Federal Register / Vol. 62, No. 221 / Monday, November 17, 1997 / Notices 61339

successor in interest to NDA’s 12–748

and 16–470, filed a Notice of

Participation; on May 10, 1989, the

Administrative Law Judge issued his

Initial Decision, ordering that NDA’s

12–748 and 16–470, and others, be

withdrawn; Jones Medical, as well as

two other parties, appealed that

decision to the Commissioner. On the

basis of the present withdrawal of

approval of NDA’s 12–748 and 16–470

for failing to file required annual

reports, the appeal by Jones Medical in

Docket No. 87N–0262 is regarded as

withdrawn.

The Director, Center for Drug

Evaluation and Research, under section

505(e) of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 355(e)), and

under authority of 21 CFR 5.82, finds

that the holders of the applications

listed above have repeatedly failed to

submit reports required by § 314.81.

Therefore, under this finding, approval

of the NDA’s listed above, and all

amendments and supplements thereto,

is hereby withdrawn, effective

November 17, 1997.

Dated: November 6, 1997.

Janet Woodcock,

Director, Center for Drug Evaluation and

Research.

[FR Doc. 97–30148 Filed 11–14–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97M–0459]

Osteonics Corp.; Premarket Approval

of the Osteonics Constrained

Acetabular Insert

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application submitted

by Osteonics Corp., Allendale, NJ, for

premarket approval, under the Federal

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

of the Osteonics Constrained Acetabular

Insert. After reviewing the

recommendation of the Orthopedic and

Rehabilitation Devices Panel, FDA’s

Center for Devices and Radiological

Health (CDRH) notified the applicant,

by letter of June 13, 1997, of the

approval of the application.

DATES: Petitions for administrative

review by December 17, 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: Erin

I. Keith, Center for Devices and

Radiological Health (HFZ–410), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2036.

SUPPLEMENTARY INFORMATION: On

December 16, 1996, Osteonics Corp.,

Allendale, NJ 07401–1677, submitted to

CDRH an application for premarket

approval of the Osteonics Constrained

Acetabular Insert. The device is a

constrained hip and is indicated for use

as a component of a total hip prosthesis

in primary and revision patients at high

risk of hip dislocation due to a history

of prior dislocation, bone loss, joint or

soft tissue laxity, neuromuscular

disease, or intraoperative instability.

On June 10, 1997, the Orthopedic and

Rehabilitation Devices Panel of the

Medical Devices Advisory Committee,

an FDA advisory committee, reviewed

and recommended approval of the

application. On June 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 Federal Food,

Drug, and Cosmetic 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 December 17, 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: October 16, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–30149 Filed 11–14–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Eye Institute; Notice of

Meeting of Board of Scientific

Counselors

Pursuant to Public Law 92–463,

notice is hereby given of the meeting of

the Board of Scientific Counselors,

National Eye Institute, December 8 and

9, 1997 in Building 10, Room 10B16,

National Institutes of Health, Bethesda,

Maryland.

This meeting will be open to the

public on December 8 from 9 a.m. until

approximately 10 a.m. for general

remarks by the Director, Intramural

Research Program, National Eye

Institute (NEI), on matters concerning

the intramural program of the NEI.

Attendance by the public will be limited

to space available.

In accordance with provisions set

forth in section 552b(c)(6), Title 5,

U.S.C. and section 10(d) of Public Law

92–463, the meting will be closed to the

public on December 8 from

approximately 10 a.m. until recess and
61340 Federal Register / Vol. 62, No. 221 / Monday, November 17, 1997 / Notices

on December 9 from 8:30 a.m. until

adjournment for the review, discussion,

and evaluation of individual projects

conducted by the Laboratory of Sensory

Motor Research. These evaluations and

discussions could reveal personal

information concerning individuals

associated with the projects, including

consideration of personnel

qualifications and performance, and the

competence of individual investigators,

the disclosure of which would

constitute a clearly unwarranted

invasion of personal privacy.

Ms. Colleen Genovese, Counselor

Assistant, NEI, Building 10, Room

10N202 Bethesda, Maryland 20892,

(301) 496–3123, will provide a summary

of the meeting, roster of committee

members, and substantive program

information upon request. Individuals

who plan to attend and need special

assistance, such as sign language

interpretation or other reasonable

accommodations, should contact Ms.

Genovese in advance of the meeting.

(Catalog of Federal Domestic Assistance

Program No. 93.867, Vision Research;

National Institutes of Health)

Dated: November 7, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–30083 Filed 11–14–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Neurological

Disorders and Stroke Division of

Extramural Activities; Notice of Closed

Meeting

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

meeting:

Name of Committee: National Institute of

Neurological Disorders and Stroke Special

Emphasis Panel (Telephone Conference Call).

