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	Unchanged	Available
Form FDA 3542a Patent Information Prior to Approval	Form and Instruction	Unchanged	Available
Form FDA 3542 Patent Information After Approval	Form and Instruction	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	Repair queued
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
NSURE Proposed Rule Supporting Statement 2022.docx	Supporting Statement A	Uploaded 2023-10-27	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
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 and Instruction	Unchanged	Patent Information Prior to Approval
5662	Subpart B - Applications	Form and Instruction	Unchanged	Patent Information After Approval
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
263041	Requirements for failures in implementation of an ACNU		New
263040	Other postmarketing reports; submission of each individual consumer affected by a failure in implementation of an ACNU		New
263039	Submission of separate application for nonprescription drug product with an ACNU		New
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: 202310-0910-005
Status: Historical Inactive	Previous ICR Reference No: 202209-0910-003
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: Comment filed on proposed rule and continue	Conclusion Date: 11/28/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 10/27/2023
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is not approved at this time. Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments. 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	36 Months From Approved	08/31/2024
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:
0910-AH62	Proposed rulemaking	87 FR 38313	06/28/2022

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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
Other postmarketing reports; submission of each individual consumer affected by a failure in implementation of an ACNU
PART 314: Subparts E through I	FDA 3938	Drug Master File
Requirements for failures in implementation of an ACNU
Submission of separate application for nonprescription drug product with an ACNU
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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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: 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.

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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: 10/27/2023

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