[Federal Register Volume 60, Number 208 (Friday, October 27, 1995)]
[Notices]
[Pages 55035-55036]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-26632]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 95N-0344]


Drug Export; AVONEXTM, Recombinant Interferon Beta-1a

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that 
Biogen, Inc., has filed an application requesting approval for the 
export of the human biological product AVONEXTM, Recombinant 
Interferon Beta-1a to the United Kingdom.

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: 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 

[[Page 55036]]
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 Biogen, Inc., Fourteen 
Cambridge Center, Cambridge, MA 02142, has filed an application 
requesting approval for the export of the human biological product 
AVONEXTM, Recombinant Interferon Beta-1a to the United Kingdom. 
AVONEXTM, Recombinant Interferon Beta-1a is indicated for the 
treatment of relapsing forms of multiple sclerosis. The application was 
received and filed in the Center for Biologics Evaluation and Research 
on October 2, 1995, 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 November 6, 1995, 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: October 13, 1995.
James C. Simmons,
Director, Office of Compliance, Center for Biologics Evaluation and 
Research.
[FR Doc. 95-26632 Filed 10-26-95; 8:45 am]
BILLING CODE 4160-01-F