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:
0910-0933
ICR Reference No:
202501-0910-002
Status:
Historical Inactive
Previous ICR Reference No:
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CTP
Title:
Tobacco Product Standard for Nicotine Yield of Cigarettes and Certain Other Combusted Tobacco Products
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:
Comment filed on proposed rule
Conclusion Date:
09/05/2025
Retrieve Notice of Action (NOA)
Date Received in OIRA:
01/16/2025
Terms of Clearance:
In accordance with 5 CFR 1320, the information collection is not approved at this time. Prior to publication of a final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
36 Months From Approved
Responses
0
0
0
Time Burden (Hours)
0
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
The Food and Drug Administration is proposing to establish tobacco product standards, including product standards that include provisions for nicotine yields and for the reduction or elimination of other constituents (including smoke constituents) or harmful components. The proposed rule, if finalized, would set forth the requirements to limit nicotine yield by setting a maximum nicotine content level for finished cigarettes and certain other finished combusted tobacco products not to exceed 0.70 mg of nicotine per gram of total tobacco. The information collection requirements support the need for the FDA to assure that the public health is protected, and tobacco products are in compliance with the requirements of the FD&C Act.
Authorizing Statute(s):
US Code:
21 USC 374
US Code:
21 USC 387f
Name of Law: FFDCA
US Code:
21 USC 387i
Name of Law: FFDCA
US Code:
21 USC 387b-c
Name of Law: FFDCA
US Code:
21 USC 387j
Name of Law: FFDCA
US Code:
21 USC 331
Name of Law: FFDCA
US Code:
21 USC 371
Name of Law: FFDCA
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
0910-AI76
Proposed rulemaking
90 FR 5032
01/16/2025
Federal Register Notices & Comments
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
5
IC Title
Form No.
Form Name
Analytical test method, Sampling plan
Package label requirements (manufacturing code)
Procedures: products and related investigations of; control and disposition for nonconforming tobacco products
Product testing and batch testing
Review and familiarization with the rule - one time burden
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Changing Regulations
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
This is a new information collection.
Annual Cost to Federal Government:
$16,804
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:
Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@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:
01/16/2025
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