Premarket Notification for a New Dietary Ingredient

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form Form FDA 3880 New Dietary Ingredient Notification (NDIN): Electronic Submission	Form and Instruction	Modified	Available
Form Form FDA 3880 Reporting - Submission of a Premarket Notification for a New Dietary Ingredient	Form and Instruction	Modified	Repair queued
0330 SSA FINAL 1-18-2024.docx	Supporting Statement A	Uploaded 2024-01-18	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
5914	Reporting - Submission of a Premarket Notification for a New Dietary Ingredient	Form and Instruction	Modified	New Dietary Ingredient Notification (NDIN): Electronic Submission
5914	Reporting - Submission of a Premarket Notification for a New Dietary Ingredient	Form and Instruction	Modified
5914	Reporting - Submission of a Premarket Notification for a New Dietary Ingredient	Other-guidance	Modified

ICR Details

OMB Control No: 0910-0330	ICR Reference No: 202401-0910-005
Status: Active	Previous ICR Reference No: 202103-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Premarket Notification for a New Dietary Ingredient
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/21/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 01/18/2024
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2027	36 Months From Approved	05/31/2024
Responses	55	0	55
Time Burden (Hours)	1,435	0	1,100
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection supports the premarket notification requirements for a new dietary ingredient (NDI). Respondents include manufacturers, distributors, packagers, holders, labelers, exporters, and importers of dietary supplements that contain NDIs who must report product information to FDA at least 75 days before an NDI or a dietary supplement that contains an NDI can be introduced or delivered into interstate commerce.

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Authorizing Statute(s): US Code: 21 USC 350b(a) Name of Law: FFDCA
  

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 50876	08/02/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 2957	01/17/2024
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

table that charts list of burden

IC Title	Form No.	Form Name
Reporting - Submission of a Premarket Notification for a New Dietary Ingredient	Form FDA 3880	New Dietary Ingredient Notification (NDIN): Electronic Submission

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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	55	55	0	0	0	0
Annual Time Burden (Hours)	1,435	1,100	0	335	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: We are revising this information collection request to include additional collections of information related to the recommendations found in the 2016 revised draft guidance, “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues”. Thus, this program change has resulted in an increase in burden by 335 hours. The number of respondents has not changed.

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Annual Cost to Federal Government: $2,585,114

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: 01/18/2024

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