
[Federal Register Volume 79, Number 60 (Friday, March 28, 2014)]
[Notices]
[Pages 17549-17551]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-06917]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0723]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Reports of 
Corrections and Removals of Medical Devices and Radiation Emitting 
Products

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 April 
28, 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 oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0359. 
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, PRAStaff@fda.hhs.gov.

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.

Reports of Corrections and Removals of Medical Devices and Radiation 
Emitting Products--(OMB Control Number 0910-0359)--Extension

I. Reports of Corrections and Removals

    Under Sec.  806.10 (21 CFR 806.10), each device manufacturer or 
importer shall submit a written report to FDA of any action initiated 
to correct or remove a device to reduce a risk to health posed by the 
device or to remedy a violation of the Federal Food, Drug, and Cosmetic 
Act caused by the device, which may present a risk to health within 10 
working days of initiating the correction or removal.
    Under Sec.  806.20(a) (21 CFR 806.20(a)), each device manufacturer 
or importer of a device who initiates a correction or removal of a 
device that is not required to be reported to FDA shall keep a record 
of the correction or removal.
    FDA currently accepts by mail reports of corrections and removals 
(806 reports) associated with medical and radiation emitting products 
regulated by the Center for Devices and Radiological Health (CDRH) 
under part 806.
    For general information and assistance with 806 reports, contact 
the CDRH Division of Small Manufacturers, International and Consumer 
Assistance (DSMICA) by telephone: 1-800-638-2041 or 301-796-7100, or by 
email: dsmica@fda.hhs.gov.

II. Proposed Electronic Submission Process

    FDA is now proposing to make available, as a voluntary alternative 
to paper submissions, an electronic process for submitting 806 reports. 
The electronic process is expected to enhance consistency of submission 
data and to speed submission processing. Submission by mail will remain 
available and will be augmented by the new electronic submission 
process.
    Establishing a process for using electronic submissions does 
necessitate some preparation by reporters, which includes obtaining 
both: (1) A WebTrader account and (2) a digital verification 
certificate. Many other FDA applications also utilize WebTrader. If an 
applicant already has an account with the WebTrader Electronic 
Submission Gateway (ESG) and a digital verification certificate 
(certificate must be valid for 1 to 3 years), no additional burden or 
cost will be incurred outside of the time it takes to make the 
submission of corrections and removals. However, for calculating the 
burden for this collection, FDA is assuming that all respondents will 
be establishing a new WebTrader account and purchasing a digital 
verification certificate.
    Establishing a new account for sending electronic submissions may 
take up to 2 weeks. During that time, new reporters are advised to 
submit paper reports to avoid inadvertently missing the 10-day 
timeframes associated with submission of reports under part 806.
    Upon approval of the information collection, a submitter would go 
to http://www.fda.gov/ForIndustry/FDAeSubmitter/default.htm to submit 
an 806 report via the electronic portal. Additional information about 
FDA's ESG is posted online at http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm. You can also email

[[Page 17550]]

questions about the system to FDA's ESG Help Desk: esgreg@gnsi.com.

III. Online Support and Information

    CDRH intends to establish a Web site for online support and 
information about electronic submissions of 806 reports. The Web site 
will provide the following information:
 Introduction
 Tracking information
 Contact information
    [cir] Submitter identification
    [cir] Manufacturer information
    [cir] Recalling firm information
    [cir] Importer information
 Correction and removal report information
    [cir] Event
    [cir] Correction and removal product data
    [cir] Domestic consignee information
    [cir] Foreign consignee information
    [cir] Communication documentation
    [cir] Additional documentation (which allows for attaching 
WordTM, ExcelTM, and PDFTM documents)

