Guidance Documents Related to Coronavirus Disease 2019 (COVID-19); Availability, 31513-31520 [2020-11238]
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Federal Register / Vol. 85, No. 101 / Tuesday, May 26, 2020 / Notices
validation reviews or complaint
surveys, the State survey agency
monitors corrections as specified at
§ 488.9(c)(1).
++ TJC’s capacity to report
deficiencies to the surveyed facilities
and respond to the facility’s plan of
correction in a timely manner.
++ TJC’s capacity to provide CMS
with electronic data and reports
necessary for the effective validation
and assessment of the organization’s
survey process.
++ The adequacy of TJC’s staff and
other resources, and its financial
viability.
++ TJC’s capacity to adequately fund
required surveys.
++ TJC’s policies with respect to
whether surveys are announced or
unannounced, to ensure that surveys are
unannounced.
++ TJC’s policies and procedures to
avoid conflicts of interest, including the
appearance of conflicts of interest,
involving individuals who conduct
surveys or participate in accreditation
decisions.
++ TJC’s agreement to provide CMS
with a copy of the most current
accreditation survey together with any
other information related to the survey
as CMS may require (including
corrective action plans).
IV. Collection of Information
Requirements
This document does not impose
information collection requirements,
that is, reporting, recordkeeping or
third-party disclosure requirements.
Consequently, there is no need for
review by the Office of Management and
Budget under the authority of the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501 et seq.).
V. Response to Public Comments
Because of the large number of public
comments we normally receive on
Federal Register documents, we are not
able to acknowledge or respond to them
individually. We will consider all
comments we receive by the date and
time specified in the DATES section of
this preamble, and, when we proceed
with a subsequent document, we will
respond to the comments in the
preamble to that document.
Upon completion of our evaluation,
including our evaluation of comments
received as a result of this notice, we
will publish a final notice in the Federal
Register announcing the result of our
evaluation.
The Administrator of the Centers for
Medicare & Medicaid Services (CMS),
Seema Verma, having reviewed and
approved this document, authorizes
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Evell J. Barco Holland, who is the
Federal Register Liaison, to
electronically sign this document for
purposes of publication in the Federal
Register.
Dated: May 7, 2020.
Evell J. Barco Holland,
Federal Register Liaison, Department of
Health and Human Services.
[FR Doc. 2020–11234 Filed 5–22–20; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2020–D–1136, FDA–
2020–D–1137, FDA–2020–D–1138, FDA–
2020–D–1139]
Guidance Documents Related to
Coronavirus Disease 2019 (COVID–19);
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of FDA
guidance documents related to the
Coronavirus Disease 2019 (COVID–19)
public health emergency (PHE). This
notice of availability (NOA) is pursuant
to the process that FDA announced, in
the Federal Register of March 25, 2020,
for making available to the public
COVID–19-related guidances. The
guidances identified in this notice
address issues related to the COVID–19
PHE and have been issued in
accordance with the process announced
in the March 25, 2020, notice. The
guidances have been implemented
without prior comment, but they remain
subject to comment in accordance with
the Agency’s good guidance practices.
DATES: The announcement of the
guidances is published in the Federal
Register on May 26, 2020. The
guidances have been implemented
without prior comment, but they remain
subject to comment in accordance with
the Agency’s good guidance practices.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
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including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the name of the
guidance(s) 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
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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.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)). Submit written requests
for single copies of any 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
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. 7268,
Silver Spring, MD 20993–0002, 240–
402–7911; Erica Takai, Center for
Devices and Radiological Health
(CDRH), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 66,
Rm. 5456, Silver Spring, MD 20993–
0002, 301–796–6353; 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; 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.
SUPPLEMENTARY INFORMATION:
I. Background
On January 31, 2020, as a result of
confirmed cases of COVID–19, and after
consultation with public health officials
as necessary, Alex M. Azar II, Secretary
of Health and Human Services, pursuant
to the authority under section 319 of the
Public Health Service Act (42 U.S.C.
