Guidance Documents Related to Coronavirus Disease 2019 (COVID-19); Availability, 38372-38378 [2020-13829]
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Federal Register / Vol. 85, No. 124 / Friday, June 26, 2020 / Notices
Services (HHS) is proposing to collect
data on child welfare agencies’ efforts to
identify human trafficking and
subsequent service delivery. The goal of
the study is to better understand child
welfare practice in screening for human
trafficking, and the degree to which
screening is related to subsequent
referrals for, access to, and delivery of
specialized services for children
identified as trafficking victims or at
high-risk of trafficking.
Comments due within 60 days of
publication. In compliance with the
requirements of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
ACF is soliciting public comment on the
specific aspects of the information
collection described above.
DATES:
Copies of the proposed
collection of information can be
obtained and comments may be
forwarded by emailing
OPREinfocollection@acf.hhs.gov.
ADDRESSES:
Alternatively, copies can also be
obtained by writing to the
Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW,
Washington, DC 20201, Attn: OPRE
Reports Clearance Officer. All requests,
emailed or written, should be identified
by the title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: ACF is proposing data
collection as part of the study
‘‘Identifying and Addressing Human
Trafficking in Child Welfare Agencies,’’
exploring child welfare practice in
screening for human trafficking, and the
relationship between screening and
specialized services.
Primary data collection includes
semi-structured qualitative interviews
with state and local human trafficking
coordinators (or comparable staff
members with greatest knowledge about
human trafficking efforts); small group
interviews with casework supervisors;
Number of
respondents
(total over
request period)
Instrument
State Human Trafficking Coordinator Telephone Interview Guide ................................................................
Local Human Trafficking Coordinator Interview Guide
Casework Supervisor Group Interview Guide .............
Caseworker Case Narrative Interview Guide ..............
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Estimated Total Annual Burden
Hours: 79
Comments: The Department
specifically requests comments on (a)
Whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: Section 476(a)(1–2) (42 U.S.C.
676) of the Social Security Act Part E-Federal
Payments for Foster Care and Adoption
Assistance.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–13779 Filed 6–25–20; 8:45 am]
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Number of
responses per
respondent
(total over
request period)
25
8
40
48
Food and Drug Administration
[Docket Nos. FDA–2020–D–1106, FDA–
2020–D–1136, FDA–2020–D–1138, FDA–
2020–D–1139, FDA–2020–D–1140]
Guidance Documents Related to
Coronavirus Disease 2019 (COVID–19);
Availability
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
SUMMARY:
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Annual Burden Estimates
Data collection is expected to take
place over 2 years.
Average
burden per
response
(in hours)
1
1
1
1
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
and case narrative interviews with
caseworkers.
The interviews will be conducted by
telephone (25 state agencies) and inperson (up to 8 local agencies or
offices). Interview questions will be
focused on how agencies select, train
on, and implement screening for human
trafficking, the details of screening
protocols, and variations in
implementation. Questions will also
address the availability of specialized
services for children identified as
trafficking victims or at high-risk of
trafficking, agency steps based on
positive or suspected screening, and the
process for initiating specialized
services.
Respondents: State and local human
trafficking coordinators, casework
supervisors, and caseworkers.
Sfmt 4703
1.5
1.5
1.5
1
Total burden
(in hours)
37.5
12
60
48
Annual burden
(in hours)
19
6
30
24
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 June 26, 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
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comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the name of the guidance
document that the comments address
and the docket number for the guidance
(see table 1). Received comments will be
placed in the docket(s) and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
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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
addresses 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 documents.
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; 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 (42 U.S.C.
247d) (PHS Act), determined that a PHE
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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 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) (§ 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 document,
FDA intends to publish periodically a
consolidated NOA announcing the
availability of certain COVID–19-related
guidance documents FDA issued during
the relevant period, as included in table
1. This notice announces COVID–191 On April 21, 2020, the PHE Determination was
extended, effective April 26, 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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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—GUIDANCES RELATED TO THE COVID–19 PUBLIC HEALTH EMERGENCY
Docket No.
Center
Title of guidance
Contact information to request single copies
FDA–2020–D–1138 ...
CDRH ....
CDRH-Guidance@fda.hhs.gov. Please include the
document number 20032 and complete title of the
guidance in the request.
FDA–2020–D–1138 ...
CDRH ....
FDA–2020–D–1138 ...
CDRH ....
FDA–2020–D–1138 ...
CDRH ....
FDA–2020–D–1136 ...
CDER .....
