Guidance Documents Related to Coronavirus Disease 2019; Availability, 106-109 [2020-29058]

Download as PDF 106 Federal Register / Vol. 86, No. 1 / Monday, January 4, 2021 / Notices territorial, and tribal governments to monitor and measure progress in food defense. In 2015, the initial NAFDS Report to Congress detailed the specific Federal response to food and agriculture defense goals, objectives, key initiatives, and activities that HHS, USDA, DHS, and other stakeholders planned to accomplish to meet the objectives outlined in FSMA. The NAFDS charts a direction for how Federal Agencies, in cooperation with SLTT governments and private sector partners, protect the nation’s food supply against intentional contamination. Not later than 4 years after the initial NAFDS Report to Congress (2015), and every 4 years thereafter (i.e., 2019, 2023, 2027, etc.), HHS, USDA, and DHS are required to revise and submit an updated report to the relevant committees of Congress. FDA is the Agency primarily responsible for obtaining the information from Federal and SLTT partners to complete the NAFDS Report to Congress. An interagency working group will conduct the survey and collect and update the NAFDS as directed by FSMA, including developing metrics and measuring progress for the evaluation process. The survey of Federal and State partners will be used to determine what food defense activities, if any, Federal and/or SLTT agencies have completed (or are planning on completing) from 2021 to 2025. Planning for the local, territorial, and tribal information collections will commence during this period of renewal. The survey will continue to be repeated approximately every 2 to 4 years, as described in section 108 of FSMA. The NAFDS survey is being administered for the purpose of monitoring progress in food and agricultural defense by government agencies. A purposive sampling strategy is employed, such that the government agencies participating in food and agricultural defense are asked to respond to the voluntary survey. Food defense leaders responsible for conducting food defense activities during a food emergency for their jurisdiction are identified and will receive an emailed invitation to complete the survey online; they will be provided with a web link to the survey. The survey will be conducted electronically on the FDA.gov web portal, and results will be analyzed by the interagency working group. Description of Respondents: Respondents to this collection are SLTT government representatives (survey respondents) who are food defense leaders responsible for conducting food defense activities during a food emergency for their jurisdictions. We estimate the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Activity Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours SLTT Surveys .......................................... 500 1 500 0.33 (20 minutes) ...... 165 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The FDA Office of Partnerships reviewed the questionnaire and provided the estimate of time to complete the survey. The total burden is based on our previous experiences conducting surveys. The burden has been revised to reflect the total number of states and possible number of local, tribal, and territorial entities that may partake of the survey. Based on a review of the information collection since our last request for OMB approval, we have increased our burden estimate by 149 hours (from 16.17 to 165 hours) and 451 respondents (from 49 to 500 respondents). Dated: December 29, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–29082 Filed 12–31–20; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 17:28 Dec 31, 2020 Jkt 253001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2020–D–1825 and FDA– 2020–D–1138] Guidance Documents Related to Coronavirus Disease 2019; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of FDA guidance documents related to the Coronavirus Disease 2019 (COVID–19) public health emergency (PHE). This notice of availability (NOA) is pursuant to the process that FDA announced, in the Federal Register of March 25, 2020, for making available to the public COVID–19-related guidances. The guidances identified in this notice address issues related to the COVID–19 PHE and have been issued in accordance with the process announced in the March 25, 2020, notice. The guidances have been implemented without prior comment, but they remain subject to comment in accordance with the Agency’s good guidance practices. SUMMARY: PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 The announcement of the guidances is published in the Federal Register on January 4, 2021. DATES: You may submit either electronic or written comments on Agency guidances at any time as follows: ADDRESSES: 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. E:\FR\FM\04JAN1.SGM 04JAN1 Federal Register / Vol. 86, No. 1 / Monday, January 4, 2021 / Notices • 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 name of the guidance document that the comments address and the docket number for the guidance (see table 1). Received comments will be placed in the docket(s) 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 1 Secretary of Health and Human Services Alex M. Azar, II, ‘‘Determination that a Public Health Emergency Exists’’ (originally issued on January 31, 2020, and subsequently renewed), available at: VerDate Sep<11>2014 17:28 Dec 31, 2020 Jkt 253001 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. 