FDA guidance on this collection
requested health documents that were created during the period of
June 23, 2009, through December 31, 2009. FDA is in the process of
revising the April 2010 guidance but will continue collecting
documents created during the period of June 23, 2009 through
December 31, 2009, from any manufacturers, importers, or their
agents who still have documents to submit. The information
collected will inform FDA's development of good manufacturing
practices, review standards for new tobacco products, and
regulation of modified risk tobacco products, among others.
Respondents submit information through a facilitative electronic
form or in paper form using Form FDA 3743. In both forms, FDA is
requesting the following information: Submitter identification,
submitter point of contact, submission format and contents (as
applicable), confirmation statement, document categorization (as
applicable), document readability and accessibility, and document
metadata.
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.