Agency Information Collection Activities; Submission for OMB Review; Comment Request; Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N-0308]

Agency Information Collection Activities; Submission for OMB

Review; Comment Request; Veterinary Adverse Drug Reaction, Lack of

Effectiveness, Product Defect Report

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the

proposed collection of information listed below has been submitted to

the Office of Management and Budget (OMB) for review and clearance

under the Paperwork Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the collection of information by

December 18, 1998.

ADDRESSES: Submit written comments on the collection of information to

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.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Information

Resources Management (HFA-250), Food and Drug Administration, 5600

Fishers Lane, rm. 16B-26, Rockville, MD 20857, 301-827-1472.

SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the PRA

(44 U.S.C. 3507), FDA has submitted the following proposed collection

of information to OMB for review and clearance.

Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product

Defect Report--21 CFR Part 510--(OMB Control Number 0910-0012)

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 new animal drug applications (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. 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. Form FDA 2301 is used 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.

In the Federal Register of June 10, 1998 (63 FR 31788), the agency

requested comments on the proposed collection of information using the

reporting forms cited previously. In response, FDA received one comment

to the docket. The comment expressed favor in submitting adverse drug

reactions, lack of effectiveness and product defect reports (data),

electronically and suggested that Form FDA 1932 be formatted in

industry standard format (Microsoft Word or Word Perfect), so that

these data can be submitted electronically. The Center for Veterinary

Medicine (CVM), is developing procedures for electronic submission of

adverse drug reactions, lack of effectiveness and product defects.

Currently, CVM is not able to accept electronic submission of this

specific data until the electronic submission data standards are in

place and the hardware/software technology is set up. In the meantime,

the current regulations do allow for acceptance of computerized reports

under 21 CFR 510.302(c)(1), in lieu of Form FDA 1932. The information

contained in a computerized report and the sequence in which it is

presented must be equivalent to that required in the hard copy of Form

FDA 1932 and should include the valid OMB control number identified

with Form FDA 1932, i.e., 0910-0012. The computerized report must be

submitted in duplicate to CVM for approval prior to initial use.

Further, once the forms are approved and disseminated for use, CVM will

post electronic copies via the Worldwide

[[Page 64091]]

Web (WWW). Both the computerized report and forms available via the WWW

must be submitted via paper.

FDA estimates the burden for this collection of information as

follows:

Table 1.--Estimated Annual Reporting Burden1

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Annual

Form No. 21 CFR Section No. of Frequency per Total Annual Hours per Total Hours

Respondents Response Responses Response

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Form FDA 2301 510.302a 190 19.74 3,750 0.5 1,875

Form FDA 1932 510.302b 190 15.25 2,900 1.0 2,900

Form FDA 1932a

(voluntary) 510.302b 100 1.0 100 1.0 100

Total Burden

Hours 4,875

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

information.

Table 2.--Estimated Annual Recordkeeping Burden1

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Annual Total Annual

21 CFR Section No. of Frequency per Response per Hours per Total Hours

Recordkeepers Recordkeeping Recordkeeper Recordkeeper

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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

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\1\ There 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: November 10, 1998.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 98-30752 Filed 11-17-98; 8:45 am]

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