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Inspections of Device Establishments; Draft Guidance for Industry and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the availability of the draft guidance entitled ``Nonbinding Feedback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Reauthorization Act of 2017 (FDARA) mandated that FDA issue draft
guidance specifying how FDA provides nonbinding feedback to the owner,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 This draft guidance describes FDA's proposed approach for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 This draft guidance is not final nor is it in effect at this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DATES: Submit either electronic or written comments on the draft
guidance by April 22, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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