Information collected by the Food and
Drug Administration will be used to identify and characterize the
human cellular and tissue-based product industry. Identification of
the industry and its participants is an important and necessary
prelude to the creation of a tiered, risk-based system of
regulation for products containing human cells or tissues. The data
base created by registration and listing will be used to
communicate with industry and enable quick, efficient response to
prevent the spread of communicable diseases.
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.