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: 0910-0340	ICR Reference No: 202212-0910-002
Status: Historical Active	Previous ICR Reference No: 202112-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: General Drug Labeling Provisions and OTC Monograph Drug User Fee Submissions
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: 02/02/2023
	Date Received in OIRA: 12/19/2022
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2026	36 Months From Approved	02/28/2023
Responses	29,118	0	8,760
Time Burden (Hours)	134,124	0	98,495
Cost Burden (Dollars)	0	0	1,950,000

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	29,118	8,760	20,358
Annual Time Burden (Hours)	134,124	98,495	35,629
Annual Cost Burden (Dollars)	0	1,950,000	-1,950,000

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 information collection reflects changes to the organization of IC elements and removal cost data elements that are included 12b of our supporting statement. The summary of burden table now includes burden we attribute to recommendations discussed in agency guidance regarding statutory labeling requirements. We have also adjusted our estimate of the annual number of responses and corresponding hours to reflect and upward fluctuation of annual new drug product labeling. Cumulatively these modifications result in an increase of 20,358 responses and 35,629 hours annually.

Annual Cost to Federal Government: $1,001,407

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? Yes

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

Something went wrong when downloading this file. If you have any questions, please send an email to risc@gsa.gov.