DoD is extending information collections requirements under current OMB Control Number 0720-0032. Pharmaceutical manufacturers will base refund calculation on difference between average non-Federal price of drug sold by pharmaceutical manufacturer to wholesalers, represented by most recent annual non-Federal average manufacturing prices (non-FAMP) and corresponding Federal Ceiling Price (FCP) or, at discretion of pharmaceutical manufacturer, difference between FCP and direct commercial contract sales price attributable to applicable National Drug Code.
There has been an increase in the number of pharmaceutical manufacturers who have covered drugs eligible for the TRRP. Based upon analysis of the utilization data used in prior billings, DHA determined it needed to re-bill the 3rd Quarter Calendar Year (QCY) 2009 to 4th QCY 2011 utilization data during the last OMB renewal period. DHA does not anticipate that re-billing additional quarters will be necessary. As a result, this reduces the number of responses per respondent from 8 to 4 annually.
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.