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OMB Control No: 2070-0194	ICR Reference No: 202007-2070-003
Status: Historical Active	Previous ICR Reference No: 201701-2070-001
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 2517.03
Title: Chemical-Specific Rules under the Toxic Substances Control Act Section 8(a); Certain Nanoscale Materials (Renewal)
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: 09/22/2021
	Date Received in OIRA: 08/27/2020
Terms of Clearance: Upon resubmission, the program must use the standard 18 question Supporting Statement format.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2024	36 Months From Approved	09/30/2021
Responses	285	0	1,043
Time Burden (Hours)	40,090	0	146,855
Cost Burden (Dollars)	0	0	0

Abstract: This information collection request (ICR) covers reporting and recordkeeping requirements for persons who manufacture or process chemical substances as nanoscale materials. Under the Toxic Substances Control Act (TSCA) section 8(a), EPA requires reporting and recordkeeping for certain chemical substances as nanoscale materials. EPA requires that persons who manufacture or process these nanoscale materials notify EPA of certain information which includes production volume, methods of manufacture and processing, exposure and release information, and available health and safety information. The reporting of these activities will provide EPA with an opportunity to evaluate the information and consider appropriate action under TSCA to reduce any risk to human health or the environment. The information will also inform EPA’s assessments of new chemical nanoscale materials submitted to EPA under TSCA section 5.

Authorizing Statute(s): US Code: 15 USC 2607(a) Name of Law: Toxic Substances Control Act (TSCA)

Citations for New Statutory Requirements: None

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

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 4982	01/28/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 52995	08/27/2020
Did the Agency receive public comments on this ICR? No

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	285	1,043	-758
Annual Time Burden (Hours)	40,090	146,855	-106,765
Annual Cost Burden (Dollars)	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: The annual burden from the previously approved ICR was146,855 hours. The total annual burden requested for this ICR is 40,089 hours, or a decrease of 106,766 hours from the previous total burden. The difference between the current burden request and the previously approved requests are due to adjustments in EPA’s estimates of the burden. Several adjustments to the estimates were made, including: • In the previous ICR period, the rule required an initial one-time reporting on current nanomaterials, while the reporting covered in this period only requires the reporting of new nanomaterials. Therefore, a large portion of the adjustment in estimates stems from the decrease in the number of submissions expected after the initial one-time reporting on current nanomaterials. • Burden estimates include a one-time burden that firms incur to become familiar with the rule and its various requirements. In the first year of the rule, the manufacturers that submitted reports incurred the one-time rule familiarization burden. EPA assumes that the same manufacturers will submit reports on new nanomaterials during subsequent years and do not need to familiarize themselves with the rule. Therefore, part of the decrease in burden estimates, relative to the previous ICR period that included the first year of the rule, is due to the same manufacturers submitting reports without incurring the rule familiarization burden.

Annual Cost to Federal Government: $480,600

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

Agency Contact: Angela Hofmann 202 260-2922 hofmann.angela@epamail.epa.gov

View ICR - OIRA Conclusion