Date: November 19, 1997.

Time: 11:00 am.

Place: National Institutes of Health, 7550

Wisconsin Avenue, Room 9C10, Bethesda,

MD 20892.

Contact Person: Dr. Katherine Woodbury/

Mr. Phillip Wiethorn, Scientific Review

Administrators, NINDS, National Institutes of

Health, 7550 Wisconsin Avenue, Room 9C10,

Bethesda, MD 20892, (301) 496–9223.

Purpose/Agenda: To review and evaluate

Phase II RFP Contract Proposal(s).

This notice is being published less than 15

days prior to the meeting due to the urgent

need to meet timing limitations imposed by

the review and funding cycle.

The meeting will be closed in accordance

with the provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5, U.S.C.

Applications and/or proposals and the

discussions could reveal confidential trade

secrets or commercial property such as

patentable material and personal information

concerning individuals associated with the

applications and/or proposals, the disclosure

of which would constitute a clearly

unwarranted invasion of personal privacy.

(Catalog of Federal Domestic Assistance

Program No. 93.853, Clinical Research

Related to Neurological Disorders; No.

93.854, Biological Basis Research in the

Neurosciences)

Dated: November 7, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–30084 Filed 11–14–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Center for Scientific Review; Notice of

Closed Meetings

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following Center

for Scientific Review Special Emphasis

Panel (SEP) meetings:

Purpose/Agenda: To review individual

grant applications.

Name of SEP: Chemistry and Related

Sciences.

Date: November 17, 1997.

Time: 8:30 a.m.

Place: One Washington Circle,

Washington, DC.

Contact Person: Dr. Alec Liacouras,

Scientific Review Administrator, 6701

Rockledge Drive, Room 5154, Bethesda,

Maryland 20892, (301) 435–1740.

This notice is being published less than 15

days prior to the above meeting due to the

urgent need to meet timing limitations

imposed by the grant review and funding

cycle.

Name of SEP: Microbiological and

Immunological Sciences.

Date: December 5, 1997.

Time: 10:00 a.m.

Place: NIH, Rockledge 2, Room 4190,

Telephone Conference.

Contact Person: Dr. Garrett Keefer,

Scientific Review Administrator, 6701

Rockledge Drive, Room 4190, Bethesda,

Maryland 20892, (301) 435–1152.

Name of SEP: Clinical Sciences.

Date: December 5, 1997.

Time: 3:00 p.m.

Place: NIH, Rockledge 2, Room 4144,

Telephone Conference.

Contact Person: Dr. Paul Strudler,

Scientific Review Administrator, 6701

Rockledge Drive, Room 4144, Bethesda,

Maryland 20892, (301) 435–1716.

Name of SEP: Clinical Sciences.

Date: December 9, 1997.

Time: 1:00 p.m.

Place: NIH, Rockledge 2, Room 4112,

Telephone Conference.

Contact Person: Dr. Gopal Sharma,

Scientific Review Administrator, 6701

Rockledge Drive, Room 4112, Bethesda,

Maryland 20892, (301) 435–1783.

The meetings will be closed in accordance

with the provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5, U.S.C.

Applications and/or proposals and the

discussions could reveal confidential trade

secrets or commercial property such as

patentable material and personal information

concerning individuals associated with the

applications and/or proposals, the disclosure

of which would constitute a clearly

unwarranted invasion of personal privacy.

(Catalog of Federal Domestic Assistance

Program Nos. 93.306, 93.333, 93.337, 93.393–

93.396, 93.837–93.844, 93.846–93.878,

93.892, 93,893, National Institutes of Health,

HHS)

Dated: November 7, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, NIH.

[FR Doc. 97–30085 Filed 11–14–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Center for Scientific Review; Notice of

Closed Meeting

Pursuant to Section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following Center

for Scientific Review Special Emphasis

Panel (SEP) meeting:

Purpose/Agenda: To review individual

grant applications.

Name of SEP: Biological and Physiological

Sciences.

Date: November 14, 1997.

Time: 2:00 p.m.

Place: NIH, Rockledge 2, Room 5140,

Telephone Conference,

Contact Person: Dr. Gerald Greenhouse,

Scientific Review Administrator, 6701

Rockledge Drive, Room 5140, Bethesda,

Maryland 20892, (301) 435–1023.

This notice is being published less than 15

days prior to the above meeting due to the

urgent need to meet timing limitations

imposed by the grant review and funding

cycle.

The meetings will be closed in accordance

with the provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5, U.S.C.

Applications and/or proposals and the

discussions could reveal confidential trade

secrets or commercial property such as

patentable material and personal information

concerning individuals associated with the

applications and/or proposals, the disclosure

of which would constitute a clearly

unwarranted invasion of personal privacy.