Guidance Documents Related to Coronavirus Disease 2019 (COVID-19); Availability, 28010-28016 [2020-10146]
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Federal Register / Vol. 85, No. 92 / Tuesday, May 12, 2020 / Notices
By direction of the Commission.
April J. Tabor,
Acting Secretary.
[FR Doc. 2020–10081 Filed 5–11–20; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier CMS–8003]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995 (the
PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information (including each proposed
extension or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
the necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions,
the accuracy of the estimated burden,
ways to enhance the quality, utility, and
clarity of the information to be
collected, and the use of automated
collection techniques or other forms of
information technology to minimize the
information collection burden.
DATES: Comments must be received by
July 13, 2020.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
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SUMMARY:
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Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number ____ , Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
website address at https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS-8003 1915(c) Home and
Community Based Services (HCBS)
Waiver
Under the PRA (44 U.S.C. 3501–
3520), federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collection
1. Type of Information Collection
Request: Reinstatement without change
of a previously approved collection;
Title of Information Collection: 1915(c)
Home and Community Based Services
(HCBS) Waiver; Use: We will use the
web-based application to review and
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adjudicate individual waiver actions.
The web-based application will also be
used by states to submit and revise their
waiver requests. Form Number: CMS–
8003 (OMB control number 0938–0449);
Frequency: Yearly; Affected Public:
State, Local, or Tribal Governments;
Number of Respondents: 47; Total
Annual Responses: 71; Total Annual
Hours: 6,005. (For policy questions
regarding this collection contact Kathy
Poisal at 410–786–5940.)
Dated: May 7, 2020.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2020–10095 Filed 5–11–20; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2020–D–1106, FDA–
2020–D–1137, FDA–2020–D–1138, FDA–
2020–D–1139, and 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 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, document. 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 May 12, 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:
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Federal Register / Vol. 85, No. 92 / Tuesday, May 12, 2020 / Notices
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
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Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the name of the guidance
document that the comments address
and the docket number for the guidance
(see table 1). Received comments will be
placed in the docket(s) and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
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‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see § 10.115(g)(5)
(21 CFR 10.115(g)(5))).
Submit written requests for single
copies of any of these guidances to the
addresses noted in table 1. Where
applicable, 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, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911; Erica Takai, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5456,
Silver Spring, MD 20993–0002, 301–
796–6353; Phil Chao, Center for Food
Safety and Applied Nutrition, Food and
Drug Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–2112;
Kimberly Thomas, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
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Hampshire Ave., Bldg. 51, Rm. 6220,
Silver Spring, MD 20993–0002, 301–
796–2357; Diane Heinz, Center for
Veterinary Medicine, Food and Drug
Administration, 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 (HHS),
pursuant to the authority under section
319 of the Public Health Service Act
(PHS Act) (42 U.S.C. 247d), 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 (85 FR 16949) (the March 25, 2020,
notice) (available at: https://
www.govinfo.gov/content/pkg/FR-202003-25/pdf/2020-06222.pdf), FDA
announced procedures for making
available FDA guidance documents
related to the COVID–19 PHE. These
procedures, which operate within FDA’s
established good guidance practices
regulations, are intended to allow FDA
to rapidly disseminate Agency
recommendations and policies related
to COVID–19 to industry, FDA staff, and
other stakeholders. The March 25, 2020,
notice stated that due to the need to act
quickly and efficiently to respond to the
COVID–19 PHE, FDA believes that prior
public participation will not be feasible
or appropriate before FDA implements
COVID–19-related guidance documents.
Therefore, FDA will issue COVID–19related guidance documents for
immediate implementation without
prior public comment (see section
701(h)(1)(C) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
371(h)(1)(C) and § 10.115(g)(2)). The
guidances are available on FDA’s web
page ‘‘COVID–19-Related Guidance
Documents for Industry, FDA Staff, and
Other Stakeholders’’ (https://
www.fda.gov/emergency-preparednessand-response/mcm-issues/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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Federal Register / Vol. 85, No. 92 / Tuesday, May 12, 2020 / Notices
related-guidance-documents-industryfda-staff-and-other-stakeholders) and
through FDA’s web page ‘‘Search for
FDA Guidance Documents’’ (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 notice of
availability (NOA) for each COVID–19related guidance document, FDA
intends to publish periodically a
consolidated NOA announcing the
availability of COVID–19-related
guidance documents FDA issued during
the relevant period. This notice
announces certain COVID–19-related
guidances that are posted on FDA’s
website, as included in table 1.
Lastly, the March 25, 2020, notice
indicated that, in general, guidance
documents would be placed in dockets
established for COVID–19-related
guidance documents issued by each
Center. As noted in table 1, certain
COVID–19-related guidance documents
issued by the Center for Drug Evaluation
and Research (CDER) prior to March 24,
2020, were placed in Docket No. FDA–
2020–D–1106. FDA anticipates that, in
general, CDER will use Docket No.
FDA–2020–D–1136 for additional
COVID–19-related guidance documents
issued pursuant to the process described
in the March 25, 2020, notice.
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/office
Title of guidance
Contact information to request
single copies
FDA–2020–D–1137
Center for Biologics Evaluation
and Research
(CBER).
