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 356h Application to Market a New Drug, Abbreviated New Drug, or Biologic, for Human Use	Form	Modified	Available
Form FDA 3542a Patent Information Prior to Approval	Form and Instruction	Modified	Available
Form FDA 3542 Patent Information After Approval	Form and Instruction	Modified	Available
Form FDA 2253 TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE	Form	Modified	Available
Form FDA 2252 Transmittal of annual drug and biologic report under 314.81	Form	Modified	Available
Form FDA 3331a NDA - Field Alert Report	Form and Instruction	Modified	Available
Form FDA 3331a Subpart B - Applications	Form and Instruction	Modified	Repair queued
Form FDA 3938 Drug Master File	Form	Unchanged	Available
Form FDA 3938 PART 314: Subparts E through I	Form	Unchanged	Repair queued
0014 and 0338 PDUFA Forms Change Request Sept 2022.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2022-09-01	Repair queued
0001 NDAs SSA 2021 REV.docx	Supporting Statement A	Uploaded 2021-02-26	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
5662	Subpart B - Applications	Form	Modified	Application to Market a New Drug, Abbreviated New Drug, or Biologic, for Human Use
5662	Subpart B - Applications	Form and Instruction	Modified	Patent Information Prior to Approval
5662	Subpart B - Applications	Form and Instruction	Modified	Patent Information After Approval
5662	Subpart B - Applications	Form	Modified	TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
5662	Subpart B - Applications	Form	Modified	Transmittal of annual drug and biologic report under 314.81
5662	Subpart B - Applications	Form and Instruction	Modified	NDA - Field Alert Report
5662	Subpart B - Applications	Form and Instruction	Modified
5662	Subpart B - Applications	Instruction	Modified
184605	PART 314: Subparts E through I	Form	Unchanged	Drug Master File
184605	PART 314: Subparts E through I	Form	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: 202209-0910-003
Status: Historical Active	Previous ICR Reference No: 202109-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Applications for FDA Approval to Market a New Drug
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/16/2022
Retrieve Notice of Action (NOA)	Date Received in OIRA: 09/07/2022
Terms of Clearance: Previous terms continue: Approved pending any modifications that may result from a final guidance document.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2024	03/31/2024	03/31/2024
Responses	145,969	0	145,969
Time Burden (Hours)	4,202,464	0	4,202,464
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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Authorizing Statute(s): 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
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 73057	11/16/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 9510	02/16/2021
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

table that charts list of burden

IC Title	Form No.	Form Name
PART 314: Subparts E through I	FDA 3938	Drug Master File
Subpart B - Applications	FDA 356h, FDA 3331a, FDA 2252, FDA 2253, FDA 3542, FDA 3542a	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 ,   Patent Information After Approval ,   Patent Information Prior to Approval ,   Application to Market a New Drug, Abbreviated New Drug, or Biologic, for Human Use
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	145,969	145,969	0	0	0	0
Annual Time Burden (Hours)	4,202,464	4,202,464	0	0	0	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:

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Annual Cost to Federal Government: $146,125,000

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: 09/07/2022

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