High Chemical Co. et al.; Withdrawal of Approval of 13 New Drug Applications, 55404-55405 [05-18873]
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Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Notices
programmatic limitations regarding
which ethnic groups they can serve. We
believe that by allowing them to
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U.S.C. 1522(c)(1)).
FOR FURTHER INFORMATION CONTACT:
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Dated: September 15, 2005.
Nguyen Van Hanh,
Director, Office of Refugee Resettlement.
[FR Doc. 05–18847 Filed 9–20–05; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0143]
High Chemical Co. et al.; Withdrawal of
Approval of 13 New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is withdrawing
approval of 13 new drug applications
(NDAs) from multiple holders of these
applications. The basis for the
withdrawals is that the holders of the
applications have repeatedly failed to
file required annual reports for the
applications.
Effective September 21, 2005.
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.
DATES:
The
holders of approved applications to
market new drugs for human use are
required to submit annual reports to
SUPPLEMENTARY INFORMATION:
VerDate Aug<31>2005
14:40 Sep 20, 2005
Jkt 205001
FDA concerning each of their approved
applications in accordance with
§ 314.81 (21 CFR 314.81). In the Federal
Register of January 28, 2005 (70 FR
4134), FDA published a notice offering
an opportunity for a hearing (NOOH) on
a proposal to withdraw approval of 13
NDAs because the firms had failed to
submit the required annual reports for
these applications. On April 28, 2005,
the agency withdrew that notice (70 FR
22054) and reissued the corrected
NOOH (70 FR 22052). FDA received two
responses to the NOOH:
1. The Kendall Co. (Kendall), 15
Hampshire St., Mansfield, MA 02048,
notified the agency that they no longer
market the following products: NDA 10–
337, Fling Antiperspirant Foot Powder;
NDA 10–823, BIKE Foot and Body
Powder; and NDA 10–824, BIKE AntiFungal Aerosol Spray. Kendall informed
FDA that their historical files show they
sold their rights to these three products
(including the licenses) many years ago;
however, they did not notify the agency
of the sale. Because Kendall sold the
products many years ago, they have no
record of the new application holder.
Neither The Kendall Co. nor the new
license holder requested a hearing.
2. Bayer HealthCare LLC, Biological
Products Division, 800 Dwight Way,
Berkeley, CA 94701–1966, notified the
agency that NDA 10–541, BY-NA-MID
(Butylphenamide or B and Zinc Oxide
or Stearate) Tincture, Ointment, Lotion,
and Powder, is not a product produced
at their Berkeley site, and that they
would forward the NOOH to Bayer
HealthCare LLC, Pharmaceutical
Division, 400 Morgan Lane, West
Haven, CT 06516–4175. Bayer
HealthCare LLC in West Haven, CT,
informed the agency that NDA 10–541,
BY-NA-MID, is not their product and
that they have no regulatory files for this
product. Bayer HealthCare LLC did not
request a hearing.
No other firms responded to the
NOOH. Failure to file a written notice
of participation and request for hearing
as required by § 314.200 (21 CFR
314.200) constitutes an election by the
applicant not to make use of the
opportunity for a hearing concerning the
proposal to withdraw approval of the
applications and a waiver of any
contentions concerning the legal status
of the drug products. Therefore, the
Director, Center for Drug Evaluation and
Research, is withdrawing approval of
the 13 applications listed in the table of
this document.
PO 00000
Frm 00074
Fmt 4703
Sfmt 4703
Application
No.
Drug
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 ThreeAlarm 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 AntiFungal 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
The Director, Center for Drug
Evaluation and Research, under section
505(e) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(e)), and
under authority delegated by the
Commissioner of Food and Drugs, finds
that the holders of the applications
E:\FR\FM\21SEN1.SGM
21SEN1
Federal Register / Vol. 70, No. 182 / Wednesday, September 21, 2005 / Notices
listed in this document have repeatedly
failed to submit reports required by
§ 314.81. In addition, under § 314.200,
we find that the holders of the
applications have waived any
contentions concerning the legal status
of the drug products. Therefore, under
these findings, approval of the
applications listed in this document,
and all amendments and supplements
thereto, is hereby withdrawn, effective
September 21, 2005.
Dated: August 29, 2005.
Steven Galson,
Director, Center for Drug Evaluation and
Research.
[FR Doc. 05–18873 Filed 9–20–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Industry Exchange Workshop on Food
and Drug Administration Clinical Trial
Requirements; Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug
Administration (FDA) Dallas District, in
cooperation with the Society of Clinical
Research Associates (SoCRA), is
announcing a workshop on FDA clinical
trial statutory and regulatory
requirements. This 2-day workshop for
the clinical research community targets
sponsors, monitors, clinical
investigators, institutional review
boards, and those who interact with
them for the purpose of conducting
FDA-regulated clinical research. The
workshop will include both industry
and FDA perspectives on proper
conduct of clinical trials regulated by
FDA.
Date and Time: The public workshop
is scheduled for Wednesday, February
8, 2006, from 8:15 a.m. to 5 p.m. and
Thursday, February 9, 2006, from 8:15
a.m. to 4 p.m.
Location: The public workshop will
be held at the Crowne Plaza Hotel
Houston Medical Center, 6701 South
Main, Houston, TX 77030, 713–797–
1110, FAX: 713–796–8291.
Contact: David Arvelo, Food and Drug
Administration, 4040 North Central
Expressway, suite 900, Dallas, TX
75204, 214–253–4952, FAX: 214–253–
4970, e-mail: oraswrsbr@ora.fda.gov.
Registration: Send registration
information (including name, title, firm
name, address, telephone, and fax
number) and the registration fee of $485
SUMMARY:
VerDate Aug<31>2005
14:40 Sep 20, 2005
Jkt 205001
(member), $560 (nonmember), or $460
(government employee nonmember).
(Registration fee for nonmembers
includes a 1-year membership.) The
registration fee for FDA employees is
waived. Make the registration fee
payable to SoCRA, P.O. Box 101,
Furlong, PA 18925. To register via the
Internet go to https://www.socra.org/
html/FDA_Conference.htm (FDA has
verified the Web site address, but is not
responsible for subsequent changes to
the Web site after this document
publishes in the Federal Register). The
registrar will also accept payment by
major credit cards. For more
information on the meeting, or for
questions on registration, contact 800–
SoCRA92 (800–762–7292), or 215–345–
7369, or via e-mail: socramail@aol.com.
Attendees are responsible for their own
accommodations. To make reservations
at the Crowne Plaza Hotel Houston
Medical Center at the reduced
conference rate, contact the Crowne
Plaza Hotel Houston Medical Center
(see Location) before January 17, 2005.
The registration fee will be used to
offset the expenses of hosting the
conference, including meals,
refreshments, meeting rooms, and
materials.
Space is limited, therefore interested
parties are encouraged to register early.
Limited onsite registration may be
available. Please arrive early to ensure
prompt registration. If you need special
accommodations due to a disability,
please contact David Arvelo (see
Contact) at least 7 days in advance of
the workshop.
SUPPLEMENTARY INFORMATION: The
workshop on FDA clinical trials
statutory and regulatory requirements,
helps fulfill the Department of Health
and Human Services and FDA’s
important mission to protect the public
health by educating researchers on
proper conduct of clinical trials. Topics
for discussion include the following: (1)
FDA regulation of the conduct of
clinical research; (2) medical device,
drug, and biological product aspects of
clinical research; (3) investigator
initiated research; (4) pre-investigational
new drug application meetings and FDA
meeting process; (5) informed consent
requirements; (6) ethics in subject
enrollment; (7) FDA regulation of
institutional review boards; (8)
electronic records requirements; (9)
adverse event reporting; (10) how FDA
conducts bioresearch inspections; and
(11) what happens after the FDA
inspection. FDA has made education of
the research community a high priority
to ensure the quality of clinical data and
protect research subjects. The workshop
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Fmt 4703
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55405
helps to implement the objectives of
section 406 of the FDA Modernization
Act (21 U.S.C. 393) and the FDA Plan
for Statutory Compliance, which
includes working more closely with
stakeholders and ensuring access to
needed scientific and technical
expertise. The workshop also furthers
the goals of the Small Business
Regulatory Enforcement Fairness Act
(Public Law 104–121) by providing
outreach activities by Government
agencies directed to small businesses.
Dated: September 15, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05–18871 Filed 9–20–05; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Psychopharmacologic Drugs Advisory
Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee:
Psychopharmacologic Drugs Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on October 25, 2005, from 8 a.m.
to 5 p.m. and on October 26, 2005, from
8 a.m. to 3 p.m.
