Sodium Shale Oil Sulfonate Eligibility for Inclusion in Monograph; Over-the-Counter Dandruff, Seborrheic Dermatitis, and Psoriasis Drug Products for Human Use; Request for Safety and Effectiveness Data, 15741-15742 [E9-7766]
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Federal Register / Vol. 74, No. 65 / Tuesday, April 7, 2009 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0664]
Circulatory System Devices Panel of
the Medical Devices 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: Circulatory
System Devices Panel of the Medical
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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
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to 5:30 p.m.
Location: Hilton Washington DC
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620 Perry Pkwy., Gaithersburg, MD.
Contact Person: James Swink, Center
for Devices and Radiological Health
(HFZ–450), Food and Drug
Administration, 9200 Corporate Blvd.,
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coming to the meeting.
Agenda: The committee will discuss,
make recommendations, and vote on a
premarket approval application,
sponsored by Atritech, Inc., for the
WATCHMAN® Left Atrial Appendage
(LAA) Closure Technology. The
WATCHMAN® device, a
percutaneously placed permanent
implant, is intended as an alternative to
warfarin therapy for patients with nonvalvular atrial fibrillation. The
WATCHMAN® LAA Closure
Technology is designed to prevent
embolization of thrombi that may form
in the left atrial appendage thereby
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17:13 Apr 06, 2009
Jkt 217001
preventing the occurrence of ischemic
stroke and systemic thromboembolism.
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than 2 business days before the meeting.
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meeting, the background material will
be made publicly available at the
location of the advisory committee
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dockets/ac/acmenu.htm, click on the
year 2009 and scroll down to the
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present data, information, or views,
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person on or before April 16, 2009. Oral
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indication of the approximate time
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speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by April 9, 2009.
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require special accommodations due to
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Williams, Conference Management
Staff, at 240–276–8932, at least 7 days
in advance of the meeting.
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default.htm for procedures on public
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PO 00000
Frm 00053
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15741
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: March 30, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9–7726 Filed 4–6–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0146]
Sodium Shale Oil Sulfonate Eligibility
for Inclusion in Monograph; Over-theCounter Dandruff, Seborrheic
Dermatitis, and Psoriasis Drug
Products for Human Use; Request for
Safety and Effectiveness Data
AGENCY:
Food and Drug Administration,
HHS.
ACTION: Notice of eligibility; request for
data and information.
SUMMARY: As part of our ongoing review
of over-the-counter (OTC) drug
products, we (Food and Drug
Administration (FDA)) are announcing a
call-for-data for safety and effectiveness
information for sodium shale oil
sulfonate (SSOS), 0.5 to 2.0 percent, as
a rinse-off treatment for dandruff. We
have reviewed a time and extent
application (TEA) for SSOS and
determined that it is eligible for
consideration in our OTC drug
monograph system. We will evaluate the
submitted data and information to
determine whether SSOS can be
generally recognized as safe and
effective (GRASE) as an OTC rinse-off
treatment for dandruff.
DATES: Submit data, information, and
general comments by July 6, 2009.
ADDRESSES: You may submit comments,
identified by Docket No. FDA–2009–N–
0146, by any of the following methods:
Electronic Submissions
Submit electronic comments in the
following way:
∑ Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written submissions in the
following ways:
∑ FAX: 301–827–6870.
∑ Mail/Hand delivery/Courier (For
paper, disk, or CD–ROM submissions):
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
To ensure more timely processing of
comments, we are no longer accepting
E:\FR\FM\07APN1.SGM
07APN1
15742
Federal Register / Vol. 74, No. 65 / Tuesday, April 7, 2009 / Notices
comments submitted to the agency by email. We encourage you to continue to
submit electronic comments by using
the Federal eRulemaking Portal, as
described previously, in the ADDRESSES
portion of this document under
Electronic Submissions.
Instructions: All submissions received
must include the agency name and
Docket No. for this rulemaking. All
comments received may be posted
without change to https://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the ‘‘Comments’’ heading
of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to
read background documents or
comments received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Michael L. Chasey, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, MS 5411,
Silver Spring, MD 20993, 301–796–
2090.
SUPPLEMENTARY INFORMATION:
I. Eligibility of SSOS
In November 2007, we received a TEA
(Ref. 1) requesting that SSOS be eligible
for review under our OTC dandruff,
seborrheic dermatitis, and psoriasis
monograph (21 CFR part 358 subpart H).
