02-31568. Draft Guideline on Testing for the Detection of Mycoplasma Contamination

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice of availability and request for comments.

SUMMARY:

A draft guideline titled “Testing for the Detection of Mycoplasma Contamination” has been developed by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The draft guideline provides procedures for the testing of some veterinary biologics to detect mycoplasma contamination. Since the draft guideline applies 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 will consider all comments on the draft guideline that we receive on or before February 14, 2003.

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. 02-102-1, 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. 02-102-1. 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. 02-102-1” on the subject line.

You may read any comments that we receive on the draft guideline 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 a copy of the draft guideline “Testing for the Detection of Mycoplasma Contamination” by calling or writing to the person listed under FOR FURTHER INFORMATION CONTACT. The draft guideline is also available on the Internet at http://www.aphis.usda.gov/​vs/​cvb/​lpd/​notices.

FOR FURTHER INFORMATION CONTACT:

For information regarding VICH, contact Dr. Richard E. Hill, Director, Center for Veterinary Biologics-Licensing and Policy Development, VS, APHIS, 510 South 17th Street, Suite 104, Ames, IA 50010; [phone]. For information regarding the draft guideline “Testing for the Detection of Mycoplasma Contamination,” contact Dr. Donna M. Gatewood at the same address and telephone number.

SUPPLEMENTARY INFORMATION:

The International Cooperation on Harmonization of Technical Requirements for the Registration of Veterinary Medicinal Products (VICH) 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 as observers. The VICH initiative is conducted under the auspices of the International Office of Epizootics. The World Federation of the Animal Health Industry (COMISA, the Confederation Mondiale de L'Industrie de la Sante Animale) provides the secretarial support for VICH activities. The U.S. 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, FDA and APHIS 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.

This notice informs the public that a draft document, “Testing for the Detection of Mycoplasma Contamination” (VICH Topic GL34), has been made available for comments by the VICH Steering Committee. The draft guideline is intended to provide an international testing standard for the detection of mycoplasma contamination in veterinary biologics. Because the draft guideline applies to some veterinary biological products regulated by APHIS 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.

The draft document reflects current APHIS thinking on testing veterinary biologics for the detection of mycoplasma contamination. In accordance with the VICH process, once a final draft of “Testing for the Detection of Mycoplasma Contamination” 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, a VICH guideline specifically provides for the use of alternative approaches if those approaches are proven to be equivalent by scientifically accepted criteria.

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 testing veterinary biologics for mycoplasma contamination under 9 CFR 113.28. 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 “Testing for the Detection of Mycoplasma Contamination” 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 10th day of December 2002 .

Peter Fernandez,

Acting Administrator, Animal and Plant Health Inspection Service.