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	New
WTCHP Respondenders and Survivors (State and Local Govt) Form and Instruction	New
Clinicians Caring for WTCHP Members Form and Instruction	New
WTC Health Registry Staff Form and Instruction	New
WTC Leadership Form and Instruction	New
WTC Principal Investigators Form and Instruction	New
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
Att E_Recruitment Emails_2018-11-14.docx Supplementary Document	2018-11-20
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	New
234103	WTCHP Respondenders and Survivors (State and Local Govt) Form and Instruction	New
234102	Clinicians Caring for WTCHP Members Form and Instruction	New
234101	WTC Health Registry Staff Form and Instruction	New
234100	WTC Leadership Form and Instruction	New
234099	WTC Principal Investigators Form and Instruction	New

ICR Details

OMB Control No: 0920-1252	ICR Reference No: 201811-0920-004
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-18PR
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: 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: 03/01/2019
	Date Received in OIRA: 12/11/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2022	36 Months From Approved
Responses	110	0	0
Time Burden (Hours)	220	0	0
Cost Burden (Dollars)	7,044	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. 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.

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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, n/a	Brief Demographic Survey ,   Focus Group Discussion Guide
WTC Principal Investigators	n/a, n/a	Focus Group Discussion Guide ,   Brief Demographic Survey
WTCHP Responders and Survivors (private citizens)	n/a, n/a	Focus Group Discussion Guide ,   Brief Demographic Survey
Clinicians Caring for WTCHP Members	n/a, n/a	Focus Group Discussion Guide ,   Brief Demographic Survey
WTC Leadership	n/a, n/a	Focus Group Discussion Guide ,   Brief Demographic Survey
WTCHP Respondenders and Survivors (State and Local Govt)	n/a, n/a	Focus Group Discussion Guide ,   Brief Demographic Survey

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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	0	0	110	0	0
Annual Time Burden (Hours)	220	0	0	220	0	0
Annual Cost Burden (Dollars)	7,044	0	0	7,044	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 collection.

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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: 12/11/2018

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