Document ID: FDA-2010-D-0194-0018
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Draft Guidance for Industry and FDA Staff; Total Product Life Cycle, Infusion Pump - Premarket Notification Submissions
Posted Date: 2013-03-18T04:00Z

[Federal Register Volume 78, Number 52 (Monday, March 18, 2013)]
[Notices]
[Pages 16676-16678]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-06128]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Draft Guidance for Industry and FDA Staff; Total 
Product Life Cycle: Infusion Pump--Premarket Notification [510(k)] 
Submissions

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 and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on ``Guidance for Industry and FDA Staff; 
Total Product Life Cycle: Infusion Pump--Premarket Notification 
[510(k)] Submissions.''

DATES: Submit either electronic or written comments on the collection 
of information by May 17, 2013.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
Daniel.Gittleson@fda.hhs.gov.

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.

[[Page 16677]]

``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 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.

Draft Guidance for Industry and FDA Staff; Total Product Life Cycle: 
Infusion Pump--Premarket Notification [510(k)] Submissions--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 March 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 and additional opportunity to comment on this proposed 
information collection activity, prior to the issuance of the final 
guidance document.
    In the March 26, 2010, notice, the 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 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.
    The Agency 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.

    The premarket notification procedures discussed in the draft 
guidance (21 CFR 807, subpart E) have been approved under OMB control 
number 0910-0120. The proposed information collection seeks to add 
clinical or scientific data demonstrating that new or changed infusion 
pumps are as safe and effective as those legally marketed and do not 
raise different questions of safety and effectiveness than predicate 
devices in this generic device type. In this way manufacturers of 
infusion pumps may demonstrate substantial equivalence and receive 
premarket clearance for their devices.
    This draft guidance also refers to previously approved information 
collections found in FDA regulations. The collections of information in 
21 CFR part 803 are approved under OMB control number 0910-0437; the 
collections of information in 21 CFR part 801 are approved under OMB 
control number 0910-0485; the collections of information in 21 CFR part 
812 are approved under OMB control number 0910-0078; the collections of 
information in 21 CFR part 814, subparts B and E are approved

[[Page 16678]]

under OMB control number 0910-0231; the collections of information in 
21 CFR part 820 are approved under OMB control number 0910-0073; the 
collections of information in 21 CFR part 822 are under OMB control 
number 0910-0449; and the collections of information in 21 CFR 56.115 
are approved under OMB control number 0910-0130.

    Dated: March 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-06128 Filed 3-15-13; 8:45 am]
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