Guidance Documents Related to Coronavirus Disease 2019; Availability, 21744-21748 [2021-08474]
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Federal Register / Vol. 86, No. 77 / Friday, April 23, 2021 / Notices
Award Type: Cooperative Agreement
Supplement.
Statutory Authority: This program is
authorized under Section 317 of the
Public Health Service Act (42 U.S.C.
247(b–4)); Consolidated and Further
Continuing Appropriations Act, 2015,
Public Law 113–235 (Dec. 16, 2014).
Basis for Award: The Amputee
Coalition of America, Inc. is currently
funded to carry out the objectives of this
program, entitled The National Limb
Loss Resource Center for the period of
April 1, 2019, through March 29, 2024.
Almost 2 million Americans have
experienced amputations or were born
with limb difference and another 28
million people in our country are at risk
for amputation. The supplement will
enable the grantee to carry their work
even further, serving more people living
with limb loss and/or limb differences
and providing even more
comprehensive training and technical
assistance in the development of longterm supportive services. The additional
funding will not be used to begin new
projects or activities. The NLLRC will
enhance and expand currently funded
activities such as conducting national
outreach for the development and
dissemination of patient education
materials, programs, and services;
providing technical support and
assistance to community based limb loss
support groups; and raising awareness
about the limb loss and limb differences
communities.
Establishing an entirely new grant
project at this time would be potentially
disruptive to the current work already
well under way. More importantly, the
people living with limb loss and limb
differences currently being served by
this program could be negatively
impacted by a service disruption, thus
posing the risk of not being able to find
the right resources that could negatively
impact on health and wellbeing. If this
supplement were not provided, the
project would be less able to address the
significant unmet needs of additional
limb loss survivors. Similarly, the
project would be unable to expand its
current technical assistance and training
efforts in NLLRC concepts and
approaches, let alone reach beyond
traditional providers of services to this
population to train more ‘‘mainstream’’
providers of disability services.
Dated: April 19, 2021.
Alison Barkoff,
Administrator and Assistant Secretary for
Aging.
[FR Doc. 2021–08449 Filed 4–22–21; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2020–D–0987, FDA–
2020–D–1106, FDA–2020–D–1136, FDA–
2020–D–1137, FDA–2020–D–1825]
Guidance Documents Related to
Coronavirus Disease 2019; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of FDA
guidance documents related to the
Coronavirus Disease 2019 (COVID–19)
public health emergency (PHE). This
notice of availability (NOA) is pursuant
to the process that FDA announced, in
the Federal Register of March 25, 2020,
for making available to the public
COVID–19-related guidances. The
guidances identified in this notice
address issues related to the COVID–19
PHE and have been issued in
accordance with the process announced
in the March 25, 2020, notice. The
guidances have been implemented
without prior comment, but they remain
subject to comment in accordance with
the Agency’s good guidance practices.
DATES: The announcement of the
guidances is published in the Federal
Register on April 23, 2021.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
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
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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-201509-18/pdf/2015-23389.pdf.
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Federal Register / Vol. 86, No. 77 / Friday, April 23, 2021 / 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 § 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, 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, 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
21745
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:
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TABLE 1—GUIDANCES RELATED TO THE COVID–19 PUBLIC HEALTH EMERGENCY
Docket No.
Center
Title of guidance
FDA–2020–D–1825
CBER .......
Investigational COVID–19 Convalescent
(Updated February 2021).
FDA–2020–D–1137
CBER .......
Emergency Use Authorization for Vaccines to Prevent COVID–19 (Updated February 2021).
FDA–2020–D–1136
CDER ......
COVID–19 Container Closure System and Component Changes: Glass Vials and Stoppers Guidance for Industry (March 2021).
FDA–2020–D–1136
CDER ......
Development of Monoclonal Antibody Products Targeting SARS–CoV–2, Including Addressing the
Impact of Emerging Variants, During the COVID
19 Public Health Emergency (February 2021).
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
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Contact information to request single copies
Plasma
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.
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.
druginfo@fda.hhs.gov.
Please include the docket number FDA–2020–D–
1136 and complete title of the guidance in the request.
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
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‘‘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.
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Federal Register / Vol. 86, No. 77 / Friday, April 23, 2021 / Notices
TABLE 1—GUIDANCES RELATED TO THE COVID–19 PUBLIC HEALTH EMERGENCY—Continued
Docket No.
Center
Title of guidance
Contact information to request single copies
FDA–2020–D–1106
CDER ......