247d) (PHS Act), determined that a PHE
exists and has existed since January 27,
2020, nationwide.1 On March 13, 2020,
President Donald J. Trump declared that
the COVID–19 outbreak in the United
States constitutes a national emergency,
beginning March 1, 2020.2
In the Federal Register of March 25,
2020 (the March 25, 2020, notice)
(available at: https://www.govinfo.gov/
content/pkg/FR-2020-03-25/pdf/202006222.pdf), FDA announced procedures
for making available FDA guidances
related to the COVID–19 PHE. These
procedures, which operate within FDA’s
established good guidance practices
regulations, are intended to allow FDA
to rapidly disseminate Agency
recommendations and policies related
to COVID–19 to industry, FDA staff, and
other stakeholders. The March 25, 2020,
notice stated that due to the need to act
quickly and efficiently to respond to the
COVID–19 PHE, FDA believes that prior
public participation will not be feasible
or appropriate before FDA implements
COVID–19-related guidances. Therefore,
FDA will issue COVID–19-related
guidances for immediate
implementation without prior public
comment (see section 701(h)(1)(C) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 371(h)(1)(C) and
21 CFR 10.115(g)(2) (§ 10.115(g)(2))).
The guidances are available at FDA’s
web page entitled ‘‘COVID–19-Related
Guidance Documents for Industry, FDA
Staff, and Other Stakeholders’’ (https://
www.fda.gov/emergency-preparednessand-response/mcm-issues/covid-19related-guidance-documents-industryfda-staff-and-other-stakeholders) and
through FDA’s web page entitled
‘‘Search for FDA Guidance Documents’’
available at https://www.fda.gov/
regulatory-information/search-fdaguidance-documents.
The March 25, 2020, notice further
stated that, in general, rather than
publishing a separate NOA for each
COVID–19-related guidance, FDA
intends to publish periodically a
consolidated NOA announcing the
availability of certain COVID–19-related
guidances FDA issued during the
relevant period, as included in table 1.
This notice announces COVID–19related guidances that are posted on
FDA’s website.
II. Availability of COVID–19-Related
Guidances
Pursuant to the process described in
the March 25, 2020, notice, FDA is
announcing the availability of the
following COVID–19-related guidances:
TABLE 1—GUIDANCES RELATED TO THE COVID–19 PUBLIC HEALTH EMERGENCY
Docket No.
Center/office
Title of guidance
Contact information to request single copies
Office of Communication, Outreach and Development, 10903 New Hampshire Ave., Bldg. 71,
Rm. 3128, Silver Spring, MD 20993–0002, 1–
800–835–4709 or 240–402–8010, email
ocod@fda.hhs.gov.
CDRH-Guidance@fda.hhs.gov
Please include the document number 20014 and
complete title of the guidance in the request.
FDA–2020–D–1137 .......
CBER
Investigatory COVID–19 Convalescent Plasma
(April 2020) (Updated May 1, 2020).
FDA–2020–D–1138 .......
CDRH
FDA–2020–D–1138 .......
CDRH
Enforcement Policy for Clinical Electronic Thermometers During the Coronavirus Disease
2019 (COVID–19) Public Health Emergency
(April 4, 2020).
Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease
2019 (COVID–19) Public Health Emergency
(April 5, 2020).
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.
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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-
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CDRH-Guidance@fda.hhs.gov
Please include the document number 20014 and
complete title of the guidance in the request.
national-emergency-concerning-novel-coronavirusdisease-covid-19-outbreak/.
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TABLE 1—GUIDANCES RELATED TO THE COVID–19 PUBLIC HEALTH EMERGENCY—Continued
Docket No.
Center/office
FDA–2020–D–1138 .......
CDRH
FDA–2020–D–1138 .......
CDRH
FDA–2020–D–1138 .......
