[Federal Register Volume 75, Number 100 (Tuesday, May 25, 2010)]
[Notices]
[Page 29352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-12454]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0241]


Draft Guidance for Industry on Data Elements for Submission of 
Veterinary Adverse Event Reports to the Center for Veterinary Medicine; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry 188 entitled 
``Data Elements for Submission of Veterinary Adverse Event Reports to 
the Center for Veterinary Medicine.'' The purpose of this draft 
guidance is to assist sponsors or non-applicants with filling out form 
FDA 1932, ``Veterinary Adverse Drug Reaction, Lack of Effectiveness, 
Product Defect Report,'' as required by FDA regulations.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
by August 9, 2010.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Communications Staff (HFV-12), Center for Veterinary Medicine, Food 
and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments on the draft guidance to 
the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lynn Post, Center for Veterinary 
Medicine (HFV-210), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-276-9191, email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
188 entitled ``Data Elements for Submission of Veterinary 
Adverse Event Reports to the Center for Veterinary Medicine.'' The 
purpose of this draft guidance is to assist sponsors or non-applicants 
with filling out Form FDA 1932, in both paper and electronic format. 
Section 512(l) of the Federal Food, Drug and Cosmetic Act (the act) (21 
U.S.C. 360b(l)) and Sec.  514.80(b) (21 CFR 514.80(b)) require 
applicants of approved new animal drug applications (NADAs) and 
approved abbreviated new animal drug applications (ANADAs) to report 
adverse drug experiences and product/manufacturing defects.
    This continuous monitoring of approved NADAs and ANADAs 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 no longer be adequate, as animal drug effects can 
change over time and less apparent effects may take years to manifest. 
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.''

II. Significance of Guidance

    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance, 
when finalized, will represent the agency's current thinking on this 
topic. It does not create or confer any rights for or on any person and 
does not operate to bind FDA or the public. An alternative approach may 
be used if such approach satisfies the requirements of the applicable 
statutes and regulations.

III. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in section 512(l) of the act and Sec.  
514.80 have been approved under OMB Control No. 0910-0645.

IV. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

V. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at either http://www.fda.gov/AnimalVeterinary/default.htm or http://www.regulations.gov.

    Dated: May 19, 2010.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2010-12454 Filed 5-24-10; 8:45 am]
BILLING CODE 4160-01-S