64848 Federal Register / Vol. 62, No. 236 / Tuesday, December 9, 1997 / Notices

burden of the proposed collection of

information is as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual Responses Hours per

Response Total Hours

354(a)(3)(C) 20,000 1 1 (initial only) .25 5,000

1There are no capital costs or operating and maintenance costs associated with this collection of information.

The estimate for this proposed burden

was derived from agency records and

past experience concerning animal feed

distribution.

Dated: December 3, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–32163 Filed 12–8–97; 8:45 am]

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DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97M–0499]

ALLERGAN Medical Optics; Premarket

Approval of Model SA40N

AMOARRAY Multifocal UltravioletAbsorbing Silicone Posterior Chamber

Intraocular Lens

AGENCY: Food and Drug Administration,

HHS

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by Allergan

Medical Optics, Irvine, CA, for

premarket approval, under the Federal

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

of Model SA40N AMOArray

Multifocal Ultraviolet-Absorbing

Silicone Posterior Chamber Intraocular

Lens. After reviewing the

recommendation of the Ophthalmic

Devices Panel, FDA’s Center for Devices

and Radiological Health (CDRH)

notified the applicant, by letter of

September 5, 1997, of the approval of

the application.

DATES: Petitions for administrative

review by January 8, 1998.

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:

Ashley A. Boulware, Center for Devices

and Radiological Health (HFZ–460),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2053.

SUPPLEMENTARY INFORMATION: On

September 3, 1996, Allergan Medical

Optics, Irvine, CA 92612–9534,

submitted to CDRH an application for

premarket approval of Model SA40N

AMOArray Multifocal UltravioletAbsorbing Silicone Posterior Chamber

Intraocular Lens. The device is a

multifocal intraocular lens and is

indicated for the visual correction of

aphakia in persons 60 years of age or

older in whom a cataractous lens has

been removed and who may benefit

from useful near vision without reading

add and increased spectacle

independence across a range of

distances where the potential visual

effects associated with multifocality are

acceptable. The lens is intended for

placement in the capsular bag. The lens

is available in powers of +16 to +24

diopters.

On July 10, 1997, the Ophthalmic

Devices Panel of the Medical Devices

Advisory Committee, an FDA advisory

committee, reviewed and recommended

approval of the application. On

September 5, 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 (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 January 8, 1998, 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: October 31, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health

[FR Doc. 97–32165 Filed 12–8–97; 8:45 am]

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