Federal Register / Vol. 63, No. 1 / Friday, January 2, 1998 / Notices 87

reorganization proposals. Acts as liaison

with the HHS Office of the Assistant

Secretary for Management and Budget to

coordinate organizational proposals

requiring Secretarial approval; prepares

functional statements and official

organizational charts. Administers

ACF’s system for review, approval, and

documentation of delegations of

authority and maintains the guidelines

related to the delegations of authority.

L. The Office of Administrative

Services and Facilities Management

(OASFM) directs and manages ACF’s

administrative support services,

facilities management programs and

activities.

Provides agency-wide guidance on

administrative issues; prepares,

coordinates and disseminates

information, policy, and/or procedural

guidance on administrative and

facilities management issues. Directs

and/or coordinates management

initiatives to improve ACF

administrative and facilities

management services with the goal of

continually improving services while

reducing costs.

Maintains budgetary controls on

administrative services accounts,

reconciling accounting reports and

invoices, and monitoring all spending.

Controls OASFM Visa credit card for

small purchases. Establishes and

manages contracts and/or blanket

purchase agreements (BPAs) for

administrative support and facilities

management services, including space

design, building alteration and repair,

telecommunications, reprographics,

physical security, moving, labor, records

and property management and

inventory, systems furniture

acquisitions and assembly, fleet

management, and the Information

Resource Center (library).

Provides management and oversight

of ACF mail delivery services and

activities, including Federal and

contractor postal services nationwide,

covering all classes of U.S. Postal

Service mail, priority and express mail

services, and courier services, etc.

Directs all activities associated with

the ACF Master Housing Plan, including

coordination and development of the

agency long-range space budget;

planning, budgeting, identification,

solicitation, acceptance and utilization

of office and special purpose space,

repairs, and alterations; principal

liaison with General Services

Administration (GSA) and other Federal

agencies, building managers and

facilities engineers, architects and

commercial representatives, for space

acquisition, negotiation of lease terms,

dealing with sensitive issues such as

handicapped barriers, space shortages,

and security. Develops and maintains

space floor plans and inventories,

directory boards, and locator signs.

OASFM serves as the lead for ACF in

coordination and liaison with

Departmental, GSA, Federal Protective

Service, and other Federal agencies on

implementation of Federal security

directives. Responsible for planning and

executing the Agency’s environmental

health, safety, and physical security

programs, ensuring that appropriate

occupational health and safety and

occupant emergency evacuation plans

are in place. Serves as principal liaison

with private and/or Federal building

managers for all administrative services

and facilities management activities.

Responsible for issuing, and managing

and controlling badge and cardkey

systems to control access to agency

space for security purposes.

Develops and/or implements agency

telecommunications management policy

in accordance with Federal regulations

and procedures. Reviews and directs

payment of all agency telephone

invoices. Recommends and advises on

the design and function of

telecommunications systems, based on

user needs, costs and technological

availability. Communicates directly

with private industry service providers

to coordinate the acquisition,

installation and maintenance of voice/

data telecommunications equipment

and systems. Responsible for other

sources of communications capability

such as pagers, cellular phone service,

cable TV service, and audio

conferencing equipment and service.

Coordinates the implementation of

personal video and video conferencing.

Updates and maintains the ACF LANbased telephone directory, handles the

distribution of all commercial

directories, and updates and maintains

the databases for telephone lines, and

equipment inventories.

Plans, manages/operates employee

transportation programs, including

shuttle service and fleet management,

employee and visitor parking, and

commuter services and programs

including transit subsidies and

ridesharing. Develops and implements

ACF travel policies and procedures

consistent with Federal requirements.

Provides technical assistance and

oversight; coordinates ACF use of the

Travel Management System; manages

employee participation in the American

Express Credit Card program for travel.

Purchases and tracks common use

supplies, stationery and publications;

manages equipment repair services and

reprographics management activities;

controls and maintains equipment and

personal property inventories; develops

and coordinates records (paper) and

forms management, and real property

activities.

VIII. Within Chapter K, replace the

term ‘‘Deputy Assistant Secretary for

Program Operations’’ with ‘‘Deputy

Assistant Secretary for Administration.’’

Dated: December 24, 1997.

Olivia A. Golden,

Assistant Secretary for Children and Families.

[FR Doc. 97–34217 Filed 12–31–97; 8:45 am]

BILLING CODE 4184–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97M–0521]

Richard-James, Inc.; Premarket

Approval of SILIKON 1000-Silicone Oil

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application submitted

by Richard-James, Inc., Peabody, MA,

for premarket approval, under the

Federal Food, Drug, and Cosmetic Act

(the act), of the SILIKON 1000-Silicone

Oil. 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 25, 1997, of the approval of

the application.

DATES: Petitions for administrative

review by February 2, 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:

James F. Saviola, Center for Devices and

Radiological Health (HFZ–460), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2018.

SUPPLEMENTARY INFORMATION: On

February 22, 1995, Richard-James, Inc.,

Peabody, MA 01960, submitted to CDRH

an application for premarket approval of

the SILIKON 1000-Silicone Oil. The

device is an intraocular fluid and is

indicated for use as a prolonged retinal

tamponade in selected cases of

complicated retinal detachments where

other interventions are not appropriate
88 Federal Register / Vol. 63, No. 1 / Friday, January 2, 1998 / Notices

for patient management. Complicated

retinal detachments or recurrent retinal

detachments occur most commonly in

eyes with proliferative vitreoretinopathy

(PVR), proliferative diabetic retinopathy

(PDR), cytomegalovirus (CMV) retinitis,

giant tears, and following perforating

injuries. SILIKON 1000 is also indicated

for primary use in detachments due to

acquired immune deficiency syndrome

(AIDS) related CMV retinitis and other

viral infections affecting the retina. On January 13, 1997, the Ophthalmic

Devices Panel of the Medical Devices

Advisory Committee, an FDA advisory

committee, reviewed and recommended

approval of the application. On

September 25, 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 February 2, 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: December 1, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–34156 Filed 12–31–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97M–0519]

Vitrophage, Inc.; Premarket Approval

of VITREON

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application submitted

by Vitrophage, Inc., Lyons, IL, for

premarket approval, under the Federal

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

of VITREON . 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 30, 1997, of the approval of

the application.

DATES: Petitions for administrative

review by February 2, 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:

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

December 6, 1991, Vitrophage, Inc.,

Lyons, IL 60534, submitted to CDRH an

application for premarket approval of

VITREON. The device is a purified

perfluorocarbon liquid and is indicated

for use as an intraoperative surgical aid

during vitreoretinal surgery in patients

with primary and recurrent complicated

retinal detachments. Complicated cases

include giant retinal tear or retinal

dialysis, proliferative vitreoretinopathy,

proliferative diabetic retinopathy,

tractional retinal detachments, and

blunt or penetrating ocular trauma.

On October 19, 1995, the Ophthalmic

Devices Panel of the Medical Devices

Advisory Committee, an FDA advisory

committee, reviewed and recommended

approval of the application. On

September 30, 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 February 2, 1998, file with the

Dockets Management Branch (address

above) two copies of each petition and

supporting data and information,