Menley & James Laboratories, Inc. et al.; Withdrawal of Approval of Six New Drug Applications, 57586-57587 [E7-19865]
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Federal Register / Vol. 72, No. 195 / Wednesday, October 10, 2007 / Notices
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of RHY, MO ..
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90CY2175
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157,500
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FOR FURTHER INFORMATION CONTACT:
Curtis O. Porter, Acting Associate
Commissioner, Family and Youth
Services Bureau, ACYF, ACF, DHHS.
Portals Building, 1250 Maryland
Avenue, SW., Washington, DC 20024;
202–205–8102.
Dated: September 28, 2007.
Susan Orr,
Associate Commissioner, Administration on
Children, Youth and Families.
[FR Doc. E7–19881 Filed 10–9–07; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Award Announcement; Administration
on Children, Youth and Families
Administration on Children,
Youth and Families, Administration for
Children and Families, Department of
Health and Human Services.
ACTION: Award announcement.
AGENCY:
CFDA NO.: 93.550, 93.623, 93.557.
SUMMARY: The Administration on
rwilkins on PROD1PC63 with NOTICES
Children, Youth and Families (ACYF),
Family and Youth Services Bureau
(FYSB) announces the approval of a
Application
No.
NDA 6–410
VerDate Aug<31>2005
deviation to supplement the National
Runaway Switchboard for the purpose
of expanding their services. Congress
authorized the establishment of a
‘‘national communications system to
assist runaway and homeless youth in
making contact with their families and
service providers’’ through the Runaway
and Homeless Youth Act (RHYA) of the
Juvenile Justice and Delinquency
Prevention Act of 1974, as amended.
Funding for the system was first
authorized in fiscal year 1980. (The
system currently is authorized through
Part C, section 331, of the ‘‘Runaway,
Homeless, and Missing Children
Protection Act,’’ Pub. L. 108–96.)
The Administration on Children,
Youth and Families, Family and Youth
Services Bureau (FYSB), herein
announces an expansion supplement
award to the National Runaway
Switchboard (NRS) for two initiatives; a
comprehensive research project on
runaway and at-risk youth and a
comprehensive database conversion.
The results of the comprehensive
research project will enable NRS to
better understand how to communicate
with youth and develop strategies to
connect with them and them with the
NRS. The comprehensive database
conversion will enhance the
Switchboard’s capability to download
and manage information. This project
will provide the NRS with the internal
controls necessary to query and analyze
data collected in their crisis logs. It is
anticipated that the enhanced internal
controls will result in a significant
improvement in the way needs of
runaway, homeless and other youth in
at-risk situations are met. This
expansion supplement is for a nine
month project period for the amount of
$162,637.
FOR FURTHER INFORMATION CONTACT:
Curtis O. Porter, Acting Associate
Commissioner, Family and Youth
Services Bureau, ACYF, ACF, DHHS.
Portals Building, 1250 Maryland
Avenue, SW., Washington, DC 20024;
202–205–8102.
Dated: September 28, 2007.
Susan Orr,
Associate Commissioner, Administration on
Children, Youth and Families.
[FR Doc. E7–19886 Filed 10–9–07; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0246]
Menley & James Laboratories, Inc. et
al.; Withdrawal of Approval of Six New
Drug Applications
AGENCY:
ACTION:
DATES:
PO 00000
Effective October 10, 2007.
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.
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).
In the Federal Register of June 28,
2007 (72 FR 35498), FDA published a
notice offering an opportunity for a
hearing (NOOH) on a proposal to
withdraw approval of six NDAs because
the firms had failed to submit the
required annual reports for these
applications. The holders of these
applications did not respond to the
NOOH. Failure to file a written notice
of participation and request for hearing
as required by part 314 (21 CFR 314) in
§ 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 six applications listed in the table of
this document.
SUPPLEMENTARY INFORMATION:
Applicant
Benzedrex (propylhexadrine) Nasal Spray
Jkt 214001
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is withdrawing
approval of six 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.
Drug
17:08 Oct 09, 2007
Food and Drug Administration,
HHS.
Frm 00074
Menley & James Laboratories, Inc., Commonwealth Corporate Center, 100 Tournament Dr., Horsham, PA 19044
Fmt 4703
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E:\FR\FM\10OCN1.SGM
10OCN1
Federal Register / Vol. 72, No. 195 / Wednesday, October 10, 2007 / Notices
Application
No.
Drug
57587
Applicant
NDA 7–518
Synthetic Vitamin A
Pfizer Laboratories, Division of Pfizer, Inc., 235 East 42nd
St., New York, NY 10017
NDA 8–837
Isoniazid Tablets
Barnes Hind, 895 Kifer Rd., Sunnyvale, CA 94806
NDA 8–851
NDK Fluoride Dentifrice (sodium monofluorophosphate)
NDK Co., c/o J.W. Emmer/Kenneth Emmer, 215 Genevieve
Dr., Lafayette, LA 70503
NDA 9–395
Paskalium (potassium aminosalicylate)
Glenwood, 111 Cedar Lane, Englewood, NJ 07631
NDA 19–518
Extra Strength Aim (sodium monofluorophosphate)
Chesebrough-Ponds USA Co., 33 Benedict Pl., P.O. Box
6000, Greenwich, CT 06836–6000
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, finds that the holders of
the applications 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
October 10, 2007.
Dated: September 24, 2007.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation
and Research.
