Deposit of Biological Materials

OMB Control No: 0651-0022	ICR Reference No: 202209-0651-004
Status: Active	Previous ICR Reference No: 202001-0651-002
Agency/Subagency: DOC/PTO	Agency Tracking No:
Title: Deposit of Biological Materials
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/07/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 02/28/2023
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2026	36 Months From Approved	04/30/2023
Responses	3,301	0	951
Time Burden (Hours)	3,305	0	955
Cost Burden (Dollars)	9,259,809	0	2,823,237

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Abstract: Information on the deposit of biological materials in depositories is required for (a) the United States Patent and Trademark Office (USPTO) determination of compliance with 35 U.S.C. 2(b)(2) and 112, and 37 CFR 1.801-1809, where inventions sought to be patented rely on biological material subject to the deposit requirements, including notification to the interested public on where to obtain samples of deposits; and (b) in compliance with 37 CFR 1.803 to demonstrate that the depositories are qualified to store and test the biological material submitted to them under patent application.

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Authorizing Statute(s): PL: Pub.L. 112 - 29 1-37 Name of Law: LEAHY–SMITH AMERICA INVENTS 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:
	87 FR 71304	11/22/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 12350	02/27/2023
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title Form No. Form Name Deposited Materials WIPO Form BP/2, WIPO Form BP/3, WIPO Form BP/9, WIPO Form BP/1 Statement in the Case of an Original Deposit (Rule 6.1) ,   Statement in the Case of a New Deposit with the Same International Depositary Authority (Rule 6.2) ,   Statement in the Case of a New Deposit with Another International Depositary Authority (Rule 6.2) ,   Viability Statement (Rule 10.2) (International Form) Depository Approval

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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	3,301	951	0	0	2,350	0
Annual Time Burden (Hours)	3,305	955	0	0	2,350	0
Annual Cost Burden (Dollars)	9,259,809	2,823,237	0	0	6,436,572	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: For this renewal, the USPTO estimates that the items in this information collection will naturally fluctuate based on respondent need. Overall USPTO is estimating that these adjustments result in more responses (+2,350) and associated time burden (+2,350). USPTO is estimating that total annual (non-hour) costs will increase (+$6,436,572) due to the corresponding increase in responses.

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Annual Cost to Federal Government: $39,559

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.     Yes

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

Agency Contact: Raul Tamayo 571 272-7728 [email protected]

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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: 02/28/2023

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