Draft Guideline on Stability Testing of Biotechnological/Biological Veterinary Medicinal Products, VICH Topic GL17

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice of availability and request for comments.

SUMMARY:

A draft guideline titled “Stability Testing of Biotechnological/Biological Veterinary Medicinal Products” has been developed by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The guideline contains proposed international standards for the generation and submission of stability data for products such as cytokines (interferons, interleukins, colony-stimulating factors, tumor necrosis factors), monoclonal antibodies, and vaccines consisting of well-characterized proteins or polypeptides, including some conventional vaccines. Because the draft guidelines pertain 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 April 3, 2000.

ADDRESSES:

Please send your comment and three copies to: Docket No. 99-068-1, 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. 99-068-1.

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 “Stability Testing of Biotechnological/Biological Veterinary Medicinal Products” by writing to or calling the person listed under FOR FURTHER INFORMATION CONTACT.

FOR FURTHER INFORMATION CONTACT:

Dr. Albert P. Morgan, CVB-LPD, 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, “Stability Testing of Biotechnological/Biological Veterinary Medicinal Products” (VICH Topic GL17), has been made available by the VICH Steering Committee for comments by interested parties. The guideline is intended to function as an international standard for the generation and submission of stability data for products such as cytokines (interferons, interleukins, colony-stimulating factors, and tumor necrosis factors), monoclonal antibodies, and vaccines consisting of well-characterized proteins or polypeptides. Because the guideline pertains to some veterinary biological products regulated by APHIS under the Virus-Serum-Toxin Act—particularly with regard to prelicensing stability studies—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 pertains to the generation and submission of studies testing the stability of veterinary biological products that consist of well-characterized proteins and polypeptides, their derivatives, and products of which they are components. (The draft guideline refers to such studies as “stability studies.”) In accordance with the VICH process, once a final draft of “Stability Testing of Biotechnological/Biological Veterinary Medicinal Products” 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 approval of stability studies conducted to establish and extend expiration dates for applicable veterinary biological products under 9 CFR 114.13 and 114.14. 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 “Stability Testing of Biotechnological/Biological Veterinary Medicinal Products” 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.