[Federal Register Volume 60, Number 85 (Wednesday, May 3, 1995)]
[Notices]
[Pages 21823-21824]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-10898]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 95N-0108]
Drug Export; VAQTATM Hepatitis A Vaccine, Purified
Inactivated
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that
Merck & Co., Inc., has filed an application requesting approval for the
export of the final bulk human biological product VAQTATM
Hepatitis A Vaccine, Purified Inactivated to the Federal Republic of
Germany 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 Conn, Center for Biologics
Evaluation and Research (HFM-610), 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 Merck & Co., Inc., P.O. Box 4, West Point, PA
19486, has filed an application requesting approval for the export of
the final bulk human biological product VAQTATM Hepatitis A
Vaccine, Purified Inactivated, to the United Kingdom for filling into
syringes and export to the Federal Republic of Germany and the United
Kingdom. The VAQTATM Hepatitis A Vaccine, Purified Inactivated, is
a highly purified inactivated whole virus vaccine derived from
hepatitis A virus grown in cell culture in human fibroblasts. The
application was received and filed in the Center for Biologics
Evaluation and Research on February 13, 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
[[Page 21824]] 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 May 15, 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: April 12, 1995.
James C. Simmons,
Acting Director, Office of Compliance, Center for Biologics Evaluation
and Research.
[FR Doc. 95-10898 Filed 5-2-95; 8:45 am]
BILLING CODE 4160-01-F
