Spectrum of Flavoring Chemical-Related Lung Disease

Forms and Documents

Document Name	Status
SS.B_Flavorings_13BF.docx Supporting Statement B	2013-05-31
Appx F_IRB Appr.docx Supplementary Document	2013-05-31
Appx E_ExtRevCmets.docx Supplementary Document	2013-05-31
Appx C.docx Supplementary Document	2013-05-31
Appx B.docx Supplementary Document	2013-05-31
Appx A.docx Supplementary Document	2013-05-31
Appx L3_PhoneScript_Flavorings-ENG.docx Supplementary Document	2013-06-24
Appx L4_PhoneScript_Flavorings-SPAN.docx Supplementary Document	2013-06-24
Appx I4_Flav_Info Fact Sheet.SPAN.docx Supplementary Document	2013-06-21
Appx I3_Flav_InfoFactSheet.ENG.docx Supplementary Document	2013-06-21
Appx H4_Flav_Announcement.SPAN.docx Supplementary Document	2013-06-21
Appx H3_Flav_Announcement.ENG.docx Supplementary Document	2013-06-21
Appx I2_Pop_InfoFactSheet. SPAN.docx Supplementary Document	2013-06-21
Appx I1_Pop_InfoFactSheet.ENG.docx Supplementary Document	2013-06-21
Appx H2_Pop_Announcement.SPAN.docx Supplementary Document	2013-06-21
Appx H1_Pop_Announcement.ENG.docx Supplementary Document	2013-06-21
Appx L2_PhoneScript_Popcorn-SPAN.docx Supplementary Document	2013-06-24
Appx L1_PhoneScript_Popcorn-ENG.docx Supplementary Document	2013-06-24
SS.A_Flavorings_13BF.docx Supporting Statement A	2013-05-31

IC Document Collections

IC ID	Document Title	Status
207502	Flavoring workers - Questionnaire Other-WORD	New
207501	Popcorn workers - Job History Form Other-WORD	New
207500	Flavoring workers - Informed Consent Other-WORD	New
207499	Flavoring workers - Medication Form Other-WORD	New
207498	Popcorn workers - Medication Form Other-WORD	New
207497	Popcorn workers - Informed Consent Other-WORD	New
207496	Popcorn workers - Questionnaire Other-WORD	New
207495	Flavoring workers - Job History Form Other-WORD	New

ICR Details

OMB Control No: 0920-0979	ICR Reference No: 201306-0920-011
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 19722
Title: Spectrum of Flavoring Chemical-Related Lung Disease
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 without change	Conclusion Date: 08/23/2013
	Date Received in OIRA: 06/25/2013
Terms of Clearance: Approved consistent with the understanding that the design of this study does not allow for the generalizability of results to populations beyond the study cohort. The study cohort was not designed to be representative of workers in microwave popocorn or flavor manufacturing plants.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2015	24 Months From Approved
Responses	548	0	0
Time Burden (Hours)	105	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: The National Institute for Occupational Safety and Health (NIOSH) is conducting a medical survey of flavoring-exposed workers as part of the NORA-funded research project, Spectrum of Flavoring Chemical-Related Lung Disease. The purpose of this project is to characterize the nature of restrictive lung disease occurring in popcorn and flavoring workers. The significance of this work is that past conclusions about emerging lung disease hazards in flavoring-exposed workers can be extended, if necessary, to the full range of conditions that employees, physicians, companies, and regulators must take into account in their efforts to prevent the burden of disease associated with flavorings. Respondents to this survey will be from two populations of workers: those who participated in a previous NIOSH survey at a microwave popcorn plant, and those at a flavoring manufacturing plant that had a high prevalence of restriction. The study will involve a questionnaire, lung function tests, high-resolution computed tomography (HRCT), and blood collection. It is anticipated that it will take approximately no more than 3.5 hours to complete the job and medication history forms, NIOSH testing, and the HRCT. Participants will receive a letter with the results of their own medical testing, and we plan to publish and present overall study results after data collection.

---

Authorizing Statute(s): US Code: 42 USC 85a Name of Law: Occupational Safety and Health Investigations of Places of Employment
   PL: Pub.L. 91 - 596 20(a)(1) Name of Law: Occupational Safety and Health Act
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 68780	11/16/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 33096	06/03/2013
Did the Agency receive public comments on this ICR? Yes

---

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

IC Title	Form No.	Form Name
Flavoring workers - Job History Form
Popcorn workers - Questionnaire
Popcorn workers - Informed Consent
Popcorn workers - Medication Form
Flavoring workers - Informed Consent
Popcorn workers - Job History Form
Flavoring workers - Questionnaire
Flavoring workers - Medication Form

---

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	548	0	0	548	0	0
Annual Time Burden (Hours)	105	0	0	105	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 submission.

---

Annual Cost to Federal Government: $132,053

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

---

Common Form ICR:  No

---

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: 06/25/2013

---