Guidance Documents Related to Coronavirus Disease 2019; Availability, 46641-46646 [2020-16852]
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Federal Register / Vol. 85, No. 149 / Monday, August 3, 2020 / Notices
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to the process that FDA announced, in
the Federal Register of March 25, 2020,
for making available to the public
COVID–19-related guidances. The
guidances identified in this notice
address issues related to the COVID–19
PHE and have been issued in
accordance with the process announced
in the March 25, 2020, notice. The
guidance documents have been
implemented without prior comment,
but they remain subject to comment in
accordance with the Agency’s good
guidance practices.
DATES: The announcement of the
guidances is published in the Federal
Register on August 3, 2020. The
guidance documents 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
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Submit electronic comments in the
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Submissions’’ and ‘‘Instructions’’).
Dated: July 29, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020–16839 Filed 7–30–20; 11:15 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2020–D–1106, FDA–
2020–D–1136, FDA–2020–D–1137, FDA–
2020–D–1138, FDA–2020–D–1139, and FDA–
2020–D–1140]
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
SUMMARY:
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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
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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.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
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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
guidance document.
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; Erica Takai, Center for
Devices and Radiological Health
(CDRH), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Rm. 5456, HFZ–450, Silver Spring, MD
20993–0002, 301–796–6353; Phil Chao,
Center for Food Safety and Applied
Nutrition (CFSAN), CPK1 Rm 1C001,
HFS–024, Food and Drug
Administration, College Park, MD
20740, 240–402–2112; Diane Heinz,
Center for Veterinary Medicine (CVM),
Food and Drug Administration, MPN2
RME435 HFV–6, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–5692.
SUPPLEMENTARY INFORMATION:
I. Background
On January 31, 2020, as a result of
confirmed cases of COVID–19, and after
consultation with public health officials
as necessary, Alex M. Azar II, Secretary
of Health and Human Services, pursuant
to the authority under section 319 of the
Public Health Service Act (PHS Act),
determined that a PHE exists and has
existed since January 27, 2020,
nationwide.1 On March 13, 2020,
President Donald J. Trump declared that
the COVID–19 outbreak in the United
States constitutes a national emergency,
beginning March 1, 2020.2
1 On April 21, 2020, the PHE Determination was
extended, effective April 26, 2020; on July 23, 2020,
it was extended again, effective July 25, 2020. These
PHE Determinations are available at https://
www.phe.gov/emergency/news/healthactions/phe/
Pages/default.aspx.
2 Proclamation on Declaring a National
Emergency Concerning the Novel Coronavirus
Disease (COVID–19) Outbreak (March 13, 2020),
available at https://www.whitehouse.gov/
presidential-actions/proclamation-declaringnational-emergency-concerning-novel-coronavirusdisease-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-202003-25/pdf/2020-06222.pdf), FDA
announced procedures for making
available FDA guidance documents
related to the COVID–19 PHE. These
procedures, which operate within FDA’s
established good guidance practices
regulations, are intended to allow FDA
to rapidly disseminate Agency
recommendations and policies related
to COVID–19 to industry, FDA staff, and
other stakeholders. The March 25, 2020,
notice stated that due to the need to act
quickly and efficiently to respond to the
COVID–19 PHE, FDA believes that prior
public participation will not be feasible
or appropriate before FDA implements
COVID–19-related guidance documents.
Therefore, FDA will issue COVID–19related guidance documents for
immediate implementation without
prior public comment (see section
701(h)(1)(C) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
371(h)(1)(C) and 21 CFR 10.115(g)(2)
(§ 10.115(g)(2))). The guidances are
available at FDA’s web page titled
‘‘COVID–19-Related Guidance
Documents for Industry, FDA Staff, and
Other Stakeholders’’ (https://
www.fda.gov/emergency-preparednessand-response/mcm-issues/covid-19related-guidance-documents-industryfda-staff-and-other-stakeholders) and
through FDA’s web page titled ‘‘Search
for FDA Guidance Documents’’
available at https://www.fda.gov/
regulatory-information/search-fdaguidance-documents.
The March 25, 2020, notice further
stated that, in general, rather than
publishing a separate NOA for each
COVID–19-related guidance document,
FDA intends to publish periodically a
consolidated NOA announcing the
availability of certain COVID–19-related
guidance documents 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 guidance
documents:
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TABLE 1—GUIDANCE RELATED TO THE COVID–19 PUBLIC HEALTH EMERGENCY
Docket No.
Center
Title of guidance
Contact information to request single copies
FDA–2020–D–1106 .....
