Federal Register / Vol. 63, No. 111 /Wednesday, June 10, 1998 / Notices 31789

detection of a problem or complaints

from product users or their veterinarians

using forms FDA Forms 1932 and

1932a. Form FDA 2301 is available for

the required transmittal of periodic

reports and promotional material for

new animal drugs. Respondents to this

collection of information are applicants

of approved NADA’s.

FDA estimates the burden for this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Form 21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

FDA 2301 510.302(a) 190 19.74 3,750 0.5 1875

FDA 1932 510.302(b) 190 15.26 2,900 1.0 290

FDA 1932a (voluntary) 510.302(b) 100 1.0 100 1.0 100

Total Burden Hours 4,875

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

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

510.300(a) and 510.301(a) 190 15.26 3,750 10.35 38,812

510.300(b) and 510.301(b) 190 19.74 2,900 0.50 1,450

Total Burden Hours 40,262

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

The estimate of the times required for

record preparation and maintenance is

based on agency communication with

industry. Other information needed to

calculate the total burden hours

(i.e., adverse drug reaction, lack of

effectiveness, and product defect

reports) are derived from agency records

and experience.

Dated: June 3, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–15485 Filed 6–9–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0131]

Scott Feuer; Final Debarment Order

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is issuing an

order under the Federal Food, Drug, and

Cosmetic Act (the act) debarring Scott

Feuer, 25 Glenwood Rd., Tenafly, NJ

07670, for a period of 5 years from

providing services in any capacity to a

person that has an approved or pending

drug product application. FDA bases

this order on finding that Mr. Feuer was

convicted of conspiracy to commit an

offense against the United States and

that Mr. Feuer’s conduct undermined

the process for the regulation of drugs.

Mr. Feuer has failed to request a hearing

and, therefore, has waived his

opportunity for a hearing concerning

this action.

EFFECTIVE DATE: June 2, 1998.

ADDRESSES: Application for termination

of debarment to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Leanne Cusumano, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

2041.

SUPPLEMENTARY INFORMATION:

I. Background

On March 24, 1993, the United States

District Court for the District of

Maryland accepted Mr. Feuer’s plea of

guilty to one count of conspiracy to

commit an offense against the United

States under 18 U.S.C. 371 and 18

U.S.C. 2. This conspiracy conviction

was based on Mr. Feuer’s directing

others to change manufacturing

procedures for the generic drug

Fenoprophen, falsifying records in order

to conceal from the FDA the

manufacturing changes, and distributing

the Fenoprophen without FDA approval

of the formula actually distributed. As a result of this conviction, FDA

served Mr. Feuer by certified mail on

March 2, 1998, a notice proposing to

debar him for a period of 5 years from

providing services in any capacity to a

person that has an approved or pending

drug product application, and offered

him an opportunity for a hearing on the

proposal. The proposal was based on a

finding, under section 306(a)(2)(B) of

the act (21 U.S.C. 335a(a)(2)(B)), that Mr.

Feuer was convicted of a conspiracy to

commit a felony under Federal law for

conduct relating to the regulation of a

drug product and that Mr. Feuer’s

conduct undermined the process for the

regulation of drugs. Mr. Feuer did not

request a hearing. His failure to request

a hearing constitutes a waiver of his

opportunity for a hearing and a waiver

of any contentions concerning his

debarment.

II. Findings and Order

Therefore, the Director of the Center

for Drug Evaluation and Research, under

section 306(b) of the act, and under

authority delegated to her (21 CFR

5.99(b)), finds that Scott Feuer has been

convicted of conspiracy to commit a

felony under Federal law for conduct

relating to the regulation of a drug

product and that Mr. Feur’s conduct

undermined the process for the

regulation of drugs.

As a result of the foregoing finding,

Scott Feuer is debarred from providing

services in any capacity to a person with

an approved or pending drug product

application under section 505, 507, 512,

or 802 of the act (21 U.S.C. 355, 357,

360b, or 382), or under section 351 of

the Public Health Service Act (42 U.S.C.

262), effective June 2, 1998 (sections

306(c)(1)(B) and (c)(2)(A)(ii) and 201(dd)

of the act (21 U.S.C. 321(dd))), for a
31790 Federal Register / Vol. 63, No. 111 /Wednesday, June 10, 1998 / Notices

period of 5 years. Any person with an

approved or pending drug product

application who knowingly uses the

services of Mr. Feuer in any in any

capacity during his period of debarment

will be subject to civil money penalties

(section 307(a)(6) of the act (21 U.S.C.

335b(a)(6))). If Mr. Feuer, during his

period of debarment, provides services

in any capacity to a person with an

approved or pending drug product

application, he will be subject to civil

money penalties (section 307(a)(7) of the

act). In addition, FDA will not accept or

review any abbreviated new drug

applications or abbreviated antibiotic

drug applications submitted by or with

the assistance of Mr. Feuer during his

period of debarment.

