Guidance Documents Related to Coronavirus Disease 2019; Availability, 12461-12464 [2022-04637]

Download as PDF Federal Register / Vol. 87, No. 43 / Friday, March 4, 2022 / Notices 12461 U.S. FOOD & DRUG ADMINISTRATION January 11, 2022 Michael Campbell Head of Regulatory Affairs & Quality Quotient Suisse SA Route de Crassier 13 Eysins, VD 1262 S,vitzerland Re: Revocation ofEUA201083 Dear Michael Campbell: This letter is in response to a request from Quotient Suisse SA, received December 22, 2021, that the U.S. Food and Drug Administration (FDA) terminate the MosaiQ COVID-19 Antibody Magazine-EUA201083 issued on September 25, 2020 and amended April 27, 2021 and September 23, 202 l. Quotient Suisse SA decided not to continue to commercially support the MosaiQ COVID-19 Antibody Magazine. The authorization of a device for emergency use under section 564 of the Federal Food, Drug; and Cosmetic Act (the Act) (21 U.S. C. 360bbb-3) may, pursuant to section 564(g)(2) of the Act, be revoked when circumstances make such revocation appropriate to protect the public health or safety (section 564(g)(2)(C) of the Act). Because Quotient Suisse SA has notified FDA that Quotient Suisse SA has decided not to continue to commercially support the product and requested FDA terminate the MosaiQ COVID-19 Antibody Magazine - EUA20 I 083, FDA has determined that it is appropriate to protect the public health or safety to revoke this authorization. Accordingly, FDA hereby revokes EUA201083 for the MosaiQ COVID-19 Antibody Magazine, pursuantto section 564(g)(2)(C) of the Act. As of the date of this letter, the MosaiQ COVID-19 Antibody Magazine is no longer authorized for emergency use by FDA. Notice of this revocation will be published in the Federal Register, pursuantto section 564(h)( 1) of the Act. Sincerely, /s/ Dated: February 28, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–04635 Filed 3–3–22; 8:45 am] Food and Drug Administration [Docket Nos. FDA–2020–D–1825 and FDA– 2020–D–1136] BILLING CODE 4164–01–C lotter on DSK11XQN23PROD with NOTICES1 DEPARTMENT OF HEALTH AND HUMAN SERVICES 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 SUMMARY: VerDate Sep<11>2014 17:05 Mar 03, 2022 Jkt 256001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 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 E:\FR\FM\04MRN1.SGM 04MRN1 EN04MR22.004</GPH> Jacqueline A. ff Shaughnessy, Ph.D. Acting Chief Scientist Food and Drug Administration 12462 Federal Register / Vol. 87, No. 43 / Friday, March 4, 2022 / Notices 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 March 4, 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’’). lotter on DSK11XQN23PROD with NOTICES1 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 VerDate Sep<11>2014 17:05 Mar 03, 2022 Jkt 256001 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 Kimberly Thomas, Center for Drug Evaluation and Research (CDER), Food and Drug Administration, PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 10903 New Hampshire Ave., Bldg. 51, Rm. 6220, Silver Spring, MD 20993– 0002, 301–796–2357. 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 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-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 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\04MRN1.SGM 04MRN1 Federal Register / Vol. 87, No. 43 / Friday, March 4, 2022 / Notices ‘‘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/regulatory- information/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. 12463 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: 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 (Revised January 7, 2022). FDA–2020–D–1136 ....... CDER ....... COVID–19 Public Health Emergency Policy on COVID–19-Related Sanitation Tunnels (February 2022). 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. druginfo@fda.hhs.gov. Please include the docket number FDA–2020–D–1136 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 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 COVID–19 guidance title Investigational COVID–19 Convalescent (Updated: January 7, 2022). Plasma CFR cite referenced in COVID–19 guidance Another guidance title referenced in COVID–19 guidance 21 CFR part 312 ............................ 21 CFR parts 606 and 630 ............ ........................................................ Form FDA 3926 ............................. B. CDER Guidance While this guidance contains no collection of information, it does refer to previously approved FDA collections of information (listed in table 3). Therefore, clearance by OMB under the PRA is not required for this guidance. The previously approved collections of information are subject to review by OMB control No(s). 0910–0014 0910–0116 0910–0814 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: lotter on DSK11XQN23PROD with NOTICES1 TABLE 3—CDER GUIDANCES AND COLLECTIONS COVID–19 guidance title CFR cite referenced in COVID–19 guidance Another guidance referenced in COVID–19 guidance COVID–19 Public Health Emergency Policy on COVID–19-Related Sanitation Tunnels (February 2022). 21 CFR part 312 ......... —Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID– 19) Public Health Emergency (March 2020). —COVID–19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID–19 Related Drugs and Biological Products (May 2020). IV. Electronic Access Persons with access to the internet may obtain COVID–19-related guidances at: VerDate Sep<11>2014 17:05 Mar 03, 2022 Jkt 256001 • FDA web page entitled ‘‘COVID–19Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders,’’ available at https:// www.fda.gov/emergency-preparedness- PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 OMB control No(s). 