This information collection supports
Food and Drug Administration (FDA, the agency, us or we)
regulations found in 21 CFR Part 10, 21 CFR Parts 12 through 16,
and 21 CFR Part 19 (21 CFR §§ 10, 12-16, and 19). These regulations
are established in accordance with the Administrative Procedures
Act and implement administrative practice and procedures to give
instructions to those conducting business with FDA.
The information collection
reflects an overall increase to the collection by 4,526 hours and
869 responses annually resulting from consolidating related
elements.
$305,510
No
Yes
No
No
No
No
No
Domini Bean 301 796-5733
domini.bean@fda.hhs.gov
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.