82 FR 14367 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Reports of Corrections and Removals

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 52 (March 20, 2017)

Page Range		14367-14369
FR Document		2017-05415

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.

Federal Register, Volume 82 Issue 52 (Monday, March 20, 2017)

[Federal Register Volume 82, Number 52 (Monday, March 20, 2017)]
[Notices]
[Pages 14367-14369]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-05415]


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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 
(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, [email protected].

[[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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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)............
----------------------------------------------------------------------------------------------------------------
\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

14368 Federal Register / Vol. 82, No. 52 / Monday, March 20, 2017 / Notices

SUPPLEMENTARY INFORMATION: Under the when appropriate, and other forms of complete information regarding these
PRA (44 U.S.C. 3501–3520), Federal information technology. corrections and removals to determine
Agencies must obtain approval from the whether recall action is adequate.
Medical Devices; Reports of Corrections
Office of Management and Budget Failure to collect this information
and Removals—21 CFR Part 806
(OMB) for each collection of would prevent FDA from receiving
information they conduct or sponsor. OMB Control Number 0910–0359— timely information about devices that
‘‘Collection of information’’ is defined Extension may have a serious effect on the health
in 44 U.S.C. 3502(3) and 5 CFR FDA is requesting approval for the of users of the devices.
1320.3(c) and includes Agency requests collection of information regarding Reports of corrections and removals
or requirements that members of the reports of corrections and removals may be submitted to FDA via mail or
public submit reports, keep records, or required under part 806 (21 CFR part using FDA’s Electronic Submission
provide information to a third party. 806), which implements section 519(g) Gateway (ESG). We estimate that
Section 3506(c)(2)(A) of the PRA (44 of the Federal Food, Drug, and Cosmetic approximately 99 percent of submitters
U.S.C. 3506(c)(2)(A)) requires Federal Act (the FD&C Act) (21 U.S.C. 360i(g)), will use the ESG. Our estimate of the
Agencies to provide a 60-day notice in as amended by the Food and Drug reporting and recordkeeping burden is
the Federal Register concerning each Modernization Act of 1997 (FDAMA) based on Agency records and our
proposed collection of information, (Pub. L. 105–115). A description of the experience with this program, as well as
including each proposed extension of an information collection requirements are similar programs that utilize FDA’s ESG.
existing collection of information, provided as follows:
before submitting the collection to OMB For respondents for who submit
Under § 806.10 (21 CFR 806.10),
for approval. To comply with this corrections and removals using the
within 10 working days of initiating any
requirement, FDA is publishing notice electronic process, the operating and
action to correct or remove a device to
of the proposed collection of maintenance costs associated with this
reduce a risk to health posed by the
information set forth in this document. information collection are
device or to remedy a violation of the
With respect to the following approximately $30 per year to purchase
FD&C Act caused by the device which
collection of information, FDA invites may present a risk to health, device a digital verification certificate
comments on these topics: (1) Whether manufacturers or importers must submit (certificate must be valid for 1 to 3
the proposed collection of information a written report to FDA of the correction years). This burden may be minimized
is necessary for the proper performance or removal. if the respondent has already purchased
of FDA’s functions, including whether Under § 806.20(a), device a verification certificate for other
the information will have practical manufacturers or importers that initiate electronic submissions to FDA.
utility; (2) the accuracy of FDA’s a correction or removal that is not However, FDA is assuming that all
estimate of the burden of the proposed required to be reported to FDA must respondents who submit corrections
collection of information, including the keep a record of the correction or and removals using the electronic
validity of the methodology and removal. process will be establishing a new
assumptions used; (3) ways to enhance The information collected in the WebTrader account and purchasing a
the quality, utility, and clarity of the reports of corrections and removals will digital verification certificate. We
information to be collected; and (4) be used by FDA to identify marketed therefore estimate the total operating
ways to minimize the burden of the devices that have serious problems and and maintenance costs to be $30,660
collection of information on to ensure that defective devices are annually (1,022 respondents × $30).
respondents, including through the use removed from the market. This will FDA estimates the burden of this
of automated collection techniques, assure that FDA has current and collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Total
Number of Average
Number of Total annual operating and
Activity (21 CFR part) responses per burden per Total hours 2
respondents responses maintenance
respondent response costs

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
1 There are no capital costs associated with this collection of information.
2 Totalsmay 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 bur-
den 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 Infor-
mation 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 Total Average
sradovich on DSK3GMQ082PROD with NOTICES

Number of
Activity (21 CFR part) records per annual burden per Total hours
recordkeepers recordkeeper records recordkeeping

Records of corrections and removals (part 806) ................. 93 1 93 10 930
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

VerDate Sep<11>2014 18:36 Mar 17, 2017 Jkt 241001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\20MRN1.SGM 20MRN1

Document Created: 2017-03-18 01:11:13
Document Modified: 2017-03-18 01:11:13

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Submit either electronic or written comments on the collection of information by May 19, 2017.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]
FR Citation		82 FR 14367

82 FR 14367 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices; Reports of Corrections and Removals

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 52 (March 20, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration