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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

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.

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

Citations for New Statutory Requirements: None

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

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

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

IC Title	Form No.	Form Name
Interviews
Pretest

ICR Summary of Burden

	Total Approved	Previously Approved
Annual Number of Responses	140	140
Annual Time Burden (Hours)	211	211
Annual Cost Burden (Dollars)	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:

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

Agency Contact: Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

View ICR - OIRA Conclusion