Acquisition Regulation Clause Patent Rights and Rights in Data

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
FR for 60 Day Public Comment Request - OMB 0990-0419 (2023-08339).pdf	Supplementary Document	Uploaded 2023-06-23	Available
0990-0419 Support Statement for PRA Submission.docx	Supporting Statement A	Uploaded 2023-06-23	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
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: 202306-0990-004
Status: Active	Previous ICR Reference No: 202004-0990-005
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: 10/24/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 06/28/2023
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2026	36 Months From Approved	10/31/2023
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 Determination of Exceptional Circumstances (DEC) were executed, additional legal protection for the patent and data rights of third parties beyond those covered by FAR 27.306 were necessary A DEC is executed consistent with the policy and objectives of the Bayh-Dole Act, 35 U.S.C. 200, et seq., to ensure that subject inventions made under contracts and subcontracts (at all tiers) are used in a manner to promote free competition and enterprise without unduly encumbering future research and discovery; to encourage maximum participation of small business firms in federally supported research and development efforts; to promote collaboration between commercial concerns and nonprofit organizations including universities; to ensure that the Government obtains sufficient rights in federally supported inventions to meet its needs; to protect the public against nonuse or unreasonable use of inventions; and in the case of fulfilling the mission of the U.S. Department of Health and Human Services, to ultimately to benefit the public health.

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Authorizing Statute(s): US Code: 35 USC 200-212 Name of Law: Bayh-Dole Act
   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
  

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:
	88 FR 24429	04/20/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 41972	06/28/2023
Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

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

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ICR Summary of Burden

table that charts list 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: $97,382

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: 06/28/2023

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