Guidance Documents Related to Coronavirus Disease 2019 (COVID-19); Availability, 65820-65824 [2020-22968]
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Federal Register / Vol. 85, No. 201 / Friday, October 16, 2020 / Notices
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• Confidential Submissions—To
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more information about FDA’s posting
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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.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Giaquinto Friedman, Office of
Generic Drugs, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1670,
Silver Spring, MD 20993–0002, 240–
402–7930.
In the
Federal Register of June 1, 2020 (85 FR
33169), FDA published a notice with a
90-day comment period to solicit
comments on the listing of patent
information in the FDA publication,
‘‘Approved Drug Products With
Therapeutic Equivalence Evaluations’’
(commonly known as the ‘‘Orange
Book’’).
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SUPPLEMENTARY INFORMATION:
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The Agency has received a request for
an extension of the comment period for
the public docket in order to develop a
response to the request for comment.
FDA has considered the request and
is reopening the comment period for the
public docket for 30 days, until
November 16, 2020. The Agency
believes that an additional 30 days will
allow adequate time for interested
persons to submit comments.
Dated: October 13, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–22969 Filed 10–15–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2020–D–1136 and FDA–
2020–D–1106]
Guidance Documents Related to
Coronavirus Disease 2019 (COVID–19);
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 October 16, 2020. The
guidances have been implemented
without prior comment, but they remain
subject to comment in accordance with
the Agency’s good guidance practices.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
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• 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
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Federal Register / Vol. 85, No. 201 / Friday, October 16, 2020 / Notices
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 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 guidances.
FOR FURTHER INFORMATION CONTACT:
Kimberly Thomas, Center for Drug
Evaluation and Research (CDER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6220,
Silver Spring, MD 20993–0002, 301–
796–2357.
SUPPLEMENTARY INFORMATION:
I. Background
On January 31, 2020, as a result of
confirmed cases of COVID–19, and after
consultation with public health officials
as necessary, Alex M. Azar II, Secretary
of Health and Human Services, pursuant
to the authority under section 319 of the
Public Health Service Act (42 U.S.C.
247d) (PHS Act), determined that a PHE
exists and has existed since January 27,
2020, nationwide.1 On March 13, 2020,
President Donald J. Trump declared that
the COVID–19 outbreak in the United
States constitutes a national emergency,
beginning March 1, 2020.2
In the Federal Register of March 25,
2020 (the March 25, 2020, notice)
(available at https://www.govinfo.gov/
content/pkg/FR-2020-03-25/pdf/202006222.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
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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
(FD&C Act) (21 U.S.C. 371(h)(1)(C) and
21 CFR 10.115(g)(2) (§ 10.115(g)(2))).
The guidances are available at FDA’s
web page entitled ‘‘COVID–19-Related
Guidance Documents for Industry, FDA
Staff, and Other Stakeholders’’ (https://
www.fda.gov/emergency-preparednessand-response/mcm-issues/covid-19related-guidance-documents-industryfda-staff-and-other-stakeholders) and
through FDA’s web page entitled
‘‘Search for FDA Guidance Documents’’
available at https://www.fda.gov/
regulatory-information/search-fdaguidance-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–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
Contact information to request single copies
FDA–2020–D–1136
CDER .............
druginfo@fda.hhs.gov. Please include the docket
number FDA–2020–D–1136 and complete title of
the guidance in the request.
FDA–2020–D–1136
CDER .............
FDA–2020–D–1106
CDER .............
Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID–19
Public Health Emergency Questions and Answers (August 2020).
Resuming Normal Drug and Biologics Manufacturing Operations During the COVID–19 Public
Health Emergency (September 2020).
FDA Guidance on Conduct of Clinical Trials of
Medical Products during COVID–19 Public
Health Emergency (March 2020) (Updated September 2020).
druginfo@fda.hhs.gov. Please include the docket
number FDA–2020–D–1136 and complete title of
the guidance in the request.
Clinicaltrialconduct-COVID19@fda.hhs.gov. Please
include the docket number FDA–2020–D–1106
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
1 On April 21, 2020, the PHE Determination was
extended, effective April 26, 2020; on July 23, 2020,
it was extended, effective July 25, 2020; on October
2, 2020, it was extended, effective October 23, 2020.
These PHE Determinations are available at https://
www.phe.gov/emergency/news/healthactions/phe/
Pages/default.aspx.
