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January 2, 2008, FDA announced the availability of a draft guidance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version of the same draft guidance document (73 FR 75438).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