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

Forms and Documents

Document Name	Status
pra0435 ss 2009 final.doc Supporting Statement A	2009-08-18

IC Document Collections

IC ID	Document Title	Status
43602	Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures	Modified
190513	Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures	New
190512	Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures	New
190511	Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures	New
190510	Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures	New
190509	Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures	New
190508	Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures	New
190507	Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures	New
190506	Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures	New
190505	Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures	New
190504	Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures	New
190503	Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures	New
190502	Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures	New
190501	Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures	New
190500	Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures	New
190499	Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures	New
190498	Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures	New
190497	Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures	New
190496	Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures	New
190495	Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures	New
190494	Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures	New
190493	Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures	New
190492	Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures	New
190491	Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures	New
190490	Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures	New
190489	Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures	New

ICR Details

OMB Control No: 0910-0435	ICR Reference No: 200908-0910-005
Status: Historical Active	Previous ICR Reference No: 200606-0910-003
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: 10/26/2009
	Date Received in OIRA: 08/31/2009
Terms of Clearance: Per previous terms of clearance--and given that the burden estimates continue to swing dramatically from submission to submission--approval is granted for 2 years so that the estimates are more frequently updated. Where burden estimates swing dramatically, FDA should attempt to reassess estimates more frequently to ensure that the estimates on record are accurate. To the extent that the swings are actually due to poor estimation, FDA should attempt to improve the way estimates are produced.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2011	36 Months From Approved	10/31/2009
Responses	64,805,294	0	2,702,413
Time Burden (Hours)	2,629,106	0	2,702,413
Cost Burden (Dollars)	0	0	0

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Abstract: The regulations that are the subject of this information collection implement PDMA. PDMA was enacted by Congress because there were insufficient safeguards in the drug distribution system to prevent the introduction and retail sale of substandard, ineffective, or counterfeit drugs, and that a wholesale drug diversion submarket had developed that prevented effective control over the true sources of drugs. Congress found, amont other things, that large amounts of drugs had been reimported into the U.S. as U.S. goods returned causing a health....

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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:
	74 FR 12365	03/24/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 36229	07/22/2009
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
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures
Prescription Drug Marketing Act of 1987; Policies, Requirements, and Administrative Procedures

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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	2,702,413	0	0	62,102,881	0
Annual Time Burden (Hours)	2,629,106	2,702,413	0	0	-73,307	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: $435,000

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

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: 08/31/2009

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