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
0014 INDs SSA AUG 2023 to add ICH Guidance REV.docx Supporting Statement A	2023-08-08
83-C for 0014 to add SPAs MARCH 2023.docx Justification for No Material/Nonsubstantive Change	2023-03-13
0014 and 0338 PDUFA Forms Change Request Sept 2022.docx Justification for No Material/Nonsubstantive Change	2022-09-01

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
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	Modified
189331	CDER: 312 Subpart D - Responsibilities of Sponsors and Investigators; including investigator reports and sponsor notifications	Unchanged
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	Unchanged
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: 202308-0910-009
Status: Received in OIRA	Previous ICR Reference No: 202303-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Investigational New Drug Regulations
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 08/09/2023

	Requested	Previously Approved
Expiration Date	36 Months From Approved	03/31/2025
Responses	245,623	236,381
Time Burden (Hours)	32,668,615	32,529,871
Cost Burden (Dollars)	0	0

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Abstract: This information collection supports FDA regulations regarding investigational new drug applications. We are revising the information collection to account for activities associated with recommendations found in the guidance document entitled E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) (March 2018), currently approved in OMB control number 0910-0843. The guidance is intended to facilitate implementation of improved and efficient approaches to clinical trial design, including conduct, oversight, recording, and reporting.

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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: 12

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)

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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	245,623	236,381	0	0	9,242	0
Annual Time Burden (Hours)	32,668,615	32,529,871	0	0	138,744	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: By including burden previously accounted for under control no. 0910-0843, we have adjusted our estimate to include an additional 9,242 responses and 138,744 hours annually. This increase is reflected in the IC element entitled, “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),” accompanied by the subject guidance.

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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: 08/09/2023

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