Review Transparency & Communication for New Molecular Entity NDAs & Original BLAs in Prescription Drug User Fee Act

ICR 201908-0910-016

OMB: 0910-0746

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2019-08-30
Supplementary Document
2017-10-25
Supplementary Document
2017-10-25
IC Document Collections
IC ID
Document
Title
Status
206912 Unchanged
206911 Unchanged
ICR Details
0910-0746 201908-0910-016
Active 201710-0910-016
HHS/FDA CDER
Review Transparency & Communication for New Molecular Entity NDAs & Original BLAs in Prescription Drug User Fee Act
Extension without change of a currently approved collection   No
Regular
Approved without change 09/30/2019
Retrieve Notice of Action (NOA) 09/03/2019
  Inventory as of this Action Requested Previously Approved
09/30/2022 36 Months From Approved 09/30/2019
140 0 140
211 0 211
0 0 0

This information collection supports Food and Drug Administration (FDA) performance goals and procedures as set forth under the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BsUFA). These goals are the result of agency, industry, and public input, as Congressionally mandated under the applicable statutes and represent the renewed performance goals agreed to by FDA in support of these respective programs.

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

Not associated with rulemaking

  84 FR 8877 03/12/2019
84 FR 42926 08/19/2019
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.
09/03/2019


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