Reporting Harmful and
Potentially Harmful Constituents in Tobacco Products and Tobacco
Smoke Under the Federal Food, Drug, and Cosmetic Act
Extension without change of a currently approved collection
No
Regular
09/30/2025
Requested
Previously Approved
36 Months From Approved
09/30/2025
285
424
12,436
19,163
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)
Form FDA 3787h, Form FDA 3787g, Form FDA 3787a, Form FDA 3787d
, Form FDA 3787f, Form FDA 3787e
Cigarette Filler Form FDA 3787h , Cigarette Smoke- Other
Regimen Form FDA 3787g , Cigarette Report Form FDA 3787a ,
Cigarette Smoke- Intense Regimen Form FDA 3787f ,
Cigarette Smoke- ISO Regimen Form FDA 3787e , Product
Indentification Form FDA 3787d
Smokeless Form FDA 3787i , Smokeless Tobacco Product
Report Form FDA 3787b
Total Request
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
285
424
0
0
-139
0
Annual Time Burden (Hours)
12,436
19,163
0
0
-6,727
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
No
No
The total estimated burden for
this information collection is expected to be 12,436 hours and 285
annual responses. Our estimated burden for the information
collection reflects an overall decrease of 139 annual responses and
a corresponding decrease of 6,757 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 7 years.
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.
Roll Your Own Tobacco Product - (904(c)(1) Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms