Prescription Drug Marketing

Forms and Documents

Document Name	Status
0435 PDMA SSA 2018 Ext.pdf Supporting Statement A	2018-05-24

IC Document Collections

IC ID	Document Title	Status
43602	Prescription Drug Marketing: Reporting (reimportation requests; sample receipts, reconciliation report, etc.)	Modified
190513	Authorized Distributors of Record	Removed
190512	Drug Origin Statement	Removed
190511	Drug Origin Statement	Removed
190510	Drug Samples Donated to Charitable Institutions	Removed
190509	Distribution of Donated Drug samples	Removed
190508	Donated Drug Samples	Removed
190507	Destroyed or Returned Drug Samples	Removed
190506	Loss or Theft of Drug Samples	Removed
190505	Falsification of Drug Sample Records	Removed
190504	Administrative Systems	Removed
190503	Representatives Lists	Removed
190502	Investigation of Discrepancies and Losses	Removed
190501	Inventory Record and Reconciliation Report	Removed
190500	Practitioner Verification	Removed
190499	Returned Drugs and Documentation	Removed
190498	Returned Drugs	Removed
190497	Reconciliation Report	Removed
190496	Contact Person	Removed
190495	Convictions	Removed
190494	Loss or Theft of Samples	Removed
190493	Falsification of Records	Removed
190492	Drug Sample Receipts	Removed
190491	Drug Sample Requests	Removed
190490	Drug Sample Receipts	Removed
190489	Prescription Drug Marketing: Recordkeeping	Modified

ICR Details

OMB Control No: 0910-0435	ICR Reference No: 201804-0910-016
Status: Active	Previous ICR Reference No: 201503-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Prescription Drug Marketing
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: 06/25/2018
	Date Received in OIRA: 05/24/2018
Terms of Clearance: Approved consistent with the understanding that, upon finalization of any agency rulemaking amending 21 CFR Part 203 (see RIN 0910-AH56), FDA will submit a request to revise the information collection accordingly.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2021	36 Months From Approved	06/30/2018
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 information collection supports implementation of the Prescription Drug Marketing Act and FDA regulations. The 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:
	82 FR 58808	12/14/2017
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 24127	05/24/2018
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Inventory Record and Reconciliation Report
Practitioner Verification
Returned Drugs and Documentation
Returned Drugs
Reconciliation Report
Contact Person
Convictions
Loss or Theft of Samples
Falsification of Records
Drug Sample Receipts
Drug Sample Receipts
Drug Samples Donated to Charitable Institutions
Distribution of Donated Drug samples
Donated Drug Samples
Destroyed or Returned Drug Samples
Loss or Theft of Drug Samples
Falsification of Drug Sample Records
Administrative Systems
Representatives Lists
Investigation of Discrepancies and Losses
Drug Sample Requests
Authorized Distributors of Record
Drug Origin Statement
Drug Origin Statement
Prescription Drug Marketing: Reporting (reimportation requests; sample receipts, reconciliation report, etc.)
Prescription Drug Marketing: Recordkeeping

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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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 05/24/2018

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