[Federal Register Volume 79, Number 237 (Wednesday, December 10, 2014)]
[Notices]
[Pages 73323-73324]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-28830]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0588]


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products; 
Guidance for Industry on Pharmacovigilance of Veterinary Medicinal 
Products: Electronic Standards for Transfer of Data; 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 (GFI #214) entitled 
``Pharmacovigilance of Veterinary Medicinal Products: Electronic 
Standards for Transfer of Data'' (VICH GL35). This guidance has been 
developed for veterinary use by the International Cooperation on 
Harmonisation of Technical Requirements for Registration of Veterinary 
Medicinal Products (VICH). This VICH guidance document is intended to 
provide recommended standards to construct a single Adverse Event 
Report (AER) electronic message to transmit VICH GL42 contents to all 
member regions and Product Problem Reports (PPR) to FDA for veterinary 
medicinal products. Please note that VICH GL42 has been harmonized in 
GFI #188, ``Data Elements for Submission of Veterinary Adverse Event 
Reports to the Center for Veterinary Medicine.''

DATES: Submit either electronic or written comments on Agency guidance 
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 request. 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 on the 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: Margarita Brown, Center for Veterinary 
Medicine (HFV-240), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-276-9048, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    In recent years, many important initiatives have been undertaken by 
regulatory authorities and industry associations to promote the 
international harmonization of regulatory requirements. FDA has 
participated in efforts to enhance harmonization and has expressed its 
commitment to seek scientifically based, harmonized technical 
procedures for the development of pharmaceutical products. One of the 
goals of harmonization is to identify, and then reduce, differences in 
technical requirements for drug development among regulatory agencies 
in different countries.
    FDA has actively participated in the International Conference on 
Harmonisation of Technical Requirements for Registration of 
Pharmaceuticals for Human Use for several years to develop harmonized 
technical requirements for the approval of human pharmaceutical and 
biological products among the European Union, Japan, and the United 
States. The VICH is a parallel initiative for veterinary medicinal 
products. The VICH is concerned with developing harmonized technical 
requirements for the approval of veterinary medicinal products in the 
European Union, Japan, and the United States, and includes input from 
both regulatory and industry representatives.
    The VICH Steering Committee is composed of member representatives 
from the European Commission, European Medicines Evaluation Agency, 
European Federation of Animal Health, Committee on Veterinary Medicinal 
Products, FDA, U.S. Department of Agriculture, the Animal Health 
Institute, the Japanese Veterinary Pharmaceutical Association, the 
Japanese Association of Veterinary Biologics, and the Japanese Ministry 
of Agriculture, Forestry, and Fisheries.
    Six observers are eligible to participate in the VICH Steering 
Committee: One representative from the government of Australia/New 
Zealand, one representative from the industry in Australia/New Zealand, 
one representative from the government of Canada, one representative 
from the industry of Canada, one representative from the government of 
South Africa, and one representative from the industry of South Africa. 
The VICH Secretariat, which coordinates the preparation of 
documentation, is provided by the International

[[Page 73324]]

Federation for Animal Health (IFAH). An IFAH representative also 
participates in the VICH Steering Committee meetings.

II. Guidance on Electronic Standards for Transfer of Data

    In the Federal Register of September 15, 2011 (76 FR 57060), FDA 
published a notice of availability for a draft guidance document 
entitled ``Pharmacovigilance of Veterinary Medicinal Products: 
Electronic Standards for Transfer of Data'' (VICH GL35). Interested 
persons were given until November 14, 2011, to comment on the draft 
guidance. FDA received a few comments on the draft guidance, and those 
comments, as well as those received by other VICH member regulatory 
agencies, were considered as the guidance was finalized. The guidance 
announced in this document finalizes the draft guidance dated September 
15, 2011. The final guidance is a product of the Pharmacovigilance 
Expert Working Group of the VICH.
    In order to allow for electronic exchange of this information 
between stakeholders, further specification of the field descriptors 
and their relationships, including agreement on format of the 
electronic message is essential. This VICH guidance document is 
intended to provide recommended standards to construct a single 
electronic message to transmit data elements for submission of AERs to 
all member regions. The need to transfer and disseminate information 
quickly, accurately and easily between Regulatory Authorities and 
Marketing Authorization Holders on a worldwide scope is especially 
pertinent to the notification and assimilation of information for 
pharmacovigilance. Whereas the recommended definition of the 
pharmacovigilance information has been set forth within the draft 
guidance entitled, ``Pharmacovigilance of Veterinary Medicinal 
Products: Management of Adverse Event Reports (AER's)'' (VICH GL24), 
and the final guidances entitled ``Pharmacovigilance of Veterinary 
Medicinal Products: Controlled Lists of Terms'' (VICH GL30) and 
``Pharmacovigilance of Veterinary Medicinal Products: Data Elements for 
Submission of Adverse Event Reports'' (VICH GL42), this guidance 
defines recommended electronic standards for transfer of data. Please 
note that VICH GL42 has been harmonized in GFI #188, ``Data Elements 
for Submission of Veterinary Adverse Event Reports to the Center for 
Veterinary Medicine.''

III. Significance of Guidance

    This guidance, developed under the VICH process, has been revised 
to conform to FDA's good guidance practices regulation (21 CFR 10.115). 
For example, the document has been designated ``guidance'' rather than 
``guideline.'' In addition, guidance documents must not include 
mandatory language such as ``shall,'' ``must,'' ``require,'' or 
``requirement,'' unless FDA is using these words to describe a 
statutory or regulatory requirement.
    The guidance represents 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 applicable 
statutes and regulations.

IV. 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 this guidance have been approved under 
OMB control number 0910-0645.

V. Comments

    Interested persons may submit either electronic comments regarding 
this document to 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.

VI. 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: December 4, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28830 Filed 12-9-14; 8:45 am]
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