Guidance Documents Related to Coronavirus Disease 2019; Availability, 10285-10289 [2021-03421]
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Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices
propose a legislative priority project
should include the priority area(s) in the
project goal, all objectives and
indicators as reflected in the project’s
framework, project approach, Objective
Work Plan and Outcome Tracker.
Reviewers should provide 10 points if
all elements are included in the
application to address one or more of
the economic development priority
areas.
In addition, during tribal
consultation, additional social
development priorities areas were
identified by Native communities to
potentially fund through the SEDS
program. Therefore, 5 bonus points will
be awarded to applications that address
one or more of the following Native
community priority areas: Native
Veterans, Missing and Murdered Native
Americans (MMNA), or Emergency
Preparedness and Response.
Applications that address one of more of
these priorities areas should include the
priority area in the project goal, all
objectives, indicator(s), and target
population (either as participants or
beneficiaries). Reviewers should
provide 5 points if all elements are
included in the application to address
one or more priority areas. Since social
and economic development projects
have different project goals, no
application will be eligible to receive
both sets of bonus points. In addition,
the SEDS program areas of interest will
be expanded to include MMNA and
Anti-Human Trafficking.
7. Changes to SEDS–AK FOA—
Section 803 of NAPA, 42 U.S.C. 2991b.
ANA will also incorporate the new
legislative economic development
priorities into the SEDS–AK FOA.
Therefore, new program areas of interest
for SEDS–AK will include the
following: (1) The development of a
Tribal code or court system for purposes
of economic development, including
commercial codes, training for court
personnel, and the development of
nonprofit subsidiaries or other tribal
business structures; (2) the development
of native community development
financial institutions, including training
and administrative expenses; (3) the
development of a tribal master plans for
community and economic development
and infrastructure. Therefore, 10 bonus
points will be awarded to applications
that address one or more of these
priority areas. Applications that propose
a legislative priority project should have
it included in the project goal, all
objectives and indicators as reflected in
the project’s framework, the project
approach, and the Objective Work Plan
and Outcome Tracker. Reviewers should
provide 10 points if all elements are
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included in the application to address
one or more of the economic
development priority areas. In addition,
ANA plans to modify the description of
the program purpose for the SEDS–AK
FOA to provide a competitive advantage
for smaller Alaska Native villages or
organizations that have never received
ANA funding. Therefore, the FOA will
state that reviewers should award 5
bonus points in the scoring criteria if an
eligible entity has never received an
ANA award. ANA staff will confirm
during the objective review process if an
applicant organization for SEDS–AK has
received a past ANA award.
8. Changes to EMI FOA—Section
803C of NAPA, 42 U.S.C. 2991b–3. In
accordance with 42 U.S.C. 2991b–
3(c)(7), applicants for an EMI grant must
submit an official document that
certifies the applicant has at least 3
years of experience in operating and
administering a Native American
language survival school, a Native
American language nest, or any other
educational program in which
instruction is conducted in a Native
American language, in accordance with
Public Law 109–394. Therefore, the EMI
FOA will have a new evaluation
criterion to score 10 points to ensure the
application includes a certification
document that demonstrates the
applicant has at least 3 years of
experience in operating a language nest,
survival school, or other native language
educational program. As a result, the
EMI FOA’s scoring criteria will change
as follows:
Approach for a maximum of 75
points, to consist of the following: Nest
or Survival School Certification (10
points); Long Term Community Goal (2
points); Current Community Condition
(3 points); Project Goal (2 points);
Objectives (6 points); Outcomes and
Indicators (5 points); Outputs (3 points);
Outcome Tracker and Outcome
Tracking Strategy (7 points);
Community-Based Strategy (8 points);
Readiness and Implementation Strategy
(16 points); and the Objective Work Plan
(OWP) (13 points).
Organizational Capacity for a
maximum of 10 points.
Budget and Budget Justification for a
maximum of 15 points, to consist of the
following: Line Item Budget (5 points)
and Budget Justification (10 points).
9. Changes to SEDS–GO FOA—
Sections 803 and 803B of NAPA, 42
U.S.C. 2991b; 2991b–2. In FY 2020,
ANA introduced a new FOA as a special
initiative under the SEDS program to
support growing organizations to
provide funding to enhance their
internal capacity and infrastructure to
better serve their members or their
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10285
communities. There will be no
substantive changes to application
requirements in the FY 2021 SEDS–GO
FOA. There will be slight changes to the
evaluation scoring criteria, which will
be as follows:
Approach (for a maximum of 70
points) to consist of the following:
Introduction to the Applicant
Organization (6 points); Targeted
Challenge (6 points); Project Goal (6
points); SMART Objectives (6 points);
Outcomes and Indicators (6 points);
Description of Project Implementation
Strategy (25 points); Objective Work
Plan (OWP) (15 points).
Organizational Capacity—15 points.
Budget and Budget Justification (for a
maximum of 15 points) to consist of a
Line Item Budget (5 points) and a
Budget Justification (10 points).
Bonus Points—5 bonus points may be
provided to applicants that have never
received an ANA grant award.
Statutory Authority: Section 814 of
the Native American Programs Act of
1974, as amended.
Elizabeth Leo,
Senior Grant Policy Specialist, Office of
Administration, Administration for Children
and Families.
[FR Doc. 2021–03345 Filed 2–18–21; 8:45 am]
BILLING CODE 4184–34–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–D–1136]
Guidance Documents Related to
Coronavirus Disease 2019; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of FDA
guidance documents related to the
Coronavirus Disease 2019 (COVID–19)
public health emergency (PHE). This
notice of availability (NOA) is pursuant
to the process that FDA announced, in
the Federal Register of March 25, 2020,
for making available to the public
COVID–19-related guidances. The
guidances identified in this notice
address issues related to the COVID–19
PHE and have been issued in
accordance with the process announced
in the March 25, 2020, notice. The
guidances have been implemented
without prior comment, but they remain
subject to comment in accordance with
the Agency’s good guidance practices.
SUMMARY:
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Federal Register / Vol. 86, No. 32 / Friday, February 19, 2021 / Notices
The announcement of the
guidances is published in the Federal
Register on February 19, 2021.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
DATES:
tkelley on DSKBCP9HB2PROD with NOTICES
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
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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, 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
PO 00000
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(CDRH), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Rm. 5456, Silver Spring, MD 20993–
0002, 301–796–6353.
SUPPLEMENTARY INFORMATION:
I. Background
On January 31, 2020, as a result of
confirmed cases of COVID–19, and after
consultation with public health officials
as necessary, the Secretary of Health
and Human Services (HHS), pursuant to
the authority under section 319 of the
Public Health Service Act (42 U.S.C.
247d), determined that a PHE exists and
has existed since January 27, 2020,
nationwide.1 On March 13, 2020, there
was a Presidential declaration that the
COVID–19 outbreak in the United States
constitutes a national emergency,
beginning March 1, 2020.2
In the Federal Register of March 25,
2020 (85 FR 16949) (the March 25, 2020,
notice) (available at https://
www.govinfo.gov/content/pkg/FR-202003-25/pdf/2020-06222.pdf), FDA
announced procedures for making
available FDA guidances related to the
COVID–19 PHE. These procedures,
which operate within FDA’s established
good guidance practices regulations, are
intended to allow FDA to rapidly
disseminate Agency recommendations
and policies related to COVID–19 to
industry, FDA staff, and other
stakeholders. The March 25, 2020,
notice stated that due to the need to act
quickly and efficiently to respond to the
COVID–19 PHE, FDA believes that prior
public participation will not be feasible
or appropriate before FDA implements
COVID–19-related guidances. Therefore,
FDA will issue COVID–19-related
guidances for immediate
implementation without prior public
comment (see section 701(h)(1)(C) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 371(h)(1)(C)) and
§ 10.115(g)(2)). The guidances are
available on FDA’s web pages entitled
‘‘COVID–19-Related Guidance
Documents for Industry, FDA Staff, and
Other Stakeholders’’ (available at
https://www.fda.gov/emergencypreparedness-and-response/mcmissues/covid-19-related-guidancedocuments-industry-fda-staff-and-other1 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/.
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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.
stakeholders) 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
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 (Updated January 2021).
