[Federal Register Volume 71, Number 11 (Wednesday, January 18, 2006)]
[Notices]
[Pages 2903-2904]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-445]


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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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