E6-445. 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.

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 [phone] 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; [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 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 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.