Any application by Mr. Feuer for

termination of debarment under section

306(d)(4) of the act should be identified

with Docket No. 98N–0131 and sent to

the Dockets Management Branch

(address above). All such submissions

are to be filed in four copies. The public

availability of information in these

submissions is governed by 21 CFR

10.20(j). Publicly available submissions

may be seen in the Dockets Management

Branch between 9 a.m. and 4 p.m.,

Monday through Friday.

Dated: May 18, 1998.

Janet Woodcock,

Director, Center for Drug Evaluation and

Research.

[FR Doc. 98–15482 Filed 6–9–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97D–0299]

International Conference on

Harmonisation; Guidance on Ethnic

Factors in the Acceptability of Foreign

Clinical Data; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is publishing a

guidance entitled ‘‘E5 Ethnic Factors in

the Acceptability of Foreign Clinical

Data.’’ The guidance was prepared

under the auspices of the International

Conference on Harmonisation of

Technical Requirements for Registration

of Pharmaceuticals for Human Use

(ICH). The guidance recommends

regulatory and development strategies to

permit clinical data collected in one

region to be used for the support of drug

and biologic registrations in another

region while allowing for the influence

of ethnic factors.

DATES: Effective June 10, 1998. Submit

written comments at any time.

ADDRESSES: Submit written comments

on the guidance to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857. Copies of the guidance are

available from the Drug Information

Branch (HFD–210), Center for Drug

Evaluation and Research, Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–827–

4573. Single copies of the guidance may

be obtained by mail from the Office of

Communication, Training and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research (CBER), or by calling the CBER

Voice Information System at 1–800–

835–4709 or 301–827–1800. Copies may

be obtained from CBER’s FAX

Information System at 1–888–CBER–

FAX or 301–827–3844.

FOR FURTHER INFORMATION CONTACT:

Regarding the guidance: Barbara G.

Matthews, Center for Biologics

Evaluation and Research (HFM–

570), Food and Drug

Administration, 1401 Rockville

Pike, Rockville, MD 20852, 301–

827–5094.

Regarding ICH: Janet J. Showalter,

Office of Health Affairs (HFY–20),

Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–827–0864.

SUPPLEMENTARY INFORMATION: In recent

years, many important initiatives have

been undertaken by regulatory

authorities and industry associations to

promote international harmonization of

regulatory requirements. FDA has

participated in many meetings designed

to enhance harmonization and is

committed to seeking scientifically

based harmonized technical procedures

for pharmaceutical development. One of

the goals of harmonization is to identify

and then reduce differences in technical

requirements for drug development

among regulatory agencies.

ICH was organized to provide an

opportunity for tripartite harmonization

initiatives to be developed with input

from both regulatory and industry

representatives. FDA also seeks input

from consumer representatives and

others. ICH is concerned with

harmonization of technical

requirements for the registration of

pharmaceutical products among three

regions: The European Union, Japan,

and the United States. The six ICH

sponsors are the European Commission,

the European Federation of

Pharmaceutical Industries Associations,

the Japanese Ministry of Health and

Welfare, the Japanese Pharmaceutical

Manufacturers Association, the Centers

for Drug Evaluation and Research and

Biologics Evaluation and Research,

FDA, and the Pharmaceutical Research

and Manufacturers of America. The ICH

Secretariat, which coordinates the

preparation of documentation, is

provided by the International

Federation of Pharmaceutical

Manufacturers Associations (IFPMA).

The ICH Steering Committee includes

representatives from each of the ICH

sponsors and the IFPMA, as well as

observers from the World Health

Organization, the Canadian Health

Protection Branch, and the European

Free Trade Area.

In the Federal Register of July 31,

1997 (62 FR 41054), FDA published a

draft tripartite guideline entitled

‘‘Ethnic Factors in the Acceptability of

Foreign Clinical Data’’ (E5). The notice

gave interested persons an opportunity

to submit comments by October 29,

1997.

After consideration of the comments

received and revisions to the guidance,

a final draft of the guidance was

submitted to the ICH Steering

Committee and endorsed by the three

participating regulatory agencies on

February 5, 1998.

In accordance with FDA’s good

guidance practices (62 FR 8961,

February 27, 1997), this document has

been designated a guidance, rather than

a guideline.

The guidance is intended to facilitate

the registration of drugs and biologics

among ICH regions by recommending a

framework for evaluating the impact of

ethnic factors on a drug’s effect, i.e., its

efficacy and safety at a particular dosage

and dose regimen. The guidance

recommends regulatory and

development strategies that will permit

adequate evaluation of the influence of

ethnic factors, minimize duplication of

clinical studies, and expedite the drug

approval process.

This guidance represents the agency’s

current thinking on ethnic factors in the

acceptability of foreign clinical data for

approval of both drugs and biologics. It

does not create or confer any rights for

or on any person and does not operate

to bind FDA or the public. An

alternative approach may be used if

such approach satisfies the

requirements of the applicable statute,

regulations, or both.

As with all of FDA’s guidances, the

public is encouraged to submit written

comments with new data or other new

information pertinent to this guidance.

The comments in the docket will be