Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Nonbinding Feedback After Certain Food and Drug Administration Inspections of Device Establishments, 14684-14686 [2020-05131]
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14684
Federal Register / Vol. 85, No. 50 / Friday, March 13, 2020 / Notices
unforeseeable’’ events for purposes of
BPD reporting (see § 606.171(b)(1)(ii)).
Accordingly, establishments have been
submitting BPD reports regarding PDI
that may affect the safety, purity, or
potency of a distributed product. PDI
events continue to be reported, and the
numbers have increased over time.
Reports of PDI events have consistently
been the highest number of reports
received from blood establishments,
representing a significant burden to
industry and FDA. For example, from
FYs 2000 through 2017, FDA has
received approximately 18,000 to 40,000
PDI reports each year. The total number
of PDI reports submitted by blood
establishments in FY 2017 was 37,265
of 51,434 total BPD reports, representing
approximately 72 percent of all BPD
reports submitted by blood
establishments. In reviewing the data for
the past 18 years, based on the
extraordinarily high number of PDI
reports, FDA has concluded that PDI
events are no longer ‘‘unexpected or
unforeseeable,’’ and will likely continue
to occur. Because PDI events are no
longer ‘‘unexpected or unforeseeable,’’
and also do not represent deviations
from CGMP, applicable regulations,
applicable standards, or established
specifications, such events are not
reportable under § 606.171.
FDA is issuing this guidance for
immediate implementation in
accordance with § 10.115(g)(3) (21 CFR
10.115(g)(3)) without initially seeking
prior comment because the Agency has
determined that prior public
participation is not feasible or
appropriate (see § 10.115(g)(2)).
Specifically, we made this
determination because this guidance
presents a less burdensome policy for
reporting BPDs that is consistent with
public health. It eliminates the reporting
of PDI events as BPD reports because
these reports are no longer unexpected
or unforeseeable based on PDI data for
the past 18 years, without
compromising public health
protections.
This guidance is expected to
significantly reduce the BPD reporting
burden on industry and the burden on
FDA to review these reports. Based on
the above FY 2017 PDI data, FDA
expects that the elimination of PDI
reports will result in a 72 percent
reduction in total BPD reports received
(elimination of 37,265 of 51,434 total
reports in FY 2017). FDA anticipates
that this will substantially and
proportionally reduce the blood
industry’s estimated annual reporting
burden under § 606.171, which FDA
recently estimated to be 92,384 total
annual hours (84 FR 70979 at 70981;
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December 26, 2019). The revised
recommendations are also consistent
with public health.
Given the substantial number of PDI
reports FDA has received, the Agency is
aware that these events occur, and the
submission of additional PDI reports to
FDA is unlikely to facilitate the
identification of manufacturing or safety
issues. PDI events are not associated
with deviations from CGMP or other
requirements, and blood establishments
generally have no control over
information provided by donors or third
parties subsequent to a donation.
Eliminating PDI reports will enable
blood establishments and FDA to
prioritize resources on BPD reports that
are more likely to inform corrective
actions to protect the public health.
Additionally, blood establishments are
required to comply with applicable
regulations regarding, among other
things, establishing, maintaining, and
following standard operating procedures
(SOPs) (see § 606.100(b) (21 CFR
606.100(b)) and maintaining records
(see § 606.160 (21 CFR 606.160)). FDA
will continue to assess SOPs and
records associated with PDI events
during routine inspections of blood
establishments. Thus, this revised
guidance presents a less burdensome
policy for reporting PDI events that is
consistent with public health.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (§ 10.115). FDA is
issuing this guidance for immediate
implementation in accordance with
§ 10.115(g)(3) without initially seeking
prior comment because the Agency has
determined that prior public
participation is not feasible or
appropriate. The guidance represents
the current thinking of FDA on
biological product deviation reporting
for blood and plasma 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.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved FDA collections of
information. 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. 3501–3521). The
collections of information under
§§ 600.14 and 606.171 were approved
under OMB control number 0910–0458;
the collections of information under
§§ 606.100 and 606.160 were approved
under OMB control number 0910–0116;
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the collections of information under 21
CFR 211.192 and 211.198 were
approved under OMB control number
0910–0139; and the collections of
information under 21 CFR 601.12 were
approved under OMB control number
0910–0338.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics or
https://www.regulations.gov.
