[Federal Register Volume 85, Number 175 (Wednesday, September 9, 2020)]
[Notices]
[Pages 55678-55682]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19883]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2020-D-1106 and FDA-2020-D-1138]
Guidance Documents Related to Coronavirus Disease 2019;
Availability
AGENCY: Food and Drug Administration, Health and Human Services (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 guidance documents 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 September 9, 2020. The guidances have been implemented
without prior comment, but they remain subject to comment in accordance
with the Agency's good guidance practices.
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
[[Page 55679]]
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 document.
FOR FURTHER INFORMATION CONTACT: 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; or Erica Takai, Center for Devices and Radiological Health
(CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5456, (HFZ-450), 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, pursuant to the
authority under section 319 of the Public Health Service Act (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\ On April 21, 2020, the PHE Determination was extended,
effective April 26, 2020; on July 23, 2020, it was extended again,
effective July 25, 2020. These PHE Determinations are 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/.
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In the Federal Register of March 25, 2020 (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 guidance documents 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 guidance
documents. Therefore, FDA will issue COVID-19-related guidance
documents 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 at FDA's web page titled ``COVID-19-Related
Guidance Documents for Industry, FDA Staff, and Other Stakeholders''
(https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders) and through FDA's web page titled ``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
document, FDA intends to publish periodically a consolidated NOA
announcing the availability of certain COVID-19-related guidances 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
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Contact information to
Docket No. Center Title of guidance request single copies
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FDA-2020-D-1106................... Center for Drug Temporary Policy for druginfo@fda.hhs.gov,
Evaluation and Preparation of Certain Please include the
Research (CDER). Alcohol-Based Hand docket number FDA-2020-D-
Sanitizer Products During 1106 and complete title
the Public Health of the guidance in the
Emergency (COVID-19) request.
(March 2020) (Updated
August 7, 2020).
FDA-2020-D-1106................... CDER................. Policy for Temporary druginfo@fda.hhs.gov,
Compounding of Certain Please include the
Alcohol-Based Hand docket number FDA-2020-D-
Sanitizer Products During 1106 and complete title
the Public Health of the guidance in the
Emergency (March 2020) request.
(Updated August 7, 2020).
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FDA-2020-D-1106................... CDER................. Temporary Policy for druginfo@fda.hhs.gov,
Manufacture of Alcohol Please include the
for Incorporation Into docket number FDA-2020-D-
Alcohol-Based Hand 1106 and complete title
Sanitizer Products During of the guidance in the
the Public Health request.
Emergency (COVID-19)
(March 2020) (Updated
August 7, 2020).
FDA-2020-D-1138................... Center for Devices Enforcement Policy for CDRH-
and Radiological Viral Transport Media [email protected],
Health (CDRH). During the Coronavirus Please include the
Disease 2019 (COVID-19) document number 20038
Public Health Emergency and complete title of
(July 2020). the guidance in the
request.
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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. CDER Guidances
The guidances listed in the table below refer to previously
approved collections of information. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521).
The collections of information in the following FDA regulations and
guidances have been approved by OMB as listed in the table below. These
guidances also contain a collection of information not approved under a
current collection. This collection of information has been granted a
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 2--CDER Guidances and Collections
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CFR cite(s)
COVID-19 guidance title referenced in COVID-19 Another guidance referenced OMB Control No(s).
guidance in COVID-19 guidance
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Temporary Policy for Preparation of 27 CFR parts 20 and 21 --Policy for Temporary 0910-0045, 0910-0139,
Certain Alcohol-Based Hand Compounding of Certain 0910-0230, 0910-0291,
Sanitizer Products During the Alcohol-Based Hand 0910-0340, 0910-0641,
Public Health Emergency (COVID- Sanitizer Products During 0910-0645, 0910-0800.
19)--UPDATE of guidance announced the Public Health
in March 2020. Emergency.
--Temporary Policy for
Manufacture of Alcohol for
Incorporation Into Alcohol-
Based Hand Sanitizer
Products During the Public
Health Emergency (COVID-
19).
--Providing Regulatory
Submissions in Electronic
Format--Drug Establishment
Registration and Drug
Listing.
--Postmarketing Adverse
Event Reporting for
Nonprescription Human Drug
Products Marketed Without
an Approved Application.
Temporary Policy for Manufacture of 27 CFR parts 20 and 21 --Policy for Temporary 0910-0045, 0910-0139,
Alcohol for Incorporation Into Compounding of Certain 0910-0230, 0910-0291,
Alcohol-Based Hand Sanitizer Alcohol-Based Hand 0910-0340, 0910-0641,
Products During the Public Health Sanitizer Products During 0910-0645.
Emergency (COVID-19)--UPDATE of the Public Health
guidance announced in March 2020. Emergency.
--Temporary Policy for
Preparation of Certain
Alcohol-Based Hand
Sanitizer Products During
the Public Health
Emergency (COVID-19).
--Providing Regulatory
Submissions in Electronic
Format--Drug Establishment
Registration and Drug
Listing.
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Policy for Temporary Compounding of ...................... --Current Good 0910-0045, 0910-0139,
Certain Alcohol-Based Hand Manufacturing Practices 0910-0230, 0910-0291,
Sanitizer Products During the for Finished 0910-0340, 0910-0641,
Public Health Emergency--UPDATE of Pharmaceuticals and 0910-0645.
guidance announced in March 2020. Medical Gases.
--Postmarketing Adverse
Drug Experience Reporting..
--MedWatch: Adverse Event
and Product Experience
Reporting System (Paper-
Based).
--Format and Content
Requirements for Over-the-
Counter Drug Product
Labeling.
--FDA Adverse Event and
Product Experience
Reports; Electronic
Submissions.
--Adverse Event Reporting
for Outsourcing Facilities
Under Section 503B of the
Federal Food, Drug, and
Cosmetic Act.
--Temporary Policy for
Preparation of Certain
Alcohol-Based Hand
Sanitizer Products During
the Public Health
Emergency (COVID-19).
--Temporary Policy for
Manufacture of Alcohol for
Incorporation Into Alcohol-
Based Hand Sanitizer
Products During the Public
Health Emergency (COVID-
19).
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B. CDRH Guidances
The guidance indicated in the table below refers to previously
approved collections of information. These collections of information
are subject to review by the OMB under the PRA. The collections of
information in the following FDA regulations and guidance have been
approved by OMB as listed in the table below. This guidance also
contains a new collection of information not approved under a current
collection. This new collection of information 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
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CFR cites(s) Another guidance New collection
COVID-19 guidance title referenced in referenced in OMB Control No(s). covered by PHE
COVID-19 guidance COVID-19 guidance PRA waiver
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Enforcement Policy for Viral Emergency Use 0910-0595 .................
Transport Media During the Authorization of
Coronavirus Disease 2019 Medical Products
(COVID-19) Public Health and Related
Emergency (July 2020). Authorities;
Guidance for
Industry and
Other
Stakeholders.
Administrative 0910-0607 .................
Procedures for
Clinical
Laboratory
Improvement
Amendments of
1988
Categorization.
21 CFR parts 800, .................. 0910-0485 .................
801, and 809.
21 CFR part 803... .................. 0910-0437 .................
21 CFR part 806... .................. 0910-0359 .................
21 CFR part 807, .................. 0910-0625 .................
subparts A
through D.
21 CFR part 807, .................. 0910-0120 .................
subpart E.
21 CFR part 820... .................. 0910-0073 .................
21 CFR part 830 .................. 0910-0720 .................
and 21 CFR 801.20.
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.
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[[Page 55682]]
IV. Electronic Access
Persons with access to the internet may obtain COVID-19-related
guidances at:
The 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;
the 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: September 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-19883 Filed 9-8-20; 8:45 am]
BILLING CODE 4164-01-P