Alternative Procedures for Blood and Blood
Components During the COVID–19 Public
Health Emergency (April 2020).
FDA–2020–D–1138
Center for Devices
and Radiological
Health (CDRH).
FDA–2020–D–1138
CDRH ....................
FDA–2020–D–1138
CDRH ....................
FDA–2020–D–1138
CDRH ....................
FDA–2020–D–1138
CDRH ....................
FDA–2020–D–1139
Center for Food
Safety and Applied Nutrition
(CFSAN).
Enforcement Policy for Non-Invasive Remote
Monitoring Devices Used to Support Patient
Monitoring During the Coronavirus Disease2019 (COVID–19) Public Health Emergency
(March 2020).
Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During
the Coronavirus Disease 2019 (COVID–19)
Public Health Emergency (March 2020).
Enforcement Policy for Sterilizers, Disinfectant
Devices, and Air Purifiers During the
Coronavirus Disease 2019 (COVID–19) Public
Health Emergency (March 2020).
Enforcement Policy for Gowns, Other Apparel,
and Gloves During the Coronavirus Disease
(COVID–19) Public Health Emergency (March
2020).
Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease
(COVID–19) Public Health Emergency (Issued
March 25, 2020) (Revised April 2, 2020).
Temporary Policy Regarding Nutrition Labeling of
Certain Packaged Food During the COVID–19
Public Health Emergency (March 2020).
Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research, 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–1139
CFSAN ..................
FDA–2020–D–1139
CFSAN ..................
FDA–2020–D–1106
CDER ....................
FDA–2020–D–1106
CDER ....................
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Temporary Policy Regarding Nutrition Labeling of
Standard Menu Items in Chain Restaurants
and Similar Retail Food Establishments During
the COVID–19 Public Health Emergency (April
2020).
Temporary Policy Regarding Packaging and Labeling of Shell Eggs Sold by Retail Food Establishments During the COVID–19 Public
Health Emergency (April 2020).
FDA Guidance on Conduct of Clinical Trials of
Medical Products during COVID–19 Public
Health Emergency (March 18, 2020) (Updated
March 27, 2020, April 2, 2020, and April 16,
2020).
Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the
Public Health Emergency (COVID–19) (March
19, 2020) (Updated March 27, 2020, and April
15, 2020).
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CDRH-Guidance@fda.hhs.gov. Please include
the document number 20015 and complete
title of the guidance in the request.
CDRH-Guidance@fda.hhs.gov Please include
the document number 20019 and complete
title of the guidance in the request.
CDRH-Guidance@fda.hhs.gov Please include
the document number 20020 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.
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.
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.
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.
Clinicaltrialconduct-COVID19@fda.hhs.gov.
Please include the docket number FDA–2020–
D–1106 and complete title of the guidance in
the request.
druginfo@fda.hhs.gov. Please include the docket
number FDA–2020–D–1106 and complete title
of the guidance in the request.
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TABLE 1— GUIDANCES RELATED TO THE COVID–19 PUBLIC HEALTH EMERGENCY—Continued
Docket No.
Center/office
Title of guidance
Contact information to request
single copies
FDA–2020–D–1106
CDER ....................
FDA–2020–D–1106
CDER ....................
druginfo@fda.hhs.gov. Please include the docket
number FDA–2020–D–1106 and complete title
of the guidance in the request.
druginfo@fda.hhs.gov. Please include the docket
number FDA–2020–D–1106 and complete title
of the guidance in the request.
FDA–2020–D–1106
CDER ....................
FDA–2020–D–1140
Center for Veterinary Medicine
(CVM).
FDA–2020–D–1140
CVM ......................
Policy for Certain REMS Requirements During
the COVID–19 Public Health Emergency
(March 2020).
Temporary Policy for Manufacture of Alcohol for
Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID–19) Guidance for Industry
(March 24, 2020) (Updated March 27, 2020,
and April 15, 2020).
Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During
the Public Health Emergency (March 2020)
(Updated April 15, 2020).
CVM GFI #269—Enforcement Policy Regarding
Federal VCPR Requirements to Facilitate Veterinary Telemedicine During the COVID–19
Outbreak (March 2020).
CVM GFI #270—Guidance on the Conduct and
Review of Studies to Support New Animal
Drug Development during the COVID–19 Public Health Emergency (April 2020).
Although these guidance documents
have been implemented immediately
without prior comment, FDA will
consider all comments received and
revise the guidances as appropriate (see
§ 10.115(g)(3)).
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. Significance of Guidances
IV. Paperwork Reduction Act of 1995
These guidances are being issued
consistent with FDA’s good guidance
practices regulation (§ 10.115). The
guidances represent the current thinking
A. Center for Biologics Evaluation and
Research
This guidance refers to previously
approved collections of information.
AskCVM@fda.hhs.gov. Please include the docket number FDA–2020–D–1140 and complete
title of the guidance in the request.
≤AskCVM@fda.hhs.gov. Please include the
docket number FDA–2020–D–1140 and complete title of the guidance in the request.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction 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:
COVID–19 guidance title
21 CFR Cite referenced in
COVID–19 guidance
Another guidance title
referenced in COVID–19
guidance
Alternative Procedures for Blood and Blood Components During the COVID–19 Public Health Emergency.
