Notice to Public of Website Location of Center for Devices and Radiological Health Fiscal Year 2021 Proposed Guidance Development, 66333-66335 [2020-23104]

Download as PDF Federal Register / Vol. 85, No. 202 / Monday, October 19, 2020 / Notices FEDERAL COMMUNICATIONS COMMISSION GENERAL SERVICES ADMINISTRATION [FRS 17148] [Notice–PBS–2020–10; Docket No. 2020– 0002; Sequence No. 39] Notice of Intent To Prepare an Environmental Assessment for the Lease and Operation of a Community Based Outpatient Clinic Wireless E911 Location Accuracy Requirements Federal Communications Commission. AGENCY: ACTION: The Association of PublicSafety Communications OfficialsInternational, Inc. (APCO) and CTIA have each filed a Petition for Reconsideration in the Commission’s Wireless E911 Location Accuracy rulemaking proceeding, PS Docket 07– 114. SUMMARY: Oppositions to the Petitions must be filed on or before November 3, 2020. Replies to an opposition must be filed on or before November 13, 2020. DATES: Federal Communications Commission, 445 12th Street SW, Washington, DC 20554. ADDRESSES: John Evanoff, john.evanoff@fcc.gov, of the Public Safety and Homeland Security Bureau, Policy and Licensing Division, (202) 418–0848. FOR FURTHER INFORMATION CONTACT: This is a summary of the Commission’s document, released on October 8, 2020 (DA 20–1175). The Petitions may be accessed online via the Commission’s Electronic Comment Filing System at: https://www.fcc.gov/ecfs/. The Commission will not send a Congressional Review Act (CRA) submission to Congress or the Government Accountability Office pursuant to the CRA, 5 U.S.C. 801 because no rules are being adopted by the Commission. Subject. Wireless E911 Location Accuracy Requirements, Report and Order, FCC 20–98, published at 85 FR 53234, August 28, 2020, in PS Docket No. 07–114. This Notice is being published pursuant to 47 CFR 1.429(e). See also 47 CFR 1.4(b)(1) and 1.429(f), (g). Number of Petitions filed: 2. jbell on DSKJLSW7X2PROD with NOTICES SUPPLEMENTARY INFORMATION: Federal Communications Commission. Marlene Dortch, Secretary, Office of the Secretary. [FR Doc. 2020–22981 Filed 10–16–20; 8:45 am] BILLING CODE 6712–01–P VerDate Sep<11>2014 18:05 Oct 16, 2020 Jkt 253001 Office of Public Buildings Service (PBS); General Services Administration, (GSA). ACTION: Notice of Intent. AGENCY: Petitions for reconsideration. Pursuant to the requirements of the National Environmental Policy Act of 1969 (NEPA), the Council on Environmental Quality Regulations, and the GSA PBS NEPA Desk Guide, GSA is issuing this notice to advise the public that an Environmental Assessment (EA) will be prepared for the lease and operation of a Community Based Outpatient Clinic (CBOC) for the Department of Veterans Affairs (VA) in the Hampton Roads region of Virginia. DATES: Agencies and the public are encouraged to provide written comments regarding the scope of the EA. Comments must be received on or before November 18, 2020. ADDRESSES: Submit comments in response to Notice–PBS–2020–10, by any of the following methods: • Mail: General Services Administration, Portfolio Division ATTN: VA Hampton Roads CBOC. General Services Administration, 100 South Independence Mall W, Philadelphia, PA 19106, Room 2191. • Email: VA.HamptonRoads.CBOC@ gsa.gov. SUMMARY: FOR FURTHER INFORMATION CONTACT: General Services Administration, MidAtlantic Region, ATTN: Todd Glodek, PHONE: (215) 606–1757, EMAIL: VA.HamptonRoads.CBOC@gsa.gov. SUPPLEMENTARY INFORMATION: Background The General Services Administration intends to prepare an Environmental Assessment (EA) to analyze the potential impacts resulting from the development of a new leased Community-Based Outpatient Clinic (CBOC) in the Hampton Roads region of southeast Virginia. The new site is intended to support the growing veteran population in the Hampton Roads region by providing increased levels of health and wellness services. While an existing 13,000 square foot CBOC is in operation in Virginia Beach, Virginia, this site cannot support necessary expansion to support increased levels of health care service. PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 66333 The Proposed Action would consist of acquiring property to construct a standalone building to provide primary care, mental health, and eye clinic services. A selected developer would be responsible for acquiring the selected site, constructing the proposed facility, and assuming ownership and maintenance of the site. Alternatives Under Consideration The EA will consider Action Alternatives for the proposed CBOC on available sites offered by developers within the Hampton Roads region as well as the No Action Alternative. The Action Alternatives will analyze the development and operation of the CBOC. The CBOC would be developed to support identified program requirements for approximately 186,200 square feet within two contiguous floors and 1,050 parking spaces within a contiguous site. Under the No Action Alternative, no CBOC would be developed. Scoping Process Scoping will be accomplished through public notifications in the Virginian Pilot and direct mail correspondence to appropriate federal, state, and local agencies; surrounding property owners; and private organizations and citizens who have previously expressed or are known to have an interest in the Project. The primary purpose of the scoping process is for the public to assist GSA in determining the scope and content of the environmental analysis. Dated: October 9, 2020. John Calhoun, Director, Portfolio Management Division (3PT). [FR Doc. 2020–23038 Filed 10–16–20; 8:45 am] BILLING CODE 6820–89–P 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. The Food and Drug Administration (FDA or the Agency) is announcing the website location where the Agency will post two lists of SUMMARY: E:\FR\FM\19OCN1.SGM 19OCN1 66334 Federal Register / Vol. 85, No. 202 / Monday, October 19, 2020 / Notices 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. 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. ADDRESSES: jbell on DSKJLSW7X2PROD with NOTICES 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 VerDate Sep<11>2014 18:05 Oct 16, 2020 Jkt 253001 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-201509-18/pdf/2015-23389.pdf. PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 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 E:\FR\FM\19OCN1.SGM 19OCN1 Federal Register / Vol. 85, No. 202 / Monday, October 19, 2020 / Notices 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. jbell on DSKJLSW7X2PROD with NOTICES 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 VerDate Sep<11>2014 18:05 Oct 16, 2020 Jkt 253001 66335 23 guidances and 11 guidance revisions in FY 2020. of several guidance documents is also being considered as resources permit. B. Finalization of Draft Guidance Documents 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/guidancedocuments-medical-devices-andradiation-emitting-products/cdrhproposed-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. 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 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 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 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2020–N–1359] Sugars that Are Metabolized Differently Than Traditional Sugars AGENCY: Food and Drug Administration, HHS. Notice; request for information and comments. ACTION: The Food and Drug Administration (FDA or we) is establishing a docket and invites information about and comments on the nutrition labeling of sugars that are metabolized differently than traditional sugars. We are taking this action to inform our regulatory approach to these distinctly metabolized sugars to promote the public health and help consumers make informed dietary decisions. SUMMARY: Submit either electronic or written comments on the notice by December 18, 2020. ADDRESSES: You may submit comments as follows. Please note that late, DATES: E:\FR\FM\19OCN1.SGM 19OCN1

Agencies

[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.

-----------------------------------------------------------------------

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

[[Page 66334]]

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

[[Page 66335]]

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
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