FDA–2020–D–1136 ...
CDER .....
FDA–2020–D–1136 ...
CDER .....
FDA–2020–D–1136 ...
CDER .....
FDA–2020–D–1136 ...
CDER .....
FDA–2020–D–1136 ...
CDER .....
FDA–2020–D–1106 ...
CDER .....
FDA–2020–D–1139 ...
CFSAN ...
FDA–2020–D–1139 ...
CFSAN ...
FDA–2020–D–1140 ...
CVM .......
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 (May 6, 2020).
Supplements for Approved Premarket Approval
(PMA) or Humanitarian Device Exemption (HDE)
Submissions During the Coronavirus Disease
2019 (COVID–19) Public Health Emergency (May
21, 2020).
Enforcement Policy for Face Masks and Respirators
During the Coronavirus Disease (COVID–19) Public Health Emergency (April 2020) (Updated May
26, 2020).
Recommendations for Sponsors Requesting EUAs
for Decontamination and Bioburden Reduction
Systems for Face Masks and Respirators During
the Coronavirus Disease (COVID–19) Public
Health Emergency (May 26, 2020).
Exemption and Exclusion of Certain Requirements
of the Drug Supply Chain Security Act During the
COVID–19 Public Health Emergency (April 30,
2020).
COVID–19 Public Health Emergency: General Considerations for Pre-IND Meeting Requirements for
COVID–19 Related Drugs and Biological Products
(May 11, 2020).
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 (April 10, 2020) (Updated May 14, 2020).
Temporary Policy for Compounding of Certain Drugs
for Hospitalized Patients by Outsourcing Facilities
During the COVID–19 Public Health Emergency
(April 2020) (Updated May 21, 2020).
Temporary Policy for Compounding of Certain Drugs
for Hospitalized Patients by Pharmacy
Compounders not Registered as Outsourcing Facilities During the COVID–19 Public Health Emergency (April 2020) (Updated May 21, 2020).
Effects of the COVID–19 Public Health Emergency
on Formal Meetings and User Fee Applications—
Questions and Answers (May 26, 2020).
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID–19 Public Health
Emergency (March 2020) (Updated May 14 and
June 3, 2020).
Returning Refrigerated Transport Vehicles and Refrigerated Storage Units to Food Uses After Using
Them to Preserve Human Remains During the
COVID–19 Pandemic (May 12, 2020).
Temporary Policy Regarding Certain Food Labeling
Requirements During the COVID–19 Public Health
Emergency: Minor Formulation Changes and
Vending Machines (May 22, 2020).
GFI# 271 Reporting and Mitigating Animal Drug
Shortages during the COVID–19 Public Health
Emergency (May 7, 2020).
Although these guidance documents
have been implemented immediately
without prior comment, FDA will
consider all comments received and
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CDRH-Guidance@fda.hhs.gov. Please include the
document number 20028 and complete title of the
guidance in the request.
CDRH-Guidance@fda.hhs.gov. Please include the
document number 20018 and complete title of the
guidance in the request.
CDRH-Guidance@fda.hhs.gov. Please include the
document number 20033 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.
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.
clinicaltrialconduct-COVID19@fda.hhs.gov. Please
include the docket number FDA–2020–D–1106
and complete title of the guidance in the request.
Retail Food Protection Staff, Office of Food Safety,
Center for Food Safety and Applied Nutrition,
Food and Drug Administration, 5001 Campus Dr.,
College Park, MD 20740.
Office of Nutrition and Food Labeling, Food Labeling
and Standards Staff, Center for Food Safety and
Applied Nutrition, Food and Drug Administration,
5001 Campus Dr., College Park, MD 20740.
AskCVM@fda.hhs.gov. Please include the docket
number FDA–2020–N–1140 and complete title of
the guidance in the request.
revise the guidances as appropriate (see
§ 10.115(g)(3)).
These guidances are being issued
consistent with FDA’s good guidance
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practices regulation (§ 10.115). The
guidances represent the current thinking
of FDA. They do not establish any rights
for any person and are not binding on
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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. 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 the Office of Management and
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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:
TABLE 2—CDRH GUIDANCES AND COLLECTIONS
Another guidance title
referenced in COVID–19
guidance
COVID–19 guidance title
CFR cite referenced in
COVID–19 guidance
Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During
the Coronavirus Disease 2019 (COVID–19) Public Health
Emergency.
21 CFR part 814, subparts A
through E.
21 CFR part 814, subpart H ...
21 CFR part 820 .....................
21 CFR parts 800, 801, and
809.
