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 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 

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. 

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 

Charlie_Stockman@nps.gov. 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 

Charlie_Stockman@nps.gov. 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. 

Federal Register / Vol. 74, No. 65 / Tuesday, April 7, 2009 / Notices 15743 

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 

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) 

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 CBRAcomments@fws.gov. 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.