CDER .........................
druginfo@fda.hhs.gov. Please include the
docket number FDA–2020–D–1106 and
complete title of the guidance in the request.
FDA–2020–D–1106 .....
CDER .........................
FDA–2020–D–1106 .....
CDER .........................
FDA–2020–D–1136 .....
CDER .........................
FDA–2020–D–1136 .....
CDER .........................
CBER, CDRH, CVM ...
Temporary Policy for Preparation of Certain
Alcohol-Based Hand Sanitizer Products
During the Public Health Emergency
(COVID–19) (March 2020) (Updated June
1, 2020).
Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency
(March 2020) (Updated June 1, 2020).
Temporary Policy for Manufacture of Alcohol
for Incorporation Into Alcohol-Based Hand
Sanitizer Products During the Public Health
Emergency (COVID–19) (March 2020) (Updated June 1, 2020).
Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of
Drug Samples During the COVID–19 Public Health Emergency (June 8, 2020).
Statistical Considerations for Clinical Trials
During the COVID–19 Public Health Emergency Guidance for Industry (June 2020).
FDA–2020–D–1136 .....
CDER, CVM, CBER ...
FDA–2020–D–1137 .....
CBER .........................
FDA–2020–D–1138 .....
CDRH .........................
FDA–2020–D–1138 .....
CDRH .........................
FDA–2020–D–1138 .....
CDRH, CBER .............
FDA–2020–D–1139 .....
CFSAN .......................
Although these guidance documents
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
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Good Manufacturing Practice Considerations
for Responding to COVID–19 Infection in
Employees in Drug and Biological Products
Manufacturing (June 2020).
Development and Licensure of Vaccines to
Prevent COVID–19 (June 2020).
Enforcement Policy for Non-Invasive Remote
Monitoring Devices Used to Support Patient Monitoring During the Coronavirus
Disease 2019 (COVID–19) Public Health
Emergency (Revised) (March 20, 2020)
(Updated June 5, 2020).
Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a
Device Under Section 506J of the FD&C
Act During the COVID–19 Public Health
Emergency (May 6, 2020) (Updated June
19, 2020).
Effects of the COVID–19 Public Health Emergency on Formal Meetings and User Fee
Applications for Medical Devices—Questions and Answers (June 2020).
Reporting a Temporary Closure or Significantly Reduced Production by a Human
Food Establishment and Requesting FDA
Assistance During the COVID–19 Public
Health Emergency (May 27, 2020).
for any person and are not binding on
FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
III. Paperwork Reduction Act of 1995
A. CDER Guidances
The guidances listed in the table
below refer to previously approved
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druginfo@fda.hhs.gov. Please include the
docket number FDA–2020–D–1106 and
complete title of the guidance in the request.
druginfo@fda.hhs.gov. Please include the
docket number FDA–2020–D–1106 and
complete title of the guidance in the request.
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.
druginfo@fda.hhs.gov. Please include the
docket number FDA–2020–D–1136 and
complete title of the guidance in the request.
Office of Communication, Outreach and Development, 10903 New Hampshire Ave.,
Bldg. 71, Rm. 3128, Silver Spring, MD
20993–0002. Phone 1–800–835–4709 or
240–402–8010, email ocod@fda.hhs.gov.
CDRH-Guidance@fda.hhs.gov. Please include the document number 20014 and
complete title of the guidance in the request.
CDRH-Guidance@fda.hhs.gov. Please include the document number 20032 and
complete title of the guidance in the request.
CDRH-Guidance@fda.hhs.gov. Please include the document number 20040 and
complete title of the guidance in the request.
INFOCenter-CFSAN@fda.hhs.gov. Please include the docket number, FDA–2020–D–
1139, and complete title of the guidance in
the request.
collections of information. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information in the following FDA
regulations and guidance 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 referenced in COVID–19 guidance
Good Manufacturing Practice Considerations for
Responding to COVID–19 Infections in Employees in Drug and Biological Products Manufacturing—June 2020.
21 CFR 211, 211.22,
211.28(d), 211.100.
21 CFR 212.20, 212.30,
212.50, 212.70,
212.71
21 CFR 600.10(c)(1)
0910–0130
0910–0139
0910–0667
0910–0675
0910–0759
0910–0032
0910–0669
Temporary Policy on Prescription Drug Marketing
Act Requirements for Distribution of Drug
Samples during the COVID–19 Public Health
Emergency—Guidance for Industry.
Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the
Public Health Emergency (COVID–19)—UPDATE of guidance announced in March 2020.
21 CFR 203 ..................
(1) ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients.