In February 2008, we received a
supplement to the TEA, which included
data and information clarifying some
points in the TEA (Ref. 2). After
reviewing the TEA and its supplement,
we believe that it includes adequate
data demonstrating that SSOS has been
marketed for a material time and to a
material extent as required by § 330.14
(21 CFR 330.14) (Ref. 3). SSOScontaining products have been marketed
directly to consumers for over 5
continuous years in 26 countries, with
an estimated 21 million dosage units
marketed in 34 countries.
The applicant requested that SSOS be
indicated for use to treat dandruff and
psoriasis, in rinse-off and leave-on
formulations. However, nearly all of the
submitted marketing data concerns
SSOS in rinse-off formulations for
dandruff treatment. More marketing
experience of SSOS in leave-on
formulations for dandruff treatment
would be necessary to find SSOS
VerDate Nov<24>2008
17:13 Apr 06, 2009
Jkt 217001
eligible in leave-on formulations. SSOS
in leave-on formulations does not meet
the ‘‘material extent’’ requirement of
§ 330.14(b)(2) and section 201 of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321). Only 2 to 4 million
dosage units of SSOS in leave-on
formulations have been sold, which is
inadequate compared to the number of
dosage units sold for other conditions
found eligible for inclusion in the OTC
drug monograph system via the TEA
process (tens of millions). Therefore, we
conclude that SSOS, 0.5 to 2.0 percent
in rinse-off formulations for dandruff
treatment, is eligible for inclusion in the
OTC dandruff, seborrheic dermatitis,
and psoriasis monograph.
II. Request for Data and Information
We invite all interested persons to
submit data and information on the
safety and effectiveness of SSOS in
order for us to determine whether it is
GRASE and not misbranded under
recommended conditions of OTC use
(see § 330.14(f)). The data submitted
should include animal and human
studies that meet current scientific
standards. The TEA does not include an
official or proposed United States
Pharmacopeia-National Formulary
(USP–NF) drug monograph. According
to § 330.14(i), an official or proposed
USP–NF monograph for each ingredient
must also be included as part of the
safety and effectiveness data for this
ingredient.
III. Marketing Policy
Under § 330.14(h), any product
containing SSOS may not be marketed
as an OTC drug in the United States at
this time unless it is the subject of an
approved new drug application or
abbreviated new drug application.
IV. References
The following references are on
display in the Division of Dockets
Management (see ADDRESSES) and may
be seen by interested persons between 9
a.m. and 4 p.m., Monday through
Friday.
1. TEA for Sodium Shale Oil
Sulfonate (SSOS) Submitted by DOW
Pharmaceutical Sciences, Inc., dated
November 30, 2007.
2. Supplement to the SSOS TEA
Submitted by DOW Pharmaceutical
Sciences, Inc., dated February 1, 2008.
3. FDA’s evaluation of the TEA for
SSOS.
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
Dated: March 24, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E9–7766 Filed 4ndash;6–09; 8:45
am]
BILLING CODE 4160–01–S
DEPARTMENT OF INTERIOR
National Park Service
60-Day Notice of Intention To Request
Clearance of Collection of Information;
Opportunity for Public Comment
AGENCY: Department of Interior,
National Park Service.
ACTION: Notice and request for
comments.
SUMMARY: Under the provisions of the
Paperwork Reduction Act of 1995 and 5
CFR part 1320, Reporting and Record
Keeping Requirements, the National
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comments on an extension of a
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will be accepted on or before June 8,
2009.
ADDRESSES: Send comments to: Charlie
Stockman, Outdoor Recreation Planner,
Rivers, Trails and Conservation
Assistance Program, NPS, 1849 C St.,
NW., (2220), Washington, DC 20240; or
via fax at 202/371–5179; or via e-mail at
Charlie_Stockman@nps.gov. All
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To Request a Draft of Proposed
Collection of Information Contact:
Charlie Stockman, NPS, 1849 C St.,
NW., (2220), Washington, DC 20005; or
via phone at 202/354–6900; or via fax at
202/371–5179; or via e-mail at
Charlie_Stockman@nps.gov. You are
entitled to a copy of the entire ICR
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Information Collection.
Form(s): None.
OMB Control Number: 1024–0226.
Expiration Date: 8/31/2009.
Type of Request: Extension of a
currently approved collection of
information.
E:\FR\FM\07APN1.SGM
07APN1
Agencies
[Federal Register Volume 74, Number 65 (Tuesday, April 7, 2009)]
[Notices]
[Pages 15741-15742]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-7766]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0146]
Sodium Shale Oil Sulfonate Eligibility for Inclusion in
Monograph; Over-the-Counter Dandruff, Seborrheic Dermatitis, and
Psoriasis Drug Products for Human Use; Request for Safety and
Effectiveness Data
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of eligibility; request for data and information.
