Applications for FDA Approval to Market a New Drug

ICR 202003-0910-010

OMB: 0910-0001

Federal Form Document

Forms and Documents
Document
Name
Status
Form
Modified
Form
Modified
Supporting Statement A
2021-02-26
Justification for No Material/Nonsubstantive Change
2021-02-25
IC Document Collections
ICR Details
0910-0001 202003-0910-010
Received in OIRA 202002-0910-006
HHS/FDA CDER
Applications for FDA Approval to Market a New Drug
Revision of a currently approved collection   No
Regular 02/26/2021
  Requested Previously Approved
36 Months From Approved 03/31/2021
145,969 95,327
4,202,464 4,637,036
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.

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

Not associated with rulemaking

  85 FR 73057 11/16/2020
86 FR 9510 02/16/2021
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 145,969 95,327 0 0 50,642 0
Annual Time Burden (Hours) 4,202,464 4,637,036 0 0 -434,572 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The information collection reflects changes and adjustments resulting in an increase in annual responses by 50,642, with a decrease in hours by -434,572.

$146,125,000
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.
02/26/2021


© 2024 OMB.report | Privacy Policy