[Federal Register Volume 84, Number 81 (Friday, April 26, 2019)]
[Notices]
[Pages 17837-17838]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08470]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(PRA), Federal Agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on information collection requirements 
relating to shipment of nonsterile devices that are to be sterilized 
elsewhere or are shipped to other establishments for further 
processing, labeling, or repacking.

DATES: Submit either electronic or written comments on the collection 
of information by June 25, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before June 25, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of June 25, 2019. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-N-0375 for ``Agreement for Shipment of Devices for 
Sterilization.'' Received comments, those filed in a timely manner (see 
ADDRESSES), will be placed in the docket and, except for those 
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

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: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an

[[Page 17838]]

existing collection of information, before submitting the collection to 
OMB for approval. To comply with this requirement, FDA is publishing 
notice of the proposed collection of information set forth in this 
document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

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 (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.
    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               .5            1,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                                               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: April 23, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-08470 Filed 4-25-19; 8:45 am]
 BILLING CODE 4164-01-P


