[Federal Register Volume 72, Number 96 (Friday, May 18, 2007)]
[Notices]
[Pages 28021-28022]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-9556]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service

[Docket No. APHIS-2007-0056]


Draft Guidelines on Pharmacovigilance of Veterinary Medicinal 
Products: Controlled Lists of Terms

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: Controlled Lists of Terms.'' This draft 
guideline provides guidance for the development and maintenance of the 
controlled lists of terms required to complete the controlled data 
fields contained in adverse event reports concerning the use of 
veterinary medicinal products. 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

[[Page 28022]]

comments to the VICH Steering Committee.

DATES: We will consider all comments that we receive on or before July 
17, 2007.

ADDRESSES: You may submit comments by either of the following methods:
    Federal eRulemaking Portal: Go to http://www.regulations.gov, 
select ``Animal and Plant Health Inspection Service'' from the agency 
drop-down menu, then click ``Submit.'' In the Docket ID column, select 
APHIS-2007-0056 to submit or view public comments and to view 
supporting and related materials available electronically. After the 
close of the comment period, the docket can be viewed using the 
``Advanced Search'' function in Regulations.gov.
    Postal Mail/Commercial Delivery: Please send four copies of your 
comment (an original and three copies) to Docket No. APHIS-2007-0056, 
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-2007-0056.
    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 ``Pharmacovigilance of Veterinary Medicinal 
Products: Controlled Lists of Terms'' (VICH Topic GL30) has been made 
available by the VICH Steering Committee for comments by interested 
parties. The guideline is intended to provide guidance for the 
development and maintenance of the controlled lists of terms required 
to complete the controlled data fields contained in adverse event 
reports concerning the use of marketed veterinary medicinal products. 
Because the draft guideline applies to some veterinary biological 
products regulated by APHIS under the Virus-Serum-Toxin Act--
particularly with regard to development and maintenance of the 
controlled lists of terms--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 
development and maintenance of the controlled lists of terms required 
to complete the controlled data fields used for the submission and 
exchange of spontaneous adverse events reports between marketing 
authorization holders (licensees/permittees) and regulatory authorities 
concerning the clinical effects of marketed veterinary medicinal 
products. 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: Controlled Lists of Terms'' 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 11th day of May 2007.
Kevin Shea,
Acting Administrator, Animal and Plant Health Inspection Service.
 [FR Doc. E7-9556 Filed 5-17-07; 8:45 am]
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