Review Transparency & Communication for New Molecular Entity NDAs & Original BLAs

ICR 202208-0910-017

OMB: 0910-0746

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2022-08-30
IC Document Collections
IC ID
Document
Title
Status
206912 Modified
206911 Modified
ICR Details
0910-0746 202208-0910-017
Received in OIRA 201908-0910-016
HHS/FDA CDER
Review Transparency & Communication for New Molecular Entity NDAs & Original BLAs
Revision of a currently approved collection   No
Regular 08/31/2022
  Requested Previously Approved
36 Months From Approved 09/30/2022
240 140
210 211
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.

US Code: 21 USC 301 Name of Law: Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking

  87 FR 16006 03/21/2022
87 FR 52782 08/29/2022
No

2
IC Title Form No. Form Name
Interviews
Surveys

  Total Request 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 240 140 0 0 100 0
Annual Time Burden (Hours) 210 211 0 0 -1 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
Since last OMB review and approval of the information collection, we have adjusted our burden estimate to include the same number of respondents for surveys and interviews, resulting in 100 additional responses, but one fewer hour, annually.

$245,000
No
    No
    No
No
No
No
No
Domini Bean 301 796-5733 [email protected]

  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.
08/31/2022


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