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:
202207-0910-001
Status:
Historical Active
Previous ICR Reference No:
201909-0910-010
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 with change
Conclusion Date:
08/31/2022
Retrieve Notice of Action (NOA)
Date Received in OIRA:
07/25/2022
Terms of Clearance:
In the next submission, FDA will provide a summary of the agency's thinking on updates to the existing HPHC template in its electronic submission software, eSubmitter, to allow for more efficient reporting of updates, like product name changes to previously filed HPHC reports.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
08/31/2025
36 Months From Approved
08/31/2022
Responses
424
0
70
Time Burden (Hours)
19,163
0
2,516
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:
87 FR 6869
02/07/2022
30-day Notice:
Federal Register Citation:
Citation Date:
87 FR 41730
07/13/2022
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
3
IC Title
Form No.
Form Name
Cigarette - (904(c)(1) Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms / Testing of HPHC
Form FDA 3787g, Form FDA 3787h, Form FDA 3787a, Form FDA 3787f, Form FDA 3787e, Form FDA 3787d
Roll Your Own Tobacco Product - (904(c)(1) Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms
Form FDA 3787c, Form FDA 3787j
Smokeless - (904(c)(1) Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms
Form FDA 3787b, Form FDA 3787i
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
424
70
0
0
354
0
Annual Time Burden (Hours)
19,163
2,516
0
0
16,647
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:
The total estimated burden for this information collection is expected to be 19,163 hours and 424 annual responses. Our estimated burden for the information collection reflects an overall increase of 354 annual responses and a corresponding increase of 16,647 hours. We attribute this adjustment to updated methodology in which the current estimates are derived from historical statutory tobacco product applications submitted and authorized by FDA in the past 4 years as (1) manufacturers and importers (or their agents) of authorized products are required to submit HPHC reports at least 90 days prior to delivery for introduction into interstate commerce for all new products and (2) initial reporting under section 904(a)(3) of the FD&C Act for statutory products was completed in 2012.
Annual Cost to Federal Government:
$352,515
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
Yes
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
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?
No
Agency Contact:
Amber Sanford 301 796-8867 amber.sanford@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:
07/25/2022
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