Investigational New Drug Regulations

Forms and Documents

Document Name	Status
Form Form FDA 1572 CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers Form	Unchanged
Form FDA 5023 Right to try reporting requirements Form and Instruction	New
0014 83C to add 0893 burden - Right To Try.docx Justification for No Material/Nonsubstantive Change	2025-12-02
0014 INDs SSA AUG 2023 to add ICH Guidance REV.docx Supporting Statement A	2023-08-08

IC Document Collections

IC ID	Document Title	Status
5669	CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers Form	Unchanged
278276	Right to try reporting requirements Form and Instruction	New
215564	CBER: IND Required Recordkeeping	Unchanged
189340	CDER: IND Required Recordkeeping	Unchanged
189332	CDER: 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical studies and issuance of guidance to help comply with regulatory requirements (312.145) Other-Agency Guidance	Unchanged
189331	CDER: 312 Subpart D - Responsibilities of Sponsors and Investigators; including investigator reports and sponsor notifications	Modified
189330	CDER: 312 Subpart C - Administrative Actions; including sponsor requests to FDA	Unchanged
189329	CDER: 312 Subpart B - IND Application; including content and form, safety reports, and annual reports Other-Agency Guidance Document	Unchanged
189328	CDER: 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers	Unchanged
189323	CBER: Part 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical stuides	Unchanged
189320	CBER: Part 312 Subpart D - Responsibilities of Sponsors and Investigators; including investigator reports and sponsor notifications	Modified
189319	CBER: Part 312 Subpart C - Administrative Actions; including sponsor requests to FDA	Unchanged
189313	CBER: Part 312 Subpart B - IND Application; including content and form, safety reports, and annual reports	Unchanged

ICR Details

OMB Control No: 0910-0014	ICR Reference No: 202509-0910-004
Status: Received in OIRA	Previous ICR Reference No: 202403-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Investigational New Drug Regulations
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 12/02/2025

	Requested	Previously Approved
Expiration Date	09/30/2026	09/30/2026
Responses	246,818	246,808
Time Burden (Hours)	32,670,413	32,670,410
Cost Burden (Dollars)	0	0

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Abstract: This information collection supports FDA implementation of regulations regarding investigational new drug applications. Respondents to the information collection are those who undertake clinical investigations of products that are subject to section 505 of the Federal Food, Drug, and Cosmetic Act or to the licensing provisions of the Public Health Service Act (58 Stat. 632, as amended (42 U.S.C. 201 et seq.)). The regulations are intended to ensure adherence to procedures and requirements governing the use of investigational new drugs, including procedures and requirements for the submission to, and review by, the Food and Drug Administration of investigational new drug applications (IND's).

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Authorizing Statute(s): US Code: 21 USC 301 et seq. Name of Law: Federal Food, Drug, and Cosmetic Act
  

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:
	88 FR 21682	04/11/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 53496	08/08/2023
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 13

IC Title	Form No.	Form Name
CBER: IND Required Recordkeeping
CBER: Part 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers	FDA 1571, FDA 1571, Form FDA 1572	Statement of Investigator ,   Investigator e-Form screenshots ,   Investigational New Drug Application
CBER: Part 312 Subpart B - IND Application; including content and form, safety reports, and annual reports
CBER: Part 312 Subpart C - Administrative Actions; including sponsor requests to FDA
CBER: Part 312 Subpart D - Responsibilities of Sponsors and Investigators; including investigator reports and sponsor notifications
CBER: Part 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical stuides
CDER: IND Required Recordkeeping
CDER: 312 Subpart A - General Provisions; including applicability of requirements and requests for waivers
CDER: 312 Subpart B - IND Application; including content and form, safety reports, and annual reports
CDER: 312 Subpart C - Administrative Actions; including sponsor requests to FDA
CDER: 312 Subpart D - Responsibilities of Sponsors and Investigators; including investigator reports and sponsor notifications
CDER: 312 Subpart F - Miscellaneous provisions including import & export requirements and foreign clinical studies and issuance of guidance to help comply with regulatory requirements (312.145)
Right to try reporting requirements	FDA 5023	Right to Try Annual Summary

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ICR Summary of Burden

	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	246,818	246,808	0	10	0	0
Annual Time Burden (Hours)	32,670,413	32,670,410	0	3	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: Increase reflects burden currently approved in control no. 0910-0893.

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Annual Cost to Federal Government: $821,184

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: 12/02/2025

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