60 day notice publisched

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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 http://
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 http://
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

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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.

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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
Park Service (NPS) invites public
comments on an extension of a
currently approved collection of
information (OMB #1024–0226).
DATES: Public comments on this
Information Collection Request (ICR)
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
[email protected]. All
responses to the Notice will be
summarized and included in the request
for the Office of Management and
Budget (OMB) approval. All comments
will become a matter of public record.
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
[email protected]. You are
entitled to a copy of the entire ICR
package free of charge once the package
is submitted to OMB for review. You
can access this ICR at http://
www.reginfo.gov/public/.
SUPPLEMENTARY INFORMATION:
Title: National Park Service
Partnership Assistance Programs GPRA
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.

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Federal Register / Vol. 74, No. 65 / Tuesday, April 7, 2009 / Notices
Description of Need: The Government
Performance and Results Act (GPRA) of
1995 (Pub. L. 103–62) and the National
Park Service (NPS) Strategic Plan
require that the NPS develop goals to
improve program effectiveness and
public accountability. GPRA also
requires Federal agencies to prepare
annual performance reports
documenting the progress made toward
achieving long-term goals. Surveys for
the Rivers, Trails, and Conservation
Assistance Program (RTCA) and the
Federal Lands to Parks Program (FLP)
will measure performance and suggest
improvements towards these goals. Data
from these studies are needed to meet
the requirement of GPRA and the NPS
Strategic Plan. The two programs are to
meet Long-term Goal IIIb2. This goal
states: 95% of communities served are
satisfied with NPS partnership
assistance in providing recreational
conservation benefits on lands and
waters. The NPS needs the information
in these collections to assess the annual
progress being made toward meeting
Long-term Goal IIIb2 of the NPS
Strategic Plan.
The proposed surveys will provide
the NPS with data from its partners.
Partners are those individuals or
organizations that seek NPS assistance
through these two programs. NPS will
obtain critical information to determine
if it’s meeting the diverse needs of its
constituency and how to respond to
future changes. The information sought
is not collected elsewhere by the
Federal Government. The NPS needs
this information to help evaluate and
improve its partnership assistance
programs. NPS’ RTCA Program and FLP
Program will conduct surveys to assess
client satisfaction with the services
received and to identify needed program
improvements. The NPS goal in
conducting these surveys is to use the
information to identify areas of strength
and weakness in its recreation and
conservation assistance programs, to
provide an information base for
improving those programs, and to
provide a required performance
measurement (Goal IIIb2 of the National
Park Service Strategic Plan) under
GPRA. The obligation to respond is
voluntary.
Automated Data Collection: The
information will be collected primarily
through the use of an electronic survey.
Description of respondents: This is a
census survey of all principal
cooperating organizations and agencies
which have received substantial
assistance from the Rivers, Trails and
Conservation Assistance Program or the
Federal Lands to Parks Program during

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the prior Fiscal Year (October 1 through
September 30).
Estimated average number of
responses: 150 per year.
Frequency of response: 1 per
respondent.
Estimated average time burden per
respondent: 10 minutes.
Estimated total annual reporting
burden: 25 hours per year.
Comments are invited on: (1) The
practical utility of the information being
gathered; (2) the accuracy of the burden
hour estimate; (3) ways to enhance the
quality, utility, and clarity of the
information being collected; and (4)
ways to minimize the burden to
respondents, including use of
automated information collection
techniques or other forms of information
technology. Before including your
address, phone number, e-mail address,
or other personal identifying
information in your comment, you
should be aware that your entire
comment—including your personal
identifying information—may be made
publicly available at any time. While
you can ask us in your comment to
withhold your personal identifying
information from public review, we
cannot guarantee that we will be able to
do so.
Dated: March 31, 2009.
Cartina A. Miller,
Information Collection Clearance Officer,
National Park Service.
[FR Doc. E9–7717 Filed 4–6–09; 8:45 am]
BILLING CODE

DEPARTMENT OF THE INTERIOR
Fish and Wildlife Service
[FWS–R9–FHC–2008–N0328; 94300–1124–
0000–T5]

Coastal Barrier Resources System
Digital Mapping Pilot Project
AGENCY: Fish and Wildlife Service,
Interior.
ACTION: Notice of availability; request
for comments.
SUMMARY: This notice announces the
availability of the Report to Congress:
John H. Chafee Coastal Barrier
Resources System Digital Mapping Pilot
Project and draft maps for public review
and comment. This notice also advises
the public where the report and draft
maps may be obtained and where
comments should be sent.
DATES: We must receive comments on or
before July 6, 2009.
ADDRESSES: Mail or hand-deliver
(during normal business hours)

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comments to Katie Niemi, Coastal
Barriers Coordinator, Division of Habitat
and Resource Conservation, U.S. Fish
and Wildlife Service, 4401 N. Fairfax
Drive, Room 860A, Arlington, VA 22203
or send comments by electronic mail (email) to [email protected]. For
information about how to get copies of
the pilot project report and maps or
where to go to view them, see
SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT:
Katie Niemi, Coastal Barriers
Coordinator, (703) 358–2161.
SUPPLEMENTARY INFORMATION:
Background
The Coastal Barrier Resources Act
(CBRA) of 1982 (16 U.S.C. 3501 et seq.)
established the John H. Chafee Coastal
Barrier Resources System (CBRS) to
minimize the loss of human life; reduce
wasteful Federal expenditures; and
minimize the damage to fish, wildlife,
and other natural resources associated
with coastal barriers. Most new Federal
expenditures and financial assistance
that have the effect of encouraging
development are prohibited within the
CBRS. In the Coastal Barrier
Improvement Act of 1990 (Pub. L. 101–
591), Congress amended CBRA to add
new units, enlarge some previously
designated units, add Otherwise
Protected Areas (OPAs) as a new
category of lands, and approve a series
of maps entitled ‘‘John H. Chafee
Coastal Barrier Resources System’’ and
dated October 24, 1990. These maps
identify and depict those coastal
barriers located on the coasts of the
Atlantic Ocean, Gulf of Mexico, Great
Lakes, Virgin Islands, and Puerto Rico
that are subject to the Federal funding
limitations outlined in CBRA.
The Secretary of the Interior
(Secretary), through the U.S. Fish and
Wildlife Service (Service), is responsible
for administering CBRA, which
includes: maintaining the official maps
of the CBRS; consulting with Federal
agencies that propose spending funds
within the CBRS; and making
recommendations to Congress regarding
whether certain areas were
appropriately included in the CBRS.
Aside from three minor exceptions, only
Congress through new legislation, can
modify the CBRS boundaries to add or
remove land. These exceptions include:
(1) The CBRA 5-year review
requirement that solely considers
changes that have occurred to the CBRS
by natural forces such as erosion and
accretion; (2) voluntary additions to the
CBRS by property owners; and (3)
additions of excess Federal property to
the CBRS.

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