[Federal Register: December 16, 2002 (Volume 67, Number 241)]
[Notices]
[Page 77035-77036]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16de02-26]
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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
regulations@aphis.usda.gov. 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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