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
220689	Additional HPHC reports	New
203556	Annual Roll Your Own Tobacco Product Report - Reporting of Harmful and Potentially Harmful Constituents	Removed
203555	Roll Your Own Tobacco Product Reporting and Testing of Harmful and Potentially Harmful Constituents (in Accordance with Section 904(c)(1) of the FD&C Act)	Modified
203554	Annual Smokeless Product Report - Reporting of Harmful and Potentially Harmful Constituents	Removed
203553	Smokeless Reporting and Testing of Harmful and Potentially Harmful Constituents (in Accordance with Section 904(c)(1) of the FD&C Act)	Modified
203552	Annual Cigarette Report - Reporting of Harmful and Potentially Harmful Constituends	Removed
203551	Cigarette Reporting and Testing of Harmful and Potentially Harmful Constituents (in Accordance with Section 904(c)(1) of the FD&C Act)	Modified

ICR Details

OMB Control No: 0910-0732	ICR Reference No: 201603-0910-003
Status: Historical Active	Previous ICR Reference No: 201510-0910-010
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: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/27/2016
	Date Received in OIRA: 03/21/2016
Terms of Clearance: Approved consistent with the understanding that burden associated with HPHC reporting from manufacturers of newly deemed tobacco products are accounted for in OMB Control No. 0910-0768.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2019	36 Months From Approved	06/30/2016
Responses	281	0	1,896
Time Burden (Hours)	4,447	0	88,434
Cost Burden (Dollars)	0	0	0

---

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.

---

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

---

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

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 70232	11/13/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 12501	03/09/2016
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Cigarette Reporting and Testing of Harmful and Potentially Harmful Constituents (in Accordance with Section 904(c)(1) of the FD&C Act)	a, b, c
Smokeless Reporting and Testing of Harmful and Potentially Harmful Constituents (in Accordance with Section 904(c)(1) of the FD&C Act)	a, b, c
Roll Your Own Tobacco Product Reporting and Testing of Harmful and Potentially Harmful Constituents (in Accordance with Section 904(c)(1) of the FD&C Act)	a, b, c
Annual Cigarette Report - Reporting of Harmful and Potentially Harmful Constituends	b, a, c
Annual Smokeless Product Report - Reporting of Harmful and Potentially Harmful Constituents	a, b, c
Annual Roll Your Own Tobacco Product Report - Reporting of Harmful and Potentially Harmful Constituents	a, b, c
Additional HPHC reports	d, g, f, e, h, i, j

---

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	281	1,896	0	-1,615	0	0
Annual Time Burden (Hours)	4,447	88,434	0	-83,987	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: Miscellaneous Actions

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

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This collection of information is an extension with changes and reflects an adjustment in its inventory since last approved by OMB. FDA estimates there will be a decrease in the burden by 83,987 hours and 1,010 responses (from 88,434 hours and 1,896 responses in the currently approved ICR to 4,447 hours and 886 responses in the proposed ICR).

---

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

---

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: 03/21/2016

---