Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Reports of Corrections and Removals, 14367-14369 [2017-05415]
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Federal Register / Vol. 82, No. 52 / Monday, March 20, 2017 / Notices
public workshop entitled ‘‘Identification
and Characterization of the Infectious
Disease Risks of Human Cells, Tissues,
and Cellular and Tissue-based
Products.’’ The document was
published with an error in the Web site
address to access the transcript of the
workshop. This document corrects that
error.
FOR FURTHER INFORMATION CONTACT:
Monica Kapoor, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3111C,
Silver Spring, MD 20993,
CBERPublicEvents@fda.hhs.gov; or Staci
Revette, Center for Biologics Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 3109B, Silver
Spring, MD 20993, CBERPublicEvents@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of Thursday, December
29, 2016, in FR Doc. 2016–31628, on
page 96008, the following correction is
made:
On page 96008, in the second column
under the Transcripts caption of section
III, Participating in the Public
Workshop, the third sentence in the
fourth paragraph is corrected to read,
‘‘Please be advised that as soon as a
transcript of the public workshop is
available, it will be accessible at: https://
www.fda.gov/BiologicsBloodVaccines/
NewsEvents/
WorkshopsMeetingsConferences/
ucm525001.htm.’’
Dated: March 14, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–05417 Filed 3–17–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–4620]
Food and Drug Administration,
sradovich on DSK3GMQ082PROD with NOTICES
HHS.
ACTION:
Notice.
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 (the PRA), Federal Agencies are
SUMMARY:
VerDate Sep<11>2014
18:36 Mar 17, 2017
Jkt 241001
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
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Devices;
Reports of Corrections and Removals
AGENCY:
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 May 19, 2017.
ADDRESSES: You may submit comments
as follows:
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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.’’
PO 00000
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14367
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 will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov/ or at the
Division of Dockets Management
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 Division of Dockets
Management. 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
E:\FR\FM\20MRN1.SGM
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14368
Federal Register / Vol. 82, No. 52 / Monday, March 20, 2017 / Notices
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 extension 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,
SUPPLEMENTARY INFORMATION:
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 (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 § 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 which
may present a risk to health, device
manufacturers or importers must submit
a written report to FDA of the correction
or removal.
Under § 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 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 for 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 × $30).
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity (21 CFR part)
Electronic process setup 3 .......................
Submission of corrections and removals
(part 806) ..............................................
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours 2
1,022
1
1,022
3.08
3,148
1,033
1
1,033
10
Total
operating and
maintenance
costs
30,660
10,330
1 There
are no capital costs associated with this collection of information.
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.
2 Totals
sradovich on DSK3GMQ082PROD with NOTICES
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Activity (21 CFR part)
Records of corrections and removals (part 806) .................
1 There
Number of
records per
recordkeeper
93
Total
annual
records
1
Average
burden per
recordkeeping
93
are no capital costs or operating and maintenance costs associated with this collection of information.
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18:36 Mar 17, 2017
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Total hours
930
Federal Register / Vol. 82, No. 52 / Monday, March 20, 2017 / Notices
Dated: March 14, 2017.
Leslie Kux,
Associate Commissioner for Policy.
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’’).
[FR Doc. 2017–05415 Filed 3–17–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0017]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Voluntary National
Retail Food Regulatory Program
Standards
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) 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 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 information
collection provisions of the Voluntary
National Retail Food Regulatory
Program Standards.
DATES: Submit either electronic or
written comments on the collection of
information by May 19, 2017.
ADDRESSES: You may submit comments
as follows:
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
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
VerDate Sep<11>2014
18:36 Mar 17, 2017
Jkt 241001
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2011–N–0017 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Voluntary National Retail Food
Regulatory Program Standards.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
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 Division of Dockets
Management. 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’’
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
14369
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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
PRAStaff@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 extension 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,
E:\FR\FM\20MRN1.SGM
20MRN1
]]>Agencies
[Federal Register Volume 82, Number 52 (Monday, March 20, 2017)]
[Notices]
[Pages 14367-14369]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05415]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
(the 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 May 19, 2017.
ADDRESSES: You may submit comments as follows:
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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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 will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov/ or at the Division of
Dockets Management 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 Division of Dockets
Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.
[[Page 14368]]
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 extension 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.
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 which 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 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 for 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).
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Number of Number of Total annual Average burden Total hours operating and
Activity (21 CFR part) respondents responses per responses per response \2\ maintenance
respondent 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\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Activity (21 CFR part) Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
Records of corrections and 93 1 93 10 930
removals (part 806)............
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 14369]]
Dated: March 14, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05415 Filed 3-17-17; 8:45 am]
BILLING CODE 4164-01-P
