Document ID: FDA-2014-N-1409-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Records and Reports Concerning Experiences With Approved New Animal Drugs: Adverse Event Reports
Posted Date: 2014-12-16T05:00Z

[Federal Register Volume 79, Number 241 (Tuesday, December 16, 2014)]
[Notices]
[Pages 74728-74729]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-29426]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 January 
15, 2015.

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: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0284. 
Also include the FDA 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 Road; COLE-14526, Silver 
Spring, MD 20993-0002 PRAStaff@fda.hhs.gov.

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 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 
514.80)(b)). Additionally, section 571(e)(3) of the FD&C Act (21 U.S.C. 
360ccc(e)(3)) requires that

[[Page 74729]]

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 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 
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 avail themselves of 
the FDA Safety Reporting Portal.
    In the Federal Register of September 29, 2014 (79 FR 58355), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                             Number of
         21 CFR section/section of the FD&C act            FDA form No.      Number of     responses per   Total annual   Average burden    Total hours
                                                                            respondents     respondent       responses     per response
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514.80(b)(1), 514.80(b)(2)(i) and (ii), 514.80(b)(3)....            1932              22           81.05           1,783               1           1,783
Voluntary reporting FDA Form 1932a for the public.......           1932a             197               1             197               1             197
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
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    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         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
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514.80(e).......................             646            7.20            4651              14          65,117
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: December 10, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-29426 Filed 12-15-14; 8:45 am]
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