Evaluation of the Program for Enhanced Review Transparency & Communication for New Molecular Entity NDAs & Original BLAs in Prescription Drug User Fee Act

Forms and Documents

Document Name	Status
0746 Supporting Statement Part A 2016.pdf Supporting Statement A	2016-07-27
PDUFA V PROGRAM EVALUATION PART B of SS FINAL 8-13-13.docx Supporting Statement B	2013-08-13
PDUFA_V_Committment_Letter_1-12-2012.pdf Supplementary Document	2013-05-03
FDA PDUFA V ProgramEvaluation_Post-Action Sponsor Interview_Protocol_4-23-13.docx Supplementary Document	2013-05-03

IC Document Collections

IC ID	Document Title	Status
206912	Interviews Other-Interview Script	Unchanged
206911	Pretest Other-Interview Script	Unchanged

ICR Details

OMB Control No: 0910-0746	ICR Reference No: 201607-0910-013
Status: Historical Active	Previous ICR Reference No: 201305-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Evaluation of the Program for Enhanced Review Transparency & Communication for New Molecular Entity NDAs & Original BLAs in Prescription Drug User Fee Act
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: 09/21/2016
	Date Received in OIRA: 07/28/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2019	36 Months From Approved	09/30/2016
Responses	140	0	140
Time Burden (Hours)	211	0	211
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection involves interviews of pharmaceutical manufacturers who submit new molecular entity (NME) new drug application(NDAs) and original biologics license applications (BLAs) to the Food and Drug Administration (FDA) under the Program for Enhanced Review Transparency and Communication ("the Program") during fiscal years (FYs) 2013-2017. The Program is part of the FDA performance committments under the fifth authorization of the Prescription Drug User Fee Act (PDUFA) that allows FDA to collect user fees for the review of human drug and biologics applications for FYs 2013-2017. The Program is described in detail in Section II.B of the document entitled "PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2013 through 2017" (the "Commitment Letter). This document specifies that the Program must be evaluated in interim and final assessments by an independent contractor and that these assessments must include interviews of sponsors who submit NME NDAs and original BLAs that are reviewed under the Program. The purpose of these interviews is to collect feedback from applicants on the success of the Program in promoting review transparency and communication during the review process.

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Authorizing Statute(s): Statute at Large: 126 Stat. 993 Name of Statute: null
  

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:
	80 FR 76699	12/10/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 47398	07/21/2016
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
Pretest
Interviews

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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	140	140	0	0	0	0
Annual Time Burden (Hours)	211	211	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: $50,000

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: 07/28/2016

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