Nonbinding Feedback After Certain Food and Drug Administration Inspections of Device Establishments; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 4823-4825 [2019-02620]
Download as PDF
<![CDATA[
Federal Register / Vol. 84, No. 33 / Tuesday, February 19, 2019 / Notices
devices to provide additional
recommendations to stakeholders.
In the Federal Register of November
17, 2017 (82 FR 54349), FDA announced
the availability of the draft guidance of
the same title dated November 2017.
FDA considered comments received on
the draft guidance. FDA revised the
guidance as appropriate in response to
the comments and made editorial
changes to improve clarity. The
guidance announced in this notice
finalizes the draft guidance dated
November 2017.
Elsewhere in this issue of the Federal
Register, FDA is announcing the
availability of a document entitled
‘‘Expedited Programs for Regenerative
Medicine Therapies for Serious
Conditions; Guidance for Industry.’’
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Evaluation of
Devices Used with Regenerative
Medicine Advanced Therapies.’’ It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations. This
guidance is not subject to Executive
Order 12866.
tkelley on DSKBCP9HB2PROD with NOTICES
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 807 have been approved
under OMB control number 0910–0120;
the collections of information in 21 CFR
part 812 have been approved under
OMB control number 0910–0078; the
collections of information in 21 CFR
part 814 have been approved under
OMB control numbers 0910–0231 and
0910–0332; the collections of
information in 21 CFR part 1271 have
been approved under OMB control
number 0910–0543; and the collections
of information in the guidance
document ‘‘De Novo Classification
Process (Evaluation of Automatic Class
III Designation)’’ have been approved
under OMB control number 0910–0844.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/BiologicsBlood
Vaccines/GuidanceCompliance
RegulatoryInformation/Guidances/
VerDate Sep<11>2014
17:46 Feb 15, 2019
Jkt 247001
default.htm or https://
www.regulations.gov.
Dated: February 13, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–02692 Filed 2–15–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–4711]
Nonbinding Feedback After Certain
Food and Drug Administration
Inspections of Device Establishments;
Draft Guidance for Industry and Food
and Drug Administration Staff;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance entitled ‘‘Nonbinding
Feedback After Certain FDA Inspections
of Device Establishments.’’ The FDA
Reauthorization Act of 2017 (FDARA)
mandated that FDA issue draft guidance
specifying how FDA provides
nonbinding feedback to the owner,
operator, or agent in charge of a device
establishment after an inspection of
such establishment within 45 days of
FDA’s receipt of a request for such
feedback if the request meets certain
statutory criteria. This draft guidance
describes FDA’s proposed approach for
providing nonbinding feedback,
including the procedures for requesting
nonbinding feedback and FDA’s review
of requests for nonbinding feedback.
This draft guidance is not final nor is it
in effect at this time.
DATES: Submit either electronic or
written comments on the draft guidance
by April 22, 2019 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
Submit either electronic or written
comments on the collection of
information by April 22, 2019.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
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,
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
4823
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–
2018–D–4711 for ‘‘Nonbinding
Feedback After Certain FDA Inspections
of Device Establishments.’’ 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 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
E:\FR\FM\19FEN1.SGM
19FEN1
4824
Federal Register / Vol. 84, No. 33 / Tuesday, February 19, 2019 / Notices
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.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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance
document is available for download
from the internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the draft guidance
document entitled ‘‘Nonbinding
Feedback After Certain FDA Inspections
of Device Establishments’’ to the Office
of the Center Director, Guidance and
Policy Development, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request.
tkelley on DSKBCP9HB2PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Mary Wen, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1529, Silver Spring,
MD 20993–0002, 240–402–4913; or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993, 240–402–
7911.
