Guidance on Meetings with Industry and Investigators on the Research and Development of Tobacco Products

ICR 201903-0910-013

OMB: 0910-0731

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2019-03-14
ICR Details
0910-0731 201903-0910-013
Active 201602-0910-005
HHS/FDA CTP
Guidance on Meetings with Industry and Investigators on the Research and Development of Tobacco Products
Extension without change of a currently approved collection   No
Regular
Approved without change 08/29/2019
Retrieve Notice of Action (NOA) 06/04/2019
  Inventory as of this Action Requested Previously Approved
08/31/2022 36 Months From Approved 08/31/2019
83 0 67
2,324 0 1,876
0 0 0

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.

PL: Pub.L. 111 - 111 31 Name of Law: Family Smoking Prevention and Tobacco Control Act
  
None

Not associated with rulemaking

  83 FR 46174 09/12/2018
84 FR 25062 05/30/2019
No

1
IC Title Form No. Form Name
Guidance on Meetings with Industry and Investigators on the Research and Development of Tobacco Products

  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 83 67 0 0 16 0
Annual Time Burden (Hours) 2,324 1,876 0 0 448 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
Our estimated burden for the information collection reflects an overall increase of 16 respondents and 448 hours. We attribute this adjustment to an increase in the number of industry meetings as the premarket tobacco product application compliance deadlines will come due in the next 3 years. Additionally, the cost burden has increased by 18,750 due to the burden adjustment and updated wage rates.

$116,000
No
    Yes
    No
No
No
No
Uncollected
Amber Sanford 301 796-8867 [email protected]

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
06/04/2019


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