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

Forms and Documents

Document Name	Status
further amendments ss 4-14-11.doc Supporting Statement A	2011-04-14

IC Document Collections

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

ICR Details

OMB Control No: 0910-0690	ICR Reference No: 201104-0910-007
Status: Historical Inactive	Previous ICR Reference No:
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: Comment filed on proposed rule	Conclusion Date: 07/24/2011
	Date Received in OIRA: 04/21/2011
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is not approved at this time. Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.

	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: The Tobacco Control Act was enacted on June 22, 2009, amending the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and providing FDA with the authority to regulate tobacco products (Public Law 11-31; 123 Stat. 1776). In enacting the Tobacco Control Act, Congress sought to ensure that FDA had authority to provide effective oversight and to impose appropriate regulatory controls on the tobacco industry. In order to effectuate these purposes, FDA is seeking to amend several provisions of its general regulations to reflect the Agency's new authority and mandate regarding tobacco products to amend certain of its general regulations to include tobacco products, where appropriate, in light of FDA's authority to regulate these products under the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act). With these amendments, tobacco products will be subject to the same general requirements that apply to other FDA-regulated products. FDA proposes to amend title 21 of the Code of Federal Regulations (CFR), reflecting the Agency's authority over tobacco products under the Tobacco Control Act. FDA proposes to add "tobacco products" to the list of products covered by ? 1.21(a) and (c)(1) (21 CFR 1.21(a) and (c)(1)) and ? 1.101(a) and (b) (21 CFR 1.101(a) and (b)). The agency also proposes to revise the definition of "product" in ? 7.3(f) (21 CFR 7.3(f)) to include tobacco products; and revise ? 16.1(b) (21 CFR 16.1(b)) to add provisions from the Tobacco Control Act that allow for hearings.

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Authorizing Statute(s): PL: Pub.L. 111 - 111 31 Name of Law: Family Smoking Prevention & Tobacco Control Act
   US Code: 15 USC 1333 Name of Law: Federal Cigarette Labeling and Advertising Act
   US Code: 15 USC 4402 Name of Law: Comprehensive Smokeless Tobacco Health Education Act of 1986
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AG60	Proposed rulemaking	76 FR 20901	04/14/2011

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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: 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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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 new collection of information was created by the addition of tobacco products to the inventory of FDA-regulated products upon passage of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) in June 2009. The Agency has estimated the number of tobacco product exporters and the respective burden hours associated with the recordkeeping requirements for this information collection by reviewing Agency records, using Agency expert resources, and conferring with another federal Agency who has had experience and information regarding tobacco product exporters. FDA estimates that between 30 and 158 establishments could be involved in the exporting of tobacco products and each establishment may have to maintain records up to 3 times per year, at a total of 22 hours per recordkeeper. The agency estimates, therefore, that 10,428 burden hours (the higher end of the burden hour estimate) will be needed for tobacco product exporters to create and maintain records demonstrating compliance with section 801(e)(1) of the FD&C Act.

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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: 04/21/2011

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