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OMB Control No:	ICR Reference No: 202511-0910-004
Status: Received in OIRA	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Small Dispensers Assessment Under the Drug Supply Chain Security Act
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 12/03/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	30,873	0
Time Burden (Hours)	7,052	0
Cost Burden (Dollars)	375,956	0

ICR Summary of Burden

	Total Request	Change Due to New Statute
Annual Number of Responses	30,873	30,873
Annual Time Burden (Hours)	7,052	7,052
Annual Cost Burden (Dollars)	375,956	375,956

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: This is a new information collection required by the Drug Supply Chain Security Act.

Annual Cost to Federal Government: $612,720

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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. Yes

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: Anne Taylor 240 402-5683 anne.taylor@fda.hhs.gov