Tobacco Product Standard: NNN Level of Finished Smokeless Tobacco Products

Forms and Documents

Document	Type	Status	Availability
Form FDA 3979 Reporting: Alternative Test Method (FDA 3979) and Waiver from Electronic Submission	Form and Instruction	New	Available
NNN Smokeless product standard ss 1-23-17.docx	Supporting Statement A	Uploaded 2017-01-23	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
225138	Third Party Disclosure: Labeling, labeling changes, stability testing, sampling plans		New
225137	Recordkeeping: Changes, testing, labeling records, notifications, procedures for nonconforming products		New
225135	Reporting: Alternative Test Method (FDA 3979) and Waiver from Electronic Submission	Form and Instruction	New

ICR Details

OMB Control No: 0910-0830	ICR Reference No: 201701-0910-008
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Tobacco Product Standard: NNN Level of Finished Smokeless 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: 05/08/2017
	Date Received in OIRA: 01/25/2017
Terms of Clearance: FDA will consider public comments submitted in relation to the proposed rulemaking affiliated with this information collection request and resubmit the information collection request to OMB at the final rulemaking stage for review and approval.

	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

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Abstract: This ICR proposes to collect information from tobacco manufacturers of finished tobacco products sold in the United States. The proposed rule would establish a product standard to establish a limit of NNN in finished smokeless tobacco products. The rule would establish standard product testing and sampling plans. FDA has created a new form (FDA Form 3979) if a respondent submits an alternative to the standard test method.

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Authorizing Statute(s): PL: Pub.L. 111 - 31 123 Name of Law: Tobacco Control Act
  

Citations for New Statutory Requirements: PL: Pub.L. 111 - 31 123 Name of Law: Tobacco Control Act

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-ZA46	Proposed rulemaking	82 FR 8004	01/23/2017

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Reporting: Alternative Test Method (FDA 3979) and Waiver from Electronic Submission	FDA 3979	Alternative Test Method Notification
Third Party Disclosure: Labeling, labeling changes, stability testing, sampling plans
Recordkeeping: Changes, testing, labeling records, notifications, procedures for nonconforming products

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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.

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Annual Cost to Federal Government: $29,440

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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

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Common Form ICR:  No

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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: 01/25/2017

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