Guidance Documents Related to Coronavirus Disease 2019; Availability, 3303-3306 [2022-01146]

Download as PDF Federal Register / Vol. 87, No. 14 / Friday, January 21, 2022 / Notices 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 21 CFR 10.115(g)(5)). Submit written requests for single copies of the draft guidance to the Division of Operational Policy, Office of Regulatory Affairs, Food and Drug Administration, Element Building, 12420 Parklawn Dr., Rockville, MD 20852. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: jspears on DSK121TN23PROD with NOTICES1 Chris Henderson, Office of Regulatory Affairs, Food and Drug Administration, Element Building, 12420 Parklawn Dr., Rockville, MD 20857 240–402–8186, Christopher.henderson@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry and FDA staff entitled ‘‘Collecting and Providing 702(b) Portions of FDA Official Samples—Questions and Answers.’’ Section 702 of the FD&C Act (21 U.S.C. 372) authorizes FDA to conduct examinations and investigations and to collect samples. Under section 702(b) of the FD&C Act, when FDA collects a sample of a food, drug, or cosmetic for analysis, FDA must, upon request, provide a part of such official sample for examination or analysis by any person named on the label of the article, or the owner thereof, or his attorney or agent. Additionally, FDA was authorized to establish, by regulation, reasonable exceptions to, and impose reasonable terms and conditions relating to, the requirement to collect and provide a 702(b) portion of an official sample to the owner, as necessary for the proper administration of the provisions of the FD&C Act. FDA’s regulation at 21 CFR 2.10 was issued to establish those reasonable exceptions, and terms and conditions, and to implement section 702(b) of the FD&C Act. This draft guidance is intended to assist industry and FDA staff with issues and questions related to the requirements for FDA to collect and VerDate Sep<11>2014 17:39 Jan 20, 2022 Jkt 256001 provide portions of official samples under section 702(b) of the FD&C Act and its implementing regulation in 21 CFR 2.10. 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 ‘‘Collecting and Providing 702(b) Portions of FDA Official Samples— Questions and Answers.’’ 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. II. Paperwork Reduction Act of 1995 FDA tentatively concludes that this draft guidance contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments/search-general-and-crosscutting-topics-guidance-documents, https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https:// www.regulations.gov. Dated: January 14, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–01143 Filed 1–20–22; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2020–D–1137, FDA– 2020–D–1138, FDA–2020–D–0987] 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 SUMMARY: PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 3303 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 21, 2022. 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. • 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 E:\FR\FM\21JAN1.SGM 21JAN1 3304 Federal Register / Vol. 87, No. 14 / Friday, January 21, 2022 / Notices (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-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 guidance. 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, the 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), determined that a PHE exists and has existed since January 27, 2020, nationwide.1 On March 13, 2020, there was a Presidential declaration that the COVID–19 outbreak in the United States constitutes a national emergency, beginning March 1, 2020.2 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 (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: jspears on DSK121TN23PROD with NOTICES1 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–1137 ........ CBER ........... Policy for Certain REMS Requirements During the Tocilizumab Shortage Related to the COVID–19 Public Health Emergency (December 2021). 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. 1 Secretary of Health and Human Services, ‘‘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 VerDate Sep<11>2014 17:39 Jan 20, 2022 Jkt 256001 Disease (COVID–19) Outbreak (March 13, 2020), available at: https://trumpwhitehouse.archives.gov/ presidential-actions/proclamation-declaringnational-emergency-concerning-novel-coronavirusdisease-covid-19-outbreak/. On February 24, 2021, there was a Presidential Declaration continuing the national emergency concerning the COVID–19 pandemic beyond March 1, 2021. See Continuation PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 of the National Emergency Concerning the Coronavirus Disease 2019 (COVID–19) Pandemic (February 24, 2021), available at https:// www.federalregister.gov/documents/2021/02/26/ 2021-04173/continuation-of-the-nationalemergency-concerning-the-coronavirus-disease2019-covid-19-pandemic. E:\FR\FM\21JAN1.SGM 21JAN1 3305 Federal Register / Vol. 87, No. 14 / Friday, January 21, 2022 / Notices TABLE 1—GUIDANCES RELATED TO THE COVID–19 PUBLIC HEALTH EMERGENCY—Continued Docket No. Center Title of guidance FDA–2020–D–1138 ........ CDRH ........... FDA–2020–D–0987 ........ CDRH ........... Enforcement Policy for Viral Transport Media During the Coronavirus Disease (COVID–19) Public Health Emergency (Revised November 2021). Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised November 2021). 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 Contact information to request single copies 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). CDRH-Guidance@fda.hhs.gov. Please include the document number 20038–R2 and complete title of the guidance in the request. CDRH-Guidance@fda.hhs.gov. Please include the document number 20010–R4 and complete title of the guidance in the request. 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 guidance have been approved by OMB as listed in the following table: TABLE 2—CBER GUIDANCE AND COLLECTIONS COVID–19 guidance title CFR cite referenced in COVID–19 guidance Policy for Certain REMS Requirements During the Tocilizumab Shortage Related to the COVID–19 Public Health Emergency (December 2021). 21 CFR part 314 (New Drug Applications and Abbreviated New Drug Applications). 21 CFR parts 210, 211 and 610 (Current Good Manufacturing Practices). 21 CFR part 600 (Adverse Experience Reports). 21 CFR part 601 (Biologic License Applications). B. CDRH Guidances The guidances listed below refer to previously approved FDA collections of information. These 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 table below (table 3). These guidances also contain a new collection of information not approved under a current collection. These new collections of information have been granted a public health emergency (PHE) waiver from the PRA Another guidance title referenced in COVID–19 guidance OMB control No(s). .................................... 0910–0001 .................................... 0910–0139 .................................... 0910–0308 .................................... 0910–0338 by the Department of Health and Human Services (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/publichealth-emergency-declaration-prawaivers. TABLE 3—CDRH GUIDANCES AND COLLECTIONS COVID–19 guidance title CFR cite referenced in COVID–19 guidance jspears on DSK121TN23PROD with NOTICES1 Enforcement Policy for Viral Transport Media During the Coronavirus Disease 2019 (COVID–19) Public Health Emergency (Revised November 2021) (document number 20038–R2). 800, 801, and 809 ................. 803 ......................................... 806 ......................................... VerDate Sep<11>2014 17:39 Jan 20, 2022 Jkt 256001 PO 00000 Frm 00028 Another guidance referenced in COVID– 19 guidance OMB Control No(s). Emergency Use Authorization of Medical Products and Related Authorities; Guidance for Industry and Other Stakeholders. 0910–0595 Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization. 0910–0607 ................................................ ................................................ ................................................ 0910–0485 0910–0437 0910–0359 Fmt 4703 Sfmt 4703 E:\FR\FM\21JAN1.SGM 21JAN1 New Collection covered by PHE PRA Waiver 3306 Federal Register / Vol. 87, No. 14 / Friday, January 21, 2022 / Notices TABLE 3—CDRH GUIDANCES AND COLLECTIONS—Continued COVID–19 guidance title CFR cite referenced in COVID–19 guidance Another guidance referenced in COVID– 19 guidance 807, subparts A through D .... 807, subpart E ....................... 820 ......................................... 830 and 801.20 ...................... ................................................ ................................................ ................................................ ................................................ OMB Control No(s). New Collection covered by PHE PRA Waiver 0910–0625 0910–0120 0910–0073 0910–0720 Manufacturer voluntary reporting to FDA of viral transport media manufacturing capacity information. Manufacturer voluntary reporting to FDA of sterile phosphate buffered saline/saline manufacturing capacity information. Policy for Coronavirus Disease–2019 Tests During the Public Health Emergency (Revised November 2021) (document number 20010–R4). 803 ......................................... Emergency Use Authorization of Medical Products and Related Authorities; Guidance for Industry and Other Stakeholders. 0910–0595 Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization. 0910–0607 Medical Device Reporting ...... 0910–0437 Confirmation to FDA that the developer of a diagnostic or serology test on FDA’s notification lists and for which an Emergency Use Authorization (EUA) request was submitted, wants FDA to continue reviewing its EUA request. jspears on DSK121TN23PROD with NOTICES1 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. VerDate Sep<11>2014 17:39 Jan 20, 2022 Jkt 256001 Dated: January 14, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–01146 Filed 1–20–22; 8:45 am] Food and Drug Administration [Docket No. FDA–2022–N–0049] BILLING CODE 4164–01–P PO 00000 DEPARTMENT OF HEALTH AND HUMAN SERVICES Revocation of Five Authorizations of Emergency Use of In Vitro Diagnostic Devices for Detection and/or Diagnosis of COVID–19; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the SUMMARY: Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\21JAN1.SGM 21JAN1

