMB Comment: Consideration will be

given to comments and suggestions

received within 30 days of publication.

Written comments and

recommendations for the proposed

information collection should be sent

directly to the following: Office of

Management and Budget, Paperwork

Reduction Project, 725 17th Street, NW.,

Washington, DC 20503, Attn: Ms.

Wendy Taylor.

Dated: April 3, 1995.

Roberta Katson,

Acting Director, Office of Information

Resource Management.

[FR Doc. 95–8783 Filed 4–13–95; 8:45 am]

BILLING CODE 4184–01–M

Food and Drug Administration

[Docket No. 95N–0095]

Drug Export; Aerrane (Isoflurane)

100% in 250 Milliliter (mL) Amber Glass

Bottles

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Ohmeda, Inc., has filed an

application requesting approval for the

export of the human drug AErrane

(isoflurane) 100% in 250 mL amber

glass bottles to the Netherlands.

ADDRESSES: Relevant information on

this application may be directed to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

rm. 1–23, 12420 Parklawn Dr.,

Rockville, MD 20857, and to the contact

person identified below. Any future

inquiries concerning the export of

human drugs under the Drug Export

Amendments Act of 1986 should also be

directed to the contact person.

FOR FURTHER INFORMATION CONTACT:

James E. Hamilton, Center for Drug

Evaluation and Research (HFD–310),

Food and Drug Administration, 7520

Standish Pl., Rockville, MD 20855, 301–

594–0063.

SUPPLEMENTARY INFORMATION: The drug

export provisions in section 802 of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 382) provide that

FDA may approve applications for the

export of drugs that are not currently

approved in the United States. Section

802(b)(3)(B) of the act sets forth the

requirements that must be met in an

application for approval. Section

802(b)(3)(C) of the act requires that the

agency review the application within 30

days of its filing to determine whether

the requirements of section 802(b)(3)(B)

have been satisfied. Section 802(b)(3)(A)

of the act requires that the agency

publish a notice in the Federal Register

within 10 days of the filing of an

application for export to facilitate public

participation in its review of the

application. To meet this requirement,

the agency is providing notice that

Ohmeda, Inc., 110 Allen Rd., P.O. Box

804, Liberty Corner, NJ 07938–0804, has

filed an application requesting approval

for the export of the human drug

AErrane (isoflurane) 100% in 250 mL

amber glass bottles to the Netherlands.

The product is used for the induction

and maintenance of general anesthesia.

The firm holds an approved new drug

application (Forane) for this product

packaged in 100 mL amber glass bottles.

The application was received and filed

in the Center for Drug Evaluation and

Research on February 7, 1995, which

shall be considered the filing date for

purposes of the act.

Interested persons may submit

relevant information on the application

to the Dockets Management Branch

(address above) in two copies (except

that individuals may submit single

copies) and identified with the docket

number found in brackets in the

heading of this document. These

submissions may be seen in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday.

The agency encourages any person

who submits relevant information on

the application to do so by April 24,

1995, and to provide an additional copy

of the submission directly to the contact

person identified above, to facilitate