[Federal Register Volume 65, Number 232 (Friday, December 1, 2000)]
[Notices]
[Pages 75235-75236]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-30599]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 00-116-1]


Draft Guideline on Pharmacovigilance of Veterinary Medicinal 
Products: Management of Adverse Event Reports, VICH Topic GL24

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice of availability and request for comments.

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SUMMARY: A draft guideline titled ``Pharmacovigilance of Veterinary 
Medicinal Products: Management of Adverse Event Reports'' has been 
developed by the International Cooperation on Harmonization of 
Technical Requirements for Registration of Veterinary Medicinal 
Products (VICH). The draft guideline deals with the spontaneous 
reporting system for identification of possible adverse events 
following the use of marketed veterinary medicinal products. Because 
the draft guideline applies, in part, to veterinary biological products 
regulated by the Animal and Plant Health Inspection Service under the 
Virus-Serum-Toxin Act, 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.

DATES: We invite you to comment on the draft guidelines. We will 
consider all comments that we receive by January 30, 2001.

[[Page 75236]]


ADDRESSES: Please send four copies of your comment (an original and 
three copies) to: Docket No. 00-116-1, Regulatory Analysis and 
Development, PPD, APHIS, Suite 3C03, 4700 River Road Unit 118, 
Riverdale, MD 20737-1238.
Please state that your comment refers to Docket No. 00-116-1.
    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.
    APHIS documents published in the Federal Register, and related 
information, including the names of organizations and individuals who 
have commented on APHIS rules, are available on the Internet at http://www.aphis.usda.gov/ppd/rad/webrepor.html.
    You may request a copy of the draft guideline ``Pharmacovigilance 
of Veterinary Medicinal Products: Management of Adverse Event Reports'' 
by writing to or calling the person listed under FOR FURTHER 
INFORMATION CONTACT.

FOR FURTHER INFORMATION CONTACT: Dr. Albert P. Morgan, Center for 
Veterinary Biologics-Licensing and Policy Development, VS, APHIS, 4700 
River Road Unit 148, Riverdale, MD 20737-1231; phone (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 International Office of Epizootics (OIE, the 
Office International des Epizooties) 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 regarding 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.
    The draft document that is the subject of this notice, 
``Pharmacovigilance of Veterinary Medicinal Products: Management of 
Adverse Event Reports'' (VICH Topic GL24), has been made available by 
the VICH Steering Committee for comments by interested parties. The 
draft guideline, which defines pharmacovigilance of veterinary 
medicinal products as the detection and investigation of the effects of 
veterinary medicinal products, mainly aimed at safety and efficacy in 
animals and safety in people exposed to these products, deals with the 
spontaneous reporting system for 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 adverse event reports--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 draft document reflects current APHIS thinking on the 
generation and submission of adverse event reports concerning 
veterinary biological products. (The draft guideline refers to such 
products as ``veterinary medicinal products.'') In accordance with the 
VICH process, once a final draft of ``Pharmacovigilance of Veterinary 
Medicinal Products: Management of Adverse Event Reports'' 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, the 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 guidance document for use by U.S. veterinary biologics licensees, 
permittees, and applicants. In addition, APHIS will consider its use as 
a basis for the investigation of adverse event reports that raise 
questions regarding the purity, safety, potency, or efficacy of 
veterinary biological products under 9 CFR 116.5. APHIS may also use 
the final guidance document as the basis for proposed additions or 
amendments to its 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 
version of ``Pharmacovigilance of Veterinary Medicinal Products: 
Management of Adverse Event Reports'' may be introduced into APHIS' 
veterinary biologics regulatory program in the future, we encourage 
your comments on the draft version.

    Authority: 21 U.S.C. 151 et seq.

    Done in Washington, DC, this 22nd day of November 2000.
Craig A. Reed,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 00-30599 Filed 11-30-00; 8:45 am]
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