Extension without change of a currently approved collection
No
Regular
04/14/2021
Requested
Previously Approved
36 Months From Approved
04/30/2021
1,277,656
1,523,502
513,528
584,477
0
0
This information collection supports
FDA regulations governing recalls. The information collection
provisions apply to all regulated products (i.e., food, including
animal feed; drugs, including animal drugs; medical devices,
including in vitro diagnostic products; cosmetics; biological
products intended for human use; and tobacco). Respondents to the
collection are those who introduce FDA-regulated products into
interstate commerce or who are otherwise subject to the applicable
regulations.
We have adjusted our estimate
to reflect an overall decrease in the average number of annual
responses by 245,846 and a decrease in the average number of annual
burden hours by 70,949.25 since our last review of the information
collection. The adjustment reflects a decrease in FDA-product
recalls over the most recent calendar years.
$27,313,886
No
No
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.