Federal Register / Vol. 73, No. 178 / Friday, September 12, 2008 / Notices 53029 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments or information to 

http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Domini Cassis, Center for Devices and 

Radiological Health (HFZ–215), Food 

and Drug Administration, 1350 Piccard 

Dr., Rockville, MD 20850, 240–276– 

2342, e-mail: 

domini.cassis@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of March 24, 

2008 (73 FR 15530), FDA published a 

notice of a meeting for the Ophthalmic 

Devices Panel of the Medical Devices 

Advisory Committee (the panel). At the 

meeting on April 25, 2008, the panel 

was asked to consider general issues 

concerning the post market experience 

with laser-assisted in situ keratomileusis 

(LASIK) procedures. Interested persons 

were invited to present data, 

information, or views, orally or in 

writing, to the panel regarding these 

topics. At the conclusion of the meeting, 

FDA requested that interested persons 

provide input on LASIK, including 

comments regarding tools the agency 

uses to improve patient safety, such as 

patient labeling, information on FDA’s 

LASIK Web site, and other outreach 

initiatives. 

Using information gathered at the 

April 25, 2008, panel meeting, the 

agency has updated information 

contained on its LASIK Web site, has 

strengthened its post market 

surveillance activities, and is now 

seeking ways to better understand 

quality of life issues following LASIK 

procedures that may relate to safety and 

effectiveness of LASIK devices. At this 

time, the agency is interested in 

receiving public comments regarding 

the post market experience associated 

with the use of LASIK, as well as 

information regarding potential barriers 

that may exist in providing the agency 

with feedback regarding LASIK 

procedures. Information and comments 

submitted to the docket will assist us in 

identifying ways in which we can 

improve our public outreach efforts 

regarding the safety and effectiveness of 

LASIK devices. 

II. Submission of Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

All comments submitted to the public 

docket are public information and may 

be posted to the FDA’s Web site at 

http://www.fda.gov for public viewing. 

Comments are to be identified with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Please note that on January 15, 2008, 

the FDA Web site transitioned to the 

Federal Dockets Management System 

(FDMS). FDMS is a Government-wide, 

electronic docket management system. 

Electronic submissions will be accepted 

by FDA only through the FDMS at 

http://www.regulations.gov. 

Dated: September 8, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–21339 Filed 9–11–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0474] 

Ecamsule Eligibility for Inclusion in 

Monograph; Over-the-Counter 

Sunscreen 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: The Food and Drug 

Administration is announcing a call-fordata for safety and effectiveness 

information on the following condition 

as part of FDA’s ongoing review of overthe-counter (OTC) drug products: 

Ecamsule (terephthalylidene dicamphor 

sulfonic acid), in concentrations of up to 

10 percent, as a sunscreen single active 

ingredient and in combination with 

other sunscreen active ingredients that 

are generally recognized as safe and 

effective (GRASE) and are found in the 

sunscreen monograph regulations. FDA 

reviewed a time and extent application 

(TEA) for ecamsule and determined that 

it is eligible for consideration in our 

OTC drug monograph system. FDA will 

evaluate the submitted data and 

information to determine whether 

ecamsule can be generally recognized as 

safe and effective (GRASE) for its 

proposed OTC use. 

DATES: Submit data, information, and 

general comments by December 11, 

2008. 

ADDRESSES: You may submit comments, 

identified by docket number FDA– 

2008–N–0474, by any of the following 

methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

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 

comments submitted to the agency by email. FDA encourages 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(s). and Regulatory 

Information Number (RIN) (if a RIN 

number has been assigned) 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(s), 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 Ecamsule 

In September 2007, FDA received a 

TEA (Ref. 1) requesting that ecamsule be 

eligible for review under our OTC 

sunscreen drug monograph (part 352 (21 

CFR part 352)). After reviewing the 

TEA, the agency believes that it 


ebenthall on PROD1PC60 with NOTICES
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. 


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