[Federal Register Volume 60, Number 202 (Thursday, October 19, 1995)]
[Notices]
[Pages 54076-54077]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-25886]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95N-0334]
Drug Export; Atrovent (Ipratropium Bromide) Nasal Spray
0.03%, 10 Milliliter (mL) and 30 mL
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that
Boehringer Ingelheim Pharmaceuticals Inc., has filed an application
requesting approval for the export of the human drug Atrovent
(ipratropium bromide) Nasal Spray 0.03%, 10 mL and 30 mL to Canada.
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 drugs under the Drug Export Amendments Act of 1986 should also be
directed to the contact 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 Boehringer Ingelheim Pharmaceuticals Inc., 900
Ridgebury Rd., Ridgefield, CT 06877, has filed an application
requesting approval for the export of the human drug Atrovent
(ipratropium bromide) Nasal Spray 0.03%, 10 mL and 30 mL to Canada.
This drug product is used for the symptomatic relief of rhinorrhea
associated with allergic or non-allergic perennial rhinitis. The
application was received and filed in the Center for Drug Evaluation
and Research on September 28, 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 October 30,
[[Page 54077]]
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 Drug Evaluation and Research (21 CFR 5.44).
Dated: October 4, 1995.
Betty L. Jones,
Deputy Director, Office of Compliance, Center for Drug Evaluation and
Research.
[FR Doc. 95-25886 Filed 10-18-95; 8:45 am]
BILLING CODE 4160-01-F
