Study to Estimate Radiation Doses and Cancer Risk From Radioactive Fallout From The Trinity Nuclear Test (NCI)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 6 Key Informants and Academics Interview	Form	New	Available
Form 5 Pre-Focus Group Guide	Form	New	Repair queued
Form 4 Focus Groups	Form	New	Repair queued
Form 2 Consent Form	Form	New	Available
Form 1 Recruitment Screener (English/Spanish)	Form	New	Available
30-Day FRN Trinity.pdf	Supplementary Document	Uploaded 2016-08-25	Available
ATTACHMENT 19- Privacy Act Memo.pdf	Supplementary Document	Uploaded 2016-08-22	Repair queued
ATTACHMENT 18-References.docx	Supplementary Document	Uploaded 2016-08-22	Repair queued
ATTACHMENT 17 - Collection and Analysis Individuals.docx	Supplementary Document	Uploaded 2016-08-22	Available
ATTACHMENT 3 - Pilot Study Summary of Findings.docx	Supplementary Document	Uploaded 2016-08-22	Available
ATTACHMENT 16 - Communication Plan.docx	Supplementary Document	Uploaded 2016-08-22	Repair queued
ATTACHMENT 14B - UNM-14-254 Approval Letter.pdf	Supplementary Document	Uploaded 2016-08-22	Repair queued
ATTACHMENT 14A-NCI_IRB_Outcome_Letter.pdf	Supplementary Document	Uploaded 2016-08-22	Available
ATTACHMENT 13 - Incentive receipt.docx	Supplementary Document	Uploaded 2016-08-22	Available
ATTACHMENT 12 - TRINITY STUDY CONSULTANTS.docx	Supplementary Document	Uploaded 2016-08-22	Available
ATTACHMENT 11 - Literature Review.docx	Supplementary Document	Uploaded 2016-08-22	Available
ATTACHMENT 10-Background on dietary recall and focus groups.docx	Supplementary Document	Uploaded 2016-08-22	Available
ATTACHMENT 6 - Participant Letter.docx	Supplementary Document	Uploaded 2016-08-22	Repair queued
ATTACHMENT 4B-Recruitment Flier-Spanish.docx	Supplementary Document	Uploaded 2016-08-22	Available
ATTACHMENT 4A - Recruitment Flier-English.docx	Supplementary Document	Uploaded 2016-08-22	Available
ATTACHMENT 2 - Fallout map of New Mexico.docx	Supplementary Document	Uploaded 2016-08-22	Available
ATTACHMENT 1 - Trinity Background.docx	Supplementary Document	Uploaded 2016-08-22	Available
SSB Trinity.docx	Supporting Statement B	Uploaded 2016-08-22	Available
SSA Trinity.docx	Supporting Statement A	Uploaded 2016-08-22	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
223145	Key Informants and Academics Interview	Form	New
223144	Pre-Focus Group Guide	Form	New
223142	Focus Groups	Form	New
223141	Consent Form	Form	New
223117	Recruitment Screener (English/Spanish)	Form	New

ICR Details

OMB Control No:	ICR Reference No: 201608-0925-003
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Study to Estimate Radiation Doses and Cancer Risk From Radioactive Fallout From The Trinity Nuclear Test (NCI)
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: 02/02/2017
	Date Received in OIRA: 08/25/2016
Terms of Clearance:

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 Information Collection Request (ICR) is for a radiation-related cancer risk projection study for the residents of the state of New Mexico (NM) potentially exposed to radioactive fallout from the Trinity nuclear test conducted in 1945. Data will be collected on diet and lifestyle from three groups in NM (non-Hispanic white, Hispanic, and Native American) alive in the 1940s via focus groups and key informant interviews. These data will be used to derive means and ranges of exposure-related parameters. Little information is currently available about dietary patterns among Native American community members or Hispanics in New Mexico in the 1940s combined.

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Authorizing Statute(s): US Code: 42 USC sect 285a Name of Law: Public Health Service 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:
	81 FR 29875	05/13/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 58522	08/25/2016
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 5

table that charts list of burden

IC Title	Form No.	Form Name
Recruitment Screener (English/Spanish)	1	screener
Key Informants and Academics Interview	6	Key Informant Interview Guide
Consent Form	2, 3	Informed Consent ,   Informed Consent SPANISH
Focus Groups	4	Focus Group Guide and Wall Charts
Pre-Focus Group Guide	5	Pre-Focus Group Guide

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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: New submission

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Annual Cost to Federal Government: $378,878

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: 08/25/2016

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