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

Forms and Documents

Document Name	Status
Deeming NPRM SS-041814.doc Supporting Statement A	2014-04-19

IC Document Collections

IC ID	Document Title	Status
210603	Exemptions From the Required Warning Statement Requirement	New
210602	Environmental Assessments Applications for Premarket Review of New Tobacco Products	New
210600	Request for meeting with CTP's Office of Science to discuss Investigational Plan	New
210599	Obtaining an FDA order authorizing marketing of tobacco product (the application)	New
210598	Establishing that a Tobacco Product was Commercially Marketed in the United States as of February 15, 2007	New
210597	Cigars 2 largest manufacturers Establishing that a Tobacco Product was Commercially Marketed in the United States as of February 15, 2007	New
210594	Further Amendments to General Regulations of the FDA to Incorporate Tobacco Products	New
210593	Importation of Tobacco Products	New
210592	Environmental Assessments Reports Intended to Demonstrate the Substantial Equivalence of a New Tobacco Product	New
210591	Reports Intended to Demonstrate the Substantial Equivalence of a New Tobacco Product	New
210590	Exemption from SE Report to demonstrate tobacco product modified under section 905(j)(3)	New
210589	Preparation of an Environmental Assessment	New
210588	Preparation of Additional Information for Tobacco Product Exemption from Substantial Equivalence Request	New
210587	Preparation of Tobacco Product Exemption from Substantial Equivalence Request	New
210570	Health Document Submission	New
210569	Tobacco Product Ingredient Listing	New
210568	Obtaining a Dun and Bradstreet D-U-N-S Number	New
210567	Tobacco Product Listing	New
210566	Tobacco Product Establishment Registration	New

ICR Details

OMB Control No: 0910-0768	ICR Reference No: 201403-0910-002
Status: Historical Inactive	Previous ICR Reference No:
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: Comment filed on proposed rule	Conclusion Date: 07/08/2014
	Date Received in OIRA: 04/28/2014
Terms of Clearance: OMB files this comment in accordance with 5 CFR 1320.11(c). This OMB action is not an approval to conduct or sponsor an information collection under the Paperwork Reduction Act of 1995. This action has no effect on any current approvals. If OMB has assigned this ICR a new OMB Control Number, the OMB Control Number will not appear in the active inventory. For future submissions of this information collection, reference the OMB Control Number provided. In accordance with 5 CFR 1320, OMB is not approving the collection at this time. Prior to publication of the final rule, the agency should provide a summary of all comments related to the information collection requirements contained in the rule and any changes made in response to these comments.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Food and Drug Administration (FDA) is issuing a proposed 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 proposed rule would extend 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. This proposed rule also would prohibit the sale of tobacco products covered under the rule to individuals under the age of 18 and would require the display of health warnings on tobacco product packages and in advertisements for tobacco products covered under the rule. FDA is taking this action to address the public health concerns associated with the use of tobacco products.

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

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AG38	Proposed rulemaking	79 FR 23141	04/25/2014

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 23141	04/25/2014
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 19

IC Title	Form No.	Form Name
Preparation of Tobacco Product Exemption from Substantial Equivalence Request
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
Cigars 2 largest manufacturers Establishing that a Tobacco Product was Commercially Marketed in the United States as of February 15, 2007
Environmental Assessments Applications for Premarket Review of New Tobacco Products
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 Additional Information for Tobacco Product Exemption from Substantial Equivalence Request
Preparation of an Environmental Assessment
Environmental Assessments Reports Intended to Demonstrate the Substantial Equivalence of a New Tobacco Product
Tobacco Product Establishment Registration
Tobacco Product Listing
Health Document Submission
Exemptions From the Required Warning Statement Requirement
Obtaining a Dun and Bradstreet D-U-N-S Number
Tobacco Product Ingredient Listing
Establishing that a Tobacco Product was Commercially Marketed in the United States as of February 15, 2007

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

Burden Increase Due to: Miscellaneous Actions

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: 04/28/2014

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