High Chemical Co. et al.; Proposal to Withdraw Approval of 13 New Drug Applications; Opportunity for a Hearing; Reissuance, 22052-22053 [05-8469]
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Federal Register / Vol. 70, No. 81 / Thursday, April 28, 2005 / Notices
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Exposure to Environmental Chemicals
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Acting Director, Management Analysis and
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[FR Doc. 05–8497 Filed 4–27–05; 8:45 am]
BILLING CODE 4163–18–P
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
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
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.
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
§ 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.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\28APN1.SGM
28APN1
Federal Register / Vol. 70, No. 81 / Thursday, April 28, 2005 / Notices
Application No.
Drug
22053
Applicant
NDA 0–763
Sterile Solution Procaine Injection 2% (Procaine Hydrochloride (HCl))
High Chemical Co., 1760 N. Howard St.,
Philadelphia, PA 19122
NDA 2–959
Nicotinic Acid (Niacin) Tablets
The Blue Line Chemical Co., 302 South
Broadway, St. Louis, MO 63102
NDA 4–236
Sherman (thiamine HCl) Elixir
Do.
NDA 4–368
Ascorbic Acid Tablets
Do.
NDA 5–159
D.S.D. (diethylstilbestrol dipropionate)
Do.
NDA 9–452
Multifuge (piperazine citrate) Syrup
Do.
NDA 10–055
Fire Gard Three-Alarm Burn Relief
(Methylcellulose)
Gard Products, Inc., 2560 Tara Lane, Brunswick, GA 31520
NDA 10–337
Fling Antiperspirant Foot Powder
Bauer & Black, A Division of The Kendall
Co., One Federal St., Boston, MA 02110
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 10–823
BIKE Foot and Body Powder
Bauer & Black, A Division of The Kendall Co.
NDA 10–824
BIKE Anti-Fungal Aerosol Spray
Do.
NDA 11–233
TKO with Entrin Roll-On Liquid
Modern-Labs, Inc., Maple Rd., Gambrills, MD
21504
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
VerDate jul<14>2003
16:00 Apr 27, 2005
Jkt 205001
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.
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
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
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
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28APN1
]]>Agencies
[Federal Register Volume 70, Number 81 (Thursday, April 28, 2005)]
[Notices]
[Pages 22052-22053]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-8469]
-----------------------------------------------------------------------
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