0910–0001 0910–0014 and-response/mcm-issues/covid-19related-guidance-documents-industryfda-staff-and-other-stakeholders; • FDA web page entitled ‘‘Search for FDA Guidance Documents’’ available at E:\FR\FM\04MRN1.SGM 04MRN1 12464 Federal Register / Vol. 87, No. 43 / Friday, March 4, 2022 / Notices to addressing the needs of PWD; on April 6, 2022, the NACSD will hold a second public meeting session specifically to the needs of older adults. Agendas for all meeting and meeting registration links will be available on the Committees respective web page, https://www.phe.gov/nacsd and https:// www.phe.gov/nacidd. https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments; or • https://www.regulations.gov. Dated: February 28, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–04637 Filed 3–3–22; 8:45 am] BILLING CODE 4164–01–P Members of the public may attend the meetings via a toll-free phone number or Zoom teleconference, which requires pre-registration. The meeting links to pre-register will be posted on https://www.phe.gov/nacsd and https:// www.phe.gov/nacidd. Members of the public may provide written comments or submit questions for consideration via email to the NACSD (NACSD@ hhs.gov) or the NACIDD (NACIDD@ hhs.gov). Members of the public are also encouraged to provide comments after the meetings. ADDRESSES: DEPARTMENT OF HEALTH AND HUMAN SERVICES National Advisory Committee on Seniors and Disasters and National Advisory Committee on Individuals With Disabilities and Disasters; Notice of Meeting Office of the Assistant Secretary for Preparedness and Response (ASPR), Department of Health and Human Services (HHS). ACTION: Notice of meeting. AGENCY: The National Advisory Committee on Seniors and Disasters (NACSD) and the National Advisory Committee on Individuals With Disabilities and Disasters (NACIDD), or Committees, were established by sections 2811B and 2811C, respectively, of the Public Health Service (PHS) Act, as amended by the Pandemic and All Hazards Preparedness and Advancing Innovation Act (PAHPAIA) of 2019. The Committees are governed by the provisions of the Federal Advisory Committee Act (FACA) and the General Services Administration FACA Final Rule. The Committees evaluate issues and programs and provide findings, advice, and recommendations to the Secretary of HHS to support and enhance all-hazards public health and medical preparedness, response, and recovery. The NACSD provides focus on the unique needs of older adults, while the NACIDD focuses on helping HHS meet the needs of people with disabilities (PWD). The Secretary of HHS has formally delegated authority to operate the NACSD and the NACIDD to ASPR. DATES: The NACSD and NACIDD will conduct a joint, virtual, inaugural public meeting on March 30, 2022. The newly appointed members of the two advisory committees will be sworn in as Special Government Employees, followed by presentations and discussion of challenges, opportunities, and priorities for national public health and medical preparedness, response, and recovery specific to the needs of older adults and PWD in disasters. On April 1, 2022, the NACIDD will hold a second public meeting session dedicated specifically lotter on DSK11XQN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:05 Mar 03, 2022 Jkt 256001 Dr. Maxine Kellman, NACSD Designated Federal Official, 202–260–0447, NACSD@hhs.gov; Tabinda Burney, NACIDD Designated Federal Official, 202–699–1779, NACIDD@hhs.gov. Office of the Assistant Secretary for Preparedness and Response (ASPR), Department of Health and Human Services (HHS), Washington, DC. FOR FURTHER INFORMATION CONTACT: The NACSD and the NACIDD invite those who are involved in or represent academia, professional groups, advocacy organizations, or U.S. state, tribal, territorial, or local government to request up to four minutes to address the committees via Zoom. Requests to provide remarks during the public meetings must be sent via email to the NACSD (NACSD@hhs.gov) or the NACIDD (NACIDD@hhs.gov) at least 15 days prior to the meeting along with a brief description of the topic. We would specifically like to request inputs from the public on challenges, opportunities, and strategic priorities for national public health and medical preparedness, response, and recovery specific to the needs of people with disabilities and/or older adults before, during, and after disasters. Presenters who are selected for the public meetings will have audio only for up to four minutes during the meeting. Slides, documents, and other presentation material sent along with the request to speak will be provided to the committee members separately. Please indicate additionally whether the presenter will be willing to take questions from the committee members (at their discretion) immediately following their SUPPLEMENTARY INFORMATION: PO 00000 Frm 00042 Fmt 4703 Sfmt 9990 presentation (for up to four additional minutes). Dawn O’Connell, Assistant Secretary for Preparedness and Response. [FR Doc. 2022–04651 Filed 3–3–22; 8:45 am] BILLING CODE 4150–37–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Diabetes and Digestive and Kidney Diseases Special Emphasis Panel; Collaborative Islet Transplant Registry Special Emphasis Panel. Date: March 15, 2022. Time: 2:30 p.m. to 4:00 p.m. Agenda: To review and evaluate cooperative agreement applications. Place: National Institutes of Health/NIDDK, 6707 Democracy Blvd., Bethesda, MD 20892 (Virtual Meeting). Contact Person: Peter J. Kozel, Ph.D., Chief, Training and Mentored Research Section, Scientific Review Branch, Division of Extramural Activities, 6707 Democracy Blvd., Room 7009, Bethesda, MD 20892, kozelp@ mail.nih.gov, 301–594–4721. This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.847, Diabetes, Endocrinology and Metabolic Research; 93.848, Digestive Diseases and Nutrition Research; 93.849, Kidney Diseases, Urology and Hematology Research, National Institutes of Health, HHS) Dated: March 1, 2022. Miguelina Perez, Program Analyst, Office of Federal Advisory Committee Policy. [FR Doc. 2022–04623 Filed 3–3–22; 8:45 am] BILLING CODE 4140–01–P E:\FR\FM\04MRN1.SGM 04MRN1