Dated: March 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–05103 Filed 3–12–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–4711]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Nonbinding
Feedback After Certain Food and Drug
Administration Inspections of Device
Establishments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995
(PRA).
DATES: Fax written comments on the
collection of information by April 13,
2020.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–NEW and
title ‘‘Nonbinding Feedback After
Certain FDA Inspections of Device
Establishments.’’ Also include the FDA
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
SUMMARY:
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Federal Register / Vol. 85, No. 50 / Friday, March 13, 2020 / Notices
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Requests for Nonbinding Feedback
After Certain FDA Inspections of Device
Establishments
jbell on DSKJLSW7X2PROD with NOTICES
OMB Control Number 0910–NEW
The guidance document entitled
‘‘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 guidance also
identifies a standardized method for
communicating and submitting requests
for nonbinding feedback and describes
how FDA evaluates and responds to
such requests.
In the Federal Register of February
19, 2019 (84 FR 4823), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. We received comments on
the following PRA related topics:
FDA received several comments
regarding whether the proposed
collection of information is necessary
for the proper performance of FDA’s
functions, including whether the
information will have practical utility.
(Comment 1) One commenter
requested that FDA clarify the benefits
of requesting nonbinding feedback (e.g.,
whether nonbinding feedback, and a
subsequent reaction to that feedback)
could prevent a Warning Letter from
being issued.
(Response) FDA believes that the
benefits of requesting nonbinding
feedback are clear. Specifically, timely
nonbinding feedback could help firms
determine whether proposed actions to
address inspectional observations are
adequate, possibly avoiding
unnecessary investment in potential
solutions not likely to satisfactorily
address an inspectional observation.
FDA’s considerations and procedures
for determining whether a Warning
Letter should be issued are identified in
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Jkt 250001
other documents (e.g., FDA’s Regulatory
Procedures Manual).
(Comment 2) Multiple commenters
felt that the guidance applies narrow
criteria that forecloses meaningful
access to Agency feedback. For example,
some commenters felt that FDA should
provide feedback on any emerging
safety issue, not just those that are likely
to cause death or serious injury.
(Response) Section 704(h)(2) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 374(h)(2)) sets
forth eligibility criteria for a request for
nonbinding feedback. FDA’s guidance
describes situations involving
significant observations that the Agency
believes meet the statutory criteria. In
addition, we note that firms have other
options to engage with FDA.
FDA received several comments
related to ways to enhance the quality,
utility, and clarity of the information to
be collected.
(Comment 3) Multiple commenters
asked whether findings from Medical
Device Single Audit Program (MDSAP)
audits are eligible to receive nonbinding
feedback.
(Response) The Medical Device Single
Audit Program is a voluntary program
that allows an MDSAP-recognized
Auditing Organization to conduct a
single regulatory audit of a medical
device manufacturer that satisfies the
relevant requirements of the regulatory
authorities participating in the program.
MDSAP audits do not meet the
definition of an inspection set forth in
section 704 of the FD&C Act; therefore,
findings from MDSAP audits are not
eligible to receive nonbinding feedback.
(Comment 4) One commenter stated
that the guidance contradicts least
burdensome principles.
(Response) FDA disagrees with the
comment. As stated in FDA’s guidance,
‘‘The Least Burdensome Provisions:
Concepts and Principles,’’ 1 FDA defines
‘‘least burdensome’’ to be ‘‘the
minimum amount of information
necessary to adequately address a
relevant regulatory question or issue
through the most efficient manner at the
right time.’’ FDA believes that the
nonbinding feedback program is
fundamentally ‘‘least burdensome,’’
because it strives to help firms avoid
unnecessary investment in potential
solutions not likely to satisfactorily
address an inspectional observation. By
providing a mechanism in which firms
can, voluntarily, seek nonbinding
feedback on proposed actions to address
1 The guidance is available at: https://
www.fda.gov/regulatory-information/search-fdaguidance-documents/least-burdensome-provisionsconcept-and-principles.
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14685
certain inspectional observations, the
program seeks to help firms resolve
regulatory issues through the most
efficient manner at the right time, using
the minimum amount of information
necessary.