(2) ICH Q5A Viral Safety Evaluation of biotechnology Products Derived From Cell Lines
of Human or Animal Origin.
(3) ICH Q9 Quality Risk Management .................
(4) Planning for the Effects of High Absenteeism
to Ensure Availability of Medically Necessary
Drug Products.
(5) Enforcement Policy for Sterilizers, disinfectant Devices, and Air Purifiers During the
Coronavirus Disease 2019 (COVID–19) Public
Health Emergency.
(6) Temporary Policy Regarding Non-Standard
PPE Practices for Sterile Compounding by
Pharmacy Compounders not Registered as
Outsourcing Facilities During the COVID–19
Public Health Emergency.
(7) GFI #271 Reporting and Mitigating Animal
Drug Shortages during the COVID–19 Public
Health Emergency.
...............................................................................
Temporary Policy for Manufacture of Alcohol for
Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID–19)—UPDATE of guidance announced in March 2020.
27 CFR Part 20 and 21
(1) Temporary Compounding of Certain AlcoholBased Hand Sanitizer Products During the
Public Health Emergency (COVID–19).
(2) Temporary Policy for Manufacture of Alcohol
for Incorporation Into Alcohol-Based Hand
Sanitizer Products During the Public Health
Emergency (COVID–19).
(3) Adverse Event Reporting Requirements ........
None .....................................................................
Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During
the Public Health Emergency Immediately in
Effect Guidance for Industry—UPDATE of
guidance announced in March 2020.
.......................................
0910–0045
0910–0139
0910–0230
0910–0291
0910–0340
0910–0641
0910–0645
0910–0800
0910–0045
0910–0139
0910–0230
0910–0291
0910–0340
0910–0641
0910–0645
0910–0800
0910–0045
0910–0139
0910–0230
0910–0291
0910–0340
0910–0641
0910–0645
0910–0800
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The guidance, Statistical
Considerations for Clinical Trials during
the COVID–19 Public Health
Emergency, contains no collection of
information. Therefore, clearance by
OMB under the PRA is not required.
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27 CFR Part 20 and 21
(1) Temporary Policy for Preparation of Certain
Alcohol-Based Hand Sanitizer Products During
the Public Health Emergency (COVID–19).
(2) Temporary Policy for Manufacture of Alcohol
for Incorporation into Alcohol-Based Hand
Sanitizer Products During the Public Health
Emergency (COVID–19).
B. CBER Guidances
The guidance listed in the table below
refer to previously approved collection
of information. This collection of
information is subject to review by the
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OMB Control
No(s).
0910–0435
OMB under the PRA. The collection of
information in the following FDA
regulations and guidance have been
approved by OMB as listed in the
following table:
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TABLE 3—CBER GUIDANCES AND COLLECTIONS
COVID–19 guidance title
CFR cite referenced
in COVID–19 guidance
Another guidance title referenced
in COVID–19 guidance
Development and Licensure of Vaccines to Prevent COVID–19.
21 CFR part 312 .............
21 CFR part 58 ...............
21 CFR part 50 ...............
21 CFR parts 210, 211,
and 610.
221 CFR part 600 ...........
221 CFR part 601 ...........
..............................................................................
..............................................................................
..............................................................................
..............................................................................
0910–0114
0910–0119
0910–0130
0910–0139
..............................................................................
..............................................................................
—Form FDA 3500A .............................................
—Establishment and Operation of Clinical Trial
Data Monitoring Committees.
—Emergency Use Authorization of Medical
Products and Related Authorities.
0910–0308
0910–0338
0910–0291
0910–0581
0910–0595
C. CDRH Guidances
collections of information. These
collections of information are subject to
review by OMB under the PRA. The
collections of information in the
The guidances listed in the table
below refer to previously approved
OMB Control
No(s).
following FDA regulations and guidance
have been approved by OMB as listed in
the following table:
TABLE 4—CDRH GUIDANCES AND COLLECTIONS
COVID–19 guidance title
CFR cite referenced
in COVID–19 guidance
Another guidance title referenced
in COVID–19 guidance
Enforcement Policy for Non-Invasive Remote
Monitoring Devices Used to Support Patient
Monitoring During the Coronavirus Disease
2019 (COVID–19) Public Health Emergency
(Revised) (March 20, 2020) (Updated June 5,
2020).
Effects of the COVID–19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices—Questions and
Answers (June 22, 2020).
807, subpart E ................
800, 801, and 809 ..........
..............................................................................
..............................................................................
0910–0120
0910–0485
.........................................
