[Federal Register Volume 85, Number 202 (Monday, October 19, 2020)]
[Notices]
[Pages 66333-66335]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-23104]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-1021]


Notice to Public of Website Location of Center for Devices and 
Radiological Health Fiscal Year 2021 Proposed Guidance Development

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
announcing the website location where the Agency will post two lists of

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guidance documents that the Center for Devices and Radiological Health 
(CDRH or the Center) intends to publish in fiscal year (FY) 2021. In 
addition, FDA has established a docket where interested persons may 
comment on the priority of topics for guidance, provide comments and/or 
propose draft language for those topics, suggest topics for new or 
different guidance documents, comment on the applicability of guidance 
documents that have issued previously, and provide any other comments 
that could benefit the CDRH guidance program and its engagement with 
stakeholders. This feedback is critical to the CDRH guidance program to 
ensure that we meet stakeholder needs.

DATES: Submit either electronic or written comments by December 18, 
2020.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before December 18, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of December 18, 2020. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

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-2012-N-1021 for ``Notice to Public of Website Location of CDRH 
Fiscal Year 2021 Proposed Guidance Development.'' Received comments, 
those filed in a timely manner (see ADDRESSES), 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, 240-
402-7500.
     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.govinfo.gov/content/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, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Erica Takai, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5456, Silver Spring, MD 20993-0002, 301-796-6353.

SUPPLEMENTARY INFORMATION:

I. Background

    During negotiations on the Medical Device User Fee Amendments of 
2012, Title II, Food and Drug Administration Safety and Innovation Act 
(Pub. L. 112-144), FDA agreed to meet a variety of quantitative and 
qualitative goals intended to help get safe and effective medical 
devices to market more quickly. Among these commitments included:
     Annually posting a list of priority medical device 
guidance documents that the Agency intends to publish within 12 months 
of the date this list is published each fiscal year (the ``A-list''), 
and
     Annually posting a list of device guidance documents that 
the Agency intends to publish, as the Agency's guidance-development 
resources permit each fiscal year (the ``B-list'').
    The Medical Device User Fee Amendments of 2017 (MDUFA IV), FDA 
Reauthorization Act of 2017 (Pub. L. 115-52), maintained these 
commitments.
    In addition, to ensure that final guidance documents continue to 
provide stakeholders with the Agency's current thinking, CDRH annually 
conducts a staged review of previously issued final guidances in 
collaboration with stakeholders. CDRH intends to annually provide lists 
of previously issued final guidances that are subject to review through 
FY 2025 so that by 2025, FDA and stakeholders will have assessed the 
applicability of all guidances older than 10 years. For instance, in 
the annual notice for FY 2022, CDRH expects to provide a list of the 
final guidance documents that issued in 2012, 2002, 1992, and 1982; the 
annual notice for FY 2023 is expected to provide a list of the final 
guidance documents that issued in 2013, 2003, 1993, and 1983, and so 
on.
    FDA welcomes comments on any or all of the guidance documents on 
the

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lists as explained in 21 CFR 10.115(f)(5). FDA has established Docket 
No. FDA-2012-N-1021 where comments on the FY 2021 lists, draft language 
for guidance documents on those topics, suggestions for new or 
different guidances, and relative priority of guidance documents may be 
submitted and shared with the public (see ADDRESSES). FDA believes this 
docket is a valuable tool for receiving information from interested 
persons. FDA anticipates that feedback from interested persons will 
allow CDRH to better prioritize and more efficiently draft guidances to 
meet the needs of the Agency and our stakeholders.
    In addition to posting the lists of prioritized device guidance 
documents, CDRH has identified as a priority, and has devoted resources 
to, finalization of draft guidance documents. To assure the timely 
completion or reissuance of draft guidances, in FY 2015 CDRH committed 
to performance goals for current and future draft guidance documents. 
For draft guidance documents issued after October 1, 2014, CDRH 
committed to finalize, withdraw, reopen the comment period, or issue 
new draft guidance on the topic for 80 percent of the documents within 
3 years of the close of the comment period and for the remaining 20 
percent, within 5 years. As part of MDUFA IV commitments, FDA 
reaffirmed this commitment, as resources permit.
    Fulfillment of these commitments will be reflected through the 
issuance of updated guidance on existing topics, withdrawal of 
guidances that no longer reflect FDA's current thinking on a particular 
topic, and annual updates to the A-list and B-list announced in this 
notice.

II. CDRH Guidance Development Initiatives

A. Metrics for FY 2020 A-List and B-List Publication

    Stakeholder feedback on guidance priorities is important to ensure 
that the CDRH guidance program meets the needs of stakeholders. The 
feedback received on the FY 2020 list was mostly in agreement, and CDRH 
continued to work toward issuing the guidances on this list. Some 
guidances requested for inclusion in the FY2020 list by stakeholders 
have been included as part of the FY 2021 list. In FY 2020, CDRH 
published 14 of 27 guidances on the FY 2020 list (12 from the A-list, 2 
from the B-list). In addition, FDA is committed to providing timely 
guidance to support response efforts to the Coronavirus Disease 2019 
(COVID-19) pandemic. As such, FDA has shifted resources to issue 23 
guidances and 11 guidance revisions in FY 2020.

B. Finalization of Draft Guidance Documents

    Of the 23 draft guidances issued in FY 2015, CDRH finalized 91 
percent within 3 years of the comment period close and 91 percent 
within 5 years. In addition, in FY 2020, two draft guidances issued 
prior to October 1, 2014, remain for which no action has been taken 
yet, and CDRH has been continuing to work towards taking an action on 
these remaining draft guidances.
    Looking forward, in FY 2021, CDRH will strive to finalize, 
withdraw, or reopen the comment period for 50 percent of existing draft 
guidances issued prior to October 1, 2015.

C. Applicability of Previously Issued Final Guidance

    At the website where CDRH has posted the ``A-list'' and ``B-list'' 
for FY 2021, CDRH has also posted a list of final guidance documents 
that issued in 2011, 2001, 1991, and 1981 for our annual review of 
previously issued final guidances. CDRH is interested in external 
feedback on whether any of these final guidances should be revised or 
withdrawn. In addition, for guidances that are recommended for 
revision, information explaining the need for revision, such as the 
impact and risk to public health associated with not revising the 
guidance, would also be helpful as the Center considers potential 
action with respect to these guidances. CDRH will consider the comments 
received from this retrospective review when determining priorities for 
updating guidance documents and will revise these as resources permit.
    Consistent with the Good Guidance Practices regulation at 21 CFR 
10.115(f)(4), CDRH would appreciate suggestions that CDRH revise or 
withdraw an already existing guidance document. We request that the 
suggestion clearly explain why the guidance document should be revised 
or withdrawn and, if applicable, how it should be revised. While we are 
requesting feedback on the list of previously issued final guidances 
located in the annual agenda website, feedback on any guidance is 
appreciated and will be considered.
    In FY 2020, CDRH received comments regarding guidances issued in 
2010, 2000, 1990, and 1980 and has withdrawn 52 guidance documents in 
response to comments received and because these guidance documents were 
determined to no longer represent the Agency's current thinking. The 
revision of several guidance documents is also being considered as 
resources permit.

III. Website Location of Guidance Lists

    This notice announces the website location of the document that 
provides the A- and B-lists of guidance documents, which CDRH is 
intending to publish during FY 2021. To access these two lists, visit 
FDA's website at https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/cdrh-proposed-guidance-development. We note that the topics on this and past 
guidance priority lists may be removed or modified based on current 
priorities, as well as comments received regarding these lists. 
Furthermore, FDA and CDRH priorities are subject to change at any time 
(e.g., newly identified safety issues). The Agency is not required to 
publish every guidance on either list if the resources needed would be 
to the detriment of meeting quantitative review timelines and statutory 
obligations. In addition, the Agency is not precluded from issuing 
guidance documents that are not on either list.

    Dated: October 14, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-23104 Filed 10-16-20; 8:45 am]
BILLING CODE 4164-01-P