[Federal Register Volume 82, Number 49 (Wednesday, March 15, 2017)]
[Pages 13817-13819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05095]



Food and Drug Administration

[Docket No. FDA-2017-N-0041]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Safety Assurance Case

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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 
(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 the information collection associated with 
safety assurance cases.

DATES: Submit either electronic or written comments on the collection 
of information by May 15, 2017.

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

[[Page 13818]]

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-2017-N-0041 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Safety Assurance Case.'' 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 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 
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.

Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, [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.

Safety Assurance Case--OMB Control Number 0910-0766--Extension

    In January 2011, the Food and Drug Administration (FDA) announced 
its intention to evaluate the use of assurance cases as part of our 
Plan of Action to strengthen the 510(k) program following the 
publication of the draft guidance on infusion pumps (April 26, 2010, 75 
FR 21632). The initial test assurance case focused on infusion pumps 
because the Infusion Pump Improvement Initiative was also exploring the 
use of assurance cases as a means of improving premarket review. The 
infusion pump assurance case beta testing included infusion pump 
devices classified under 21 CFR 880.5725.
    The assurance case consists of a structured argument, supported by 
a body of valid scientific evidence that provides an organized and 
comprehensible case that the infusion pump is comparably safe for its 
intended use within its environment of use. The argument should be 
commensurate with the potential risk posed by the infusion pump, the 
complexity of the infusion pump, and the familiarity with the 
identified risks and mitigation measures.
    Assurance cases are dependent on individual product specifications, 
hazards, design, and documentation. For this reason, assurance cases 
are considered to be device-specific, meaning any newly developed 
device would have its own unique assurance case. If the manufacturer 
submits a 510(k) for modifications to a legally marketed infusion pump 
for which no assurance case exists, FDA recommends that manufacturers 
develop and submit a case for their infusion pump.
    Following the completion of the assurance case beta testing, FDA 
has written an Infusion Pump Total Life Cycle final guidance with 
recommendations for how manufacturers of infusion pumps should submit 
an assurance case with their premarket notification (510(k)) 
submissions. The guidance recommends that an assurance case demonstrate 
mitigation of infusion pump related hazardous situations through 
analysis of operational, environmental, electrical, hardware, software, 
mechanical, biological, chemical, and use hazards, as appropriate.
    FDA is requesting extension of approval for the information 
collection requirements contained within an

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assurance case. The assurance case requires the device sponsor to 
explicitly describe how and why their device meets FDA regulatory 
requirements, as they relate to safety.
    The respondents to this collection of information are infusion pump 
manufacturers subject to FDA's laws and regulations.
    FDA estimates the burden of this collection of information as 

                                                     Table 1--Estimated Annual Reporting Burden \1\
                                                                                         Number of
                              Activity                                  Number of      responses  per    Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
Assurance Case Report..............................................              31                1               31              112            3,472
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA's estimate of 31 respondents is based on the number of 
manufacturers of infusion pumps listed in FDA's Registration and 
Listing database (FURLS). The estimated average burden per response, 
112 hours, is based on FDA's expectation of the amount of information 
that will be contained in the report, on public comment received 
regarding the burden, on consultation with stakeholders/industry, and 
on FDA's experience in the creation of an assurance case argument 
structures for use in the guidance. Our estimate also reflects that 
some information used to support the assurance case, such as activities 
conducted under existing design controls, is already covered in another 
information collection request (OMB control number 0910-0073) and is 
therefore not included in the burden estimate in this information 
collection request. The respondents to this collection of information 
are infusion pump manufacturers.

    Dated: March 9, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05095 Filed 3-14-17; 8:45 am]