Schmid Laboratories, Inc. et al.; Withdrawal of Approval of Five New Drug Applications, 55334-55335 [2010-22603]
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Federal Register / Vol. 75, No. 175 / Friday, September 10, 2010 / Notices
Committee Act, as amended (5 U.S.C.
Appendix 2).
AHRQ is seeking nominations to fill
approximately 20 to 30 percent of its
study section membership, across the
following study sections:
(1) Health System Research (HSR),
(2) Health Care Technology and
Decision Sciences (HCTDS),
(3) Health Care Quality and
Effectiveness Research (HCQER), and
(4) Health Care Research Training
(HCRT).
The primary research foci and
functions of these four study sections
are described on the AHRQ Web site:
(http:Ilwww.AHRQ
.qovlfundlpeerrevlpeerdesc. htm).
Individuals from the health services
research and health care community
who could serve as peer reviewers on
these study sections are sought to
replace study section members whose
terms have expired. In sending your
nomination, please specify the
nominee’s professional/scientific/
technical expertise, affiliations and full
contact information, if this information
is available.
Factors that will be considered in the
selection of individuals to serve on
study sections include: competence in a
scientific, technical or clinical
discipline or research specialty,
particularly in health services research;
fairness and evenhandedness in
judgment and review; ability to work
effectively in a group context; and
commitment to complete work
assignments.
A diversity of perspectives is valuable
to AHRQ’s work. To help obtain a
diversity of perspectives among
nominees, AHRQ encourages
nominations of women and members of
minority populations. AHRQ also seeks
broad geographic representation.
DATES: AHRQ would like to receive your
recommendations no later than Friday,
October 1,2010.
ADDRESSES: Please direct your
correspondence to: Kishena C.
Wadhwani, PhD., M.P.H., Director,
Division of Scientific Review (DSR),
Office of Extramural Research,
Education and Priority Populations
(OEREP), Agency for Healthcare
Research and Quality (AHRQ),
Department of Health and Human
Services (DHHS), 540 Gaither Road,
Room 2032, Rockville, MD 20850,
Phone: (301) 427–1556, Fax: (301) 427–
1562, e-mail: Kishena.WadhwanjAHRQ
hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Kishena C. Wadhwani, PhD., M.P.H.
(See ADDRESSES section.)
SUPPLEMENTARY INFORMATION:
Background
Currently, AHRQ has one chartered
Health Services Research Initial Review
Group (IRG) responsible for the peer
review of research and training grant
applications submiffed for funding
consideration. The IRG is to advise the
Director of the Agency on matters
related to scientific and technical merit
of research grant proposals to improve
the quality, safety, efficiency, and
effectiveness of health care for all
Americans.
This IRG is currently comprised of
four subcommittees or study sections,
each with a particular research focus
around which peer reviewers’ expertise
is assembled. These study sections
convene three times per year to review
the grant applications submitted to the
three different submission cycles. Study
section members are appointed for up to
a maximum of four years.
Dated: September 1, 2010.
Carolyn M. Clancy,
Director, AHRQ.
[FR Doc. 2010–22544 Filed 9–9–10; 8:45 am]
BILLING CODE 416Q–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0444]
Schmid Laboratories, Inc. et al.;
Withdrawal of Approval of Five New
Drug Applications
AGENCY:
ACTION:
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of five 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.
SUMMARY:
DATES:
Effective September 10, 2010.
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6366,
Silver Spring, MD 20993–0002, 301–
796–3601.
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 September
24, 2009 (74 FR 49760), FDA published
a notice offering an opportunity for a
hearing (NOOH) on a proposal to
withdraw approval of five 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 § 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 five applications listed in table 1 of
this document.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration,
HHS.
TABLE 1.
srobinson on DSKHWCL6B1PROD with NOTICES
Application
No.
Drug
Applicant
NDA 5–766
Ramses Vaginal Jelly
Schmid Laboratories, Inc., Route 46 West, Little Falls, NJ 07424
NDA 7–220
Synthetic Vitamin A (vitamin A palmitate)
Merck & Co., Inc., 770 Sumneytown Pike, P.O. Box 4, West Point, PA 19486
NDA 8–595
Immolin Vaginal Cream Jel
Schmid Laboratories, Inc.
NDA 8–612
Silicote (simethicone) Ointment
Arnar-Stone Laboratories, Inc., 601 East Kensington Rd., Mount Prospect, IL 60056
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Federal Register / Vol. 75, No. 175 / Friday, September 10, 2010 / Notices
55335
TABLE 1.—Continued
Application
No.
NDA 10–915
Drug
Applicant
Q.E.D. Hairgroom (captan)
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
September 10, 2010.
Dated: August 31, 2010.
Janet Woodcock,
Director, Center for Drug Evaluation and
Research.
[FR Doc. 2010–22603 Filed 9–9–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HOMELAND
SECURITY
Office of the Secretary
[Docket No. DHS–2010–0075]
Privacy Act of 1974; Privacy Act of
1974: Department of Homeland
Security/ALL–031 Information Sharing
Environment Suspicious Activity
Reporting Initiative System of Records
Privacy Office, DHS.
Notice of Privacy Act system of
AGENCY:
ACTION:
records.
In accordance with the
Privacy Act of 1974, the Department of
Homeland Security proposes to
establish a new Department of
Homeland Security system of records
titled, ‘‘Department of Homeland
Security/ALL—031 Information Sharing
Environment Suspicious Activity
Reporting Initiative System of Records.’’
