[Federal Register Volume 78, Number 52 (Monday, March 18, 2013)]
[Notices]
[Pages 16676-16678]
From the Federal Register Online via the Government Publishing 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Comment Request; Draft Guidance for Industry and FDA Staff; Total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,
[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.
[[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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