(Comment 5) One commenter asked
whether outputs of the draft guidance,
such as requests for nonbinding
feedback or FDA’s responses to requests
for nonbinding feedback, will be placed
in a public database.
(Response) The FD&C Act does not
require requests for nonbinding
feedback or FDA’s responses to requests
for nonbinding feedback to be placed in
a public database. However, FDA may
take additional actions (e.g., issue
Warning Letters or safety
communications) in response to
significant inspectional observations,
some of which may be posted publicly.
(Comment 6) Multiple commenters
requested that FDA extend the
‘‘deadline’’ for requesting nonbinding
feedback beyond 15 days after issuance
of a Form FDA 483. For example, some
commenters felt that imposing a 15 day
‘‘deadline’’ for requesting nonbinding
feedback would result in rushed
remediations without a sufficient
understanding of the root-cause of the
underlying quality system deviations.
(Response) Firms are not required to
submit requests for nonbinding
feedback. To be eligible for nonbinding
feedback, a request for nonbinding
feedback must involve a public health
priority, implicate systemic or major
actions, or relate to emerging safety
issues. FDA believes that a corrective
action should be taken as expeditiously
as possible in response to an
observation that meets one or more of
the statutory criteria. In situations
where a firm is unable to submit a
timely request for nonbinding feedback,
the firm has other options to engage
with FDA.
(Comment 7) Multiple commenters
requested that FDA allow multiple
chances to seek nonbinding feedback.
For example, some commenters stated
that a firm’s initial corrective action
plan may change over time and that
remediation may take months; therefore,
firms may need feedback more than
once and more than 15 days after
issuance of a Form FDA 483.
(Response) FDA believes that
inspectional observations that involve a
public health priority, implicate
systemic or major actions, or relate to
emerging safety issues should be
corrected as expeditiously as possible.
FDA acknowledges that in some
situations, firms may desire feedback
more than once. If multiple requests for
nonbinding feedback are timely and
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Federal Register / Vol. 85, No. 50 / Friday, March 13, 2020 / Notices
meet the other statutory requirements,
FDA is required to respond to each
request within 45 days. If multiple
requests for nonbinding feedback are
not timely, then these requests will not
be subject to a response from FDA
within 45 days.
Finally, FDA acknowledges that when
the inspectional observations involve a
public health priority, implicate a
systemic or major action, or relate to an
emerging safety issue, continued
communication between FDA and the
firm may be needed after issuance of the
nonbinding feedback to ensure adequate
protection of public health. In such
cases, FDA may continue
communication with the firm and/or
take any action necessary to ensure
adequate protection of public health.
FDA received one comment regarding
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.
(Comment 8) One commenter
requested that FDA develop templates
for manufacturers to submit when
requesting nonbinding feedback.
(Response) At this time, FDA does not
believe that providing a template would
be appropriate since the content of the
request for nonbinding feedback is
expected to be situationally dependent
and different firms may have different
preferred formats for requesting
nonbinding feedback. FDA believes that
use of a template may be too restrictive
and could result in pertinent
information not being included in the
request for nonbinding feedback.
Nonetheless, FDA may choose to utilize
a template at a later date if it determines
it would be beneficial to firms to do so.
FDA estimates the burden of this
collection of information as follows:
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 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: March 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–05131 Filed 3–12–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
jbell on DSKJLSW7X2PROD with NOTICES
National Institute on Drug Abuse;
Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Board of Scientific
Counselors, NIDA.
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended for the review, discussion,
and evaluation of individual intramural
programs and projects conducted by the
NATIONAL INSTITUTE ON DRUG
ABUSE, including consideration of
personnel qualifications and
VerDate Sep<11>2014
18:16 Mar 12, 2020
Jkt 250001
performance, and the competence of
individual investigators, the disclosure
of which would constitute a clearly
unwarranted invasion of personal
privacy.
Name of Committee: Board of Scientific
Counselors, NIDA.
Date: May 7–8, 2020.
Time: 8:00 a.m. to 3:15 p.m.
Agenda: To review and evaluate personnel
qualifications and performance, and
competence of individual investigators.
Place: Intramural Research Program,
Biomedical Research Center, Johns Hopkins
Bayview Campus, 251 Bayview Boulevard,
Room BRC 03C219, Baltimore, MD 21224.