2 Proclamation on Declaring a National
Emergency Concerning the Novel Coronavirus
Disease (COVID–19) Outbreak (Mar. 13, 2020),
available at https://www.whitehouse.gov/
presidential-actions/proclamation-declaringnational-emergency-concerning-novel-coronavirusdisease-covid-19-outbreak/.
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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
CDER Guidances
The guidances listed in the table
below refer to previously approved FDA
collections of information. 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. However, these 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:
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TABLE 2—CDER GUIDANCES AND COLLECTIONS
COVID–19 guidance title
CFR cite referenced in
COVID–19 guidance
Another guidance title referenced in COVID–
19 guidance
OMB control No(s).
Guidance for Industry: Resuming Normal Drug
and Biologics Manufacturing Operations
During the COVID–19 Public Health Emergency.
21 CFR 210 and 211,
21 CFR 514.80, 21
CFR 600.
0910–0001, 0910–
0032, 0910–0139,
0910–0338, 0910–
0669, 0910–0675,
0910–0759, 0910–
0806.
Manufacturing, Supply Chain, and Drug and
Biological Product Inspections During
COVID–19 Public Health Emergency; Questions and Answers.
21 CFR 314.50;
314.95, 314.125,
314.127; 601.2 and
601.20.
—Q7 Good Manufacturing Practice Guidance
for Active Pharmaceutical Ingredients.
—Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products.
—Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing
Under Section 506C of the FD&C Act.
—Reporting and Mitigating Animal Drug
Shortages During the COVID–19 Public
Health Emergency.
—Prioritization of the Review of Original
ANDAs, Amendments, and Supplements.
—Requests for Expedited Review of New
Drug Application and Biologics License Application Prior Approval Supplements Submitted for Chemistry, Manufacturing, and
Controls Changes.
—Administrative Processing of Original Biologics License Applications (BLA) and New
Drug Applications (NDA).
—Changes to an Approved Application for
Specified Biotechnology and Specified Synthetic Biological Products.
—Changes to an Approved Application: Biological Products.
—Changes to an Approved NDA or ANDA;
Questions and Answers.
—Changes to an Approved NDA or ANDA.
—CMC Postapproval Manufacturing Changes
To Be Documented in Annual Reports.
—Changes to an Approved Application: Biological Products: Human Blood and Blood
Components Intended for Transfusion or
for Further Manufacture.
—CMC Postapproval Manufacturing Changes
for Specified Biological Products To Be
Documented in Annual Reports.
—Chemistry, Manufacturing, and Controls
Changes to an Approved Application: Certain Biological Products.
—Immediate Release Solid Oral Dosage
Forms; Scale-Up and Postapproval
Changes: Chemistry, Manufacturing, and
Controls, In Vitro Dissolution Testing, and
In Vivo Bioequivalence Documentation.
—SUPAC–IR: Questions and Answers about
SUPAC–IR Guidance.
—Nonsterile Semisolid Dosage Forms; ScaleUp and Postapproval Changes: Chemistry,
Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence
Documentation.
—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.
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0910–0001, 0910–
0014, 0910–0338,
0910–0045, 0910–
0139, 0910–0759.
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TABLE 2—CDER GUIDANCES AND COLLECTIONS—Continued
CFR cite referenced in
COVID–19 guidance
COVID–19 guidance title
Another guidance title referenced in COVID–
19 guidance
OMB control No(s).
—SUPAC: Manufacturing Equipment Addendum.
The guidance listed in the table below
refers to previously approved FDA
collections of information. Therefore,
clearance by OMB under the PRA is not
required for this guidance. However,
these collections of information are
subject to review by OMB under the
PRA. The previously approved
collections of information in the
following FDA regulations and guidance
have been approved by OMB as listed in
the table below. This guidance also
contains a collection of information not
approved under a current collection.
This collection of information has been
granted a PHE waiver from the PRA by
the Department of Health and Human
Services (HHS) on March 19, 2020,
under section 319(f) of the PHS Act.
Information concerning the PHE PRA
waiver can be found on the HHS
website at https://aspe.hhs.gov/publichealth-emergency-declaration-prawaivers.
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TABLE 3—CDER GUIDANCES AND COLLECTIONS
COVID–19 guidance title
CFR cite referenced in COVID–19
guidance
Another guidance referenced in
COVID–19 guidance
OMB control No(s).
Guidance on Conduct of Clinical Trials
of Medical Products during COVID–
19 Public Health Emergency (Updated September 21, 2020).
21 CFR part 11, 21 CFR part 50, 21
CFR part 56, 21 CFR part 312, 21
CFR part 314, 21 CFR part 320, 21
CFR part 601, 21 CFR part 812.
