National Toxicology Program Level of Concern Categories Study

Forms and Documents

Document Name	Status
Form 1 LoC Cards Experts Form and Instruction	New
Form 1 Study Consent Experts Form and Instruction	New
30-day 2016-02266.pdf Supplementary Document	2016-02-05
Statement A_Attachment 4_IRB exemption status.pdf Supplementary Document	2016-02-03
Statement A_Attachment 3_Advisory Committee.pdf Supplementary Document	2016-02-03
Revised_Statement B_Attachment 1_LoC Scenarios (1).pdf Supplementary Document	2016-08-01
Revised_NTP LoC_Supporting Statement B 07252016_NTP Response (2).docx Supporting Statement B	2016-08-01
Revised_NTP LoC_Supporting Statement A 07252016_NTP.docx Supporting Statement A	2016-08-01

IC Document Collections

IC ID	Document Title	Status
219965	LoC Cards Experts Form and Instruction	New
219964	Study Consent Experts Form and Instruction	New

ICR Details

OMB Control No: 0925-0746	ICR Reference No: 201602-0925-005
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: National Toxicology Program Level of Concern Categories Study
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 with change	Conclusion Date: 08/01/2016
	Date Received in OIRA: 02/08/2016
Terms of Clearance: Approved consistent with the understanding that results communicated in any presentations, publications, or reports will clearly describe that findings from this exploratory study are preliminary and based on a convenience sample of respondents examining a subset of hypothetical hazard situations that may not be representative of the universe of hazard and exposure scenarios for all substances. All communications and reports will detail the limitations inherent in the study and that outcomes are not intended to be implemented as an updated Level of Concern framework. Future cognitive testing of any alternate LoC models will be conducted using respondents from the general public as well as toxicology experts from academia and industry prior to any formal implementation or communication of an updated LoC framework.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2019	36 Months From Approved
Responses	600	0	0
Time Burden (Hours)	620	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The National Toxicology Program (NTP) conducts literature-based evaluations to identify substances in our environment that are hazards for human health. NTP has used a five-point scale to communicate its opinion, or “level of concern” (LoC) conclusion, regarding the potential for environmental substances, physical agents, or mixtures (collectively referred to as “substances”) to cause adverse health effects in humans under specific exposure conditions or for a specific population. Recently, NTP implemented a new approach with systematic-review methodologies for conduct of these evaluations. Although LoC categories have been a useful communication tool, NTP has identified confusion among some of its scientific advisors and the public regarding what the LoC categories mean and how conclusions are reached. As part of its implementation of systematic-review methodologies, NTP is now updating the LoC framework, including re-assessing the LoC categories, to determine what changes are needed to ensure integrated consideration of relevant and reliable data and enhance transparency in describing how conclusions are reached. This effort should improve the LoC framework as a risk communication tool.

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Authorizing Statute(s): US Code: 42 USC Chapter 6A,Subchapter III Name of Law: Health Research Extension Act
  

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:
	80 FR 50298	08/19/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 6281	02/05/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Study Consent Experts	1	Attachment 5 Study Consent Form
LoC Cards Experts	1	Attachment 1 LoC Cards Website Screen shots

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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	600	0	0	600	0	0
Annual Time Burden (Hours)	620	0	0	620	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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: new collection

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Annual Cost to Federal Government: $156,606

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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: 02/08/2016

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