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission
Program: Guidance for Industry and Food and
Drug Administration Staff.
Emergency Use Authorization of Medical Products and Related Authorities; Guidance for Industry and Other Stakeholders.
..............................................................................
0910–0756
..............................................................................
De Novo Classification Process (Evaluation of
Automatic Class III Designation): Guidance for
Industry and Food and Drug Administration
Staff.
..............................................................................
..............................................................................
0910–0120
0910–0844
814, subparts A through
E.
807, subpart E ................
814, subpart H ................
812 ..................................
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The guidance indicated in the table
below refers to previously approved
collections of information. These
collections of information are subject to
review by the OMB under the PRA. The
collections of information in the
following FDA regulations and guidance
have been approved by OMB as listed in
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the table. This guidance also contains a
new collection of information not
approved under a current collection.
This new collection of information has
been granted a PHE waiver from the
PRA by the Department of Health and
Human Services (HHS) on March 19,
2020, under section 319(f) of the PHS
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OMB Control
No(s).
0910–0595
0910–0231
0910–0332
0910–0078
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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Federal Register / Vol. 85, No. 149 / Monday, August 3, 2020 / Notices
TABLE 5—CDRH GUIDANCES AND COLLECTIONS
CFR cite
referenced
in COVID–19
guidance
COVID–19 guidance title
Notifying CDRH of Permanent
Discontinuance or Interruption
in Manufacturing of a Device
Under Section 506J of the
FD&C Act During the COVID–
19 Public Health Emergency
(Revised) (May 6, 2020) (Updated June 19, 2020).
807, subparts A
through D.
Another guidance referenced
in COVID–19 guidance
Emergency Use Authorization of
Medical Products and Related
Authorities; Guidance for Industry and Other Stakeholders.
OMB Control
No(s).
New collection covered by
PHE PRA waiver
0910–0625
0910–0595
Notifications to FDA about
changes in the production of
certain medical device products
that will help the Agency prevent or mitigate shortages of
such devices during the
COVID–19 public health emergency.
Updates to FDA every two weeks
after initial notification on the
shortage situation, including the
expected timeline for recovery.
Voluntary submission of other information that enables FDA to
work more effectively with manufacturers and other entities to
prevent or limit any negative
impact on patients or
healthcare providers during the
COVID–19 public health emergency.
D. CFSAN Guidances
The guidance indicated in the table
below refers to previously approved
collections of information. These
collections of information are subject to
review by the OMB under the PRA. The
collections of information in the
following FDA regulations and guidance
have been approved by OMB as listed in
the table. This guidance also contains a
new collection of information not
approved under a current collection.
This new collection of information has
been granted a PHE waiver from the
PRA by HHS on March 19, 2020, under
section 319(f) of the PHS Act.
Information concerning the PHE PRA
waiver can be found on the HHS
website at https://aspe.hhs.gov/publichealth-emergency-declaration-prawaivers.
TABLE 6—CFSAN GUIDANCES AND COLLECTIONS
CFR cite
referenced
in COVID–19
guidance
COVID–19 guidance title
Reporting a Temporary Closure
or Significantly Reduced Production by a Human Food Establishment and Requesting
FDA Assistance During the
COVID–19 Public Health Emergency.
21 CFR part 1,
subpart H.
khammond on DSKJM1Z7X2PROD with NOTICES
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-
VerDate Sep<11>2014
20:39 Jul 31, 2020
Jkt 250001
Another guidance referenced in
COVID–19 guidance
.......................................................
OMB Control
No(s).
0910–0502
preparedness-and-response/mcmissues/covid-19-related-guidancedocuments-industry-fda-staff-and-otherstakeholders;
• 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.
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
New Collection covered by
PHE PRA waiver
Establishments have the option to
report to FDA temporary closures or significant reductions
of production and to request
assistance from FDA.
Dated: July 28, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020–16852 Filed 7–31–20; 8:45 am]
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]]>Agencies
[Federal Register Volume 85, Number 149 (Monday, August 3, 2020)]
[Notices]
[Pages 46641-46646]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16852]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2020-D-1106, FDA-2020-D-1136, FDA-2020-D-1137, FDA-
2020-D-1138, FDA-2020-D-1139, and FDA-2020-D-1140]
Guidance Documents Related to Coronavirus Disease 2019;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of FDA guidance documents related to the Coronavirus
Disease 2019 (COVID-19) public health emergency (PHE). This notice of
availability (NOA) is pursuant to the process that FDA announced, in
the Federal Register of March 25, 2020, for making available to the
public COVID-19-related guidances. The guidances identified in this
notice address issues related to the COVID-19 PHE and have been issued
in accordance with the process announced in the March 25, 2020, notice.
The guidance documents have been implemented without prior comment, but
they remain subject to comment in accordance with the Agency's good
guidance practices.
DATES: The announcement of the guidances is published in the Federal
Register on August 3, 2020. The guidance documents 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
[[Page 46642]]
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.
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.
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
guidance document.
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; Erica Takai,
Center for Devices and Radiological Health (CDRH), Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5456, HFZ-450,
Silver Spring, MD 20993-0002, 301-796-6353; Phil Chao, Center for Food
Safety and Applied Nutrition (CFSAN), CPK1 Rm 1C001, HFS-024, Food and
Drug Administration, College Park, MD 20740, 240-402-2112; Diane Heinz,
Center for Veterinary Medicine (CVM), Food and Drug Administration,
MPN2 RME435 HFV-6, 7500 Standish Pl., Rockville, MD 20855, 240-402-
5692.
SUPPLEMENTARY INFORMATION:
I. Background
On January 31, 2020, as a result of confirmed cases of COVID-19,
and after consultation with public health officials as necessary, Alex
M. Azar II, Secretary of Health and Human Services, pursuant to the
authority under section 319 of the Public Health Service Act (PHS Act),
determined that a PHE exists and has existed since January 27, 2020,
nationwide.\1\ On March 13, 2020, President Donald J. Trump declared
that the COVID-19 outbreak in the United States constitutes a national
emergency, beginning March 1, 2020.\2\
---------------------------------------------------------------------------
\1\ On April 21, 2020, the PHE Determination was extended,
effective April 26, 2020; on July 23, 2020, it was extended again,
effective July 25, 2020. These PHE Determinations are available at
https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx.
\2\ Proclamation on Declaring a National Emergency Concerning
the Novel Coronavirus Disease (COVID-19) Outbreak (March 13, 2020),
available at https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.
---------------------------------------------------------------------------
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 guidance documents related to the COVID-19 PHE. These
procedures, which operate within FDA's established good guidance
practices regulations, are intended to allow FDA to rapidly disseminate
Agency recommendations and policies related to COVID-19 to industry,
FDA staff, and other stakeholders. The March 25, 2020, notice stated
that due to the need to act quickly and efficiently to respond to the
COVID-19 PHE, FDA believes that prior public participation will not be
feasible or appropriate before FDA implements COVID-19-related guidance
documents. Therefore, FDA will issue COVID-19-related guidance
documents for immediate implementation without prior public comment
(see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 371(h)(1)(C) and 21 CFR 10.115(g)(2) (Sec.
10.115(g)(2))). The guidances are available at FDA's web page titled
``COVID-19-Related Guidance Documents for Industry, FDA Staff, and
Other Stakeholders'' (https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders) and through FDA's web page titled
``Search for FDA Guidance Documents'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.
The March 25, 2020, notice further stated that, in general, rather
than publishing a separate NOA for each COVID-19-related guidance
document, FDA intends to publish periodically a consolidated NOA
announcing the availability of certain COVID-19-related guidance
documents 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
guidance documents:
[[Page 46643]]
Table 1--Guidance Related to the COVID-19 Public Health Emergency
----------------------------------------------------------------------------------------------------------------
Contact information to
Docket No. Center Title of guidance request single copies
----------------------------------------------------------------------------------------------------------------
FDA-2020-D-1106................... CDER................. Temporary Policy for [email protected].
Preparation of Certain Please include the
Alcohol-Based Hand docket number FDA-2020-D-
Sanitizer Products During 1106 and complete title
the Public Health of the guidance in the
Emergency (COVID-19) request.
(March 2020) (Updated
June 1, 2020).
FDA-2020-D-1106................... CDER................. Policy for Temporary [email protected].
Compounding of Certain Please include the
Alcohol-Based Hand docket number FDA-2020-D-
Sanitizer Products During 1106 and complete title
the Public Health of the guidance in the
Emergency (March 2020) request.
(Updated June 1, 2020).
FDA-2020-D-1106................... CDER................. Temporary Policy for [email protected].
Manufacture of Alcohol Please include the
for Incorporation Into docket number FDA-2020-D-
Alcohol-Based Hand 1106 and complete title
Sanitizer Products During of the guidance in the
the Public Health request.
Emergency (COVID-19)
(March 2020) (Updated
June 1, 2020).
FDA-2020-D-1136................... CDER................. Temporary Policy on [email protected].
