53030 Federal Register / Vol. 73, No. 178 / Friday, September 12, 2008 / Notices 

includes adequate data demonstrating 

that ecamsule has been marketed for a 

material time and to a material extent as 

required by § 330.14 (21 CFR 330.14) 

(Ref. 2). Ecamsule-containing sunscreen 

products have been marketed directly to 

consumers for over 5 continuous years 

in 48 countries, with an estimated 472 

million dosage units marketed in 55 

countries. Therefore, ecamsule, in 

concentrations of up to 10 percent, is 

eligible for inclusion in the OTC 

sunscreen drug monograph as a single 

active ingredient and in combination 

with GRASE sunscreen active 

ingredients found in § 352.10. 

II. Request for Data and Information 

FDA invites all interested persons to 

submit data and information on the 

safety and effectiveness of this single 

active ingredient in order for us to 

determine whether it is GRASE and not 

misbranded under recommended 

conditions of OTC use (see § 330.14(f)). 

FDA is also seeking data to establish the 

safety and effectiveness of ecamsule for 

use as a sunscreen active ingredient 

when combined with GRASE sunscreen 

active ingredients found in § 352.10. 

The effectiveness data should include 

studies conducted according to the 

testing procedures in the sunscreen 

monograph (i.e., part 352, subpart D). 

Such data for combinations should meet 

both criteria described in the sunscreen 

monograph (§ 352.20): 

• The ingredient contributes a Sun 

Protection Factor (SPF) of at least 2 to 

the final formulation; 

• The SPF of the final formulation 

equals at least two times the number of 

active ingredients 

The safety data should include animal 

and human studies that meet current 

scientific standards (see § 330.14(f)(1) 

and 21 CFR 330.10(a)(2)). 

III. Marketing Policy 

Under § 330.14(h), any product 

containing the condition for which data 

and information are requested 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 Ecamsule (Terephthalylidene 

Dicamphor Sulfonic Acid) Submitted by 

L’Oreal USA Products, Inc., dated September 

18, 2007. 

2. FDA’s evaluation of the TEA for 

ecamsule. 

Dated: September 4, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–21291 Filed 9–11–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Child Health and 

Human Development; Proposed 

Collection; Comment Request; Health 

Behaviors in School-Age Children 

SUMMARY: In compliance with the 

requirement of Section 3506(c)(2)(A) of 

the Paperwork Reduction Act of 1995, 

for opportunity for public comment on 

proposed data collection projects, the 

National Institute of Child Health and 

Human Development (NICHD), the 

National Institutes of Health (NIH) will 

publish periodic summaries of proposed 

projects to be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

Proposed Collection 

Title: Health Behaviors in School-Age 

Children—United States. 

Type of Information Collection 

Request: Extension OMB control 

number 0925–0557, expiration date 01/ 

31/09. 

Need and Use of Information 

Collection: The goal of this research is 

to obtain data from a survey of 

adolescent health behavior conducted in 

the United States with a national 

probability sample of adolescents. This 

information will enable the 

improvement of health services and 

programs for youth. The study should 

provide needed information about 

adolescents nationally and will also 

enable international comparisons. 

This U.S. survey is linked to the 

broader Health Behaviors in School-Age 

Children (HBSC) study, in which 

surveys are conducted every four years 

among nationally representative 

samples of students at ages 11, 13, and 

15 years of age in about 40 countries. 

The HBSC was conducted in the U.S. 

previously in 1997/1998, 2001/2002 and 

2005/2006. Previous HBSC–U.S. surveys 

showed that U.S. 15-year-old youth are 

less likely to smoke than students in 

most other countries surveyed, even 

though 11-year-old U.S. students 

experiment with tobacco at higher rates 

than youth in other countries. The most 

recent survey demonstrated that U.S. 

youth are more likely to be overweight 

and obese than students in the other 

HBSC countries and more likely to be 

dieting to lose weight. U.S. eating habits 

were also shown to be somewhat less 

healthful than in other countries, with 

a comparatively high proportion of 

youth consuming sugar-sweetened soft 

drinks and among the lowest 

proportions of youth eating breakfast. 

The 2009/2010 U.S. survey will address 

a sample of health-related factors 

according to rigorous research protocols 

developed by the HBSC. The 

international HBSC survey requires at 

least 1,536 youth in each age group 

(ages 11, 13, and 15) and a total of 5,000 

students. In the U.S., a nationally 

representative sample of children in 

grades 6 through 10 will be surveyed 

and minority children will be oversampled to permit comparisons across 

under-represented populations. The 

children will be students from 

approximately 420 schools; in order to 

assess health programs in those schools 

and how the school environment 

supports health behaviors, a school 

administrator and the lead health 

education teacher from each school will 

be surveyed. 

Affected Public: School-age children. 