FDA–2020–D–1137
CBER .....
FDA–2020–D–1136
CDER .....
FDA–2020–D–1136
CDER .....
FDA–2020–D–1136
CDER .....
FDA–2020–D–1138
CDRH ....
Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products
During COVID–19 Public Health Emergency (January 2021).
Review Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment Is Needed During the COVID–19 Public
Health Emergency (December 2020).
Protecting Participants in Bioequivalence Studies for
Abbreviated New Drug Applications During the
COVID–19 Public Health Emergency (January
2021).
COVID–19: Potency Assay Considerations for
Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV–2 Infectivity (January
2021).
Coagulation
Systems
for
Measurement
of
Viscoelastic Properties: Enforcement Policy During
the Coronavirus Disease 2019 (COVID–19) Public
Health Emergency (January 2021).
Office of Communication, Outreach and Development, 10903 New Hampshire Ave., Bldg. 71, Rm.
3128, Silver Spring, MD 20993–0002, 1–800–835–
4709 or 240–402–8010; email ocod@fda.hhs.gov.
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
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.
CDRH-Guidance@fda.hhs.gov. Please include the
document number 20041–R1 and complete title of
the guidance in the request.
FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
III. Paperwork Reduction Act of 1995
A. CBER 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
tkelley on DSKBCP9HB2PROD with NOTICES
Investigational COVID–19 Convalescent Plasma; Guidance for Industry (Updated: January 15, 2021).
Manufacturing Considerations for Licensed
and Investigational Cellular and Gene Therapy Products During COVID–19 Public
Health Emergency (January 2021).
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Another guidance title
referenced in COVID–19
guidance
CFR cite referenced in
COVID–19 guidance
COVID–19 guidance title
OMB control
No(s).
21 CFR part 312, 21 CFR
parts 606 and 630.
Form FDA 3926 ......................
0910–0014, 0910–0116,
0910–0814.
21 CFR 1271.50, 21 CFR part
211, 21 CFR part 312
(INDs), 21 CFR part 601
(BLAs), 21 CFR 314.420
(Master Files).
.................................................
0910–0543, 0910–0139,
0910–0014, 0910–0338,
0910–0001.
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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
tkelley on DSKBCP9HB2PROD with NOTICES
Review Timelines for Applicant Responses to
Complete Response Letters When a Facility
Assessment Is Needed During the COVID–
19 Public Health Emergency (December
2020).
21 CFR 314.3(b), 21 CFR
600.3 and 600.21, 21 CFR
601.20(d).
Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications
During the COVID–19 Public Health Emergency.
21 CFR 50, 21 CFR 312, 21
CFR 314.3, 21 CFR
314.101, 21 CFR 314.105,
21 CFR 320.1, 21 CFR
320.23(b), 21 CFR 320.24–
26, 21 CFR 320.31, 21
CFR 314.94, 314.101,
314.105.
COVID–19: Potency Assay Considerations for
Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS–CoV–2 Infectivity.
21 CFR 211.165, 21 CFR
211.194, 21 CFR 601.2, 21
CFR 610.3, 21 CFR 610.10.
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Another guidance title
referenced in COVID–19
guidance
CFR cite referenced in
COVID–19 guidance
COVID–19 guidance title
PO 00000
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Fmt 4703
Manufacturing, Supply Chain,
and Drug and Biological
Product Inspections During
COVID–19 Public Health
Emergency: Questions and
Answers.
Referencing Approved Drug
Products in ANDA Submissions.
Bioequivalence Studies With
Pharmacokinetic Endpoints
for Drugs Submitted Under
an Abbreviated New Drug
Application.
Conduct of Clinical Trials of
Medical Products during the
COVID–19 Public Health
Emergency.
ANDA Submissions—Content
and Format of Abbreviated
New Drug Application.
Controlled Correspondence
Related to Generic Drug
Development.
Formal Meetings Between
FDA and ANDA Applicants
of Complex Products Under
GDUFA.
Use of Electronic Informed
Consent in Clinical Investigations—Questions and
Answers.
Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring.
ICH guidance for Industry
Q6B Specifications: Test
Procedures and Acceptance
Criteria for Biotechnological/
Biological Products.
