Document ID: FDA-2013-N-0723-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Reports of Corrections and Removals of Medical Devices and Radiation Emitting Products
Posted Date: 2013-06-28T04:00Z

[Federal Register Volume 78, Number 125 (Friday, June 28, 2013)]
[Notices]
[Pages 38992-38993]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-15468]

[[Page 38992]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Proposed Collection; 
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 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, 
including each proposed revision of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on an electronic process for 
submitting reports of corrections and removals (806 reports) that are 
associated with medical and radiation emitting products regulated by 
FDA's Center for Devices and Radiological Health (CDRH). The electronic 
process is expected to both enhance consistency of submission data and 
speed submission processing.

DATES: Submit either electronic or written comments on the collection 
of information by August 27, 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: 
    Regarding the collection of information: 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.
    Regarding reports of corrections and removals: Ronny D. Brown, 
Division of Risk Management Operations, Office of Compliance, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2611, 
Silver Spring, MD 20993, 301-796-6163, Ronny.Brown@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. 
``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 revision 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.

Reports of Corrections and Removals--21 CFR Part 806 (OMB Control 
Number 0910-0359)--Revision

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 (the FD&C 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 CDRH under part 806 (21 CFR 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 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 Electronic Submission Gateway is posted at http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm. You can also 
email questions about the system to FDA's Electronic Submissions 
Gateway Help Desk: esgreg@gnsi.com.

[[Page 38993]]

    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 hours     operating &
                 Activity (21 CFR Part)                     respondents    responses per     responses     per response         \2\         maintenance
                                                                            respondent                                                         costs
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Electronic process set-up (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 Electronic Submission Gateway. 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.

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.

    Dated: June 24, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-15468 Filed 6-27-13; 8:45 am]
BILLING CODE 4160-01-P