Generic Clearance to Collect Medical Outcome and Risk Factor Data from a Cohort of U.S. Radiologic Technologists

Forms and Documents

Document Name	Status
Attachments 4A-4C - IRB Approvals.doc Supplementary Document	2007-08-15
Attachment 3B - MV-HIPAA authorization-rev 2005 0923.doc Supplementary Document	2007-07-26
Attachment 3A - cons_GS_B_DNAPilot1tube_rev20051013_wSig.doc Supplementary Document	2007-08-15
Attachment 2A - broch_GS_DNAPilot1_rev20060918.doc Supplementary Document	2007-07-26
RT.B.doc Supporting Statement B	0000-00-00
0925-0405 2 Radiologic Tech - Information Collection Instrument GQ-Sub012907 (Attachment2)[1].pdf Supplementary Document	0000-00-00
Attachment 1 - Information Collection Instrument GQ-Sub012907.pdf Supplementary Document	2007-08-15
RT.A.doc Supporting Statement A	0000-00-00

IC Document Collections

IC ID	Document Title	Status

ICR Details

OMB Control No: 0925-0405	ICR Reference No: 200702-0925-002
Status: Historical Active	Previous ICR Reference No: 200311-0925-002
Agency/Subagency: HHS/NIH	Agency Tracking No:
Title: Generic Clearance to Collect Medical Outcome and Risk Factor Data from a Cohort of U.S. Radiologic Technologists
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 02/06/2008
	Date Received in OIRA: 02/28/2007
Terms of Clearance: This latest ICR request (i.e. to add on blood/DNA testing as part of this overall generic ICR) is withdrawn per NIH request. Should NIH decide to pursue this particular part of the study, NIH shall revise its HIPAA and consent forms so that the study--as it is described on those forms--is consistent with how it is described in the supporting statement, particularly with regard to privacy protocols (i.e. under what circumstances--and to whom--private health information shall be disclosed) and the storage/banking of specimens for future research. Moreover, the HIPAA and consent forms shall be revised to better protect the privacy of respondents' sensitive health information. Upon resubmission of this ICR, NIH will have obtained IRB approval for these changes. Previous terms of clearance remain in effect. NIH is also authorized to carry on with other aspects of this generic clearance which have already been approved. It is only the latest ICR request that is withdrawn at this time.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2011	36 Months From Approved	02/29/2008
Responses	5,630	0	59,200
Time Burden (Hours)	5,630	0	29,500
Cost Burden (Dollars)	0	0	0

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Abstract: U.S. radiologic technologists who are participants in an ongoing cohort study will be asked to respond to occasional surveys to ascertain incident cancers, benign conditions associated with high risk of cancer, and selected other health outcomes, as well as demographic, lifestyle, reproductive, employment, and other characteristics that may influence health risks. The primary aim of this project is to substantially increase knowledge about the long-term health effect associated with protracted low- to moderate-dose radiation exposures.

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Authorizing Statute(s): US Code: 42 USC 411 Name of Law: National Cancer 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:
	71 FR 78445	12/29/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 9010	02/28/2007
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 0

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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	5,630	59,200	0	-53,570	0	0
Annual Time Burden (Hours)	5,630	29,500	0	-23,870	0	0
Annual Cost Burden (Dollars)	0	0	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The previous annual burden was 29,500. We are now asking for 5,630, which is a minus 23,870. The decrease relates to the fact that we plan to conduct only one survey under this approval rather than the three requested under the generic clearance.

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Annual Cost to Federal Government: $400,000

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: 02/28/2007

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