Agency Information Collection Activities: Proposed Collection; Comment Request

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.

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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

[[Page 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

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Annual

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

Respondents Response Responses Response

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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

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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

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

Recordkeepers Recordkeeping Records 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: 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