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

Forms and Documents

Document Name	Status
Terms of Clearance and FDA's Response to OMB's Comment - 0910-0435.doc Supplementary Document	2012-03-12
Supporting Statement A (0910-0435) 2011.doc Supporting Statement A	2011-09-29

IC Document Collections

IC ID	Document Title	Status
43602	203.11 Applications for reimportation to provide emergency care	Modified
190513	203.50(d) - Recordkeeping; List of authorized distributors	Modified
190512	203.50(b) - Recordkeeping; Retention of drug origin statement	Modified
190511	203.50(a) - Third Party Disclosure; Drug Origin Statement	Modified
190510	203.39(g) - Recordkeeping; Inventor and reconciliation of donations to charitable institutions	Modified
190509	203.39(f) - Recordkeeping; Donation and distribution or other disposition of donated drug samples	Modified
190508	203.39(e) - Recordkeeping; Samples donated to charitable institutions	Modified
190507	203.39(d) - Recordkeeping; Samples destroyed or returned by charitable institutions	Modified
190506	203.37(b) - Recordkeeping; Report of investigation of significant loss or known theft	Modified
190505	203.37(a) - Recordkeeping;Falsification of Drug Sample records	Modified
190504	203.34 - Recordkeeping; Policies and Procedures for administrative systems	Modified
190503	203.31(e) - Recordkeeping; Lists of manufacturers' and distributors' representatives	Modified
190502	203.31(d)(4) - Recordkeeping; Discrepancies and Significant Losses	Modified
190501	203.31(d)(1) and (d)(2) - Recordkeeping; Inventory Record and Reconciliation report	Modified
190500	203.30(a)(2) and 203.31(a)(2) - Recordkeeping; Verification of Licensing	Modified
190499	203.23(c) - Recordkeeping; Proper storage, handling, and shipping conditions for returned drugs	Modified
190498	203.23(a) and (b) - Recordkeeping; Credit memo for returned drugs	Modified
190497	203.39(g) Preparation of reconciliation report for donated samples	Modified
190496	203.37(d) Notification of the individual responsible for RFI	Modified
190495	203.37(c) Notification of conviction of certain offenses involving drug samples	Modified
190494	203.37(b) Investigation of significant loss or known theft	Modified
190493	203.37(a) Investigation of falsification of records	Modified
190492	203.31(a)(3), (a)(4) and (c) Drug sample receipts for samples distributed by means other than mail or a common carrier	Modified
190491	203.31(a)(1) and (b) Drug sample requests for samples distributed by means other than mail or a common carrier	Modified
190490	203.30(a)(3), (a)(4) and (c) Drug Sample Receipts	Modified
190489	203.30(a)(1) and (b) Drug sample requests	Modified

ICR Details

OMB Control No: 0910-0435	ICR Reference No: 201110-0910-002
Status: Historical Active	Previous ICR Reference No: 200908-0910-005
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: 04/09/2012
	Date Received in OIRA: 10/05/2011
Terms of Clearance: 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
Expiration Date	04/30/2015	36 Months From Approved	04/30/2012
Responses	64,805,294	0	64,805,294
Time Burden (Hours)	2,629,106	0	2,629,106
Cost Burden (Dollars)	0	0	0

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Abstract: 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).

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 32362	06/06/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 60501	09/29/2011
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 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

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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:

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Annual Cost to Federal Government: $480,000

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

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Common Form ICR:  No

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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: 10/05/2011

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