Reporting Harmful and
Potentially Harmful Constituents in Tobacco Products and Tobacco
Smoke Under the Federal Food, Drug, and Cosmetic Act
No
material or nonsubstantive change to a currently approved
collection
No
Regular
10/25/2024
Requested
Previously Approved
08/31/2025
08/31/2025
424
424
19,163
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 3787g, Form FDA 3787h, Form FDA 3787a, Form FDA 3787d
, Form FDA 3787f, Form FDA 3787e
Cigarette Smoke- Other Regimen Form FDA 3787g ,
Cigarette Filler Form FDA 3787h , Cigarette Report Form FDA
3787a , Cigarette Smoke- ISO Regimen Form FDA 3787e ,
Product Indentification Form FDA 3787d , Cigarette Smoke-
Intense Regimen Form FDA 3787f
Smokeless Tobacco Product Report Form FDA 3787b ,
Smokeless Form FDA 3787i
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
424
424
0
0
0
0
Annual Time Burden (Hours)
19,163
19,163
0
0
0
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 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.
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