601.12 .....................................
640.120
part 630
N/A ..........................................
B. Center for Devices and Radiological
Health
These guidances refer to previously
approved collections of information.
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druginfo@fda.hhs.gov. Please include the docket
number FDA–2020–D–1106 and complete title
of the guidance in the request.
These collections of information are
subject to review by OMB under the
PRA. The collections of information in
the following FDA regulations and
21 CFR Cite referenced in
COVID–19 Guidance
Another guidance title
referenced in COVID–19
guidance
Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the
Coronavirus Disease-2019 (COVID–19) Public Health
Emergency.
Enforcement Policy for Ventilators and Accessories and
Other Respiratory Devices During the Coronavirus Disease
2019 (COVID–19) Public Health Emergency.
807, subpart E ........................
800, 801, and 809 ..................
.................................................
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800, 801, and 809 ..................
803
807, subpart E
812
820
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0910–0338
0910–0338
0910–0116
guidance have been approved by OMB
as listed in the following table:
COVID–19 guidance title
VerDate Sep<11>2014
OMB Control
No(s).
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OMB Control
No(s).
0910–0120
0910–0485
0910–0485
0910–0437
0910–0120
0910–0078
0910–0073
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21 CFR Cite referenced in
COVID–19 Guidance
COVID–19 guidance title
Another guidance title
referenced in COVID–19
guidance
Emergency Use Authorization
of Medical Products and
Related Authorities; Guidance for Industry and Other
Stakeholders.
Enforcement Policy for Sterilizers, Disinfectant Devices, and
Air Purifiers During the Coronavirus Disease 2019
(COVID–19) Public Health Emergency.
Enforcement Policy for Gowns, Other Apparel, and Gloves
During the Coronavirus Disease (COVID–19) Public Health
Emergency.
Enforcement Policy for Face Masks and Respirators During
the Coronavirus Disease (COVID–19) Public Health Emergency (Revised).
..............................................................................................
800, 801, and 809 ..................
807, subpart E
807, subparts A through D
814, subparts A through E .....
820
830 and 801.20
800, 801, and 809 ..................
806
807, subparts A through D
807, subpart E ........................
820 ..........................................
830 and 801.20 .......................
800, 801, and 809 ..................
803 ..........................................
806 ..........................................
807, subpart E ........................
807, subparts A through D .....
820
830 and 801.20
Emergency Use Authorization
of Medical Products and
Related Authorities; Guidance for Industry and Other
Stakeholders.
C. Center for Food Safety and Applied
Nutrition
These collections of information are
subject to review by OMB under the
PRA. The collections of information in
the following FDA regulations and
These guidances refer to previously
approved collections of information.
0910–0595
0910–0485
0910–0120
0910–0625
0910–0231
0910–0073
0910–0720
0910–0485
0910–0359
0910–0625
0910–0120
0910–0073
0910–0720
0910–0485
0910–0437
0910–0359
0910–0120
0910–0625
0910–0073
0910–0720
0910–0595
guidances have been approved by OMB
as listed in the following table:
COVID–19 guidance title
21 CFR Cite referenced in
COVID–19 guidance
Another guidance title
referenced in COVID–19
guidance
Temporary Policy Regarding Nutrition Labeling of Standard
Menu Items in Chain Restaurants and Similar Retail Food
Establishments During the COVID–19 Public Health Emergency.
Temporary Policy Regarding Packaging and Labeling of Shell
Eggs Sold by Retail Food Establishments During the
COVID–19 Public Health Emergency.
101.11 .....................................
.................................................
0910–0782
part 101 ...................................
Temporary Policy Regarding
Nutrition Labeling of Certain
Packaged Food During the
COVID19 Public Health
Emergency; 0910–0381,
0910–0792.
0910–0381
This guidance 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
jbell on DSKJLSW7X2PROD with NOTICES
OMB Control
No(s).
VerDate Sep<11>2014
18:47 May 11, 2020
Jkt 250001
as listed in the table below. 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
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
OMB Control
No(s).
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.
E:\FR\FM\12MYN1.SGM
12MYN1
Federal Register / Vol. 85, No. 92 / Tuesday, May 12, 2020 / Notices
COVID–19 guidance title
21 CFR Cite referenced in
COVID–19 guidance
Temporary Policy Regarding Nutrition Labeling of Certain Packaged
Food During the COVID–19 Public
Health Emergency.
part 101; section 403(w) of
the FD&C Act (21
U.S.C. 343(w)).
D. Center for Drug Evaluation and
Research
FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID–19 Public Health
Emergency (Updated).
These guidances 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
jbell on DSKJLSW7X2PROD with NOTICES
Temporary Policy for
Preparation of Certain
Alcohol-Based Hand
Sanitizer Products
During the Public
Health Emergency
(COVID–19).
VerDate Sep<11>2014
........................
18:47 May 11, 2020
Jkt 250001
................................
21 CFR Cite
referenced in
COVID–19
guidance
COVID–19 guidance title
21 CFR Cite
referenced in
COVID–19
guidance
OMB Control
No(s).
50.27(a)
312.30
312.60
312.62
812.35(a)
812.140
Policy for Temporary Compounding of Certain
Alcohol-Based Hand Sanitizer Products During the Public Health Emergency.
Temporary Policy for Manufacture of Alcohol for
Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID–19).
Providing Regulatory Submissions in Electronic
Format—Drug Establishment Registration and
Drug Listing.
Postmarketing Adverse Event Reporting for
Nonprescription Human Drug Products Marketed Without an Approved Application.
Fmt 4703
guidances have been approved by OMB
as listed in the following table:
Use of Electronic Informed Consent in Clinical Investigations.
Another guidance referenced in COVID–19
guidance
Frm 00031
If a food product does not have the
required labeling information, a
restaurant may create a label to
include this information (new respondent).
Another guidance referenced in COVID–19 guidance
as listed in the table below. These
guidances also contain 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
PO 00000
New collection covered by PHE
PRA waiver
0910–0381,
0910–0792
These collections of information are
subject to review by OMB under the
PRA. The collections of information in
the following FDA regulations and
This guidance refers to previously
approved collections of information.
COVID–19 guidance title
Another guidance
referenced in
COVID–19
guidance
Sfmt 4703
28015
OMB Control
No(s).
0910–0001
0910–0014
0910–0755
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.
OMB Control
No(s).
0910–0045
0910–0139
0910–0230
0910–0291
0910–0340
0910–0641
0910–0645
0910–0800
E:\FR\FM\12MYN1.SGM
New collection covered by PHE
PRA waiver
For proposed use of an alternative grade of ethanol, firms
are requested to submit to
FDA information on the ethanol concentration and levels
of impurities listed in the USP
monograph and other potentially harmful impurities in the
manufacturing environment.
12MYN1
28016
Federal Register / Vol. 85, No. 92 / Tuesday, May 12, 2020 / Notices
COVID–19 guidance title
21 CFR Cite
referenced in
COVID–19
guidance
Policy for Temporary
Compounding of Certain Alcohol-Based
Hand Sanitizer Products During the Public
Health Emergency
(Updated).
........................
Temporary Policy for
Manufacture of Alcohol for Incorporation
Into Alcohol-Based
Hand Sanitizer Products During the Public
Health Emergency
(COVID–19).
........................
Another guidance referenced in COVID–19
guidance
Current Good Manufacturing Practices for Finished Pharmaceuticals and Medical Gases.
Postmarketing Adverse Drug Experience Reporting.
MedWatch: Adverse Event and Product Experience Reporting System (Paper-Based).
Format and Content Requirements for Over-theCounter Drug Product Labeling.
FDA Adverse Event and Product Experience
Reports; Electronic Submissions.
Adverse Event Reporting for Outsourcing Facilities Under Section 503B of the Federal Food,
Drug, and Cosmetic Act.
Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During
the Public Health Emergency (COVID–19).
Temporary Policy for Manufacture of Alcohol for
Incorporation Into Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID–19).
Policy for Temporary Compounding of Certain
Alcohol-Based Hand Sanitizer Products During the Public Health Emergency.
Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During
the Public Health Emergency (COVID–19).
Providing Regulatory Submissions in Electronic
Format—Drug Establishment Registration and
Drug Listing.
The final guidance entitled ‘‘Policy
for Certain REMS Requirements During
the COVID–19 Public Health
Emergency’’ contains no collection of
information. Therefore, clearance by
OMB under the PRA is not required.
E. Center for Veterinary Medicine
21 CFR Cite
referenced in
COVID–19
guidance
GFI #270—Guidance on the Conduct and Review of Studies to Support
New Animal Drug Development during the COVID–19 Public Health
Emergency.
........................
V. Electronic Access
Dated: May 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
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18:47 May 11, 2020
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Frm 00032
Fmt 4703
0910–0045
0910–0139
0910–0230
0910–0291
0910–0340
0910–0641
0910–0645
For proposed use of an alternative grade of ethanol, firms
are requested to submit to
FDA information on the ethanol concentration and levels
of impurities listed in the USP
monograph and other potentially harmful impurities in the
manufacturing environment.
OMB Control
No(s).
0910–0032
0910–0669
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–1081]
Hospira Inc., et al.; Withdrawal of
Approval of Seven Abbreviated New
Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of seven
abbreviated new drug applications
(ANDAs) from multiple applicants. The
BILLING CODE 4164–01–P
PO 00000
For proposed use of an alternative grade of ethanol, firms
are requested to submit to
FDA information on the ethanol concentration and levels
of impurities listed in the USP
monograph and other potentially harmful impurities in the
manufacturing environment.
FDA Guidance on Conduct of Clinical Trials of Medical Products
during COVID–19 Public Health
Emergency.
related-guidance-documents-industryfda-staff-and-other-stakeholders; the
FDA web page ‘‘Search for FDA
Guidance Documents,’’ available at
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments; or https://
www.regulations.gov.
[FR Doc. 2020–10146 Filed 5–11–20; 8:45 am]
0910–0139
0910–0230
0910–0291
0910–0340
0910–0645
Another guidance title referenced in
COVID–19 guidance
The final guidance entitled ‘‘GFI
#269—Enforcement Policy Regarding
Federal VCPR Requirements to
Facilitate Veterinary Telemedicine
During the COVID–19 Outbreak’’
contains no collection of information.
