In accordance with 5 CFR 1320, the information collection is approved for 6 months. However, prior to launch of the system, FDA must submit final screenshots of the website where this information will be collected and a completed phone script. FDA may submit these documents as a non-substantive, non-material change to the collection.
Inventory as of this Action
Requested
Previously Approved
03/31/2010
6 Months From Approved
1,700
0
0
283
0
0
0
0
0
On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (FSPTCA) (Public Law 111-31) into law. The FSPTCA amended the Federal Food, Drug, and Cosmetic Act (FFDCA) by adding a new chapter granting FDA important new authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors. As part of our enforcement strategy, FDA is creating a Tobacco Call Center (with a toll-free number) to handle complaint investigations for violations of the cigarette flavor ban. Callers will be able to report violations of the flavor ban and FDA will conduct targeted follow-up investigation of complaints that are received. When callers report a violation, the caller will be asked for certain information: name, caller contact information, purchase date, description of the tobacco product, and address of the retail outlet or Internet address where the violative product was viewed.
FDA is requesting emergency OMB approval of the information collection pertaining to section 907(a)(1)(A) of the FFDCA, as amended by FSPTCA, which provides a general tobacco standard special rule for cigarettes that becomes effective on September 22, 2009.
This is a new collection. On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (FSPTCA) (Public Law 111-31) into law. The FSPTCA amended the Federal Food, Drug, and Cosmetic Act (FFDCA) by adding a new chapter granting FDA important new authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors. The ability to solicit complaint information regarding violations of the cigarette flavor ban is an important component of FDA's enforcement of the FSPTCA.
$32,300
No
No
Uncollected
Uncollected
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.
Form FDA 3734: Reporting violations of section 907(a)(1)(A) of the FFDCA