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. You may submit comments on any guidance at any time (see § 10.115(g)(5) (21 CFR 10.115(g)(5))). Submit written requests for single copies of these guidances to the address noted in table 1. Send two selfaddressed adhesive labels to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidances. FOR FURTHER INFORMATION CONTACT: Stephen Ripley, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240– 402–7911, or Erica Takai, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5456, Silver Spring, MD 20993– 0002, 301–796–6353. SUPPLEMENTARY INFORMATION: I. Background On January 31, 2020, as a result of confirmed cases of COVID–19, and after consultation with public health officials as necessary, Alex M. Azar II, Secretary of Health and Human Services (HHS), pursuant to the authority under section 319 of the Public Health Service Act (42 U.S.C. 247d) (PHS Act), determined that a PHE exists and has existed since January 27, 2020, nationwide.1 On March 13, 2020, President Donald J. Trump declared that the COVID–19 outbreak in the United States constitutes a national emergency, beginning March 1, 2020.2 https://www.phe.gov/emergency/news/ healthactions/phe/Pages/default.aspx. 2 Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID–19) Outbreak (March 13, 2020), PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 107 In the Federal Register of March 25, 2020 (85 FR 16949) (the March 25, 2020, notice) (available at https:// www.govinfo.gov/content/pkg/FR-202003-25/pdf/2020-06222.pdf), FDA announced procedures for making available FDA guidances related to the COVID–19 PHE. These procedures, which operate within FDA’s established good guidance practices regulations, are intended to allow FDA to rapidly disseminate Agency recommendations and policies related to COVID–19 to industry, FDA staff, and other stakeholders. The March 25, 2020, notice stated that due to the need to act quickly and efficiently to respond to the COVID–19 PHE, FDA believes that prior public participation will not be feasible or appropriate before FDA implements COVID–19-related guidances. Therefore, FDA will issue COVID–19-related guidances for immediate implementation without prior public comment (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C)) and § 10.115(g)(2)). The guidances are available on FDA’s web pages entitled ‘‘COVID–19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders’’ (available at https://www.fda.gov/emergencypreparedness-and-response/mcmissues/covid-19-related-guidancedocuments-industry-fda-staff-and-otherstakeholders) and ‘‘Search for FDA Guidance Documents’’ (available at https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments). The March 25, 2020, notice further stated that, in general, rather than publishing a separate NOA for each COVID–19-related guidance, FDA intends to publish periodically a consolidated NOA announcing the availability of certain COVID–19-related guidances that FDA issued during the relevant period, as included in table 1. This notice announces COVID–19related guidances that are posted on FDA’s website. II. Availability of COVID–19-Related Guidance Documents Pursuant to the process described in the March 25, 2020, notice, FDA is announcing the availability of the following COVID–19-related guidances: available at: https://www.whitehouse.gov/ presidential-actions/proclamation-declaringnational-emergency-concerning-novel-coronavirusdisease-covid-19-outbreak/. E:\FR\FM\04JAN1.SGM 04JAN1 108 Federal Register / Vol. 86, No. 1 / Monday, January 4, 2021 / Notices TABLE 1—GUIDANCES RELATED TO THE COVID–19 PUBLIC HEALTH EMERGENCY Docket No. Center Title of guidance Contact information to request single copies FDA–2020–D–1825 CBER ..... Investigational COVID–19 Convalescent Plasma (Updated November 2020). FDA–2020–D–1138 CDRH .... FDA–2020–D–1138 CDRH .... FDA–2020–D–1138 CDRH .... Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID– 19 Public Health Emergency (Revised) (November 2020). Enforcement Policy for Bioburden Reduction Systems Using Dry Heat to Support Single-User Reuse of Certain Filtering Facepiece Respirators During the Coronavirus Disease 2019 (COVID–19) Public Health Emergency (November 2020). Enforcement Policy for the Quality Standards of the Mammography Quality Standards Act During the COVID–19 Public Health Emergency (December 2020). Office of Communication, Outreach and Development, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002; 1–800–835–4709 or 240–402–8010; email ocod@fda.hhs.gov. CDRH-Guidance@fda.hhs.gov. Please include the document number 20032–R2 and complete title of the guidance in the request. Although these guidances have been implemented immediately without prior comment, FDA will consider all comments received and revise the guidances as appropriate (see § 10.115(g)(3)). These guidances are being issued consistent with FDA’s good guidance practices regulation (§ 10.115). The guidances represent the current thinking of FDA. They do not establish any rights for any person and are not binding on CDRH-Guidance@fda.hhs.gov. Please include the document number 20044 and complete title of the guidance in the request. CDRH-Guidance@fda.hhs.gov. Please include the document number 20047 and complete title of the guidance in the request. FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. III. Paperwork Reduction Act of 1995 A. CBER Guidance While this guidance contains no collection of information, it does refer to previously approved FDA collections of information (listed in table 2). Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in the following FDA regulations and guidances have been approved by OMB as listed in the following table: TABLE 2—CBER GUIDANCE AND COLLECTIONS Another guidance title referenced in COVID–19 guidance COVID–19 guidance title CFR cite referenced in COVID–19 guidance Investigational COVID–19 Convalescent Plasma (Updated November 2020). 21 CFR part 312 ...................................................... 21 CFR parts 610, 606, and 630 ............................. B. CDRH Guidances While these guidances contain no collection of information, they do refer to previously approved FDA collections of information (listed in table 3). Therefore, clearance by OMB under the PRA (44 U.S.C. 3501–3521) is not required for these guidances. These previously approved collections of information are subject to review by OMB under the PRA. The collections of information in the following FDA statutory provision, regulations and guidances have been approved by OMB as listed in the following table. These guidances also contain a collection of ................................ ................................ Form FDA 3926 ..... OMB control No(s). 0910–0014 0910–0116 0910–0814 information that has been granted a PHE waiver from the PRA by HHS on March 19, 2020, under section 319(f) of the PHS Act. Information concerning the PHE PRA waiver can be found on the HHS website at https://aspe.hhs.gov/ public-health-emergency-declarationpra-waivers. TABLE 3—CDRH GUIDANCES AND COLLECTIONS Citation referenced in COVID–19 guidance COVID–19 guidance title Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID–19 Public Health Emergency (Revised) (November 2020). VerDate Sep<11>2014 17:28 Dec 31, 2020 Jkt 253001 PO 00000 Section 506J (21 U.S.C.356j) of the FD&C Act. 21 CFR Part 807, subparts A through D. Frm 00060 Fmt 4703 Another guidance referenced in COVID–19 guidance OMB control No(s). .................................................. 0910–0491 .................................................. 0910–0625 Sfmt 4703 E:\FR\FM\04JAN1.SGM 04JAN1 New collection covered by PHE PRA waiver 109 Federal Register / Vol. 86, No. 1 / Monday, January 4, 2021 / Notices TABLE 3—CDRH GUIDANCES AND COLLECTIONS—Continued Citation referenced in COVID–19 guidance COVID–19 guidance title Another guidance referenced in COVID–19 guidance Emergency Use Authorization of Medical Products and Related Authorities; Guidance for Industry and Other Stakeholders. OMB control No(s). New collection covered by PHE PRA waiver 0910–0595 Updates to FDA every 6 weeks after initial notification on the shortage situation. Voluntary submission of other information. Enforcement Policy for Bioburden Reduction Systems Using Dry Heat to Support Single-User Reuse of Certain Filtering Facepiece Respirators During the Coronavirus Disease 2019 (COVID–19) Public Health Emergency (November 2020). ......................... Emergency Use Authorization of Medical Products and Related Authorities; Guidance for Industry and Other Stakeholders. 0910–0595 Labeling of the bioburden reduction system. Enforcement Policy for the Quality Standards of the Mammography Quality Standards Act [MQSA] During the COVID–19 Public Health Emergency (December 2020). 21 CFR Part 900. .................................................. 0910–0309 Document the time period that the facility was temporarily closed and present information during the facility’s MQSA inspection. Document and provide the circumstances re: lack of medical physicist survey within 14 months of the last annual survey. Information on inability to meet the survey timeframes described in the guidance. Provide documentation of the dates and events that led to noncompliance and that facility will ensure compliance as soon as possible after COVID–19 restrictions are lifted. IV. Electronic Access Persons with access to the internet may obtain COVID–19-related guidances at: • FDA web page entitled ‘‘COVID–19Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders,’’ available at https:// www.fda.gov/emergency-preparednessand-response/mcm-issues/covid-19related-guidance-documents-industryfda-staff-and-other-stakeholders; • FDA web page entitled ‘‘Search for FDA Guidance Documents’’ available at https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments; or • https://www.regulations.gov. Dated: December 29, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–29058 Filed 12–31–20; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 17:28 Dec 31, 2020 Jkt 253001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–N–1414] Agency Information Collection Activities; Proposed Collection; Comment Request; Class II Special Controls Guidance Document: Labeling Natural Rubber Latex Condoms AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and SUMMARY: PO 00000 Frm 00061 Fmt 4703 Sfmt 4703 to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection for the labeling of natural rubber latex condoms. Submit either electronic or written comments on the collection of information by March 5, 2021. DATES: 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 March 5, 2021. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of March 5, 2021. 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: Electronic Submissions Submit electronic comments in the following way: E:\FR\FM\04JAN1.SGM 04JAN1

