Federal Register / Vol. 61, No. 129 / Wednesday, July 3, 1996 / Notices 34853

[Docket No. 96F–0205]

Sumitomo Chemical America, Inc.;

Filing of Food Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Sumitomo Chemical America, Inc.,

has filed a petition proposing that the

food additive regulations be amended to

provide for the additional safe use of

3,9-bis{2-[3-(3-tert-butyl-4-hydroxy-5-

methylphenyl)propionyloxy]-1,1-

dimethylethyl}-2,4,8,10-

tetraoxaspiro[5.5]-undecane as an

antioxidant and/or stabilizer in

propylene homopolymer and highpropylene olefin copolymer articles

intended for use in contact with food.

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: Vir

D. Anand, Center for Food Safety and

Applied Nutrition (HFS–216), Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3081.

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 6B4510) has been filed by

Sumitomo Chemical America, Inc., c/o

Keller and Heckman, 1001 G St. NW.,

suite 500 West, Washington, DC 20001.

The petition proposes to amend the food

additive regulations in § 178.2010

Antioxidants and/or stabilizers for

polymers (21 CFR 178.2010) to provide

for the additional safe use of 3,9-bis{2-

[3-(3-tert-butyl-4-hydroxy-5-

methylphenyl)propionyloxy]-1,1-

dimethylethyl}-2,4,8,10-

tetraoxaspiro[5.5]-undecane as an

antioxidant and/or stabilizer in

propylene homopolymer and highpropylene olefin copolymer articles

intended for use in contact with food.

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: June 17, 1996.

George H. Pauli,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 96–16976 Filed 7–2–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95M–0195]

Ciba Corning Diagnostics Corp.;

Premarket Approval of ACSTM AFP

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by Ciba

Corning Diagnostics Corp., Medfield,

MA, for premarket approval, under the

Federal Food, Drug, and Cosmetic Act

(the act), of ACSTM AFP. 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 2, 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:

Peter E. Maxim, Center for Devices and

Radiological Health (HFZ–440), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1293.

SUPPLEMENTARY INFORMATION: On

October 18, 1993, Ciba Corning

Diagnostics Corp., Medfield, MA 02052–

1688, submitted to CDRH an application

for premarket approval of ACSTM AFP.

The device is a two-site

chemiluminescence immunoassay and

is indicated for the quantitative

determination of alpha-fetoprotein

(AFP) in human serum and in amniotic

fluid from specimens obtained at 15 to

20 weeks gestation as an aid in detecting

open neural tube defects (NTD’s) when

used in conjunction with

ultrasonography and amniography; and

in human serum, as an aid in managing

nonseminomatous testicular cancer,

when used in conjunction with physical

examination, histology/pathology, and

other clinical evaluation procedures,

using the Ciba Corning ACS:180

automated chemiluminescence system.

In accordance with the provisions of

section 515(c)(2) of the act (21 U.S.C.

360e(c)(2)) as amended by the Safe

Medical Devices Act of 1990, this

premarket approval application (PMA)

was not referred to the Immunology

Devices Panel of the Medical Devices

Advisory Committee, an FDA advisory

committee, for review and

recommendation because the

information in the PMA substantially

duplicates information previously

reviewed by this panel.

On September 29, 1995, CDRH

approved the application by a letter to

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 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

procedures 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
34854 Federal Register / Vol. 61, No. 129 / Wednesday, July 3, 1996 / Notices

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 2, 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 13, 1996.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 96–16885 Filed 7–2–96; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96M-0199]

Bayer Corp.; Premarket Approval of

Technicon Immuno 1 CEA Assay

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by Bayer

Corp., 511 Benedict Ave., Tarrytown,

NY, for premarket approval, under the

Federal Food, Drug, and Cosmetic Act

(the act), of Immuno 1 CEA Assay.

FDA’s Center for Devices and

Radiological Health (CDRH) notified the

applicant, by letter of January 30, 1996,

of the approval of the application.

DATES: Petitions for administrative

review by August 2, 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:

Peter E. Maxim, Center for Devices and

Radiological Health (HFZ–440), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1293.

SUPPLEMENTARY INFORMATION: On

September 29, 1994, Miles, Inc.,

Tarrytown, NY 10591, submitted to

CDRH an application for premarket

approval of Immuno 1 CEA Assay. The

device is an in vitro diagnostic device

intended to quantitatively measure

carcinoembryonic antigen (CEA) in

human serum on the Technicon

Immuno 1 system. Measurements of

CEA aid in the management of cancer

patients by monitoring CEA

concentrations. This diagnostic method

is not intended for use on any other

system.

In accordance with the provisions of

section 515(c)(2) of the act (21 U.S.C.

360e(c)(2)) as amended by the Safe

Medical Devices Act of 1990, this

premarket approval application (PMA)

was not referred to the Immunology

Devices Panel of the Medical Devices

Advisory Committee, an FDA advisory

committee, for review and

recommendation because the

information in the PMA substantially

duplicates information previously

reviewed by this committee.

On January 30, 1996, CDRH approved

the application by a letter to 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 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

procedures 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 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 2, 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: April 9, 1996.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 96–16972 Filed 7–2–96; 8:45 am]

BILLING CODE 4160–01–F

Product and Establishment License

Applications, Refusal to File; Meeting

of Oversight Committee

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing a

meeting of its standing oversight

committee in the Center for Biologics

Evaluation and Research (CBER) that

conducts a periodic review of CBER’s

use of its refusal to file (RTF) practices

on product license applications (PLA’s)

and establishment license applications

(ELA’s). CBER’s RTF oversight

committee examines all RTF decisions

that occurred during the previous

quarter to assess consistency across

CBER offices and divisions in RTF

decisions.