Federal Register / Vol. 63, No. 17 /Tuesday, January 27, 1998 / Notices 3903

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.

Institutional Review Boards—(21 CFR

Part 56.115)—(OMB Control Number

0910–0130)—Extension

When reviewing clinical research

studies regulated by FDA, IRB’s are

required to create and maintain records

describing their operations, and make

the records available for FDA inspection

when requested. These records include:

(1) Written procedures describing the

structure and membership of the IRB

and the methods which the IRB will use

in performing its functions; (2) the

research protocols, informed consent

documents, progress reports, and

reports of injuries to subjects submitted

by investigators to the IRB; (3) minutes

of meetings showing attendance, votes

and decisions made by the IRB, the

number of votes on each decision for,

against, and abstaining, the basis for

requiring changes in or disapproving

research; (4) records of continuing

review activities; (5) copies of all

correspondence between investigators

and the IRB; (6) statements of significant

new findings provided to subjects of the

research; (7) and a list of IRB members

by name, showing each member’s

earned degrees, representative capacity,

and experience in sufficient detail to

describe each member’s contributions to

the IRB’s deliberations, and any

employment relationship between each

member and the IRB’s institution. This

information is used by the FDA in

conducting audit inspections of IRB’s to

determine whether IRB’s and clinical

investigators are providing adequate

protections to human subjects

participating in clinical research.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

56.115 2,000 14.6 10,000 65 131,400

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

The recordkeeping requirement

burden is based on the following

formula: Approximately 2,000 IRB’s

review FDA-regulated research

involving human subjects annually. The

burden for each of the paragraphs under

21 CFR 56.115 has been considered as

one for purposes of estimating the

burden. Each paragraph cannot

reasonably be segregated from one

another because all are interrelated.

FDA has about 2,000 IRB’s in its

inventory. The 2,000 IRB’s meet on an

average of 14.6 times annually. The

mean number of IRB meetings per year

was derived from a study conducted by

the agency and published by the Office

of Planning and Evaluation. The agency

estimates that approximately 4.5 hours

of person time per meeting are required

to transcribe and type the minutes of the

meeting, to maintain records of

continuing review activities, copies of

all correspondence between the IRB and

investigators, member records, and

written IRB procedures which are

approximately five pages per IRB.

Dated: January 20, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–1944 Filed 1–26–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 96P–0316]

Determination That Minocycline

Hydrochloride Tablets Were Not

Withdrawn From Sale for Reasons of

Safety or Effectiveness

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

that minocycline hydrochloride tablets

were not withdrawn from sale for

reasons of safety or effectiveness. This

determination will allow FDA to

approve abbreviated new drug

applications (ANDA’s) for minocycline

hydrochloride tablets.

FOR FURTHER INFORMATION CONTACT:

Mary E. Catchings, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

2041.

SUPPLEMENTARY INFORMATION: In 1984,

Congress enacted the Drug Price

Competition and Patent Term

Restoration Act of 1984 (Pub. L. 98–417)

(the 1984 amendments), which

authorized the approval of duplicate

versions of drug products approved

under an ANDA procedure. ANDA

sponsors must, with certain exceptions,

show that the drug for which they are

seeking approval contains the same

active ingredient in the same strength

and dosage form as the ‘‘listed drug,’’

which is a version of the drug that was

previously approved under a new drug

application (NDA). Sponsors of ANDA’s

do not have to repeat the extensive

clinical testing otherwise necessary to

gain approval of an NDA. The only

clinical data required in an ANDA are

data to show that the drug that is the

subject of the ANDA is bioequivalent to

the listed drug.

The 1984 amendments included what

is now section 505(j)(6) of the Federal

Food, Drug, and Cosmetic Act (21 U.S.C.

355(j)(6)), which requires FDA to

publish a list of all approved drugs.

FDA publishes this list as part of the

‘‘Approved Drug Products with

Therapeutic Equivalence Evaluations,’’

which is generally known as the

‘‘Orange Book.’’ Under FDA regulations,

drugs are withdrawn from the list if the

agency withdraws or suspends approval

of the drug’s NDA or ANDA for reasons

of safety or effectiveness, or if FDA

determines that the listed drug was

withdrawn from sale for reasons of

safety or effectiveness (21 CFR 314.162).

Regulations also provide that the agency

must make a determination as to
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]

BILLING CODE 4160–01–F

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]

BILLING CODE 4160–01–F