Request for Notification From Industry Organizations Interested in Participating in the Selection Process for a Nonvoting Industry Representative on the Tobacco Products Scientific Advisory Committee and Request for Nominations for Nonvoting Industry Representatives on the Tobacco Products Scientific Advisory Committee; Amendment of Notice, 48761-48762 [E9-23009]
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Federal Register / Vol. 74, No. 184 / Thursday, September 24, 2009 / Notices
48761
TABLE 1
Application No.
Drug
Applicant
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
NDA 10–915
srobinson on DSKHWCL6B1PROD with NOTICES
NDA 5–766
Q.E.D. Hairgroom (captan)
A.R. Winarick, Inc., 783 Palisade Ave., Cliffside, NJ 07010
Therefore, notice is given to the
holders of the approved applications
listed in table 1 of this document 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 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should not be withdrawn and an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 the following: (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 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 § 314.200 and in 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 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
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16:27 Sep 23, 2009
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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
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, or on the Internet at https://
www.regulations.gov.
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 of Food
and Drugs.
Dated: September 9, 2009.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation
and Research.
[FR Doc. E9–23005 Filed 9–23–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0383]
Request for Notification From Industry
Organizations Interested in
Participating in the Selection Process
for a Nonvoting Industry
Representative on the Tobacco
Products Scientific Advisory
Committee and Request for
Nominations for Nonvoting Industry
Representatives on the Tobacco
Products Scientific Advisory
Committee; Amendment of Notice
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug Administration
(FDA) is announcing an amendment to
the notice of the Request for Notification
From Industry Organizations Interested
in Participating in the Selection Process
for a Nonvoting Industry Representative
on the Tobacco Products Scientific
Advisory Committee and Request for
Nominations for Nonvoting Industry
Representatives on the Tobacco
Products Scientific Advisory
Committee. This meeting was
announced in the Federal Register of
August 26, 2009 (74 FR 43140). The
amendment is being made to reflect
changes in the DATES, ADDRESSES, and
Selection Procedure portions of the
document. There are no other changes.
FOR FURTHER INFORMATION CONTACT:
Teresa L. Hays, Food and Drug
Administration, Center for Tobacco
Products, 9200 Corporate Blvd.,
Rockville, MD 20850–3229, 301–796–
3369, FAX: 301–595–7946, e-mail:
Teresa.Hays@fda.hhs.gov.
In the
Federal Register of August 26, 2009,
FDA announced a Request for
Notification From Industry
Organizations Interested in Participating
SUPPLEMENTARY INFORMATION:
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48762
Federal Register / Vol. 74, No. 184 / Thursday, September 24, 2009 / Notices
in the Selection Process for a Nonvoting
Industry Representative on the Tobacco
Products Scientific Advisory Committee
and Request for Nominations for a
Nonvoting Industry Representatives on
the Tobacco Products Scientific
Advisory Committee of the Tobacco
Products Scientific Advisory
Committee.
On page 43140, in the third column,
the DATES portion of the document is
changed to read as follows:
DATES: Any industry organization
interested in participating in the
selection of an appropriate nonvoting
member to represent industry interests
must send a letter stating the interest to
FDA by October 26, 2009, for vacancies
listed in the notice. Concurrently,
nomination material for prospective
candidates should be sent to the FDA by
October 26, 2009.
On page 43140, in the first column,
the ADDRESSES portion of the document
is changed to read as follows:
ADDRESSES: All nominations for
membership should be sent to Teresa L.
Hays, Food and Drug Administration,
Center for Tobacco Products, 9200
Corporate Blvd., Rockville, MD 20850–
3229, 301–796–3699, FAX: 301–595–
7946, e-mail: Teresa.Hays@fda.hhs.gov.
On page 43141, beginning in the first
column, the text in the II. Selection
Procedure portion of the document is
changed to read as follows:
srobinson on DSKHWCL6B1PROD with NOTICES
Selection Procedure
Any industry organization interested
in participating in the selection of an
appropriate nonvoting member to
represent industry interests should send
a letter stating that interest to the FDA
contact (see ADDRESSES) within 30 days
of publication of this document. Within
the subsequent 30 days, FDA will send
a letter to each organization that has
expressed an interest, attaching a
complete list of all such organizations;
and a list of all nominees along with
their current resumes. The letter will
also state that it is the responsibility of
the interested organizations to confer
with one another and to select a
candidate, within 60 days after the
receipt of the FDA letter, to serve as the
nonvoting member to represent industry
interests for the Tobacco Products
Scientific Advisory Committee. The
interested organizations are not bound
by the list of nominees in selecting a
candidate. However, if no individual is
selected within 60 days, the
Commissioner of Food and Drugs will
select the nonvoting member to
represent industry interests.
This notice is issued under the
Federal Advisory Committee Act (5
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16:27 Sep 23, 2009
Jkt 217001
U.S.C. app. 2) and 21 CFR part 14,
relating to the advisory committees.
Dated: September 18, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–23009 Filed 9–23–09; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
National Protection and Programs
Directorate; Infrastructure Protection
Data Call Survey
AGENCY: National Protection and
Programs Directorate, DHS.
ACTION: 60-Day Notice and request for
comments; New Information Collection
Request: 1670—NEW.
SUMMARY: The Department of Homeland
Security, National Protection and
Programs Directorate, has submitted the
following Information Collection
Request (ICR) to the Office of
Management and Budget (OMB) for
review and clearance in accordance
with the Paperwork Reduction Act of
1995 (Pub. L. 104–13, 44 U.S.C. Chapter
35).
DATES: Comments are encouraged and
will be accepted until November 23,
2009. This process is conducted in
accordance with 5 CFR 1320.1.
