[Federal Register Volume 78, Number 205 (Wednesday, October 23, 2013)]
[Notices]
[Page 63221]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-24803]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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.

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

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

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 guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Margarita Brown, Center for Veterinary 
Medicine (HFV-241), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-276-9048. [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of May 25, 2010 (75 FR 29352), FDA 
published the notice of availability for a draft guidance 188 
entitled ``Data Elements for Submission of Veterinary Adverse Event 
Reports to the Center for Veterinary Medicine,'' giving interested 
persons until August 9, 2010, to comment on the draft guidance. FDA 
made changes to the draft document in response to these comments, to 
clarify the information that we expect to receive, to reflect ongoing 
International Cooperation on Harmonization of Technical Requirements 
for Registration of Veterinary Medicinal Products (VICH) activities in 
which FDA is participating, and to provide direction for voluntary use 
of CVM internal terms for medication errors. In addition, editorial 
changes were made to improve clarity. The guidance announced in this 
notice finalizes the draft guidance dated May 24, 2010.

II. Significance of Guidance

    This level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
the Agency's current thinking on the 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 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 Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360b(l)) have been approved under 0910-
0645.

IV. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of 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, and will be posted to the docket at http://www.regulations.gov.

V. Electronic Access

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

    Dated: October 18, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-24803 Filed 10-22-13; 8:45 am]
BILLING CODE 4160-01-P