[Federal Register Volume 74, Number 184 (Thursday, September 24, 2009)]
[Notices]
[Pages 48760-48761]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-23005]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0444]
Schmid Laboratories, Inc. et al.; Proposal To Withdraw Approval
of Five New Drug Applications; Opportunity for a Hearing
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity to request a hearing on the agency's proposal to withdraw
approval of five new drug applications (NDAs) from multiple sponsors.
The basis for the proposal is that the sponsors have repeatedly failed
to file required annual reports for these applications.
DATES: Submit written requests for a hearing by October 26, 2009;
submit data and information in support of the hearing request by
November 23, 2009.
ADDRESSES: Requests for a hearing, supporting data, and other comments
are to be identified with Docket No. FDA-2009-N-0444 and submitted to
the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6366, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: The holders of approved applications to
market new drugs for human use are required to submit annual reports to
FDA concerning each of their approved applications in accordance with
Sec. 314.81 (21 CFR 314.81). The holders of the approved applications
listed in table 1 of this document have failed to submit the required
annual reports and have not responded to the agency's request by
certified mail for submission of the reports.
[[Page 48761]]
Table 1
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Application No. Drug Applicant
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NDA 5-766 Ramses Vaginal Jelly Schmid Laboratories, Inc.,
Route 46 West, Little Falls,
NJ 07424
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NDA 7-220 Synthetic Vitamin A Merck & Co., Inc., 770
(vitamin A Sumneytown Pike, P.O. Box 4,
palmitate) West Point, PA 19486
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NDA 8-595 Immolin Vaginal Cream Schmid Laboratories, Inc.
Jel
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NDA 8-612 Silicote Arnar-Stone Laboratories,
(simethicone) Inc., 601 East Kensington
Ointment Rd., Mount Prospect, IL 60056
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NDA 10-915 Q.E.D. Hairgroom A.R. Winarick, Inc., 783
(captan) Palisade Ave., Cliffside, NJ
07010
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Therefore, notice is given to the holders of the approved
applications listed in table 1 of this document and to all other
interested persons that the Director of the Center for Drug Evaluation
and Research proposes to issue an order under section 505(e) of the
Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(e))
withdrawing approval of the applications and all amendments and
supplements thereto on the ground that the applicants have failed to
submit reports required under Sec. 314.81.
In accordance with section 505 of the act and part 314 (21 CFR part
314), the applicants are hereby provided an opportunity for a hearing
to show why the applications listed previously should not be withdrawn
and an opportunity to raise, for administrative determination, all
issues relating to the legal status of the drug products covered by
these applications.
An applicant who decides to seek a hearing shall file the
following: (1) A written notice of participation and request for a
hearing (see DATES), and (2) the data, information, and analyses relied
on to demonstrate that there is a genuine and substantial issue of fact
that requires a hearing (see DATES). Any other interested person may
also submit comments on this notice. The procedures and requirements
governing this notice of opportunity for a hearing, notice of
participation and request for a hearing, information and analyses to
justify a hearing, other comments, and a grant or denial of a hearing
are contained in Sec. 314.200 and in 21 CFR part 12.
The failure of an applicant to file a timely written notice of
participation and request for a hearing, as required by Sec. 314.200,
constitutes an election by that applicant not to avail itself of the
opportunity for a hearing concerning the proposal to withdraw approval
of the applications and constitutes a waiver of any contentions
concerning the legal status of the drug products. FDA will then
withdraw approval of the applications and the drug products may not
thereafter lawfully be marketed, and FDA will begin appropriate
regulatory action to remove the products from the market. Any new drug
product marketed without an approved new drug application is subject to
regulatory action at any time.
A request for a hearing may not rest upon mere allegations or
denials, but must present specific facts showing that there is a
genuine and substantial issue of fact that requires a hearing. Reports
submitted to remedy the deficiencies must be complete in all respects
in accordance with Sec. 314.81. If the submission is not complete or
if a request for a hearing is not made in the required format or with
the required reports, the Commissioner of Food and Drugs will enter
summary judgment against the person who requests the hearing, making
findings and conclusions, and denying a hearing.
All submissions under this notice of opportunity for a hearing must
be filed in four copies. Except for data and information prohibited
from public disclosure under 21 U.S.C. 331(j) or 18 U.S.C. 1905, the
submissions may be seen in the Division of Dockets Management (see
ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday, or on the
Internet at http://www.regulations.gov.
This notice is issued under the Federal Food, Drug, and Cosmetic
Act (sec. 505 (21 U.S.C. 355)) and under authority delegated to the
Director, Center for Drug Evaluation and Research, by the Commissioner
of Food and Drugs.
Dated: September 9, 2009.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. E9-23005 Filed 9-23-09; 8:45 am]
BILLING CODE 4160-01-S