Formal Meetings Between the FDA
and Sponsors or Applicants of
PDUFA Products.
Formal Meetings Between the FDA
and Sponsors or Applicants of
BsUFA Products.
Pediatric Study Plans: Content of and
Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans.
Draft Guidance for Industry on Demonstrating Substantial Evidence of
Effectiveness for Human Drug and
Biological Products.
Enhancing the Diversity of Clinical
Trial Populations—Eligibility Criteria,
Enrollment Practices, and Trial Design.
Pregnant Women: Scientific and Ethical Considerations for Inclusion in
Clinical Trials.
Part 11, Electronic Records; Electronic
Signatures Scope and Application.
Use of Electronic Records and Electronic Signatures in Clinical Investigations under 21 CFR Part 11—
Questions and Answers.
Safety Reporting Requirements for
INDs and BA/BE Studies.
Adverse Event Reporting to IRBs—Improving Human Subject Protection.
Use of Electronic Informed Consent In
Clinical Investigations.
E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1).
Providing Regulatory Submissions in
Electronic Format—Certain Human
Pharmaceutical Product Applications
and Related Submissions Using the
eCTD Specifications.
Best Practices for Communication Between IND Sponsors and FDA During Drug Development.
Requests for Feedback and Meetings
for Medical Device Submissions:
The Q-Submission Program..
0910–0001, 0910–
0014, 0910–
0130, 0910–
0303, 0910–
0338, 0910–
0119, 0910–
0581, 0910–
0733, 0910–
0078
IV. Electronic Access
Persons with access to the internet
may obtain COVID–19-related guidances
at:
• The FDA web page entitled
‘‘COVID–19-Related Guidance
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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;
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Collection covered
by PHE PRA
waiver
Submission by investigators of informed consent
forms to third
parties.
• the FDA web page entitled ‘‘Search
for FDA Guidance Documents’’
available at https://www.fda.gov/
regulatory-information/search-fdaguidance-documents; or
• https://www.regulations.gov.
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Federal Register / Vol. 85, No. 201 / Friday, October 16, 2020 / Notices
Dated: October 13, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–22968 Filed 10–15–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–2031]
Quality Management Maturity for
Finished Dosage Forms Pilot Program
for Domestic Drug Product
Manufacturers; Program
Announcement
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency), Center
for Drug Evaluation and Research
(CDER) is announcing its Quality
Management Maturity for Finished
Dosage Forms Pilot Program (QMM FDF
Pilot Program) for domestic drug
product manufacturers of prescription
and over-the-counter (OTC) drug
products. The purpose of the QMM FDF
Pilot Program is to gain insight from
third-party assessments of a
manufacturer’s quality management
system to inform future development of
an FDA rating system to characterize
quality management maturity (QMM).
Such a rating system would allow a
cross-sectional comparison of
manufacturers. Manufacturers that
choose to disclose their facility ratings
could benefit from a competitive
advantage, as knowledge of QMM
ratings would enable health systems and
other purchasers and payers of
medications to differentiate among drug
manufacturers. This notice invites
manufacturers that are interested in
participating in the QMM FDF Pilot
Program to submit a request to
participate.
SUMMARY:
FDA will accept requests to
participate in the QMM FDF Pilot
Program through November 30, 2020,
and the QMM FDF Pilot Program will
run through December 31, 2021. See the
‘‘Participation’’ section for selection
criteria and instructions on how to
submit a request to participate.
FOR FURTHER INFORMATION CONTACT: For
general questions about the QMM FDF
Pilot Program: Jennifer Maguire, Center
for Drug Evaluation and Research
(CDER), 10903 New Hampshire Ave.,
Silver Spring, MD 20993, Bldg. 51, Rm.
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DATES:
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4134, 240–402–4817, Jennifer.Maguire@
fda.hhs.gov.
To submit a request to participate in
the QMM FDF Pilot Program: Seongjin
(Cindy) Pak, CDER, Bldg. 51, Rm. 4220,
301–796–1673, Seongjin.Pak@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In 2002, FDA launched an initiative,
‘‘Pharmaceutical CGMPs for the 21st
Century—A Risk-Based Approach,’’ to
enhance and modernize the regulation
of pharmaceutical manufacturing and
product quality.1 One objective, among
others, was to facilitate the
implementation of a modern, risk-based
pharmaceutical quality assessment
system. The desired state has been
described as a maximally efficient, agile,
flexible pharmaceutical manufacturing
sector that reliably produces highquality drug products without extensive
regulatory oversight.
There has been significant progress
toward this vision as evidenced by FDA
programs and initiatives in such areas as
pharmaceutical development and
quality by design, quality risk
management and pharmaceutical
quality systems, process validation, and
emerging technologies. These programs
and initiatives promote use of the best
pharmaceutical science and engineering
principles throughout the product life
cycle.
Another example is the FDA Quality
Metrics Program, described in the
November 2016 revised draft guidance
for industry ‘‘Submission of Quality
Metrics Data’’ (81 FR 85226). When
final, this guidance will represent FDA’s
current thinking on this issue. In June
2018, FDA initiated two voluntary
programs that sought additional
industry input on quality metrics. FDA
solicited industry participation for a
Site Visit Program (83 FR 30751) for
manufacturing establishments to present
the advantages and challenges
associated with implementing and
managing a quality metrics program,
and for a Quality Metrics Feedback
Program (83 FR 30748) to engage
stakeholders in identifying mutually
useful and objective quality metrics.
The Agency continues to develop the
FDA Quality Metrics Program but
recognizes that quality metrics are only
one element within a manufacturer’s
larger effort to increase the maturity of
their quality management system.
Manufacturers that demonstrate QMM
1 See FDA’s final report: ‘‘Pharmaceuticals
CGMPs for the 21st Century—A Risk-Based
Approach’’ (September 2004) at https://
www.fda.gov/media/77391/download.
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operate under an enhanced quality
management system that exceeds the
minimum standards specified in current
good manufacturing practice regulations
and focuses on continual improvement.
Characteristics of a mature quality
management system include, for
example, the ability to consistently and
reliably deliver quality product over
time, operational stability, and a strong
quality culture. Additionally, for
manufacturers with a mature quality
management system, FDA can exercise
a more flexible regulatory approach,
leading toward the goal of producing
high-quality drug products without
extensive regulatory oversight.
A transparent method of evaluating
and communicating QMM is needed to
fully realize the 21st century
pharmaceutical quality vision. Toward
that end, FDA is announcing the start of
the QMM FDF Pilot Program. Through
this pilot program, a third-party
contractor identified by FDA will
conduct an assessment of a
manufacturer’s quality management
system, accompanied by FDA staff. The
Agency will gain insight from the
results of the QMM assessments to
inform the development of a rating
system to measure and rate QMM.
Assessments under the QMM FDF Pilot
Program will cover multiple topics.
Examples include but are not limited to:
1. Supply chain management;
2. manufacturing strategy and
operations;
3. safety, environmental, and
regulatory compliance;
4. inventory management;
5. performance management and
continual improvement;
6. risk management;
7. management review and
responsibility;
8. planning;
9. workforce management;
10. quality culture; and
11. customer experience.
In the same timeframe as the QMM
FDF Pilot Program, FDA will conduct a
QMM pilot program for foreign
manufacturers of active pharmaceutical
ingredients (APIs), including facilities
manufacturing drug substance
intermediates used to produce APIs.
These pilot programs are funded
separately and are intended to provide
FDA with representative information
about QMM from different types of drug
manufacturers (API and FDF).
Elsewhere in this issue of the Federal
Register, FDA is publishing ‘‘Quality
Management Maturity for Active
Pharmaceutical Ingredients Pilot
Program for Foreign Facilities; Program
Announcement.’’
E:\FR\FM\16OCN1.SGM
16OCN1
]]>Agencies
[Federal Register Volume 85, Number 201 (Friday, October 16, 2020)]
[Notices]
[Pages 65820-65824]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22968]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2020-D-1136 and FDA-2020-D-1106]
Guidance Documents Related to Coronavirus Disease 2019 (COVID-
19); 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.
DATES: The announcement of the guidances is published in the Federal
Register on October 16, 2020. The guidances have been implemented
without prior comment, but they remain subject to comment in accordance
with the Agency's good guidance practices.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the name of the
guidance document that the comments address and the docket number for
the guidance (see table 1). Received comments will be placed in the
docket(s) and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
[[Page 65821]]
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 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 guidances.
FOR FURTHER INFORMATION CONTACT: Kimberly Thomas, Center for Drug
Evaluation and Research (CDER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6220, Silver Spring, MD 20993-0002, 301-
796-2357.
SUPPLEMENTARY INFORMATION:
I. Background
On January 31, 2020, as a result of confirmed cases of COVID-19,
and after consultation with public health officials as necessary, Alex
M. Azar II, Secretary of Health and Human Services, pursuant to the
authority under section 319 of the Public Health Service Act (42 U.S.C.
247d) (PHS Act), determined that a PHE exists and has existed since
January 27, 2020, nationwide.\1\ On March 13, 2020, President Donald J.
Trump declared that the COVID-19 outbreak in the United States
constitutes a national emergency, beginning March 1, 2020.\2\
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\1\ On April 21, 2020, the PHE Determination was extended,
effective April 26, 2020; on July 23, 2020, it was extended,
effective July 25, 2020; on October 2, 2020, it was extended,
effective October 23, 2020. These PHE Determinations are available
at https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
\2\ Proclamation on Declaring a National Emergency Concerning
the Novel Coronavirus Disease (COVID-19) Outbreak (Mar. 13, 2020),
available at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
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In the Federal Register of March 25, 2020 (the March 25, 2020,
notice) (available at https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf), FDA announced procedures for making available
FDA 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 (FD&C Act) (21 U.S.C.
371(h)(1)(C) and 21 CFR 10.115(g)(2) (Sec. 10.115(g)(2))). The
guidances are available at FDA's web page entitled ``COVID-19-Related
Guidance Documents for Industry, FDA Staff, and Other Stakeholders''
(https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders) and through FDA's web page entitled ``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-1136.................. CDER....................... Manufacturing, Supply [email protected].
Chain, and Drug and Please include the
Biological Product docket number FDA-2020-
Inspections During D-1136 and complete
COVID-19 Public Health title of the guidance
Emergency Questions in the request.
and Answers (August
2020).
FDA-2020-D-1136.................. CDER....................... Resuming Normal Drug [email protected].
and Biologics Please include the
Manufacturing docket number FDA-2020-
Operations During the D-1136 and complete
COVID-19 Public Health title of the guidance
Emergency (September in the request.
2020).
FDA-2020-D-1106.................. CDER....................... FDA Guidance on Conduct Clinicaltrialconduct-
of Clinical Trials of [email protected]
Medical Products Please include the
during COVID-19 Public docket number FDA-2020-
Health Emergency D-1106 and complete
(March 2020) (Updated title of the guidance
September 2020). 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
[[Page 65822]]
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
CDER Guidances
The guidances listed in the table below refer to previously
approved FDA collections of information. 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. However, these 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--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
----------------------------------------------------------------------------------------------------------------
Guidance for Industry: Resuming 21 CFR 210 and 211, 21 --Q7 Good Manufacturing 0910-0001, 0910-0032,
Normal Drug and Biologics CFR 514.80, 21 CFR Practice Guidance for 0910-0139, 0910-0338,
Manufacturing Operations During 600. Active Pharmaceutical 0910-0669, 0910-0675,
the COVID-19 Public Health Ingredients. 0910-0759, 0910-0806.
Emergency. --Planning for the Effects
of High Absenteeism to
Ensure Availability of
Medically Necessary Drug
Products..
--Notifying FDA of a
Permanent Discontinuance
or Interruption in
Manufacturing Under
Section 506C of the FD&C
Act..
--Reporting and Mitigating
Animal Drug Shortages
During the COVID-19 Public
Health Emergency..
Manufacturing, Supply Chain, and 21 CFR 314.50; 314.95, --Prioritization of the 0910-0001, 0910-0014,
Drug and Biological Product 314.125, 314.127; Review of Original ANDAs, 0910-0338, 0910-0045,
Inspections During COVID-19 Public 601.2 and 601.20. Amendments, and 0910-0139, 0910-0759.
Health Emergency; Questions and Supplements.
Answers. --Requests for Expedited
Review of New Drug
Application and Biologics
License Application Prior
Approval Supplements
Submitted for Chemistry,
Manufacturing, and
Controls Changes..
--Administrative Processing
of Original Biologics
License Applications (BLA)
and New Drug Applications
(NDA).
--Changes to an Approved
Application for Specified
Biotechnology and
Specified Synthetic
Biological Products.
--Changes to an Approved
Application: Biological
Products.
--Changes to an Approved
NDA or ANDA; Questions and
Answers.
--Changes to an Approved
NDA or ANDA.
--CMC Postapproval
Manufacturing Changes To
Be Documented in Annual
Reports.
--Changes to an Approved
Application: Biological
Products: Human Blood and
Blood Components Intended
for Transfusion or for
Further Manufacture.
--CMC Postapproval
Manufacturing Changes for
Specified Biological
Products To Be Documented
in Annual Reports.