Analytical Procedures and
Methods Validation for
Drugs and Biologics.
ICH guidance for industry
Q2(R1) Validation of Analytical Procedures: Text and
Methodology.
Emergency Use Authorization
of Medical Products and
Related Authorities.
Bioanalytical Method Validation.
ICH guidance for industry
M4Q: The CTD—Quality.
ICH guidance for industry
Q5C Quality of Biotechnological Products: Stability
Testing of Biotechnological/
Biological Products.
ICH guidance for industry
Q8(R2) Pharmaceutical Development.
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OMB control
No(s).
0910–0001, 0910–0338,
0910–0139.
0910–0001, 0910–0014,
0910–0130, 0910–0139,
0910–0303, 0910–0572,
0910–0755, 0910–0797.
0910–0001, 0910–0014,
0910–0338, 0910–0139,
0910–0303.
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C. CDRH Guidance
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections 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 collections of
information are subject to review by
OMB under the PRA. The collections of
information in the following FDA
regulations have been approved by OMB
as listed in the following table:
TABLE 4—CDRH GUIDANCE AND COLLECTIONS
COVID–19 guidance title
CFR cite referenced in
COVID–19 guidance
Another guidance title
referenced in COVID–19
guidance
Coagulation Systems for Measurement of
Viscoelastic Properties: Enforcement Policy
During the Coronavirus Disease 2019
(COVID–19) Public Health Emergency (January 2021).
800, 801, and 809 ..................
807, subparts A through D .....
807, subpart E ........................
803 ..........................................
806 ..........................................
820 ..........................................
.................................................
IV. Electronic Access
consumer advocacy groups, healthcare
professionals, and scientific and
academic experts—notify FDA of their
intent to participate in periodic
consultation meetings on the
reauthorization of the Medical Device
User Fee Amendments (MDUFA). The
statutory authority for MDUFA expires
in September 2022. At that time, new
legislation will be required for FDA to
continue collecting user fees for the
medical device program. The Federal
Food, Drug, and Cosmetic Act (FD&C
Act) requires that FDA consult with a
range of stakeholders in developing
recommendations for the next MDUFA
program. The FD&C Act also requires
that FDA hold discussions (at least
every month) with patient and
consumer advocacy groups during
FDA’s negotiations with the regulated
industry. The purpose of this request for
notification is to ensure continuity and
progress in these monthly discussions
by establishing consistent public
stakeholder representation.
DATES: Submit notification of intention
to participate in these series of meetings
by February 26, 2021. Stakeholder
meetings will be held monthly. It is
anticipated that they will commence in
March 2021. See the SUPPLEMENTARY
INFORMATION section for registration date
and information.
ADDRESSES: The meetings will take
place virtually and will be held by
webcast only. Submit notification of
intention to participate in monthly
stakeholder meetings by email to
MDUFAVReauthorization@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Ellen Olson, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1664, Silver Spring,
MD 20993, 301–796–4322,
MDUFAVReauthorization@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
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: February 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–03421 Filed 2–18–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–2253]
Medical Device User Fees; Stakeholder
Meetings on Medical Device User Fee
Amendments of Fiscal Years 2023 to
2027 Reauthorization; Request for
Notification of Stakeholder Intention to
Participate
tkelley on DSKBCP9HB2PROD with NOTICES
AGENCY:
Food and Drug Administration,
HHS.
Notice; request for notification
of participation.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
issuing this notice to request that public
stakeholders—including patient and
SUMMARY:
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No(s).
0910–0485.
0910–0625.
0910–0120.
0910–0437.
0910–0359.
0910–0073.
I. Background
FDA is requesting that public
stakeholders—including patient and
consumer advocacy groups, healthcare
professionals, and scientific and
academic experts—notify the Agency of
their intent to participate in periodic
stakeholder consultation meetings on
the reauthorization of MDUFA. MDUFA
authorizes FDA to collect user fees from
the regulated industry for the process
for the review of medical devices. The
authorization for the current program
(MDUFA IV) expires in September 2022.
Without new legislation, FDA will no
longer be able to collect user fees for
future fiscal years to fund the medical
device review process.