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
17:46 Feb 15, 2019
Jkt 247001
I. Background
In 2017, FDARA was enacted. Section
702 of FDARA included a requirement
for FDA to issue draft guidance
specifying how FDA provides
nonbinding feedback to the owner,
operator, or agent in charge of a device
establishment after an inspection of
such establishment within 45 days of
FDA’s receipt of a request for such
feedback if the request meets certain
statutory criteria. The draft guidance,
‘‘Nonbinding Feedback After Certain
FDA Inspections of Device
Establishments,’’ describes the Agency’s
proposed approach to providing such
nonbinding feedback. The draft
guidance also identifies a standardized
method for communicating and
submitting requests for nonbinding
feedback and describes how FDA
evaluates and responds to such requests.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on nonbinding feedback after certain
FDA inspections of device
establishments. It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations. This guidance is not
subject to Executive Order 12866.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by
downloading an electronic copy from
the internet. A search capability for all
Center for Devices and Radiological
Health guidance documents is available
at https://www.fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm. This
guidance document is also available at
https://www.regulations.gov or https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/default.htm.
Persons unable to download an
electronic copy of ‘‘Nonbinding
Feedback After Certain FDA Inspections
of Device Establishments’’ may send an
email request to CDRH-Guidance@
fda.hhs.gov to receive an electronic
copy of the document. Please use the
document number 17047 to identify the
guidance you are requesting.
IV. Paperwork Reduction Act of 1995
(PRA)
Under the PRA (44 U.S.C. 3501–
3520), Federal Agencies must obtain
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
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
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.
Requests for Nonbinding Feedback
After Certain FDA Inspections of Device
Establishments
OMB Control Number 0910–NEW
The draft guidance document,
‘‘Nonbinding Feedback After Certain
FDA Inspections of Device
Establishments,’’ explains how the
owner, operator, or agent in charge of a
device establishment may submit a
request for nonbinding feedback to FDA
regarding actions the firm has proposed
to take to address certain kinds of
inspectional observations that have been
documented on an FDA Inspectional
Observations Form (Form FDA 483) and
issued to the firm upon completion of
an inspection of the firm’s
establishment. The draft guidance also
identifies a standardized method for
communicating and submitting requests
for nonbinding feedback and describes
how FDA evaluates and responds to
such requests.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\19FEN1.SGM
19FEN1
Federal Register / Vol. 84, No. 33 / Tuesday, February 19, 2019 / Notices
4825
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
Requests for nonbinding feedback after certain FDA inspections of device establishments .................................
220
1
220
500
110,000
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimate that 220 respondents per
year will request nonbinding feedback
as described in the draft guidance is
based on recent inspectional data. Based
on the recommendations in the
guidance and our experience with
similar information collections, we
believe it will take approximately 500
hours to complete a request for
nonbinding feedback. Therefore, we
estimate the burden of this information
collection to be 110,000 hours.
Dated: February 12, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–02620 Filed 2–15–19; 8:45 am]
BILLING CODE 4164–01–P
Electronic Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–6159]
Expedited Programs for Regenerative
Medicine Therapies for Serious
Conditions; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance entitled ‘‘Expedited Programs
for Regenerative Medicine Therapies for
Serious Conditions; Guidance for
Industry.’’ The guidance document
provides sponsors engaged in the
development of regenerative medicine
therapies for serious or life-threatening
diseases or conditions with FDA’s
recommendations on the expedited
development and review of these
therapies. The guidance describes the
expedited programs available to
sponsors of regenerative medicine
therapies for serious or life-threatening
diseases or conditions, including those
products designated as regenerative
advanced therapies (which FDA refers
to as ‘‘regenerative medicine advanced
therapy’’ (RMAT) designation). The
guidance also describes considerations
in the clinical development of
tkelley on DSKBCP9HB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:46 Feb 15, 2019
regenerative medicine therapies and
opportunities for sponsors of
regenerative medicine therapies to
interact with the Center of Biologics
Evaluation and Research (CBER) review
staff.
The guidance announced in this
notice finalizes the draft guidance of the
same title dated November 2017.
DATES: The announcement of the
guidance is published in the Federal
Register on February 19, 2019.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
Jkt 247001
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.