FDA–2020–D–1106
CDER ......
FDA–2020–D–0987
CDRH ......
Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer
Products During the Public Health Emergency
(COVID–19) (Updated February 2021).
Temporary Policy for Preparation of Certain AlcoholBased Hand Sanitizer Products During the Public
Health Emergency (COVID–19) (Updated February 2021).
Policy for Evaluating Impact of Viral Mutations on
COVID–19 Tests (February 2021).
druginfo@fda.hhs.gov.
Please include the docket number FDA–2020–D–
1106 and complete title of the guidance in the request.
druginfo@fda.hhs.gov.
Please include the docket number FDA–2020–D–
1106 and complete title of the guidance in the request.
CDRH-Guidance@fda.hhs.gov. Please include the
document number 21104 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 Guidances
While these guidances contain no
collection of information, they do 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 these guidances. The
previously approved collections of
information are subject to review by
OMB under the PRA. The collections of
information in the following FDA
regulations and guidances have been
approved by OMB as listed in the
following table:
TABLE 2—CBER GUIDANCES AND COLLECTIONS
CFR cite referenced in
COVID–19 guidance
COVID–19 guidance title
Emergency Use Authorization for Vaccines to Prevent COVID–19 (Updated: February 22, 2021).
21 CFR
21 CFR
21 CFR
610.
21 CFR
21 CFR
Another guidance title referenced in COVID–19 guidance
314.420 .................
part 312 .................
parts 210, 211, and
0910–0001
0910–0014
0910–0139
0910–0308
0910–0338
part 600 .................
part 601 .................
Emergency Use Authorization of Medical Products and Related Authorities.
Investigational COVID–19 Convalescent Plasma; Guidance for Industry
(Updated: February 11, 2021).
21 CFR part 312 .................
21 CFR parts 606 and 630
Form FDA 3926 .......................................................................................
B. CDER Guidances
While these guidances contain no
collection of information, they do refer
to previously approved FDA collections
of information (listed in table 3).
OMB control
No(s).
Therefore, clearance by OMB under the
PRA (44 U.S.C. 3501–3521) is not
required for these guidances. The
previously approved collections of
information are subject to review by
0910–0595
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:
TABLE 3—CDER GUIDANCES AND COLLECTIONS
CFR cite referenced in
COVID–19 guidance
COVID–19 guidance title
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COVID–19 Container Closure System and Component Changes: Glass
Vials and Stoppers Guidance for Industry (March 2021).
21
21
21
21
CFR
CFR
CFR
CFR
314.70 ...................
314.97 ...................
601.12 ...................
314.420 .................
Another guidance title referenced in COVID–19 guidance
Requests for Expedited Review of New Drug Application and Biologics
License Application Prior Approval Supplements Submitted for
Chemistry, Manufacturing, and Controls Changes.
Comparability Protocols for Human Drugs and Biologics: Chemistry,
Manufacturing, and Controls Information (April 2016).
Chemistry, Manufacturing, and Controls Changes to an Approved Application: Certain Biological Products (December 2017).
Changes to an Approved Application for Specified Biotechnology and
Specified Synthetic Biological Products (July 1997).
Changes to an Approved NDA or ANDA (April 2004).
Container Closure Systems for Packaging Human Drugs and Biologics; Chemistry, Manufacturing, and Controls Documentation (May
1999).
CMC Postapproval Manufacturing Changes for Specified Biological
Products To Be Documented in Annual Reports (August 2017).
Comparability Protocols for Human Drugs and Biologics: Chemistry,
Manufacturing, and Controls Information (April 2016).
Drug Master Files (October 2019).
Harmonizing Compendial Standards With Drug Application Approval
Using the USP Pending Monograph Process (July 2019).
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OMB control
No(s).
0910–0001
0910–0338
0910–0139
Federal Register / Vol. 86, No. 77 / Friday, April 23, 2021 / Notices
21747
TABLE 3—CDER GUIDANCES AND COLLECTIONS—Continued
COVID–19 guidance title
Development of Monoclonal Antibody Products Targeting SARS-CoV–2,
Including Addressing the Impact of Emerging Variants, During the
COVID–19 Public Health Emergency (February 2021).
CFR cite referenced in
COVID–19 guidance
Another guidance title referenced in COVID–19 guidance
21 CFR 312 ........................
21 CFR 601.20 ...................
Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID–19 Public Health Emergency; Questions and
Answers (August 2020).
PAC–ATLS: Postapproval Changes—Analytical Testing Laboratory
Sites (April 1998).
Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products (November
1994).
Immediate Release Solid Oral Dosage Forms; Scale-Up and Postapproval Changes: Chemistry, Manufacturing, and Controls, In Vitro
Dissolution Testing, and In Vivo Bioequivalence Documentation (November 1995).
Nonsterile Semisolid Dosage Forms; Scale-Up and Postapproval
Changes: Chemistry, Manufacturing, and Controls; In Vitro Release
Testing and In Vivo Bioequivalence Documentation (May 1997).
SUPAC: Manufacturing Equipment Addendum (December 2014).
SUPAC–IR: Questions and Answers about SUPAC–IR Guidance
(February 1997).
SUPAC–MR: Modified Release Solid Oral Dosage Forms; Scale-Up
and Postapproval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation (September 1997).
Q6A Specifications: Test Procedures and Acceptance Criteria for New
Drug Substances and New Drug Products: Chemical Substances
(December 2000).
Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (August 1999).
Q9 Quality Risk Management (June 2006).
Q10 Pharmaceutical Quality System (April 2009).
Emergency Use Authorization of Medical Products and Related Authorities (January 2017).
COVID–19: Potency Assay Considerations for Monoclonal Antibodies
and Other Therapeutic Proteins Targeting SARS-CoV–2 Infectivity
(January 2021).
S6(R1) Preclinical Safety Evaluation of Biotechnology-Delivered Pharmaceuticals (May 2012).
CGMP for Phase 1 Investigational Drugs (July 2008)..
COVID–19 Public Health Emergency: General Considerations for PreIND Meeting Requests for COVID–19 Related Drugs and Biological
Products.
Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use (February 1997)..
COVID–19: Developing Drugs and Biological Products for Treatment
or Prevention (February 2021).
Antiviral Product Development—Conducting and Submitting Virology
Studies to the Agency (June 2006).
Temporary Compounding of Certain Alcohol-Based Hand Sanitizer
Products During the Public Health Emergency (COVID–19).
Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID–19) (Updated February 10, 2021).
Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID–19) (Updated February 10, 2021).
21 CFR 207.17 ...................
21 CFR 207.25 ...................
21 CFR 207.41 ...................
Temporary Policy for Manufacture of Alcohol for Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health
Emergency (COVID–19).
Adverse Event Reporting Requirements.
Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID–19).
Q3C Guideline on Impurities: Guideline for Residual Solvents.
Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID–19).
OMB control
No(s).
0910–0014
0910–0001
0910–0338
0910–0139
0910–0045
0910–0139
0910–0230
0910–0291
0910–0340
0910–0641
0910–0645
0910–0800
0910–0045
0910–0139
0910–0230
0910–0291
0910–0340
0910–0641
Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID–19).
Q3C Guideline on Impurities: Guideline for Residual Solvents.
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C. CDRH Guidance
While this guidance contains no
collection of information, it does refer to
a previously approved FDA collection of
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information (listed in table 4).
Therefore, clearance by OMB under the
PRA (44 U.S.C. 3501–3521) is not
required for this guidance. The
previously approved collection of
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information is subject to review by OMB
under the PRA. The collection of
information in the following FDA
guidance has been approved by OMB as
listed in the following table:
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Federal Register / Vol. 86, No. 77 / Friday, April 23, 2021 / Notices
TABLE 4—CDRH GUIDANCE AND COLLECTIONS
CFR cite referenced in
COVID–19 guidance
COVID–19 guidance title
Policy for Evaluating Impact of Viral Mutations on
COVID–19 Tests (February 2021).
IV. Electronic Access
Persons with access to the internet
may obtain COVID–19-related guidances
at:
• FDA web page entitled ‘‘COVID–19Related Guidance Documents for
Industry, FDA Staff, and Other
Stakeholders,’’ available at https://
www.fda.gov/emergency-preparednessand-response/mcm-issues/covid-19related-guidance-documents-industryfda-staff-and-other-stakeholders;
• FDA web page entitled ‘‘Search for
FDA Guidance Documents’’ available at
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments; or
• https://www.regulations.gov.
Dated: April 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–08474 Filed 4–22–21; 8:45 am]
BILLING CODE 4164–01–P
Another guidance title referenced in COVID–19
guidance
Emergency Use Authorization of Medical Products and Related Authorities; Guidance for Industry and Other Stakeholders.
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995
(PRA).
