Federal Register / Vol. 63, No. 99 / Friday, May 22, 1998 / Notices 28387

or the offices of the Board of Governors

not later than June 9, 1998.

A. Federal Reserve Bank of

Philadelphia (Michael E. Collins, Senior

Vice President) 100 North 6th Street,

Philadelphia, Pennsylvania 19105-1521:

1. Commerce Bancorp, Cherry Hill,

Pennsylvania; to acquire Commerce

Capital, Philadelphia, Pennsylvania,

and thereby engage in Tier II securities

underwriting and dealing and related

activites, including bonds issued by notfor-profit entities that qualify under

Section 501(c)(3) of the Internal

Revenue Code for a tax exempt status;

and bonds issued by private entities that

qualify under Section 142(d) of the

Internal Revenue Code for a partially tax

exempt status (subject to only to the

alternative minimum tax). See Citicorp,

75 Fed. Res. Bull., 751 (1989) & 83 Fed.

Res. Bull. 510 (1997).

B. Federal Reserve Bank of Chicago

(Philip Jackson, Applications Officer)

230 South LaSalle Street, Chicago,

Illinois 60690-1413:

1. CITBA Financial Corporation,

Mooresville, Indiana; to acquire

Independent Bankers Life Insurance

Company of Indiana, Phoenix, Arizona,

a reinsurance subsidiary, and thereby

indirectly engage in underwriting credit

life, accident and health insurance

directly related to extensions of credit

by the banks and bank holding

companies owning stock in the

insurance agency, pursuant to §

225.28(b)(11)(i) of the Board’s

Regulation Y.

Board of Governors of the Federal Reserve

System, May 19, 1998.

Jennifer J. Johnson,

Deputy Secretary of the Board.

[FR Doc. 98–13788 Filed 5–21–98; 8:45 am]

BILLING CODE 6210–01–F

FEDERAL RESERVE SYSTEM

Sunshine Act Meeting

AGENCY HOLDING THE MEETING: Board of

Governors of the Federal Reserve

System.

TIME AND DATE: 10:00 a.m., Wednesday,

May 27, 1998.

PLACE: Marriner S. Eccles Federal

Reserve Board Building, 20th and C

Streets, NW., Washington, DC 20551.

STATUS: Closed.

MATTERS TO BE CONSIDERED:

1. Personnel actions (appointments,

promotions, assignments,

reassignments, and salary actions)

involving individual Federal Reserve

System employees.

2. Any matters carried forward from a

previously announced meeting.

CONTACT PERSON FOR MORE INFORMATION:

Joseph R. Coyne, Assistant to the Board;

202–452–3204.

SUPPLEMENTARY INFORMATION: You may

call 202–452–3206 beginning at

approximately 5 p.m. two business days

before the meeting for a recorded

announcement of bank and bank

holding company applications

scheduled for the meeting; or you may

contact the Board’s Web site at http://

www.bog.frb.fed.us for an electronic

announcement that not only lists

applications, but also indicates

procedural and other information about

the meeting.

DATED: May 20, 1998.

Jennifer J. Johnson,

Deputy Secretary of the Board.

[FR Doc. 98–13862 Filed 5–20–98; 12:55 pm]

BILLING CODE 6210–01–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98P–0160]

Determination That Cimetidine 100 mg

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 cimetidine 100 milligram (mg)

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 drugs that

refer to cimetidine 100 mg tablets.

FOR FURTHER INFORMATION CONTACT:

Virginia G. Beakes, 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’s

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 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 citizen petitions dated March 9,

1998 (Docket No. 98P–0160/CP 1), and

March 13, 1998 (Docket No. 98P–0160/

CP 2), submitted in accordance with 21

CFR 314.122, Apotex Corp. and

Novopharm Limited, respectively,

requested that the agency determine

whether cimetidine (Tagamet HB) 100

mg tablets were withdrawn from sale for

reasons of safety or effectiveness.

Cimetidine 100 mg tablets are the

subject of approved NDA 20–238 held

by SmithKline Beecham Consumer

Healthcare LP (SmithKline Beecham). In

1997, SmithKline Beecham withdrew

cimetidine 100 mg tablets from sale.

FDA has reviewed its records and,

under § 314.161, has determined that

cimetidine 100 mg tablets were not

withdrawn from sale for reasons of

safety or effectiveness. Accordingly, the

agency will maintain cimetidine 100 mg

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 cimetidine 100 mg

tablets may be approved by the agency.
28388 Federal Register / Vol. 63, No. 99 / Friday, May 22, 1998 / Notices

Dated: May 14, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–13650 Filed 5–21–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Medical Devices; Implementation of

Third Party Review Under the Food

and Drug Administration

Modernization Act of 1997; Emergency

Processing Request Under OMB

Review

[Docket No. 98N–0331]

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing a

program under which persons may be

accredited to review premarket

notifications and recommend initial

classification of certain medical devices.

