View Information Collection Request (ICR) Package

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View ICR - OIRA Conclusion

OMB Control No: 0910-0393	ICR Reference No: 202210-0910-010
Status: Historical Active	Previous ICR Reference No: 201908-0910-014
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Prescription Drug Product Labeling; Medication Guide Requirements
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 02/07/2023
	Date Received in OIRA: 10/31/2022
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2026	36 Months From Approved	02/28/2023
Responses	503,758,169	0	507,957,217
Time Burden (Hours)	27,263,874	0	27,491,378
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	503,758,169	507,957,217	-4,199,048
Annual Time Burden (Hours)	27,263,874	27,491,378	-227,504
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: The information collection reflects a downward adjustment in the number of respondents, which we attribute to a decrease in submissions we have received over the past few years. We have also adjusted the number of third-party respondents to reflect the current estimate of pharmacies to 88,000. As noted in Question 8 above, we have removed the burden we attribute to reporting associated with supplements and other changes to approved ANDAs, NDAs, and BLAs (21 CFR 314.70(b)(3)(ii) and 601.12(f)), as this burden is accounted for in other approved collections. Cumulatively these adjustments result in an overall decrease of 4,199,048 responses and 227,504 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? No

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

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