Daily Rules, Proposed Rules, and Notices of the Federal Government


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.
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: Submit electronic comments in the following way:

* Federal eRulemaking Portal: 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. We encourage you to continue to submit electronic comments by using the Federal eRulemaking Portal, as described previously, in theADDRESSESportion of this document underElectronic 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, including any personal information provided. For additional information on submitting comments, see the "Comments" heading of theSUPPLEMENTARY INFORMATIONsection of this document.

Docket: For access to the docket to read background documents or comments received, go tohttp://www.regulations.govand 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.

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). 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 § 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 (seeADDRESSES) 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.