Substantial Equivalence Applications for Tobacco Products

Forms and Documents

Document	Type	Status	Availability
Form FDA 3964 Tobacco Amendment and General Correspondence	Form and Instruction	New	Available
Form FDA 3965 Tobacco Substantial Equivalence Report Submission	Form and Instruction	New	Available
0673 Supporting Statement NPRM 2019.docx	Supporting Statement A	Uploaded 2019-04-02	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
225068	Recordkeeping SE Report under 1107.18 and 1107.58		New
225064	Waiver from Electronic submission 1107.62 (b)		New
225063	Tobacco Amendment and General Correspondence	Form and Instruction	New
225062	Tobacco Substantial Equivalence Report Submission	Form and Instruction	New
221154	Product Quantity Change Bundled SE Report	Other-Guidance	Modified
221153	Full SE 905(j)(1)(A)(i) and 910(a) Bundled	Other-Guidance	Modified
215515	Product Quantity Change SE Report	Other-Guidance	Modified
195793	(Full SE) Reports Demonstrating Substantial Equivalence for Tobacco Products (Sections 905(j) and 910(a))	Instruction	Modified

ICR Details

OMB Control No: 0910-0673	ICR Reference No: 201701-0910-004
Status: Historical Inactive	Previous ICR Reference No: 201609-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Substantial Equivalence Applications for Tobacco Products
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule and continue	Conclusion Date: 05/07/2019
	Date Received in OIRA: 04/03/2019
Terms of Clearance: OMB is withholding approval at this time. Prior to publication of the final rule, the agency should provide a summary of any comments related to the information collection and their response, including any changes made to the ICR as a result of comments. In addition, the agency must enter the correct burden estimates.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2019	36 Months From Approved	09/30/2019
Responses	979	0	979
Time Burden (Hours)	171,878	0	171,878
Cost Burden (Dollars)	0	0	0

---

Abstract: The Food and Drug Administration (FDA) is now issuing a proposed rule that would establish requirements for the content and format of reports intended to establish the substantial equivalence of a tobacco product. The reports would be submitted in the form of substantial equivalence applications (SE applications). The proposed rule would establish the information an SE application must include so that FDA may make a substantial equivalence determination. In addition, the proposed rule would establish the general procedures FDA intends to follow when evaluating SE applications, including procedures that would address communications with the applicant and the confidentiality of data in an SE application.

---

Authorizing Statute(s): PL: Pub.L. 111 - 31 905 Name of Law: Federal Food, Drug, and Cosmetic Act
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AG89	Proposed rulemaking	84 FR 12740	04/02/2019

---

Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 8

IC Title	Form No.	Form Name
(Full SE) Reports Demonstrating Substantial Equivalence for Tobacco Products (Sections 905(j) and 910(a))
Full SE 905(j)(1)(A)(i) and 910(a) Bundled
Product Quantity Change Bundled SE Report
Tobacco Amendment and General Correspondence	FDA 3964	Tobacco Amendment and General Correspondence Report
Waiver from Electronic submission 1107.62 (b)
Recordkeeping SE Report under 1107.18 and 1107.58
Tobacco Substantial Equivalence Report Submission	FDA 3965	Tobacco Substantial Evidence Report Submission
Product Quantity Change SE Report

---

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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This is a new proposed rule. FDA estimates that the burden for new requirements will increase by 1,126 hours (413 reporting + 713 recordkeeping). The new estimated total for this collection is 173,004.

---

Annual Cost to Federal Government: $2,320,000

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? Uncollected

---

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: 04/03/2019

---