Prescription Drug Please include the
Marketing Act docket number FDA-2020-D-
Requirements for 1136 and complete title
Distribution of Drug of the guidance in the
Samples During the COVID- request.
19 Public Health
Emergency (June 8, 2020).
FDA-2020-D-1136................... CDER................. Statistical Considerations [email protected].
CBER, CDRH, CVM...... for Clinical Trials Please include the
During the COVID-19 docket number FDA-2020-D-
Public Health Emergency 1136 and complete title
Guidance for Industry of the guidance in the
(June 2020). request.
FDA-2020-D-1136................... CDER, CVM, CBER...... Good Manufacturing [email protected].
Practice Considerations Please include the
for Responding to COVID- docket number FDA-2020-D-
19 Infection in Employees 1136 and complete title
in Drug and Biological of the guidance in the
Products Manufacturing request.
(June 2020).
FDA-2020-D-1137................... CBER................. Development and Licensure Office of Communication,
of Vaccines to Prevent Outreach and
COVID-19 (June 2020). Development, 10903 New
Hampshire Ave., Bldg.
71, Rm. 3128, Silver
Spring, MD 20993-0002.
Phone 1-800-835-4709 or
240-402-8010, email
[email protected].
FDA-2020-D-1138................... CDRH................. Enforcement Policy for Non- CDRH-
Invasive Remote [email protected]
Monitoring Devices Used Please include the
to Support Patient document number 20014
Monitoring During the and complete title of
Coronavirus Disease 2019 the guidance in the
(COVID-19) Public Health request.
Emergency (Revised)
(March 20, 2020) (Updated
June 5, 2020).
FDA-2020-D-1138................... CDRH................. Notifying CDRH of a CDRH-
Permanent Discontinuance [email protected]
or Interruption in Please include the
Manufacturing of a Device document number 20032
Under Section 506J of the and complete title of
FD&C Act During the COVID- the guidance in the
19 Public Health request.
Emergency (May 6, 2020)
(Updated June 19, 2020).
FDA-2020-D-1138................... CDRH, CBER........... Effects of the COVID-19 CDRH-
Public Health Emergency [email protected]
on Formal Meetings and Please include the
User Fee Applications for document number 20040
Medical Devices-- and complete title of
Questions and Answers the guidance in the
(June 2020). request.
FDA-2020-D-1139................... CFSAN................ Reporting a Temporary INFOCenter-
Closure or Significantly [email protected]
Reduced Production by a Please include the
Human Food Establishment docket number, FDA-2020-
and Requesting FDA D-1139, and complete
Assistance During the title of the guidance in
COVID-19 Public Health the request.
Emergency (May 27, 2020).
----------------------------------------------------------------------------------------------------------------
Although these guidance documents have been implemented immediately
without prior comment, FDA will consider all comments received and
revise the guidances as appropriate (see Sec. 10.115(g)(3)).
These guidances are being issued consistent with FDA's good
guidance practices regulation (Sec. 10.115). The guidances represent
the current thinking of FDA. They do not establish any rights for any
person and are not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.
III. Paperwork Reduction Act of 1995
A. CDER Guidances
The guidances listed in the table below refer to previously
approved collections of information. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521).
The collections of information in the following FDA regulations and
guidance have been approved by OMB as listed in the following table:
[[Page 46644]]
Table 2--CDER Guidances and Collections
----------------------------------------------------------------------------------------------------------------
Another guidance
COVID-19 guidance title CFR cite referenced referenced in COVID-19 OMB Control No(s).
in COVID-19 guidance guidance
----------------------------------------------------------------------------------------------------------------
Good Manufacturing Practice 21 CFR 211, 211.22, (1) ICH Q7 Good 0910-0130
Considerations for Responding to 211.28(d), 211.100. Manufacturing Practice 0910-0139
COVID-19 Infections in Employees 21 CFR 212.20, Guidance for Active 0910-0667
in Drug and Biological Products 212.30, 212.50, Pharmaceutical 0910-0675
Manufacturing--June 2020. 212.70, 212.71. Ingredients. 0910-0759
21 CFR 600.10(c)(1).. (2) ICH Q5A Viral Safety 0910-0032
Evaluation of 0910-0669
biotechnology Products
Derived From Cell Lines
of Human or Animal Origin.
(3) ICH Q9 Quality Risk
Management.
(4) Planning for the
Effects of High
Absenteeism to Ensure
Availability of Medically
Necessary Drug Products.
(5) Enforcement Policy for
Sterilizers, disinfectant
Devices, and Air
Purifiers During the
Coronavirus Disease 2019
(COVID-19) Public Health
Emergency..
