[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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