Source: https://www.federalregister.gov/documents/2009/09/24/E9-23005/schmid-laboratories-inc-et-al-proposal-to-withdraw-approval-of-five-new-drug-applications
Timestamp: 2017-09-19 15:44:14
Document Index: 92024631

Matched Legal Cases: ['§\u2009314', '§\u2009314', 'art 314', 'art 314', '§\u2009314', 'art 12']

Federal Register :: Schmid Laboratories, Inc. et al.; Proposal To Withdraw Approval of Five New Drug Applications; Opportunity for a Hearing
Schmid Laboratories, Inc. et al.; Proposal To Withdraw Approval of Five New Drug Applications; Opportunity for a Hearing
Submit written requests for a hearing by October 26, 2009; submit data and information in support of the hearing request by November 23, 2009.
74 FR 48760
48760-48761 (2 pages)
E9-23005
https://www.federalregister.gov/d/E9-23005 https://www.federalregister.gov/d/E9-23005
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.
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.
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
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.
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.
[FR Doc. E9-23005 Filed 9-23-09; 8:45 am]