Understanding Long-term Respiratory Morbidity in Former Styrene-exposed Workers: Medical Survey

Forms and Documents

Document Name	Status
Form 0920-21ID HRCT Scan informed consent Form	New
Consent Form and Instruction	Modified
Former employee medical questionnaire Form	Modified
Request for Nonsubstantive Change 0920-1332.docx Justification for No Material/Nonsubstantive Change	2021-09-28
Attachment 22 PIA form.pdf Supplementary Document	2020-09-23
Attachment 11 FDA package insert.pdf Supplementary Document	2020-09-23
Attachment 9 Albuterol drug information.docx Supplementary Document	2020-09-23
Attachment 5 Medical survey Contol Card.pptx Supplementary Document	2020-09-23
Attachment 21 IRB approval letter.pdf Supplementary Document	2020-09-23
Attachment 20 Notification Letter.docx Supplementary Document	2020-09-23
Attachment 18 Information sheet_medical survey.ppt Supplementary Document	2020-09-23
Attachment 17 General Invitation letter.docx Supplementary Document	2020-09-23
Attachment 15 Information sheet.ppt Supplementary Document	2020-09-23
Attachment 14 Information session ppt.pptx Supplementary Document	2020-09-23
Attachment 2 60 day FRN.pdf Supplementary Document	2020-09-23
Attachment 1 Laws and Regulations.docx Supplementary Document	2020-09-23
SupSta B (9.15.20).docx Supporting Statement B	2020-09-22
SupSta A_Updated (9.15.20).docx Supporting Statement A	2020-09-22

IC Document Collections

IC ID	Document Title	Status
249551	HRCT Scan Other-HRCT Protocol	New
249550	HRCT Scan informed consent Form	New
243752	Consent Form and Instruction	Modified
243750	Blood test procedures Instruction	Modified
243749	Color vision test procedures Instruction	Modified
243748	Bronchodilator test procedures Instruction	Modified
243747	Spirometry procedures Instruction	Modified
243746	Nitrogen multibreath washout test procedures Instruction	Modified
243745	Impulse oscillometry procedures Instruction	Modified
243744	Exhaled nitric oxide procedures Instruction	Modified
243743	Former employee medical questionnaire Form	Modified

ICR Details

OMB Control No: 0920-1332	ICR Reference No: 202109-0920-011
Status: Received in OIRA	Previous ICR Reference No: 202009-0920-016
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-20ID
Title: Understanding Long-term Respiratory Morbidity in Former Styrene-exposed Workers: Medical Survey
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 09/30/2021

	Requested	Previously Approved
Expiration Date	04/30/2023	04/30/2023
Responses	5,598	2,729
Time Burden (Hours)	1,461	712
Cost Burden (Dollars)	33,600	16,391

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Abstract: The purpose of this project is to understand the prevalence of long-term respiratory morbidity in styrene-exposed workers. The sites of field research for this project are Bellingham, WA and Kelso, WA, which were the sites of two reinforced plastic boatbuilding plants that closed in 1989 and 1993. A maximum of 676 study subjects will be enrolled to participate in a medical and job history questionnaire, lung function testing, color vision assessment, and biomarker analysis.

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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:
	85 FR 11988	02/28/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 61950	10/01/2020
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 11

IC Title	Form No.	Form Name
Blood test procedures
Bronchodilator test procedures
Color vision test procedures
Consent	none	Consent
Exhaled nitric oxide procedures
Former employee medical questionnaire	none	Former employee medical questionnaire
HRCT Scan
HRCT Scan informed consent	0920-21ID	HRCT consent form
Impulse oscillometry procedures
Nitrogen multibreath washout test procedures
Spirometry procedures

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ICR Summary of Burden

	Total Request	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	5,598	2,729	0	2,869	0	0
Annual Time Burden (Hours)	1,461	712	0	749	0	0
Annual Cost Burden (Dollars)	33,600	16,391	0	17,209	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 change request is for 0920-1332 to add an additional medical test to medical survey participants. The request is for 1,141 hours.

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Annual Cost to Federal Government: $894,305

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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? No

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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: 09/30/2021

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