Agencies

[Federal Register Volume 86, Number 1 (Monday, January 4, 2021)]
[Notices]
[Pages 106-109]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-29058]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-D-1825 and FDA-2020-D-1138]

Guidance Documents Related to Coronavirus Disease 2019;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of FDA guidance documents related to the Coronavirus
Disease 2019 (COVID-19) public health emergency (PHE). This notice of
availability (NOA) is pursuant to the process that FDA announced, in
the Federal Register of March 25, 2020, for making available to the
public COVID-19-related guidances. The guidances identified in this
notice address issues related to the COVID-19 PHE and have been issued
in accordance with the process announced in the March 25, 2020, notice.
The guidances have been implemented without prior comment, but they
remain subject to comment in accordance with the Agency's good guidance
practices.

DATES: The announcement of the guidances is published in the Federal
Register on January 4, 2021.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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.

[[Page 107]]

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 name of the
guidance document that the comments address and the docket number for
the guidance (see table 1). Received comments will be placed in the
docket(s) 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.
You may submit comments on any guidance at any time (see Sec.
10.115(g)(5) (21 CFR 10.115(g)(5))).
Submit written requests for single copies of these guidances to the
address noted in table 1. Send two self-addressed adhesive labels to
assist that office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidances.

FOR FURTHER INFORMATION CONTACT: Stephen Ripley, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911, or Erica Takai, Center for Devices and Radiological Health
(CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5456, Silver Spring, MD 20993-0002, 301-796-6353.

SUPPLEMENTARY INFORMATION:

I. Background

On January 31, 2020, as a result of confirmed cases of COVID-19,
and after consultation with public health officials as necessary, Alex
M. Azar II, Secretary of Health and Human Services (HHS), pursuant to
the authority under section 319 of the Public Health Service Act (42
U.S.C. 247d) (PHS Act), determined that a PHE exists and has existed
since January 27, 2020, nationwide.\1\ On March 13, 2020, President
Donald J. Trump declared that the COVID-19 outbreak in the United
States constitutes a national emergency, beginning March 1, 2020.\2\
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\1\ Secretary of Health and Human Services Alex M. Azar, II,
``Determination that a Public Health Emergency Exists'' (originally
issued on January 31, 2020, and subsequently renewed), available at:
https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
\2\ Proclamation on Declaring a National Emergency Concerning
the Novel Coronavirus Disease (COVID-19) Outbreak (March 13, 2020),
available at: https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
---------------------------------------------------------------------------