    Within the online help provided by FDA, users will find yellow 
light bulb icons. These icons indicate supplemental tips and 
information.
    In the Federal Register of June 28, 2013 (78 FR 38992), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. FDA received two sets of comments, which 
were fundamentally the same. Comments relevant to the information 
request are addressed in this document.
    (Comment 1) The comments state that the proposed collection of 
information and the electronic process of collecting reports of 
corrections and removals do not appear to be necessary for the proper 
performance of FDA's functions. However, they do not provide supporting 
details for this assertion. The comments also state that the proposal 
to allow information to be reported via an electronic process promises 
to deliver efficiency advantages to the Agency. The comments request 
that FDA identify improvements in resources or processing time as a 
result of the electronic collection methods.
    (Response) We believe that the information collection is necessary 
for the proper performance of FDA's functions. The information 
collected in the reports of corrections and removals is used by FDA to 
identify marketed devices that have serious problems and to ensure that 
FDA has current and complete information regarding these corrections 
and removals to help determine whether recall action is appropriate and 
adequate. Failure to collect this information would prevent FDA from 
receiving timely information about devices that may have a serious 
effect on the health of users of the devices.
    While we expect the electronic submission of corrections and 
removals to improve the efficiency with which FDA processes the 
reports, we have not quantified data specific to time savings for FDA 
and we note that such quantification is beyond the scope of the 
information collection request. We believe that submitters will find 
the electronic submission process to be user friendly and that it will 
enhance the consistency of submission data. We estimate that an 
electronic report will take the same amount of time for the submitter 
as a paper report takes. We also note that electronic submission is 
voluntary and a submitter may still send a paper report.
    (Comment 2) The comments state that it is unclear how the collected 
information will be used and made available to the public. They ask 
whether all information that is collected via electronic means will be 
made available to the public and whether there is a process that can be 
used by reporters to identify certain information as confidential. One 
commenter expressed concerns regarding whether information such as 
phone and email conversations, agreements on dispositions, etc., would 
be made available on the public Web site.
    (Response) The addition of the electronic submission process does 
not change how the data will be used or disclosed to the public as 
compared to a paper submission; it simply provides a different means to 
submit the same information collected previously via paper submission. 
The data elements that are displayed publicly can be viewed at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm. Followup 
phone and email conversations, etc., are not part of the electronic 
submission system. Under the Freedom of Information Act (FOIA) (5 
U.S.C. 552), the public has broad access to government documents. 
Reports and other information submitted to FDA under part 806 are 
releasable if they fall within the scope of the Agency's regulation 
concerning ``Public Information'' (21 CFR part 20). However, FOIA 
exempts disclosures of certain government records from mandatory public 
disclosures (5 U.S.C. 552(b)(1)-(b)(9)). One such provision exempts 
from public disclosure ``trade secrets'' and ``confidential commercial 
or financial information'' that is privileged (5 U.S.C. 552(b)(4)).
    (Comment 3) The commenters feel that the burden is underestimated 
because the burden estimate assumes that reporters have compatible 
systems to transfer and upload information and that reporters are 
already familiar with FDA's electronic submission system. The comments 
state that the electronic submission process shifts the data entry 
burden from FDA to the reporter.
    (Response) We disagree. Most firms that report under part 806 have 
already used eSubmitter for other types of submissions, such as 
electronic medical device reporting, eCopy, and ISO submissions, and, 
therefore, would already have compatible systems and would be familiar 
with FDA's ESG.
    The addition of electronic submission does not shift burden from 
FDA to respondents because respondents already enter the data manually 
for submission in paper or email format. An electronic submission 
includes the same data elements, required by part 806, that are 
included in a paper submission.
    (Comment 4) The comments state that the collection does not 
consider the internal systems that a reporter may have to establish to 
meet the electronic reporting requirements (validating computer 
systems, developing new procedures, training staff, etc.). The 
commenters feel that these issues will add an incremental burden for 
users to implement and, possibly, maintain the electronic reporting 
process.
    (Response) Validation testing and basic training on the system are 
included in the estimated hourly burden for set up of the electronic 
process. Reporting does not require additional training or new 
procedures; the system prompts users for the required information. The 
comment does not provide suggestions for specific changes to the 
estimated burden or any data to support an increase of burden hours.
    (Comment 5) The comments express concerns about communication 
between FDA and the reporter regarding electronic submissions of 
corrections and removals. The comments question whether the Agency will 
provide feedback to manufacturers, followup requests, monthly 
reporting, or termination requests in the ``electronic record.'' The 
comments request clarification regarding how electronic submission will 
enhance the consistency of submission data.
    (Response) The electronic submission option does not change how FDA 
will communicate with firms that submit reports of corrections and 
removals. The electronic submission system is only for reports of 
corrections and removals under part 806. It does not include feedback, 
followup, monthly reporting, or terminations requests. The comments 
seem to assume that the ``electronic

[[Page 17551]]

record'' will now be kept by FDA. However, the recordkeeping 
requirements have not changed for firms that submit reports of 
corrections and removals under part 806. The predefined data elements 
of the electronic 806 report will inherently enhance the consistency of 
submission data by ensuring complete reporting, thus minimizing the 
need to solicit missing data.
    (Comment 6) The comments request the release of the data fields and 
proposed online support information for reporters to review and provide 
comments.
    (Response) Screen captures of the data fields are available in the 
public docket (http://www.regulations.gov, in Docket No. FDA-2013-N-
0723). The online support information is available as follows:
     http://www.fda.gov/forindustry/electronicsubmissionsgateway/ for information and support for the ESG, 
including information about setting up a WebTrader account;
     ESGHelpDesk@fda.hhs.gov is the email address for getting 
technical help with submissions;
     http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm193862.htm 
provides tutorials for navigation and use of the eSubmitter 
application; and
     http://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129334.htm provides a list of ORA District and Headquarters Recall 
Coordinators.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                                                                               Total
                                                                    Number of       Number of     Total annual   Average burden   Total    operating and
                     Activity (21 CFR part)                        respondents    responses per     responses     per response    hours     maintenance
                                                                                   respondent                                      \2\         costs
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Electronic process setup (one time)............................           1,022               1           1,022            9.25    9,454         $30,660
Submission of corrections and removals (part 806)..............           1,033               1           1,033              10   10,330  ..............
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\1\ There are no capital costs associated with this collection of information.
\2\ Totals may not sum due to rounding.


                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                                                         Number of                       Average burden
                       Activity (21 CFR part)                           Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
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Records of corrections and removals (part 806).....................              93                1               93               10              930
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA's estimate of the reporting and recordkeeping burden is based 
on our experience with this program and similar programs that utilize 
the ESG. For respondents who use the electronic process, the operating 
and maintenance costs associated with this information collection are 
approximately $30 per year to purchase a digital verification 
certificate (certificate must be valid for 1 to 3 years). This burden 
may be minimized if the respondent has already purchased a verification 
certificate for other electronic submissions to FDA. However, FDA is 
assuming that all respondents who submit corrections and removals using 
the electronic process will be establishing a new WebTrader account and 
purchasing a digital verification certificate.

    Dated: March 24, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-06917 Filed 3-27-14; 8:45 am]
BILLING CODE 4160-01-P