Therefore, clearance by OMB under the
PRA is not required.
Persons with access to the internet
may obtain COVID–19-related guidances
at the FDA web page ‘‘COVID–19Related Guidance Documents for
Industry, FDA Staff, and Other
Stakeholders,’’ available at https://
www.fda.gov/emergency-preparednessand-response/mcm-issues/covid-19-
New collection covered by PHE
PRA waiver
PRA. The collections of information in
the following FDA regulations and
guidance have been approved by OMB
as listed in the following table:
This guidance refers to previously
approved collections of information.
These collections of information are
subject to review by OMB under the
COVID–19 guidance title
jbell on DSKJLSW7X2PROD with NOTICES
OMB Control
No(s).
Sfmt 4703
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]]>Agencies
[Federal Register Volume 85, Number 92 (Tuesday, May 12, 2020)]
[Notices]
[Pages 28010-28016]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10146]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2020-D-1106, FDA-2020-D-1137, FDA-2020-D-1138, FDA-
2020-D-1139, and 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 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, document. 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 May 12, 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:
[[Page 28011]]
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the name of the
guidance document that the comments address and the docket number for
the guidance (see table 1). Received comments will be placed in the
docket(s) and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
You may submit comments on any guidance at any time (see Sec.
10.115(g)(5) (21 CFR 10.115(g)(5))).
Submit written requests for single copies of any of these guidances
to the addresses noted in table 1. Where applicable, 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, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911; Erica Takai, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5456,
Silver Spring, MD 20993-0002, 301-796-6353; Phil Chao, Center for Food
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus
Dr., College Park, MD 20740, 240-402-2112; Kimberly Thomas, Center for
Drug Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6220, Silver Spring, MD 20993-0002, 301-
796-2357; Diane Heinz, Center for Veterinary Medicine, Food and Drug
Administration, 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 (HHS), pursuant to
the authority under section 319 of the Public Health Service Act (PHS
Act) (42 U.S.C. 247d), 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 (85 FR 16949) (the March
25, 2020, notice) (available at: https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf), FDA announced procedures for making
available FDA guidance documents related to the COVID-19 PHE. These
procedures, which operate within FDA's established good guidance
practices regulations, are intended to allow FDA to rapidly disseminate
Agency recommendations and policies related to COVID-19 to industry,
FDA staff, and other stakeholders. The March 25, 2020, notice stated
that due to the need to act quickly and efficiently to respond to the
COVID-19 PHE, FDA believes that prior public participation will not be
feasible or appropriate before FDA implements COVID-19-related guidance
documents. Therefore, FDA will issue COVID-19-related guidance
documents for immediate implementation without prior public comment
(see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 371(h)(1)(C) and Sec. 10.115(g)(2)). The
guidances are available on FDA's web page ``COVID-19-Related Guidance
Documents for Industry, FDA Staff, and Other Stakeholders'' (https://
www.fda.gov/emergency-preparedness-and-response/mcm-issues/covid-19-
[[Page 28012]]
related-guidance-documents-industry-fda-staff-and-other-stakeholders)
and through FDA's web page ``Search for FDA Guidance Documents''
(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 notice of availability (NOA) for each COVID-
19-related guidance document, FDA intends to publish periodically a
consolidated NOA announcing the availability of COVID-19-related
guidance documents FDA issued during the relevant period. This notice
announces certain COVID-19-related guidances that are posted on FDA's
website, as included in table 1.
Lastly, the March 25, 2020, notice indicated that, in general,
guidance documents would be placed in dockets established for COVID-19-
related guidance documents issued by each Center. As noted in table 1,
certain COVID-19-related guidance documents issued by the Center for
Drug Evaluation and Research (CDER) prior to March 24, 2020, were
placed in Docket No. FDA-2020-D-1106. FDA anticipates that, in general,
CDER will use Docket No. FDA-2020-D-1136 for additional COVID-19-
related guidance documents issued pursuant to the process described in
the March 25, 2020, notice.
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 request
Docket No. Center/office Title of guidance single copies
----------------------------------------------------------------------------------------------------------------
FDA-2020-D-1137........ Center for Biologics Alternative Procedures for Office of Communication,
Evaluation and Blood and Blood Components Outreach and Development,
Research (CBER). During the COVID-19 Public Center for Biologics
Health Emergency (April 2020). Evaluation and Research,
10903 New Hampshire Ave.,
Bldg. 71, Rm. 3128, Silver
Spring, MD 20993-0002, 1-800-
835-4709 or 240-402-8010;
email [email protected].
FDA-2020-D-1138........ Center for Devices and Enforcement Policy for Non- [email protected].
Radiological Health Invasive Remote Monitoring Please include the document
(CDRH). Devices Used to Support number 20014 and complete
Patient Monitoring During the title of the guidance in the
Coronavirus Disease-2019 request.
(COVID-19) Public Health
Emergency (March 2020).
FDA-2020-D-1138........ CDRH................... Enforcement Policy for [email protected].
Ventilators and Accessories Please include the document
and Other Respiratory Devices number 20015 and complete
During the Coronavirus title of the guidance in the
Disease 2019 (COVID-19) request.
Public Health Emergency
(March 2020).
FDA-2020-D-1138........ CDRH................... Enforcement Policy for [email protected]
Sterilizers, Disinfectant Please include the document
Devices, and Air Purifiers number 20019 and complete
During the Coronavirus title of the guidance in the
Disease 2019 (COVID-19) request.
Public Health Emergency
(March 2020).
FDA-2020-D-1138........ CDRH................... Enforcement Policy for Gowns, [email protected]
Other Apparel, and Gloves Please include the document
During the Coronavirus number 20020 and complete
Disease (COVID-19) Public title of the guidance in the
Health Emergency (March 2020). request.
FDA-2020-D-1138........ CDRH................... Enforcement Policy for Face [email protected].
Masks and Respirators During Please include the document
the Coronavirus Disease number 20018 and complete
(COVID-19) Public Health title of the guidance in the
Emergency (Issued March 25, request.
2020) (Revised April 2, 2020).
FDA-2020-D-1139........ Center for Food Safety Temporary Policy Regarding Office of Nutrition and Food
and Applied Nutrition Nutrition Labeling of Certain Labeling, Food Labeling and
(CFSAN). Packaged Food During the Standards Staff, Center for
COVID-19 Public Health Food Safety and Applied
Emergency (March 2020). Nutrition, Food and Drug
Administration, 5001 Campus
Dr., College Park, MD 20740.
FDA-2020-D-1139........ CFSAN.................. Temporary Policy Regarding Office of Nutrition and Food
Nutrition Labeling of Labeling, Food Labeling and
Standard Menu Items in Chain Standards Staff, Center for
Restaurants and Similar Food Safety and Applied
Retail Food Establishments Nutrition, Food and Drug
During the COVID-19 Public Administration, 5001 Campus
Health Emergency (April 2020). Dr., College Park, MD 20740.
FDA-2020-D-1139........ CFSAN.................. Temporary Policy Regarding Office of Nutrition and Food
Packaging and Labeling of Labeling, Food Labeling and
Shell Eggs Sold by Retail Standards Staff, Center for
Food Establishments During Food Safety and Applied
the COVID-19 Public Health Nutrition, Food and Drug
Emergency (April 2020). Administration, 5001 Campus
Dr., College Park, MD 20740.
FDA-2020-D-1106........ CDER................... FDA Guidance on Conduct of Clinicaltrialconduct-
Clinical Trials of Medical [email protected] Please
Products during COVID-19 include the docket number FDA-
Public Health Emergency 2020-D-1106 and complete
(March 18, 2020) (Updated title of the guidance in the
March 27, 2020, April 2, request.
2020, and April 16, 2020).
FDA-2020-D-1106........ CDER................... Temporary Policy for [email protected]. Please
Preparation of Certain include the docket number FDA-
Alcohol-Based Hand Sanitizer 2020-D-1106 and complete
Products During the Public title of the guidance in the
Health Emergency (COVID-19) request.
(March 19, 2020) (Updated
March 27, 2020, and April 15,
2020).
[[Page 28013]]
FDA-2020-D-1106........ CDER................... Policy for Certain REMS [email protected]. Please
Requirements During the COVID- include the docket number FDA-
19 Public Health Emergency 2020-D-1106 and complete
(March 2020). title of the guidance in the
request.
FDA-2020-D-1106........ CDER................... Temporary Policy for [email protected]. Please
Manufacture of Alcohol for include the docket number FDA-
Incorporation Into Alcohol- 2020-D-1106 and complete
Based Hand Sanitizer Products title of the guidance in the
During the Public Health request.
Emergency (COVID-19) Guidance
for Industry (March 24, 2020)
(Updated March 27, 2020, and
April 15, 2020).
FDA-2020-D-1106........ CDER................... Policy for Temporary [email protected]. Please
Compounding of Certain include the docket number FDA-
Alcohol-Based Hand Sanitizer 2020-D-1106 and complete
Products During the Public title of the guidance in the
Health Emergency (March 2020) request.
(Updated April 15, 2020).
FDA-2020-D-1140........ Center for Veterinary CVM GFI #269--Enforcement [email protected]. Please
Medicine (CVM). Policy Regarding Federal VCPR include the docket number FDA-
Requirements to Facilitate 2020-D-1140 and complete
Veterinary Telemedicine title of the guidance in the
During the COVID-19 Outbreak request.
(March 2020).
FDA-2020-D-1140........ CVM.................... CVM GFI #270--Guidance on the [email protected].
Conduct and Review of Studies Please include the docket
to Support New Animal Drug number FDA-2020-D-1140 and
Development during the COVID- complete title of the
19 Public Health Emergency guidance in the request.
(April 2020).
----------------------------------------------------------------------------------------------------------------
Although these guidance documents have been implemented immediately
without prior comment, FDA will consider all comments received and
revise the guidances as appropriate (see Sec. 10.115(g)(3)).
III. Significance of Guidances
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.
