[Federal Register Volume 59, Number 195 (Tuesday, October 11, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-25079]
[[Page Unknown]]
[Federal Register: October 11, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94N-0359]
Drug Export; Acellular Pertussis Vaccine, Adsorbed
(Monocomponent)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that
Connaught Laboratories, Inc., has filed an application requesting
approval for the export of the biological product Acellular Pertussis
Vaccine, Adsorbed (monocomponent) to the Federal Republic of Germany.
ADDRESSES: Relevant information on this application may be directed to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857, and to the contact
person identified below. Any future inquiries concerning the export of
human biological products under the Drug Export Amendments Act of 1986
should also be directed to the contact person.
FOR FURTHER INFORMATION CONTACT: Frederick W. Blumenschein, Center for
Biologics Evaluation and Research (HFM-660), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-594-
1070.
SUPPLEMENTARY INFORMATION: The drug export provisions in section 802 of
the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 382)
provide that FDA may approve applications for the export of biological
products that are not currently approved in the United States. Section
802(b)(3)(B) of the Act sets forth the requirements that must be met in
an application for approval. Section 802(b)(3)(C) of the act requires
that the agency review the application within 30 days of its filing to
determine whether the requirements of section 802(b)(3)(B) have been
satisfied. Section 802(b)(3)(A) of the Act requires that the agency
publish a notice in the Federal Register within 10 days of the filing
of an application for export to facilitate public participation in its
review of the application. To meet this requirement, the agency is
providing notice that Connaught Laboratories, Inc., Rt. 611, P.O. Box
187, Swiftwater, PA 18370, has filed an application requesting approval
for the export of the biological product Acellular Pertussis Vaccine,
Adsorbed (monocomponent) to the Federal Republic of Germany. The
Acellular Pertussis Vaccine, Adsorbed (monocomponent) is used in the
primary immunization of children from the 15th month of age up to the
end of the 5th year of age against pertussis (whooping cough) and as a
fourth injection (as completion of primary immunization) in children
from the 15th month of age, having already received three injections of
a whole cell vaccine against pertussis. The application was received
and filed in the Center for Biologics Evaluation and Research on August
19, 1994, which shall be considered the filing date for purposes of the
act.
Interested persons may submit relevant information on the
application to the Dockets Management Branch (address above) in two
copies (except that individuals may submit single copies) and
identified with the docket number found in brackets in the heading of
this document. These submissions may be seen in the Dockets Management
Branch between 9 a.m. and 4 p.m., Monday through Friday.
The agency encourages any person who submits relevant information
on the application to do so by October 21, 1994, and to provide an
additional copy of the submission directly to the contact person
identified above, to facilitate consideration of the information during
the 30-day review period.
This notice is issued under the Federal Food, Drug, and Cosmetic
Act (sec. 802 (21 U.S.C. 382)) and under authority delegated to the
Commissioner of Food and Drugs (21 CFR 5.10) and redelegated to the
Center for Biologics Evaluation and Research (21 CFR 5.44).
Dated: September 9, 1994.
James C. Simmons,
Acting Director, Office of Compliance, Center for Biologics Evaluation
and Research.
[FR Doc. 94-25079 Filed 10-7-94; 8:45 am]
BILLING CODE 4160-01-P