In the Federal Register of March 25, 2020 (85 FR 16949) (the March
25, 2020, notice) (available at https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf), FDA announced procedures for making
available FDA guidances related to the COVID-19 PHE. These procedures,
which operate within FDA's established good guidance practices
regulations, are intended to allow FDA to rapidly disseminate Agency
recommendations and policies related to COVID-19 to industry, FDA
staff, and other stakeholders. The March 25, 2020, notice stated that
due to the need to act quickly and efficiently to respond to the COVID-
19 PHE, FDA believes that prior public participation will not be
feasible or appropriate before FDA implements COVID-19-related
guidances. Therefore, FDA will issue COVID-19-related guidances for
immediate implementation without prior public comment (see section
701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 371(h)(1)(C)) and Sec. 10.115(g)(2)). The guidances are
available on FDA's web pages entitled ``COVID-19-Related Guidance
Documents for Industry, FDA Staff, and Other Stakeholders'' (available
at https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders) and ``Search for FDA Guidance Documents'' (available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents).
The March 25, 2020, notice further stated that, in general, rather
than publishing a separate NOA for each COVID-19-related guidance, FDA
intends to publish periodically a consolidated NOA announcing the
availability of certain COVID-19-related guidances that FDA issued
during the relevant period, as included in table 1. This notice
announces COVID-19-related guidances that are posted on FDA's website.

II. Availability of COVID-19-Related Guidance Documents

Pursuant to the process described in the March 25, 2020, notice,
FDA is announcing the availability of the following COVID-19-related
guidances:

[[Page 108]]

Table 1--Guidances Related to the COVID-19 Public Health Emergency
------------------------------------------------------------------------
Contact
Title of information to
Docket No. Center guidance request single
copies
------------------------------------------------------------------------
FDA-2020-D-1825......... CBER........ Investigational Office of
COVID-19 Communication,
Convalescent Outreach and
Plasma Development,
(Updated 10903 New
November 2020). Hampshire
Ave., Bldg.
71, Rm. 3128,
Silver Spring,
MD 20993-0002;
1-800-835-4709
or 240-402-
8010; email
[email protected].
FDA-2020-D-1138......... CDRH........ Notifying CDRH CDRH-
of a Permanent [email protected]
Discontinuance hs.gov. Please
or include the
Interruption document
in number 20032-
Manufacturing R2 and
of a Device complete title
Under Section of the
506J of the guidance in
FD&C Act the request.
During the
COVID-19
Public Health
Emergency
(Revised)
(November
2020).
FDA-2020-D-1138......... CDRH........ Enforcement CDRH-
Policy for [email protected]
Bioburden hs.gov. Please
Reduction include the
Systems Using document
Dry Heat to number 20044
Support Single- and complete
User Reuse of title of the
Certain guidance in
Filtering the request.
Facepiece
Respirators
During the
Coronavirus
Disease 2019
(COVID-19)
Public Health
Emergency
(November
2020).
FDA-2020-D-1138......... CDRH........ Enforcement CDRH-
Policy for the [email protected]
Quality hs.gov. Please
Standards of include the
the document
Mammography number 20047
Quality and complete
Standards Act title of the
During the guidance in
COVID-19 the request.
Public Health
Emergency
(December
2020).
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Although these guidances have been implemented immediately without
prior comment, FDA will consider all comments received and revise the
guidances as appropriate (see Sec. 10.115(g)(3)).
These guidances are being issued consistent with FDA's good
guidance practices regulation (Sec. 10.115). The guidances represent
the current thinking of FDA. They do not establish any rights for any
person and are not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

III. Paperwork Reduction Act of 1995

A. CBER Guidance

While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information (listed in
table 2). Therefore, clearance by the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521) is not required for this guidance. The previously approved
collections of information are subject to review by OMB under the PRA.
The collections of information in the following FDA regulations and
guidances have been approved by OMB as listed in the following table:

