View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0732
ICR Reference No:
201208-0910-001
Status:
Historical Active
Previous ICR Reference No:
Agency/Subagency:
HHS/FDA
Agency Tracking No:
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:
New collection (Request for a new OMB Control Number)
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
03/15/2013
Retrieve Notice of Action (NOA)
Date Received in OIRA:
08/01/2012
Terms of Clearance:
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
Expiration Date
03/31/2016
36 Months From Approved
Responses
1,896
0
0
Time Burden (Hours)
88,434
0
0
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:
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
Number of Information Collection (IC) in this ICR:
6
IC Title
Form No.
Form Name
Annual Cigarette Report - Reporting of Harmful and Potentially Harmful Constituends
a, b, c
Annual Roll Your Own Tobacco Product 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
One Time Roll Your Own Tobacco Product Report - Reporting of Harmful and Potential Harmful Constituents
c, a, b
One Time Smokeless 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)
FDAA 3787a, a, b, c
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
0
0
1,896
0
0
Annual Time Burden (Hours)
88,434
0
0
88,434
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:
No
Burden Reduction Due to:
Short Statement:
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.
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
Agency Contact:
Daniel Gitteson 3017965156 daniel.gitteson@fda.hhs.gov
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:
08/01/2012
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