[Federal Register: April 28, 2005 (Volume 70, Number 81)]
[Notices]               
[Page 22052-22053]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28ap05-83]                         

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0143]

 
High Chemical Co. et al.; Proposal to Withdraw Approval of 13 New 
Drug Applications; Opportunity for a Hearing; Reissuance

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reissuance.

-----------------------------------------------------------------------

SUMMARY: 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.

DATES: Submit written requests for a hearing by May 31, 2005; submit 
data and information in support of the hearing request by June 27, 
2005.

ADDRESSES: 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.

FOR FURTHER INFORMATION CONTACT: Florine P. Purdie Center for Drug 
Evaluation and Research (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857,301-594-2041.

SUPPLEMENTARY INFORMATION: 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.
    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 the 
following table 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 22053]]



------------------------------------------------------------------------
    Application No.                Drug                  Applicant
------------------------------------------------------------------------
NDA 0-763                Sterile Solution         High Chemical Co.,
                          Procaine Injection 2%    1760 N. Howard St.,
                          (Procaine                Philadelphia, PA
                          Hydrochloride (HCl))     19122
------------------------------------------------------------------------
NDA 2-959                Nicotinic Acid (Niacin)  The Blue Line Chemical
                          Tablets                  Co., 302 South
                                                   Broadway, St. Louis,
                                                   MO 63102
------------------------------------------------------------------------
NDA 4-236                Sherman (thiamine HCl)   Do.
                          Elixir
------------------------------------------------------------------------
NDA 4-368                Ascorbic Acid Tablets    Do.
------------------------------------------------------------------------
NDA 5-159                D.S.D.                   Do.
                          (diethylstilbestrol
                          dipropionate)
------------------------------------------------------------------------
NDA 9-452                Multifuge (piperazine    Do.
                          citrate) Syrup
------------------------------------------------------------------------
NDA 10-055               Fire Gard Three-Alarm    Gard Products, Inc.,
                          Burn Relief              2560 Tara Lane,
                          (Methylcellulose)        Brunswick, GA 31520
------------------------------------------------------------------------
NDA 10-337               Fling Antiperspirant     Bauer & Black, A
                          Foot Powder              Division of The
                                                   Kendall Co., One
                                                   Federal St., Boston,
                                                   MA 02110
------------------------------------------------------------------------
NDA 10-541               BY-NA-MID                Miles, Inc., Cutter
                          (Butylphenamide or B     Biological, P.O. Box
                          and Zinc Oxide or        1986, Berkeley, CA
                          Stearate) Tincture,      94701
                          Ointment, Lotion, and
                          Powder
------------------------------------------------------------------------
NDA 10-823               BIKE Foot and Body       Bauer & Black, A
                          Powder                   Division of The
                                                   Kendall Co.
------------------------------------------------------------------------
NDA 10-824               BIKE Anti-Fungal         Do.
                          Aerosol Spray
------------------------------------------------------------------------
NDA 11-233               TKO with Entrin Roll-On  Modern-Labs, Inc.,
                          Liquid                   Maple Rd., Gambrills,
                                                   MD 21504
------------------------------------------------------------------------
NDA 19-432               Spectamine (Iofetamine   IMP, Inc., 8050 El
                          Hydrochloride I-123)     Rio, Houston, TX
                          Injection                77054
------------------------------------------------------------------------

    Therefore, under Sec.  314.150(b)(1) (21 CFR 314.150(b)(1)) and 
Sec.  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 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 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 Sec.  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 Sec.  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.
    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.
    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.

    Dated: April 5, 2005.
Steven Galson,
Acting Director, Center for Drug Evaluation and Research.
[FR Doc. 05-8469 Filed 4-27-05; 8:45 am]

BILLING CODE 4160-01-S