Deposit of Biological Materials

Forms and Documents

Document Name	Status
0651-0022 SupportingStatement 2020 final.docx Supporting Statement A	2020-01-31
ATCC Services-Pricing.html Supplementary Document	2020-01-21
Information Quality Guidelines _ USPTO 2020.html Supplementary Document	2020-01-21

IC Document Collections

IC ID	Document Title	Status
37388	Deposited Materials Other-Website	Modified
179760	Depository Approval Other-Website	Modified

ICR Details

OMB Control No: 0651-0022	ICR Reference No: 202001-0651-002
Status: Active	Previous ICR Reference No: 201611-0651-001
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: 03/31/2020
	Date Received in OIRA: 01/31/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2023	36 Months From Approved	03/31/2020
Responses	951	0	901
Time Burden (Hours)	955	0	905
Cost Burden (Dollars)	2,823,237	0	2,674,644

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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:
	84 FR 63855	11/19/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 5636	01/31/2020
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
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	951	901	0	0	50	0
Annual Time Burden (Hours)	955	905	0	0	50	0
Annual Cost Burden (Dollars)	2,823,237	2,674,644	0	0	148,593	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: The USPTO estimates that this information collection will receive 50 more annual responses (for the deposits of biological materials activity, in particular) over the 3-year period covered by this renewal request. This adjustment caused the number of burden hour to increase by 50 hours. In addition, this adjustment, along with increased estimated hourly rates, caused the annual cost burden to increase by $148,593.

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Annual Cost to Federal Government: $11,684

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? 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: 01/31/2020

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