On December 22, 2006, the President signed into law the Dietary Supplement and Nonprescription Drug Consumer Protection Act (DSNDCPA) (Public Law 109-462, 120 Stat. 3469). This law amends the Federal Food, Drug, and Cosmetic Act (the Act) with respect to serious adverse event reporting for dietary supplements and nonprescription drugs marketed without an approved application. The law also amended the Act to add section 403(y) (21 U.S.C. 343(y)), which requires the label of a dietary supplement marketed in the United States to include a domestic address or domestic telephone number through which the product's manufacturer, packer or distributor may receive a report of a serious adverse event associated with the dietary supplement. On January 2, 2008, FDA announced the availability of a draft guidance document entitled "Questions and Answers Regarding the Labeling of Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act" (73 FR 197). On December 11, 2008, FDA announced the availability of a revised version of the same draft guidance document (73 FR 75438). The guidance document contains questions and answers relating to the labeling requirements in section 403(y) of the Act and provides guidance to industry on the following topics: (1) The meaning of "domestic address" for purposes of the labeling requirements of section 403(y) of the Act; (2) FDA's recommendation for the use of an introductory statement before the domestic address or phone number that is required to appear on the product label under section 403(y) of the Act; and (3) FDA's intent regarding enforcing the labeling requirements of section 403(y) of the Act.
This is a new collection. The increase in reporting reflect our estimate of the number of dietary supplements that would need to be re-labeled to include a domestic address or telephone number of a responsible person; this burden is a one time burden.
$0
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.
Supporting Statement DS Labeling 2 11 09 CLEAN.doc
Introductory Statement for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act