GUIDANCE ON MEETINGS WITH INDUSTRY AND INVESTIGATORS ON THE RESEARCH AND DEVELOPMENT OF TOBACCO PRODUCTS

Forms and Documents

Document Name	Status
0731_Supporting Statement.docx Supporting Statement A	2016-02-04

IC Document Collections

IC ID	Document Title	Status
205100	GUIDANCE ON MEETINGS WITH INDUSTRY AND INVESTIGATORS ON THE RESEARCH AND DEVELOPMENT OF TOBACCO PRODUCTS Other-Guidance - Meetings with Industry	Modified

ICR Details

OMB Control No: 0910-0731	ICR Reference No: 201602-0910-005
Status: Historical Active	Previous ICR Reference No: 201212-0910-010
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: GUIDANCE ON MEETINGS WITH INDUSTRY AND INVESTIGATORS ON THE RESEARCH AND DEVELOPMENT OF TOBACCO PRODUCTS
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/24/2016
	Date Received in OIRA: 02/12/2016
Terms of Clearance: OMB notes that program confirms that this ICR is intended to be an ICR Extension (rather than Revision) request. Approved consistent with the understanding that burden associated with meeting requests from stakeholders representing newly deemed tobacco products are accounted for in OMB Control No. 0910-0768.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2019	36 Months From Approved	06/30/2016
Responses	67	0	67
Time Burden (Hours)	1,876	0	1,876
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR is for a guidance intended to assist tobacco manufacturers, importers, researchers, and investigators, and their representatives who seek meetings with staff of FDA’s Center for Tobacco Products (CTP). This guidance does not pertain to other types of meetings or meeting requests with CTP staff. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) offers several pathways to obtain an order from FDA to authorize the marketing of a new tobacco product before it may be introduced or delivered into interstate commerce. To provide assistance with these pathways to market products, FDA will meet with tobacco product manufacturers, importers, researchers, and investigators (or their representatives) where appropriate. This guidance is intended to assist persons who seek guidance relating to their research to inform the regulation of tobacco products or to support the development or marketing of tobacco products. This guidance describes two collections of information: (1) The submission of a meeting request containing certain information and (2) the submission of a meeting information package in advance of the meeting. The purpose of the meeting information package is to provide Agency staff the opportunity to adequately prepare for the meeting, including the review of relevant data concerning the product. In the Agency’s experience, reviewing such information is critical to achieving a productive meeting. For information that was previously submitted in a meeting request, the information package should provide updated information that reflects the most current and accurate information available.

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Authorizing Statute(s): PL: Pub.L. 111 - 111 31 Name of Law: Family Smoking Prevention and Tobacco Control 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:
	80 FR 55855	09/17/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 5758	02/03/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
GUIDANCE ON MEETINGS WITH INDUSTRY AND INVESTIGATORS ON THE RESEARCH AND DEVELOPMENT OF TOBACCO PRODUCTS

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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	67	67	0	0	0	0
Annual Time Burden (Hours)	1,876	1,876	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:

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Annual Cost to Federal Government: $116,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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: 02/12/2016

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