View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0131
ICR Reference No:
201908-0910-007
Status:
Historical Active
Previous ICR Reference No:
201608-0910-003
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
OIRA Conclusion Action:
Approved without change
Conclusion Date:
09/16/2019
Retrieve Notice of Action (NOA)
Date Received in OIRA:
08/16/2019
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
09/30/2022
36 Months From Approved
09/30/2019
Responses
2,000
0
1,800
Time Burden (Hours)
9,000
0
8,100
Cost Burden (Dollars)
0
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. 351
Statute at Large:
21 Stat. 352
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:
84 FR 17837
04/26/2019
30-day Notice:
Federal Register Citation:
Citation Date:
84 FR 40420
08/14/2019
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 Approved
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
2,000
1,800
0
0
200
0
Annual Time Burden (Hours)
9,000
8,100
0
0
900
0
Annual Cost Burden (Dollars)
0
0
0
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:
Our estimated burden for the information collection reflects an overall increase of 900 total hours and a corresponding increase of 400 records/disclosures. We attribute this to an increase in the number of agreements that we have seen in inspection data received over the last few years.
Annual Cost to Federal Government:
$8,125
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?
Uncollected
Agency Contact:
Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov
Common Form ICR:
No
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
08/16/2019
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