[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]


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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.

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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.
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    \1\ The guidance is available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/least-burdensome-provisions-concept-and-principles.
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    (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