Agreement for Shipments of Devices for Sterilization

ICR 202202-0910-004

OMB: 0910-0131

Federal Form Document

Forms and Documents
Supporting Statement A
IC Document Collections
ICR Details
0910-0131 202202-0910-004
Received in OIRA 201909-0910-009
Agreement for Shipments of Devices for Sterilization
Extension without change of a currently approved collection   No
Regular 08/16/2022
  Requested Previously Approved
36 Months From Approved 09/30/2022
8,175 2,000
36,788 9,000
0 0

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.

Statute at Large: 21 Stat. 351
   Statute at Large: 21 Stat. 352

Not associated with rulemaking

  87 FR 14540 03/15/2022
87 FR 49863 08/12/2022

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

  Total Request Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 8,175 2,000 0 0 6,175 0
Annual Time Burden (Hours) 36,788 9,000 0 0 27,788 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
This information collection has resulted in an increase of 27,778 burden hours and an increase of 6,175 records. We attribute this adjustment to an increase in the number of submissions we received over the last few years.

Amber Sanford 301 796-8867 [email protected]


On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

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