Table 2--CBER Guidance and Collections
----------------------------------------------------------------------------------------------------------------
CFR cite referenced in Another guidance title OMB control
COVID-19 guidance title COVID-19 guidance referenced in COVID-19 No(s).
-----------------------------------------------------------------------------guidance---------------------------
Investigational COVID-19 21 CFR part 312............ .............................. 0910-0014
Convalescent Plasma (Updated 21 CFR parts 610, 606, and .............................. 0910-0116
November 2020). 630.
Form FDA 3926................. 0910-0814
----------------------------------------------------------------------------------------------------------------

B. CDRH Guidances

While these guidances contain no collection of information, they do
refer to previously approved FDA collections of information (listed in
table 3). Therefore, clearance by OMB under the PRA (44 U.S.C. 3501-
3521) is not required for these guidances. These previously approved
collections of information are subject to review by OMB under the PRA.
The collections of information in the following FDA statutory
provision, regulations and guidances have been approved by OMB as
listed in the following table. These guidances also contain a
collection of information that has been granted a PHE waiver from the
PRA by HHS on March 19, 2020, under section 319(f) of the PHS Act.
Information concerning the PHE PRA waiver can be found on the HHS
website at https://aspe.hhs.gov/public-health-emergency-declaration-pra-waivers.

Table 3--CDRH Guidances and Collections
----------------------------------------------------------------------------------------------------------------
Another guidance New collection
COVID-19 guidance title Citation referenced referenced in COVID- OMB control covered by PHE PRA
in COVID-19 19 guidance No(s). waiver
-----------------------------------------guidance---------------------------------------------------------------
Notifying CDRH of a Permanent Section 506J (21 ................... 0910-0491
Discontinuance or Interruption U.S.C.356j) of the
in Manufacturing of a Device FD&C Act.
Under Section 506J of the FD&C
Act During the COVID-19 Public
Health Emergency (Revised)
(November 2020).
21 CFR Part 807, ................... 0910-0625
subparts A through
D.

[[Page 109]]

Emergency Use 0910-0595
Authorization of
Medical Products
and Related
Authorities;
Guidance for
Industry and Other
Stakeholders.
Updates to FDA
every 6 weeks
after initial
notification on
the shortage
situation.
Voluntary
submission of
other information.
Enforcement Policy for Bioburden ................... Emergency Use 0910-0595
Reduction Systems Using Dry Heat Authorization of
to Support Single-User Reuse of Medical Products
Certain Filtering Facepiece and Related
Respirators During the Authorities;
Coronavirus Disease 2019 (COVID- Guidance for
19) Public Health Emergency Industry and Other
(November 2020). Stakeholders.
Labeling of the
bioburden
reduction system.
Enforcement Policy for the 21 CFR Part 900.... ................... 0910-0309
Quality Standards of the
Mammography Quality Standards
Act [MQSA] During the COVID-19
Public Health Emergency
(December 2020).
Document the time
period that the
facility was
temporarily closed
and present
information during
the facility's
MQSA inspection.
Document and
provide the
circumstances re:
lack of medical
physicist survey
within 14 months
of the last annual
survey.
Information on
inability to meet
the survey
timeframes
described in the
guidance.
Provide
documentation of
the dates and
events that led to
noncompliance and
that facility will
ensure compliance
as soon as
possible after
COVID-19
restrictions are
lifted.
----------------------------------------------------------------------------------------------------------------

IV. Electronic Access

Persons with access to the internet may obtain COVID-19-related
guidances at:
FDA web page entitled ``COVID-19-Related Guidance
Documents for Industry, FDA Staff, and Other Stakeholders,'' available
at https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders;
FDA web page entitled ``Search for FDA Guidance
Documents'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents; or
https://www.regulations.gov.

Dated: December 29, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-29058 Filed 12-31-20; 8:45 am]
BILLING CODE 4164-01-P

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