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OMB Control No: 2070-0223	ICR Reference No: 202306-2070-003
Status: Active	Previous ICR Reference No: 202205-2070-003
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 2706.02
Title: Confidential Business Information Claims under the Toxic Substances Control Act (TSCA) (Final Rule)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/07/2023
	Date Received in OIRA: 06/15/2023
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is approved for three years. In accordance with 1320.10(a), the agency is reminded to submit the ICR for OMB review the day of Federal Register publication for the final rule.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2026	36 Months From Approved
Responses	2,139	0	0
Time Burden (Hours)	1,332	0	0
Cost Burden (Dollars)	0	0	0

Abstract: EPA is finalizing new and amended requirements concerning the assertion and maintenance of claims of business confidentiality (also known as Confidential Business Information or CBI) under the Toxic Substances Control Act (TSCA), 15 U.S.C. 2601, et seq. The Frank R. Lautenberg Chemical Safety for the 21st Century Act, Pub. L. 114182 referred to in this Notice as Lautenberg), made significant amendments to TSCA including new provisions governing the assertion of CBI claims and requirements concerning Agency review and treatment of confidentiality claims. This final rule specifies procedures for submitting and supporting CBI claims in TSCA submissions, including substantiation requirements applicable at the time of submission, exemptions from the requirement to substantiate, electronic reporting enhancements (which include new electronic reporting requirements, as well as integration of TSCA requirements to provide certain certification statements, substantiation, and generic names when making confidentiality claims), and maintenance or withdrawal of confidentiality claims. The final rule also specifies Agency procedures for reviewing and communicating with TSCA submitters about confidentiality claims, including requirements for submitters to maintain contact information, procedures EPA will use to provide notices to submitters concerning their claims, and the manner in which EPA will notify submitters concerning the impending expiration of certain claims. The final rule includes new provisions, as well as amending and reorganizing existing provisions concerning assertion of confidentiality claims in order to conform to new requirements in Lautenberg. Most procedural requirements for asserting and maintaining a confidentiality claim are organized into a new part of the CFR, which would apply to any TSCA submission, except as modified by or elaborated on elsewhere in parts 704, 707, 716, 717, 720, 721, 723, 725, 770, or 790. The following submissions under TSCA will now have new or amended procedures for substantiated claims of confidentiality: TSCA Section 8(a); 40 CFR 704 TSCA Section 12(b) Notification of Export; 40 CFR 707.75(d) TSCA Section 8(d) Health and Safety Studies; 40 CFR 716.55(a) and (c) TSCA Section 8(c) Allegations of Adverse Effects; 40 CFR 717.19 TSCA Section 5 Premanufacture Notices (PMNs); 40 CFR 720.85 and 720.90 and 720 Subpart F TSCA Section 5 40 CFR 721 Significant New Use Rules (SNURs) TSCA Section 5 Polymer Exemption; 40 CFR 723.250(f); and Low Volume Exemptions 40 CFR 723.50 TSCA Section 5 microorganisms; 40 CFR 725 Subpart C TSCA Title VI Formaldehyde Emissions Standards for Composite Wood; 40 CFR 770 TSCA Section 4 Test Orders; 40 CFR 790

Authorizing Statute(s): US Code: 15 USC 2601-2692 Name of Law: Toxic Substances Control Act

Citations for New Statutory Requirements: US Code: 15 USC 2601-2692 Name of Law: Frank R. Lautenberg Chemical Safety for the 21st Century Act.

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
2070-AK68	Final or interim final rulemaking	88 FR 37155	06/07/2023

Federal Register Notices & Comments
Did the Agency receive public comments on this ICR? Yes

Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
CDX Registration	n/a, 7710-25, 9600-033, 9600-036, 9600-034, 9600-034, 9600-035, 9600-034, 9600-036, 9600-032, 9600-030, n/a, 7710-25 MCAN, 7710-25, 9600-031	, , , , , , , , , , , , , ,
Maintaining Company Contact Information	9600-035, 9600-031, 9600-032, 9600-030, 7710-025, 9600-036, 7710-25, 9600-036, 9600-034, 9600-034, 9600-034, 9600-034, 9600-033, 7710-25	, , , , , , , , , , , , ,
Reporting Health and Safety Data Using Templates	9600-032, n/a, 9600-049, 9600-049, 9600-049, 9600-049, 9600-049, 9600-049, 9600-049	, , , , , , , ,
Rule Famiilarization	9600-034, 9600-034, 9600-034, 9600-031, 9600-036, 9600-032, 9600-030, n/a, 7710-25, 9600-035, 7710-25, 7710-25, 9600-033, 9600-036, 9600-034, 9600-034, 9600-034, 9600-034	, , , , , , , , , , , , , , , , ,
Withdrawing Confidentiality Claims and Amending Public Copy

ICR Summary of Burden

	Total Approved	Change Due to New Statute
Annual Number of Responses	2,139	2,139
Annual Time Burden (Hours)	1,332	1,332
Annual Cost Burden (Dollars)	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: This is a new data collection activity resulting from the Frank R. Lautenberg Chemical Safety for the 21st Century Act. As such, the change being implemented in this ICR period is the addition of new burden and cost for these activities. The total burden to industry for this ICR period is approximately 3,991 hours. This burden is comprised of a one-time burden of 2,945 hours in the first year after the rule is finalized and an annual, ongoing burden of 524 hours in each following year. The total cost to industry for this ICR period is approximately $359,993. This cost is comprised of a one-time cost of $270,783 in the first year after the rule is finalized and an annual, ongoing cost of $44,605 in each following year.

Annual Cost to Federal Government: $0

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

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