[Federal Register Volume 64, Number 56 (Wednesday, March 24, 1999)]
[Proposed Rules]
[Page 14156]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-7187]
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Proposed Rules
Federal Register
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This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 64, No. 56 / Wednesday, March 24, 1999 /
Proposed Rules
[[Page 14156]]
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DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
9 CFR Part 113
[Docket No. 99-015-1]
Veterinary Antibody Products; Public Meeting
AGENCY: Animal and Plant Health Inspection Service, USDA.
ACTION: Notice of public meeting.
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SUMMARY: We are advising veterinary biologics producers and the general
public that the Center for Veterinary Biologics will host a public
meeting to discuss the regulations for veterinary antibody products.
The primary purpose of the meeting is to provide an opportunity for
interested parties to discuss the requirements for demonstrating the
efficacy of products for treatment of failure of passive transfer and
for including a treatment step in the manufacture of antibody products
to inactivate potential contaminating microorganisms.
DATES: The public meeting will be held on Thursday, April 29, 1999,
from 8 a.m. to 5 p.m.
ADDRESSES: The public meeting will be held in the Scheman Building,
Iowa State Center, Ames, IA.
FOR FURTHER INFORMATION CONTACT: Ms. Kathy Clark, Center for Veterinary
Biologics-Licensing and Policy Development, VS, APHIS, 510 South 17th
Street, Suite 104, Ames, IA, 50010; telephone (515) 232-5785, ext. 112;
fax (515) 232-7120. Information is also available on the Internet at
http://www.aphis.usda.gov/vs/cvb/lpd/notices/notices.html.
SUPPLEMENTARY INFORMATION:
Background
The Center for Veterinary Biologics will be holding a public
meeting to discuss the regulations for veterinary antibody products
under the Virus-Serum-Toxin Act (21 U.S.C. 151, et seq.). The
regulations are contained in the Code of Federal Regulations, title 9,
part 113, Secs. 113.450 through 113.499. Manufacturers of antibody
products for treatment of failure of passive transfer (FPT) have had
some difficulty with the new efficacy requirements and some have
indicated that they have not been able to successfully carry out the
required treatment step during production to inactivate potential
contaminating microorganisms.
The Center for Veterinary Biologics is holding this meeting to
primarily discuss two issues. The first issue is whether the IgG
content of the IgG Species Standards produced by the Animal and Plant
Health Inspection Service and used in evaluating the efficacy of bovine
and equine FPT products is too high. The second issue is whether the
treatment requirement to inactivate potential contaminants needs to be
applied in all cases, and whether there are alternative treatments that
can be used. Participants will also have an opportunity to comment on
other aspects of the antibody product regulations. The comments
received during the meeting will aid the Center for Veterinary
Biologics in determining whether the antibody product regulations need
to be amended.
We expect to finalize the agenda soon. When the agenda is complete,
it will be available from the person listed under FOR FURTHER
INFORMATION CONTACT, as well as from the Internet address listed in
that section.
The meeting on April 29, 1999, will begin at 8 a.m. and is
scheduled to end at 5 p.m.; however, it may end earlier if all persons
desiring to speak have been heard. Persons who wish to make a prepared
statement should indicate their intention to do so at the time of
registration and provide the subject of their remarks and the
approximate length of time that will be necessary. Any person attending
the meeting who did not indicate that he or she would speak will be
given an opportunity to speak after the registered speakers have
finished, as time permits.
Registration information, registration forms, and lodging
information are available from the person listed under FOR FURTHER
INFORMATION CONTACT, as well as from the Internet address listed in
that section. If you do not register prior to the meeting, you may
register at the meeting location from 7:30 a.m. to 8:00 a.m., local
time, on the day of the meeting.
Done in Washington, DC, this 18th day of March 1999.
Craig A. Reed,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 99-7187 Filed 3-23-99; 8:45 am]
BILLING CODE 3410-34-P
