Tobacco Health Document Submission

Forms and Documents

Document Name	Status
Form FDA Tobacco Health Document Submission Form and Instruction	Modified
0654 SS TB Health Document Submission Deeming Revision Final.docx Supporting Statement A	2016-05-12
TB Health Doc Submission Guidance.pdf Supplementary Document	2013-08-06

IC Document Collections

IC ID	Document Title	Status
191698	Tobacco Health Document Submission Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0654	ICR Reference No: 201601-0910-020
Status: Historical Active	Previous ICR Reference No: 201308-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Tobacco Health Document Submission
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/27/2016
	Date Received in OIRA: 05/12/2016
Terms of Clearance: Approved consistent with the understanding that the burden increase associated with this revision request is only for the submission of health documents developed between June 23, 2009 through December 31, 2009 for existing and newly tobacco products. For all tobacco products with health documents developed after December 31, 2009, FDA will first issue an updated guidance describing the submission timelines for such products---and FDA will submit an ICR Revision request to OMB that will account for the subsequent changes in burden.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2019	36 Months From Approved	12/31/2016
Responses	32	0	8
Time Burden (Hours)	1,600	0	400
Cost Burden (Dollars)	832	0	208

---

Abstract: FDA guidance on this collection requested health documents that were created during the period of June 23, 2009, through December 31, 2009. FDA is in the process of revising the April 2010 guidance but will continue collecting documents created during the period of June 23, 2009 through December 31, 2009, from any manufacturers, importers, or their agents who still have documents to submit. The information collected will inform FDA's development of good manufacturing practices, review standards for new tobacco products, and regulation of modified risk tobacco products, among others. Respondents submit information through a facilitative electronic form or in paper form using Form FDA 3743. In both forms, FDA is requesting the following information: Submitter identification, submitter point of contact, submission format and contents (as applicable), confirmation statement, document categorization (as applicable), document readability and accessibility, and document metadata.

---

Authorizing Statute(s): US Code: 21 USC 904(a)(4) Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AG38	Final or interim final rulemaking	81 FR 28973	05/10/2016

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 23141	04/25/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 28973	05/10/2016
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Tobacco Health Document Submission	FDA	Tobacco Health Document Submission

---

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	32	8	0	24	0	0
Annual Time Burden (Hours)	1,600	400	0	1,200	0	0
Annual Cost Burden (Dollars)	832	208	0	624	0	0

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: The Food and Drug Administration (FDA) issued a final rule to deem products meeting the statutory definition of “tobacco product” to be subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FD&C Act provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the Agency by regulation deems to be subject to the law. This final rule extends the Agency’s “tobacco product” authorities to all other categories of products that meet the statutory definition of “tobacco product” in the FD&C Act, except accessories of such newly deemed tobacco products.

---

Annual Cost to Federal Government: $242,000

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

---

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: 05/12/2016

---