[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
