Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco Products

Forms and Documents

Document Name	Status
Further Amend Final Rule SS.doc Supporting Statement A	2012-02-02

IC Document Collections

IC ID	Document Title	Status
197386	Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco Products	Modified

ICR Details

OMB Control No: 0910-0690	ICR Reference No: 201202-0910-001
Status: Historical Active	Previous ICR Reference No: 201104-0910-007
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Further Amendments to General Regulations of the Food and Drug Administration to Incorporate 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 with change	Conclusion Date: 03/30/2012
	Date Received in OIRA: 02/03/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2015	36 Months From Approved
Responses	474	0	0
Time Burden (Hours)	10,428	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection is required by the Family Smoking Prevention and Tobacco Control Act. It requires tobacco companies to maintain records records demonstrating their compliance with the requirements in section 801(e)(1) of the FD&C Act. Section 801(e)(1) requires exporters to keep records demonstrating that the exported product: (1) Meets with the foreign purchaser's specifications, (2) does not conflict with the laws of the foreign country, (3) is labeled on the outside of the shipping package that is intended for export, and (4) is not sold or offered for sale in the United States. These criteria also could be met by maintaining other documentation, such as letters from a foreign government Agency or notarized certifications from a responsible company official in the United States stating that the exported product does not conflict with the laws of the foreign country.

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Authorizing Statute(s): PL: Pub.L. 111 - 31 123 Stat. 1776 Name of Law: Federal Food, Drug, and Cosmetic Act
  

Citations for New Statutory Requirements: PL: Pub.L. 111 - 31 123 Name of Law: Federal Food, Drug, and Cosmetic Act, as amended by the Tobacco Control Act

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AG60	Final or interim final rulemaking	77 FR 5171	02/02/2012

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Federal Register Notices & Comments

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
Further Amendments to General Regulations of the Food and Drug Administration to Incorporate 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	474	0	474	0	0	0
Annual Time Burden (Hours)	10,428	0	10,428	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	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: This is a new collection of information. Within this rule, FDA is finalizing several amendments to title 21 of the Code of Federal Regulstions, reflecting the Agency's authority over tobacco products under the Tobacco Control Act. The collection of information associated with this is located in section 1.101(b).

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Annual Cost to Federal Government: $0

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: 02/03/2012

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