-----------------------------------------------------------------------
SUMMARY: As part of our ongoing review of over-the-counter (OTC) drug
products, we (Food and Drug Administration (FDA)) are announcing a
call-for-data for safety and effectiveness information for sodium shale
oil sulfonate (SSOS), 0.5 to 2.0 percent, as a rinse-off treatment for
dandruff. We have reviewed a time and extent application (TEA) for SSOS
and determined that it is eligible for consideration in our OTC drug
monograph system. We will evaluate the submitted data and information
to determine whether SSOS can be generally recognized as safe and
effective (GRASE) as an OTC rinse-off treatment for dandruff.
DATES: Submit data, information, and general comments by July 6, 2009.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2009-
N-0146, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier (For paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
To ensure more timely processing of comments, we are no longer
accepting
[[Page 15742]]
comments submitted to the agency by e-mail. We encourage you to
continue to submit electronic comments by using the Federal eRulemaking
Portal, as described previously, in the ADDRESSES portion of this
document under Electronic Submissions.
Instructions: All submissions received must include the agency name
and Docket No. for this rulemaking. All comments received may be posted
without change to https://www.regulations.gov, including any personal
information provided. For additional information on submitting
comments, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION
section of this document.
Docket: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number, found in brackets in the heading of this document, into
the ``Search'' box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Michael L. Chasey, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, MS 5411, Silver Spring, MD 20993, 301-796-
2090.
SUPPLEMENTARY INFORMATION:
I. Eligibility of SSOS
In November 2007, we received a TEA (Ref. 1) requesting that SSOS
be eligible for review under our OTC dandruff, seborrheic dermatitis,
and psoriasis monograph (21 CFR part 358 subpart H). In February 2008,
we received a supplement to the TEA, which included data and
information clarifying some points in the TEA (Ref. 2). After reviewing
the TEA and its supplement, we believe that it includes adequate data
demonstrating that SSOS has been marketed for a material time and to a
material extent as required by Sec. 330.14 (21 CFR 330.14) (Ref. 3).
SSOS-containing products have been marketed directly to consumers for
over 5 continuous years in 26 countries, with an estimated 21 million
dosage units marketed in 34 countries.
The applicant requested that SSOS be indicated for use to treat
dandruff and psoriasis, in rinse-off and leave-on formulations.
However, nearly all of the submitted marketing data concerns SSOS in
rinse-off formulations for dandruff treatment. More marketing
experience of SSOS in leave-on formulations for dandruff treatment
would be necessary to find SSOS eligible in leave-on formulations. SSOS
in leave-on formulations does not meet the ``material extent''
requirement of Sec. 330.14(b)(2) and section 201 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321). Only 2 to 4 million dosage
units of SSOS in leave-on formulations have been sold, which is
inadequate compared to the number of dosage units sold for other
conditions found eligible for inclusion in the OTC drug monograph
system via the TEA process (tens of millions). Therefore, we conclude
that SSOS, 0.5 to 2.0 percent in rinse-off formulations for dandruff
treatment, is eligible for inclusion in the OTC dandruff, seborrheic
dermatitis, and psoriasis monograph.
II. Request for Data and Information
We invite all interested persons to submit data and information on
the safety and effectiveness of SSOS in order for us to determine
whether it is GRASE and not misbranded under recommended conditions of
OTC use (see Sec. 330.14(f)). The data submitted should include animal
and human studies that meet current scientific standards. The TEA does
not include an official or proposed United States Pharmacopeia-National
Formulary (USP-NF) drug monograph. According to Sec. 330.14(i), an
official or proposed USP-NF monograph for each ingredient must also be
included as part of the safety and effectiveness data for this
ingredient.
III. Marketing Policy
Under Sec. 330.14(h), any product containing SSOS may not be
marketed as an OTC drug in the United States at this time unless it is
the subject of an approved new drug application or abbreviated new drug
application.
IV. References
The following references are on display in the Division of Dockets
Management (see ADDRESSES) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. TEA for Sodium Shale Oil Sulfonate (SSOS) Submitted by DOW
Pharmaceutical Sciences, Inc., dated November 30, 2007.
2. Supplement to the SSOS TEA Submitted by DOW Pharmaceutical
Sciences, Inc., dated February 1, 2008.
3. FDA's evaluation of the TEA for SSOS.
Dated: March 24, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-7766 Filed 4ndash;6-09; 8:45 am]
BILLING CODE 4160-01-S