Exposure Assessment and Epidemiological Study of U.S. Workers Exposed to Carbon Nanotubes and Nanofibers

Forms and Documents

Document Name	Status
Informed Consent Form	New
Exposure Assessment Questionnaire Form	New
Attachment F-rev1.docx Supplementary Document	2013-06-07
CNT-protocol-cross-sectional-to-HSRB-final_mod1_02052013.pdf Supplementary Document	2013-05-21
SB Supporting Statement B_nanomaterials_toCDC-final.docx Supporting Statement B	2013-02-27
AttachmentE-HSRB.pdf Supplementary Document	2013-02-27
Attachment B-CNT-60-d-FRN_09-20-2012.pdf Supplementary Document	2013-02-27
Attachment A-OSHAct.docx Supplementary Document	2013-02-27
Attachment C-2-Exposure factors.docx Supplementary Document	2013-02-28
Supporting Statement A_nanomaterials_6 7 13.docx Supporting Statement A	2013-06-07

IC Document Collections

IC ID	Document Title	Status
207241	Medical Examination, Biospecimen Collection, and Exposure Monitoring Other-Examination	New
206194	Informed Consent Form	New
206193	Exposure Assessment Questionnaire Form	New

ICR Details

OMB Control No: 0920-0973	ICR Reference No: 201303-0920-010
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 18981
Title: Exposure Assessment and Epidemiological Study of U.S. Workers Exposed to Carbon Nanotubes and Nanofibers
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: 06/10/2013
	Date Received in OIRA: 03/18/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2016	36 Months From Approved
Responses	99	0	0
Time Burden (Hours)	66	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The proposed research is a cross-sectional study of the small current workforce involved with CNT and CNF in manufacturing and distribution, to be conducted in the following phases: 1) Industrywide exposure assessment study to evaluate worker exposure and further development and refinement of measurement methods for CNT and CNF, and 2) A cross-sectional study relating various metrics of CNT and CNF exposure (namely, the inhalable fraction of elemental carbon mass concentration, the respirable fraction of elemental carbon mass concentration, and size-classified CNT- or CNF-containing structure counts) to measures of early pulmonary or cardiovascular health effects.

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Authorizing Statute(s): US Code: 29 USC 669 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:
	77 FR 58396	09/20/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 15366	03/11/2013
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Informed Consent	none	Consent
Exposure Assessment Questionnaire	none	Questionnaire
Medical Examination, Biospecimen Collection, and Exposure Monitoring

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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	99	0	0	99	0	0
Annual Time Burden (Hours)	66	0	0	66	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 data collection request.

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Annual Cost to Federal Government: $429,415

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: 03/18/2013

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