2004D-0027 - Time and Extent Applications
FDA Comment Number : EC1
Submitter : Mr. Carl D'Ruiz Date & Time: 04/13/2004 12:04:30
Organization : Ciba Specialty Chemicals Corporation (Ciba)
Drug Industry
Category :
Issue Areas/Comments
Ciba Specialty Chemicals Corporation (Ciba), Home & Personal Care Segment wishes to make the following comments to FDAs Draft Guidance for Industry on Time and Extent Applications as publish in 69 FR 6309, February 10, 2004 (Docket No. 2004D-0027/0277). Ciba applauds FDAs speedy issuance of the draft guidance and makes the following constructive comments in the interest of building a more robust and efficient process.

Process & Timing Issues

As indicated in the draft guidance, the TEA process is a 2-step procedure that involves a primary decision of eligibility of a condition into the OTC drug monograph system and a secondary review and evaluation of the data supporting the efficacy and safety of eligible conditions in existing or newly created OTC drug monographs.

FDA addresses the timing issues associated with the first step of the TEA process by stating that it would typically respond to a TEA within 180 days. However, no response time frames, nor guidance, are given for the efficacy and safety review portion of the TEA process. In order to make the process more efficient, it would be extremely useful if FDA could provide review and response timeframes for the efficacy and safety information submitted in support of an eligible condition. Moreover, specific details regarding type of information required and data format would go a long way in helping streamline the review and approval process for all parties involved.

To date, four TEAs have been submitted to FDA under the TEA process. In the case of the three UV filters submitted for inclusion into the OTC sunscreen monograph, it took FDA approximately 11 months to issue a notice of eligibility and call for data from the time that the TEAs were submitted. In the case of the one dandruff ingredient, it took FDA about 7 months to issue a notice of eligibility and data call-in from the date the TEA was submitted. In all cases, eligible conditions were given 60 days for submitting efficacy and safety data on single ingredients.

Clearly, it is taking more than 180 days to process TEAs under the current process. Moreover, it is currently unclear how long it will take FDA to review efficacy and safety data submitted for eligible conditions or include approved conditions in an existing or newly created OTC drug monograph.

Therefore, in order to help streamline, structure, and make the TEA process more user friendly for all parties involved, we urge FDA to consider the following:

? Assignment of rigid timeframes for the review of efficacy and safety information submitted in support of an eligible condition (e.g., 180 days);
? The evaluation and adoption of procedures and practices successfully used in other FDA Centers for helping streamline the approval of conditions under the TEA process (e.g., CFSAN Pre-market Notification for Food Contact Substances);
? Stipulation of the type of data (and format) that need to be submitted in support of the efficacy and safety of eligible conditions;
- Making a voluntary fee for review option available for expedited reviews;
- Utilization of external expert panels on a case-by-case basis (e.g., Cosmetic Ingredient Review (CIR) Panel) for the review of efficacy and safety information when internal resources are not available;
- Consider holding a TEA workshop to address current and future TEA needs; and
- Addition of more staff (full time equivalents - FTEs) to the TEA program.

Ciba thanks the FDA for the opportunity to comment on this important process and welcomes the opportunity to assist the agency in developing an effective and efficient TEA program. Please contact the undersigned at (336) 801-2493 if you have any further questions or comments.


Carl David D?Ruiz, MPH
Director, Regulatory Affairs
Home & Personal Care
Ciba Specialty Chemicals Corporation
High Point, NC (USA)