An Investigation of Lung Health at an Indium-Tin Oxide Production Facility

Forms and Documents

Document Name	Status
Attachment G.docx Supplementary Document	2014-06-23
Attachment H.docx Supplementary Document	2014-06-23
SupSta B_0920-14CL.docx Supporting Statement B	2014-03-11
Att M_IRB Approval.docx Supplementary Document	2014-03-11
Att B_60d FRN.pdf Supplementary Document	2014-03-11
Att A_Authorizing Leg.docx Supplementary Document	2014-03-11
Att H Results letter for Blood tests.docx Supplementary Document	2014-03-11
Att G_Results letter for Lung tests.docx Supplementary Document	2014-03-11
Att L_Results letter for personal air sampling.docx Supplementary Document	2014-03-11
Att K_Personal Air Sampling Log.docx Supplementary Document	2014-03-11
Supporting statement A.docx Supporting Statement A	2014-06-23

IC Document Collections

IC ID	Document Title	Status
210762	Exposure Monitoring (mock form) Other-WOrd	New
210761	Medical Testing Other-WORD	New
210760	Personal Air Sampling _ Contact Information Form Other-WORD	New
210759	Script for Industrial Hygiene Samples Other-WORD	New
210758	Authorization to Disclose Other-WORD	New
210757	Consent Other-WORD	New
210756	Recruitment Letter Other-WORD	New
210755	Indium Facility Questionnaire Other-WORD	New

ICR Details

OMB Control No: 0920-1024	ICR Reference No: 201403-0920-006
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 21559
Title: An Investigation of Lung Health at an Indium-Tin Oxide Production Facility
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: 06/23/2014
	Date Received in OIRA: 03/18/2014
Terms of Clearance: The primary goal of understanding the relationship between exposure and lung health outcomes in this facility, and using them to reduce exposures and prevent lung disease at this particular facility. To the extent that the industrial processes and exposures at this facility are relevant to some facilities in the United States and many more in Asia, the lessons learned may be useful to other workplaces here and abroad. We strongly encourage CDC, in consultation with their IRB, to develop a standardized template for returning the test results to participants that differentiates between comparisons to population studies vs. comparisons to clinical reference guidelines.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2015	12 Months From Approved
Responses	765	0	0
Time Burden (Hours)	254	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Indium-tin oxide (ITO) is a sintered material used in the manufacture of devices such as liquid crystal displays, touch panels, solar cells, and architectural glass. Indium lung disease is a novel, potentially fatal industrial disease that has occurred in workers making, using, or recycling ITO. This project aims to understand and prevent this occupational lung disease by investigating the relationship between exposure and lung health among current ITO manufacturing workers. CDC requests OMB approval to collect standardized information from current employees of the ITO production facility through an informed consent document, an interviewer-administered questionnaire, and a contact information form. As part of the same project, employees will be offered the opportunity to participate in medical testing and personal air sampling.

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Authorizing Statute(s): PL: Pub.L. 91 - 596 20(a)[1] Name of Law: Occupational Safety and Health 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:
	78 FR 69417	11/19/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 13053	03/07/2014
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 8

IC Title	Form No.	Form Name
Indium Facility Questionnaire
Recruitment Letter
Consent
Authorization to Disclose
Script for Industrial Hygiene Samples
Personal Air Sampling _ Contact Information Form
Medical Testing
Exposure Monitoring (mock form)

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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	765	0	0	765	0	0
Annual Time Burden (Hours)	254	0	0	254	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 request for a new OMB Control Number.

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Annual Cost to Federal Government: $305,161

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? Yes

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: 03/18/2014

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