01-30108. 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 ...

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice of availability and request for comments.

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 [e-mail]. 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 [phone] 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; [phone].

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 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.