Document ID: FDA-2009-N-0444-0001
Agency: fda
Document Type: Notice
Title: Schmid Laboratories, Inc. et al.; Proposal To Withdraw Approval of Five New Drug Applications; Opportunity for a Hearing
Posted Date: 2009-09-24T04:00Z

[Federal Register: September 24, 2009 (Volume 74, Number 184)]
[Notices]               
[Page 48760-48761]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24se09-76]                         

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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
------------------------------------------------------------------------
 Application No.            Drug                     Applicant
------------------------------------------------------------------------
NDA 5-766          Ramses Vaginal Jelly   Schmid Laboratories, Inc.,
                                           Route 46 West, Little Falls,
                                           NJ 07424
------------------------------------------------------------------------
NDA 7-220          Synthetic Vitamin A    Merck & Co., Inc., 770
                    (vitamin A             Sumneytown Pike, P.O. Box 4,
                    palmitate)             West Point, PA 19486
------------------------------------------------------------------------
NDA 8-595          Immolin Vaginal Cream  Schmid Laboratories, Inc.
                    Jel
------------------------------------------------------------------------
NDA 8-612          Silicote               Arnar-Stone Laboratories,
                    (simethicone)          Inc., 601 East Kensington
                    Ointment               Rd., Mount Prospect, IL 60056
------------------------------------------------------------------------
NDA 10-915         Q.E.D. Hairgroom       A.R. Winarick, Inc., 783
                    (captan)               Palisade Ave., Cliffside, NJ
                                           07010
------------------------------------------------------------------------

    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