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
36 Months From Approved
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0
0
0
0
0
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0
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.
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
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.
$0
No
No
No
No
No
Uncollected
Jonnalynn Capezzuto 3018274659
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:
(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;
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.
further amendments ss 4-14-11.doc
Further Amendments to General Regulations of the Food and Drug Administration to Incorporate Tobacco Products