[Federal Register Volume 60, Number 151 (Monday, August 7, 1995)]
[Notices]
[Pages 40182-40183]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-19426]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 95N-0239]


Drug Export; Neupogen Recombinant Methionyl Granulocyte 
Colony Stimulating Factor (r-metHuG-CSF) With Sorbitol

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that 
Amgen, Inc., has filed an application requesting approval for the 
export of the human biological product Neupogen Recombinant 
Methionyl Granulocyte Colony Stimulating Factor (r-metHuG-CSF) with 
sorbitol in vials, pre-filled syringes, and purified bulk, to 
Australia, Austria, Belgium, Canada, Denmark, Finland, France, Federal 
Republic of Germany, Iceland, Ireland, Italy, Japan, Luxembourg, the 
Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland, 
and 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 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 

[[Page 40183]]
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 Amgen, Inc., 1840 Dehavilland Dr., Thousand 
Oaks, CA 91320-1789, has filed an application requesting approval for 
the export of the human biological product Neupogen 
Recombinant Methionyl Granulocyte Colony Stimulating Factor (r-metHuG-
CSF) with sorbitol in vials, pre-filled syringes, and purified bulk, to 
Australia, Austria, Belgium, Canada, Denmark, Finland, France, Federal 
Republic of Germany, Iceland, Ireland, Italy, Japan, Luxembourg, The 
Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland, 
and the United Kingdom. Neupogen is indicated for the 
reduction in the duration of neutropenia and its clinical sequelae in 
patients undergoing myeloblative therapy followed by autologous or 
allogeneic bone marrow transplantation and the reduction in the 
incidence of febrile neutropenia in patients treated with established 
cytotoxic chemotherapy for non-myeloid malignancy. Neupogen 
is used in patients, children or adults, with severe chronic 
neutropenia (severe congenital neutropenia, cyclic neutropenia, and 
idiopathic neutropenia) induces a sustained increase in absolute 
neutrophil counts in peripheral blood and a reduction of infection and 
related events. The application was received and filed in the Center 
for Biologics Evaluation and Research on June 15, 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 August 17, 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: July 24, 1995.
James C. Simmons,
Acting Director, Office of Compliance, Center for Biologics Evaluation 
and Research.
[FR Doc. 95-19426 Filed 8-4-95; 8:45 am]
BILLING CODE 4160-01-F