FRN Publication Worksheet word

BRIEF

Federal Register Notice (FRN) Publication Request Worksheet

Agency (Select one) CDC

ATSDR

Office of Management and Budget (OMB) Control Number:

Expiration Date (mm/dd/yyyy)

Agency Information Collection Request (ICR) Tracking Number (CDC ID #): Project Title:

2019 LUNG INJURY RESPONSE UNDERSTANDING VAPING PRACTICES IN THE UNITED STATES. New Emergency

Information Collection

Requesting CDC/ATSDR CIO and Program:

ONDIEH: NCIPC

Was this proposed information collection request package vetted through an internal

CIO clearance process with relevant project and Paperwork Reduction Act oversight officials?

Yes ^No

FRN Type (Publication Requested) (Select one) 60-Day FRN

30-Day FRN

Emergency Review FRN Other

FRN Approval Category (Select one) Routine

Non-Routine

Non-routine = Urgent collections (either a public health emergency or soon to expire OMB approval). Routine = Everything else.

Use of Information collection (Select one) Application for Benefit

Program Evaluation

General Purpose Statistics Regulatory/Compliance Program Planning/Management

Public Health/Emergency Response Research

Surveillance/Surveillance Core Functions

Service Delivery/Customer Feedback Administrative

Audit Other

Type of ICR (Select one)

New collection (Request for a new OMB Control Number) Extension without change of a currently approved collection Revision of a currently approved collection *¹

Reinstatement without change of a previously approved collection Reinstatement with change of a previously approved collection Existing collection in use without an OMB Control Number

¹ *For Revision Requests, in the Brief Summary section below, explain what has changed:

• Is there a change in the data collection instrument? Why? What caused the change?

• Is there an increase or decrease in respondents? From what (i.e., current approval) to what? What is the reason for the change?

• Is there an increase or decrease in burden? From what (i.e., current approval) to what? What is the reason for the change?

Requested Approval Period for proposed ICR (Select one) ^{Three years from approval date}

Two years from approval date

One year from approval date

Six months from approval date (Maximum for Emergency reviews) Other

The proposed data collection is in support of a: (Select one)

Provide the Title, Contract Number or Funding Announcement (FA) Number and Grant Number

Contract:

Grant/CoAg: Other - Specify:

Who will collect the data? (Select all that apply) ^CDC

Grantees

Public Health Partners Contractors

Other

AFFECTED PUBLIC: Choose all that apply Individuals and Households

State, Local, or Tribal Governments Federal Government

Private Sector - If affected Public is Private Sector, check all the following that apply:

Is the proposed ICR related to the Affordable Care Act (PPACA, P.L. 111-148 &111-152)? Does the proposed collection pose burdens on practicing physicians or their patients? If yes, identify burden type below.	Yes Yes	No No
BURDEN TYPE Time Effort Financial Resources

LEGAL STATUTES

Authorizing Statute(s):

Public Health Service Act (42 USC 241)

Note: Authorizing Statuses include applicable Public Law, U.S. Code, Executive Orders, and Statuses

RULEMAKING

Associated Rulemaking Information:

Yes ^No

FR NOTICES / COMMENTS (For 30-Day FRN Requests)

60. day Notice: Federal Register Citation: Volume No. Page # Publication Date: Did the Agency receive public comments on the 60-day FRN? Yes No

If yes, how many comments were received?

Of the comments received, how many did the CDC/ATSDR program consider substantive?

BRIEF SUMMARY OF INFORMATION COLLECTION

State information collection’s purpose and the importance of collecting this information now:

The goal of this 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. The goals of this study are to:

1. Collect data about product types, brands, devices, and frequency of use from a convenience sample of individuals who report vaping THC-containing products but who have not developed e-cigarette, or vaping, product use associated lung injury (EVALI)

2. Assess the vaping characteristics/behaviors of non-cases (those who vape but have not developed EVALI) to those of EVALI cases

State proposed use of collected data:

The results of this information collection will inform CDC’s ongoing public health response to the multi- state lung injury outbreak by helping to narrow the list of products, substances, and risk factors requiring further public health action, epidemiological and clinical analyses, and laboratory testing.

Provide location(s) of data collection activities:

WA, CA, UT, CO, ND, TX, IL, WI, MN, TN, NC, PA, NY, NJ, MA.

Describe methods for collecting data:

An opt-in internet panel survey of approximately 5,250 individuals who report vaping THC-containing products within the last 3 months who have not developed EVALI. This method allows for the rapid collection of information on a timely issue. We will compare the frequency of usage characteristics between the survey sample (controls who have not developed EVALI) and EVALI cases.

Describe sampling plan:

A geographically diverse convenience sample of individuals who are vaping the same or similar products at the same or similar frequency but have not developed EVALI.

Collaborative Efforts:

Completely describe collaborative efforts (names, dates, roles, where documented in ICR's justification, etc.):

Name	Date	Role	Where Documented in ICR's Justification
Departments of Health in 49 states, Washington DC, the US Virgin Islands, and Puerto Rico to monitor EVALI cases.	'2019	Other	SSA A4
National Center for Injury Prevention and Control and the CDC’s Office on Smoking and Health	'2019	Other	SSA A4
		Other
		Other

RESPONDENTS

Total number of data collection instruments: 1

Total number of Respondents: 126000

Total number of Responses: ¹²⁶⁰⁰⁰

Total Burden Hours: 5000

(Find specific information on respondent, response, and burden estimations in the Supporting Statement)

Provide any additional comments:

OBLIGATION TO RESPOND

Mandatory

Required to Obtain or Retain Benefits Voluntary

COSTS

Annual Cost to Federal Government: ^$104,232.00

^{Annual Cost to Respondents:} $90,600.00

(Sum/total the "Estimated Annualized Burden Costs to Respondents" in Section A12 and "Estimates of Other Total Annual Cost Burden to Respondents or Record Keepers" in Section A13 of the Supporting Statement A of the Information Collection Request)

INCENTIVES

Will CDC/ATSDR offer incentives for proposed information collection project? If yes, what type(s) or kind(s) of incentive(s) will be offered? ^{Gift Card(s)}

Provide the incentive amounts that will be offered to information collection respondents/participants ^$2.00

Yes ^No

Is the incentive offered within scope of Federal/Office of Management and Budget standards

for incentives? Yes ^No

FRN Publication Approval Needed by: ^11/22/2019

2

CDC 0.1559 (E), July 2017, CDC Adobe Acrobat DC, S508 Electronic Version, July 2017