Ecamsule Eligibility for Inclusion in Monograph; Over-the-Counter Sunscreen Drug Products for Human Use; Request for Safety and Effectiveness Data, 53029-53030 [E8-21291]

Download as PDF Federal Register / Vol. 73, No. 178 / Friday, September 12, 2008 / Notices Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments or information to https://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. ebenthall on PROD1PC60 with NOTICES 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. VerDate Aug<31>2005 15:18 Sep 11, 2008 Jkt 214001 All comments submitted to the public docket are public information and may be posted to the FDA’s Web site at https://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 https://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. Notice of eligibility; request for data and information. ACTION: 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. PO 00000 Frm 00086 Fmt 4703 Sfmt 4703 53029 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: 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 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 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(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. ADDRESSES: 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 E:\FR\FM\12SEN1.SGM 12SEN1 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 Estimated number of respondents ebenthall on PROD1PC60 with NOTICES Type of respondents Adolescents ..................................................................................................... School Administrators ...................................................................................... The estimated annualized cost to respondents is $5,392. There are no VerDate Aug<31>2005 15:18 Sep 11, 2008 Jkt 214001 Frm 00087 Fmt 4703 Sfmt 4703 Estimated number of responses per respondent 14,672 386 Capital Costs to report. There are no PO 00000 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. 1 1 Average burden hours per response Estimated total annual burden hours requested 0.75 0.33 Operating or Maintenance Costs to report. E:\FR\FM\12SEN1.SGM 12SEN1 11,004 127

Agencies

[Federal Register Volume 73, Number 178 (Friday, September 12, 2008)]
[Notices]
[Pages 53029-53030]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-21291]


-----------------------------------------------------------------------

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-for-data 
for safety and effectiveness information on the following condition as 
part of FDA's ongoing review of over-the-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: 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 comments submitted to the agency by e-mail. 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 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(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

[[Page 53030]]

includes adequate data demonstrating that ecamsule has been marketed 
for a material time and to a material extent as required by Sec.  
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 Sec.  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 Sec.  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 Sec.  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 (Sec.  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 Sec.  330.14(f)(1) and 21 CFR 
330.10(a)(2)).

III. Marketing Policy

    Under Sec.  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
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