21 CFR part 803 .....................
Recommendations for Sponsors Requesting EUAs for Decontamination and Bioburden Reduction Systems for Face
Masks and Respirators During the Coronavirus Disease
2019 (COVID–19) Public Health Emergency.
Enforcement Policy for Face Masks and Respirators During
the Coronavirus Disease (COVID–19) Public Health Emergency.
The guidance indicated in the table
below refers 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
21 CFR parts 800, 801, and
809.
21 CFR part 803 .....................
21 CFR part 806 .....................
21 CFR part 807, subpart E ...
21 CFR part 807, subparts A
through D.
21 CFR part 820 .....................
21 CFR part 830 and 801.20
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
OMB control
No(s).
0910–0231
0910–0332
0910–0073
.................................................
0910–0485
.................................................
Emergency Use Authorization
of Medical Products and
Related Authorities.
.................................................
0910–0437
0910–0595
0910–0485
.................................................
.................................................
.................................................
.................................................
0910–0437
0910–0359
0910–0120
0910–0625
.................................................
.................................................
Emergency Use Authorization
of Medical Products and
Related Authorities.
0910–0073
0910–0720
0910–0595
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—CDRH GUIDANCE AND COLLECTIONS
COVID–19 guidance title
CFR cite referenced in
COVID–19 guidance
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.
21 CFR part 807, subparts A
through D.
Another guidance referenced in
COVID–19 guidance
OMB control
No(s).
New collection covered by PHE PRA waiver
0910–0625
Emergency Use Authorization
of Medical Products and Related Authorities; Guidance
for Industry and Other Stakeholders.
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 PHE.
Updates to FDA every 2 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
PHE.
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B. CDER 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
following FDA regulations and
guidances have been approved by OMB
as listed in the following table:
TABLE 4—CDER GUIDANCES AND COLLECTIONS
CFR cite
referenced in COVID–19
guidance
COVID–19 guidance title
Another guidance title referenced in COVID–19 guidance
Effects of the COVID–19 Public Health Emergency on
Formal Meetings and User Fee Applications..
§ 10.115(g)(2) ......................
Planning for the Effects of High Absenteeism to Ensure
Availability of Medically Necessary Drug Products.
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.
Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.
Exemption and Exclusion of Certain Requirements of the
Drug Supply Chain Security Act During the COVID–19
Public Health Emergency..
..............................................
General Considerations for Pre-IND Meeting Requirements for COVID–19 Related Drugs and Biological
Products..
21 CFR part 312 ..................
Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification.
Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs.
Definitions of Suspect Product and Illegitimate Product
for Verification Obligations Under the Drug Supply
Chain Security Act.
COVID–19: Developing Drugs and Biological Products
for Treatment or Prevention.
Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products.
Emergency Use Authorization of Medical Products and
Related Authorities.
Preclinical Assessment of Investigational Cellular and
Gene Therapy Products.
Guidance for Clinical Trial Sponsors: Establishment and
Operation of Clinical Trial Data Monitoring Committees.
Use of Liquids and/or Soft Foods as Vehicles for Drug
Administration: General Considerations for Selection
and In Vitro Methods for Product Quality Assessments.
Demonstrating Substantial Evidence of Effectiveness for
Human Drug and Biological Products.
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
guidances have been approved by OMB
as listed in the below table. These
guidances also contain new collections
of information not approved under a
current collection. These new
collections of information have been
granted a PHE waiver from the PRA by
OMB control
No(s).
0910–0001
0910–0014
0910–0429
0910–0693
0910–0718
0910–0719
0910–0727
0910–0777
0910–0800
0910–0806
0910–0827
0910–0859
0910–0001
0910–0014
0910–0338
0910–0429
0910–0595
0910–0719
0910–0814
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-emergencydeclaration-pra-waivers.
TABLE 5— CDER GUIDANCES AND COLLECTIONS
CFR cite referenced in
COVID–19 guidance
COVID–19 guidance title
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Temporary Policy for
Compounding of Certain
Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID–19
Public Health Emergency.
Temporary Policy for
Compounding of Certain
Drugs for Hospitalized Patients by Pharmacy
Compounders not Registered as Outsourcing Facilities During the COVID–19
Public Health Emergency.
VerDate Sep<11>2014
21 CFR
600.82.
314.81,
21
CFR
..................................................
19:42 Jun 25, 2020
Jkt 250001
PO 00000
Another guidance referenced
in COVID–19 guidance
OMB control
No(s).
New collection covered by
PHE PRA waiver
Current Good Manufacturing
Practice—Guidance
for
Human Drug Compounding
Outsourcing Facilities Under
Section 503B of the FD&C
Act.
Compounded Drug Products
That are Essentially Copies
of a Commercially Available
Drug Product under Section
503A of the Federal Food,
Drug, and Cosmetic Act.
Temporary
Policy
for
Compounding of Certain
Drugs for Hospitalized Patients by Outsourcing Facilities During the COVID–19
Public Health Emergency.
Prescription
Requirement
Under Section 503A of the
Federal Food, Drug, and
Cosmetic Act.
0910–0777, 0910–0338, 0910–
0001, 0910–0139.
To provide suitability and proof
of sterility for the container
closure systems used.
0910–0001, 0910–0139, 0910–
0338.
For reporting of adverse
events by pharmacy
compounders to the
MedWatch system and
maintaining records of drugs
suppliers and patients who
receive the compounded
products.
Frm 00021
Fmt 4703
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26JNN1
Federal Register / Vol. 85, No. 124 / Friday, June 26, 2020 / Notices
38377
TABLE 5— CDER GUIDANCES AND COLLECTIONS—Continued
CFR cite referenced in
COVID–19 guidance
jbell on DSKJLSW7X2PROD with NOTICES
COVID–19 guidance title
Another guidance referenced
in COVID–19 guidance
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.
21 CFR parts 210 and 211 ......
Guidance on Conduct of Clinical Trials of Medical Products during COVID–19 Public Health Emergency.
21 CFR part 11, 21 CFR part
50, 21 CFR part 56, 21 CFR
part 312, 21 CFR part 314,
21 CFR part 601, 21 CFR
part 812.
VerDate Sep<11>2014
19:42 Jun 25, 2020
Jkt 250001
PO 00000
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.
Enforcement Policy for Face
Masks and Respirators During the Coronavirus Disease
(COVID–19) Public Health
Emergency (Revised).
Enforcement Policy for Gowns,
Other Apparel, and Gloves
During the Coronavirus Disease (COVID–19) Public
Health Emergency.
Electronic Drug Product Reporting for Human Drug
Compounding Outsourcing
Facilities
Under
Section
503B of the Federal Food,
Drug, and Cosmetic Act.
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.
Frm 00022
Fmt 4703
Sfmt 4703
OMB control
No(s).
New collection covered by
PHE PRA waiver
0910–0139 ...............................
Recordkeeping of
compounding performed
without standard PPE; recordkeeping of any change of
sterilization/aseptic processing methods; documentation of mitigation strategies
for sterile compounding without standard PPE.
0910–0001, 0910–0014,
0130, 0910–0303,
0338, 0910–0119,
0581, 0910–0733,
0078.
Submission by investigators of
informed consent forms to
third parties.
E:\FR\FM\26JNN1.SGM
0910–
0910–
0910–
0910–
26JNN1
38378
Federal Register / Vol. 85, No. 124 / Friday, June 26, 2020 / Notices
TABLE 5— CDER GUIDANCES AND COLLECTIONS—Continued
CFR cite referenced in
COVID–19 guidance
COVID–19 guidance title
Another guidance referenced
in COVID–19 guidance
OMB control
No(s).
New collection covered by
PHE PRA waiver
Requests for Feedback and
Meetings for Medical Device
Submissions: The Q-Submission Program.
C. CFSAN Guidance
The guidance indicated in the table
below refers 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 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 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 GUIDANCE AND COLLECTIONS
COVID–19 guidance title
CFR cite referenced in
COVID–19 guidance
Another guidance referenced
in COVID–19 guidance
OMB control
No(s).
New collection covered by
PHE PRA waiver
Temporary Policy Regarding
Certain Mandatory Food Labeling Requirements During
the COVID–19 Public Health
Emergency: Minor Formulation Changes and Vending
Machines.
21 CFR part 101; section
403(w) of the FD&C Act.
..................................................
0910–0381, 0910–0782, 0910–
0792.
Recommend that manufacturers post ingredient omissions or substitutions not reflected on the product label.
The guidance entitled ‘‘Returning
Refrigerated Transport Vehicles and
Refrigerated Storage Units to Food Uses
After Using Them to Preserve Human
Remains During the COVID–19
Pandemic’’ contains no collection of
information. Therefore, clearance by
OMB under the PRA is not required.
D. CVM Guidance
This guidance indicated in the table
below refers 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
indicated 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-declarationpra-waivers.