Location: Hilton, The Ballrooms, 620
Perry Pkwy., Gaithersburg, MD. The
hotel phone number is 301–977–8900.
Contact Person: Karen TempletonSomers, Center for Drug Evaluation and
Research (HFD–21), Food and Drug
Administration, 5600 Fishers Lane (for
express delivery, 5630 Fishers Lane, rm.
1093), Rockville, MD 20857, 301–827–
7001, FAX: 301–827–6776, e-mail:
somersk@cder.fda.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area), code
3014512544. Please call the Information
Line for up-to-date information on this
meeting. The background material will
become available no later than the day
before the meeting and will be posted
on FDA’s Web site at https://
E:\FR\FM\21SEN1.SGM
21SEN1
]]>Agencies
[Federal Register Volume 70, Number 182 (Wednesday, September 21, 2005)]
[Notices]
[Pages 55404-55405]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-18873]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N-0143]
High Chemical Co. et al.; Withdrawal of Approval of 13 New Drug
Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 13 new drug applications (NDAs) from multiple holders of these
applications. The basis for the withdrawals is that the holders of the
applications have repeatedly failed to file required annual reports for
the applications.
DATES: Effective September 21, 2005.
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). In the Federal Register of January 28,
2005 (70 FR 4134), FDA published a notice offering an opportunity for a
hearing (NOOH) on a proposal to withdraw approval of 13 NDAs because
the firms had failed to submit the required annual reports for these
applications. On April 28, 2005, the agency withdrew that notice (70 FR
22054) and reissued the corrected NOOH (70 FR 22052). FDA received two
responses to the NOOH:
1. The Kendall Co. (Kendall), 15 Hampshire St., Mansfield, MA
02048, notified the agency that they no longer market the following
products: NDA 10-337, Fling Antiperspirant Foot Powder; NDA 10-823,
BIKE Foot and Body Powder; and NDA 10-824, BIKE Anti-Fungal Aerosol
Spray. Kendall informed FDA that their historical files show they sold
their rights to these three products (including the licenses) many
years ago; however, they did not notify the agency of the sale. Because
Kendall sold the products many years ago, they have no record of the
new application holder. Neither The Kendall Co. nor the new license
holder requested a hearing.
2. Bayer HealthCare LLC, Biological Products Division, 800 Dwight
Way, Berkeley, CA 94701-1966, notified the agency that NDA 10-541, BY-
NA-MID (Butylphenamide or B and Zinc Oxide or Stearate) Tincture,
Ointment, Lotion, and Powder, is not a product produced at their
Berkeley site, and that they would forward the NOOH to Bayer HealthCare
LLC, Pharmaceutical Division, 400 Morgan Lane, West Haven, CT 06516-
4175. Bayer HealthCare LLC in West Haven, CT, informed the agency that
NDA 10-541, BY-NA-MID, is not their product and that they have no
regulatory files for this product. Bayer HealthCare LLC did not request
a hearing.
No other firms responded to the NOOH. Failure to file a written
notice of participation and request for hearing as required by Sec.
314.200 (21 CFR 314.200) constitutes an election by the applicant not
to make use of the opportunity for a hearing concerning the proposal to
withdraw approval of the applications and a waiver of any contentions
concerning the legal status of the drug products. Therefore, the
Director, Center for Drug Evaluation and Research, is withdrawing
approval of the 13 applications listed in the table of this document.
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 0-763 Sterile Solution High Chemical Co., 1760
Procaine Injection 2% N. Howard St.,
(Procaine Philadelphia, PA 19122
Hydrochloride (HCl))
------------------------------------------------------------------------
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
------------------------------------------------------------------------
The Director, Center for Drug Evaluation and Research, under
section 505(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(e)), and under authority delegated by the Commissioner of Food and
Drugs, finds that the holders of the applications
[[Page 55405]]
listed in this document have repeatedly failed to submit reports
required by Sec. 314.81. In addition, under Sec. 314.200, we find
that the holders of the applications have waived any contentions
concerning the legal status of the drug products. Therefore, under
these findings, approval of the applications listed in this document,
and all amendments and supplements thereto, is hereby withdrawn,
effective September 21, 2005.
Dated: August 29, 2005.
Steven Galson,
Director, Center for Drug Evaluation and Research.
[FR Doc. 05-18873 Filed 9-20-05; 8:45 am]
BILLING CODE 4160-01-S
