In accordance with 5 CFR 1320, the information collection is approved for three years. During this approval the Center for Tobacco Products must work with CDC over the next year to identify duplication within the tobacco product ingredient collections. As part of this effort, HHS, including CDC and FDA, should determine why this collection of information by the Center for Tobacco Products would not eliminate the need for and the practical utility of CDCÂs annual collection of this information. HHS should also consider whether the authority delegated to CDC for this collection should be delegated to the Center for Tobacco Products.
Inventory as of this Action
Requested
Previously Approved
03/31/2016
36 Months From Approved
1,896
0
0
88,434
0
0
0
0
0
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.
PL:
Pub.L. 111 - 111 31
Name of Law: The Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act)
This is a new collection of information. FDA estimates the one-time reporting burden for this guidance would be 230,652 hours during the first year for section 904(a)(3) reporting plus ongoing annual burden of 11,550 hours for section 904(c)(1) reporting. The burden estimate for this collection of information includes the time it will take to read the guidance document, test the products, and prepare the HPHC report.
To avoid overcounting the one-time reporting burden, FDA has annualized the one-time reporting burden over the 3-year expected OMB period of approval. The annualized one-time burden for collections of information gathered under section 904(a)(3) is 76,884 hours.
The total annual burden for this collection of information is estimated to be 88,434 hours, which is the annualized one-time burden estimate for section 904(a)(3) associated with the submission of an HPHC (76,884 hours) and the annual burden estimate for section 904(c)(1) (11,550 hours). FDA has assumed a respondents will report once for section 904(a)(3) because this guidance is intended to remain in effect while industry is developing laboratory capacity to comply fully with section 904(a)(3) of the FD&C Act. We also assume any new product reporting requirements under section 904(c)(1) will be provided annually to FDA. We also anticipate this guidance will be revised or withdrawn as FDA moves toward full implementation and enforcement of the statutory requirement to report quantities by brand and subbrand of all HPHCs on FDA's established HPHC list.
The Guidance Document is currently being reviewed by HHS, and should be private until is is approved by HHS.
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:
(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;
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.
Annual Roll Your Own Tobacco Product Report - Reporting of Harmful and Potentially Harmful Constituents