[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; VAQTA<SUP>TM 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 VAQTA<SUP>TM 
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 VAQTA<SUP>TM 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 VAQTA<SUP>TM 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