[Federal Register Volume 73, Number 32 (Friday, February 15, 2008)]
[Notices]
[Pages 8845-8846]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-2913]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2008-0024]


Draft Guideline: Target Animal Safety for Veterinary Live and 
Inactivated Vaccines

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice of availability and request for comments.

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SUMMARY: The International Cooperation on Harmonization of Technical 
Requirements for the Registration of Veterinary Medicinal Products 
(VICH) has developed a draft guideline titled ``Target Animal Safety 
for Veterinary Live and Inactivated Vaccines.'' This draft guideline 
provides guidance for designing and executing studies to evaluate the 
safety of the final formulation of veterinary live and inactivated 
vaccines in animals. Because the draft guideline may have an effect on 
the requirements for vaccines that are regulated by the Animal and 
Plant Health Inspection Service under the Virus-Serum-Toxin Act, we are 
requesting comments on the scope of the 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 will consider all comments that we receive on or before April 
15, 2008.

ADDRESSES: You may submit comments by either of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov/fdmspublic/component/main?main=DocketDetail&d=APHIS-2008-0024 to submit or view comments and 
to view supporting and related materials available electronically.
     Postal Mail/Commercial Delivery: Please send two copies of 
your comment to Docket No. APHIS-2008-0024, Regulatory Analysis and 
Development, PPD, APHIS, Station 3A-03.8, 4700 River Road Unit 118, 
Riverdale, MD 20737-1238. Please state that your comment refers to 
Docket No. APHIS-2008-0024.
    Reading Room: 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.
    Other Information: Additional information about APHIS and its 
programs is available on the Internet at http://www.aphis.usda.gov.

FOR FURTHER INFORMATION CONTACT: Dr. Albert P. Morgan, Center for 
Veterinary Biologics-Policy Evaluation and Licensing, VS, APHIS, 4700 
River Road Unit 148, Riverdale, MD 20737-1231; (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 World Organization for Animal Health 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 on 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 guideline ``Target Animal Safety for Veterinary Live and 
Inactivated Vaccines'' (VICH Topic GL44) has been made available by the 
VICH Steering Committee for comments by interested parties. The 
guideline is intended to provide guidance for designing and executing 
studies to evaluate the safety of the final formulation of veterinary 
live and inactivated vaccines prior to approval for licensing/
registration. Because the draft guideline applies to some veterinary 
vaccines regulated by APHIS under the Virus-Serum-Toxin Act--
particularly with regard to the safety of the dose of the vaccine on 
the health and welfare of the target animal--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 guideline reflects current APHIS thinking regarding 
designing and executing studies to assess the safety of the final 
formulation of live and inactivated veterinary vaccines in target 
animals. In accordance with the VICH process, once a final draft of the 
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 guideline for use by U.S. veterinary biologics licensees, 
permittees, and applicants. In addition, we may consider using the 
final guideline as the basis for proposed amendments to the 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 ``Target Animal Safety 
for Veterinary Live and Inactivated Vaccines'' may be introduced into 
APHIS' veterinary biologics regulatory program in the future, we 
encourage your comments on the draft guideline.

[[Page 8846]]

    The draft guideline may be viewed on the Regulations.gov Web site 
or in our reading room (see ADDRESSES above for instructions for 
accessing Regulations.gov and information on the location and hours of 
the reading room). You may request paper copies of the draft guideline 
by calling or writing to the person listed under FOR FURTHER 
INFORMATION CONTACT.

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

    Done in Washington, DC, this 11th day of February 2008.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. E8-2913 Filed 2-14-08; 8:45 am]
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