Contact Person: Joshua Kysiak, Program
Specialist, Biomedical Research Center,
Intramural Research Program, National
Institute on Drug Abuse, NIH, DHHS, 251
Bayview Boulevard, Baltimore, MD 21224,
443–740–2465, kysiakjo@nida.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.277, Drug Abuse Scientist
Development Award for Clinicians, Scientist
Development Awards, and Research Scientist
Awards; 93.278, Drug Abuse National
Research Service Awards for Research
Training; 93.279, Drug Abuse and Addiction
Research Programs, National Institutes of
Health, HHS)
Dated: March 9, 2020.
Tyeshia M. Roberson,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–05096 Filed 3–12–20; 8:45 am]
BILLING CODE 4140–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Member
Conflict SEP.
Date: April 14, 2020.
Time: 12:00 p.m. to 1:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Bethesda, MD 20892 (Telephone Conference
Call).
Contact Person: Ramesh Vemuri, Ph.D.,
Chief, Scientific Review Branch, Scientific
Review Branch, National Institute on Aging,
National Institutes of Health, 7201 Wisconsin
Avenue, Gateway Building, Suite 2W200,
Bethesda, MD 20892, (301) 402–7700, rv23r@
nih.gov.
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]]>Agencies
[Federal Register Volume 85, Number 50 (Friday, March 13, 2020)]
[Notices]
[Pages 14684-14686]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-05131]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-4711]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Nonbinding Feedback
After Certain Food and Drug Administration Inspections of Device
Establishments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995 (PRA).
DATES: Fax written comments on the collection of information by April
13, 2020.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-NEW and
title ``Nonbinding Feedback After Certain FDA Inspections of Device
Establishments.'' Also include the FDA docket number found in brackets
in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
[[Page 14685]]
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Requests for Nonbinding Feedback After Certain FDA Inspections of
Device Establishments
OMB Control Number 0910-NEW
The guidance document entitled ``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 guidance also identifies a
standardized method for communicating and submitting requests for
nonbinding feedback and describes how FDA evaluates and responds to
such requests.
In the Federal Register of February 19, 2019 (84 FR 4823), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. We received comments on the following PRA
related topics:
FDA received several comments regarding whether the proposed
collection of information is necessary for the proper performance of
FDA's functions, including whether the information will have practical
utility.
(Comment 1) One commenter requested that FDA clarify the benefits
of requesting nonbinding feedback (e.g., whether nonbinding feedback,
and a subsequent reaction to that feedback) could prevent a Warning
Letter from being issued.
(Response) FDA believes that the benefits of requesting nonbinding
feedback are clear. Specifically, timely nonbinding feedback could help
firms determine whether proposed actions to address inspectional
observations are adequate, possibly avoiding unnecessary investment in
potential solutions not likely to satisfactorily address an
inspectional observation. FDA's considerations and procedures for
determining whether a Warning Letter should be issued are identified in
other documents (e.g., FDA's Regulatory Procedures Manual).
(Comment 2) Multiple commenters felt that the guidance applies
narrow criteria that forecloses meaningful access to Agency feedback.
For example, some commenters felt that FDA should provide feedback on
any emerging safety issue, not just those that are likely to cause
death or serious injury.
(Response) Section 704(h)(2) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 374(h)(2)) sets forth eligibility
criteria for a request for nonbinding feedback. FDA's guidance
describes situations involving significant observations that the Agency
believes meet the statutory criteria. In addition, we note that firms
have other options to engage with FDA.
FDA received several comments related to ways to enhance the
quality, utility, and clarity of the information to be collected.
(Comment 3) Multiple commenters asked whether findings from Medical
Device Single Audit Program (MDSAP) audits are eligible to receive
nonbinding feedback.
(Response) The Medical Device Single Audit Program is a voluntary
program that allows an MDSAP-recognized Auditing Organization to
conduct a single regulatory audit of a medical device manufacturer that
satisfies the relevant requirements of the regulatory authorities
participating in the program. MDSAP audits do not meet the definition
of an inspection set forth in section 704 of the FD&C Act; therefore,
findings from MDSAP audits are not eligible to receive nonbinding
feedback.
