Document ID: FDA-2016-N-4620-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; 
Reports of Corrections and Removals
Posted Date: 2017-06-26T04:00Z

[Federal Register Volume 82, Number 121 (Monday, June 26, 2017)]
[Notices]
[Pages 28857-28858]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-13248]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-4620]

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

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 July 
26, 2017.

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: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
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.

Medical Devices; Reports of Corrections and Removals--21 CFR Part 806

OMB Control Number 0910-0359--Extension

    FDA is requesting approval for the collection of information 
regarding reports of corrections and removals required under part 806 
(21 CFR part 806), which implements section 519(g) of the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360i(g)), as amended 
by the Food and Drug Modernization Act of 1997 (FDAMA) (Pub. L. 105-
115). A description of the information collection requirements are 
provided as follows:
    Under Sec.  806.10 (21 CFR 806.10), within 10 working days of 
initiating any action to correct or remove a device to reduce a risk to 
health posed by the device or to remedy a violation of the FD&C Act 
caused by the device that may present a risk to health, device 
manufacturers or importers must submit a written report to FDA of the 
correction or removal.
    Under Sec.  806.20(a), device manufacturers or importers that 
initiate a correction or removal that is not required to be reported to 
FDA must keep a record of the correction or removal.
    The information collected in the reports of corrections and 
removals will be used by FDA to identify marketed devices that have 
serious problems and

[[Page 28858]]

to ensure that defective devices are removed from the market. This will 
assure that FDA has current and complete information regarding these 
corrections and removals to determine whether recall action is 
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.
    Reports of corrections and removals may be submitted to FDA via 
mail or using FDA's Electronic Submission Gateway (ESG). We estimate 
that approximately 99 percent of submitters will use the ESG. Our 
estimate of the reporting and recordkeeping burden is based on Agency 
records and our experience with this program, as well as similar 
programs that utilize FDA's ESG.
    For respondents who submit corrections and removals using 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. We therefore estimate the total operating and 
maintenance costs to be $30,660 annually (1,022 respondents x $30).
    In the Federal Register of March 20, 2017 (82 FR 14367), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                        Number of                        Average
               Activity (21 CFR part)                   Number of     responses per   Total annual     burden per      Total hours   Total operating and
                                                       respondents     respondent       responses       response           \2\        maintenance costs
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Electronic process setup \3\.......................           1,022               1           1,022            3.08           3,148              $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.
\3\ We estimate that approximately 99 percent of respondents will submit corrections and removals using the electronic process. The actual burden hours
  for setup of the electronic process listed in the reporting burden table are divided by 3 to avoid double counting in the Office of Information and
  Regulatory Affairs Consolidated Information System. However, the one-time Average Burden per Response is 9.25 hours, resulting in a total one-time
  burden of 9,454 hours for the setup of the electronic process.

                                                   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.

    Dated: June 20, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-13248 Filed 6-23-17; 8:45 am]
 BILLING CODE 4164-01-P