The FTC should consider comments received regarding the information collection instrument(s) and provide a response and any necessary adjustments in its next submission to OMB.
Inventory as of this Action
Requested
Previously Approved
08/31/2014
08/31/2014
08/31/2014
1,470
0
1,470
53,756
0
53,756
0
0
0
The Federal Trade Commission is proposing amendments to the premerger notification rules to provide a framework for determining when a transaction involving the transfer of rights to a patent in the pharmaceutical, including biologics, and medicine manufacturing industry (North American Industry Classification System Industry Group 3254)is reportable under the Hart Scott Rodino Act.
The Commission proposes amending sections 801.1 and 801.2 of the HSR Rules to reflect the longstanding staff position that a transaction involving the transfer of exclusive rights to a patent in the pharmaceutical industry, which typically takes the form of an exclusive license, is potentially reportable under the Act. Based on outside input, further FTC staff projections, and conservative rounding, these proposed amendments would increase non-index filing transactions from the current estimate of 1,428 to 1,500; this, in turn, based on a continuing estimate of 37 hours per non-index filing, would yield 2,664 additional burden hours.
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.