IV. Paperwork Reduction Act of 1995
A. Center for Biologics Evaluation and Research
This guidance 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
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:
----------------------------------------------------------------------------------------------------------------
Another guidance title
COVID-19 guidance title 21 CFR Cite referenced in referenced in COVID-19 OMB Control
COVID-19 guidance guidance No(s).
----------------------------------------------------------------------------------------------------------------
Alternative Procedures for Blood and 601.12.................... N/A....................... 0910-0338
Blood Components During the COVID-19 640.120................... 0910-0338
Public Health Emergency. part 630.................. 0910-0116
----------------------------------------------------------------------------------------------------------------
B. Center for Devices and Radiological Health
These guidances 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:
----------------------------------------------------------------------------------------------------------------
Another guidance title
COVID-19 guidance title 21 CFR Cite referenced in referenced in COVID-19 OMB Control
COVID-19 Guidance guidance No(s).
----------------------------------------------------------------------------------------------------------------
Enforcement Policy for Non-Invasive 807, subpart E............ .......................... 0910-0120
Remote Monitoring Devices Used to 800, 801, and 809......... 0910-0485
Support Patient Monitoring During the
Coronavirus Disease-2019 (COVID-19)
Public Health Emergency.
Enforcement Policy for Ventilators and 800, 801, and 809......... 0910-0485
Accessories and Other Respiratory 803....................... 0910-0437
Devices During the Coronavirus Disease 807, subpart E............ 0910-0120
2019 (COVID-19) Public Health Emergency. 812....................... 0910-0078
820....................... 0910-0073
[[Page 28014]]
Emergency Use 0910-0595
Authorization of Medical
Products and Related
Authorities; Guidance for
Industry and Other
Stakeholders.
Enforcement Policy for Sterilizers, 800, 801, and 809......... 0910-0485
Disinfectant Devices, and Air Purifiers 807, subpart E............ 0910-0120
During the Coronavirus Disease 2019 807, subparts A through D. 0910-0625
(COVID-19) Public Health Emergency.
814, subparts A through E. 0910-0231
820....................... 0910-0073
830 and 801.20............ 0910-0720
Enforcement Policy for Gowns, Other 800, 801, and 809......... 0910-0485
Apparel, and Gloves During the 806....................... 0910-0359
Coronavirus Disease (COVID-19) Public 807, subparts A through D. 0910-0625
Health Emergency.
807, subpart E............ 0910-0120
820....................... 0910-0073
830 and 801.20............ 0910-0720
Enforcement Policy for Face Masks and 800, 801, and 809......... 0910-0485
Respirators During the Coronavirus 803....................... 0910-0437
Disease (COVID-19) Public Health 806....................... 0910-0359
Emergency (Revised). 807, subpart E............ 0910-0120
807, subparts A through D. 0910-0625
820 0910-0073
830 and 801.20............ 0910-0720
Emergency Use 0910-0595
Authorization of Medical
Products and Related
Authorities; Guidance for
Industry and Other
Stakeholders.
----------------------------------------------------------------------------------------------------------------
C. Center for Food Safety and Applied Nutrition
These guidances 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:
----------------------------------------------------------------------------------------------------------------
Another guidance title
COVID-19 guidance title 21 CFR Cite referenced in referenced in COVID-19 OMB Control
COVID-19 guidance guidance No(s).
----------------------------------------------------------------------------------------------------------------
Temporary Policy Regarding Nutrition 101.11.................... .......................... 0910-0782
Labeling of Standard Menu Items in
Chain Restaurants and Similar Retail
Food Establishments During the COVID-19
Public Health Emergency.
Temporary Policy Regarding Packaging and part 101.................. Temporary Policy Regarding 0910-0381
Labeling of Shell Eggs Sold by Retail Nutrition Labeling of
Food Establishments During the COVID-19 Certain Packaged Food
Public Health Emergency. During the COVID19 Public
Health Emergency; 0910-
0381, 0910-0792.
----------------------------------------------------------------------------------------------------------------
This guidance 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 below. 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.
[[Page 28015]]
----------------------------------------------------------------------------------------------------------------
21 CFR Cite Another guidance New collection
COVID-19 guidance title referenced in referenced in COVID-19 OMB Control covered by PHE PRA
COVID-19 guidance No(s). waiver
-----------------------------------guidance---------------------------------------------------------------------
Temporary Policy Regarding part 101; ......................... 0910-0381, If a food product
Nutrition Labeling of section 403(w) 0910-0792 does not have the
Certain Packaged Food During of the FD&C Act required labeling
the COVID-19 Public Health (21 U.S.C. information, a
Emergency. 343(w)). restaurant may
create a label to
include this
information (new
respondent).
----------------------------------------------------------------------------------------------------------------
D. Center for Drug Evaluation and Research
This guidance 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 guidances have been approved by OMB as listed in the
following table:
----------------------------------------------------------------------------------------------------------------
21 CFR Cite
referenced in Another guidance referenced in OMB Control
COVID-19 guidance title COVID-19 COVID-19 guidance No(s).
guidance
----------------------------------------------------------------------------------------------------------------
FDA Guidance on Conduct of Clinical Trials 50.27(a) Use of Electronic Informed Consent 0910-0001
of Medical Products during COVID-19 Public 312.30 in Clinical Investigations. 0910-0014
Health Emergency (Updated). 312.60 0910-0755
312.62
812.35(a)
812.140
----------------------------------------------------------------------------------------------------------------
These guidances 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
table below. These guidances also contain 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.
