MEDICAL SUPPLIES, MAINTENANCE
STANDARDS, PACKAGE LABELING REQUIREMENT TO ASSURE PROPER SHIPMENT,
SEGREGATION AND STERILIZATION OF NONSTERILE DEVICES, LABELED AS
STERILE, A WRITTEN AGREEMENT IS REQUIRED BETWEEN T RETURN PRODUCT
TO THE MANUFACTURER FOR RELABELING AND DISTRIBUTION. I PROVIDES FDA
A MECHANISM FOR PROTECTING CONSUMERS FROM MISBRANDED
PRODUCT.
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.