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Burden
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View Information Collection (IC) List
View Supporting Statement and Other Documents
Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0435
ICR Reference No:
200908-0910-005
Status:
Historical Active
Previous ICR Reference No:
200606-0910-003
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Type of Information Collection:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
10/26/2009
Retrieve Notice of Action (NOA)
Date Received in OIRA:
08/31/2009
Terms of Clearance:
Per previous terms of clearance--and given that the burden estimates continue to swing dramatically from submission to submission--approval is granted for 2 years so that the estimates are more frequently updated. Where burden estimates swing dramatically, FDA should attempt to reassess estimates more frequently to ensure that the estimates on record are accurate. To the extent that the swings are actually due to poor estimation, FDA should attempt to improve the way estimates are produced.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
10/31/2011
36 Months From Approved
10/31/2009
Responses
64,805,294
0
2,702,413
Time Burden (Hours)
2,629,106
0
2,702,413
Cost Burden (Dollars)
0
0
0
Abstract:
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....
Authorizing Statute(s):
None
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
74 FR 12365
03/24/2009
30-day Notice:
Federal Register Citation:
Citation Date:
74 FR 36229
07/22/2009
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
26
IC Title
Form No.
Form Name
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
ICR Summary of Burden
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
64,805,294
2,702,413
0
0
62,102,881
0
Annual Time Burden (Hours)
2,629,106
2,702,413
0
0
-73,307
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
Annual Cost to Federal Government:
$435,000
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
Uncollected
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
Uncollected
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Eliazabeth Berbakos 3018271482
Common Form ICR:
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
08/31/2009
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