CDRH
FDA–2020–D–1138 .......
CDRH
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–1139 .......
CFSAN
Title of guidance
Contact information to request single copies
Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the
Coronavirus Disease 2019 (COVID–19) Public
Health Emergency (April 6, 2020).
Enforcement Policy for Extracorporeal Membrane
Oxygenation and Cardiopulmonary Bypass Devices During the Coronavirus Disease 2019
(COVID–19) Public Health Emergency (April 6,
2020).
Enforcement Policy for Digital Health Devices for
Treating Psychological Disorders During the
Coronavirus Disease 2019 (COVID–19) Public
Health Emergency (April 14, 2020).
Enforcement Policy for Telethermographic Systems During the Coronavirus Disease 2019
(COVID–19) Public Health Emergency (April
16, 2020).
Enforcement Policy for Non-Invasive Fetal and
Maternal Monitoring Devices Used to Support
Patient Monitoring During the Coronavirus Disease 2019 (COVID–19) Public Health Emergency (April 23, 2020).
Enforcement Policy for Imaging Systems During
the Coronavirus Disease 2019 (COVID–19)
Public Health Emergency (April 23, 2020).
Enforcement Policy for Remote Digital Pathology
Devices During the Coronavirus Disease 2019
(COVID–19) Public Health Emergency (April
24, 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).
Policy for the Temporary Use of Portable Cryogenic Containers Not in Compliance With 21
CFR 211.94(e)(1) For Oxygen and Nitrogen
During the COVID–19 Public Health Emergency (April 2020) (Updated April 20, 2020).
Temporary Policy for Compounding of Certain
Drugs for Hospitalized Patients by Outsourcing
Facilities During the COVID–19 Public Health
Emergency (April 16, 2020) (Updated May 8,
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 Guidance for Industry (April 20,
2020) (Updated May 8, 2020).
Temporary Policy on Repackaging or Combining
Propofol Drug Products During the COVID–19
Public Health Emergency (April 22, 2020).
CDRH-Guidance@fda.hhs.gov
Please include the document number 20014 and
complete title of the guidance in the request.
Temporary Policy on Regulatory Enforcement of
21 CFR Part 118 (the Egg Safety Rule) During
the COVID–19 Public Health Emergency (April
6, 2020).
Although these guidances have been
implemented immediately without prior
comment, FDA will consider all
comments received and revise the
guidances as appropriate (see
§ 10.115(g)(3)).
These guidances are being issued
consistent with FDA’s good guidance
practices regulation (§ 10.115). The
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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 20014 and
complete title of the guidance in the request.
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 20014 and
complete title of the guidance in the request.
CDRH-Guidance@fda.hhs.gov
Please include the document number
complete title of the guidance in the
CDRH-Guidance@fda.hhs.gov
Please include the document number
complete title of the guidance in the
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20014 and
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.
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.
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.
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request.
III. Paperwork Reduction Act of 1995
A. CBER
The guidance indicated below refers
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
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Act of 1995 (44 U.S.C. 3501–3521)
(PRA). The collections of information in
the following FDA regulations and
guidance have been approved by OMB
as listed in the following table:
TABLE 2—CBER GUIDANCE
COVID–19 guidance title
CFR cite referenced in COVID–19
guidance
Another guidance title referenced in
COVID–19 guidance
Investigatory COVID–19 Convalescent
Plasma.
21 CFR part 312 .....................................
≤21 CFR 606.121 ....................................
21 CFR part 630 .....................................
Form FDA 3926 .......................................
N/A ...........................................................
..................................................................
..................................................................
..................................................................
B. CDRH
The guidances listed below refer to
previously approved collections of
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information. These collections of
information are subject to review by
OMB under the PRA. The collections of
information in the following FDA
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OMB control
No(s).