Submit written comments
(including recommendations) on the
collection of information by May 24,
2021.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function. The OMB
control number for this information
collection is 0910–0428. Also include
the FDA docket number found in
brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0781]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Record Retention
Requirements for the Soy Protein and
Risk of Coronary Heart Disease Health
Claim
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance. Record Retention
Requirements for the Soy Protein and
Risk of Coronary Heart Disease Health
SUPPLEMENTARY INFORMATION:
Claim—21 CFR 101.82
OMB Control Number 0910–0428—
Extension
Notice.
The Food and Drug
Administration (FDA) is announcing
Section 403(r)(3)(A) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
SUMMARY:
OMB control
No(s).
0910–0595
343(r)(3)(A)) provides for the use of food
label statements characterizing a
relationship of any nutrient of the type
required to be in the label or labeling of
the food to a disease or a health related
condition only where that statement
meets the requirements of the
regulations issued by the Secretary of
Health and Human Services to authorize
the use of such a health claim. Section
101.82 (21 CFR 101.82) of our
regulations authorizes a health claim for
food labels about soy protein and the
risk of coronary heart disease.
Accordingly, we established the
previously referenced information
collection in support of the regulation.
In the Federal Register of October 31,
2017 (82 FR 50324), we published a
proposed rule to revoke the underlying
regulation found at § 101.82. We are
taking this action based on our review
of the totality of publicly available
scientific evidence currently available
and our tentative conclusion that such
evidence does not support our previous
determination that there is significant
scientific agreement among qualified
experts for a health claim regarding the
relationship between soy protein and
reduced risk of coronary heart disease.
Upon finalization of the proposed rule,
the associated information collection
requirements under this OMB control
number will be revoked. Until such time
and in accordance with the PRA, we
retain our currently approved burden
estimate for this information collection.
In the Federal Register of October 21,
2020 (85 FR 66999), we published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
khammond on DSKJM1Z7X2PROD with NOTICES
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
21 CFR section
Number
recordkeepers
Number of
records per
recordkeeping
25
1
101.82(c)(2)(ii)(B) .................................................................
1 There
Total annual
records
25
Average
burden per
recordkeeping
1
Total hours
25
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
VerDate Sep<11>2014
18:15 Apr 22, 2021
Jkt 253001
OMB approval, we have made no
adjustments to our burden estimate. The
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
records currently required to be retained
under § 101.82(c)(2)(ii)(B) are the
E:\FR\FM\23APN1.SGM
23APN1
]]>Agencies
[Federal Register Volume 86, Number 77 (Friday, April 23, 2021)]
[Notices]
[Pages 21744-21748]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08474]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2020-D-0987, FDA-2020-D-1106, FDA-2020-D-1136, FDA-
2020-D-1137, FDA-2020-D-1825]
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 April 23, 2021.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
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.
[[Page 21745]]
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, 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, 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-1825................. CBER................ Investigational COVID-19 Office of Communication,
Convalescent Plasma Outreach and Development,
(Updated February 2021). 10903 New Hampshire Ave.,
Bldg. 71, Rm. 3128, Silver
Spring, MD 20993-0002, 1-
800-835-4709 or 240-402-
8010; email
[email protected].
FDA-2020-D-1137................. CBER................ Emergency Use Authorization Office of Communication,
for Vaccines to Prevent Outreach and Development,
COVID-19 (Updated February 10903 New Hampshire Ave.,
2021). Bldg. 71, Rm. 3128, Silver
Spring, MD 20993-0002, 1-
800-835-4709 or 240-402-
8010; email
[email protected].
FDA-2020-D-1136................. CDER................ COVID-19 Container Closure [email protected].
System and Component Please include the docket
Changes: Glass Vials and number FDA-2020-D-1136 and
Stoppers Guidance for complete title of the
Industry (March 2021). guidance in the request.
FDA-2020-D-1136................. CDER................ Development of Monoclonal [email protected].
Antibody Products Please include the docket
Targeting SARS-CoV-2, number FDA-2020-D-1136 and
Including Addressing the complete title of the
Impact of Emerging guidance in the request.
Variants, During the COVID
19 Public Health Emergency
(February 2021).
[[Page 21746]]
FDA-2020-D-1106................. CDER................ Temporary Policy for [email protected].
Manufacture of Alcohol for Please include the docket
Incorporation Into Alcohol- number FDA-2020-D-1106 and
Based Hand Sanitizer complete title of the
Products During the Public guidance in the request.
Health Emergency (COVID-
19) (Updated February
2021).