(Comment 4) One commenter stated that the guidance contradicts
least burdensome principles.
(Response) FDA disagrees with the comment. As stated in FDA's
guidance, ``The Least Burdensome Provisions: Concepts and Principles,''
\1\ FDA defines ``least burdensome'' to be ``the minimum amount of
information necessary to adequately address a relevant regulatory
question or issue through the most efficient manner at the right
time.'' FDA believes that the nonbinding feedback program is
fundamentally ``least burdensome,'' because it strives to help firms
avoid unnecessary investment in potential solutions not likely to
satisfactorily address an inspectional observation. By providing a
mechanism in which firms can, voluntarily, seek nonbinding feedback on
proposed actions to address certain inspectional observations, the
program seeks to help firms resolve regulatory issues through the most
efficient manner at the right time, using the minimum amount of
information necessary.
---------------------------------------------------------------------------
\1\ The guidance is available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/least-burdensome-provisions-concept-and-principles.
---------------------------------------------------------------------------
(Comment 5) One commenter asked whether outputs of the draft
guidance, such as requests for nonbinding feedback or FDA's responses
to requests for nonbinding feedback, will be placed in a public
database.
(Response) The FD&C Act does not require requests for nonbinding
feedback or FDA's responses to requests for nonbinding feedback to be
placed in a public database. However, FDA may take additional actions
(e.g., issue Warning Letters or safety communications) in response to
significant inspectional observations, some of which may be posted
publicly.
(Comment 6) Multiple commenters requested that FDA extend the
``deadline'' for requesting nonbinding feedback beyond 15 days after
issuance of a Form FDA 483. For example, some commenters felt that
imposing a 15 day ``deadline'' for requesting nonbinding feedback would
result in rushed remediations without a sufficient understanding of the
root-cause of the underlying quality system deviations.
(Response) Firms are not required to submit requests for nonbinding
feedback. To be eligible for nonbinding feedback, a request for
nonbinding feedback must involve a public health priority, implicate
systemic or major actions, or relate to emerging safety issues. FDA
believes that a corrective action should be taken as expeditiously as
possible in response to an observation that meets one or more of the
statutory criteria. In situations where a firm is unable to submit a
timely request for nonbinding feedback, the firm has other options to
engage with FDA.
(Comment 7) Multiple commenters requested that FDA allow multiple
chances to seek nonbinding feedback. For example, some commenters
stated that a firm's initial corrective action plan may change over
time and that remediation may take months; therefore, firms may need
feedback more than once and more than 15 days after issuance of a Form
FDA 483.
(Response) FDA believes that inspectional observations that involve
a public health priority, implicate systemic or major actions, or
relate to emerging safety issues should be corrected as expeditiously
as possible. FDA acknowledges that in some situations, firms may desire
feedback more than once. If multiple requests for nonbinding feedback
are timely and
[[Page 14686]]
meet the other statutory requirements, FDA is required to respond to
each request within 45 days. If multiple requests for nonbinding
feedback are not timely, then these requests will not be subject to a
response from FDA within 45 days.
Finally, FDA acknowledges that when the inspectional observations
involve a public health priority, implicate a systemic or major action,
or relate to an emerging safety issue, continued communication between
FDA and the firm may be needed after issuance of the nonbinding
feedback to ensure adequate protection of public health. In such cases,
FDA may continue communication with the firm and/or take any action
necessary to ensure adequate protection of public health.
FDA received one comment regarding 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.
(Comment 8) One commenter requested that FDA develop templates for
manufacturers to submit when requesting nonbinding feedback.
(Response) At this time, FDA does not believe that providing a
template would be appropriate since the content of the request for
nonbinding feedback is expected to be situationally dependent and
different firms may have different preferred formats for requesting
nonbinding feedback. FDA believes that use of a template may be too
restrictive and could result in pertinent information not being
included in the request for nonbinding feedback. Nonetheless, FDA may
choose to utilize a template at a later date if it determines it would
be beneficial to firms to do so.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Requests for nonbinding feedback after certain FDA inspections of 220 1 220 500 110,000
device establishments.............................................
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\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 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: March 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05131 Filed 3-12-20; 8:45 am]
BILLING CODE 4164-01-P