This system of records will allow DHS
to compile suspicious activity report
data that meet the Information Sharing
Environment Suspicious Activity
Reporting Functional Standard and
share these Suspicious Activity
Reporting data with authorized
participants in the Nationwide
Suspicious Activity Reporting Initiative,
srobinson on DSKHWCL6B1PROD with NOTICES
SUMMARY:
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A.R. Winarick, Inc., 783 Palisade Ave., Cliffside, NJ 07010
including other DHS components,
Federal departments and agencies,
State, local and Tribal law enforcement
agencies, and the private sector.
Additionally, the Department of
Homeland Security is issuing a Notice
of Proposed Rulemaking to exempt this
system from certain provisions of the
Privacy Act elsewhere in the Federal
Register. This newly established system
will be included in the Department of
Homeland Security’s inventory of
record systems.
DATES: Submit comments on or before
October 12, 2010. This new system will
be effective October 12, 2010.
ADDRESSES: You may submit comments,
identified by docket number DHS–
2010–0075 by one of the following
methods:
• Federal e-Rulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
• Fax: 703–483–2999.
• Mail: Mary Ellen Callahan, Chief
Privacy Officer, Privacy Office,
Department of Homeland Security,
Washington, DC 20528.
• Instructions: All submissions
received must include the agency name
and docket number for this rulemaking.
All comments received will be posted
without change to https://
www.regulations.gov, including any
personal information provided.
• Docket: For access to the docket to
read background documents or
comments received go to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: For
general questions please contact: Ronald
Athmann (202–447–4332), Office of
Intelligence and Analysis, Department
of Homeland Security, Washington, DC
20528. For privacy issues please
contact: Mary Ellen Callahan (703–235–
0780), Chief Privacy Officer, Privacy
Office, U.S. Department of Homeland
Security, Washington, DC 20528.
SUPPLEMENTARY INFORMATION:
I. Background
In accordance with the Privacy Act of
1974, 5 U.S.C. 552a, the Department of
Homeland Security (DHS) proposes to
establish a new DHS system of records
titled, ‘‘DHS/ALL–031 Information
Sharing Environment (ISE) Suspicious
Activity Reporting (SAR) Initiative
System of Records.’’
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This system of records will allow DHS
components that produce, receive, and
store suspicious activity reports (SARs)
pursuant to their existing authorities,
responsibilities, platforms, and
programs to compile and share report
data that also meet the ISE–SAR
Functional Standard with authorized
participants in the Nationwide SAR
Initiative (NSI) including, Federal
departments and agencies, State, local
and Tribal law enforcement agencies,
and the private sector. The NSI is one
of a number of government-wide efforts
designed to implement guidelines first
issued by the President on December 16,
2005, for establishing the ISE pursuant
to section 1016 of the Intelligence
Reform and Terrorism Prevention Act of
2004 (IRTPA), as amended. The NSI
establishes a nationwide capability to
gather, document, process, analyze and
share information about suspicious
activity, incidents, or behavior
reasonably indicative of terrorist
activities (hereafter collectively referred
to as suspicious activity or activities) to
enable rapid identification and
mitigation of potential terrorist threats.
There is a long history of
documenting of suspicious activity,
particularly in the law enforcement
community; these reports are sometimes
referred to as suspicious activity reports,
tips and leads, or other similar terms.
Federal, State, local and Tribal agencies
and the private sector currently collect
and document suspicious activities in
support of their responsibilities to
investigate and prevent potential
crimes, protect citizens, and apprehend
and prosecute criminals. Since some of
these documented activities may bear a
nexus to terrorism, the Program
Manager for the Information Sharing
Environment (PM–ISE) has developed a
standardized process for identifying,
documenting, and sharing terrorismrelated SAR data (hereinafter referred to
as an ‘‘ISE–SAR’’), which meet the
definition and criteria set forth in the
ISE Functional Standard Suspicious
Activity Reporting, (Version 1.5, May
2009) to the maximum extent possible
consistent with the protection of
individual privacy, civil rights, and civil
liberties. The Functional Standard
defines an ISE–SAR as official
documentation of observed behavior
determined to have a potential nexus to
terrorism (i.e., to be reasonably
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]]>Agencies
[Federal Register Volume 75, Number 175 (Friday, September 10, 2010)]
[Notices]
[Pages 55334-55335]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-22603]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0444]
Schmid Laboratories, Inc. et al.; Withdrawal of Approval of Five
New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing
approval of five 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 10, 2010.
FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6366, Silver Spring, MD 20993-0002, 301-
796-3601.
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 September 24, 2009 (74 FR 49760), FDA
published a notice offering an opportunity for a hearing (NOOH) on a
proposal to withdraw approval of five 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 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 five applications listed in
table 1 of this document.
Table 1.
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 5-766 Ramses Vaginal Schmid Laboratories, Inc., Route
Jelly 46 West, Little Falls, NJ 07424
------------------------------------------------------------------------
NDA 7-220 Synthetic Vitamin A Merck & Co., Inc., 770 Sumneytown
(vitamin A Pike, P.O. Box 4, West Point, PA
palmitate) 19486
------------------------------------------------------------------------
NDA 8-595 Immolin Vaginal Schmid Laboratories, Inc.
Cream Jel
------------------------------------------------------------------------
NDA 8-612 Silicote Arnar-Stone Laboratories, Inc.,
(simethicone) 601 East Kensington Rd., Mount
Ointment Prospect, IL 60056
------------------------------------------------------------------------
[[Page 55335]]
NDA 10-915 Q.E.D. Hairgroom A.R. Winarick, Inc., 783 Palisade
(captan) Ave., Cliffside, NJ 07010
------------------------------------------------------------------------
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 September 10, 2010.
Dated: August 31, 2010.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2010-22603 Filed 9-9-10; 8:45 am]
BILLING CODE 4160-01-S
