[Federal Register Volume 61, Number 79 (Tuesday, April 23, 1996)]
[Notices]
[Pages 17902-17903]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-9897]



-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0124]


Drug Export; DifferinTM (Adapalene) 0.1% Topical Gel

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that 
Galderma Laboratories, Inc., has filed an application requesting 
approval for the export of the human drug DifferinTM (Adapalene) 
0.1% Topical Gel to Canada.

ADDRESSES: Relevant information on this application may be directed to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857, and to the contact 
person identified below. Any future inquiries concerning the export of 
human drugs under the Drug Export Amendments Act of 1986 should also be 
directed to the contract person.

FOR FURTHER INFORMATION CONTACT:
James E. Hamilton, Center for Drug Evaluation and Research (HFD-310), 
Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855, 
301-594-3150.

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 drugs 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 Galderma Laboratories, Inc., 3000 Alta Mesa 
Blvd., Forth Worth, TX 76133, has filed an application requesting 
approval for the export of the human drug DifferinTM (Adapalene) 
0.1% Topical Gel to Canada. This product is indicated for the topical 
treatment of acne vulgaris. The application was received and filed in 
the Center for Drug Evaluation and Research on October 16, 1995, which 
shall be considered the filing date for purposes of the act.
    Interested persons may submit relevant information on the 
application

[[Page 17903]]

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 May 3, 1996, and to provide an 
additional copy of the submission directly to the contract 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 Drug Evaluation and Research (21 CFR 5.44).

    Dated: April 5, 1996.
Betty L. Jones,
Deputy Director, Office of Compliance, Center for Drug Evaluation and 
Research.
[FR Doc. 96-9897 Filed 4-22-96; 8:45 am]
BILLING CODE 4160-01-F