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 CDCs 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