Document ID: FDA-2009-N-0146-0001
Agency: fda
Document Type: Notice
Title: Sodium Shale Oil Sulfonate Eligibility for Inclusion in Monograph; Over-the-Counter Dandruff, Seborrheic Dermatitis, and Psoriasis Drug Products for Human Use; Request for Safety and Effectiveness Data
Posted Date: 2009-04-07T04:00Z

[Federal Register: April 7, 2009 (Volume 74, Number 65)]
[Notices]               
[Page 15741-15742]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07ap09-61]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0146]

 
Sodium Shale Oil Sulfonate Eligibility for Inclusion in 
Monograph; Over-the-Counter Dandruff, Seborrheic Dermatitis, and 
Psoriasis 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.

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SUMMARY: As part of our ongoing review of over-the-counter (OTC) drug 
products, we (Food and Drug Administration (FDA)) are announcing a 
call-for-data for safety and effectiveness information for sodium shale 
oil sulfonate (SSOS), 0.5 to 2.0 percent, as a rinse-off treatment for 
dandruff. We have reviewed a time and extent application (TEA) for SSOS 
and determined that it is eligible for consideration in our OTC drug 
monograph system. We will evaluate the submitted data and information 
to determine whether SSOS can be generally recognized as safe and 
effective (GRASE) as an OTC rinse-off treatment for dandruff.

DATES: Submit data, information, and general comments by July 6, 2009.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2009-
N-0146, 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

[[Page 15742]]

comments submitted to the agency by e-mail. 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 Sec.  330.14 (21 CFR 330.14) (Ref. 3). 
SSOS-containing 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 Sec.  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 Sec.  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 Sec.  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 Sec.  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