31788 Federal Register / Vol. 63, No. 111 /Wednesday, June 10, 1998 / Notices

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

58.29(b) 400 20 8,000 .21 1,700

58.35(b)(1) through (b)(6) and (c) 400 270.76 108,400 3.36 363,900

58.63(b) and (c) 400 60 24,000 .09 2,200

58.81(a) through (c) 400 301.8 120,000 .14 16,800

58.90(c) and (g) 400 62.7 25,000 .13 3,200

58.105(a) and (b) 400 5 2,000 11.8 23,600

58.107(d) 400 1 400 4.25 1,700

58.113(a) 400 15.33 6,132 6.8 41,700

58.120 400 15.38 6,160 32.7 201,200

58.195 400 251.5 100,000 3.9 392,400

Total 1,048,400

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

Dated: June 3, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–15409 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–0308]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

AGENCY: Food and Drug

Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for public comment on the

proposed collection of certain

information by the agency. Under the

Paperwork Reduction Act of 1995 (the

PRA), Federal agencies are required to

publish notice in the Federal Register

concerning each proposed collection of

information, including each proposed

reinstatement of an existing collection

of information, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

reporting and recordkeeping

requirements obligating holders of

approved new animal drug applications

(NADA’s) and abbreviated new animal

drug applications to submit information

on adverse drug reactions, lack of

effectiveness and product defects.

DATES: Submit written comments on the

collection of information by August 10,

1998.

ADDRESSES: Submit written comments

on the collection of information to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. All comments

should be identified with the docket

number found in brackets in the

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Denver Presley, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1472.

SUPPLEMENTARY INFORMATION: Under the

PRA (44 U.S.C. 3501–3520), Federal

agencies must obtain approval from the

Office of Management and Budget

(OMB) for each collection of

information they conduct or sponsor.

‘‘Collection of information’’ is defined

in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c) and includes agency requests

or requirements that members of the

public submit reports, keep records, or

provide information to a third party.

Section 3506(c)(2)(A) of the PRA (44

U.S.C. 3506(c)(2)(A)) requires Federal

agencies to provide a 60-day notice in

the Federal Register concerning each

proposed collection of information,

including each proposed reinstatement

of an existing collection, before

submitting the collection to OMB for

approval. To comply with this

requirement, FDA is publishing notice

of the proposed collection of

information listed below.

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.

Veterinary Adverse Drug Reaction,

Lack of Effectiveness, Product Defect

Report—21 CFR Part 510—(OMB

Control Number 0910–0012—

Reinstatement)

Section 512(l) of the Federal Food,

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

360b(l)), 21 CFR 510.300, 510.301, and

510.302 require that applicants of

approved NADA’s submit within 15

working days of receipt, complete

records of reports of certain adverse

drug reactions and unusual failure of

new animal drugs. Other reporting

requirements of adverse reactions to

these drugs must be reported annually

or semiannually in a specific format.

This continuous monitoring of

approved new animal drugs, affords the

primary means by which FDA obtains

information regarding potential

problems in safety and effectiveness of

marketed animal drugs and potential

manufacturing problems. Data already

on file with FDA is not adequate

because animal drug effects can change

over time and less apparent effects may

take years to manifest themselves.

Reports are reviewed along with those

previously submitted for a particular

drug to determine if any change is

needed in the product or labeling, such

as package insert changes, dosage

changes, additional warnings or

contraindications, or product

reformulation.

Adverse reaction reports are required

to be submitted by the drug

manufacturer on FDA Forms 1932 or

1932a (voluntary reporting form),

following complaints from animal

owners or veterinarians. Also, product

defects and lack of effectiveness

complaints are submitted to FDA by the

drug manufacturer following their own
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