[Federal Register Volume 85, Number 35 (Friday, February 21, 2020)]
[Notices]
[Pages 10168-10169]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03458]
[[Page 10168]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-4620]
Agency Information Collection Activities; Proposed Collection;
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 or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the submission of reports of corrections
and removals that are associated with medical and radiation emitting
products regulated by FDA's Center for Devices and Radiological Health.
DATES: Submit either electronic or written comments on the collection
of information by April 21, 2020.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before April 21, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 21, 2020. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2016-N-4620 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Medical Devices; Reports of
Corrections and Removals.'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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 extension of an existing collection of information,
before submitting the collection to OMB
[[Page 10169]]
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.
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 (FD&C Act) (21 U.S.C. 360i(g)), as amended by
the Food and Drug Administration Modernization Act of 1997 (Pub. L.
105-115). A description of the information collection requirements is
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) (21 CFR 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 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 50 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 $50 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 $25,850 annually (517 respondents x $50).
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 Total hours operating and
Activity (21 CFR part) respondents responses per responses burden per \2\ maintenance
respondent response costs
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Electronic process setup \3\............................ 517 1 517 3.08 \4\ 1,592 $25,850
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 50 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 4,782 hours for the setup of the electronic process.
\4\ Total is rounded to the nearest hour.
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.
New information technology applications have allowed us to more
accurately calculate the number of registrants of medical device
facilities that submit information electronically. We have therefore
revised the number of respondents to the information collection. This
adjustment has resulted in a 1,556-hour decrease of the estimated
burden.
Dated: February 10, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-03458 Filed 2-20-20; 8:45 am]
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