Investigational New Drug Applications: Annual Reporting

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
RIN AI37 IND Applications Annual Reporting DEC 2022 SSA.docx	Supporting Statement A	Uploaded 2023-11-06	Repair queued
Investigational New Drug Application Annual Reporting PRIA.pdf	Supplementary Document	Uploaded 2023-11-06	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
263233	Investigational New Drug Applications: Annual Reporting - BIOLOGICS (CBER)		New
263232	Investigational New Drug Applications: Annual Reporting DRUGS (CDER)		New

ICR Details

OMB Control No: 0910-0924	ICR Reference No: 202311-0910-007
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Investigational New Drug Applications: Annual Reporting
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule	Conclusion Date: 12/08/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 11/07/2023
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.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection supports implementation of FDA rulemaking to revise required elements for annual reporting under 21 CFR 312.33.

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Authorizing Statute(s): US Code: 21 USC 321 et seq. Name of Law: Federal Food Drug & Cosmetic Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AI37	Proposed rulemaking	87 FR 75551	12/09/2022

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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: 2

table that charts list of burden

IC Title	Form No.	Form Name
Investigational New Drug Applications: Annual Reporting - BIOLOGICS (CBER)
Investigational New Drug Applications: Annual Reporting DRUGS (CDER)

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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 rulemaking would add 11,592 responses and 4,595,190 hours annually to FDA’s active information collection inventory.

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Annual Cost to Federal Government: $1,000,000

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.     Yes

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: 11/07/2023

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