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View ICR - OIRA Conclusion

OMB Control No: 0910-0001	ICR Reference No: 202512-0910-013
Status: Active	Previous ICR Reference No: 202507-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Applications for FDA Approval to Market a New Drug
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: 01/14/2026
	Date Received in OIRA: 12/31/2025
Terms of Clearance: Previous Terms of Clearance Continued: Prior to the next submission, FDA will work to improve the clarity and consistency of the burden estimates while also betterer understand the impact COVID had on the past 3 years of data. New Terms of Clearance: Please discontinue OMB control no. 0910-0754

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2027	07/31/2027	07/31/2027
Responses	130,305	0	130,301
Time Burden (Hours)	3,576,450	0	3,576,050
Cost Burden (Dollars)	0	0	0

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	130,305	130,301	4
Annual Time Burden (Hours)	3,576,450	3,576,050	400
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: For efficiency of agency operations, we are requesting to include burden attributable to related activity under 21 CFR 200.5: Mailing of important information about drugs, currently approved under OMB control no. 0910-0754

Annual Cost to Federal Government: $271,665,580

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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