Federal Register / Vol. 62, No. 236 / Tuesday, December 9, 1997 / Notices 64847

SUMMARY: Pursuant to section 10(a)(2) of

the Federal Advisory Committee Act

(Pub. L. No. 92–463), as amended,

notice is hereby given that a public

hearing of the Federal Accounting

Standards Advisory Board will be held

on Thursday, December 18, 1997 from

1:00 P.M. to 4:00 P.M. in room 7C13 of

the General Accounting Office, 441 G

St., N.W., Washington, D.C.

The purpose of the hearing is to hear

testimony from interested parties on

Accounting for Internal Use Software.

Those interested in testifying should

contact Wendy Comes, Executive

Director, no later than one week prior to

the hearing. Also, they should at the

same time provide a short biography

and written copies of their testimony.

Any interested person may attend the

hearing as an observer. Board

discussions and reviews are open to the

public.

FOR FURTHER INFORMATION CONTACT:

Wendy M. Comes, Executive Staff

Director, 441 G St., N.W., Room 3B18,

Washington, D.C. 20548, or call (202)

512–7357. E-Mail to:

ComesW.fasab@gao.gov. Fax: 202–512–

7366.

Authority: Federal Advisory Committee

Act. Pub. L. No. 92–463, Section 10(a)(2), 86

Stat. 770, 774 (1972) (current version at 5

U.S.C. app. section 10(a)(2) (1988); 41 CFR

101–6.1015 (1990).

Dated: December 3, 1997.

Wendy M. Comes,

Executive Director.

[FR Doc. 97–32191 Filed 12–8–97; 8:45 am]

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GENERAL ACCOUNTING OFFICE

Federal Accounting Standards

Advisory Board

AGENCY: General Accounting Office.

ACTION: Notice of December meeting.

SUMMARY: Pursuant to section 10(a)(2) of

the Federal Advisory Committee Act

(Pub. L. No. 92–463), as amended,

notice is hereby given that the Federal

Accounting Standards Advisory Board

will meet on Friday, December 19, 1997,

from 9 a.m. to 4 p.m. in Room 7C13 of

the General Accounting Office building,

441 G St., NW., Washington, DC.

The purpose of the meeting is to

discuss the following issues: (1) Natural

Resources; (2) Credit Reform proposed

amendments; (3) Social Insurance; (4)

follow-up issues from the public hearing

on accounting for internal use software

of December 18; and (5) the addition of

new projects for 1998.

Any interested person may attend the

meeting as an observer. Board

discussions and reviews are open to the

public.

FOR FURTHER INFORMATION CONTACT:

Wendy Comes, Executive Director, 441

G St., NW., Room 3B18, Washington, DC

20548, or call (202) 512–7350.

Authority: Federal Advisory Committee

Act, Pub. L. No. 92–463, Section 10(a)(2), 86

Stat. 770, 774 (1972) (current version at 5

U.S.C. app. section 10(a)(2) (1988); 41 CFR

101–6.1015 (1990).

Dated: December 3, 1997.

Wendy M. Comes,

Executive Director.

[FR Doc. 97–32192 Filed 12–8–97; 8:45 am]

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DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N-0496]

Agency Emergency Processing

Request Under OMB Review

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a proposed collection of

information has been submitted to the

Office of Management and Budget

(OMB) for emergency processing under

the Paperwork Reduction Act of 1995

(the PRA). The purpose of the proposed

collection of information is to enable

FDA to comply in a timely manner with

the congressional mandate in section

504 of the Federal Food Drug and

Cosmetic Act (the act) as added by the

Animal Drug Availability Act (ADAA)

of 1996, which requires that distributors

of animal feeds containing a veterinary

feed directive (VFD) drug notify FDA of

their intent to engage in distribution.

FDA is requesting OMB approval within

10 days of receipt of this clearance

submission.

DATES: Submit written comments by

December 19, 1997.

ADDRESSES: Submit written comments

to the Office of Information and

Regulatory Affairs, OMB, New

Executive Office Bldg., 725 17th St.

NW., rm. 10235, Washington, DC 20503,

Attn: Desk Officer for FDA. All

comments should be identified with the

docket number found in brackets in the

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Denver Presley, Office of Information

Resources Management (HFA-250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857, 301-

827-1472.

SUPPLEMENTARY INFORMATION: FDA has

requested emergency processing of this

proposed collection of information

under section 3507(j) of the PRA and 5

CFR 1320.13 because the information is

needed so that FDA can process letters

from animal feed distributors notifying

the agency of their intent to distribute

animal feeds containing VFD drugs as

mandated by the ADAA.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

Newley added section 504 of the act

(21 U.S.C. 354) created a new class of

drugs for use in animal feed, referred to

as VFD drugs, which are limited to use

only under the professional supervision

of a licensed veterinarian. Under section

504(a)(3)(C) (21 U.S.C. 354(a)(3)(C)), a

distributor must upon first engaging in

the distribution of animal feeds

containing VFD drugs notify the agency

of its name and place of business. The

information the agency needs to

implement this statutory requirement

includes the following specific

information: Distributor name, site

street address, mailing address (if

different), city state, zip code, name and

title of individual submitting the letter,

the date signed, and a statement

acknowledging the intent to distribute.

The information will be used as

confirmation of distributors for this new

class of drugs. To date, FDA has

received letters from approximately 500

distributors. FDA is working diligently

to implement procedural regulations for

VFD drugs. Thus, approval of this

request by OMB will allow FDA to

obtain the information that distributors

must provide under section 504(a)(3)(C)

as well as provide the agency with a

listing of distributors legally authorized

to distribute animal feeds containing

VFD drugs.

Respondents to this collection of

information are animal feed and animal

drug distributors. FDA estimates the
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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