At the same time, FDA is announcing

the termination of the Third Party

Review Pilot Program. This notice

announces the criteria to accredit or

deny accreditation to persons

(Accredited Persons) who request to

conduct premarket notification reviews

consistent with provisions of the FDA

Modernization Act of 1997 (FDAMA).

FDA is also announcing that this

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). FDA is requesting OMB approval

within 45 days of receipt of this

submission. FDA is taking this action to

implement section 210 of FDAMA. The

availability of guidance detailing the

review of submissions, training for third

party reviewers, and basic document

processing by FDA is announced

elsewhere in this issue of the Federal

Register.

DATES: Submit written comments on

the collection of information by June 22,

1998. FDA will begin accepting

applications for accreditation of

Accredited Persons on July 20, 1998,

and intends to make a list of Accredited

Persons available on or about September

23, 1998. Beginning November 21, 1998,

the agency will accept reviews and

recommendations from Accredited

Persons. On that same date, FDA plans

to terminate the Third Party Review

Pilot Program that began on August 1,

1996. FDA is currently planning to

provide periodic training sessions for

Accredited Persons, with the first such

session scheduled for October 14-16,

1998.

ADDRESSES: Submit written comments

on the collection of information 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: John

F. Stigi, Division of Small

Manufacturers Assistance (HFZ–220),

Center for Devices and Radiological

Health, Food and Drug Administration,

1350 Piccard Dr., Rockville, MD 20850,

301–443–6597, FAX 301–443–8818.

SUPPLEMENTARY INFORMATION:

I. Background

A. Third Party Review Pilot Program

In the Federal Register of April 3,

1996 (61 FR 14789), FDA announced

that it would begin a 2-year voluntary

pilot program to test the feasibility of

using third party reviewers to improve

the efficiency of the agency’s review of

510(k)’s for selected low-and-moderate

risk medical devices. FDA had

previously solicited public comments

on its plans for the pilot program in a

notice issued in the Federal Register of

June 1, 1995 (60 FR 28618), and at a

public workshop held June 19, 1995.

The comments received by the agency

were addressed in the Federal Register

notice (61 FR 14789).

The program announced in the April

3, 1996, notice provided for third party

review for 251 types of devices that

were included in the pilot program.

These included all class I devices that

were not exempt from 510(k) at that

time (221 devices), and 30 class II

devices, 24 of which were to be phased

into the program over time.

Under the pilot program, persons

required to submit 510(k)’s for the

eligible devices were permitted to

contract with an FDA Recognized Third

Party and submit a 510(k) directly to the

third party for review. Persons who did

not wish to participate in the pilot

continued to submit 510(k)’s directly to

FDA. The third party applied FDA’s

510(k) review criteria and submitted its

documented review and

recommendation on the substantial

equivalence of the device to FDA. FDA

then checked the review and issued a

decision letter. FDA established a 30-

day performance goal for its issuance of

final decisions based on third party

reviews.

The purpose of the pilot program was

to: (1) Provide manufacturers of eligible

devices with an alternative review

process that could yield more rapid

marketing clearance decisions, and (2)

enable FDA to target its scientific review

resources at higher-risk devices while

maintaining confidence in the review by

third parties of low-to-moderate risk

devices. The pilot program was

intended to determine the feasibility of

these outcomes.

The agency received applications for

recognition as third party reviewers

from 37 prospective third parties. These

applications were reviewed by a Third

Party Recognition Board established by

FDA. On July 11, 1996, FDA made

publicly available a list of seven

Recognized Third Parties, and

immediately began a training program

for third party review.

The pilot program began August 1,

1996, as scheduled. During the first 18

months of the pilot program, FDA

received 22 510(k)’s that were reviewed

by Recognized Third Parties. In contrast,

during the same period, FDA received

more than 1,300 510(k)’s for third partyeligible devices that were not reviewed

by third parties.

B. FDA Modernization Act of 1997

The President signed FDAMA into

law on November 21, 1997. Section 210

of FDAMA codifies and expands the

ongoing Third Party Review Pilot

Program by establishing a new section

523 of Federal Food, Drug, and

Cosmetic Act (the act) (21 U.S.C. 360m),

directing FDA to accredit persons in the

private sector to conduct the initial

review of 510(k)’s for selected low-tomoderate risk devices. This section

specifies that an Accredited Person may

not review class III devices or class II

devices that are permanently

implantable, life-supporting, lifesustaining, or for which clinical data are

required. This section also sets limits on

the number of class II devices requiring

clinical data that may be ineligible for

Accredited Person review.

II. FDAMA Third Party Review

Program

Under the provisions of FDAMA, FDA

is establishing the criteria it will use to

determine whether it will accredit or

deny accreditation of persons for the

purpose of reviewing reports submitted

under section 510(k) of the act (21

U.S.C. 360(k)) and making

recommendations to FDA regarding the

initial classification of devices under

section 513(f)(1) of the act (21 U.S.C.

360c(f)(1)). As intended by Congress,