[Federal Register Volume 84, Number 157 (Wednesday, August 14, 2019)]
[Notices]
[Pages 40420-40421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17477]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0375]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Agreement for 
Shipment of Devices for Sterilization

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or we) is announcing 
that a proposed collection of information has been submitted to the 
Office of Management and Budget (OMB) for review and clearance under 
the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
September 13, 2019.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0131. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Agreement for Shipment of Devices for Sterilization--21 CFR 801.150

OMB Control Number 0910-0131--Extension

    Under sections 501(c) and 502(a) of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 351(c) and 352(a)), nonsterile 
devices that are labeled as sterile but are in interstate transit to a 
facility to be sterilized are adulterated and misbranded. FDA 
regulations at Sec.  801.150(e) (21 CFR 801.150(e)) establish 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 sterilization at another establishment, a practice that 
facilitates the processing of devices and is economically necessary for 
some firms.
    Under Sec.  801.150(e)(1), manufacturers and sterilizers may sign 
an agreement containing the following: (1) Contact information of the 
firms involved and the identification of the signature authority of the 
shipper and receiver, (2) instructions for maintaining accountability 
of the number of units in each shipment, (3) acknowledgment that the 
devices that are nonsterile are being shipped for further processing, 
and (4) specifications for sterilization processing. This agreement 
allows the manufacturer to ship misbranded products to be sterilized 
without initiating regulatory action and provides FDA with a means to 
protect consumers from use of nonsterile products. During routine plant 
inspections, FDA normally reviews agreements that must be kept for 2 
years after final shipment or delivery of devices (see Sec.  
801.150(a)(2)).
    The respondents to this collection of information are device 
manufacturers and contract sterilizers. FDA's estimate of the reporting 
burden is based on data obtained from industry over the past several 
years. It is estimated that each of the firms subject to this 
requirement prepares an average of 20 written agreements each year. 
This estimate varies greatly, from 1 to 100, because some firms provide 
sterilization services on a part-time basis for only one customer, 
while others are large facilities with many customers. The average time 
required to prepare each written agreement is estimated to be 4 hours. 
This estimate varies depending on whether the agreement is the initial 
agreement or an annual renewal, on the format each firm elects to use, 
and on the length of time required to reach agreement. The estimate 
applies only to those portions of the written agreement that pertain to 
the requirements imposed by this regulation. The written agreement 
generally also includes contractual agreements that are a usual and 
customary business practice. The recordkeeping requirements of Sec.  
801.150(a)(2) consist of making copies and maintaining the records 
required under the third-party disclosure section of this collection.
    In the Federal Register of April 26, 2019 (84 FR 17837), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. Although one comment was received, it was 
not responsive to the four collection of information topics solicited.
    FDA estimates the burden of this collection of information as 
follows:

                                                   Table 1--Estimated Annual Recordkeeping Burden \1\
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                                                                                         Number of                      Average  burden
                          21 CFR section                                Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
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Record retention, 801.150(a)(2)...................................              100               20            2,000              0.5            1,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 40421]]


                                               Table 2--Estimated Annual Third-Party Disclosure Burden \1\
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                                                                                         Number of
                      Activity/21 CFR section                           Number of     disclosures per    Total annual   Average  burden    Total hours
                                                                       respondents       respondent      disclosures    per  disclosure
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Agreement and labeling requirements, 801.150(e)...................              100               20            2,000                4            8,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    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 increase to an increase in the 
number of agreements that we have seen in inspection data received over 
the last few years.

    Dated: August 7, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-17477 Filed 8-13-19; 8:45 am]
 BILLING CODE 4164-01-P