Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act

Forms and Documents

Document Name	Status

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Document Title	Status
203556	Annual Roll Your Own Tobacco Product Report - Reporting of Harmful and Potentially Harmful Constituents	Unchanged
203555	One Time Roll Your Own Tobacco Product Report - Reporting of Harmful and Potential Harmful Constituents	Unchanged
203554	Annual Smokeless Product Report - Reporting of Harmful and Potentially Harmful Constituents	Unchanged
203553	One Time Smokeless Report - Reporting of Harmful and Potentially Harmful Constituents	Unchanged
203552	Annual Cigarette Report - Reporting of Harmful and Potentially Harmful Constituends	Unchanged
203551	Reporting of Harmful and Potentially Harmful Constituents (in Accordance with Sections 904(a)(3) and 904(c)(1) of the Federal Food, Drug, and Cosmetic Act)	Unchanged

ICR Details

OMB Control No: 0910-0732	ICR Reference No: 201510-0910-010
Status: Historical Active	Previous ICR Reference No: 201410-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act
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 with change	Conclusion Date: 11/20/2015
	Date Received in OIRA: 10/23/2015
Terms of Clearance: This is a new Terms of Clearance that is included in 0910-0732 due to the prior terms of clearance established under this OMB Control number, but they apply to CTP collection 0910-0650: The data to be collected under FDA’s Center for Tobacco Products (OMB Control No. 0910-0650) overlap with similar tobacco product ingredient collections conducted by the Center for Disease Control (OMB Control No.’s: 0920-0210 and 0920-0338). 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	03/31/2016	03/31/2016	03/31/2016
Responses	1,896	0	1,896
Time Burden (Hours)	88,434	0	88,434
Cost Burden (Dollars)	0	0	0

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Abstract: This collection requires each tobacco product manufacturer or importer, or an agent, to report to FDA "all constituents, including smoke constituents, identified by [FDA] as harmful or potentially harmful to health in each tobacco product, and as applicable in the smoke of each tobacco product." These entities must also provide similar information at least 90 days prior to introducing the product into interstate commerce.

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Authorizing Statute(s): PL: Pub.L. 111 - 111 31 Name of Law: The Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act)
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking
	Other Documents for OIRA Review

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 20030	04/03/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 44636	07/30/2012
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
One Time Roll Your Own Tobacco Product Report - Reporting of Harmful and Potential Harmful Constituents	a, b, c
Annual Roll Your Own Tobacco Product Report - Reporting of Harmful and Potentially Harmful Constituents	a, b, c
Reporting of Harmful and Potentially Harmful Constituents (in Accordance with Sections 904(a)(3) and 904(c)(1) of the Federal Food, Drug, and Cosmetic Act)	b, c, a
Annual Cigarette Report - Reporting of Harmful and Potentially Harmful Constituends	a, b, c
One Time Smokeless Report - Reporting of Harmful and Potentially Harmful Constituents	a, b, c
Annual Smokeless Product Report - Reporting of Harmful and Potentially Harmful Constituents	a, b, c

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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	1,896	1,896	0	0	0	0
Annual Time Burden (Hours)	88,434	88,434	0	0	0	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:

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Annual Cost to Federal Government: $376,000

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: 10/23/2015

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