Information Request Regarding pH of Smokeless Tobacco Products

Forms and Documents

Document Name	Status
0910_New pH_904b_Letter.docx Supplementary Document	2014-10-23
0910_New pH_904b_Supporting Statement.docx Supporting Statement A	2014-10-23

IC Document Collections

IC ID	Document Title	Status
212145	Other Manufacturers who have no documents or do not manufacture Smokeless tobacco products Instruction	New
212144	Additional tobacco product manufacturers & importers with previous FDA submissions Instruction	New
212137	Tobacco Product Manufacturers and Importers with LTDL collections Instruction	New

ICR Details

OMB Control No: 0910-0781	ICR Reference No: 201406-0910-020
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Information Request Regarding pH of 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: Approved without change	Conclusion Date: 01/26/2015
	Date Received in OIRA: 11/10/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2018	36 Months From Approved
Responses	125	0	0
Time Burden (Hours)	1,615	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Food and Drug Administration (FDA), Center for Tobacco Products (CTP), is proposing to collect information from tobacco manufacturers and/or their agents via a letter to become better informed about the impact of the use and public health effects of tobacco products. This proposed ICR will collect information regarding the effects of smokeless tobacco product pH on the public health under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act). The information collected will include information that industry is required to provide under the FD&C Act, as well as voluntary information requests beyond the inquiries described in the FD&C Act. FDA will use the information collected to assess the effects of product pH of smokeless tobacco products on consumers and the public health.

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Authorizing Statute(s): PL: Pub.L. 111 - 31 31 Name of Law: Family Smoking Prevention and Tobacco Control Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 42797	07/23/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 64394	10/29/2014
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Tobacco Product Manufacturers and Importers with LTDL collections
Additional tobacco product manufacturers & importers with previous FDA submissions
Other Manufacturers who have no documents or do not manufacture Smokeless tobacco products

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ICR Summary of Burden

	Total Approved	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	125	0	0	125	0	0
Annual Time Burden (Hours)	1,615	0	0	1,615	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new collection of information.

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Annual Cost to Federal Government: $387,000

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: 11/10/2014

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