Agencies

[Federal Register Volume 87, Number 43 (Friday, March 4, 2022)]
[Notices]
[Pages 12461-12464]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-04637]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-D-1825 and FDA-2020-D-1136]

Guidance Documents Related to Coronavirus Disease 2019;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of 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

[[Page 12462]]

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 March 4, 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 (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 Kimberly Thomas, Center for Drug Evaluation and Research
(CDER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6220, Silver Spring, MD 20993-0002, 301-796-2357.

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\
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\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.
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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

[[Page 12463]]

``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 request single
Docket No. Center Title of guidance copies
----------------------------------------------------------------------------------------------------------------
FDA-2020-D-1825............ CBER........... Investigational COVID- Office of Communication, Outreach and
19 Convalescent Development, 10903 New Hampshire Ave.,
Plasma (Revised Bldg. 71, Rm. 3128, Silver Spring, MD
January 7, 2022). 20993-0002, 1-800-835-4709 or 240-402-
8010; email [email protected].
FDA-2020-D-1136............ CDER........... COVID-19 Public Health [email protected]. Please include the
Emergency Policy on docket number FDA-2020-D-1136 and
COVID-19-Related complete title of the guidance in the
Sanitation Tunnels request.
(February 2022).
----------------------------------------------------------------------------------------------------------------

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
----------------------------------------------------------------------------------------------------------------
Another guidance title
COVID-19 guidance title CFR cite referenced in referenced in COVID-19 OMB control
COVID-19 guidance guidance No(s).
----------------------------------------------------------------------------------------------------------------
Investigational COVID-19 Convalescent 21 CFR part 312........... .......................... 0910-0014
Plasma (Updated: January 7, 2022). 21 CFR parts 606 and 630.. 0910-0116
Form FDA 3926............. 0910-0814
----------------------------------------------------------------------------------------------------------------

B. CDER Guidance

While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information (listed in
table 3). Therefore, clearance by OMB under the PRA 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 3--CDER Guidances and Collections
----------------------------------------------------------------------------------------------------------------
CFR cite referenced in COVID- Another guidance referenced in OMB control
COVID-19 guidance title 19 guidance COVID-19 guidance No(s).
----------------------------------------------------------------------------------------------------------------
COVID-19 Public Health 21 CFR part 312............. --Enforcement Policy for 0910-0001
Emergency Policy on COVID-19- Sterilizers, Disinfectant Devices, 0910-0014
Related Sanitation Tunnels and Air Purifiers During the
(February 2022). Coronavirus Disease 2019 (COVID-
19) Public Health Emergency (March
2020).
--COVID-19 Public Health Emergency:
General Considerations for Pre-IND
Meeting Requests for COVID-19
Related Drugs and Biological
Products (May 2020).
----------------------------------------------------------------------------------------------------------------

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

[[Page 12464]]

https://www.fda.gov/regulatory-information/search-fda-guidance-documents; or
https://www.regulations.gov.

Dated: February 28, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-04637 Filed 3-3-22; 8:45 am]
BILLING CODE 4164-01-P

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