Prior to its
next submission, FDA shall consult with the affected industry to
assess the burden estimates associated with information collection
requirements.
Inventory as of this Action
Requested
Previously Approved
06/30/1994
06/30/1994
05/31/1991
5,300
0
1
3,092
0
1
0
0
0
THE REGULATION SETS FORTH GUIDELINES
FOR STATE LICENSING OF WHOLESALE DRUG DISTRIBUTORS THAT WOULD
PRESCRIBE MINIMUM REQUIREMENTS FOR THE STORAGE AND HANDLING OF
PRESCRIPTION DRUGS AND FOR THE ESTABLISHMENT A MAINTENANCE OF
RECORDS OF DISTRIBUTIONS OF SUCH DRUGS.
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.