Federal Register / Vol. 61, No. 131 / Monday, July 8, 1996 / Notices 35771

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Elke

Jensen, Center for Food Safety and

Applied Nutrition (HFS–217), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3109.

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 6B4506) has been filed by

Henkel Corp., 300 Brookside Ave.,

Ambler, PA 19002. The petition

proposes to amend the food additive

regulations in part 176 Indirect Food

Additives: Paper and Paperboard

Components (21 CFR part 176) to

provide for the safe use of α-sulfo-ω-

(dodecyloxy)poly(oxyethylene), sodium

salt as an emulsifier in the production

of acrylic and vinyl acetate polymer

coatings for paper and paperboard. 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 (insert date 30 days after date of

publication in the Federal Register),

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: June 20, 1996.

George H. Pauli,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 96–17233 Filed 7–5–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 93F–0402]

Lonza, Inc.; Withdrawal of Food

Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

withdrawal, without prejudice to a

future filing, of a food additive petition

(FAP 4B4405) proposing that the food

additive regulations be amended to

provide for the safe use of

decylisononyldimethyl ammonium

chloride as a slimicide in the

manufacture of paper and paperboard

intended to contact food.

FOR FURTHER INFORMATION CONTACT:

Mitchell A. Cheeseman, Center for Food

Safety and Applied Nutrition (HFS–

217), Food and Drug Administration,

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

202–418–3083.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

November 17, 1993 (58 FR 60665), FDA

announced that a food additive petition

(FAP 4B4405) had been filed by Lonza,

Inc., c/o Delta Analytical Corp., 7910

Woodmont Ave., Bethesda, MD 20814

(currently c/o Lewis & Harrison, 122 C

St. NW., suite 740, Washington, DC

20001). The petition proposed to amend

the food additive regulations to provide

for the safe use of

decylisononyldimethyl ammonium

chloride as a slimicide in the

manufacture of paper and paperboard

intended to contact food. Lonza, Inc.,

has now withdrawn the petition without

prejudice to a future filing (21 CFR

171.7).

Dated: June 25, 1996.

Alan M. Rulis,

Director, Office of Premarket Approval,

Center for Food Safety and Applied Nutrition.

[FR Doc. 96–17234 Filed 7–5–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96M–0218]

Adeza Biomedical Corp.; Premarket

Approval of Fetal Fibronectin Enzyme

Immunoassay Kit

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by Adeza

Biomedical Corp., Sunnyvale, CA, for

premarket approval, under the Federal

Food, Drug, and Cosmetic Act (the act),

of Fetal Fibronectin Enzyme

Immunoassay Kit. After reviewing the

recommendation of the Clinical

Chemistry and Clinical Toxicology

Devices Panel, FDA’s Center for Devices

and Radiological Health (CDRH)

notified the applicant, by letter of

September 29, 1995, of the approval of

the application.

DATES: Petitions for administrative

review by August 7, 1996.

ADDRESSES: Written requests for copies

of the summary of safety and

effectiveness data and petitions for

administrative review to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Cornelia B. Rooks, Center for Devices

and Radiological Health (HFZ–440),

Food and Drug Administration, 2098

Gaither Rd., Rockville, MD 20850, 301–

594–1243.

SUPPLEMENTARY INFORMATION: On

October 31, 1994, Adeza Biomedical

Corp., Sunnyvale, CA 94089, submitted

to CDRH an application for premarket

approval of Fetal Fibronectin Enzyme

Immunoassay Kit. The device is to be

used as an aid in assessing the risk of

preterm delivery in ≤ 7 days or ≤ 14 days

from the time of sample collection in

pregnant women with signs and

symptoms of early preterm labor, intact

amniotic membranes, and minimal

cervical dilatation (< 3 centimeters),

sampled between 24 weeks, 0 days and

34 weeks, 6 days gestation.

The negative predictive values of 99.5

percent and 99.2 percent, for delivery in

≤ 7 and ≤ 14 days respectively, make it

highly likely that delivery will not occur

in these timeframes. In addition,

although the positive predictive values

were found to be 12.7 percent and 16.7

percent for delivery in ≤ 7 and ≤ 14 days,

respectively, this represents an

approximate 4-fold increase over the

reliability of predicting delivery given

no test information.

On April 6, 1995, the Clinical

Chemistry and Clinical Toxicology

Devices Panel of the Medical Devices

Advisory Committee, an FDA advisory

committee, reviewed and recommended

approval of the application.

On September 29, 1995, CDRH

approved the application by a letter to
35772 Federal Register / Vol. 61, No. 131 / Monday, July 8, 1996 / Notices

the applicant from the Director of the

office of Device Evaluation, CDRH.

A summary of the safety and

effectiveness data on which CDRH

based its approval is on file in the

Dockets Management Branch (address

above) and is available from that office

upon written request. Requests should

be identified with the name of the

device and the docket number found in

brackets in the heading of this

document.

Opportunity for Administrative Review

Section 515(d)(3) of the act (21 U.S.C.