--Chemistry, Manufacturing,
and Controls Changes to an
Approved Application:
Certain Biological
Products.
--Immediate Release Solid
Oral Dosage Forms; Scale-
Up and Postapproval
Changes: Chemistry,
Manufacturing, and
Controls, In Vitro
Dissolution Testing, and
In Vivo Bioequivalence
Documentation.
--SUPAC-IR: Questions and
Answers about SUPAC-IR
Guidance.
--Nonsterile Semisolid
Dosage Forms; Scale-Up and
Postapproval Changes:
Chemistry, Manufacturing,
and Controls; In Vitro
Release Testing and In
Vivo Bioequivalence
Documentation.
--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.
[[Page 65823]]
--SUPAC: Manufacturing
Equipment Addendum.
----------------------------------------------------------------------------------------------------------------
The guidance listed in the table below refers to previously
approved FDA collections of information. Therefore, clearance by OMB
under the PRA is not required for this guidance. However, these
collections of information are subject to review by OMB under the PRA.
The previously approved collections of information in the following FDA
regulations and guidance have been approved by OMB as listed in the
table below. This guidance also contains a collection of information
not approved under a current collection. This collection of information
has been granted a PHE waiver from the PRA by the Department of Health
and Human Services (HHS) on March 19, 2020, under section 319(f) of the
PHS Act. Information concerning the PHE PRA waiver can be found on the
HHS website at https://aspe.hhs.gov/public-health-emergency-declaration-pra-waivers.
Table 3--CDER Guidances and Collections
----------------------------------------------------------------------------------------------------------------
CFR cite Another guidance
COVID-19 guidance title referenced in referenced in OMB control No(s). Collection covered
COVID-19 guidance COVID-19 guidance by PHE PRA waiver
----------------------------------------------------------------------------------------------------------------
Guidance on Conduct of Clinical 21 CFR part 11, 21 Formal Meetings 0910-0001, 0910- Submission by
Trials of Medical Products CFR part 50, 21 Between the FDA 0014, 0910-0130, investigators of
during COVID-19 Public Health CFR part 56, 21 and Sponsors or 0910-0303, 0910- informed consent
Emergency (Updated September CFR part 312, 21 Applicants of 0338, 0910-0119, forms to third
21, 2020). CFR part 314, 21 PDUFA Products. 0910-0581, 0910- parties.
CFR part 320, 21 Formal Meetings 0733, 0910-0078
CFR part 601, 21 Between the FDA
CFR part 812. and Sponsors or
Applicants of
BsUFA Products..
Pediatric Study
Plans: Content of
and Process for
Submitting
Initial Pediatric
Study Plans and
Amended Pediatric
Study Plans..
Draft Guidance for
Industry on
Demonstrating
Substantial
Evidence of
Effectiveness for
Human Drug and
Biological
Products..
Enhancing the
Diversity of
Clinical Trial
Populations--Elig
ibility Criteria,
Enrollment
Practices, and
Trial Design..
Pregnant Women:
Scientific and
Ethical
Considerations
for Inclusion in
Clinical Trials..
Part 11,
Electronic
Records;
Electronic
Signatures Scope
and Application..
Use of Electronic
Records and
Electronic
Signatures in
Clinical
Investigations
under 21 CFR Part
11--Questions and
Answers.
Safety Reporting
Requirements for
INDs and BA/BE
Studies..
Adverse Event
Reporting to
IRBs--Improving
Human Subject
Protection..
Use of Electronic
Informed Consent
In Clinical
Investigations..
E6(R2) Good
Clinical
Practice:
Integrated
Addendum to ICH
E6(R1)..
Providing
Regulatory
Submissions in
Electronic
Format--Certain
Human
Pharmaceutical
Product
Applications and
Related
Submissions Using
the eCTD
Specifications..
Best Practices for
Communication
Between IND
Sponsors and FDA
During Drug
Development..
Requests for
Feedback and
Meetings for
Medical Device
Submissions: The
Q-Submission
Program..
----------------------------------------------------------------------------------------------------------------
IV. Electronic Access
Persons with access to the internet may obtain COVID-19-related
guidances at:
The FDA web page entitled ``COVID-19-Related Guidance
Documents for Industry, FDA Staff, and Other Stakeholders,'' available
at https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders;
the FDA web page entitled ``Search for FDA Guidance
Documents'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents; or
https://www.regulations.gov.
[[Page 65824]]
Dated: October 13, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-22968 Filed 10-15-20; 8:45 am]
BILLING CODE 4164-01-P