0910–0014
0910–0116
0910–0116
0910–0814
regulations and guidance have been
approved by OMB as listed in the
following table:
BILLING CODE 4164–01–P
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BILLING CODE 4164–01–C
C. CDER
The guidances listed 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—GUIDANCES AND REGULATIONS
CFR or FD&C Act cite referenced
in COVID–19 guidance
Another guidance title referenced in COVID–
19 guidance
OMB control
No(s).
Policy for Temporary Use of Portable Cryo- 21 CFR parts 201, 210, 211.84,
genic Containers Not in Compliance With
211.94, and 211.100.
21 CFR 211.94 for Oxygen and Nitrogen
During COVID–19 Public Health Emergency.
Temporary Policy for Compounding of Certain 21 CFR 314.81, 21 CFR 600.82,
Drugs for Hospitalized Patients by OutSection 503B(b)(1)(A)(i) of the
sourcing Facilities During the COVID–19
FD&C
Act
(21
U.S.C.
Public Health Emergency.
353b(b)(1)(A)(i).
Current Good Manufacturing Practice for
Medical Gases Medical Gas Containers
and Closures; Current Good Manufacturing Practice Requirements.
Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of
the FD&C Act.
0910–0139
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0910–0777
0910–0338
0910–0001
0910–0139
EN26MY20.027</GPH>
COVID–19 guidance title
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TABLE 4—GUIDANCES AND REGULATIONS—Continued
COVID–19 guidance title
CFR or FD&C Act cite referenced
in COVID–19 guidance
Another guidance title referenced in COVID–
19 guidance
OMB control
No(s).
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.
......................................................
0910–0001
0910–0139
0910–0338
Temporary Policy on Repackaging or Combining Propofol Drug Products During the
COVID–19 Public Health Emergency.
......................................................
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.
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.
Repackaging of Certain Human Drugs by
Pharmacies and Outsourcing Facilities.
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.
Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by
Outsourcing Facilities During the COVID–
19 Public Health Emergency.
The guidance indicated 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 below
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
0910–0139
0910–0572
0910–0777
0910–0800
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—NEW PRA INFORMATION COLLECTION
CFR cite
referenced in
COVID–19
guidance
COVID–19 guidance title
Temporary Policy Regarding NonStandard 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.
D. CFSAN
The guidance indicated below refers
to previously approved collections of
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Another guidance referenced in
COVID–19 guidance
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.
information. These collections of
information are subject to review by
OMB under the PRA. The collections of
information in the following FDA
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No.
0910–0139
New collection covered by PHE
PRA waiver
Recordkeeping of compounding
without standard PPE; recordkeeping of any change of sterilization/aseptic processing methods; documentation of mitigation
strategies for sterile
compounding without standard
PPE.
regulations and guidance have been
approved by OMB as listed in the
following table:
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TABLE 6—CFSAN GUIDANCE
COVID–19 guidance title
Temporary Policy Regarding Enforcement of 21 CFR Part 118 (the Egg Safety
Rule) During the COVID–19 Public Health Emergency.
IV. Electronic Access
Another guidance title
referenced in
COVID–19 guidance
OMB control
No.
21 CFR part 118 ......
...................................
0910–0660
Comments on the ICR must be
received on or before June 25, 2020.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 795–7714. When submitting
comments or requesting information,
please include the document identifier
0937–0198–30D and project title for
reference.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
DATES:
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/
regulatory-information/search-fdaguidance-documents; or
• https://www.regulations.gov.
Dated: May 19, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–11238 Filed 5–22–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0937–0198]
Agency Information Collection
Request; 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
CFR cite referenced
in COVID–19
guidance
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
SUMMARY:
Title of the Collection: Public Health
Service Polices on Research
Misconduct (42 CFR part 93)—OMB No.
0937–0198—Extension—Office of
Research Integrity.
