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

ICR 201212-0910-010

OMB: 0910-0731

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2012-12-03
ICR Details
0910-0731 201212-0910-010
Historical Active
HHS/FDA
GUIDANCE ON MEETINGS WITH INDUSTRY AND INVESTIGATORS ON THE RESEARCH AND DEVELOPMENT OF TOBACCO PRODUCTS
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 02/13/2013
Retrieve Notice of Action (NOA) 12/13/2012
  Inventory as of this Action Requested Previously Approved
02/29/2016 36 Months From Approved
67 0 0
1,876 0 0
0 0 0

The information collection in this guidance is 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) relating to their plans to conduct research to inform the regulation of tobacco products or support the development or marketing of tobacco products. This guidance does not pertain to other types of meetings or meeting requests with CTP staff. The information collected will help FDA better understand issues discussed during these meetings. The Tobacco Control Act (Pub. L. 111-31) offers tobacco product manufacturers several pathways to obtain an order from FDA to authorize the marketing of a tobacco product before it may be introduced or delivered into interstate commerce. To provide assistance with these pathways to market particular products, FDA offers to meet with tobacco product manufacturers, importers, researchers, and investigators (or their representatives) where appropriate. This guidance assists persons wishing to meet with FDA regarding their research to inform the regulation of tobacco products, or to support the development or marketing of tobacco products.

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

Not associated with rulemaking

  77 FR 31368 05/25/2012
77 FR 74194 12/13/2012
Yes

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 67 0 0 67 0 0
Annual Time Burden (Hours) 1,876 0 0 1,876 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new information collection.

$116,000
No
No
No
No
No
Uncollected
Daniel Gitteson 3017965156 daniel.gitteson@fda.hhs.gov

  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.
12/13/2012


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