360e(d)(3)) authorizes any interested

person to petition, under section 515(g)

of the act, for administrative review of

CDRH’s decision to approve this

application. A petitioner may request

either a formal hearing under part 12 (21

CFR part 12) of FDA’s administrative

practices and regulations or a review of

the application and CDRH’s action by an

independent advisory committee of

experts. A petition is to be in the form

of a petition for reconsideration under

§ 10.33(b) (21 CFR 10.33(b)). A

petitioner shall identify the form of

review requested (hearing or

independent advisory committee) and

shall submit with the petition

supporting data and information

showing that there is a genuine and

substantial issue of material fact for

resolution through administrative

review. After reviewing the petition,

FDA will decide whether to grant or

deny the petition and will publish a

notice of its decision in the Federal

Register. If FDA grants the petition, the

notice will state the issue to be

reviewed, the form of the review to be

used, the persons who may participate

in the review, the time and place where

the review will occur, and other details.

Petitioners may, at any time on or

before August 7, 1996, file with the

Dockets Management Branch (address

above) two copies of each petition and

supporting data and information,

identified with the name of the device

and the docket number found in

brackets in the heading of this

document. Received petitions may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(secs. 515(d), 520(h) (21 U.S.C. 360e(d),

360j(h))) and under authority delegated

to the Commissioner of Food and Drugs

(21 CFR 5.10) and redelegated to the

Director, Center for Devices and

Radiological Health (21 CFR 5.53).

Dated: June 21, 1996.

Joesph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 96–17235 Filed 7–5–96; 8:45 am]

BILLING CODE 4160–01–F

National Institutes of Health

National Cancer Institute; Notice of

Meeting

Pursuant to Public Law 92–463,

notice is hereby given of a meeting of

the President’s Cancer Panel.

The meeting will be open to the

public as indicated below, with

attendance by the public limited to

space available. Individuals who plan to

attend and need special assistance, such

as sign language interpretation or other

reasonable accommodations, should

notify the Contact Person listed below.

The meeting will be closed in

accordance with the provisions set forth

in sec. 552b(c)(9), Title 5, U.S.C. for

discussion of future meetings and

preparation of the annual report to the

President. These discussions could

disclose information, the premature

disclosure of which would be likely to

significantly frustrate implementation of

proposed action the Panel may plan to

take.

Carole Frank, the Committee

Management Officer, National Cancer

Institute, Executive Plaza North, Room

630M, 6130 Executive Blvd., MSC 7405,

Bethesda, MD 20891–7405 (301–496–

5708) will provide a summary of the

meeting and the roster of committee

members upon request. Other

information pertaining to the meetings

may be obtained from the contact

person indicated below.

Committee Name: President’s Cancer

Panel.

Date: July 29–30, 1996.

Place: Fred Hutchinson Cancer Center,

Stuart Auditorium, First Hill, 1124 Columbia

Street, Seattle, WA 98104.

Closed: July 29, 1996—7 p.m. to 10 p.m.

Agenda: Planning session to discuss future

meetings and preparation of the mandatory

annual report of the Chairman to the

President.

Open: July 30, 1996—8:30 a.m. to 5:00 p.m.

Agenda: Managed Care’s Role in the War

on Cancer. Where are we today? Existing

problems for cutting edge clinical research in

today’s environment.

Contact Person: Dr. Maureen O. Wilson,

Executive Secretary, National Cancer

Institute, NIH, Building 31, Room 4B43,

Bethesda, MD 20892, (301) 496–1148.

(Catalog of Federal Domestic Assistance

Program Numbers: 93:393, Cancer Cause and

Prevention Research; 93.394, Cancer

Detection and Diagnosis Research; 93.395,

Cancer Treatment Research; 93.396, Cancer

Biology Research; 93.397, Cancer Centers

Support; 93.398, Cancer Research Manpower;

93.399, Cancer Control.)

Dated: July 1, 1996.

Susan K. Feldman,

Committee Management Officer, NIH.

[FR Doc. 96–17209 Filed 7–5–96; 8:45 am]

BILLING CODE 4140–01–M

National Institute of Allergy and

Infectious Diseases; Notice of Closed

Meeting

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. appendix 2), notice

is hereby given of the following

National Institute of Allergy and

Infectious Diseases Special Emphasis

Panel (SEP) meeting:

Name of SEP: Unsolicited AIDS Related

Career Award, Conference and Supplement

Applications

Date: July 26, 1996

Time: 8:30 a.m.

Place: Doubletree Hotel, Rockville Room,

1750 Rockville Pike, Rockville, MD 20852,

(301) 468–1100.

Contact Person: Dr. Paula Strickland,

Scientific Review Adm., 6003 Executive

Boulevard, Solar Bldg., Room 4C02,

Bethesda, MD 20892–7610, (301) 402–0643.

Purpose/Agenda: To evaluate grant

applications.

The meeting will be closed in accordance

with the provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5, U.S.C.

Applications and/or proposals and the

discussions could reveal confidential trade

secrets or commercial property such as

patentable material and personal information

concerning individuals associated with the

applications and/or proposals, the disclosure

of which would constitute a clearly

unwarranted invasion of personal privacy.

(Catalog of Federal Domestic Assistance

Programs Nos. 93.855, Immunology, Allergic

and Immunologic Diseases Research; 93.856,

Microbiology and Infectious Diseases

Research, National Institutes of Health.)

Dated: July 1, 1996.

Susan K. Feldman,

Committee Management Officer, NIH.

[FR Doc. 96–17210 Filed 7–5–96; 8:45 am]

BILLING CODE 4140–01–M

National Institute of Environmental

Health Sciences; Notice of a Closed

Meeting

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. appendix 2), notice

is hereby given of the following

National Institute of Environmental

Health Sciences Special Emphasis Panel

(SEP) meeting:

Name of SEP: The Use of Transgenic

Model Systems in Molecular Toxicology.