Abstract: The Office of Research
Integrity is requesting an extension on a
currently approved collection. The
purpose of the Institutional Assurance
and Annual Report on Possible Research
Misconduct form PHS–6349 is to
provide data on the amount of research
misconduct activity occurring in
institutions conducting PHS-supported
research. The purpose of the Assurance
of Compliance by Sub-Award Recipients
form PHS–6315 is to establish an
assurance of compliance for a subawardee institution. Forms PHS 6349
and PHS–6315 are also used to provide
an annual assurance that the institution
has established and will follow
administrative policies and procedures
for responding to allegations of research
misconduct that comply with the Public
Health Service (PHS) Policies on
Research Misconduct (42 CFR Part 93).
Research misconduct is defined as
receipt of an allegation of research
misconduct and/or the conduct of an
inquiry and/or investigation into such
allegations. These data enable the ORI to
monitor institutional compliance with
the PHS regulation.
Need and Proposed Use: The
information is needed to fulfill section
493 of the Public Health Service Act (42
U.S.C. 289b), which requires assurances
from institutions that apply for financial
assistance under the Public Health
Service Act for any project or program
that involves the conduct of biomedical
or behavioral research. In addition, the
information is also required to fulfill the
assurance and annual reporting
requirements of 42 CFR Part 93. ORI
uses the information to monitor
institutional compliance with the
regulation. Lastly, the information may
be used to respond to congressional
requests for information to prevent
misuse of Federal funds and to protect
the public interest.
ESTIMATED ANNUALIZED BURDEN HOUR TABLE
Average
burden hours
per
response
Type of respondent
PHS–6349 .........................................
PHS–6315 .........................................
Awardee Institutions .........................
Sub-Awardee Institutions .................
5748
110
1
1
12/60
5/60
1150
9
Total ...........................................
...........................................................
........................
........................
........................
1159
VerDate Sep<11>2014
19:08 May 22, 2020
Jkt 250001
PO 00000
Frm 00090
Fmt 4703
Number of
respondents
Number of
responses per
respondent
Forms
(if necessary)
Sfmt 4703
E:\FR\FM\26MYN1.SGM
26MYN1
Total burden
hours
]]>Agencies
[Federal Register Volume 85, Number 101 (Tuesday, May 26, 2020)]
[Notices]
[Pages 31513-31520]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-11238]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2020-D-1136, FDA-2020-D-1137, FDA-2020-D-1138, FDA-
2020-D-1139]
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 guidances have been implemented without prior comment, but they
remain subject to comment in accordance with the Agency's good guidance
practices.
DATES: The announcement of the guidances is published in the Federal
Register on May 26, 2020. The guidances have been implemented without
prior comment, but they remain subject to comment in accordance with
the Agency's good guidance practices.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the name of the
guidance(s) 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
[[Page 31514]]
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 any 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 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. 7268, Silver Spring, MD 20993-0002, 240-
402-7911; Erica Takai, Center for Devices and Radiological Health
(CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5456, Silver Spring, MD 20993-0002, 301-796-6353; 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; 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.
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 guidances related to the COVID-19 PHE. These procedures, which
operate within FDA's established good guidance practices regulations,
are intended to allow FDA to rapidly disseminate Agency recommendations
and policies related to COVID-19 to industry, FDA staff, and other
stakeholders. The March 25, 2020, notice stated that due to the need to
act quickly and efficiently to respond to the COVID-19 PHE, FDA
believes that prior public participation will not be feasible or
appropriate before FDA implements COVID-19-related guidances.
Therefore, FDA will issue COVID-19-related guidances for immediate
implementation without prior public comment (see section 701(h)(1)(C)
of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
371(h)(1)(C) and 21 CFR 10.115(g)(2) (Sec. 10.115(g)(2))). The
guidances are available at FDA's web page entitled ``COVID-19-Related
Guidance Documents for Industry, FDA Staff, and Other Stakeholders''
(https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders) and through FDA's web page entitled ``Search for FDA
Guidance Documents'' available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.
