[Federal Register: January 28, 2005 (Volume 70, Number 18)]
[Notices]               
[Page 4134-4135]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28ja05-87]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0010]

 
High Chemical Co. et al.; Proposal to Withdraw Approval of 13 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 for 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.

DATES: Submit written requests for a hearing by February 28, 2005; 
submit data and information in support of the hearing request by March 
29, 2005.

ADDRESSES: Requests for a hearing, supporting data, and other comments 
are to be identified with Docket No. 2005N-0010 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 (HFD-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-2041.

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 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 4135]]



------------------------------------------------------------------------
    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 Rio,
                          Hydrochloride I-123)     Houston, TX 77054
                          Injection
------------------------------------------------------------------------

    Therefore, 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 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: (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 document. 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 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 NDA 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 (the 
Commissioner) 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 section 301 of the act (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 act (section 505 (21 U.S.C. 355)) 
and under authority delegated to the Director, Center for Drug 
Evaluation and Research, by the Commissioner.

    Dated: January 19, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-1656 Filed 1-27-05; 8:45 am]

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