FDA-2020-D-1106................. CDER................ Temporary Policy for [email protected].
Preparation of Certain Please include the docket
Alcohol-Based Hand number FDA-2020-D-1106 and
Sanitizer Products During complete title of the
the Public Health guidance in the request.
Emergency (COVID-19)
(Updated February 2021).
FDA-2020-D-0987................. CDRH................ Policy for Evaluating [email protected].
Impact of Viral Mutations Please include the
on COVID-19 Tests document number 21104 and
(February 2021). 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 Guidances
While these guidances contain no collection of information, they do
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 these guidances. The previously approved
collections of information are subject to review by OMB under the PRA.
The collections of information in the following FDA regulations and
guidances have been approved by OMB as listed in the following table:
Table 2--CBER Guidances 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).
----------------------------------------------------------------------------------------------------------------
Emergency Use Authorization for 21 CFR 314.420........... 0910-0001
Vaccines to Prevent COVID-19 21 CFR part 312.......... ............................. 0910-0014
(Updated: February 22, 2021). 21 CFR parts 210, 211, ............................. 0910-0139
and 610. ............................. 0910-0308
21 CFR part 600.......... ............................. 0910-0338
21 CFR part 601..........
Emergency Use Authorization 0910-0595
of Medical Products and
Related Authorities.
Investigational COVID-19 Convalescent 21 CFR part 312.......... 0910-0014
Plasma; Guidance for Industry 21 CFR parts 606 and 630. ............................. 0910-0116
(Updated: February 11, 2021).
Form FDA 3926................ 0910-0814
----------------------------------------------------------------------------------------------------------------
B. CDER Guidances
While these guidances contain no collection of information, they do
refer to previously approved FDA collections of information (listed in
table 3). Therefore, clearance by OMB under the PRA (44 U.S.C. 3501-
3521) is not required for these guidances. 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
----------------------------------------------------------------------------------------------------------------
Another guidance title
COVID-19 guidance title CFR cite referenced in referenced in COVID-19 OMB control
COVID-19 guidance guidance No(s).
----------------------------------------------------------------------------------------------------------------
COVID-19 Container Closure System and 21 CFR 314.70............ Requests for Expedited Review 0910-0001
Component Changes: Glass Vials and 21 CFR 314.97............ of New Drug Application and 0910-0338
Stoppers Guidance for Industry (March 21 CFR 601.12............ Biologics License 0910-0139
2021). 21 CFR 314.420........... Application Prior Approval
Supplements Submitted for
Chemistry, Manufacturing,
and Controls Changes.
Comparability Protocols for
Human Drugs and Biologics:
Chemistry, Manufacturing,
and Controls Information
(April 2016).
Chemistry, Manufacturing, and
Controls Changes to an
Approved Application:
Certain Biological Products
(December 2017).
Changes to an Approved
Application for Specified
Biotechnology and Specified
Synthetic Biological
Products (July 1997).
Changes to an Approved NDA or
ANDA (April 2004).
Container Closure Systems for
Packaging Human Drugs and
Biologics; Chemistry,
Manufacturing, and Controls
Documentation (May 1999).
CMC Postapproval
Manufacturing Changes for
Specified Biological
Products To Be Documented in
Annual Reports (August 2017).
Comparability Protocols for
Human Drugs and Biologics:
Chemistry, Manufacturing,
and Controls Information
(April 2016).
Drug Master Files (October
2019).
Harmonizing Compendial
Standards With Drug
Application Approval Using
the USP Pending Monograph
Process (July 2019).
[[Page 21747]]
Manufacturing, Supply Chain,
and Drug and Biological
Product Inspections During
COVID-19 Public Health
Emergency; Questions and
Answers (August 2020).
PAC-ATLS: Postapproval
Changes--Analytical Testing
Laboratory Sites (April
1998).
Submission Documentation for
Sterilization Process
Validation in Applications
for Human and Veterinary
Drug Products (November
1994).
Immediate Release Solid Oral
Dosage Forms; Scale-Up and
Postapproval Changes:
Chemistry, Manufacturing,
and Controls, In Vitro
Dissolution Testing, and In
Vivo Bioequivalence
Documentation (November
1995).
Nonsterile Semisolid Dosage
Forms; Scale-Up and
Postapproval Changes:
Chemistry, Manufacturing,
and Controls; In Vitro
Release Testing and In Vivo
Bioequivalence Documentation
(May 1997).
SUPAC: Manufacturing
Equipment Addendum (December
2014).
