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