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: 0910-0572	ICR Reference No: 202202-0910-001
Status: Active	Previous ICR Reference No: 202112-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Labeling Requirements for Human Prescription Drug and Biological Products
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/15/2022
Retrieve Notice of Action (NOA)	Date Received in OIRA: 02/11/2022
Terms of Clearance: Approved with the understanding that, upon approval of this request, FDA will discontinue the collections of information currently approved under OMB control numbers 0910-0734, 0910-0537 and 0910-0670.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2025	01/31/2025	01/31/2025
Responses	433,323	0	432,929
Time Burden (Hours)	1,913,864	0	1,912,106
Cost Burden (Dollars)	129,150	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	433,323	432,929	394
Annual Time Burden (Hours)	1,913,864	1,912,106	1,758
Annual Cost Burden (Dollars)	129,150	0	129,150

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: For efficiency of agency operations, we are requesting to consolidate the related information collection activity and account for burden we attribute to the recommendations found in the referenced guidance document, as well as burden associated with waiver requests from bar code requirements in 21 CFR part 201. Accordingly, we have adjusted the estimated burden in control number 0910-0572 by 394 responses, 1,758 hours, and $129,150 cost annually to reflect these changes. Upon approval of this request, we intend to discontinue the collections of information currently approved under OMB control numbers 0910-0734, 0910-0537 and 0910-0670.

Annual Cost to Federal Government: $0

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: Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov