
[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]


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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Inspections of Device Establishments; Draft Guidance for Industry and 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.

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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the availability of the draft guidance entitled ``Nonbinding Feedback 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Reauthorization Act of 2017 (FDARA) mandated that FDA issue draft 
guidance specifying how FDA provides nonbinding feedback to the owner, 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 This draft guidance describes FDA's proposed approach for 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 This draft guidance is not final nor is it in effect at this 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DATES: Submit either electronic or written comments on the draft 
guidance by April 22, 2019 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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\
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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 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