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
• 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–
2017–D–6159 for ‘‘Expedited Programs
for Regenerative Medicine Therapies for
Serious Conditions; Guidance for
Industry.’’ 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
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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
E:\FR\FM\19FEN1.SGM
19FEN1
]]>Agencies
[Federal Register Volume 84, Number 33 (Tuesday, February 19, 2019)]
[Notices]
[Pages 4823-4825]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02620]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-4711]
Nonbinding Feedback After Certain Food and Drug Administration
Inspections of Device Establishments; Draft Guidance for Industry and
Food and Drug Administration Staff; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Nonbinding Feedback
After Certain FDA Inspections of Device Establishments.'' The FDA
Reauthorization Act of 2017 (FDARA) mandated that FDA issue draft
guidance specifying how FDA provides nonbinding feedback to the owner,
operator, or agent in charge of a device establishment after an
inspection of such establishment within 45 days of FDA's receipt of a
request for such feedback if the request meets certain statutory
criteria. This draft guidance describes FDA's proposed approach for
providing nonbinding feedback, including the procedures for requesting
nonbinding feedback and FDA's review of requests for nonbinding
feedback. This draft guidance is not final nor is it in effect at this
time.
DATES: Submit either electronic or written comments on the draft
guidance by April 22, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance. Submit either electronic or written comments
on the collection of information by April 22, 2019.
ADDRESSES: You may submit comments on any guidance at any time 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): 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-2018-D-4711 for ``Nonbinding Feedback After Certain FDA Inspections
of Device Establishments.'' 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 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
[[Page 4824]]
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.gpo.gov/fdsys/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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Nonbinding Feedback After Certain FDA Inspections of Device
Establishments'' to the Office of the Center Director, Guidance and
Policy Development, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request.
FOR FURTHER INFORMATION CONTACT: Mary Wen, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1529, Silver Spring, MD 20993-0002, 240-402-4913;
or Stephen Ripley, Center for Biologics Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
In 2017, FDARA was enacted. Section 702 of FDARA included a
requirement for FDA to issue draft guidance specifying how FDA provides
nonbinding feedback to the owner, operator, or agent in charge of a
device establishment after an inspection of such establishment within
45 days of FDA's receipt of a request for such feedback if the request
meets certain statutory criteria. The draft guidance, ``Nonbinding
Feedback After Certain FDA Inspections of Device Establishments,''
describes the Agency's proposed approach to providing such nonbinding
feedback. The draft guidance also identifies a standardized method for
communicating and submitting requests for nonbinding feedback and
describes how FDA evaluates and responds to such requests.
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on nonbinding
feedback after certain FDA inspections of device establishments. It
does not establish any rights for any person and is not binding on FDA
or the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations. This guidance
is not subject to Executive Order 12866.
III. Electronic Access
Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov or
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to
download an electronic copy of ``Nonbinding Feedback After Certain FDA
Inspections of Device Establishments'' may send an email request to
CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the
document. Please use the document number 17047 to identify the guidance
you are requesting.
IV. Paperwork Reduction Act of 1995 (PRA)
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 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.
Requests for Nonbinding Feedback After Certain FDA Inspections of
Device Establishments
OMB Control Number 0910-NEW
The draft guidance document, ``Nonbinding Feedback After Certain
FDA Inspections of Device Establishments,'' explains how the owner,
operator, or agent in charge of a device establishment may submit a
request for nonbinding feedback to FDA regarding actions the firm has
proposed to take to address certain kinds of inspectional observations
that have been documented on an FDA Inspectional Observations Form
(Form FDA 483) and issued to the firm upon completion of an inspection
of the firm's establishment. The draft guidance also identifies a
standardized method for communicating and submitting requests for
nonbinding feedback and describes how FDA evaluates and responds to
such requests.
FDA estimates the burden of this collection of information as
follows:
[[Page 4825]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Requests for nonbinding feedback after certain FDA inspections of 220 1 220 500 110,000
device establishments.............................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Our estimate that 220 respondents per year will request nonbinding
feedback as described in the draft guidance is based on recent
inspectional data. Based on the recommendations in the guidance and our
experience with similar information collections, we believe it will
take approximately 500 hours to complete a request for nonbinding
feedback. Therefore, we estimate the burden of this information
collection to be 110,000 hours.
Dated: February 12, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-02620 Filed 2-15-19; 8:45 am]
BILLING CODE 4164-01-P
