Tobacco Health Document Submission

Forms and Documents

Document Name	Status
Form FDA 3743 Tobacco Health Document Submission (Form FDA 3743) Form and Instruction	Removed
Form 3743 Tobacco Health Document Submission Form and Instruction	Modified
TB Health Doc Submission Guidance.pdf Supplementary Document	2013-08-06
SS TB Health Document Submission 8-26-13.doc Supporting Statement A	2013-08-27

IC Document Collections

IC ID	Document Title	Status
191699	Tobacco Health Document Submission (Form FDA 3743) Form and Instruction	Removed
191698	Tobacco Health Document Submission Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0654	ICR Reference No: 201308-0910-007
Status: Historical Active	Previous ICR Reference No: 201007-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: 20268
Title: Tobacco Health Document Submission
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/13/2013
	Date Received in OIRA: 08/28/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2016	36 Months From Approved	12/31/2013
Responses	8	0	832
Time Burden (Hours)	400	0	8,000
Cost Burden (Dollars)	208	0	828

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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.

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

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:
	78 FR 21379	04/10/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 49527	08/14/2013
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Tobacco Health Document Submission (Form FDA 3743)	FDA 3743	Tobacco Health Document Submission
Tobacco Health Document Submission	3743	Tobacco Health Document Submission

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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	8	832	0	0	-824	0
Annual Time Burden (Hours)	400	8,000	0	0	-7,600	0
Annual Cost Burden (Dollars)	208	828	0	0	-620	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement: FDA expects that this collection of information will experience a burden decrease of 7,600 hours because the number of documents received each year since the original collection period has fallen to less than 5 percent of what was received in the original collection period. FDA expects this is because most documents created within the specified period have already been submitted. Also, the number of respondents who might still have documents to submit has decreased.

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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

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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: 08/28/2013

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