Applications for FDA Approval to Market a New Drug

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form FDA 3542 Patent Information Submitted Upon and After Approval of an NDA or Supplement	Form	Unchanged	Available
Form FDA 3542a Patent Information Submitted with an NDA, or Supplement	Form	Unchanged	Available
Form FDA 356h Application to Market a New Drug, Abbreviated New Drug, or Biologic, for Human Use	Form	Unchanged	Available
Form FDA 2253 TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE	Form	Unchanged	Available
Form FDA 2252 Transmittal of annual drug and biologic report under 314.81	Form	Unchanged	Available
Form FDA 3331a NDA - Field Alert Report	Form and Instruction	Unchanged	Available
Form FDA 3331a Subpart B - Applications	Form and Instruction	Unchanged	Repair queued
Form FDA 3938 Drug Master File	Form	Unchanged	Available
Form FDA 3938 PART 314: Subparts E through I	Form	Unchanged	Repair queued
0001 NDAs SSA 2025 for RIN AH62 - ACNU.docx	Supporting Statement A	Uploaded 2025-07-24	Repair queued
ACNU FinalRule_SupportingStatement_2024.docx	Supporting Statement A	Uploaded 2024-12-19	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
5662	Subpart B - Applications	Form	Unchanged	Patent Information Submitted Upon and After Approval of an NDA or Supplement
5662	Subpart B - Applications	Form	Unchanged	Patent Information Submitted with an NDA, or Supplement
5662	Subpart B - Applications	Form	Unchanged	Application to Market a New Drug, Abbreviated New Drug, or Biologic, for Human Use
5662	Subpart B - Applications	Form	Unchanged	TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
5662	Subpart B - Applications	Form	Unchanged	Transmittal of annual drug and biologic report under 314.81
5662	Subpart B - Applications	Form and Instruction	Unchanged	NDA - Field Alert Report
5662	Subpart B - Applications	Form and Instruction	Unchanged
5662	Subpart B - Applications	Instruction	Unchanged
273207	(RULE) Other postmarketing reports; submission of each individual consumer affected by a failure in implementation of an ACNU		New
273206	(RULE) Submission of separate application for nonprescription drug product with an ACNU		New
273205	(RULE) Requirements for failures in implementation of an ACNU		New
184605	PART 314: Subparts E through I	Form	Unchanged	Drug Master File
184605	PART 314: Subparts E through I	Form	Unchanged
184605	PART 314: Subparts E through I	Instruction	Unchanged
184601	Subpart D - FDA Action on Applications	Other-Agency Guidance	Unchanged
184600	Subpart C - Abbreviated Applications	Other-Agency Guidance	Unchanged

ICR Details

OMB Control No: 0910-0001	ICR Reference No: 202412-0910-010
Status: Historical 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.

table that charts list comparision

	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

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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.

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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

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AH62	Final or interim final rulemaking	89 FR 105288	12/26/2024

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 7

table that charts list of burden

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 3331a, FDA 2252, FDA 2253, FDA 3542a, FDA 3542, FDA 356h	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

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ICR Summary of Burden

table that charts list 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.

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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

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Common Form ICR:  No

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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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