Source: https://www.federalregister.gov/documents/2005/04/28/05-8469/high-chemical-co-et-al-proposal-to-withdraw-approval-of-13-new-drug-applications-opportunity-for-a
Timestamp: 2018-07-18 19:25:56
Document Index: 7331132

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

Federal Register :: High Chemical Co. et al.; Proposal to Withdraw Approval of 13 New Drug Applications; Opportunity for a Hearing; Reissuance
High Chemical Co. et al.; Proposal to Withdraw Approval of 13 New Drug Applications; Opportunity for a Hearing; Reissuance
Submit written requests for a hearing by May 31, 2005; submit data and information in support of the hearing request by June 27, 2005.
70 FR 22052
Docket No. 2005N-0143
05-8469
https://www.federalregister.gov/d/05-8469 https://www.federalregister.gov/d/05-8469
Notice; reissuance.
The Food and Drug Administration (FDA) is reissuing the notice announcing an opportunity to request a hearing on the agency's proposal to withdraw approval of 13 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. In the Federal Register of January 28, 2005 (70 FR 4134), FDA published a notice announcing an opportunity for a hearing on the agency's proposal to withdraw approval of 13 NDAs from multiple sponsors. That notice published with an inadvertent error; in a document published elsewhere in this issue of the Federal Register, the agency is withdrawing that notice.
Requests for a hearing, supporting data, and other comments are to be identified with Docket No. 2005N-0143 to be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Florine P. Purdie Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,301-594-2041.
FDA is reissuing the notice announcing an opportunity to request a hearing on the agency's proposal to withdraw approval of 13 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. In the Federal Register of January 28, 2005 (70 FR 4134), FDA published a notice announcing an opportunity for a hearing on the agency's proposal to withdraw approval of 13 NDAs from multiple sponsors. That notice published with an inadvertent error; in a document published elsewhere in this issue of the Federal Register, the agency is withdrawing that notice.
NDA 10-541 BY-NA-MID (Butylphenamide or B and Zinc Oxide or Stearate) Tincture, Ointment, Lotion, and Powder Miles, Inc., Cutter Biological, P.O. Box 1986, Berkeley, CA 94701
NDA 19-432 Spectamine (Iofetamine Hydrochloride I-123) Injection IMP, Inc., 8050 El Rio, Houston, TX 77054
Therefore, under § 314.150(b)(1) (21 CFR 314.150(b)(1)) and § 314.200 (21 CFR 314.200), notice is given to the holders of the approved applications listed in the table 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 to request a hearing to show why the applications listed previously should not be withdrawn.
An applicant who decides to seek a hearing shall file: (1) On or before May 31, 2005, a written notice of participation and request for a hearing, and (2) on or before June 27, 2005, the data, information, and analyses relied on to demonstrate that there is a genuine and substantial issue of fact that requires a hearing. 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 part 12 (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 to request 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.
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.
[FR Doc. 05-8469 Filed 4-27-05; 8:45 am]