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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
2070-0012
ICR Reference No:
200712-2070-005
Status:
Historical Active
Previous ICR Reference No:
200409-2070-001
Agency/Subagency:
EPA/OCSPP
Agency Tracking No:
0574.13
Title:
Pre-Manufacture Review Reporting and Exemption Requirements for New Chemical Substances and Significant New Use Reporting Requirements for Chemical Substances. (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 with change
Conclusion Date:
12/22/2008
Retrieve Notice of Action (NOA)
Date Received in OIRA:
12/18/2007
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
12/31/2011
36 Months From Approved
12/31/2008
Responses
2,329
0
1,674
Time Burden (Hours)
148,084
0
163,791
Cost Burden (Dollars)
0
0
0
Abstract:
TSCA requires businesses to notify the Agency 90 days prior to the manufacture or import of a new chemical substance or an existing chemical substance for a significant new use. EPA reviews the information to evaluate the effects of the chemical on human health and the environment. The submitter is free to manufacture or import the new chemical substance if the Agency takes no further regulatory action within 90 days of receipt of the notification. Submitters can also apply for certain exemptions with shorter review times.
Authorizing Statute(s):
US Code:
15 USC 2605
Name of Law: Toxic Substances Control Act
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:
72 FR 26353
05/09/2007
30-day Notice:
Federal Register Citation:
Citation Date:
72 FR 71685
12/18/2007
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
14
IC Title
Form No.
Form Name
Bona Fide Intent Notifications (Bona Fides)
Instant Photographic Film Articles Exemption
Low Volume and Low Release/Low Exposure Exemptions (LVE/LoREX)
7710-25
Premanufacture Notice
Microbial Commercial Activity Notices (MCANs)
Non-Testing Activities under Section 5(e) Consent Orders
Notice of Commencement
7710-56
Notice of Commencement of Manufacture or Import
PMN-Related Significant New Use Notices (SNUNs)
7710-25
Premanufacture Notice
Polymer Exemption Post-Manufacture Annual Reports
Pre-Manufacture Notifications
EPA Form 7710-25, EPA Form 7710-25
Premanufacture Notice (part 1)
,
Premanufacture Notice (part 2)
Research and Development Exemption
TSCA Experimental Release Applications (TERAs)
Test Data Submissions under Section 5(e) Consent Orders
Test-Marketing Exemptions (TMEs)
7710-25
Premanufacture Notice
Tier I/Tier II Exemptions
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
2,329
1,674
0
0
655
0
Annual Time Burden (Hours)
148,084
163,791
0
0
-15,707
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:
Annual Cost to Federal Government:
$7,213,968
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
Uncollected
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
Uncollected
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
Uncollected
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Angela Hofmann
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:
12/18/2007
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