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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:
201503-0910-001
Status:
Historical Active
Previous ICR Reference No:
201110-0910-002
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CDER
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:
05/18/2015
Retrieve Notice of Action (NOA)
Date Received in OIRA:
03/06/2015
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
05/31/2018
36 Months From Approved
05/31/2015
Responses
64,805,294
0
64,805,294
Time Burden (Hours)
2,629,106
0
2,629,106
Cost Burden (Dollars)
0
0
0
Abstract:
These regulations are intended to protect the public against the threat of subpotent, adulterated, counterfeit, and misbranded drugs posed by the existence of drug diversion schemes and a drug diversion submarket, and the absence of appropriate controls over and creation and maintenance of appropriate records regarding the distribution of prescription drugs.
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:
79 FR 68273
11/14/2014
30-day Notice:
Federal Register Citation:
Citation Date:
80 FR 10697
02/27/2015
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
26
IC Title
Form No.
Form Name
Administrative Systems
Authorized Distributors of Record
Convictions
Destroyed or Returned Drug Samples
Distribution of Donated Drug samples
Drug Origin Statement
Falsification of Drug Sample Records
Inventory Record and Reconciliation Report
Investigation of Discrepancies and Losses
Loss or Theft of Drug Samples
Returned Drugs
Contact Person
Donated Drug Samples
Drug Origin Statement
Drug Sample Receipts
Drug Sample Receipts
Drug Sample Requests
Drug Sample Requests
Drug Samples Donated to Charitable Institutions
Falsification of Records
Loss or Theft of Samples
Practitioner Verification
Re-importation
Reconciliation Report
Representatives Lists
Returned Drugs and Documentation
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
64,805,294
0
0
0
0
Annual Time Burden (Hours)
2,629,106
2,629,106
0
0
0
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:
$825,000
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]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
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:
Ila Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov
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:
03/06/2015
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