SUPAC-IR: Questions and
Answers about SUPAC-IR
Guidance (February 1997).
SUPAC-MR: Modified Release
Solid Oral Dosage Forms;
Scale-Up and Postapproval
Changes: Chemistry,
Manufacturing, and Controls;
In Vitro Dissolution Testing
and In Vivo Bioequivalence
Documentation (September
1997).
Q6A Specifications: Test
Procedures and Acceptance
Criteria for New Drug
Substances and New Drug
Products: Chemical
Substances (December 2000).
Q6B Specifications: Test
Procedures and Acceptance
Criteria for
Biotechnological/Biological
Products (August 1999).
Q9 Quality Risk Management
(June 2006).
Q10 Pharmaceutical Quality
System (April 2009).
Development of Monoclonal Antibody 21 CFR 312............... Emergency Use Authorization 0910-0014
Products Targeting SARS-CoV-2, 21 CFR 601.20............ of Medical Products and 0910-0001
Including Addressing the Impact of Related Authorities (January 0910-0338
Emerging Variants, During the COVID- 2017). 0910-0139
19 Public Health Emergency (February
2021).
COVID-19: Potency Assay
Considerations for
Monoclonal Antibodies and
Other Therapeutic Proteins
Targeting SARS-CoV-2
Infectivity (January 2021).
S6(R1) Preclinical Safety
Evaluation of Biotechnology-
Delivered Pharmaceuticals
(May 2012).
CGMP for Phase 1
Investigational Drugs (July
2008)..
COVID-19 Public Health
Emergency: General
Considerations for Pre-IND
Meeting Requests for COVID-
19 Related Drugs and
Biological Products.
Points to Consider in the
Manufacture and Testing of
Monoclonal Antibody Products
for Human Use (February
1997)..
COVID-19: Developing Drugs
and Biological Products for
Treatment or Prevention
(February 2021).
Antiviral Product
Development--Conducting and
Submitting Virology Studies
to the Agency (June 2006).
Temporary Policy for Preparation of Temporary Compounding of 0910-0045
Certain Alcohol-Based Hand Sanitizer Certain Alcohol-Based Hand 0910-0139
Products During the Public Health Sanitizer Products During 0910-0230
Emergency (COVID-19) (Updated the Public Health Emergency 0910-0291
February 10, 2021). (COVID-19). 0910-0340
0910-0641
0910-0645
0910-0800
Temporary Policy for
Manufacture of Alcohol for
Incorporation Into Alcohol-
Based Hand Sanitizer
Products During the Public
Health Emergency (COVID-19).
Adverse Event Reporting
Requirements.
Policy for Testing of Alcohol
(Ethanol) and Isopropyl
Alcohol for Methanol,
Including During the Public
Health Emergency (COVID-19).
Q3C Guideline on Impurities:
Guideline for Residual
Solvents.
Temporary Policy for Manufacture of 21 CFR 207.17............ Temporary Policy for 0910-0045
Alcohol for Incorporation Into 21 CFR 207.25............ Preparation of Certain 0910-0139
Alcohol-Based Hand Sanitizer Products 21 CFR 207.41............ Alcohol-Based Hand Sanitizer 0910-0230
During the Public Health Emergency Products During the Public 0910-0291
(COVID-19) (Updated February 10, Health Emergency (COVID-19). 0910-0340
2021). 0910-0641
Policy for Testing of Alcohol
(Ethanol) and Isopropyl
Alcohol for Methanol,
Including During the Public
Health Emergency (COVID-19).
Q3C Guideline on Impurities:
Guideline for Residual
Solvents.
----------------------------------------------------------------------------------------------------------------
C. CDRH Guidance
While this guidance contains no collection of information, it does
refer to a previously approved FDA collection of information (listed in
table 4). Therefore, clearance by OMB under the PRA (44 U.S.C. 3501-
3521) is not required for this guidance. The previously approved
collection of information is subject to review by OMB under the PRA.
The collection of information in the following FDA guidance has been
approved by OMB as listed in the following table:
[[Page 21748]]
Table 4--CDRH 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).
----------------------------------------------------------------------------------------------------------------
Policy for Evaluating Impact of Viral Emergency Use Authorization 0910-0595
Mutations on COVID-19 Tests (February of Medical Products and
2021). Related Authorities;
Guidance for Industry and
Other Stakeholders.
----------------------------------------------------------------------------------------------------------------
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: April 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-08474 Filed 4-22-21; 8:45 am]
BILLING CODE 4164-01-P
