[Federal Register: February 3, 2000 (Volume 65, Number 23)]
[Notices]
[Page 5305-5306]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03fe00-36]
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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]
BILLING CODE 3410-34-U
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