This ICR collects information
regarding waiver requests or exemptions from bar code requirement
regulations. A request that FDA waive the bar code requirement for
a particular drug product must include the following information:
(1) Compliance with the bar code requirement would adversely affect
the safety, effectiveness, purity, or potency of the drug or not be
technologically feasible, and the concerns underlying the request
could not reasonably be addressed by measures such as package
redesign or use of overwraps; or (2) an alternative regulatory
program or method of product use renders the bar code unnecessary
for patient safety.
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.