Food and Drug Administration, HHS.
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.
Submit written requests for a hearing by October 26, 2009; submit data and information in support of the hearing request by November 23, 2009.
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.Start Further Info
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.End Further Info End Preamble Start Supplemental 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 § 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.Start Printed Page 48761
|NDA 5-766||Ramses Vaginal Jelly||Schmid Laboratories, Inc., Route 46 West, Little Falls, NJ 07424|
|NDA 7-220||Synthetic Vitamin A (vitamin A palmitate)||Merck & Co., Inc., 770 Sumneytown Pike, P.O. Box 4, West Point, PA 19486|
|NDA 8-595||Immolin Vaginal Cream Jel||Schmid Laboratories, Inc.|
|NDA 8-612||Silicote (simethicone) Ointment||Arnar-Stone Laboratories, Inc., 601 East Kensington Rd., Mount Prospect, IL 60056|
|NDA 10-915||Q.E.D. Hairgroom (captan)||A.R. Winarick, Inc., 783 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 § 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 § 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 § 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 § 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.Start Signature
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