(6) Temporary Policy
Regarding Non-Standard
PPE Practices for Sterile
Compounding by Pharmacy
Compounders not
Registered as Outsourcing
Facilities During the
COVID-19 Public Health
Emergency..
(7) GFI #271 Reporting and
Mitigating Animal Drug
Shortages during the
COVID-19 Public Health
Emergency..
Temporary Policy on Prescription 21 CFR 203........... .......................... 0910-0435
Drug Marketing Act Requirements
for Distribution of Drug Samples
during the COVID-19 Public Health
Emergency--Guidance for Industry.
Temporary Policy for Preparation of 27 CFR Part 20 and 21 (1) Temporary Compounding 0910-0045
Certain Alcohol-Based Hand of Certain Alcohol-Based 0910-0139
Sanitizer Products During the Hand Sanitizer Products 0910-0230
Public Health Emergency (COVID- During the Public Health 0910-0291
19)--UPDATE of guidance announced Emergency (COVID-19). 0910-0340
in March 2020. (2) Temporary Policy for 0910-0641
Manufacture of Alcohol 0910-0645
for Incorporation Into 0910-0800
Alcohol-Based Hand
Sanitizer Products During
the Public Health
Emergency (COVID-19).
(3) Adverse Event
Reporting Requirements.
Temporary Policy for Manufacture of 27 CFR Part 20 and 21 None...................... 0910-0045
Alcohol for Incorporation Into 0910-0139
Alcohol-Based Hand Sanitizer 0910-0230
Products During the Public Health 0910-0291
Emergency (COVID-19)--UPDATE of 0910-0340
guidance announced in March 2020. 0910-0641
0910-0645
0910-0800
Policy for Temporary Compounding of ..................... (1) Temporary Policy for 0910-0045
Certain Alcohol-Based Hand Preparation of Certain 0910-0139
Sanitizer Products During the Alcohol-Based Hand 0910-0230
Public Health Emergency Sanitizer Products During 0910-0291
Immediately in Effect Guidance for the Public Health 0910-0340
Industry--UPDATE of guidance Emergency (COVID-19). 0910-0641
announced in March 2020. (2) Temporary Policy for 0910-0645
Manufacture of Alcohol 0910-0800
for Incorporation into
Alcohol-Based Hand
Sanitizer Products During
the Public Health
Emergency (COVID-19).
----------------------------------------------------------------------------------------------------------------
The guidance, Statistical Considerations for Clinical Trials during
the COVID-19 Public Health Emergency, contains no collection of
information. Therefore, clearance by OMB under the PRA is not required.
B. CBER Guidances
The guidance listed in the table below refer to previously approved
collection of information. This collection of information is subject to
review by the OMB under the PRA. The collection of information in the
following FDA regulations and guidance have been approved by OMB as
listed in the following table:
[[Page 46645]]
Table 3--CBER Guidances and Collections
----------------------------------------------------------------------------------------------------------------
Another guidance title
COVID-19 guidance title CFR cite referenced in referenced in COVID- OMB Control No(s).
COVID-19 guidance 19 guidance
----------------------------------------------------------------------------------------------------------------
Development and Licensure of 21 CFR part 312........ ...................... 0910-0114
Vaccines to Prevent COVID-19. 21 CFR part 58......... ...................... 0910-0119
21 CFR part 50......... ...................... 0910-0130
21 CFR parts 210, 211, ...................... 0910-0139
and 610.
221 CFR part 600....... ...................... 0910-0308
221 CFR part 601....... ...................... 0910-0338
--Form FDA 3500A...... 0910-0291
--Establishment and 0910-0581
Operation of Clinical 0910-0595
Trial Data Monitoring
Committees.
--Emergency Use
Authorization of
Medical Products and
Related Authorities.
----------------------------------------------------------------------------------------------------------------
C. CDRH Guidances
The guidances listed in the table below refer to previously
approved collections of information. These collections of information
are subject to review by OMB under the PRA. The collections of
information in the following FDA regulations and guidance have been
approved by OMB as listed in the following table:
Table 4--CDRH Guidances and Collections
----------------------------------------------------------------------------------------------------------------
Another guidance title
COVID-19 guidance title CFR cite referenced in referenced in COVID- OMB Control No(s).