TABLE 7—CVM GUIDANCE AND COLLECTION
CFR cite referenced in
COVID–19 guidance
Another guidance referenced
in COVID–19 guidance
OMB control
No(s).
21 CFR 514.1(a)) .....................
..................................................
0910–0032, 0910–0669 ...........
COVID–19 guidance title
GFI# 271, Reporting and Mitigating Animal Drug Shortages during the COVID–19
Public Health Emergency.
jbell on DSKJLSW7X2PROD 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/emergencypreparedness-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/
VerDate Sep<11>2014
19:42 Jun 25, 2020
Jkt 250001
regulatory-information/search-fdaguidance-documents; or
• https://www.regulations.gov.
Dated: June 22, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–13829 Filed 6–25–20; 8:45 am]
BILLING CODE 4164–01–P
PO 00000
New collection covered by
PHE PRA waiver
Reporting and mitigating animal drug shortages.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1459]
Generic Drug User Fee Amendments;
Public Meeting; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA, the Agency, or
we) is hosting a virtual public meeting
entitled ‘‘Generic Drug User Fee
SUMMARY:
Frm 00023
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]]>Agencies
[Federal Register Volume 85, Number 124 (Friday, June 26, 2020)]
[Notices]
[Pages 38372-38378]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-13829]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2020-D-1106, FDA-2020-D-1136, FDA-2020-D-1138, FDA-
2020-D-1139, FDA-2020-D-1140]
Guidance Documents Related to Coronavirus Disease 2019 (COVID-
19); 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 June 26, 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
[[Page 38373]]
comment does not include any confidential information that you or a
third party may not wish to be posted, such as medical information,
your or anyone else's Social Security number, or confidential business
information, such as a manufacturing process. Please note that if you
include your name, contact information, or other information that
identifies you in the body of your comments, that information will be
posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the name of the
guidance document that the comments address and the docket number for
the guidance (see table 1). Received comments will be placed in the
docket(s) and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of these guidances to the
addresses 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 documents.
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; 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 (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\
---------------------------------------------------------------------------
\1\ On April 21, 2020, the PHE Determination was extended,
effective April 26, 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 (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 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
document, FDA intends to publish periodically a consolidated NOA
announcing the availability of certain COVID-19-related guidance
documents FDA issued during the relevant period, as included in table
1. This notice announces COVID-19-
[[Page 38374]]
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:
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-1138..................... CDRH.................. Notifying CDRH of CDRH-
Permanent [email protected]
Discontinuance or Please include the
Interruption in document number 20032
Manufacturing of a and complete title of
Device Under Section the guidance in the
506J of the FD&C Act request.
During the COVID-19
Public Health Emergency
(May 6, 2020).
FDA-2020-D-1138..................... CDRH.................. Supplements for Approved CDRH-
Premarket Approval [email protected]
(PMA) or Humanitarian Please include the
Device Exemption (HDE) document number 20028
Submissions During the and complete title of
Coronavirus Disease the guidance in the
2019 (COVID-19) Public request.
Health Emergency (May
21, 2020).
FDA-2020-D-1138..................... CDRH.................. Enforcement Policy for CDRH-
Face Masks and [email protected]
Respirators During the Please include the
Coronavirus Disease document number 20018
(COVID-19) Public and complete title of
Health Emergency (April the guidance in the
2020) (Updated May 26, request.
2020).
FDA-2020-D-1138..................... CDRH.................. Recommendations for CDRH-
Sponsors Requesting [email protected]
EUAs for Please include the
Decontamination and document number 20033
Bioburden Reduction and complete title of
Systems for Face Masks the guidance in the
and Respirators During request.
the Coronavirus Disease
(COVID-19) Public
Health Emergency (May
26, 2020).
FDA-2020-D-1136..................... CDER.................. Exemption and Exclusion [email protected].
of Certain Requirements Please include the
of the Drug Supply docket number FDA-2020-
Chain Security Act D-1136 and complete
During the COVID-19 title of the guidance
Public Health Emergency in the request.
(April 30, 2020).
FDA-2020-D-1136..................... CDER.................. COVID-19 Public Health [email protected].
Emergency: General Please include the
Considerations for Pre- docket number FDA-2020-
IND Meeting D-1136 and complete
Requirements for COVID- title of the guidance
19 Related Drugs and in the request.
Biological Products
(May 11, 2020).
FDA-2020-D-1136..................... CDER.................. Temporary Policy [email protected].
Regarding Non-Standard Please include the
PPE Practices for docket number FDA-2020-
Sterile Compounding by D-1136 and complete
Pharmacy Compounders title of the guidance
not Registered as in the request.
Outsourcing Facilities
During the COVID-19
Public Health Emergency
(April 10, 2020)
(Updated May 14, 2020).
FDA-2020-D-1136..................... CDER.................. Temporary Policy for [email protected].
Compounding of Certain Please include the
Drugs for Hospitalized docket number FDA-2020-
Patients by Outsourcing D-1136 and complete
Facilities During the title of the guidance
COVID-19 Public Health in the request.
Emergency (April 2020)
(Updated May 21, 2020).
FDA-2020-D-1136..................... CDER.................. Temporary Policy for [email protected].
Compounding of Certain Please include the
Drugs for Hospitalized docket number FDA-2020-
Patients by Pharmacy D-1136 and complete
Compounders not title of the guidance
Registered as in the request.
Outsourcing Facilities
During the COVID-19
Public Health Emergency
(April 2020) (Updated
May 21, 2020).
FDA-2020-D-1136..................... CDER.................. Effects of the COVID-19 [email protected].
Public Health Emergency Please include the
on Formal Meetings and docket number FDA-2020-
User Fee Applications-- D-1136 and complete
Questions and Answers title of the guidance
(May 26, 2020). in the request.
FDA-2020-D-1106..................... CDER.................. FDA Guidance on Conduct clinicaltrialconduct-
of Clinical Trials of [email protected]
Medical Products during Please include the
COVID-19 Public Health docket number FDA-2020-
Emergency (March 2020) D-1106 and complete
(Updated May 14 and title of the guidance
June 3, 2020). in the request.
FDA-2020-D-1139..................... CFSAN................. Returning Refrigerated Retail Food Protection
Transport Vehicles and Staff, Office of Food
Refrigerated Storage Safety, Center for Food
Units to Food Uses Safety and Applied
After Using Them to Nutrition, Food and
Preserve Human Remains Drug Administration,
During the COVID-19 5001 Campus Dr.,
Pandemic (May 12, 2020). College Park, MD 20740.
FDA-2020-D-1139..................... CFSAN................. Temporary Policy Office of Nutrition and
Regarding Certain Food Food Labeling, Food
Labeling Requirements Labeling and Standards
During the COVID-19 Staff, Center for Food
Public Health Safety and Applied
Emergency: Minor Nutrition, Food and
Formulation Changes and Drug Administration,
Vending Machines (May 5001 Campus Dr.,
22, 2020). College Park, MD 20740.
FDA-2020-D-1140..................... CVM................... GFI# 271 Reporting and [email protected].
Mitigating Animal Drug Please include the
Shortages during the docket number FDA-2020-
COVID-19 Public Health N-1140 and complete
Emergency (May 7, 2020). title of the guidance
in the request.
----------------------------------------------------------------------------------------------------------------
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
[[Page 38375]]
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. 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 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:
Table 2--CDRH Guidances and Collections
----------------------------------------------------------------------------------------------------------------
Another guidance title
COVID-19 guidance title CFR cite referenced in referenced in COVID-19 OMB control
COVID-19 guidance guidance No(s).
----------------------------------------------------------------------------------------------------------------
Supplements for Approved Premarket Approval 21 CFR part 814, subparts 0910-0231
(PMA) or Humanitarian Device Exemption A through E. 0910-0332
(HDE) Submissions During the Coronavirus 21 CFR part 814, subpart 0910-0073
Disease 2019 (COVID-19) Public Health H.
Emergency. 21 CFR part 820..........
21 CFR parts 800, 801, ........................ 0910-0485
and 809.
Recommendations for Sponsors Requesting 21 CFR part 803.......... ........................ 0910-0437
EUAs for Decontamination and Bioburden Emergency Use 0910-0595
Reduction Systems for Face Masks and Authorization of
Respirators During the Coronavirus Disease Medical Products and
2019 (COVID-19) Public Health Emergency. Related Authorities.
Enforcement Policy for Face Masks and 21 CFR parts 800, 801, ........................ 0910-0485
Respirators During the Coronavirus Disease and 809. ........................ ..............
(COVID-19) Public Health Emergency. 21 CFR part 803.......... ........................ 0910-0437
21 CFR part 806.......... ........................ 0910-0359
21 CFR part 807, subpart ........................ 0910-0120
E.
21 CFR part 807, subparts ........................ 0910-0625
A through D.
