01-2165. 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.

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 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 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 [phone]. 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 [phone]. 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; [phone]. 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, [phone]. 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; [phone].

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.