COVID-19 guidance 19 guidance
----------------------------------------------------------------------------------------------------------------
Enforcement Policy for Non-Invasive 807, subpart E......... ...................... 0910-0120
Remote Monitoring Devices Used to 800, 801, and 809...... ...................... 0910-0485
Support Patient Monitoring During
the Coronavirus Disease 2019 (COVID-
19) Public Health Emergency
(Revised) (March 20, 2020) (Updated
June 5, 2020).
Effects of the COVID-19 Public ....................... Requests for Feedback 0910-0756
Health Emergency on Formal Meetings and Meetings for
and User Fee Applications for Medical Device
Medical Devices--Questions and Submissions: The Q-
Answers (June 22, 2020). Submission Program:
Guidance for Industry
and Food and Drug
Administration Staff.
Emergency Use 0910-0595
Authorization of
Medical Products and
Related Authorities;
Guidance for Industry
and Other
Stakeholders.
814, subparts A through ...................... 0910-0231
E.
807, subpart E......... ...................... 0910-0120
De Novo Classification 0910-0844
Process (Evaluation
of Automatic Class
III Designation):
Guidance for Industry
and Food and Drug
Administration Staff.
814, subpart H......... ...................... 0910-0332
812.................... ...................... 0910-0078
----------------------------------------------------------------------------------------------------------------
The guidance indicated in the table below refers to previously
approved collections of information. These collections of information
are subject to review by the OMB under the PRA. The collections of
information in the following FDA regulations and guidance have been
approved by OMB as listed in the table. This guidance also contains a
new collection of information not approved under a current collection.
This new collection of information has been granted a PHE waiver from
the PRA by 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.
[[Page 46646]]
Table 5--CDRH Guidances and Collections
----------------------------------------------------------------------------------------------------------------
CFR cite Another guidance New collection
COVID-19 guidance title referenced in referenced in OMB Control No(s). covered by PHE
COVID-19 guidance COVID-19 guidance PRA waiver
----------------------------------------------------------------------------------------------------------------
Notifying CDRH of Permanent 807, subparts A 0910-0625
Discontinuance or Interruption through D. Emergency Use 0910-0595
in Manufacturing of a Device Authorization of
Under Section 506J of the FD&C Medical Products
Act During the COVID-19 Public and Related
Health Emergency (Revised) Authorities;
(May 6, 2020) (Updated June Guidance for
19, 2020). Industry and
Other
Stakeholders.
Notifications to
FDA about
changes in the
production of
certain medical
device products
that will help
the Agency
prevent or
mitigate
shortages of
such devices
during the COVID-
19 public health
emergency.
Updates to FDA
every two weeks
after initial
notification on
the shortage
situation,
including the
expected
timeline for
recovery.
Voluntary
submission of
other
information that
enables FDA to
work more
effectively with
manufacturers
and other
entities to
prevent or limit
any negative
impact on
patients or
healthcare
providers during
the COVID-19
public health
emergency.
----------------------------------------------------------------------------------------------------------------
D. CFSAN Guidances
The guidance indicated in the table below refers to previously
approved collections of information. These collections of information
are subject to review by the OMB under the PRA. The collections of
information in the following FDA regulations and guidance have been
approved by OMB as listed in the table. This guidance also contains a
new collection of information not approved under a current collection.
This new collection of information has been granted a PHE waiver from
the PRA by HHS on March 19, 2020, under section 319(f) of the PHS Act.
Information concerning the PHE PRA waiver can be found on the HHS
website at https://aspe.hhs.gov/public-health-emergency-declaration-pra-waivers.
Table 6--CFSAN Guidances and Collections
----------------------------------------------------------------------------------------------------------------
CFR cite Another guidance New Collection
COVID-19 guidance title referenced in referenced in OMB Control No(s). covered by PHE
COVID-19 guidance COVID-19 guidance PRA waiver
----------------------------------------------------------------------------------------------------------------
Reporting a Temporary Closure 21 CFR part 1, .................. 0910-0502 Establishments
or Significantly Reduced subpart H. have the option
Production by a Human Food to report to FDA
Establishment and Requesting temporary
FDA Assistance During the closures or
COVID-19 Public Health significant
Emergency. reductions of
production and
to request
assistance from
FDA.
----------------------------------------------------------------------------------------------------------------
IV. Electronic Access
Persons with access to the internet may obtain COVID-19-related
guidances at:
The FDA web page entitled ``COVID-19-Related Guidance
Documents for Industry, FDA Staff, and Other Stakeholders,'' available
at https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders;
the FDA web page entitled ``Search for FDA Guidance
Documents'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents; or
https://www.regulations.gov.
Dated: July 28, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-16852 Filed 7-31-20; 8:45 am]
BILLING CODE 4164-01-P
