15526 Federal Register / Vol. 62, No. 62 / Tuesday, April 1, 1997 / Notices

summary must include a description of

the proposed services; a justification for

the projected allocation for each

component including relationship of

funds allocated to numbers of clients

served, characteristics of clients,

duration of training and services, and

cost per placement. In addition, the

program component summary must

describe any ancillary services or

subcomponents such as day care,

transportation, or language training.

X. Reporting Requirements

States are required to submit quarterly

reports on the outcomes of the targeted

assistance program, using Schedule A

and Schedule C of the new ORR–6

Quarterly Performance Report form

which was sent to States in ORR State

Letter 95–35 on November 6, 1995.

Dated: March 26, 1997.

Lavinia Limon,

Director, Office of Refugee Resettlement.

[FR Doc. 97–8188 Filed 3–31–97; 8:45 am]

BILLING CODE 4184–01–P

Food and Drug Administration

[Docket No. 97F–0116]

Mitsui Petrochemical Industries, Ltd.;

Filing of Food Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Mitsui Petrochemical Industries,

Ltd., has filed a petition proposing that

the food additive regulations be

amended to provide for the safe use of

4-methylpentene-1 copolymers resulting

from the copolymerization of 4-

methylpentene-1 and 1-alkenes having

from 12 to 18 carbon atoms for use in

contact with food.

DATES: Written comments on the

petitioner’s environmental assessment

by May 1, 1997.

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:

Spring C. Randolph, Center for Food

Safety and Applied Nutrition (HFS–

215), Food and Drug Administration,

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

202–418–3191.

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 7B4534) has been filed by

Mitsui Petrochemical Industries, Ltd., 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 § 177.1520 Olefin

polymers (21 CFR 177.1520) to provide

for the safe use of 4-methylpentene-1

copolymers manufactured by the

catalytic copolymerization of 4-

methylpentene-1 with 1-alkenes having

from 12 to 18 carbon atoms 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

public display at the Dockets

Management Branch (address above) for

public review and comment. Interested

persons may, on or before May 1, 1997,

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: March 6, 1997.

Alan M. Rulis,

Director, Office of Premarket Approval,

Center for Food Safety and Applied Nutrition.

[FR Doc. 97–8115 Filed 3–31–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 97M–0125]

Roche Molecular Systems, Inc.;

Premarket Approval of AMPLICOR

Mycobacterium Tuberculosis Test

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by Roche

Molecular Systems, Inc., Somerville, NJ

for premarket approval, under the

Federal Food, Drug, and Cosmetic Act

(the act), of the AMPLICOR (MTB)

Test. After reviewing the

recommendation of the Microbiology

Devices Panel, FDA’s Center for Devices

and Radiological Health (CDRH)

notified the applicant, by letter of

November 26, 1996, of the approval of

the application.

DATES: Petitions for administrative

review by May 1, 1997.

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:

Sharon L. Hansen, Center for Devices

and Radiological Health (HFZ–440),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2096.

SUPPLEMENTARY INFORMATION: On

December 22, 1994, Roche Molecular

Systems, Inc., Somerville, NJ 08876–

3711, submitted to CDRH an application

for premarket approval of the

AMPLICOR (MTB) Test. The device is

a target amplified in vitro diagnostic test

for the qualitative detection of M.

tuberculosis complex DNA in

concentrated sediments prepared from

sputum (induced or expectorated),

bronchial specimens including

bronchoalveolar lavages or aspirates, or

tracheal aspirates. The AMPLICOR

MTB Test is intended for use as an

adjunctive test for evaluating acid fast

bacilli (AFB) smear positive sediments

prepared using NALC-NaOH or NaOH

digestion-decontamination of

respiratory specimens from untreated

patients suspected of having

tuberculosis. Untreated patients are

patients who have: (1) Received no

antituberculosis therapy; (2) had less

than 7 days of therapy; or (3) have not

received such therapy in the last 12

months. Only untreated patients may be

evaluated with the AMPLICOR MTB

Test, which should only be performed

in institutions proficient in the culture

and identification of M. tuberculosis

(ATS Level II and III or CAP extent 3

and 4). The test should always be

performed in conjunction with a

mycobacterial culture.

On January 25, 1996, the

Microbiology Devices Panel of the

Medical Devices Advisory Committee,
Federal Register / Vol. 62, No. 62 / Tuesday, April 1, 1997 / Notices 15527

an FDA advisory committee, reviewed

and recommended approval of the

application. On November 26, 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 (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 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 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 May 1, 1997, 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: February 20, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–8114 Filed 3–31–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 97M–0120]

Angelini Pharmaceuticals, Inc.;

Premarket Approval of the 2-In-1 Drop

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by Angelini

Pharmaceuticals, Inc., River Edge, NJ,

for premarket approval, under the

Federal Food, Drug, and Cosmetic Act

(the act), of the 2-In-1 Drop. FDA’s

Center for Devices and Radiological

Health (CDRH) notified the applicant,

by letter of February 13, 1997, of the

approval of the application.

DATES: Petitions for administrative

review by May 1, 1997.

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:

James F. Saviola, Center for Devices and

Radiological Health (HFZ–460), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1744.

SUPPLEMENTARY INFORMATION: On May

25, 1994, Angelini Pharmaceuticals,

Inc., River Edge, NJ 07661, submitted to

CDRH an application for premarket

approval of the 2-In-1 Drop. The device

is a contact lens drop, packaged in a

single-use container, that is indicated

for use with soft (hydrophilic) contact

lenses (including disposables) and rigid

gas permeable contact lenses as a

lubricating and rewetting agent during

the wearing period and as a wetting

agent to cushion lenses prior to

placement on the eye. The 2-In-1 Drop

may also be used in place of a daily

cleaner as part of an appropriate

chemical disinfection regimen.

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

application was not referred to the

Ophthalmic Devices Panel of the

Medical Device Advisory Committee, an

FDA advisory committee, for review and

recommendation because the

information in the application

substantially duplicates information

previously reviewed by this panel.

On February 13, 1997, 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 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

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 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 May 1, 1997, 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