Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.

View ICR - OIRA Conclusion

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:

	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

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	55	55	0
Annual Time Burden (Hours)	1,435	1,100	335
Annual Cost Burden (Dollars)	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request to include additional collections of information related to the recommendations found in the 2016 revised draft guidance, “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues”.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.

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

Agency Contact: Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@fda.hhs.gov