21 CFR part 820.......... ........................ 0910-0073
21 CFR part 830 and ........................ 0910-0720
801.20.
Emergency Use 0910-0595
Authorization of
Medical Products and
Related Authorities.
----------------------------------------------------------------------------------------------------------------
The guidance indicated in the table below refers 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 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.
Table 3--CDRH Guidance and Collections
----------------------------------------------------------------------------------------------------------------
Another guidance
COVID-19 guidance CFR cite referenced referenced in COVID- OMB control New collection covered by PHE
title in COVID-19 guidance 19 guidance No(s). PRA waiver
----------------------------------------------------------------------------------------------------------------
Notifying CDRH of 21 CFR part 807, 0910-0625
Permanent subparts A through D. .................... ...........
Discontinuance or Emergency Use 0910-0595
Interruption in Authorization of
Manufacturing of a Medical Products
Device Under Section and Related
506J of the FD&C Act Authorities;
During the COVID-19 Guidance for
Public Health Industry and Other
Emergency. 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 PHE.
Updates to FDA every 2 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
PHE.
----------------------------------------------------------------------------------------------------------------
[[Page 38376]]
B. 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 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 4--CDER Guidances and Collections
----------------------------------------------------------------------------------------------------------------
Another guidance title
COVID-19 guidance title CFR cite referenced in referenced in COVID-19 OMB control
COVID-19 guidance guidance No(s).
----------------------------------------------------------------------------------------------------------------
Effects of the COVID-19 Public Health Sec. 10.115(g)(2)...... Planning for the Effects of 0910-0001
Emergency on Formal Meetings and User High Absenteeism to Ensure 0910-0014
Fee Applications.. Availability of Medically 0910-0429
Necessary Drug Products. 0910-0693
Formal Meetings Between the 0910-0718
FDA and Sponsors or 0910-0719
Applicants of PDUFA Products. 0910-0727
Formal Meetings Between the
FDA and Sponsors or
Applicants of BsUFA Products.
Exemption and Exclusion of Certain ......................... Drug Supply Chain Security 0910-0777
Requirements of the Drug Supply Chain Act Implementation: 0910-0800
Security Act During the COVID-19 Identification of Suspect 0910-0806
Public Health Emergency.. Product and Notification. 0910-0827
Verification Systems Under 0910-0859
the Drug Supply Chain
Security Act for Certain
Prescription Drugs.
Definitions of Suspect
Product and Illegitimate
Product for Verification
Obligations Under the Drug
Supply Chain Security Act.
General Considerations for Pre-IND 21 CFR part 312.......... COVID-19: Developing Drugs 0910-0001
Meeting Requirements for COVID-19 and Biological Products for 0910-0014
Related Drugs and Biological Treatment or Prevention. 0910-0338
Products.. Formal Meetings Between the 0910-0429
FDA and Sponsors or 0910-0595
Applicants of PDUFA Products. 0910-0719
Emergency Use Authorization
of Medical Products and
Related Authorities.
Preclinical Assessment of 0910-0814
Investigational Cellular and
Gene Therapy Products.
Guidance for Clinical Trial
Sponsors: Establishment and
Operation of Clinical Trial
Data Monitoring Committees.
Use of Liquids and/or Soft
Foods as Vehicles for Drug
Administration: General
Considerations for Selection
and In Vitro Methods for
Product Quality Assessments.
Demonstrating Substantial
Evidence of Effectiveness
for Human Drug and
Biological Products.
----------------------------------------------------------------------------------------------------------------
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 guidances have been
approved by OMB as listed in the below table. These guidances also
contain new collections of information not approved under a current
collection. These new collections of information have 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 5-- CDER Guidances and Collections
----------------------------------------------------------------------------------------------------------------
Another guidance New collection
COVID-19 guidance CFR cite referenced referenced in COVID- OMB control No(s). covered by PHE PRA
title in COVID-19 guidance 19 guidance waiver
----------------------------------------------------------------------------------------------------------------
Temporary Policy for 21 CFR 314.81, 21 Current Good 0910-0777, 0910- To provide
Compounding of CFR 600.82. Manufacturing 0338, 0910-0001, suitability and
Certain Drugs for Practice--Guidance 0910-0139. proof of sterility
Hospitalized Patients for Human Drug for the container
by Outsourcing Compounding closure systems
Facilities During the Outsourcing used.
COVID-19 Public Facilities Under
Health Emergency. Section 503B of the
FD&C Act.
