[Federal Register Volume 66, Number 16 (Wednesday, January 24, 2001)]
[Notices]
[Pages 7614-7615]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-2165]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 00-123-1]


Draft Guidelines for Testing of Residual Formaldehyde (VICH Topic 
GL25) and Testing of Residual Moisture (VICH Topic GL26)

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice of availability and request for comments.

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SUMMARY: Two draft guidelines, titled ``Testing of Residual 
Formaldehyde'' and ``Testing of Residual Moisture,'' have been 
developed by the International Cooperation on Harmonization of 
Requirements for Registration of Veterinary Medicinal Products (VICH). 
These draft guidelines provide, respectively, general requirements for 
residual formaldehyde and residual moisture testing. Because the 
guidelines apply to final product testing for formaldehyde-containing 
veterinary vaccines and final product testing for residual moisture in 
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 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 March 26, 2001.

ADDRESSES: Please send four copies of your comment (an original and 
three copies) to: Docket No. 00-123-1, 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. 00-123-1.
    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

[[Page 7615]]

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 guideline ``Testing of Residual 
Formaldehyde'' by writing to Mr. P. Frank Ross, USDA, APHIS, VS, 
National Veterinary Services Laboratories, 1800 Dayton Road, Ames, IA 
50010, or by calling (515) 663-8397. You may request a copy of the 
draft guideline ``Testing of Residual Moisture'' by writing to Mr. 
Gerald G. Christianson, USDA, APHIS, VS, Center for Veterinary 
Biologics Laboratories, 1800 Dayton Road, Ames, IA 50010, or by calling 
(515) 663-7416. Both draft guidelines are 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, Licensing and Policy 
Development, USDA, APHIS, VS, CVB-LPD, 510 South 17th Street, Suite 
104, Ames, IA 50010; (515) 232-5785. For information regarding the 
draft guideline ``Testing of Residual Formaldehyde,'' contact Mr. P. 
Frank Ross, USDA, APHIS, VS, National Veterinary Services Laboratories, 
1800 Dayton Road, Ames, IA 50010, (515) 663-8397. For information 
regarding the draft guideline ``Testing of Residual Moisture,'' contact 
Mr. Gerald G. Christianson, USDA, APHIS, VS, Center for Veterinary 
Biologics Laboratories, 1800 Dayton Road, Ames, IA 50010; (515) 663-
7416.

SUPPLEMENTARY INFORMATION: The International Cooperation on 
Harmonization of Technical Requirements for the Registration of 
Veterinary Medicinal Products (VICH) is a unique project 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 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 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 first of the draft documents that are the subject of this 
notice, ``Testing of Residual Formaldehyde'' (VICH Topic GL25), has 
been made available by the VICH Steering Committee for comments by 
interested parties. The guideline is intended to provide general 
requirements for residual formaldehyde testing. Because the guideline 
would apply to some veterinary biological products regulated by APHIS 
under the Virus-Serum-Toxin Act--particularly with regard to final 
product testing for residual formaldehyde--we are requesting comments 
on its provisions so that we may include any relevant comments on the 
draft in the agency's comments to the VICH Steering Committee.
    The second draft document, ``Testing of Residual Moisture'' (VICH 
Topic GL26), has also been made available by the VICH Steering 
Committee for comments by interested parties. The guideline is intended 
to provide general requirements for residual moisture testing. Again, 
because the guideline would apply to some veterinary biological 
products regulated by APHIS under the Virus-Serum-Toxin Act--
particularly with regard to final product testing for residual 
moisture--we are requesting comments on its provisions so that we may 
include any relevant comments on the draft in the agency's comments to 
the VICH Steering Committee.
    The two draft documents reflect, respectively, current APHIS 
thinking on the testing of veterinary vaccines for formaldehyde and for 
residual moisture. 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 guidance documents for use by U.S. veterinary biologics 
licensees, permittees, and applicants. In addition, APHIS may consider 
the use of each final guideline as the basis for proposed 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 versions of 
``Testing of Residual Formaldehyde'' and ``Testing of Residual 
Moisture'' may be introduced into APHIS' veterinary biologics 
regulatory program in the future, we encourage your comments on the 
draft versions of those documents.

    Authority: 21 U.S.C. 151 et seq.

    Done in Washington, DC, this 18th day of January 2001.
Bobby R. Acord,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 01-2165 Filed 1-23-01; 8:45 am]
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