Viruses, serums, toxins, etc.: Veterinary antibody products; meeting,

[Federal Register: March 24, 1999 (Volume 64, Number 56)]

[Proposed Rules]

[Page 14156]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr24mr99-19]

Proposed Rules Federal Register

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.

[[Page 14156]]

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.

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. 99-7187Filed3-23-99; 8:45 am]

BILLING CODE 3410-34-P