[Federal Register Volume 79, Number 68 (Wednesday, April 9, 2014)]
[Notices]
[Pages 19616-19617]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-07915]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0194]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Draft Guidance for 
Industry and FDA Staff; Total Product Life Cycle: Infusion Pump--
Premarket Notification Submissions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) 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 May 9, 
2014.

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-NEW and 
the title ``Draft Guidance for Industry and FDA Staff; Total Product 
Life Cycle: Infusion Pump--Premarket Notification [510(k)] 
Submissions.'' Also include the FDA docket number found in brackets in 
the heading of this document.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, [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.

Draft Guidance for Industry and FDA Staff; Total Product Life Cycle: 
Infusion Pump--Premarket Notification [510(k)] Submissions--(OMB 
Control Number 0910-NEW)

    This draft guidance is intended to assist industry in preparing 
premarket notification submissions for infusion pumps and to identify 
device features that manufactures should address throughout the total 
product life cycle. The draft guidance is available at (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm206153.htm).
    In the Federal Register of April 26, 2010 (75 FR 21632), FDA 
published a notice seeking comment on the proposed information 
collection activity. Given the lapse in time since its publication, FDA 
is reissuing this notice, responding to a single comment and providing 
the public an additional opportunity to comment on this proposed 
information collection activity, prior to the issuance of the final 
guidance document.
    In the April 26, 2010, notice, FDA estimated it will receive 31 
infusion pump submissions annually. The Agency reached this estimate by 
averaging the number of premarket notifications for infusion pumps 
submitted to FDA over the past 5 years. The draft guidance identifies 
56 potential hazards FDA recommends addressing if applicable to a 
particular device. Although there may be additional hazards identified 
by a manufacturer, the Agency believes these hazards may offset FDA 
identified hazards not applicable to a particular device. FDA estimates 
it will take infusion pump manufactures approximately 56 hours 
(approximately 1 hour per hazard) to complete the case assurance report 
described in section 6 of the draft guidance. FDA reached this estimate 
based on its expectation of the amount of information that will be 
contained in the report.
    However, based on a single public comment provided to FDA, related 
to the FDA burden estimate, we are

[[Page 19617]]

adjusting the burden associated with this collection. The public 
comment is summarized as follows: ``It will take significantly longer 
than one hour to conduct assurance case reports for each of the 56 
potential hazards identified * * *. For instance, due to the iterative 
nature of the assurance case report process, each of the applicable 
hazards will need to be re-evaluated at multiple stages of the 
development process. In addition, it will be difficult to estimate the 
time required to conduct an assurance case report without specific 
guidance on the assurance case reports.''
    While the commenter believes the reporting burden is greater than 1 
hour, and FDA agrees, it is also important to note that the burden 
associated with this new recommendation to present data is the time and 
effort necessary to comply with submitting a new 510(k) or 510(k) 
supplements for legally marketed infusion pumps for which no assurance 
case exists. The Agency has revised the burden estimate, by averaging 
the number of premarket notifications for infusion pumps submitted to 
FDA over the past 5 years. The draft guidance identifies 56 potential 
hazards FDA recommends addressing if applicable to a particular device. 
Although there may be additional hazards identified by a manufacturer, 
the Agency believes the reporting of these hazards may be offset by FDA 
identified hazards not applicable to a particular device. FDA has 
revised the estimate of time it will take infusion pump manufactures 
from approximately 56 hours to 112 hours (approximately 2 hours per 
hazard) to submit the case assurance report described in section 6 of 
the draft guidance. FDA reached this estimate based on its expectation 
of the amount of information that will be contained in the report and 
the public comment received.
    The respondents to this collection of information are infusion pump 
manufacturers subject to FDA's laws and regulations.
    In the Federal Register of March 18, 2013 (78 FR 16676), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information to which two comments were received.
    One commenter had created their own assurance case and used their 
results to assist in answering the 60-day notice. The commenter 
developed an Infusion Pump Assurance Case (IPAC) report template and 
conducted an informal survey of infusion pump manufacturers asking them 
to estimate the time and resources required to prepare their assurance 
case submissions in man months. Based on company responses, the average 
in man months for development of an assurance case was 12.83 man 
months. The highest response was 36 man months. Even with use of a 
least burdensome template similar to the IPAC, we would anticipate that 
the number of hours to prepare an assurance case submission would be 
significant. The commenter does not provide the methodology used in 
their estimate of man months, including details regarding the number of 
hours in a man month. Therefore, we decline to adjust our burden hour 
estimate at this time.
    Another commenter estimates the time that it takes infusion pump 
manufacturers to complete an assurance case report is approximately 560 
hours for a manufacturer with experience completing assurance case 
reports, which is substantially longer than FDA's estimate of 
approximately 112 hours. Increased knowledge and experience in creating 
assurance case reports has reduced the number of hours required, and 
the commenter estimates that this equates to approximately 10 hours 
needed for each of the 56 hazards identified in the draft guidance, or 
560 hours allotted for an experienced team.
    Though the commenter's assurance case was comprehensive, it 
included activities that should already be conducted under their 
existing design controls (e.g., gathering data from all aspects of 
product development and performing a cross-functional review). These 
activities are already covered under the Quality Systems ICR (OMB 
control number 0910-0073) and, to avoid double-counting the burden, 
should not be counted as burden in this information collection request.
    FDA has been engaged over the past 2 years in the creation of an 
assurance case argument structures for use in the final infusion pump 
guidance and the Association for the Advancement of Medical 
Instrumentation Technical Information Reports. These are certainly 
time-intensive efforts. However, in our own experience, much of the 
effort is focused on correct and complete identification of hazards and 
effective mitigation strategies. Again, these activities, while used to 
support the bulk of the assurance case, are already required and should 
therefore not be counted as burden in this information collection 
request.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
   Guidance Title: Infusion Pumps--Premarket Notification 510(k)        Number of      responses per     Total annual   Average  burden    Total hours
                            Submissions                                respondents       respondent       responses      per  response
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Guidance Section 6--Assurance Case Report..........................              31                1               31              112            3,472
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: April 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07915 Filed 4-8-14; 8:45 am]
BILLING CODE 4160-01-P