Tier 2 Data Collection for Certain Chemicals Under the Endocrine Disruptor Screening Program (EDSP)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form EPA Form No. 6300- Consortium Participants	Form and Instruction	New	Repair queued
Form EPA Form No. 6300- Tier 2 Test Order Recipients	Form and Instruction	New	Repair queued
2479.01_ss_Attachment E_R2C_2015-06-25.docx	Supplementary Document	Uploaded 2015-07-15	Repair queued
2479.01_ss_Attachment D_2014-10-23.pdf	Supplementary Document	Uploaded 2015-07-15	Repair queued
2479.01_ss_Attachment C_2015-06-08-1.docx	Supplementary Document	Uploaded 2015-07-30	Repair queued
2479.01_ss_Attachment B_2015-06-08-1.docx	Supplementary Document	Uploaded 2015-07-30	Repair queued
2479.01_ss_Attachment A(2)_Inerts-Template_2015-06-25.docx	Supplementary Document	Uploaded 2015-07-15	Repair queued
2479.01_ss_Attachment A(1)_PAI Template_2015-06-25.docx	Supplementary Document	Uploaded 2015-07-15	Repair queued
2479ss01.docx	Supporting Statement A	Uploaded 2015-07-30	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
217483	Consortium Participants	Form and Instruction	New
217482	Data Generators/Submitters	Instruction	New
217479	Tier 2 Test Order Recipients	Form and Instruction	New

ICR Details

OMB Control No:	ICR Reference No: 201507-2070-001
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: EPA/OCSPP	Agency Tracking No: 2479.01
Title: Tier 2 Data Collection for Certain Chemicals Under the Endocrine Disruptor Screening Program (EDSP)
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OIRA Conclusion Action: Withdrawn	Conclusion Date: 06/11/2019
	Date Received in OIRA: 08/03/2015
Terms of Clearance: EPA requested that this ICR be withdrawn from OMB review. OMB is processing this request per EPA.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This is a new information collection request (ICR) under the Paperwork Reduction Act (PRA), covering the information collection activities associated with Tier 2 testing of chemicals under EPA's Endocrine Disruptor Screening Program (EDSP). The EDSP consists of a two-tiered approach to screen chemicals for potential endocrine disrupting effects. The purpose of Tier 1 screening is to identify substances that have potential bioactivity with estrogen, androgen, or thyroid hormone systems using a battery of assays. Based on a Weight-of-Evidence (WoE) analysis of the Tier 1 battery results, substances that have potential bioactivity with estrogen, androgen or thyroid hormone systems will be considered for Tier 2 testing, which is designed to identify any adverse endocrine-related effects caused by the substance, and to establish a quantitative relationship between the dose and that endocrine effect. A separate ICR addresses the information collection activities associated with Tier 1 screening orders (see OMB Control No. 2070-0176), so this ICR only addresses the information collection activities associated with Tier 2 of the EDSP.

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Authorizing Statute(s): US Code: 21 USC 346a Name of Law: Federal Food, Drug, and Cosmetic Act (FFDCA)
  

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:
	78 FR 37803	06/24/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 45974	08/03/2015
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

table that charts list of burden

IC Title	Form No.	Form Name
Consortium Participants	EPA Form No. 6300-07-C	EDSP Tier 2 Testing, Initial Response Form for Consortia/Task Forces
Tier 2 Test Order Recipients	EPA Form No. 6300-07	EDSP Tier 2 Testing, Initial Response Form for Order Recipients
Data Generators/Submitters

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Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a request for a new approval from OMB.

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Annual Cost to Federal Government: $348,946

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]? 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: 08/03/2015

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