Center for Tobacco Products, Food and Drug Administration Funded Trainee/Scholar Survey

Forms and Documents

Document	Type	Status	Availability
OMB Change Request Memo 0910-0887.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2021-06-16	Repair queued
FDA CTP Trainee Scholar Survey 4102020.pdf	Supplementary Document	Uploaded 2020-05-05	Repair queued
Supporting Statement Part B Trainee Scholar Survey 2020.docx	Supporting Statement B	Uploaded 2020-01-13	Repair queued
Supporting Statement Part A Trainee Scholar Survey 0887 Clean.docx	Supporting Statement A	Uploaded 2021-06-16	Repair queued

IC Document Collections

IC ID	Collection	Type	Status	Form
239230	Notification Email	Other-Email Notification for PIs and TDs	Unchanged
239229	Trainee List Email	Other-Trainee List Email	Unchanged
239228	Follow-Up Email	Other-Reminder Email	Unchanged
239227	Survey	Other-Survey Instrument	Modified
239226	Informed Consent	Other-Informed Consent	Unchanged
239225	Email Invitation	Other-Email Invitation	Unchanged
239224	Lead Letter	Other-Lead Letter	Unchanged

ICR Details

OMB Control No: 0910-0887	ICR Reference No: 202106-0910-009
Status: Received in OIRA	Previous ICR Reference No: 202001-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Center for Tobacco Products, Food and Drug Administration Funded Trainee/Scholar 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: 06/16/2021

	Requested	Previously Approved
Expiration Date	05/31/2023	05/31/2023
Responses	2,524	2,524
Time Burden (Hours)	143	143
Cost Burden (Dollars)	0	0

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Abstract: The U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP) and the National Institutes of Health (NIH) maintain an interagency partnership to foster the development of the emerging field of tobacco regulatory science (TRS). This study will use the Center for Tobacco Products, Food and Drug Administration Funded Trainee/Scholar Survey to gather data on the characteristics, activities, and impact of training programs funded by the CTP and other partners. This evaluation will also determine how CTP-funded research and associated training programs and activities increase knowledge and skills related to TRS and interest to pursue careers in a TRS-related field. This survey provides support to determine the extent to which programs and activities generate positive impacts to increase the number of researchers who focus on TRS and TRS-related topics, specifically within CTP’s priority domains. The survey builds upon previous evaluations of trainees and training activities and provides necessary evidence to inform FDA decision-making. The web survey will gather responses from current and former Tobacco Centers of Regulatory Science (TCORS) trainees and other CTP-funded trainees and scholars. Results will provide insights and directions to support future training and funding investments.

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Authorizing Statute(s): None

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:
	84 FR 48148	09/12/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 713	01/07/2020
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
Email Invitation
Follow-Up Email
Informed Consent
Lead Letter
Notification Email
Survey
Trainee List Email

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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	2,524	2,524	0	0	0	0
Annual Time Burden (Hours)	143	143	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new information collection.

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Annual Cost to Federal Government: $76,150

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.     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? 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: 06/16/2021

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