[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