Tobacco Product Establishment Registration and Submission of Certain Health Information

Forms and Documents

Document Name	Status
Form FDA 3742 Tobacco Product Ingredient Listing electronic and paper submission (vape shops that qualify as manufacturers) Form and Instruction	Unchanged
Form FDA 3742 Tobacco Product Renewal Ingredient Listing Form and Instruction	Modified
Form FDA 3471 Tobacco Product Establishment Renewal Registration and Listing Form and Instruction	Unchanged
Form FDA 3742 Tobacco Product Initial Ingredient Listing Form and Instruction	Modified
Form FDA 3471 Tobacco Product Establishment Initial Registration and Listing and Product Listing Form and Instruction	Unchanged
0910-0650 Change Request memo Dec 16.docx Justification for No Material/Nonsubstantive Change	2016-12-09
0910-0650 Change Request memo 7.7.16.docx Justification for No Material/Nonsubstantive Change	2016-07-07
0910-0650 Deeming Revision supporting statement July 2016 (clean).docx Supporting Statement A	2016-07-07

IC Document Collections

IC ID	Document Title	Status
221396	Tobacco Product Ingredient Listing electronic and paper submission (vape shops that qualify as manufacturers) Form and Instruction	Unchanged
217657	Tobacco Product Ingredient Listing electronic and paper submission Instruction	Modified
217656	Tobacco Product Renewal Ingredient Listing Form and Instruction	Modified
217655	Tobacco Product Establishment Renewal Registration and Listing Form and Instruction	Unchanged
191383	Obtaining a Dun and Bradstreet D-U-N-S Number Instruction	Unchanged
191382	Tobacco Product Initial Ingredient Listing Form and Instruction	Modified
191227	Tobacco Product Establishment Initial Registration and Listing and Product Listing Form and Instruction	Unchanged

ICR Details

OMB Control No: 0910-0650	ICR Reference No: 201612-0910-004
Status: Historical Active	Previous ICR Reference No: 201607-0910-001
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: 12/20/2016
	Date Received in OIRA: 12/14/2016
Terms of Clearance: Previous terms continue: 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	85,494
Time Burden (Hours)	96,063	0	96,063
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
Tobacco Product Ingredient Listing electronic and paper submission (vape shops that qualify as manufacturers)	FDA 3742	Listing of Ingredients in Tobacco Products
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 Initial Ingredient Listing	FDA 3742	Listing of Ingredients in Tobacco Products
Obtaining a Dun and Bradstreet D-U-N-S Number
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 Renewal Ingredient Listing	FDA 3742	Listing of Ingredients in Tobacco Products
Tobacco Product Ingredient Listing electronic and paper submission	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	85,494	0	0	0	0
Annual Time Burden (Hours)	96,063	96,063	0	0	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: No

Burden Reduction Due to:

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

---

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: 12/14/2016

---