Study to Improve Thyroid Doses from Fallout Exposure in Kazakhstan

Forms and Documents

Document Name	Status
Form 1 Study to Improve Thyroid Doses from Fallout Exposure in Kazakhstan Form	New
SSMA_IRBapprovalScan.doc Supplementary Document	2007-10-16
Response to OMB questions 5_Oct_2007 FINAL.doc Supplementary Document	2007-10-16
OMB further questions final resp 15Oct.doc Supplementary Document	2007-10-16
Consent Form FINAL Oct 14cl_2007.doc Supplementary Document	2007-10-16
Kazakhstan SS_OMB_Section B Oct15_FINAL.DOC Supporting Statement B	2007-10-16
Kazakhstan SS_OMB_Section A Oct15_FINAL.DOC Supporting Statement A	2007-10-16

IC Document Collections

IC ID	Document Title	Status
180668	Study to Improve Thyroid Doses from Fallout Exposure in Kazakhstan Form	New

ICR Details

OMB Control No: 0925-0582	ICR Reference No: 200706-0925-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Study to Improve Thyroid Doses from Fallout Exposure in Kazakhstan
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 with change	Conclusion Date: 10/17/2007
	Date Received in OIRA: 06/11/2007
Terms of Clearance: This ICR is approved consistent with memos of 10-5-07 and 10-16-07. Accordingly, NIH shall exercise caution in how NIH reports the results of this study.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2010	36 Months From Approved
Responses	128	0	0
Time Burden (Hours)	256	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Radiation Epidemiology Branch (REB), Division of Cancer Epidemiology and Genetics, National Cancer Institute (NCI), of the National Institutes of Health (NIH) is authorized under the Public Health Service Act, Section 411, [42 USC 285a] to collect information to generate hypotheses concerning environmental and host determinants of cancer. This petition is for approval of a new data collection entitled, Study to Improve Thyroid Doses from Fallout Exposure in Kazakhstan. With this submission, the NIH Office of Communications and Public Liaison, seeks to obtain OMB?s approval to collect information from approximately 32 men and 96 women who were adult residents of four villages near the Semipalatinsk Nuclear Test Site (SNTS) in Kazakhstan to improve dose estimation for an ongoing study of thyroid disease risk in individuals exposed as children to internal and external radiation fallout exposures from weapons testing at the SNTS. The men will be asked about construction materials used in houses and schools (shielding), types of dairy animals from which milk was obtained, and pasturing and feeding practices. The women will asked about types and amounts of milk and milk products consumed by children and themselves, and the amount of time children spent outdoors. These data will allow investigators to evaluate and change, as appropriate, the current assumptions and input values for parameters in the dose estimation model, and thereby improve estimated internal and external radiation doses and better characterize dose uncertainties.

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Authorizing Statute(s): US Code: 42 USC 411 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:
	72 FR 2286	01/18/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 30016	05/31/2007
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Study to Improve Thyroid Doses from Fallout Exposure in Kazakhstan	1, 2, 3, 4	Focus Group Guide ,   Women ,   Not in Session ,   Evaluation

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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	128	0	0	128	0	0
Annual Time Burden (Hours)	256	0	0	256	0	0
Annual Cost Burden (Dollars)	0	0	0	0	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: $69,301

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 06/11/2007

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