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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0650
ICR Reference No:
201607-0910-001
Status:
Historical Active
Previous ICR Reference No:
201601-0910-017
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CTP
Title:
Tobacco Product Establishment Registration and Submission of Certain Health Information
Type of Information Collection:
No material or nonsubstantive change to a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
07/12/2016
Retrieve Notice of Action (NOA)
Date Received in OIRA:
07/07/2016
Terms of Clearance:
Previous terms continue: This revision request satisfies the previous terms of clearance by accounting for the increase in burden due to inclusion of additional respondents as a result of the Tobacco Deeming Rule. The data to be collected by CTP in this ICR (OMB Control No. 0910-0650) and Center for Disease Control (OMB Control No.’s: 0920-0210 and 0920-0338) overlap in terms of the similar tobacco product ingredient collections being conducted. However, at this time, the CTP data cannot currently be used by CDC due to both logistical reasons and restrictions on the use of information collected. OMB encourages the agencies to consider future efforts to eliminate duplication and reduce burden on respondents
Inventory as of this Action
Requested
Previously Approved
Expiration Date
06/30/2019
06/30/2019
06/30/2019
Responses
85,494
0
85,694
Time Burden (Hours)
96,063
0
96,507
Cost Burden (Dollars)
44
0
44
Abstract:
The Federal Food, Drug, and Cosmetic Act (FD&C Act), amended by the Tobacco Control Act of 2009, grants FDA the authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors. Section 905 of the FD&C Act requires the annual registration of any establishment in any State engaged in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products. Section 904 of the FD&C Act requires that each tobacco product manufacturer or importer submit a listing of all ingredients and additives that are added by the manufacturer to each tobacco product by brand and by quantity in each brand and sub brand. Section 904 also requires that a tobacco product manufacturer advise the FDA in writing prior to adding any new tobacco additive or increasing in quantity an existing tobacco additive. It also requires that a tobacco product manufacturer advise the FDA in writing prior to eliminating or decreasing an existing additive, or adding or increasing an additive designated by the FDA as not a human or animal carcinogen, or otherwise harmful to health under intended conditions of use.
Authorizing Statute(s):
US Code:
21 USC 905
Name of Law: FFDCA
US Code:
21 USC 904
Name of Law: FFDCA
PL:
Pub.L. 111 - 111 31
Name of Law: Family Smoking Prevention and Tobacco Control Act
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
0910-AG38
Final or interim final rulemaking
81 FR 28973
05/10/2016
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
79 FR 23141
04/25/2014
30-day Notice:
Federal Register Citation:
Citation Date:
81 FR 28973
05/10/2016
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
7
IC Title
Form No.
Form Name
Obtaining a Dun and Bradstreet D-U-N-S Number
Tobacco Product Establishment Initial Registration and Listing and Product Listing
FDA 3741a, FDA 3471
Registration and Listing for Owners and Operators of Domestic Tobacco Product Establishments
,
Registration and Listing for Owners and Operators of Domestic Deemed Tobacco Product Establishments
Tobacco Product Establishment Renewal Registration and Listing
FDA 3471, FDA 3741a
Registration and Listing for Owners and Operators of Domestic Tobacco Product Establishments
,
Registration and Listing for Owners and Operators of Domestic Deemed Tobacco Product Establishments
Tobacco Product Ingredient Listing electronic and paper submission
FDA 3742
Listing of Ingredients in Tobacco Products
Tobacco Product Ingredient Listing electronic and paper submission (vape shops that qualify as manufacturers)
FDA 3742
Listing of Ingredients in Tobacco Products
Tobacco Product Initial Ingredient Listing
FDA 3742
Listing of Ingredients in Tobacco Products
Tobacco Product Renewal Ingredient Listing
FDA 3742
Listing of Ingredients in Tobacco Products
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
85,494
85,694
0
-200
0
0
Annual Time Burden (Hours)
96,063
96,507
0
-444
0
0
Annual Cost Burden (Dollars)
44
44
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:
Yes
Burden Reduction Due to:
Miscellaneous Actions
Short Statement:
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.
Annual Cost to Federal Government:
$928,000
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
Agency Contact:
Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@fda.hhs.gov
Common Form ICR:
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:
(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:
07/07/2016
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