Please note that
the burden hours are significantly different that the prior
submission because records kept under 21 CFR 203.5 were not
received by the FDA due to a delay to the effective date. FDA will
submit an 83-C to provide a more accurate future estimate once it
begins to receive information under this section.
Inventory as of this Action
Requested
Previously Approved
08/31/2009
36 Months From Approved
08/31/2006
2,702,413
0
102,261,312
2,702,413
0
10,634,432
0
0
0
The regulations that are the subject
of this information collection implement PDMA. PDMA was enacted by
Congress because there were insufficient safeguards in the drug
distribution system to prevent the introduction and retail sale of
substandard, ineffective, or counterfeit drugs, and that a
wholesale drug diversion submarket had developed that prevented
effective control over the true sources of drugs. Congress found,
amont other things, that large amounts of drugs had been reimported
into the U.S. as U.S. goods returned causing a health....
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.
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures