Deeming Tobacco Products To Be Subject to the FD&C Act

Forms and Documents

Document Name	Status
Deeming Final Rule SS Final 5-5-2016.docx Supporting Statement A	2016-05-05

IC Document Collections

IC ID	Document Title	Status
210603	Exemptions From the Required Warning Statement Requirement	Modified
210602	Environmental Assessments Applications for Premarket Review of New Tobacco Products	Removed
210600	Request for meeting with CTP's Office of Science to discuss Investigational Plan	Modified
210599	Obtaining an FDA order authorizing marketing of tobacco product (the application)	Modified
210598	Small Scale Manufacturer Report	Modified
210597	Cigar Warning Plan Manufacturers, Importers and Retailers	Modified
210594	Further Amendments to General Regulations of the FDA to Incorporate Tobacco Products	Removed
210593	Importation of Tobacco Products	Removed
210592	Environmental Assessments Reports Intended to Demonstrate the Substantial Equivalence of a New Tobacco Product	Removed
210591	Reports Intended to Demonstrate the Substantial Equivalence of a New Tobacco Product	Removed
210590	Exemption from SE Report to demonstrate tobacco product modified under section 905(j)(3)	Removed
210589	Preparation of an Environmental Assessment	Removed
210588	Preparation of Additional Information for Tobacco Product Exemption from Substantial Equivalence Request	Removed
210587	Preparation of Tobacco Product Exemption from Substantial Equivalence Request	Removed
210570	Health Document Submission	Removed
210569	Tobacco Product Ingredient Listing	Removed
210568	Obtaining a Dun and Bradstreet D-U-N-S Number	Removed
210567	Tobacco Product Listing	Removed
210566	Tobacco Product Establishment Registration	Removed

ICR Details

OMB Control No: 0910-0768	ICR Reference No: 201602-0910-002
Status: Historical Active	Previous ICR Reference No: 201403-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Deeming Tobacco Products To Be Subject to the FD&C Act
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/04/2016
	Date Received in OIRA: 05/10/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2019	36 Months From Approved
Responses	1,355	0	0
Time Burden (Hours)	1,326,000	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: 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. This final rule also prohibits the sale of "covered tobacco products" to individuals under the age of 18 and requires the display of health warnings on cigarette tobacco, roll-your own tobacco, and covered tobacco product packages and in advertisements. The rule also provides that manufacturers, distributors, importers, and retailers are responsible for ensuring that the covered tobacco products (in addition to cigarettes and smokeless tobacco) they manufacture, label, advertise, package, distribute, import, sell, or otherwise hold for sale comply with all applicable requirements. FDA is taking this action to reduce the death and disease from tobacco products.

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Authorizing Statute(s): PL: Pub.L. 111 - 31 101 Name of Law: The Family Smoking Prevention and Tobacco Control Act
   US Code: 21 USC 301 et seq Name of Law: The Federal Food, Drug, and Cosmetic Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AG38	Final or interim final rulemaking	81 FR 28973	05/10/2016

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 5

IC Title	Form No.	Form Name
Cigar Warning Plan Manufacturers, Importers and Retailers
Environmental Assessments Reports Intended to Demonstrate the Substantial Equivalence of a New Tobacco Product
Obtaining an FDA order authorizing marketing of tobacco product (the application)
Request for meeting with CTP's Office of Science to discuss Investigational Plan
Preparation of Tobacco Product Exemption from Substantial Equivalence Request
Exemptions From the Required Warning Statement Requirement
Tobacco Product Ingredient Listing
Health Document Submission
Tobacco Product Establishment Registration
Tobacco Product Listing
Obtaining a Dun and Bradstreet D-U-N-S Number
Environmental Assessments Applications for Premarket Review of New Tobacco Products
Preparation of Additional Information for Tobacco Product Exemption from Substantial Equivalence Request
Preparation of an Environmental Assessment
Exemption from SE Report to demonstrate tobacco product modified under section 905(j)(3)
Reports Intended to Demonstrate the Substantial Equivalence of a New Tobacco Product
Importation of Tobacco Products
Further Amendments to General Regulations of the FDA to Incorporate Tobacco Products
Small Scale Manufacturer Report

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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	1,355	0	0	1,355	0	0
Annual Time Burden (Hours)	1,326,000	0	0	1,326,000	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new information collection.

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Annual Cost to Federal Government: $6,380,000

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

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Common Form ICR:  No

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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: 05/10/2016

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