2019 Lung Injury Response Understanding Vaping Practices in the United States

Forms and Documents

Document Name	Status
Form Survey Understanding Vaping Practices in the United States Survey Form and Instruction	New
Form Survey Understanding Vaping Practices in the United States Survey Form and Instruction	New
Emeregncy Request memo EVALI.pdf Supplementary Document	2019-11-25
FRN Publication Request Worksheet- Emergency EVALI.docx Supplementary Document	2019-11-25
Attachment 4_EVALI PIA.docx Supplementary Document	2019-11-25
Attachment 01_Emergency Review Request Memo Vaping V3 (002).docx Supplementary Document	2019-11-22
Attachment 8_Lung Injury Response 2019 AOC.pdf Supplementary Document	2019-11-22
Attachment 7_EVALI IRB Docs - Determination.docx Supplementary Document	2019-11-22
Attachment 6_EVALI Consent Form V2.docx Supplementary Document	2019-11-22
Attachment 5_EVALI survey Invitation Email.docx Supplementary Document	2019-11-22
Attachment 4_EVALI PIA.pdf Supplementary Document	2019-11-22
Attachment 3_Background and rationale for EVALI survey questions.docx Supplementary Document	2019-11-22
Attachment 1_ PHSA Authorizing Legislation.doc Supplementary Document	2019-11-22
Emergency SSB Vaping ICR V5.docx Supporting Statement B	2019-11-25
Emergency SSA Vaping ICR V7.docx Supporting Statement A	2019-11-25

IC Document Collections

IC ID	Document Title	Status
238644	Understanding Vaping Practices in the United States Survey Form and Instruction	New
238643	Understanding Vaping Practices in the United States Survey Form and Instruction	New

ICR Details

OMB Control No: 0920-1276	ICR Reference No: 201911-0920-010
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-20DC
Title: 2019 Lung Injury Response Understanding Vaping Practices in the United States
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Emergency	Approval Requested By: 11/25/2019
OIRA Conclusion Action: Approved with change	Conclusion Date: 11/26/2019
	Date Received in OIRA: 11/25/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/29/2020	3 Months From Approved
Responses	126,000	0	0
Time Burden (Hours)	5,000	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The goal of this emergency data collection is to conduct a formative study to collect data from individuals who vape/dab tetrahydrocannabinol (THC) but who have not developed lung injury in order to compare characteristics with those who have developed the injury to help further the ongoing public health investigation.

Emergency Justfication: I have determined that this information must be collected prior to the expiration of time periods established under Part 1320, and that this information is essential for CDC’s emergency response in the investigation of e-cigarette, or vaping, product use associated lung injury (EVALI) , and to assist each state/local/territory jurisdiction in making rapid, practical decisions for actions to prevent and control this public health problem. CDC cannot reasonably comply with the normal clearance because our initial investigation suggests that collection of data comparing cases of people who report vaping THC but have not developed EVALI in a timely way is essential for narrowing the list of products, substances, and risk factors requiring further public health investigation and action (e.g., prioritizing samples for laboratory testing). Because the collection of data is expected to begin as soon as possible, accelerated OMB review is requested. Therefore, CDC requests a 90-day emergency clearance to launch collection of data.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: PHSA
  

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

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Understanding Vaping Practices in the United States Survey	Survey	EVALI Survey
Understanding Vaping Practices in the United States Survey	Survey	EVALI Survey

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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	126,000	0	0	126,000	0	0
Annual Time Burden (Hours)	5,000	0	0	5,000	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 Emergency ICR.

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Annual Cost to Federal Government: $104,232

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.     No

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.     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: 11/25/2019

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