[Federal Register Volume 75, Number 204 (Friday, October 22, 2010)]
[Notices]
[Pages 65293-65294]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-26748]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2010-0098]


Draft Guidelines on Pharmacovigilance of Veterinary Medicinal 
Products: Electronic Standards for Transfer of Data

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 ``Pharmacovigilance of 
Veterinary Medicinal Products: Electronic Standards for Transfer of 
Data.'' This draft guideline provides information concerning the 
development of a single electronic message to transmit adverse event 
reports concerning veterinary biologics between regulatory authorities 
in the European Union, Japan, and the United States and marketing 
authorization holders (veterinary biologics licensees and permittees) 
in those regions. Because the draft guideline applies to 
pharmacovigilance and adverse event reporting on 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 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 
December 21, 2010.

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-2010-0098 to submit or view comments and 
to view supporting and related materials available electronically.
     Postal Mail/Commercial Delivery: Please send one copy of 
your comment to Docket No. APHIS-2010-0098, 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-2010-0098.
    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

[[Page 65294]]

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 ``Pharmacovigilance of Veterinary Medicinal 
Products: Electronic Standards for Transfer of Data'' (VICH Topic GL35) 
has been made available by the VICH Steering Committee for comments by 
interested parties. The guideline is intended to provide standards to 
construct a single electronic message to transmit the contents of 
adverse event reports concerning the use of veterinary medicinal 
products to all regions. Because the draft guideline applies to some 
veterinary biological products regulated by APHIS under the Virus-
Serum-Toxin Act--particularly with regard to electronic messages to 
transmit adverse event reports--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 on the use of 
electronic messages to transmit adverse event reports concerning the 
use of veterinary medicinal products between marketing authorization 
holders (licensees/permittees) and regulatory authorities in the three 
regions. 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 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 ``Pharmacovigilance of 
Veterinary Medicinal Products: Electronic Standards for Transfer of 
Data'' may be introduced into APHIS' veterinary biologics regulatory 
program in the future, we encourage your comments on the draft 
guideline.
    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 18th day of October 2010.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2010-26748 Filed 10-21-10; 8:45 am]
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