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

ICR 201710-0910-016

OMB: 0910-0746

Federal Form Document

Forms and Documents
Document
Name
Status
Justification for No Material/Nonsubstantive Change
2017-10-25
Supplementary Document
2017-10-25
Supplementary Document
2017-10-25
Supporting Statement A
2016-07-27
IC Document Collections
IC ID
Document
Title
Status
206912 Unchanged
206911 Unchanged
ICR Details
0910-0746 201710-0910-016
Historical Active 201607-0910-013
HHS/FDA CDER
Evaluation of the Program for Enhanced Review Transparency & Communication for New Molecular Entity NDAs & Original BLAs in Prescription Drug User Fee Act
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 11/14/2017
Retrieve Notice of Action (NOA) 10/27/2017
  Inventory as of this Action Requested Previously Approved
09/30/2019 09/30/2019 09/30/2019
140 0 140
211 0 211
0 0 0

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.

Statute at Large: 126 Stat. 993 Name of Statute: null
  
None

Not associated with rulemaking

  80 FR 76699 12/10/2015
81 FR 47398 07/21/2016
No

2
IC Title Form No. Form Name
Pretest
Interviews

  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
No
No

$50,000
No
    No
    No
No
No
No
Uncollected
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
10/27/2017


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