--------------------------------------------------------------------------------------------------------------------------------------------------------
21 CFR Cite referenced in Another guidance referenced in COVID- OMB Control New collection covered by
COVID-19 guidance title COVID-19 guidance 19 guidance No(s). PHE PRA waiver
--------------------------------------------------------------------------------------------------------------------------------------------------------
Temporary Policy for Preparation of ........................... Policy for Temporary Compounding of 0910-0045 For proposed use of an
Certain Alcohol-Based Hand Sanitizer Certain Alcohol-Based Hand Sanitizer 0910-0139 alternative grade of
Products During the Public Health Products During the Public Health 0910-0230 ethanol, firms are
Emergency (COVID-19). Emergency. 0910-0291 requested to submit to FDA
Temporary Policy for Manufacture of 0910-0340 information on the ethanol
Alcohol for Incorporation Into 0910-0641 concentration and levels of
Alcohol-Based Hand Sanitizer Products 0910-0645 impurities listed in the
During the Public Health Emergency 0910-0800 USP monograph and other
(COVID-19). potentially harmful
Providing Regulatory Submissions in impurities in the
Electronic Format--Drug Establishment manufacturing environment.
Registration and Drug Listing.
Postmarketing Adverse Event Reporting
for Nonprescription Human Drug
Products Marketed Without an Approved
Application.
[[Page 28016]]
Policy for Temporary Compounding of ........................... Current Good Manufacturing Practices 0910-0139 For proposed use of an
Certain Alcohol-Based Hand Sanitizer for Finished Pharmaceuticals and 0910-0230 alternative grade of
Products During the Public Health Medical Gases. 0910-0291 ethanol, firms are
Emergency (Updated). Postmarketing Adverse Drug Experience 0910-0340 requested to submit to FDA
Reporting. 0910-0645 information on the ethanol
MedWatch: Adverse Event and Product concentration and levels of
Experience Reporting System (Paper- impurities listed in the
Based). USP monograph and other
Format and Content Requirements for potentially harmful
Over-the-Counter Drug Product impurities in the
Labeling. manufacturing environment.
FDA Adverse Event and Product
Experience Reports; Electronic
Submissions.
Adverse Event Reporting for
Outsourcing Facilities Under Section
503B of the Federal Food, Drug, and
Cosmetic Act.
Temporary Policy for Preparation of
Certain Alcohol-Based Hand Sanitizer
Products During the Public Health
Emergency (COVID-19).
Temporary Policy for Manufacture of
Alcohol for Incorporation Into
Alcohol-Based Hand Sanitizer Products
During the Public Health Emergency
(COVID-19).
Temporary Policy for Manufacture of ........................... Policy for Temporary Compounding of 0910-0045 For proposed use of an
Alcohol for Incorporation Into Certain Alcohol-Based Hand Sanitizer 0910-0139 alternative grade of
Alcohol-Based Hand Sanitizer Products During the Public Health 0910-0230 ethanol, firms are
Products During the Public Health Emergency. 0910-0291 requested to submit to FDA
Emergency (COVID-19). Temporary Policy for Preparation of 0910-0340 information on the ethanol
Certain Alcohol-Based Hand Sanitizer 0910-0641 concentration and levels of
Products During the Public Health 0910-0645 impurities listed in the
Emergency (COVID-19). USP monograph and other
Providing Regulatory Submissions in potentially harmful
Electronic Format--Drug Establishment impurities in the
Registration and Drug Listing. manufacturing environment.
--------------------------------------------------------------------------------------------------------------------------------------------------------
The final guidance entitled ``Policy for Certain REMS Requirements
During the COVID-19 Public Health Emergency'' contains no collection of
information. Therefore, clearance by OMB under the PRA is not required.
E. Center for Veterinary Medicine
This guidance 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:
----------------------------------------------------------------------------------------------------------------
Another guidance title
COVID-19 guidance title 21 CFR Cite referenced referenced in COVID-19 OMB Control
in COVID-19 guidance guidance No(s).
----------------------------------------------------------------------------------------------------------------
GFI #270--Guidance on the Conduct and Review ....................... FDA Guidance on Conduct 0910-0032
of Studies to Support New Animal Drug of Clinical Trials of 0910-0669
Development during the COVID-19 Public Medical Products during
Health Emergency. COVID-19 Public Health
Emergency.
----------------------------------------------------------------------------------------------------------------
The final guidance entitled ``GFI #269--Enforcement Policy
Regarding Federal VCPR Requirements to Facilitate Veterinary
Telemedicine During the COVID-19 Outbreak'' contains no collection of
information. Therefore, clearance by OMB under the PRA is not required.
V. Electronic Access
Persons with access to the internet may obtain COVID-19-related
guidances at the FDA web page ``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 ``Search for FDA Guidance Documents,'' available at
https://www.fda.gov/regulatory-information/search-fda-guidance-documents; or https://www.regulations.gov.
Dated: May 7, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-10146 Filed 5-11-20; 8:45 am]
BILLING CODE 4164-01-P
