Document ID: FDA-2014-N-1409-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection;
Comment Request; Records and Reports Concerning Experiences With
Approved New Animal Drugs: Adverse Event Reports
Posted Date: 2014-09-29T04:00Z

[Federal Register Volume 79, Number 188 (Monday, September 29, 2014)]
[Notices]
[Pages 58355-58357]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-23059]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1409]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Records and Reports Concerning Experiences With 
Approved New Animal Drugs: Adverse Event Reports

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 adverse event reporting by FDA 
on new animal drugs and product/manufacturing defects collected on 
paper forms.

DATES: Submit either electronic or written comments on the collection 
of information by November 28, 2014.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

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

[[Page 58356]]

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 Experiences With Approved New Animal 
Drugs: Adverse Event Reports on Paper Forms FDA 1932, 1932a, and 2301--
21 CFR 514.80; OMB Control Number 0910-0284--Extension

    Section 512(l) of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 360b(l) and 514.80 (21 CFR 514.80) of FDA 
regulations require applicants of approved new animal drug applications 
(NADAs) and abbreviated new animal drug applications (ANADAs) to report 
adverse drug experiences and product/manufacturing defects (see Sec.  
514.80)(b)). Additionally, Section 571(e)(3) of the FD&C Act (21 U.S.C. 
360ccc(e)(3)) requires that applicants for conditional approval of new 
animal drugs (CNADAs) maintain adequate reports and records of adverse 
drug experiences and product/manufacturing defects as applicable under 
section 512(l) of the FD&C Act.
    The continuous monitoring of approved NADAs, ANADAs, and CNADAs 
affords the primary means by which FDA obtains information regarding 
potential problems with the safety and efficacy of marketed approved 
new animal drugs as well as potential product/manufacturing problems. 
Post-approval marketing surveillance is important because data 
previously submitted to FDA may not be adequate as animal drug effects 
can change over time and less apparent effects may take years to 
manifest.
    Under Sec.  514.80(d), an applicant must report adverse drug 
experiences and product/manufacturing defects on Form FDA 1932, 
``Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product 
Defect Report.'' Periodic drug experience reports and special drug 
experience reports must be accompanied by a completed Form FDA 2301, 
``Transmittal of Periodic Reports and Promotional Material for New 
Animal Drugs,'' (see Sec.  514.80). Form FDA 1932a, ``Veterinary 
Adverse Drug Reaction, Lack of Effectiveness or Product Defect 
Report,'' allows for voluntary reporting of adverse drug experiences or 
product/manufacturing defects.
    In 2010, electronic versions of Forms FDA 1932 and 1932a were 
incorporated into the FDA Safety Reporting Portal. This electronic 
system is used for collecting, submitting, and processing adverse event 
reports and other safety information for all FDA-regulated products. 
Burden for the electronic version of these forms is accounted for under 
OMB control number 0910-0645. This approval request accounts for the 
collection of information using existing paper Forms FDA 1932, 1932a, 
and 2301 and is currently approved under OMB control number 0910-0284. 
FDA estimates that, at this time, approximately 50 percent of the 
respondents utilize paper forms for submitting this information. We 
expect this number to decrease as more respondents make use of the FDA 
Safety Reporting Portal.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                   FDA                      Number of
  21 CFR Section or section of     form      Number of    responses per   Total annual   Average burden   Total
          the FD&C Act             No.      respondents     respondent      responses     per response    hours
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514.80(b)(1), 514.80(b)(2)(i)       1932              22          81.05           1,783               1    1,783
 and (ii), 514.80(b)(3)........
Voluntary reporting FDA Form       1932a             197           1                197               1      197
 1932a for the public..........
514.80(b)(4)...................     2301             200           8.11           1,622              16   25,952
514.80(b)(5)(i)................     2301             200           0.57             114               2      228
514.80(b)(5)(ii)...............     2301             200          20.12           4,024               2    8,048
514.80(b)(5)(iii)..............     2301             190           0.1               20               2       40
                                --------------------------------------------------------------------------------
    Total Hours................  .......  ..............  .............  ..............  ..............   36,248
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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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                                                                                         Number of                       Average burden
                           21 CFR Section                               Number of       records per      Total annual      per record      Total hours
                                                                      record keepers   record keeper       records          keeping
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514.80(e)..........................................................             646             7.20             4651               14            65117
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

[[Page 58357]]

    Dated: September 23, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-23059 Filed 9-26-14; 8:45 am]
BILLING CODE 4164-01-P