This ICR is approved consistent with revised supporting statement, revised burden estimates, revised instrument, and FDA memo of 9/24/09. FDA has clarified that policy decisions will not flow directly from this study alone, as it is a qualitative study on a very small sample and is more akin to a formative or "proof of concept" investigation. As such, FDA is encouraged to engage in further, more rigorous study (e.g. a peer review process or expert solicitation process) in order to establish more reliably what the best methodologies may be for assessing the safety of a proprietary drug name, particularly if FDA is considering making such methodologies mandatory on the part of industry. We understand that rulemaking would be required before such data analysis and submission can be made mandatory. Finally, FDA is reminded that the cost and burden estimates provided in the supporting statement should match that which is submitted through ICRAS/ROCIS.
table that charts list comparision
Inventory as of this Action
Requested
Previously Approved
09/30/2012
36 Months From Approved
45
0
0
9,613
0
0
0
0
0
FDA also agreed to develop and implement a voluntary pilot program to enable pharmaceutical firms participating in the pilot to evaluate proposed proprietary names and to submit the data generated from those evaluations to the FDA for review. The concept paper is intended to help pharmaceutical firms choose appropriate proprietary names for their drug and biological products before submitting marketing applications to FDA and describes how pharmaceutical firms may use "best practices" to carry out their own proprietary name reviews and provide FDA with the data that result from those reviews.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
OMB passback questions a.doc
concept pilot pro names.pdf
Registration