06-8023. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Records and Reports Concerning Experience With Approved New Animal Drugs

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

DATES:

Fax written comments on the collection of information by October 23, 2006.

ADDRESSES:

To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: [phone].

FOR FURTHER INFORMATION CONTACT:

Denver Presley, Office of Management Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472.

SUPPLEMENTARY INFORMATION:

In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

Records and Reports Concerning Experience With Approved New Animal Drugs—21 CFR 518.80—(OMB Control No. 0910-0284)—Extension

Implementation of section 512(l) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(l)) and § 514.80 (21 CFR 514.80) requires applicants of approved new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) to submit product/manufacturing defects, initial and followup reports for adverse drug experiences and lack of effectiveness of new animal drugs, increased frequency 15-day alert reports, periodic drug experience reports (annually or semi-annually in a specific format), and other reports (special drug experience reports, advertisement and promotional material submissions, and distributor statements).

This continuous monitoring of approved NADAs affords the primary means by which FDA obtains information regarding potential problems in safety and effectiveness of marketed animal drugs and potential manufacturing problems. Current data 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.

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 detection of a problem or complaints from product users or their veterinarians using FDA forms 1932 and 1932a. Form FDA 2301 is used to submit the required transmittal of periodic reports and promotional material for new animal drugs. The reporting and recordkeeping burden estimates are based on the submission of reports to the Division of Surveillance, Center for Veterinary Medicine (CVM). The total annual responses are also based on the submission of reports to the Division of Surveillance, CVM. The annual frequency of response was calculated as the total annual responses divided by the number of respondents.

In the Federal Register of May 19, 2006 (71 FR 29157), FDA published a 60-day notice requesting public comment on the information collection provisions. In response to this notice, FDA received seven comments, four of which required a response by CVM that are addressed as follows: One comment stated that FDA's estimate for the burden of the proposed collection of information seems unrealistic and inaccurate. The comment proposed 16 hours of response time for Drug Experience Reports (DER), and 49 hours for recordkeeping for each DER. FDA agrees that 16 hours is a reasonable response time required to make a DER report. In view of increased reporting requirements under § 514.80 (b)(4), CVM has increased the “Hours per Response” under this citation in “Table 1—Estimated Annual Reporting Burden,” from 11 to 16 hours thereby increasing the total burden hours to 19,616. The comment also proposed 49 hours response time per record for each DER. However, based on CVM's experience and previous surveys of industry, the 49 hours of response per record for each DER is excessive. In view of increased requirements, under § 514.80(e)³, CVM has increased the “Hours per Record” under this citation in “Table 2—Estimated Annual Recordkeeping Burden,” from 10.35 to 14 hours, thereby increasing the total burden hours to 33,320.

Another comment suggested that the burden collections may be potentially reduced by: (1) Reducing submission requirements with established safety and (2) by automating the information collection system. FDA agrees with the comment regarding both suggestions. Under § 514.80(b)(4), it states for yearly periodic DER reports, an applicant may petition FDA to change the anniversary date and/or change the frequency of reporting. Regarding the comment suggesting automation of the information collection system, future burden estimates for collections of information will be considered when automated reporting requirements are implemented by FDA.

Another comment wanted to know the purpose for submitting a periodic report for a known event for a product with an established record. As previously stated, under § 514.80(b)(4), an applicant may petition FDA to change the anniversary date and/or change the frequency of reporting.

The respondents to this collection of information are applicants of approved NADAs and ANADAs.

FDA estimates the burden of this collection of information as follows:

Table 1.—ESTIMATED ANNUAL REPORTING BURDEN¹

21 CFR Section	FDA Form No.	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Hours
514.80(b)(1)	1932	190	0.50	95	1	95
514.80(b)(2)(i)	1932	190	64.65	12,283	1	12,283
514.80(b)(2)(ii)	1932	190	31.62	6,007	1	6,007
514.80(b)(3)	1932	340	2.94	1,000	1	1,000
Voluntary reporting FDA Form 1932a for public	1923a	250	1	250	1	250
514.80(b)(4)	2301	190	6.45	1,226	16	19,616
514.80(b)(5)(i)	2301	190	0.13	25	2	50
514.80(b)(5)(ii)	2301	190	4.06	772	2	1544
514.80(b)(5)(iii)	2301	530	0.11	56	2	112
Total Hours						40,957
1 There 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 Record	Total Hours
514.80(e)2	530	36.58	19,385	0.5	9,693
514.80(e)3	530	4.49	2,379	14	33,320
Total					43,013
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Recordkeeping estimates for § 514.80(b)(1), (b)(2)(i), (b)(2)(ii), and (b)(3); Form FDA 1932.
3 Recordkeeping estimates for § 514.80(b)(2)(iii), (b)(4), (b)(5), and (c); Form FDA 2301.

The reporting and recordkeeping burden estimates for this collection of information are based on the submission of reports to the Division of Surveillance, CVM. The total annual response numbers are also based on the submission of reports to the Division of Surveillance, CVM. The annual frequency of response was calculated as the total annual responses divided by the number of respondents.

Dated: September 15, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.