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

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT FINAL 0435 3-3-15.doc Supporting Statement A	2015-03-03

IC Document Collections

IC ID	Document Title	Status
43602	Re-importation	Modified
190513	Authorized Distributors of Record	Modified
190512	Drug Origin Statement	Modified
190511	Drug Origin Statement	Modified
190510	Drug Samples Donated to Charitable Institutions	Modified
190509	Distribution of Donated Drug samples	Modified
190508	Donated Drug Samples	Modified
190507	Destroyed or Returned Drug Samples	Modified
190506	Loss or Theft of Drug Samples	Modified
190505	Falsification of Drug Sample Records	Modified
190504	Administrative Systems	Modified
190503	Representatives Lists	Modified
190502	Investigation of Discrepancies and Losses	Modified
190501	Inventory Record and Reconciliation Report	Modified
190500	Practitioner Verification	Modified
190499	Returned Drugs and Documentation	Modified
190498	Returned Drugs	Modified
190497	Reconciliation Report	Modified
190496	Contact Person	Modified
190495	Convictions	Modified
190494	Loss or Theft of Samples	Modified
190493	Falsification of Records	Modified
190492	Drug Sample Receipts	Modified
190491	Drug Sample Requests	Modified
190490	Drug Sample Receipts	Modified
190489	Drug Sample Requests	Modified

ICR Details

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
	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

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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.

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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:
	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

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Number of Information Collection (IC) in this ICR: 26

IC Title	Form No.	Form Name
Representatives Lists
Administrative Systems
Falsification of Drug Sample Records
Loss or Theft of Drug Samples
Destroyed or Returned Drug Samples
Donated Drug Samples
Distribution of Donated Drug samples
Drug Samples Donated to Charitable Institutions
Drug Origin Statement
Drug Origin Statement
Authorized Distributors of Record
Re-importation
Drug Sample Requests
Drug Sample Receipts
Drug Sample Requests
Drug Sample Receipts
Falsification of Records
Loss or Theft of Samples
Convictions
Contact Person
Reconciliation Report
Returned Drugs
Returned Drugs and Documentation
Investigation of Discrepancies and Losses
Practitioner Verification
Inventory Record and Reconciliation Report

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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: $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

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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: 03/06/2015

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