Stakeholder Interviews for the Evaluation of the World Trade Center Health Program for Impact Assessment and Strategic Planning for Translational Research

Forms and Documents

Document Name	Status
Interviews with WTCHP Responders and Survivors (private citizens) Form and Instruction	New
Interviews with WTCHP Responders and Survivors (state/local govt) Form and Instruction	New
Interviews with Clinicians Caring for WTCHP Members Form and Instruction	New
Interviews with WTC Health Registry Staff Form and Instruction	New
Interviews with Leadershp from WTC Clinical Centers of Excellence Form and Instruction	New
Interviews with Principal Investigators of WTCHP-funded Research Form and Instruction	New
Att H_NIOSH IRB-Determination-Form-tcv 041718.pdf Supplementary Document	2019-08-12
Att F_RAND IRB determination_08282018.pdf Supplementary Document	2019-08-12
Att E_Recruitment materials.docx Supplementary Document	2019-08-12
Att C_Consent_2019-07-30.docx Supplementary Document	2019-08-12
Att B_60day FRN.pdf Supplementary Document	2019-08-12
Att A_Legislation_08282018.docx Supplementary Document	2019-08-12
WTCHP SSB interviews 2019-07-30.docx Supporting Statement B	2019-08-12
WTCHP SSA interviews 2019-07-30.docx Supporting Statement A	2019-08-12

IC Document Collections

IC ID	Document Title	Status
237334	Interviews with WTCHP Responders and Survivors (private citizens) Form and Instruction	New
237333	Interviews with WTCHP Responders and Survivors (state/local govt) Form and Instruction	New
237332	Interviews with Clinicians Caring for WTCHP Members Form and Instruction	New
237331	Interviews with WTC Health Registry Staff Form and Instruction	New
237330	Interviews with Leadershp from WTC Clinical Centers of Excellence Form and Instruction	New
237324	Interviews with Principal Investigators of WTCHP-funded Research Form and Instruction	New

ICR Details

OMB Control No: 0920-1280	ICR Reference No: 201907-0920-006
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-19AEN
Title: Stakeholder Interviews for the Evaluation of the World Trade Center Health Program for Impact Assessment and Strategic Planning for Translational Research
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: 01/03/2020
	Date Received in OIRA: 08/13/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2023	12 Months From Approved
Responses	17	0	0
Time Burden (Hours)	17	0	0
Cost Burden (Dollars)	906	0	0

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Abstract: The World Trade Center Health Program (WTCHP) was established by the James Zadroga 9/11 Health and Compensation Act of 2010. As required by the Act, the WTCHP carries out a robust research program while providing critical monitoring and treatment services for its 75,000 members, who include responders at the World Trade Center (WTC) and related sites and survivors who were in the New York City disaster area. The research mission is to identify physical and mental health conditions that may be related to the 9/11 terrorist attacks and define effective diagnostic procedures and treatments for WTC-related health conditions. The Research to Care (RTC) model is the theoretical framework used by NIOSH to prioritize, conduct, and assess research that informs clinical care for WTCHP members. NIOSH proposes to conduct interviews with representatives of different stakeholder groups to explore their perspectives on translational research in the context of the WTCHP.

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Authorizing Statute(s): US Code: 42 USC Chapter 6A, Subchapter XXXI Name of Law: James Zadroga 9/11 Health and Compensation Act of 2010
  

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:
	84 FR 13923	04/08/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 40057	08/13/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Interviews with Leadershp from WTC Clinical Centers of Excellence	n/a, n/a	WTCHP Brief Demographic Survey ,   WTCHP Impact Assessment and Strategic Planning In-depth Interview Discussion Guide
Interviews with WTCHP Responders and Survivors (state/local govt)	n/a, n/a	WTCHP Brief Demographic Survey ,   WTCHP Impact Assessment and Strategic Planning In-depth Interview Discussion Guide
Interviews with Principal Investigators of WTCHP-funded Research	n/a, n/a	WTCHP Impact Assessment and Strategic Planning In-depth Interview Discussion Guide ,   WTCHP Brief Demographic Survey
Interviews with WTCHP Responders and Survivors (private citizens)	n/a, n/a	WTCHP Brief Demographic Survey ,   WTCHP Impact Assessment and Strategic Planning In-depth Interview Discussion Guide
Interviews with WTC Health Registry Staff	n/a, n/a	WTCHP Brief Demographic Survey ,   WTCHP Impact Assessment and Strategic Planning In-depth Interview Discussion Guide
Interviews with Clinicians Caring for WTCHP Members	n/a, n/a	WTCHP Brief Demographic Survey ,   WTCHP Impact Assessment and Strategic Planning In-depth Interview Discussion Guide

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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	17	0	0	17	0	0
Annual Time Burden (Hours)	17	0	0	17	0	0
Annual Cost Burden (Dollars)	906	0	0	906	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: This is a new, one-time information collection.

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Annual Cost to Federal Government: $11,197

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

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? 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: 08/13/2019

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