This information
collection request is approved subject to the following: the burden
hours and statement required by 5 CFR 1320.21 will be added in all
appropriate places.
Inventory as of this Action
Requested
Previously Approved
09/30/1991
09/30/1991
08/31/1988
7,347
0
5,000
6,613
0
4,700
0
0
0
MEDICAL EQUIPMENT. MEDICAL SUPPLIES.
SECTION 510 OF THE FD&C ACT REQUIRES MANUFACTURERS AND OTHER
SPECIFIED PROCESSORS OF MEDICAL DEVIC TO PROVIDE A LIST OF ALL
DEVICES MANUFACTURED IN ANY ESTABLISHMENT WHICH THEY OWN OR
OPERATE. SUCH INFORMATION MUST BE PERIODICALLY UPDATED AS SPECIFIED
IN 21 CFR 807.37.
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.