Temporary Policy for .................... Compounded Drug 0910-0001, 0910- For reporting of
Compounding of Products That are 0139, 0910-0338. adverse events by
Certain Drugs for Essentially Copies pharmacy compounders
Hospitalized Patients of a Commercially to the MedWatch
by Pharmacy Available Drug system and
Compounders not Product under maintaining records
Registered as Section 503A of the of drugs suppliers
Outsourcing Federal Food, Drug, and patients who
Facilities During the and Cosmetic Act. receive the
COVID-19 Public Temporary Policy for compounded products.
Health Emergency. Compounding of
Certain Drugs for
Hospitalized
Patients by
Outsourcing
Facilities During
the COVID-19 Public
Health Emergency.
Prescription
Requirement Under
Section 503A of the
Federal Food, Drug,
and Cosmetic Act.
[[Page 38377]]
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.
Temporary Policy 21 CFR parts 210 and Enforcement Policy 0910-0139........... Recordkeeping of
Regarding Non- 211. for Face Masks and compounding
Standard PPE Respirators During performed without
Practices for Sterile the Coronavirus standard PPE;
Compounding by Disease (COVID-19) recordkeeping of any
Pharmacy Compounders Public Health change of
not Registered as Emergency (Revised). sterilization/
Outsourcing Enforcement Policy aseptic processing
Facilities During the for Gowns, Other methods;
COVID-19 Public Apparel, and Gloves documentation of
Health Emergency. During the mitigation
Coronavirus Disease strategies for
(COVID-19) Public sterile compounding
Health Emergency. without standard
PPE.
Electronic Drug
Product Reporting
for Human Drug
Compounding
Outsourcing
Facilities Under
Section 503B of the
Federal Food, Drug,
and Cosmetic Act.
Guidance on Conduct of 21 CFR part 11, 21 Formal Meetings 0910-0001, 0910- Submission by
Clinical Trials of CFR part 50, 21 CFR Between the FDA and 0014, 0910-0130, investigators of
Medical Products part 56, 21 CFR Sponsors or 0910-0303, 0910- informed consent
during COVID-19 part 312, 21 CFR Applicants of PDUFA 0338, 0910-0119, forms to third
Public Health part 314, 21 CFR Products. 0910-0581, 0910- parties.
Emergency. part 601, 21 CFR Formal Meetings 0733, 0910-0078.
part 812. 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--Eligibi
lity 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.
[[Page 38378]]
Requests for Feedback
and Meetings for
Medical Device
Submissions: The Q-
Submission Program.
----------------------------------------------------------------------------------------------------------------
C. CFSAN Guidance
The guidance indicated in the table below refers 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 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 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 Guidance and Collections
----------------------------------------------------------------------------------------------------------------
Another guidance New collection
COVID-19 guidance CFR cite referenced referenced in COVID- OMB control No(s). covered by PHE PRA
title in COVID-19 guidance 19 guidance waiver
----------------------------------------------------------------------------------------------------------------
Temporary Policy 21 CFR part 101; .................... 0910-0381, 0910- Recommend that
Regarding Certain section 403(w) of 0782, 0910-0792. manufacturers post
Mandatory Food the FD&C Act. ingredient omissions
Labeling Requirements or substitutions not
During the COVID-19 reflected on the
Public Health product label.
Emergency: Minor
Formulation Changes
and Vending Machines.
----------------------------------------------------------------------------------------------------------------
The guidance entitled ``Returning Refrigerated Transport Vehicles
and Refrigerated Storage Units to Food Uses After Using Them to
Preserve Human Remains During the COVID-19 Pandemic'' contains no
collection of information. Therefore, clearance by OMB under the PRA is
not required.
D. CVM Guidance
This guidance indicated in the table below refers 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 indicated 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 7--CVM Guidance and Collection
----------------------------------------------------------------------------------------------------------------
Another guidance New collection
COVID-19 guidance CFR cite referenced referenced in COVID- OMB control No(s). covered by PHE PRA
title in COVID-19 guidance 19 guidance waiver
----------------------------------------------------------------------------------------------------------------
GFI# 271, Reporting 21 CFR 514.1(a))..... .................... 0910-0032, 0910-0669 Reporting and
and Mitigating Animal mitigating animal
Drug Shortages during drug shortages.
the COVID-19 Public
Health Emergency.
----------------------------------------------------------------------------------------------------------------
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: June 22, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-13829 Filed 6-25-20; 8:45 am]
BILLING CODE 4164-01-P