Section 738A(b)(1) of the FD&C Act
(21 U.S.C. 379j–1(b)(1)) requires that
FDA consult with a range of
stakeholders, including representatives
from patient and consumer advocacy
groups, healthcare professionals, and
scientific and academic experts, in
developing recommendations for the
next MDUFA program. FDA initiated
the reauthorization process by holding a
public meeting on October 27, 2020,
where stakeholders and other members
of the public were given an opportunity
to present their views on the
reauthorization. The FD&C Act further
requires that FDA continue meeting
with the representatives of patient and
consumer advocacy groups at least once
every month during negotiations with
the regulated industry to continue
discussions of stakeholder views on the
reauthorization and their suggestions for
changes. It is anticipated that these
monthly stakeholder consultation
meetings will commence in March 2021.
FDA is issuing this Federal Register
notice to request that stakeholder
representatives from patient and
consumer advocacy groups, healthcare
professional associations, as well as
E:\FR\FM\19FEN1.SGM
19FEN1
]]>Agencies
[Federal Register Volume 86, Number 32 (Friday, February 19, 2021)]
[Notices]
[Pages 10285-10289]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03421]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 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 without prior comment, but they
remain subject to comment in accordance with the Agency's good guidance
practices.
[[Page 10286]]
DATES: The announcement of the guidances is published in the Federal
Register on February 19, 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.
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\
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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/.
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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 ``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-
[[Page 10287]]
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 January 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................ Manufacturing Office of Communication,
Considerations for Outreach and Development,
Licensed and 10903 New Hampshire Ave.,
Investigational Cellular Bldg. 71, Rm. 3128, Silver
and Gene Therapy Products Spring, MD 20993-0002, 1-
During COVID-19 Public 800-835-4709 or 240-402-
Health Emergency (January 8010; email
2021). [email protected].
FDA-2020-D-1136................. CDER................ Review Timelines for [email protected].
Applicant Responses to Please include the docket
Complete Response Letters number FDA-2020-D-1136 and
When a Facility Assessment complete title of the
Is Needed During the COVID- guidance in the request.
19 Public Health Emergency
(December 2020).
FDA-2020-D-1136................. CDER................ Protecting Participants in [email protected].
Bioequivalence Studies for Please include the docket
Abbreviated New Drug number FDA-2020-D-1136 and
Applications During the complete title of the
COVID-19 Public Health guidance in the request.
Emergency (January 2021).
FDA-2020-D-1136................. CDER................ COVID-19: Potency Assay [email protected].
Considerations for Please include the docket
Monoclonal Antibodies and number FDA-2020-D-1136 and
Other Therapeutic Proteins complete title of the
Targeting SARS-CoV-2 guidance in the request.
Infectivity (January 2021).
FDA-2020-D-1138................. CDRH................ Coagulation Systems for [email protected].
Measurement of Please include the
Viscoelastic Properties: document number 20041-R1
Enforcement Policy During and complete title of the
the Coronavirus Disease guidance in the request.
2019 (COVID-19) Public
Health Emergency (January
2021).
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Although these guidances have been implemented immediately without
prior comment, FDA will consider all comments received and revise the
guidances as appropriate (see Sec. 10.115(g)(3)).
These guidances are being issued consistent with FDA's good
guidance practices regulation (Sec. 10.115). The guidances represent
the current thinking of FDA. They do not establish any rights for any
person and are not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.
III. Paperwork Reduction Act of 1995
A. CBER 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 No(s).
COVID-19 guidance guidance
----------------------------------------------------------------------------------------------------------------
Investigational COVID-19 Convalescent 21 CFR part 312, 21 CFR Form FDA 3926.......... 0910-0014, 0910-0116,
Plasma; Guidance for Industry parts 606 and 630. 0910-0814.
(Updated: January 15, 2021).
Manufacturing Considerations for 21 CFR 1271.50, 21 CFR ....................... 0910-0543, 0910-0139,
Licensed and Investigational part 211, 21 CFR part 0910-0014, 0910-0338,
Cellular and Gene Therapy Products 312 (INDs), 21 CFR 0910-0001.
During COVID-19 Public Health part 601 (BLAs), 21
Emergency (January 2021). CFR 314.420 (Master
Files).
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[[Page 10288]]
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 No(s).
COVID-19 guidance guidance
----------------------------------------------------------------------------------------------------------------
Review Timelines for Applicant 21 CFR 314.3(b), 21 CFR Manufacturing, Supply 0910-0001, 0910-0338,
Responses to Complete Response 600.3 and 600.21, 21 Chain, and Drug and 0910-0139.
Letters When a Facility Assessment CFR 601.20(d). Biological Product
Is Needed During the COVID-19 Public Inspections During
Health Emergency (December 2020). COVID-19 Public Health
Emergency: Questions
and Answers.
Protecting Participants in 21 CFR 50, 21 CFR 312, Referencing Approved 0910-0001, 0910-0014,
Bioequivalence Studies for 21 CFR 314.3, 21 CFR Drug Products in ANDA 0910-0130, 0910-0139,
Abbreviated New Drug Applications 314.101, 21 CFR Submissions. 0910-0303, 0910-0572,
During the COVID-19 Public Health 314.105, 21 CFR 320.1, Bioequivalence Studies 0910-0755, 0910-0797.
Emergency. 21 CFR 320.23(b), 21 With Pharmacokinetic
CFR 320.24-26, 21 CFR Endpoints for Drugs
320.31, 21 CFR 314.94, Submitted Under an
314.101, 314.105. Abbreviated New Drug
Application.
Conduct of Clinical
Trials of Medical
Products during the
COVID-19 Public Health
Emergency.
ANDA Submissions--
Content and Format of
Abbreviated New Drug
Application.
Controlled
Correspondence Related
to Generic Drug
Development.
Formal Meetings Between
FDA and ANDA
Applicants of Complex
Products Under GDUFA.
Use of Electronic
Informed Consent in
Clinical
Investigations--Questi
ons and Answers.
Oversight of Clinical
Investigations--A Risk-
Based Approach to
Monitoring.
COVID-19: Potency Assay 21 CFR 211.165, 21 CFR ICH guidance for 0910-0001, 0910-0014,
Considerations for Monoclonal 211.194, 21 CFR 601.2, Industry Q6B 0910-0338, 0910-0139,
Antibodies and Other Therapeutic 21 CFR 610.3, 21 CFR Specifications: Test 0910-0303.
Proteins Targeting SARS-CoV-2 610.10. Procedures and
Infectivity. Acceptance Criteria
for Biotechnological/
Biological Products.
Analytical Procedures
and Methods Validation
for Drugs and
Biologics.
ICH guidance for
industry Q2(R1)
Validation of
Analytical Procedures:
Text and Methodology.
Emergency Use
Authorization of
Medical Products and
Related Authorities.
Bioanalytical Method
Validation.
ICH guidance for
industry M4Q: The CTD--
Quality.
ICH guidance for
industry Q5C Quality
of Biotechnological
Products: Stability
Testing of
Biotechnological/
Biological Products.
ICH guidance for
industry Q8(R2)
Pharmaceutical
Development.
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[[Page 10289]]
C. CDRH Guidance
While this guidance contains no collection of information, it does
refer to previously approved FDA collections 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
collections of information are subject to review by OMB under the PRA.
The collections of information in the following FDA regulations have
been approved by OMB as listed in the following table:
Table 4--CDRH Guidance and Collections
----------------------------------------------------------------------------------------------------------------
Another guidance title
COVID-19 guidance title CFR cite referenced in referenced in COVID-19 OMB control No(s).
COVID-19 guidance guidance
----------------------------------------------------------------------------------------------------------------
Coagulation Systems for Measurement 800, 801, and 809...... ....................... 0910-0485.
of Viscoelastic Properties: 807, subparts A through 0910-0625.
Enforcement Policy During the D. .......................
Coronavirus Disease 2019 (COVID-19) 807, subpart E......... 0910-0120.
Public Health Emergency (January 803.................... 0910-0437.
2021). 806.................... 0910-0359.
820.................... 0910-0073.
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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: February 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-03421 Filed 2-18-21; 8:45 am]
BILLING CODE 4164-01-P
