Hart-Scott-Rodino (Premerger notification) Rules and Report Form

Forms and Documents

Document Name	Status
Form C4 Non-index Filings Form	Modified
HSR-IP Licensing NPRM Supptg Stmt final_mtd.pdf Supporting Statement A	2012-08-17

IC Document Collections

IC ID	Document Title	Status
42609	Non-index Filings Form	Modified
179430	Non-index Filings Requiring More Precise Valuation	Modified
179429	Index Filings	Unchanged

ICR Details

OMB Control No: 3084-0005	ICR Reference No: 201208-3084-002
Status: Historical Inactive	Previous ICR Reference No: 201106-3084-002
Agency/Subagency: FTC	Agency Tracking No:
Title: Hart-Scott-Rodino (Premerger notification) Rules and Report Form
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule and continue	Conclusion Date: 12/11/2012
	Date Received in OIRA: 08/20/2012
Terms of Clearance: 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
Expiration Date	08/31/2014	08/31/2014	08/31/2014
Responses	1,470	0	1,470
Time Burden (Hours)	53,756	0	53,756
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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Authorizing Statute(s): PL: Pub.L. 94 - 435 90 Stat. 1390 Name of Law: Hart-Scott-Rodino Antitrust Improvements Act of 1976
   US Code: 15 USC 18a Name of Law: Clayton Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
3084-AA91	Proposed rulemaking	77 FR 50057	08/20/2012

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Index Filings
Non-index Filings Requiring More Precise Valuation
Non-index Filings	C4	Notification and Report Form for Certain Mergers and Acquisitions (DRAFT)

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Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: 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.

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Annual Cost to Federal Government: $5,341,832

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 08/20/2012

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