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OMB Control No: 0910-0131	ICR Reference No: 202502-0910-004
Status: Received in OIRA	Previous ICR Reference No: 202202-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Agreement for Shipments of Devices for Sterilization
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular	Date Submitted to OIRA: 09/25/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	12/31/2025
Responses	8,175	8,175
Time Burden (Hours)	36,788	36,788
Cost Burden (Dollars)	0	0

Abstract: Nonsterile medical devices that are labeled as sterile but are in interstate transit to a facility to be sterilized are normally considered by the Food and Drug Administration (FDA) to be adulterated and misbranded. FDA regulations established a control mechanism by which firms may manufacture and label medical devices as "sterile" at one establishment and ship the devices in interstate commerce for actual sterilization at another establishment, a practice that facilitates the processing of devices and is economically necessary for some firms. Manufacturers and sterilizers may sign an agreement containing instructions for maintaining accountability of the number of units in each shipment, acknowledgment that the devices are nonsterile and are being shipped for further processing, and specifications for the product's sterilization processing. This agreement allows the manufacturer to ship adulterated or misbranded products to be sterilized without initiating regulatory action and provides FDA with a means to protect consumers from use of nonsterile products. The agreement must include: (a) Instructions for maintaining accountability of the number of units in each shipment; (b) acknowledgment that the devices are nonsterile, being shipped for further processing; and (c) specifications for sterilization processing. These agreements must be retained for two years, as FDA may review them up to two years after final shipment or delivery of devices.

Authorizing Statute(s): Statute at Large: 21 Stat. 352
Statute at Large: 21 Stat. 351

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 29022	07/02/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 46227	09/25/2025
Did the Agency receive public comments on this ICR? No

Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Agreement for Shipments of Devices for Sterilization

ICR Summary of Burden

	Total Request	Previously Approved
Annual Number of Responses	8,175	8,175
Annual Time Burden (Hours)	36,788	36,788
Annual Cost Burden (Dollars)	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:

Annual Cost to Federal Government: $34,872

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

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