View Information Collection Request (ICR) Package

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: 0910-0606	ICR Reference No: 202004-0910-003
Status: Historical Active	Previous ICR Reference No: 201703-0910-016
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
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: 05/29/2020
	Date Received in OIRA: 04/27/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2023	36 Months From Approved	05/31/2020
Responses	719,041	0	719,040
Time Burden (Hours)	929,148	0	929,140
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	719,041	719,040	1
Annual Time Burden (Hours)	929,148	929,140	8
Annual Cost Burden (Dollars)	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: We have made no changes to our estimate of the information collection based on our most recent review. However, in consolidating burden from OMB control number 0910-0608, the information collection reflects an increase of 8 hours and one response annually applicable to petitions under 21 CFR 111.75. We have also consolidated previously itemized elements found at Question 12 of this supporting statement into a single, cumulative estimate we attribute to the recordkeeping requirements found in 21 CFR part 111.

Annual Cost to Federal Government: $49,190

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: Domini Bean 301 796-5733 domini.bean@fda.hhs.gov

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