[Federal Register Volume 61, Number 51 (Thursday, March 14, 1996)]
[Notices]
[Pages 10585-10586]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-6027]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0085]


Drug Export; ACEL-IMUNE Diphtheria-Tetanus Toxoid 
(Acellular) Pertussis Vaccine Adsorbed

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that 
American Cyanamid Co., Lederle-Praxis Biologicals Div. has filed an 
application requesting approval for the export of the human biological 
product ACEL-IMUNE Diphtheria-Tetanus Toxoid (Acellular) 
Pertussis Vaccine Adsorbed 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, 
12420 Parklawn Dr., rm. 1-23, 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: Cathy E. Conn, Center for Biologics 
Evaluation and Research (HFM-610), Food and Drug Administration, -1401 
Rockville Pike, Rockville, MD 20852-1448, 301-594-2006.

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 human 
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 American Cyanamid Co., 
Lederle-Praxis Biologicals Div., 401 North Middletown Rd., Pearl River, 
NY 10965, has filed an application requesting approval for the export 
of the human biological product ACEL-IMUNE Diphtheria-Tetanus 
Toxoid (Acellular) Pertussis Vaccine Adsorbed to the Federal Republic 
of Germany. The ACEL-IMUNE Diphtheria-Tetanus Toxoid 
(Acellular) Pertussis Vaccine Adsorbed is for immunization against 
diphtheria, tetanus and pertussis (whooping cough) from 15 months to 6 
years of age. The application was received and filed in the Center for 
Biologics Evaluation and Research on February 23, 1996, 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

[[Page 10586]]
(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 March 25, 1996, 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: February 26, 1996.
James C. Simmons,
Director, Office of Compliance, Center for Biologics Evaluation and 
Research.
[FR Doc. 96-6027 Filed 3-13-96; 8:45 am]
BILLING CODE 4160-01-F