[Federal Register Volume 71, Number 184 (Friday, September 22, 2006)]
[Notices]
[Pages 55482-55484]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 06-8023]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0180]


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.

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

[[Page 55483]]

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: 202-395-6974.

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 Sec.  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 Sec.  
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 Sec.  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 
Sec.  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 Sec.  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 BURDEN\1\
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                                                FDA Form         No. of        Annual Frequency     Total Annual        Hours per
               21 CFR Section                     No.         Respondents        per Response        Responses           Response         Total Hours
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514.80(b)(1)                                         1932                190               0.50                 95                  1                 95
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514.80(b)(2)(i)                                      1932                190              64.65             12,283                  1             12,283
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514.80(b)(2)(ii)                                     1932                190              31.62              6,007                  1              6,007
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514.80(b)(3)                                         1932                340               2.94              1,000                  1              1,000
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Voluntary reporting FDA Form 1932a for              1923a                250                  1                250                  1                250
 public
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[[Page 55484]]

 
514.80(b)(4)                                         2301                190               6.45              1,226                 16             19,616
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514.80(b)(5)(i)                                      2301                190               0.13                 25                  2                 50
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514.80(b)(5)(ii)                                     2301                190               4.06                772                  2               1544
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514.80(b)(5)(iii)                                    2301                530               0.11                 56                  2                112
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Total Hours                                   ...........  .................  .................  .................  .................             40,957
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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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                                                        No. of         Annual Frequency
                 21 CFR Section                     Recordkeepers      per Recordkeeping   Total Annual Records    Hours per Record       Total Hours
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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
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\Recordkeeping estimates for Sec.   514.80(b)(1), (b)(2)(i), (b)(2)(ii), and (b)(3); Form FDA 1932.
\3\Recordkeeping estimates for Sec.   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.
[FR Doc. 06-8023 Filed 9-21-06; 8:45 am]
BILLING CODE 4160-01-S