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###### Department of Agriculture

###### Animal and Plant Health Inspection Service 

          - [Docket No. 00-116-1] 

# AGENCY:

Animal and Plant Health Inspection Service, USDA. 

# ACTION:

Notice of availability and request for comments. 

# 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. 

      ( print 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] 

BILLING CODE 3410-34-U