3904 Federal Register / Vol. 63, No. 17 /Tuesday, January 27, 1998 / Notices

whether a listed drug was withdrawn

from sale for reasons of safety or

effectiveness before an ANDA that refers

to that listed drug may be approved

(§ 314.161(a)(1) (21 CFR 314.161(a)(1)).

FDA may not approve an ANDA that

does not refer to a listed drug.

In a citizen petition dated August 26,

1996 (Docket No. 96P–0316/CP),

submitted in accordance with 21 CFR

314.122, Clausen & Associates, Inc.,

requested that the agency determine

whether minocycline hydrochloride

tablets were withdrawn from sale for

reasons of safety or effectiveness.

Minocycline hydrochloride (Minocin)

tablets are the subject of approved NDA

50–451 held by Lederle Laboratories. In

1996, Lederle withdrew minocycline

hydrochloride tablets from sale.

FDA has reviewed its records and,

under § 314.161, has determined that

minocycline hydrochloride tablets were

not withdrawn from sale for reasons of

safety or effectiveness. Accordingly, the

agency will maintain minocycline

hydrochloride tablets in the

‘‘Discontinued Drug Product List’’

section of the Orange Book. The

‘‘Discontinued Drug Product List’’

delineates, among other items, drug

products that have been discontinued

from marketing for reasons other than

safety or effectiveness. ANDA’s that

refer to minocycline hydrochloride

tablets may be approved by the agency.

Dated: January 20, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–1849 Filed 1–26–98; 8:45 am]

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DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98M–0036]

Xytronyx, Inc.; Premarket Approval of

the Periogard Periodontal Tissue

Monitor

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by Xytronyx,

Inc., San Diego, CA, for premarket

approval, under the Federal Food, Drug,

and Cosmetic Act (the act), of the

Periogard Periodontal Tissue Monitor

(PTM). After reviewing the

recommendation of the Devices Panel,

FDA’s Center for Devices and

Radiological Health (CDRH) notified the

applicant, by letter of June 23, 1997, of

the approval of the application.

DATES: Petitions for administrative

review by February 26, 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:

Alfred W. Montgomery, Center for

Devices and Radiological Health (HFZ–

440), Food and Drug Administration,

9200 Corporate Blvd., Rockville, MD

20850, 301–594–1243.

SUPPLEMENTARY INFORMATION: On

September 19, 1996, Xytronyx, Inc., San

Diego, CA 92121, submitted to CDRH an

application for premarket approval of

the PTM. The device is a visual,

periodontal test kit and is indicated for

use as a rapid, chair-side, visual test for

the qualitative determination of

aspartate aminotransferase (AST) in

gingival crevicular fluid. The PTM kit

detects elevated levels of AST

associated with tissue necrosis. It is

intended to be used as an objective,

biochemical adjunct to traditional

methods of monitoring patients to assist

in the decision to apply treatment and

in the evaluation of treatment

effectiveness.

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

premarket approval application (PMA)

was not referred to the Dental Products

Panel and/or the Clinical Chemistry and

Toxicology Devices Panel of the Medical

Devices Advisory Committee, FDA

advisory committees, for review and

recommendation because the

information in the PMA substantially

duplicates information previously

reviewed by the panel. On June 23,

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 February 26, 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. 98–1942 Filed 1–26–98; 8:45 am]

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