Tobacco Health Document Submission

ICR 201601-0910-020

OMB: 0910-0654

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Supporting Statement A
2016-05-12
Supplementary Document
2013-08-06
IC Document Collections
IC ID
Document
Title
Status
191698 Modified
ICR Details
0910-0654 201601-0910-020
Historical Active 201308-0910-007
HHS/FDA CTP
Tobacco Health Document Submission
Revision of a currently approved collection   No
Regular
Approved without change 06/27/2016
Retrieve Notice of Action (NOA) 05/12/2016
Approved consistent with the understanding that the burden increase associated with this revision request is only for the submission of health documents developed between June 23, 2009 through December 31, 2009 for existing and newly tobacco products. For all tobacco products with health documents developed after December 31, 2009, FDA will first issue an updated guidance describing the submission timelines for such products---and FDA will submit an ICR Revision request to OMB that will account for the subsequent changes in burden.
  Inventory as of this Action Requested Previously Approved
06/30/2019 36 Months From Approved 12/31/2016
32 0 8
1,600 0 400
832 0 208

FDA guidance on this collection requested health documents that were created during the period of June 23, 2009, through December 31, 2009. FDA is in the process of revising the April 2010 guidance but will continue collecting documents created during the period of June 23, 2009 through December 31, 2009, from any manufacturers, importers, or their agents who still have documents to submit. The information collected will inform FDA's development of good manufacturing practices, review standards for new tobacco products, and regulation of modified risk tobacco products, among others. Respondents submit information through a facilitative electronic form or in paper form using Form FDA 3743. In both forms, FDA is requesting the following information: Submitter identification, submitter point of contact, submission format and contents (as applicable), confirmation statement, document categorization (as applicable), document readability and accessibility, and document metadata.

US Code: 21 USC 904(a)(4) Name of Law: FFDCA
  
None

0910-AG38 Final or interim final rulemaking 81 FR 28973 05/10/2016

  79 FR 23141 04/25/2014
81 FR 28973 05/10/2016
Yes

1
IC Title Form No. Form Name
Tobacco Health Document Submission FDA Tobacco Health Document Submission

  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 32 8 0 24 0 0
Annual Time Burden (Hours) 1,600 400 0 1,200 0 0
Annual Cost Burden (Dollars) 832 208 0 624 0 0
Yes
Changing Regulations
No
The Food and Drug Administration (FDA) issued a final rule to deem products meeting the statutory definition of “tobacco product” to be subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FD&C Act provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the Agency by regulation deems to be subject to the law. This final rule extends the Agency’s “tobacco product” authorities to all other categories of products that meet the statutory definition of “tobacco product” in the FD&C Act, except accessories of such newly deemed tobacco products.

$242,000
No
No
No
No
No
Uncollected
Jonna Capezzuto 301 796-3794 [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.
05/12/2016


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