View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0001
ICR Reference No:
202412-0910-010
Status:
Active
Previous ICR Reference No:
202402-0910-003
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CDER
Title:
Applications for FDA Approval to Market a New Drug
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved with change
Conclusion Date:
07/24/2025
Retrieve Notice of Action (NOA)
Date Received in OIRA:
12/26/2024
Terms of Clearance:
Prior to the next submission, FDA will work to improve the clarity and consistency of the burden estimates while also betterer understand the impact COVID had on the past 3 years of data.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
07/31/2027
36 Months From Approved
08/31/2025
Responses
130,297
0
129,991
Time Burden (Hours)
3,569,300
0
3,560,180
Cost Burden (Dollars)
0
0
0
Abstract:
This information collection supports continued implementation of 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.
Authorizing Statute(s):
US Code:
21 USC 355 et seq.
Name of Law: Federal Food, Drug, and Cosmetic Act; New Drugs
US Code:
21 USC 355-1 and 355-2
Name of Law: CREATES Act
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
0910-AH62
Final or interim final rulemaking
89 FR 105288
12/26/2024
Federal Register Notices & Comments
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
7
IC Title
Form No.
Form Name
(RULE) Other postmarketing reports; submission of each individual consumer affected by a failure in implementation of an ACNU
(RULE) Requirements for failures in implementation of an ACNU
(RULE) Submission of separate application for nonprescription drug product with an ACNU
PART 314: Subparts E through I
FDA 3938
Drug Master File
Subpart B - Applications
FDA 3542a, FDA 3542, FDA 356h, FDA 3331a, FDA 2252, FDA 2253
NDA - Field Alert Report
,
Transmittal of annual drug and biologic report under 314.81
,
TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
,
Application to Market a New Drug, Abbreviated New Drug, or Biologic, for Human Use
,
Patent Information Submitted with an NDA, or Supplement
,
Patent Information Submitted Upon and After Approval of an NDA or Supplement
Subpart C - Abbreviated Applications
Subpart D - FDA Action on Applications
ICR Summary of Burden
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
130,297
129,991
0
0
306
0
Annual Time Burden (Hours)
3,569,300
3,560,180
0
0
9,120
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
Publication of ACNU final rule increases ICR by 9,120 hours and 306 responses annually.
Annual Cost to Federal Government:
$271,665,580
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
No
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
No
Agency Contact:
Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov
Common Form ICR:
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
12/26/2024
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