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

ICR 201110-0910-002

OMB: 0910-0435

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2012-03-12
Supporting Statement A
2011-09-29
IC Document Collections
IC ID
Document
Title
Status
43602
Modified
190513
Modified
190512
Modified
190511
Modified
190510
Modified
190509
Modified
190508
Modified
190507
Modified
190506
Modified
190505
Modified
190504
Modified
190503
Modified
190502
Modified
190501
Modified
190500
Modified
190499
Modified
190498
Modified
190497
Modified
190496
Modified
190495
Modified
190494
Modified
190493
Modified
190492
Modified
190491
Modified
190490
Modified
190489
Modified
ICR Details
0910-0435 201110-0910-002
Historical Active 200908-0910-005
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 04/09/2012
Retrieve Notice of Action (NOA) 10/05/2011
OMB notes compliance with the prior terms of clearance. At the time of the next submission, FDA is encouraged to provide descriptive titles for the "information collections" listed in the system. It is not appropropriate to use provision numbers to identify an IC. FDA must also properly identify the nature of the information collection: reporting, recordkeeping, or third-party disclosure. Failure to do so will result in improper submission.
  Inventory as of this Action Requested Previously Approved
04/30/2015 36 Months From Approved 04/30/2012
64,805,294 0 64,805,294
2,629,106 0 2,629,106
0 0 0

This collection is intended to achieve the goals and ensure compliance with the regulations implementing the Prescription Drug Marketing Act of 1987 (PDMA) (Pub. L. 100-293).

None
None

Not associated with rulemaking

  76 FR 32362 06/06/2011
76 FR 60501 09/29/2011
Yes

26
IC Title Form No. Form Name
203.11 Applications for reimportation to provide emergency care
203.30(a)(1) and (b) Drug sample requests
203.30(a)(3), (a)(4) and (c) Drug Sample Receipts
203.31(a)(1) and (b) Drug sample requests for samples distributed by means other than mail or a common carrier
203.31(a)(3), (a)(4) and (c) Drug sample receipts for samples distributed by means other than mail or a common carrier
203.37(a) Investigation of falsification of records
203.37(b) Investigation of significant loss or known theft
203.37(c) Notification of conviction of certain offenses involving drug samples
203.37(d) Notification of the individual responsible for RFI
203.39(g) Preparation of reconciliation report for donated samples
203.23(a) and (b) - Recordkeeping; Credit memo for returned drugs
203.23(c) - Recordkeeping; Proper storage, handling, and shipping conditions for returned drugs
203.30(a)(2) and 203.31(a)(2) - Recordkeeping; Verification of Licensing
203.31(d)(1) and (d)(2) - Recordkeeping; Inventory Record and Reconciliation report
203.31(d)(4) - Recordkeeping; Discrepancies and Significant Losses
203.31(e) - Recordkeeping; Lists of manufacturers' and distributors' representatives
203.34 - Recordkeeping; Policies and Procedures for administrative systems
203.37(a) - Recordkeeping;Falsification of Drug Sample records
203.37(b) - Recordkeeping; Report of investigation of significant loss or known theft
203.39(d) - Recordkeeping; Samples destroyed or returned by charitable institutions
203.39(e) - Recordkeeping; Samples donated to charitable institutions
203.39(f) - Recordkeeping; Donation and distribution or other disposition of donated drug samples
203.39(g) - Recordkeeping; Inventor and reconciliation of donations to charitable institutions
203.50(a) - Third Party Disclosure; Drug Origin Statement
203.50(b) - Recordkeeping; Retention of drug origin statement
203.50(d) - Recordkeeping; List of authorized distributors

  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
No
No

$480,000
No
No
No
No
No
Uncollected
Johnny Vilela 301 796-3792 juanmanuel.vilela@fda.hhs.gov

  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.
10/05/2011


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