Acquisition Regulation Clause Patent rights and Rights in Data

Forms and Documents

Document Name	Status
30-day FRN 0990-0419.pdf Supplementary Document	2020-05-18
0990-0419 HHSAR Clause_supporting st A 05_12_2020.docx Supporting Statement A	2020-05-12

IC Document Collections

IC ID	Document Title	Status
210736	Technical (4) Legal (2) Management (2)	Unchanged
210735	Administrative (2) Management (1)	Unchanged
210734	Administrative (8)	Unchanged
210733	Technical (4) Legal (2) Management (2)	Unchanged
210732	Technical (6) Legal (2) Management (2)	Unchanged
210731	Technical (8) Legal (4) Management (2)	Unchanged
210730	Technical (8) Legal (3) Management (1)	Unchanged
210729	Technical (8) Legal (2) Management (2)	Unchanged
210728	Technical(4) Legal (2) Management (2)	Unchanged

ICR Details

OMB Control No: 0990-0419	ICR Reference No: 202004-0990-005
Status: Active	Previous ICR Reference No: 201701-0990-005
Agency/Subagency: HHS/HHSDM	Agency Tracking No: 20762
Title: Acquisition Regulation Clause Patent rights and Rights in Data
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/30/2020
	Date Received in OIRA: 05/18/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2023	36 Months From Approved	06/30/2020
Responses	1,197	0	1,197
Time Burden (Hours)	10,899	0	10,899
Cost Burden (Dollars)	0	0	0

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Abstract: HHS found that systematically, over a period of several years, when Determinations of Exceptional Circumstances (DECs) were executed, additional legal protection for the patent and data rights of third parties beyond those covered by FAR were necessary. A decision was made to add two clauses--352.227-11 Patent Rights--Exceptional Circumstances and 352.227-14 Rights in Data--Exceptional Circumstances--to the HHS supplement to the FAR, the HHS Acquisition Regulation (HHSAR), to provide the additional legal protection required. These clauses would ensure that providers of proprietary material(s) to the government will retain all their preexisting rights to their material(s), and rights to any inventions made under a contract or subcontract (at all tiers), when a DEC has been executed. Rights in data regulations concern the rights of the Government, and organizations with which the Government contracts, to information developed under such contracts. The delineation of such rights is necessary in order to protect the contractor's rights to not disclose proprietary data and to insure that non-proprietary data developed with public funds is available to the public.

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Authorizing Statute(s): EO: EO 12591 Name/Subject of EO: Facilitating Access to Science and Technology
   PL: Pub.L. 96 - 517 401 Name of Law: Patent and Trademark Act
   US Code: 35 USC 200-212 Name of Law: Bayh-Dole Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 14491	03/12/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 29727	05/18/2020
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 9

IC Title	Form No.	Form Name
Technical(4) Legal (2) Management (2)
Technical (8) Legal (2) Management (2)
Technical (8) Legal (3) Management (1)
Technical (8) Legal (4) Management (2)
Technical (6) Legal (2) Management (2)
Technical (4) Legal (2) Management (2)
Administrative (8)
Administrative (2) Management (1)
Technical (4) Legal (2) Management (2)

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ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	1,197	1,197	0	0	0	0
Annual Time Burden (Hours)	10,899	10,899	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $89,217

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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? No

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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: 05/18/2020

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