The World Trade Center Health Program: Impact Assessment and Strategic Planning for Translational Research (Part 1, Formative Research: Focus Groups)

Forms and Documents

Document Name	Status
WTCHP Responders and Survivors (private citizens) Form and Instruction	Modified
WTCHP Respondenders and Survivors (State and Local Govt) Form and Instruction	Modified
Clinicians Caring for WTCHP Members Form and Instruction	Modified
WTC Health Registry Staff Form and Instruction	Modified
WTC Leadership Form and Instruction	Modified
WTC Principal Investigators Form and Instruction	Modified
WTCHP Att E_Recruitment Emails_2019-11-22 for OMB_clean.docx Supplementary Document	2019-11-25
Protocol proposed revisions 2019-11-7b.xlsx Supplementary Document	2019-11-21
Proposed revisions RAND 2019-11-7.docx Supplementary Document	2019-11-21
RAND Request for Nonsubstantive changes 2019-11-15.docx Justification for No Material/Nonsubstantive Change	2019-11-21
SSA_12032018.docx Supporting Statement A	2018-12-03
Att I_PIA (11-6-2018).pdf Supplementary Document	2018-11-20
Att H_NIOSH IRB.pdf Supplementary Document	2018-11-20
Att F_RAND IRB determination_2018-1-14.pdf Supplementary Document	2018-11-20
WTCHP Att E_Recruitment Emails_2019-11-22 for OMB_clean_rev.docx Supplementary Document	2020-01-03
Att C_Consent Form_2018-11-14 - CLEAN.docx Supplementary Document	2018-11-20
Att B_0920-18PR 60-day FRN.pdf Supplementary Document	2018-11-20
Att A_Legislation_2018-11-14.docx Supplementary Document	2018-11-20
SSB RAND revisions 2018-11-20.docx Supporting Statement B	2018-11-20

IC Document Collections

IC ID	Document Title	Status
234104	WTCHP Responders and Survivors (private citizens) Form and Instruction	Modified
234103	WTCHP Respondenders and Survivors (State and Local Govt) Form and Instruction	Modified
234102	Clinicians Caring for WTCHP Members Form and Instruction	Modified
234101	WTC Health Registry Staff Form and Instruction	Modified
234100	WTC Leadership Form and Instruction	Modified
234099	WTC Principal Investigators Form and Instruction	Modified

ICR Details

OMB Control No: 0920-1252	ICR Reference No: 201911-0920-009
Status: Active	Previous ICR Reference No: 201811-0920-004
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1252-20DA
Title: The World Trade Center Health Program: Impact Assessment and Strategic Planning for Translational Research (Part 1, Formative Research: Focus Groups)
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 01/03/2020
	Date Received in OIRA: 11/25/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2022	03/31/2022	03/31/2022
Responses	110	0	110
Time Burden (Hours)	220	0	220
Cost Burden (Dollars)	7,044	0	7,044

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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. The Zadroga Act requires the establishment of a research program on health conditions resulting from the 9/11 terrorist attacks. The ability of the WTCHP to serve its members and realize positive impacts on all of its stakeholders depends on effective translation of research activities and findings in a manner that is appropriate to diverse stakeholder groups, including investigators of WTCHP-funded research, the leadership of the WTC Clinical Centers of Excellence, WTC Health Registry staff, clinicians who provide medical services to responders and survivors, and WTCHP respondents and survivors. The focus groups proposed for this work will provide information on stakeholder views about three important translational science principles: the relevance, transparency, and usability of WTCHP research. Findings will provide guidance for the WTCHP on strategic directions, as well as produce generalizable knowledge about the translation of research into improved outcomes for individuals and populations exposed to disasters such as the 9/11 attacks. This is a request for a non-substantive change to the recruitment emails and focus group guide.

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Authorizing Statute(s): US Code: 42 USC 6A, Subchapter XXXI Name of Law: World Trade Center Health Program
  

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:
	83 FR 11535	03/15/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 63515	12/10/2018
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
WTC Health Registry Staff	n/a, none	Brief Demographic Survey ,   Focus group guide
WTC Principal Investigators	n/a, none	Brief Demographic Survey ,   Focus group guide
WTCHP Responders and Survivors (private citizens)	n/a, none	Brief Demographic Survey ,   Focus group guide
Clinicians Caring for WTCHP Members	n/a, none	Brief Demographic Survey ,   Focus group guide
WTC Leadership	n/a, none	Brief Demographic Survey ,   Focus group guide
WTCHP Respondenders and Survivors (State and Local Govt)	n/a, none	Brief Demographic Survey ,   Focus group 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	110	110	0	0	0	0
Annual Time Burden (Hours)	220	220	0	0	0	0
Annual Cost Burden (Dollars)	7,044	7,044	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:

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Annual Cost to Federal Government: $32,887

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: 11/25/2019

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