Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures

ICR 200606-0910-003

OMB: 0910-0435

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0435 200606-0910-003
Historical Active 200305-0910-005
HHS/FDA
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Extension without change of a currently approved collection   No
Regular
Approved without change 08/04/2006
Retrieve Notice of Action (NOA) 06/23/2006
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....

None
None


No

1
IC Title Form No. Form Name
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 2,702,413 102,261,312 0 0 -99,558,899 0
Annual Time Burden (Hours) 2,702,413 10,634,432 0 0 -7,932,019 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  No

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.
06/23/2006


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