[FR Doc. E7–19865 Filed 10–9–07; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N–0357]
Medical Device User Fee and
Modernization Act; Notice to Public of
Web Location of 2008 Proposed
Guidance Development; Establishment
of a Public Docket
AGENCY:
Food and Drug Administration,
HHS.
rwilkins on PROD1PC63 with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
Web location where it will post a list of
guidance documents the Center for
Devices and Radiological Health (CDRH)
is considering for development. In
addition, FDA is establishing a docket
where stakeholders may provide
comments and/or draft language for
those topics as well as suggestions for
new or different guidances.
VerDate Aug<31>2005
17:08 Oct 09, 2007
Jkt 214001
Submit written or electronic
comments at any time.
ADDRESSES: Submit written comments
to the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.fda.gov/dockets/ecomments.
Identify comments with the docket
number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Deborah A. Wolf, Center for Devices and
Radiological Health (HFZ–215), Food
and Drug Administration, 1350 Piccard
Dr., Rockville, MD 20850, 240–276–
2350.
DATES:
SUPPLEMENTARY INFORMATION:
I. Background
During negotiations over the
reauthorization of the Medical Device
User Fee and Modernization Act
(MDUFMA), FDA agreed, in return for
additional funding from industry, to
meet a variety of quantitative and
qualitative goals intended to help get
safe and effective medical devices to
market more quickly. These
commitments include annually posting
a list of guidance documents that FDA’s
Center for Devices and Radiological
Health (CDRH) is considering for
development and providing
stakeholders an opportunity to provide
comments and/or draft language for
those topics, or suggestions for new or
different guidances. This notice
announces the Web location of the list
of guidances CDRH is intending to work
on over the next fiscal year. We note
that the agency is not required to issue
every guidance on the list, nor is it
precluded from issuing guidance
documents that are not on the list. The
list includes topics that currently have
no guidance associated with them,
topics where updated guidance may be
helpful, and topics for which CDRH has
already issued Level 1 drafts that may
be finalized following review of public
PO 00000
Frm 00075
Fmt 4703
Sfmt 4703
comments. We will consider
stakeholder comments as we prioritize
our guidance efforts.
We also note that CDRH’s experience
over the years has shown that there are
many reasons CDRH staff cannot
complete the entire annual agenda of
guidances it undertakes. Staff are
frequently diverted from guidance
development to other activities,
including review of premarket
submissions or postmarket problems. In
addition, the Center is required each
year to issue a number of guidances it
cannot know about in advance. These
may involve newly identified public
health issues as well as special control
guidance documents that are necessary
for the classification of de novo devices.
It will be helpful, therefore, to receive
comments that indicate the relative
priority of different guidance topics to
interested stakeholders.
The Center expects that the recent
initiatives it has taken to streamline and
track guidance development will
improve its capacity to issue more
guidance documents. The posting and
the establishment of a docket
announced through this notice is one of
the ways CDRH hopes to enhance the
process. Through feedback from
stakeholders, including draft language
for guidance documents, CDRH expects
to be able to better prioritize and more
efficiently draft guidances that will be
useful to industry and other
stakeholders. FDA intends to update the
list each year.
FDA invites interested persons to
submit comments on any or all of the
guidance documents on the list. FDA
has established a specific Docket (see
docket number found in brackets in the
heading of this document) where
comments about the list, draft language
for guidance documents on those topics,
and suggestions for new or different
guidances may be submitted. FDA
hopes this docket will become an
important tool for receiving information
from interested parties and for sharing
this information with the public.
E:\FR\FM\10OCN1.SGM
10OCN1
]]>Agencies
[Federal Register Volume 72, Number 195 (Wednesday, October 10, 2007)]
[Notices]
[Pages 57586-57587]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-19865]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0246]
Menley & James Laboratories, Inc. et al.; Withdrawal of Approval
of Six New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of six 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 October 10, 2007.
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 June 28, 2007 (72 FR 35498), FDA
published a notice offering an opportunity for a hearing (NOOH) on a
proposal to withdraw approval of six NDAs because the firms had failed
to submit the required annual reports for these applications. The
holders of these applications did not respond to the NOOH. Failure to
file a written notice of participation and request for hearing as
required by part 314 (21 CFR 314) in Sec. 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 six
applications listed in the table of this document.
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 6-410 Benzedrex Menley & James
(propylhexadrine) Nasal Laboratories, Inc.,
Spray Commonwealth Corporate
Center, 100 Tournament
Dr., Horsham, PA 19044
------------------------------------------------------------------------
[[Page 57587]]
NDA 7-518 Synthetic Vitamin A Pfizer Laboratories,
Division of Pfizer, Inc.,
235 East 42nd St., New
York, NY 10017
------------------------------------------------------------------------
NDA 8-837 Isoniazid Tablets Barnes Hind, 895 Kifer
Rd., Sunnyvale, CA 94806
------------------------------------------------------------------------
NDA 8-851 NDK Fluoride Dentifrice NDK Co., c/o J.W. Emmer/
(sodium Kenneth Emmer, 215
monofluorophosphate) Genevieve Dr., Lafayette,
LA 70503
------------------------------------------------------------------------
NDA 9-395 Paskalium (potassium Glenwood, 111 Cedar Lane,
aminosalicylate) Englewood, NJ 07631
------------------------------------------------------------------------
NDA 19-518 Extra Strength Aim (sodium Chesebrough-Ponds USA Co.,
monofluorophosphate) 33 Benedict Pl., P.O. Box
6000, Greenwich, CT 06836-
6000
------------------------------------------------------------------------
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, finds that
the holders of the applications 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 October 10, 2007.
Dated: September 24, 2007.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. E7-19865 Filed 10-9-07; 8:45 am]
BILLING CODE 4160-01-S
