The 1993 amendments establish an
exemption for small businesses based on the number of employees and
units of products sold. To claim the exemption, the firm must file
a notice of claimed exemption with FDA. The regulations, 21 CFR
part 101.9(j)(18) and 101.36(f), set forth the information required
and procedures for submitting the notice.
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.