[Federal Register Volume 71, Number 97 (Friday, May 19, 2006)]
[Notices]
[Pages 29157-29158]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-7616]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0180]


Agency Information Collection Activities; Proposed Collection; 
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 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 requirements for recordkeeping 
and reports concerning experience with approved new animal drugs. The 
information contained in the reports required by this regulation 
enables FDA to monitor the use of new animal drugs after approval and 
to ensure their continued safety and efficacy.

DATES: Submit written or electronic comments on the collection of 
information by July 18, 2006.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. Submit written comments on 
the collection of information to the Division of Dockets Management 
(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 Management 
Programs (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 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 these topics: (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.

Records and Reports Concerning Experience With Approved New Animal 
Drugs--21 CFR 514.80--(OMB Control Number 0910-0284)--Extension

    Implementation of section 512(l) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360b) and 21 CFR 514.80 requires applicants of 
approved new animal drug applications and abbreviated new animal drug 
applications (NADAs) 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 semiannually 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. The total annual responses are also based on the 
submission of reports to the Division of Surveillance, Center for 
Veterinary Medicine. The

[[Page 29158]]

annual frequency of response was calculated as the total annual 
responses divided by the number of respondents.
    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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514.80(b)(4)                                         2301                190               6.45              1,226                 11             13,486
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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                                   ...........  .................  .................  .................  .................              34827
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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 BURDEN\1\
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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                 10.35             24,623
Total                                             .................  ....................  ....................  ....................             34,316
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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 514.80(b)(1), (b)(2)(i), (b)(2)(ii), (b)(3), and Form FDA 1932.
\3\Recordkeeping estimates for 514.80(b)(2)(iii), (b)(4), (c), (b)(5), and Form FDA 2301.


    Dated: May 12, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-7616 Filed 5-18-06; 8:45 am]
BILLING CODE 4160-01-S