[Federal Register Volume 65, Number 23 (Thursday, February 3, 2000)]
[Notices]
[Pages 5305-5306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-2379]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. 99-068-1]


Draft Guideline on Stability Testing of Biotechnological/
Biological Veterinary Medicinal Products, VICH Topic GL17

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 ``Stability Testing of 
Biotechnological/Biological Veterinary Medicinal Products'' has been 
developed by the International Cooperation on Harmonization of 
Technical Requirements for Registration of Veterinary Medicinal 
Products (VICH). The guideline contains proposed international 
standards for the generation and submission of stability data for 
products such as cytokines (interferons, interleukins, colony-
stimulating factors, tumor necrosis factors), monoclonal antibodies, 
and vaccines consisting of well-characterized proteins or polypeptides, 
including some conventional vaccines. Because the draft guidelines 
pertain 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 invite you to comment on the draft guidelines. We will 
consider all comments that we receive by April 3, 2000.

ADDRESSES:  Please send your comment and three copies to: Docket No. 
99-068-1, 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. 99-068-1.
    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 (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 ``Stability Testing of 
Biotechnological/Biological Veterinary Medicinal Products'' by writing 
to or calling the person listed under FOR FURTHER INFORMATION CONTACT.

FOR FURTHER INFORMATION CONTACT:  Dr. Albert P. Morgan, CVB-LPD, VS, 
APHIS, 4700 River Road Unit 148, Riverdale, MD 20737-1231; phone (301) 
734-8245.

SUPPLEMENTARY INFORMATION: The International Cooperation on 
Harmonization of Technical Requirements for the Registration of 
Veterinary Medicinal Products (VICH) is a unique project conducted 
under the auspices of the International Office of Epizootics (OIE, the 
Office International des Epizooties) 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 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 draft document that is the subject of this notice, ``Stability 
Testing of Biotechnological/Biological Veterinary Medicinal Products'' 
(VICH Topic GL17), has been made available by the VICH Steering 
Committee for comments by interested parties. The guideline is intended 
to function as an international standard for the generation and 
submission of stability data for products such as cytokines 
(interferons, interleukins, colony-stimulating factors, and tumor 
necrosis factors), monoclonal antibodies, and vaccines consisting of 
well-characterized proteins or polypeptides. Because the guideline 
pertains to some veterinary biological products regulated by APHIS 
under the Virus-Serum-Toxin Act--particularly with regard to 
prelicensing stability studies--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 pertains to the generation and submission of 
studies testing the stability of veterinary biological products that 
consist of well-characterized proteins and polypeptides, their 
derivatives, and products of which they are components. (The draft 
guideline refers to such studies as ``stability studies.'') In 
accordance with the VICH process, once a final draft of ``Stability 
Testing of Biotechnological/Biological Veterinary Medicinal Products'' 
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, 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 document for use by U.S. veterinary biologics licensees, 
permittees, and applicants. In addition, APHIS will consider its use as 
a basis for the approval of stability studies conducted to establish 
and extend expiration dates for applicable veterinary biological 
products under 9 CFR 114.13 and 114.14. APHIS may also use the final 
guidance document as the basis for proposed additions or amendments to 
its regulations in 9 CFR

[[Page 5306]]

chapter I, subchapter E (Viruses, Serums, Toxins, and Analogous 
Products; Organisms and Vectors). Because we anticipate that applicable 
provisions of the final version of ``Stability Testing of 
Biotechnological/Biological Veterinary Medicinal Products'' 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 28th day of January 2000.
Bobby R. Acord,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 00-2379 Filed 2-2-00; 8:45 am]
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