[Federal Register Volume 64, Number 124 (Tuesday, June 29, 1999)]
[Notices]
[Pages 34764-34765]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-16500]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service
[Docket No. 99-045-1]


Draft Guideline on Good Clinical Practices, VICH Topic GL9

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice of availability and request for comments.

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SUMMARY: We are requesting comments on a draft document titled 
``Guideline on Good Clinical Practices'' that has been developed by the 
International Cooperation on Harmonization of Technical Requirements 
for Registration of Veterinary Medicinal Products (VICH). The guideline 
is intended to be an international ethical and scientific quality 
standard for designing, conducting, monitoring, recording, auditing, 
analyzing, and reporting clinical studies evaluating veterinary 
products. Because the guideline would apply 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: To ensure that your comments are considered, we must receive 
them by August 13, 1999.

ADDRESSES: Please send your comment and three copies to: Docket No. 99-
045-1, Regulatory Analysis and

[[Page 34765]]

Development, PPD, APHIS, Suite 3C03, 4700 River Road Unit 118, 
Riverdale, MD 20737-1238. Please state that your comment refers to 
Docket No. 99-045-1.
    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 ``Guideline on Good Clinical 
Practices'' by writing to Dr. Lawrence A. Elsken, USDA, APHIS, VS, CVB-
LPD, 510 South 17th Street, Suite 104, Ames, IA 50010, or by calling 
(515) 232-5785. The draft guideline is also available on the Internet 
at http://www.aphis.usda.gov/vs/cvb/lpd/notices.

FOR FURTHER INFORMATION CONTACT: For information regarding VICH, 
contact Dr. David A. Espeseth, Special Assistant to the Deputy 
Administrator, Veterinary Services, Center for Veterinary Biologics, 
Licensing and Policy Development, VS, APHIS, 4700 River Road Unit 148, 
Riverdale, MD 20737-1231; phone (301) 734-8245. For information 
regarding the draft guideline, contact Dr. Lawrence A. Elsken, USDA, 
APHIS, VS, CVB-LPD, 510 South 17th Street, Suite 104, Ames, IA 50010; 
phone (515) 232-5785.

SUPPLEMENTARY INFORMATION: The International Cooperation on 
Harmonization of Technical Requirements for the Registration of 
Veterinary Medicinal Products (VICH) is a unique project 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 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 VICH initiative is conducted under the auspices 
of the International Office of Epizootics. 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 medicines and biologics among 
regulatory agencies in different countries.
    The draft document that is the subject of this notice, ``Guideline 
on Good Clinical Practices'' (VICH Topic GL9), has been made available 
by the VICH Steering Committee for comments by interested parties. The 
guideline is intended to be an international ethical and scientific 
quality standard for designing, conducting, monitoring, recording, 
auditing, analyzing, and reporting clinical studies evaluating 
veterinary products. Because the guideline would apply to veterinary 
biological products regulated by APHIS under the Virus-Serum-Toxin 
Act--particularly with regard to prelicensing field studies testing the 
safety or efficacy of veterinary biological products--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 reflects current APHIS thinking on the design 
and conduct of all field studies testing the safety or efficacy of 
veterinary biological products in the target species. (The draft 
guideline refers to such studies as ``clinical studies.'') Once a final 
draft of ``Guideline on Good Clinical Practices'' has been approved, 
the guideline will, in accordance with the VICH process, be recommended 
for adoption by the regulatory bodies of the European Union, Japan, and 
the United States. As with all VICH documents, the guidelines, once 
finalized, 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 the requirements of applicable regulatory 
requirements.
    Ultimately, APHIS intends to adopt the VICH Steering Committee's 
final guidance document and publish it for use by U.S. veterinary 
biologics licensees, permittees, and applicants. In addition, APHIS 
intends to use it as a basis for the approval of shipments of 
veterinary biological products for experimental use under 9 CFR 103.3. 
APHIS may also use the final guidance document as the basis for 
proposed additions or amendments to its regulations in 9 CFR subchapter 
E (Viruses, Serums, Toxins, and Analogous Products; Organisms and 
Vectors). Given that we anticipate that the applicable provisions of 
``Guideline on Good Clinical Practices'' will be introduced into APHIS' 
veterinary biologics regulatory program in the future, we encourage 
your comments on the draft version of those guidelines.

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

    Done in Washington, DC, this 24th day of June 1999.
Craig A. Reed,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 99-16500 Filed 6-28-99; 8:45 am]
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