The March 25, 2020, notice further stated that, in general, rather
than publishing a separate NOA for each COVID-19-related guidance, FDA
intends to publish periodically a consolidated NOA announcing the
availability of certain COVID-19-related guidances 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 Guidances
Pursuant to the process described in the March 25, 2020, notice,
FDA is announcing the availability of the following COVID-19-related
guidances:
Table 1--Guidances Related to the COVID-19 Public Health Emergency
----------------------------------------------------------------------------------------------------------------
Contact information to
Docket No. Center/office Title of guidance request single copies
----------------------------------------------------------------------------------------------------------------
FDA-2020-D-1137................... CBER Investigatory COVID-19 Office of Communication,
Convalescent Plasma Outreach and
(April 2020) (Updated Development, 10903 New
May 1, 2020). Hampshire Ave., Bldg.
71, Rm. 3128, Silver
Spring, MD 20993-0002, 1-
800-835-4709 or 240-402-
8010, email
[email protected].
FDA-2020-D-1138................... CDRH Enforcement Policy for [email protected]
Clinical Electronic Please include the
Thermometers During the document number 20014
Coronavirus Disease 2019 and complete title of
(COVID-19) Public Health the guidance in the
Emergency (April 4, request.
2020).
FDA-2020-D-1138................... CDRH Enforcement Policy for [email protected]
Infusion Pumps and Please include the
Accessories During the document number 20014
Coronavirus Disease 2019 and complete title of
(COVID-19) Public Health the guidance in the
Emergency (April 5, request.
2020).
[[Page 31515]]
FDA-2020-D-1138................... CDRH Enforcement Policy for [email protected]
Remote Ophthalmic Please include the
Assessment and document number 20014
Monitoring Devices and complete title of
During the Coronavirus the guidance in the
Disease 2019 (COVID-19) request.
Public Health Emergency
(April 6, 2020).
FDA-2020-D-1138................... CDRH Enforcement Policy for [email protected]
Extracorporeal Membrane Please include the
Oxygenation and document number 20014
Cardiopulmonary Bypass and complete title of
Devices During the the guidance in the
Coronavirus Disease 2019 request.
(COVID-19) Public Health
Emergency (April 6,
2020).
FDA-2020-D-1138................... CDRH Enforcement Policy for [email protected]
Digital Health Devices Please include the
for Treating document number 20014
Psychological Disorders and complete title of
During the Coronavirus the guidance in the
Disease 2019 (COVID-19) request.
Public Health Emergency
(April 14, 2020).
FDA-2020-D-1138................... CDRH Enforcement Policy for [email protected]
Telethermographic Please include the
Systems During the document number 20014
Coronavirus Disease 2019 and complete title of
(COVID-19) Public Health the guidance in the
Emergency (April 16, request.
2020).
FDA-2020-D-1138................... CDRH Enforcement Policy for [email protected]
Non-Invasive Fetal and Please include the
Maternal Monitoring document number 20014
Devices Used to Support and complete title of
Patient Monitoring the guidance in the
During the Coronavirus request.
Disease 2019 (COVID-19)
Public Health Emergency
(April 23, 2020).
FDA-2020-D-1138................... CDRH Enforcement Policy for [email protected]
Imaging Systems During Please include the
the Coronavirus Disease document number 20014
2019 (COVID-19) Public and complete title of
Health Emergency (April the guidance in the
23, 2020). request.
FDA-2020-D-1138................... CDRH Enforcement Policy for [email protected]
Remote Digital Pathology Please include the
Devices During the document number 20014
Coronavirus Disease 2019 and complete title of
(COVID-19) Public Health the guidance in the
Emergency (April 24, request.
2020).
FDA-2020-D-1136................... CDER Temporary Policy [email protected]
Regarding Non-Standard Please include the docket
PPE Practices for number FDA-2020-D-1136
Sterile Compounding by and complete title of
Pharmacy Compounders not the guidance in the
Registered as request.
