Required Warnings for Cigarette Packages and Advertisements

Forms and Documents

Document Name	Status
Cigarette Health Plan - Final Guidance - FINAL.docx Supplementary Document	2020-03-17
0877 CHW SS Final Rule.docx Supporting Statement A	2020-03-17

IC Document Collections

IC ID	Document Title	Status
237403	Recordkeeping Burden Other-Proposed Rule FRN	Unchanged
237315	Supplements Other-Proposed Rule FRN	Unchanged
237314	Initial plans Other-Proposed Rule FRN	Unchanged

ICR Details

OMB Control No: 0910-0877	ICR Reference No: 202003-0910-007
Status: Historical Active	Previous ICR Reference No: 201908-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Required Warnings for Cigarette Packages and Advertisements
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: 04/03/2020
	Date Received in OIRA: 03/18/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2023	36 Months From Approved
Responses	178	0	0
Time Burden (Hours)	11,367	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR collects information from manufacturers, distributors, and certain retailers of cigarettes who will be required to submit plans to FDA relating to the random and equal display and distribution of required warning statements on cigarette packaging and quarterly rotation of required warning statements in alternating sequence in cigarette product advertising ("plan" or "plans"). A record of the FDA-approved plan must also be established and maintained.

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Authorizing Statute(s): US Code: 21 USC 387c Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 387i Name of Law: Federal Food, Drug, and Cosmetic Act
   PL: Pub.L. 111 - 31 123 Name of Law: Tobacco Control Act
   US Code: 21 USC 371 Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 374 Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 387e(g) Name of Law: 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-AI39	Final or interim final rulemaking	85 FR 15638	03/18/2020

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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: 3

IC Title	Form No.	Form Name
Recordkeeping Burden
Supplements
Initial plans

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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	178	0	0	0	178	0
Annual Time Burden (Hours)	11,367	0	0	0	11,367	0
Annual Cost Burden (Dollars)	0	0	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: This is a new data collection.

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Annual Cost to Federal Government: $1,740,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 03/18/2020

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