Agencies

[Federal Register Volume 87, Number 14 (Friday, January 21, 2022)]
[Notices]
[Pages 3303-3306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-01146]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-D-1137, FDA-2020-D-1138, FDA-2020-D-0987]

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 21, 2022.

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.
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

[[Page 3304]]

(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 guidance.

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, the
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),
determined that a PHE exists and has existed since January 27, 2020,
nationwide.\1\ On March 13, 2020, there was a Presidential declaration
that the COVID-19 outbreak in the United States constitutes a national
emergency, beginning March 1, 2020.\2\
---------------------------------------------------------------------------

\1\ Secretary of Health and Human Services, ``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://trumpwhitehouse.archives.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/. On February 24, 2021, there
was a Presidential Declaration continuing the national emergency
concerning the COVID-19 pandemic beyond March 1, 2021. See
Continuation of the National Emergency Concerning the Coronavirus
Disease 2019 (COVID-19) Pandemic (February 24, 2021), available at
https://www.federalregister.gov/documents/2021/02/26/2021-04173/continuation-of-the-national-emergency-concerning-the-coronavirus-disease-2019-covid-19-pandemic.
---------------------------------------------------------------------------

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 (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:

Table 1--Guidances Related to the COVID-19 Public Health Emergency
----------------------------------------------------------------------------------------------------------------
Contact information to
Docket No. Center Title of guidance request single copies
----------------------------------------------------------------------------------------------------------------
FDA-2020-D-1137................... CBER.................. Policy for Certain REMS Office of Communication,
Requirements During the Outreach and
Tocilizumab Shortage Development, 10903 New
Related to the COVID-19 Hampshire Ave., Bldg.
Public Health Emergency 71, Rm. 3128, Silver
(December 2021). Spring, MD 20993-0002, 1-
800-835-4709 or 240-402-
8010; email
[email protected].

[[Page 3305]]

FDA-2020-D-1138................... CDRH.................. Enforcement Policy for CDRH-
Viral Transport Media [email protected]
During the Coronavirus Please include the
Disease (COVID-19) document number 20038-R2
Public Health Emergency and complete title of
(Revised November 2021). the guidance in the
request.
FDA-2020-D-0987................... CDRH.................. Policy for Coronavirus CDRH-
Disease-2019 Tests [email protected]
During the Public Health Please include the
Emergency (Revised document number 20010-R4
November 2021). 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 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
guidance 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 guidance No(s).
----------------------------------------------------------------------------------------------------------------
Policy for Certain REMS Requirements 21 CFR part 314 (New ............................... 0910-0001
During the Tocilizumab Shortage Drug Applications and
Related to the COVID-19 Public Abbreviated New Drug
Health Emergency (December 2021). Applications).
21 CFR parts 210, 211 ............................... 0910-0139
and 610 (Current Good
Manufacturing
Practices).
21 CFR part 600 (Adverse ............................... 0910-0308
Experience Reports).
21 CFR part 601 ............................... 0910-0338
(Biologic License
Applications).
----------------------------------------------------------------------------------------------------------------

B. CDRH Guidances

The guidances listed below refer to previously approved FDA
collections of information. These 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 table below (table 3). These guidances also
contain a new collection of information not approved under a current
collection. These new collections of information have been granted a
public health emergency (PHE) waiver from the PRA by the Department of
Health and Human Services (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 CFR cite referenced referenced in COVID- OMB Control covered by PHE PRA
in COVID-19 19 guidance No(s). Waiver
-----------------------------------------guidance---------------------------------------------------------------
Enforcement Policy for Viral Emergency Use 0910-0595 ...................
Transport Media During the Authorization of
Coronavirus Disease 2019 (COVID- Medical Products
19) Public Health Emergency and Related
(Revised November 2021) Authorities;
(document number 20038-R2). Guidance for
Industry and Other
Stakeholders.
------------------------------------------------------------------------------
Administrative 0910-0607 ...................
Procedures for
Clinical
Laboratory
Improvement
Amendments of 1988
Categorization.
------------------------------------------------------------------------------
800, 801, and 809.. ................... 0910-0485 ...................
803................ ................... 0910-0437 ...................
806................ ................... 0910-0359 ...................

[[Page 3306]]

807, subparts A ................... 0910-0625 ...................
through D.
807, subpart E..... ................... 0910-0120 ...................
820................ ................... 0910-0073 ...................
830 and 801.20..... ................... 0910-0720 ...................
------------------------------------------------------------------------------
Manufacturer
voluntary
reporting to FDA
of viral transport
media
manufacturing
capacity
information.
----------------------------------------------------------------------------------------------------------------
Manufacturer
voluntary
reporting to FDA
of sterile
phosphate buffered
saline/saline
manufacturing
capacity
information.
----------------------------------------------------------------------------------------------------------------
Policy for Coronavirus Disease-
2019 Tests During the Public
Health Emergency (Revised
November 2021) (document number
20010-R4).
----------------------------------------------------------------------------------------------------------------
Emergency Use 0910-0595 ...................
Authorization of
Medical Products
and Related
Authorities;
Guidance for
Industry and Other
Stakeholders.
----------------------------------------------------------------------------------------------------------------
Administrative 0910-0607 ...................
Procedures for
Clinical
Laboratory
Improvement
Amendments of 1988
Categorization.
----------------------------------------------------------------------------------------------------------------
803................ Medical Device 0910-0437 ...................
Reporting.
----------------------------------------------------------------------------------------------------------------
Confirmation to FDA
that the developer
of a diagnostic or
serology test on
FDA's notification
lists and for
which an Emergency
Use Authorization
(EUA) request was
submitted, wants
FDA to continue
reviewing its EUA
request.
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------

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: January 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01146 Filed 1-20-22; 8:45 am]
BILLING CODE 4164-01-P

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