Type of respondents 

Estimated 

number of 

respondents 

Estimated 

number of 

responses per 

respondent 

Average 

burden hours 

per response 

Estimated total 

annual burden 

hours 

requested 

Adolescents ..................................................................................................... 14,672 1 0.75 11,004 

School Administrators ...................................................................................... 386 1 0.33 127 

The estimated annualized cost to 

respondents is $5,392. There are no 

Capital Costs to report. There are no Operating or Maintenance Costs to 

report. 


ebenthall on PROD1PC60 with NOTICES
Federal Register / Vol. 73, No. 178 / Friday, September 12, 2008 / Notices 53031 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of the function of the 

agency, including whether the 

information will have practical utility; 

(2) 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) Ways to minimize 

the burden of the collection of 

information on those who are to 

respond, including the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and 

instruments, contact Dr. Ronald 

Iannotti, Prevention Research Branch, 

Division of Epidemiology, Statistics, 

and Prevention Research, Eunice 

Kennedy Shriver National Institute of 

Child Health and Human Development, 

Building 6100, 7B05, 9000 Rockville 

Pike, Bethesda, Maryland, 20892–7510, 

or call non-toll free number (301) 435– 

6951 or E-mail your request, including 

your address to ri25j@nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 60 days of the date of 

this publication. 

Dated: September 3, 2008. 

Paul L. Johnson, 

Project Clearance Liaison, NICHD, National 

Institutes of Health. 

[FR Doc. E8–21327 Filed 9–11–08; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Amended 

Notice of Meeting 

Notice is hereby given of a change in 

the meeting of the Cellular Signaling 

and Regulatory Systems Study Section, 

October 2, 2008, 8 a.m. to October 3, 

2008, 5 p.m., Holiday Inn Georgetown, 

2101 Wisconsin Avenue, NW., 

Washington, DC 20007 which was 

published in the Federal Register on 

August 18, 2008, 73 FR 48219–48220. 

The meeting will be held one day 

only October 2, 2008. The meeting time 

and location remain the same. The 

meeting is closed to the public. 

Dated: September 3, 2008. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E8–21036 Filed 9–11–08; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S. C. Appendix 2), notice 

is hereby given of the following 

meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as paten table material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Immunology 

Integrated Review Group, Hypersensitivity, 

Autoimmune, and Immune-mediated 

Diseases, Study Section. 

Date: October 2–3, 2008. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Washington Plaza Hotel, 10 Thomas 

Circle, NW., Washington, DC 20005. 

Contact Person: Bahiru Gametchu, DVM, 

PhD., Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4204, 

MSC 7812, Bethesda, MD 20892, 301–435– 

1225, gametchb@csr.nih.gov. 

Name of Committee: Brain Disorders and 

Clinical Neuroscience Integrated, Review 

Group Clinical Neuroplasticity and 

Neurotransmitters Study Section. 

Date: October 2–3, 2008. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications 

Place: Holiday Inn, San FransciscoFisherman’s Wharf, 1300 Columbus Avenue, 

San Francisco, CA 94133. 

Contact Person: Suzan Nadi, PhD., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5217B, 

MSC 7846, Bethesda, MD 20892, 301–435– 

1259, nadis@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel, Clinical 

Neuroscience and Neurodegeneration. 

Date: October 6, 2008. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: DoubleTree Hotel Washington, DC, 

1515 Rhode Island Avenue, NW., 

Washington, DC 20005. 

Contact Person: Seetha Bhagavan, PhD., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5194, 

MSC 7846, Bethesda, MD 20892, (301) 435– 

1121, bhagavas@csr.nih.gov. 

Name of Committee: Brain Disorders and 

Clinical Neuroscience Integrated Review 

Group Acute Neural Injury and Epilepsy 

Study Section. 

Date: October 6–7, 2008. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hotel Adagio, 550 Geary Street, San 

Francisco, CA 94102. 

Contact Person: Seetha Bhagavan, PhD., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5194, 

MSC 7846, Bethesda, MD 20892, (301) 435– 

1121, bhagavas@csr.nih.gov. 

Name of Committee: Bioengineering 

Sciences & Technologies Integrated Review 

Group Instrumentation and Systems 

Development Study Section. 

Date: October 8, 2008. 

Time: 8:30 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: The Carlyle Suites, 1731 New 

Hampshire Avenue, NW., Washington, DC 

20009. 

Contact Person: Marc Rigas, PhD., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5158, 

MSC 7849, Bethesda, MD 20892, 301–402– 

1074, rigasm@mail.nih.gov. 

Name of Committee: Musculoskeletal, Oral 

and Skin Sciences Integrated Review Group 

Skeletal Muscle and Exercise Physiology 

Study Section. 

Date: October 9, 2008. 

Time: 8:30 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: The Willam F. Bolger Center, 9600 

Newbridge Drive, Main, Potomac, MD 20854. 

Contact Person: Richard J. Bartlett, PhD., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4110, 

MSC 7814, Bethesda, MD 20892, 301–435– 

6809, bartletr@csr.nih.gov. 

Name of Committee: Oncological Sciences 

Integrated Review Group, Drug Discovery 

and Molecular Pharmacology Study Section. 

Date: October 13–14, 2008. 

Time: 8 a.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Churchill Hotel, 1914 Connecticut 

Avenue, NW., Washington, DC 20009. 

Contact Person: Hungyi Shau, PhD., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6214, 


ebenthall on PROD1PC60 with NOTICES