[Federal Register Volume 67, Number 241 (Monday, December 16, 2002)]
[Notices]
[Pages 77035-77036]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-31568]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 02-102-1]


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.

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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

[[Page 77036]]

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 
[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. 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 (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 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; (515) 232-5785. 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.
[FR Doc. 02-31568 Filed 12-13-02; 8:45 am]
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