Outsourcing Facilities
During the COVID-19
Public Health Emergency
(April 10, 2020).
FDA-2020-D-1136................... CDER Policy for the Temporary [email protected]
Use of Portable Please include the docket
Cryogenic Containers Not number FDA-2020-D-1136
in Compliance With 21 and complete title of
CFR 211.94(e)(1) For the guidance in the
Oxygen and Nitrogen request.
During the COVID-19
Public Health Emergency
(April 2020) (Updated
April 20, 2020).
FDA-2020-D-1136................... CDER Temporary Policy for [email protected]
Compounding of Certain Please include the docket
Drugs for Hospitalized number FDA-2020-D-1136
Patients by Outsourcing and complete title of
Facilities During the the guidance in the
COVID-19 Public Health request.
Emergency (April 16,
2020) (Updated May 8,
2020).
FDA-2020-D-1136................... CDER Temporary Policy for [email protected]
Compounding of Certain Please include the docket
Drugs for Hospitalized number FDA-2020-D-1136
Patients by Pharmacy and complete title of
Compounders not the guidance in the
Registered as request.
Outsourcing Facilities
During the COVID-19
Public Health Emergency
Guidance for Industry
(April 20, 2020)
(Updated May 8, 2020).
FDA-2020-D-1136................... CDER Temporary Policy on [email protected]
Repackaging or Combining Please include the docket
Propofol Drug Products number FDA-2020-D-1136
During the COVID-19 and complete title of
Public Health Emergency the guidance in the
(April 22, 2020). request.
FDA-2020-D-1139................... CFSAN Temporary Policy on Office of Nutrition and
Regulatory Enforcement Food Labeling, Food
of 21 CFR Part 118 (the Labeling and Standards
Egg Safety Rule) During Staff, Center for Food
the COVID-19 Public Safety and Applied
Health Emergency (April Nutrition, Food and Drug
6, 2020). Administration, 5001
Campus Dr., College
Park, MD 20740.
----------------------------------------------------------------------------------------------------------------
Although these guidances have been implemented immediately without
prior comment, FDA will consider all comments received and revise the
guidances as appropriate (see Sec. 10.115(g)(3)).
These guidances are being issued consistent with FDA's good
guidance practices regulation (Sec. 10.115). The guidances represent
the current thinking of FDA. They do not establish any rights for any
person and are not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.
III. Paperwork Reduction Act of 1995
A. CBER
The guidance indicated below refers 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
[[Page 31516]]
Act of 1995 (44 U.S.C. 3501-3521) (PRA). The collections of information
in the following FDA regulations and guidance have been approved by OMB
as listed in the following table:
Table 2--CBER Guidance
----------------------------------------------------------------------------------------------------------------
Another guidance title
COVID-19 guidance title CFR cite referenced in referenced in COVID-19 OMB control
COVID-19 guidance guidance No(s).
----------------------------------------------------------------------------------------------------------------
Investigatory COVID-19 Convalescent 21 CFR part 312........... N/A....................... 0910-0014
Plasma. >21 CFR 606.121........... .......................... 0910-0116
21 CFR part 630........... .......................... 0910-0116
Form FDA 3926............. .......................... 0910-0814
----------------------------------------------------------------------------------------------------------------
B. CDRH
The guidances listed 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:
BILLING CODE 4164-01-P
[[Page 31517]]
[GRAPHIC] [TIFF OMITTED] TN26MY20.026
[[Page 31518]]
[GRAPHIC] [TIFF OMITTED] TN26MY20.027
BILLING CODE 4164-01-C
C. CDER
The guidances listed 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--Guidances and Regulations
----------------------------------------------------------------------------------------------------------------
CFR or FD&C Act cite
COVID-19 guidance title referenced in COVID-19 Another guidance title OMB control
guidance referenced in COVID-19 No(s).