ADDRESSES: Written comments and
questions about this Information
Collection Request should be forwarded
to NPPD/IP/IICD, Attn.: Mary MathenyRushdan, mary.mathenyrushdan@dhs.gov.
SUPPLEMENTARY INFORMATION: The U.S.
Department of Homeland Security
(DHS) is the lead coordinator in the
national effort to identify and prioritize
the country’s critical infrastructure and
key resources (CIKR). At DHS, this
responsibility is managed by the Office
of Infrastructure Protection (IP) in the
National Protection and Programs
Directorate (NPPD). In FY2006, IP
engaged in the annual development of a
list of CIKR assets and systems to
improve IP’s CIKR prioritization efforts;
this list is called the Critical
Infrastructure List. The Critical
Infrastructure List includes assets and
systems that, if destroyed, damaged or
otherwise compromised, could result in
significant consequences on a regional
or national scale.
The IP Data Call is administered out
of the Infrastructure Information
Collection Division (IICD) in the Office
of Infrastructure Protection (IP). The IP
Data Call provides opportunities for
States and territories to collaborate with
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DHS and its Federal partners in CIKR
protection. DHS, State and territorial
Homeland Security Advisors (HSA),
Sector Specific Agencies (SSA), and
territories build their CIKR data using
the IP Data Call application. To ensure
that HSAs, SSAs and territories are able
to achieve this mission, IP requests
opinions and information in a survey
from IP Data Call participants regarding
the IP Data Call process and the Webbased application used to collect the
CIKR data. The survey data collected is
for internal IICD and IP use only.
IICD and IP will use the results of the
IP Data Call Survey to determine levels
of customer satisfaction with the IP Data
Call process and the IP Data Call
application and prioritize future
improvements. The results will also
allow IP to appropriate funds costeffectively based on user need, and
improve the process and application.
The Office of Management and Budget
is particularly interested in comments
which:
1. Evaluate whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility;
2. Evaluate the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used;
3. Enhance the quality, utility, and
clarity of the information to be
collected; and
4. Minimize the burden of the
collection of information on those who
are to respond, including through the
use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submissions
of responses.
Analysis
Agency: Department of Homeland
Security, National Protection and
Programs Directorate.
Title: IP Data Call Survey.
Form: Not Applicable.
OMB Number: 1670—NEW.
Affected Public: State, Local, or Tribal
Government.
Number of Respondents: 138.
Estimated Time per Respondent: 2
hours.
Total Burden Hours: 276.
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[Federal Register Volume 74, Number 184 (Thursday, September 24, 2009)]
[Notices]
[Pages 48761-48762]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-23009]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0383]
Request for Notification From Industry Organizations Interested
in Participating in the Selection Process for a Nonvoting Industry
Representative on the Tobacco Products Scientific Advisory Committee
and Request for Nominations for Nonvoting Industry Representatives on
the Tobacco Products Scientific Advisory Committee; Amendment of Notice
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing an amendment
to the notice of the Request for Notification From Industry
Organizations Interested in Participating in the Selection Process for
a Nonvoting Industry Representative on the Tobacco Products Scientific
Advisory Committee and Request for Nominations for Nonvoting Industry
Representatives on the Tobacco Products Scientific Advisory Committee.
This meeting was announced in the Federal Register of August 26, 2009
(74 FR 43140). The amendment is being made to reflect changes in the
DATES, ADDRESSES, and Selection Procedure portions of the document.
There are no other changes.
FOR FURTHER INFORMATION CONTACT: Teresa L. Hays, Food and Drug
Administration, Center for Tobacco Products, 9200 Corporate Blvd.,
Rockville, MD 20850-3229, 301-796-3369, FAX: 301-595-7946, e-mail:
Teresa.Hays@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the Federal Register of August 26, 2009,
FDA announced a Request for Notification From Industry Organizations
Interested in Participating
[[Page 48762]]
in the Selection Process for a Nonvoting Industry Representative on the
Tobacco Products Scientific Advisory Committee and Request for
Nominations for a Nonvoting Industry Representatives on the Tobacco
Products Scientific Advisory Committee of the Tobacco Products
Scientific Advisory Committee.
On page 43140, in the third column, the DATES portion of the
document is changed to read as follows:
DATES: Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests must send a letter stating the interest to FDA by October 26,
2009, for vacancies listed in the notice. Concurrently, nomination
material for prospective candidates should be sent to the FDA by
October 26, 2009.
On page 43140, in the first column, the ADDRESSES portion of the
document is changed to read as follows:
ADDRESSES: All nominations for membership should be sent to Teresa L.
Hays, Food and Drug Administration, Center for Tobacco Products, 9200
Corporate Blvd., Rockville, MD 20850-3229, 301-796-3699, FAX: 301-595-
7946, e-mail: Teresa.Hays@fda.hhs.gov.
On page 43141, beginning in the first column, the text in the II.
Selection Procedure portion of the document is changed to read as
follows:
Selection Procedure
Any industry organization interested in participating in the
selection of an appropriate nonvoting member to represent industry
interests should send a letter stating that interest to the FDA contact
(see ADDRESSES) within 30 days of publication of this document. Within
the subsequent 30 days, FDA will send a letter to each organization
that has expressed an interest, attaching a complete list of all such
organizations; and a list of all nominees along with their current
resumes. The letter will also state that it is the responsibility of
the interested organizations to confer with one another and to select a
candidate, within 60 days after the receipt of the FDA letter, to serve
as the nonvoting member to represent industry interests for the Tobacco
Products Scientific Advisory Committee. The interested organizations
are not bound by the list of nominees in selecting a candidate.
However, if no individual is selected within 60 days, the Commissioner
of Food and Drugs will select the nonvoting member to represent
industry interests.
This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.
Dated: September 18, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-23009 Filed 9-23-09; 8:45 am]
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