[Federal Register Volume 81, Number 76 (Wednesday, April 20, 2016)]
[Notices]
[Pages 23309-23311]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09149]


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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) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the 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 20, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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 ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Agreement for Shipment of Devices 
for Sterilization.'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://www.regulations.gov or at the Division of 
Dockets Management 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

[[Page 23310]]

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 http://www.regulations.gov. Submit both copies to the 
Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [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 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 (the 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 in 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) Instructions for maintaining 
accountability of the number of units in each shipment, (2) 
acknowledgment that the devices that are nonsterile are being shipped 
for further processing, and (3) 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
                      Activity/21 CFR section                           Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
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Record retention, Sec.   801.150(a)(2).............................              90               20            1,800              0.5              900
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 23311]]


                                               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, Sec.   801.150(e).............              90               20            1,800                4            7,200
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: April 14, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-09149 Filed 4-19-16; 8:45 am]
 BILLING CODE 4164-01-P