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

Forms and Documents

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

IC Document Collections

IC ID	Document Title	Status
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OIRA Conclusion Action: Withdrawn	Conclusion Date: 02/02/2017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:

	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

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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