--------------------------------------------------------------------------------guidance------------------------
Policy for Temporary Use of Portable 21 CFR parts 201, 210, Current Good Manufacturing 0910-0139
Cryogenic Containers Not in Compliance 211.84, 211.94, and Practice for Medical Gases
With 21 CFR 211.94 for Oxygen and 211.100. Medical Gas Containers and
Nitrogen During COVID-19 Public Health Closures; Current Good
Emergency. Manufacturing Practice
Requirements.
Temporary Policy for Compounding of 21 CFR 314.81, 21 CFR Current Good Manufacturing 0910-0777
Certain Drugs for Hospitalized 600.82, Section Practice--Guidance for Human 0910-0338
Patients by Outsourcing Facilities 503B(b)(1)(A)(i) of the Drug Compounding Outsourcing 0910-0001
During the COVID-19 Public Health FD&C Act (21 U.S.C. Facilities Under Section 503B 0910-0139
Emergency. 353b(b)(1)(A)(i). of the FD&C Act.
[[Page 31519]]
Temporary Policy for Compounding of .......................... Compounded Drug Products That 0910-0001
Certain Drugs for Hospitalized are Essentially Copies of a 0910-0139
Patients by Pharmacy Compounders not Commercially Available Drug 0910-0338
Registered as Outsourcing Facilities Product under Section 503A of
During the COVID-19 Public Health the Federal Food, Drug and
Emergency. 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.
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 on Repackaging or .......................... Repackaging of Certain Human 0910-0139
Combining Propofol Drug Products Drugs by Pharmacies and 0910-0572
During the COVID-19 Public Health Outsourcing Facilities. 0910-0777
Emergency. Temporary Policy for 0910-0800
Compounding of Certain Drugs
for Hospitalized Patients by
Pharmacy Compounders not
Registered as Outsourcing
Facilities During the COVID-
19 Public Health Emergency.
Temporary Policy for
Compounding of Certain Drugs
for Hospitalized Patients by
Outsourcing Facilities During
the COVID-19 Public Health
Emergency.
----------------------------------------------------------------------------------------------------------------
The guidance indicated 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 below 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 5--New PRA Information Collection
----------------------------------------------------------------------------------------------------------------
CFR cite Another guidance
COVID-19 guidance title referenced in referenced in COVID-19 OMB control New collection covered
COVID-19 guidance guidance No. by PHE PRA waiver
----------------------------------------------------------------------------------------------------------------
Temporary Policy Regarding Non- 21 CFR parts 210 Enforcement Policy for 0910-0139 Recordkeeping of
Standard PPE Practices for and 211. Face Masks and compounding without
Sterile Compounding by Respirators During standard PPE;
Pharmacy Compounders not the Coronavirus recordkeeping of any
Registered as Outsourcing Disease (COVID-19) change of
Facilities During the COVID-19 Public Health sterilization/aseptic
Public Health Emergency. Emergency (Revised). processing methods;
Enforcement Policy for documentation of
Gowns, Other Apparel, mitigation strategies
and Gloves During the for sterile
Coronavirus Disease compounding without
(COVID-19) Public standard PPE.
Health Emergency.
Electronic Drug
Product Reporting for
Human Drug
Compounding
Outsourcing
Facilities Under
Section 503B of the
Federal Food, Drug,
and Cosmetic Act.
----------------------------------------------------------------------------------------------------------------
D. CFSAN
The guidance indicated 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 following table:
[[Page 31520]]
Table 6--CFSAN Guidance
----------------------------------------------------------------------------------------------------------------
Another guidance title
COVID-19 guidance title CFR cite referenced in referenced in COVID-19 OMB control
COVID-19 guidance guidance No.
----------------------------------------------------------------------------------------------------------------
Temporary Policy Regarding Enforcement of 21 CFR part 118............ ........................... 0910-0660
21 CFR Part 118 (the Egg Safety Rule)
During 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: May 19, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-11238 Filed 5-22-20; 8:45 am]
BILLING CODE 4164-01-P
