Federal Register / Vol. 66, No. 103 / Tuesday, May 29, 2001 / Notices 29141

collection of information between 30

and 60 days after publication of this

document in the Federal Register.

Therefore, a comment is best assured of

having its full effect if OMB receives it

within 30 days of publication. Written

comments and recommendations for the

proposed information collection should

be sent directly to the following: Office

of Management and Budget, Paperwork

Reduction Project, 725 17th Street, NW.,

Washington, DC 20503, Attn: Desk

Officer for ACF.

Dated: May 22, 2001.

Bob Sargis,

Reports Clearance Officer.

[FR Doc. 01–13318 Filed 5–25–01; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0231]

Agency Information Collection

Activities; Proposed Collection;

Comment Request; Veterinary Adverse

Drug Reaction, Lack of Effectiveness,

Product Defect Report

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

extension 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

(NADAs) and abbreviated new animal

drug applications (ANADAs) to submit

information on adverse drug reactions,

lack of effectiveness, and product

defects.

DATES: Submit written or electronic

comments on the collection of

information by July 30, 2001.

ADDRESSES: Submit electronic

comments on the collection of

information to http://

www.accessdata.fda.gov/scripts/oc/

dockets/edockethome.cfm. Submit

written comments on the collection of

information to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. 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 set forth in this document.

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

No. 0910–0012)—Extension

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 NADAs 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. Product defects

and lack of effectiveness complaints are

submitted to FDA by the drug

manufacturer following their own

detection of a problem or complaints

from product users or their veterinarians

also using FDA forms 1932 and 1932a.

FDA form 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 NADAs.

FDA estimates the burden for this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Form No. 21 CFR Section No. of

Respondents

Annual Frequency

per Response

Total Annual

Responses

Hours per

Response Total Hours

Form FDA 2301 510.302(a) 190 13.16 2,500 0.5 1,250

Form FDA 1932 510.302(b) 190 94.74 18,000 1.0 18,000

29142 Federal Register / Vol. 66, No. 103 / Tuesday, May 29, 2001 / Notices

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued

Form No. 21 CFR Section No. of

Respondents

Annual Frequency

per Response

Total Annual

Responses

Hours per

Response Total Hours

Form FDA 1932a

(voluntary) 510.302(b) 100 1.0 100 1.0 100

Total burden

hours 19,350

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

Response per

Recordkeeper

Hours per

Recordkeeper Total Hours

510.300(a) and 510.301(a) 190 13.16 2,500 10.35 25,875

510.300(b) and 510.301(b) 190 94.74 2,900 0.50 9,000

Total burden hours 34,875

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: May 18, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 01–13298 Filed 5–25–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0222]

Agency Information Collection

Activities; Proposed Collection;

Comment Request; Medical Devices;

Third-Party Review Under FDAMA

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

extension of an existing collection of

information, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

information collection requirements for

medical devices; third-party review

under the Food and Drug

Administration Modernization Act of

1997 (FDAMA).

DATES: Submit written or electronic

comments on the collection of

information by July 30, 2001.

ADDRESSES: Submit electronic

comments on the collection of

information to http://

www.accessdata.fda.gov/scripts/oc/

dockets/edockethome.cfm. Submit

written comments on the collection of

information to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. All

comments should be identified with the

docket number found in brackets in the

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Peggy Schlosburg, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1223.

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 extension of an

existing collection of information,

before submitting the collection to OMB

for approval. To comply with this

requirement, FDA is publishing notice

of the proposed collection of

information set forth in this document.

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.

Medical Devices; Third-Party Review

Under FDAMA (OMB Control No.

0910–0375)—Extension

Section 210 of FDAMA established a

new section 523 of the Federal Food,

Drug, and Cosmetic Act (the act),

directing FDA to accredit persons in the

private sector to review certain

premarket applications and

notifications. As with the third-party

pilot program conducted previously by

FDA, participation in this third-party

review program by accredited persons is

entirely voluntary. A third party

wishing to participate will submit a

request for accreditation. Accredited

third-party reviewers have the ability to

review a manufacturer’s 510(k)