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COMMENT
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OMB Control No:
2070-0223
ICR Reference No:
202608-2070-003
Status:
Received in OIRA
Previous ICR Reference No:
202601-2070-001
Agency/Subagency:
EPA/OCSPP
Agency Tracking No:
2706.03
Title:
Confidential Business Information Claims under the Toxic Substances Control Act (TSCA) (Renewal)
Type of Information Collection:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
Date Submitted to OIRA:
08/28/2026
Requested
Previously Approved
Expiration Date
36 Months From Approved
09/30/2026
Responses
2,304
2,139
Time Burden (Hours)
623
1,332
Cost Burden (Dollars)
0
0
Abstract:
EPA is renewing the information collection 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. Among the changes to TSCA are new provisions on EPA review, submitter maintenance, time limitations for CBI claims, and an option to extend confidentiality claims for up to 10 additional years. 40 CFR 703 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.
Authorizing Statute(s):
US Code:
15 USC 2613
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:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
91 FR 9250
02/25/2026
30-day Notice:
Federal Register Citation:
Citation Date:
91 FR 55340
08/27/2026
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
2
IC Title
Form No.
Form Name
CDX Registration
9600-032, 9600-030, PFN-7710-57, 7710-25 MCAN, 7710-25, 9600-031, n/a, 9600-035, 7710-25, 9600-033, 9600-036, 9600-034, 9600-034, 9600-034, 9600-036
TSCA Section 12(b) Export Notification
,
Section 8(d) Safety and Health Data Reporting
,
Section 8(e) Notice
,
General Communications (GENCOMMS)
,
EPA Biotech Form
,
Mercury Reporting
,
Notice of Commencement (NOC)
,
Enforcement and Compliance submission
,
Primary Premanufacture Notice (PMN)
,
Polymer Exemption
,
EPA Initiated Risk Evaluation
,
Section 4 CFR 766
,
Section 4 ECA Submission
,
Section 4 Test Rules Order Submission
,
Risk Evaluation
Maintaining Company Contact Information
9600-031, 9600-032, 9600-030, 7710-025, 9600-035, 9600-036, 7710-25, 9600-036, 9600-034, 9600-034, 9600-034, 9600-034, 9600-033, 7710-25
TSCA Sec. 12(b) Export Notification
,
Section 8(d) Health and Safety Data Reporting
,
Section 8(e) Notice
,
Microbial Commercial Activity Notice (MCAN)
,
Mercury Electronic Reporting
,
Primary Premanufacture Notice (PMN)
,
EPA Initiated Risk Evaluation
,
Risk Evaluation
,
Section 4 Test Order Study Report
,
Section 4 Submission ECA
,
Section 4 CFR 766 Submission
,
Section 4 Test Rules Submission
,
Polymer Exemption
,
Notice of Commencement (NOC)
Re-substantiation of Confidential Business Information Claims
9600-036, 9600-049, 9600-060, 6300-017, 7710-56, 9600-10, 9600-032, PFN-7710-56, 9600-031, 9600-030, 9600-034, 9600-035, 7710-25
CBI Substantiation
,
Biotech
,
PMN
,
NOC
,
Form U
,
TSCA 12(b) Export Notification
,
TSCA 8(e) Notice
,
TSCA 8(d) Health & Safety Reporting
,
TSCA Section 4 Submissions
,
Mercury Electronic Reporting
,
EPA Risk Evaluation
,
Formaldehyde Annual Report
,
Notice of Activity of Manufacture Form A & B
Reporting Health and Safety Data Using Templates
9600-032, PFN-7710-57, 9600-049, 9600-049, 9600-049, 9600-049, 9600-049, 9600-049, 9600-049
Section 8(d) Health and Safety Data Reporting
,
General Communications (Gencomms)
,
TPC Reduced Testing and Exemption Notification
,
TPC Reduced Testing and Exemption Notification
,
TPC Quality Control Limit Exceedance
,
TPC Failed Quarterly Test Title VI
,
Failure to Comply Title VI
,
Annual Report Product AB Title VI
,
TPC Annual Report Title VI
Rule Famiilarization
9600-034, 9600-034, 9600-034, 9600-034, 9600-036, 9600-031, 9600-032, 9600-030, n/a, 7710-25, 9600-035, 7710-25, 7710-25, 9600-033, 9600-036, 9600-034, 9600-034, 9600-034
Section 12(b) Export Notification
,
Section 8(d) Health and Safety Data Reporting
,
Section 8(e) Notice
,
OECA Communication Form
,
Biotech MCAN
,
Mercury Electronic Reporting
,
Notice of Commencement (NOC)
,
Primary Premanufacture Notice (PMN)
,
Polymer Exemption
,
EPA Initiated Risk Evaluation (EIRE)
,
Section 4 CFR 766 Submission
,
Section 4 ECA Submission
,
Section 4 Final Study Report
,
Section 4 Test Rules Submission
,
Risk Evaluation (MRRE)
,
Section 4 Final Study Plan
,
Section 4 Initial Response
,
Section 4 Identification Response
Withdrawing Confidentiality Claims and Amending Public Copy
ICR Summary of Burden
Total Request
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
2,304
2,139
0
0
165
0
Annual Time Burden (Hours)
623
1,332
0
0
-709
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:
There is a decrease of 709 hours in the total estimated respondent burden compared with the ICR currently approved by OMB. This change, which is discussed in more detail in the ICR, reflects EPA's successful implementation of the Lautenberg provisions governing the assertion of CBI claims through the finalization of the Confidential Business Information Claims Under the Toxic Substances Control Act (TSCA) rule published on June 7, 2023 (88 FR 37155) which amended and reorganized requirements concerning Agency review and treatment of confidentiality claims. This information collection also accounts for provisions that allow submitters the opportunity to request an extension of CBI claims and for EPA to review time limitations for CBI claims and extension of confidentiality claims for up to 10 additional years. This change is an adjustment.
Annual Cost to Federal Government:
$150,892
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:
Katherine Sleasman 202 566-1204
Common Form ICR:
No
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:
08/28/2026
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