[Federal Register: January 18, 2006 (Volume 71, Number 11)]
[Notices]
[Page 2903-2904]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18ja06-17]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
[Docket No. 05-092-1]
Draft Guidelines on Pharmacovigilance of Veterinary Medicinal
Products: Management of Adverse Event Reports (VICH Topic GL24) and
Data Elements for Submission of Adverse Event Reports (VICH Topic GL42)
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice of availability and request for comments.
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SUMMARY: The International Cooperation on Harmonization of Technical
Requirements for the Registration of Veterinary Medicinal Products
(VICH) has developed two draft guidelines titled ``Pharmacovigilance of
Veterinary Medicinal Products: Management of Adverse Event Reports''
and ``Pharmacovigilance of Veterinary Medicinal Products: Data Elements
for Submission of Adverse Event Reports.'' These draft guidelines
describe, respectively, standardized terminology for the identification
of possible adverse events following the use of veterinary medicinal
products, and the specific data elements to be used for the submission
and exchange of spontaneous adverse event reports between marketing
authorization holders (licensees/permittees) and regulatory
authorities. Because the draft guidelines apply to pharmacovigilance
and adverse event reporting on veterinary vaccines regulated by the
Animal and Plant Health Inspection Service under the Virus-Serum-Toxin
Act, we are requesting comments on the scope of each guideline and its
provisions so that we may include any relevant public input on the
drafts in the Agency's comments to the VICH Steering Committee.
DATES: We will consider all comments that we receive on or before March
20, 2006.
ADDRESSES: You may submit comments by either of the following methods:
Federal eRulemaking Portal: Go to http://www.regulations.gov
and, in the ``Search for Open Regulations'' box,
select ``Animal and Plant Health Inspection Service'' from the agency
drop-down menu, then click on ``Submit.'' In the Docket ID column,
select APHIS-2005-0121 to submit or view public comments and to view
supporting and related materials available electronically. After the
close of the comment period, the docket can be viewed using the
``Advanced Search'' function in Regulations.gov.
Postal Mail/Commercial Delivery: Please send four copies
of your comment (an original and three copies) to Docket No. 05-092-1,
Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700
River Road Unit 118, Riverdale, MD 20737-1238. Please state that your
comment refers to Docket No. 05-092-1.
Reading Room: You may read any comments that we receive on this
docket in our reading room. The reading room is located in room 1141 of
the USDA South Building, 14th Street and Independence Avenue SW.,
Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m.,
Monday through Friday, except holidays. To be sure someone is there to
help you, please call (202) 690-2817 before coming.
Other Information: Additional information about APHIS and its
programs is available on the Internet at http://www.aphis.usda.gov. You
may request copies of the draft guidelines ``Pharmacovigilance of
Veterinary Medicinal Products: Management of Adverse Event Reports''
and ``Pharmacovigilance of Veterinary Medicinal Products: Data Elements
for Submission of Adverse Event Reports'' from the person listed under
FOR FURTHER INFORMATION CONTACT.
FOR FURTHER INFORMATION CONTACT: Dr. Albert P. Morgan, Center for
Veterinary Biologics--Policy Evaluation and Licensing, VS, APHIS, 4700
River Road Unit 148, Riverdale, MD 20737-1231; (301) 734-8245.
SUPPLEMENTARY INFORMATION: The International Cooperation on
Harmonization of Technical Requirements for the Registration of
Veterinary Medicinal Products (VICH) is a unique project conducted
under the auspices of the World Organization for Animal Health that
brings together the regulatory authorities of the European Union,
Japan, and the United States and representatives from the animal health
industry in the three regions. The purpose of VICH is to harmonize
technical requirements for veterinary products (both drugs and
biologics). Regulatory authorities and industry experts from Australia
and New Zealand participate in an observer capacity. The World
Federation of the Animal Health Industry (COMISA, the Confederation
Mondiale de L'Industrie de la Sante Animale) provides the secretarial
and administrative support for VICH activities.
The United States Government is represented in VICH by the Food and
Drug Administration (FDA) and the Animal and Plant Health Inspection
Service (APHIS). The FDA provides expertise on veterinary drugs, while
APHIS fills a corresponding role for veterinary biological products. As
VICH members, APHIS and FDA participate in efforts to enhance
harmonization and have expressed their commitment to seeking
scientifically based, harmonized technical requirements for the
development of veterinary drugs and biological products. One of the
goals of harmonization is to identify and reduce the differences in
technical requirements for veterinary drugs and biologics among
regulatory agencies in different countries.
Two draft guidelines have been made available by the VICH Steering
Committee for comments by interested parties. The first draft
guideline, ``Pharmacovigilance of Veterinary Medicinal Products:
Management of Adverse Event Reports'' (VICH Topic GL24), is intended to
standardize terminology for the identification of possible adverse
events following the use of marketed veterinary medicinal products.
Because the draft guideline applies to some veterinary biological
products regulated by APHIS under the Virus-Serum-Toxin Act--
particularly with regard to terminology used for adverse event
reporting--we are requesting comments on its provisions so that we may
include any relevant public input on the draft in the Agency's comments
to the VICH Steering Committee.
The second draft guideline, ``Pharmacovigilance of Veterinary
Medicinal Products: Data Elements for Submission of Adverse Event
Reports'' (VICH Topic GL42), describes the
[[Page 2904]]
specific data elements to be used for the submission and exchange of
spontaneous adverse event reports between marketing authorization
holders (licensees/permittees) and regulatory authorities. Again,
because the draft guideline applies to some veterinary biological
products regulated by APHIS under the Virus-Serum-Toxin Act--
particularly with regard to the data elements that are required to be
included in the Adverse Event Report--we are requesting comments on its
provisions so that we may include any relevant public input on the
draft in the Agency's comments to the VICH Steering Committee.
The two draft guidelines reflect, respectively, current APHIS
thinking on terminology used for the identification of adverse events,
and data elements to be used for the submission and exchange of
spontaneous Adverse Event Reports between marketing authorization
holders (licensees/permittees) and regulatory authorities concerning
the clinical effects of marketed veterinary medicinal products. In
accordance with the VICH process, once a final draft of each document
has been approved, the guideline will be recommended for adoption by
the regulatory bodies of the European Union, Japan, and the United
States. As with all VICH documents, each final guideline will not
create or confer any rights for or on any person and will not operate
to bind APHIS or the public. Further, the VICH guidelines specifically
provide for the use of alternative approaches if those approaches
satisfy applicable regulatory requirements.
Ultimately, APHIS intends to consider the VICH Steering Committee's
final guidelines for use by U.S. veterinary biologics licensees,
permittees, and applicants. In addition, we may consider the use of
each final guideline as the basis for proposed amendments to the
regulations in 9 CFR chapter I, subchapter E (Viruses, Serums, Toxins,
and Analogous Products; Organisms and Vectors). Because we anticipate
that applicable provisions of the final versions of ``Pharmacovigilance
of Veterinary Medicinal Products: Management of Adverse Event Reports''
and ``Pharmacovigilance of Veterinary Medicinal Products: Data Elements
for Submission of Adverse Event Reports'' may be introduced into APHIS'
veterinary biologics regulatory program in the future, we encourage
your comments on the draft guidelines.
Authority: 21 U.S.C. 151 et seq.
Done in Washington, DC, this 11th day of January 2006.
Paul R. Eggert,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E6-445 Filed 1-17-06; 8:45 am]
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