[Federal Register Volume 66, Number 234 (Wednesday, December 5, 2001)]
[Notices]
[Pages 63212-63214]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-30108]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 01-099-1]


Draft Guidelines on Pharmacovigilance of Veterinary Medicinal 
Products: Management of Periodic Summary Update Reports (PSUs) (VICH 
Topic GL29) and Pharmacovigilance of Veterinary Medicinal Products: 
Controlled List of Terms (VICH Topic GL30)

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice of availability and request for comments.

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[[Page 63213]]

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 Periodic Summary Update 
Reports (PSUs)'' and ``Pharmacovigilance of Veterinary Medicinal 
Products: Controlled List of Terms.'' These draft guidelines provide, 
respectively, recommendations for the management of the detection and 
investigation of the clinical effects of marketed veterinary medicinal 
products and the terminology used to describe veterinary medicinal 
products, animals, clinical signs, and associated body systems and 
organs in adverse event reports. 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 invite you to comment on this docket. We will consider all 
comments we receive that are postmarked, delivered, or e-mailed by 
February 4, 2002.

ADDRESSES: You may submit comments by postal mail/commercial delivery 
or by e-mail. If you use postal mail/commercial delivery, please send 
four copies of your comment (an original and three copies) to: Docket 
No. 01-099-1, Regulatory Analysis and Development, PPD, APHIS, Station 
3C71, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state 
that your comment refers to Docket No. 01-099-1. If you use e-mail, 
address your comment to [email protected]. Your comment must 
be contained in the body of your message; do not send attached files. 
Please include your name and address in your message and ``Docket No. 
01-099-1'' on the subject line.
    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 dockets, are available on the Internet at 
http://www.aphis.usda.gov/ppd/rad/webrepor.html.
    You may request copies of the draft guidelines ``Pharmacovigilance 
of Veterinary Medicinal Products: Management of Periodic Update Summary 
Reports (PSUs)'' and ``Pharmacovigilance of Veterinary Medicinal 
Products: Controlled List of Terms'' by contacting 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; (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 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 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 Periodic Summary Update Reports (PSUs)'' (VICH Topic 
GL29), is intended to provide general recommendations for the 
management of the detection and investigation of the clinical effects 
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 
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: Controlled List of Terms'' (VICH Topic GL30), is 
intended to provide a controlled list of terminology for describing 
clinical signs and associated body systems and organs for reporting an 
adverse event associated with the use of veterinary medicinal products. 
Again, because the draft guideline applies to some veterinary 
biological products regulated by APHIS under the Virus-Serum-Toxin 
Act--particularly with regard to ensuring that consistent terminology 
is used to describe an adverse event associated with the use of a 
veterinary medicinal product--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 the management of PSUs and the appropriate terminology for 
use in describing an adverse event concerning the use of veterinary 
biological 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

[[Page 63214]]

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 
Periodic Summary Update Reports (PSUs)'' and ``Pharmacovigilance of 
Veterinary Medicinal Products: Controlled List of Terms'' 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 29th day of November 2001.
W. Ron DeHaven,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 01-30108 Filed 12-4-01; 8:45 am]
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