Applications for FDA Approval to Market a New Drug

ICR 202310-0910-005

OMB: 0910-0001

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Unchanged
Form
Unchanged
Supporting Statement A
2023-10-27
ICR Details
0910-0001 202310-0910-005
Received in OIRA 202209-0910-003
HHS/FDA CDER
Applications for FDA Approval to Market a New Drug
Revision of a currently approved collection   No
Regular 10/27/2023
  Requested Previously Approved
36 Months From Approved 03/31/2024
146,275 145,969
4,211,584 4,202,464
0 0

This information collection supports Food and Drug Administration regulations governing applications for FDA approval to market a new drug. Respondents to the collection are individuals or entities submitting such applications to the agency in accordance with applicable statutory and regulatory provisions, and commitments established with industry in accordance with user fee performance goals.

US Code: 21 USC 355 Name of Law: Federal Food, Drug, and Cosmetic Act; New Drugs
   PL: Pub.L. 115 - 52 Titles I-IX Name of Law: FDA Reauthorization Act of 2017
  
None

0910-AH62 Proposed rulemaking 87 FR 38313 06/28/2022

No

  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 146,275 145,969 0 0 306 0
Annual Time Burden (Hours) 4,211,584 4,202,464 0 0 9,120 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The proposed information collection will expand the scope to provide for new regulatory provisions. Estimated burden from the corresponding information collection will result in an adjustment by 9,120 hours and 306 responses annually.

$146,125,000
No
    No
    No
No
No
No
No
Amber Sanford 301 796-8867 amber.sanford@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.
10/27/2023


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