Guidance Documents Related to Coronavirus Disease 2019; Availability, 73485-73487 [2020-25399]

Download as PDF Federal Register / Vol. 85, No. 223 / Wednesday, November 18, 2020 / Notices 73485 TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued Number of responses per respondent Number of respondents Activity Average burden per response Total annual responses Total hours Reconsideration Requests .......................................... Appeal of Reconsideration Denials ............................. 3 1 1 1 1 1 1 ............................. 1 ............................. 3 1 Total ...................................................................... ........................ ........................ 101 ................................ 421 1 There are no capital costs or operating and maintenance costs associated with this collection of information. We estimate 70 respondents annually will submit outsourcing facility registrations using the SPL format as specified in Agency guidance and assume each registration will require 4.5 hours to prepare and complete. We expect no more than one waiver request from the electronic submission requirement annually and assume each waiver request will require 1 hour to prepare and submit. We estimate each of the 70 registrants will remit annual establishment fees and assume this task requires 30 minutes per respondent. We estimate that 15 of those respondents will request a small business reduction in the amount of the annual establishment fee using Form FDA 3908. We estimate 14 outsourcing facilities annually will remit reinspection fees and assume this will require 30 minutes. We also estimate that we will receive three requests for reconsideration and one appeal of a denial of a request for reconsideration and assume 1 hour per respondent for this activity. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Activity Number of recordkeepers Number of records per recordkeeper Total annual records Average burden per recordkeeping Total hours Retention of small business designation notification letter. 15 1 15 0.5 (30 minutes) ..... 7.5 1 There are no capital costs or operating and maintenance costs associated with this collection of information. We estimate that annually 15 outsourcing facilities will maintain a copy of their small business designation letter and that maintaining each record will require 0.5 hour (30 minutes). These estimates reflect a slight increase in the number of annual registrations, but a decrease in reinspection fee submissions. Dated: November 12, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2020–25411 Filed 11–17–20; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket Nos. FDA–2020–D–1137 and FDA– 2020–D–1138] khammond on DSKJM1Z7X2PROD with NOTICES Guidance Documents Related to Coronavirus Disease 2019; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of FDA guidance documents related to the Coronavirus Disease 2019 (COVID–19) SUMMARY: VerDate Sep<11>2014 17:59 Nov 17, 2020 Jkt 253001 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 November 18, 2020. 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 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 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 E:\FR\FM\18NON1.SGM 18NON1 73486 Federal Register / Vol. 85, No. 223 / Wednesday, November 18, 2020 / Notices document that the comments address and the docket number for the guidance (see table 1). Received comments will be placed in the docket(s) and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https:// www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. You may submit comments on any guidance at any time (see § 10.115(g)(5) (21 CFR 10.115(g)(5))). Submit written requests for single copies of these guidances to the address noted in table 1. Send two selfaddressed adhesive labels to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidances. FOR FURTHER INFORMATION CONTACT: Stephen Ripley, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240– 402–7911, or 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. 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 (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 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 (21 U.S.C. 371(h)(1)(C)) and § 10.115(g)(2)). The guidances are available on FDA’s web pages 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) and ‘‘Search for FDA Guidance Documents’’ (available at: https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments). The March 25, 2020, notice further stated that, in general, rather than publishing a separate NOA for each COVID–19-related guidance, FDA intends to publish periodically a consolidated NOA announcing the availability of certain COVID–19-related guidances that FDA issued during the relevant period, as included in table 1. This notice announces COVID–19related guidances that are posted on FDA’s website. II. Availability of COVID–19-Related Guidance Documents Pursuant to the process described in the March 25, 2020, notice, FDA is announcing the availability of the following COVID–19-related guidances: TABLE 1—GUIDANCES RELATED TO THE COVID–19 PUBLIC HEALTH EMERGENCY Docket No. khammond on DSKJM1Z7X2PROD with NOTICES FDA–2020–D–1137 .................... Center Title of guidance CBER 1 Secretary of Health and Human Services Alex M. Azar, II, Determination that a Public Health Emergency Exists (originally issued on January 31, 2020, and subsequently renewed), available at VerDate Sep<11>2014 17:59 Nov 17, 2020 Jkt 253001 Contact information to request single copies Emergency Use Authorization for Vaccines to Prevent COVID–19 (October 2020). 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. 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/. PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\18NON1.SGM 18NON1 73487 Federal Register / Vol. 85, No. 223 / Wednesday, November 18, 2020 / Notices TABLE 1—GUIDANCES RELATED TO THE COVID–19 PUBLIC HEALTH EMERGENCY—Continued Docket No. FDA–2020–D–1138 .................... Center Title of guidance CDRH Contact information to request single copies Enforcement Policy for Modifications to FDA Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID–19) Public Health Emergency (October 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 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 Guidance While this guidance contains no collection of information, it does refer to previously approved FDA collections of information (listed in table 2). CDRH—Guidance@fda.hhs.gov/. Please include the document number 20046 and complete title of the guidance in the request. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501–3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in the following FDA regulations and guidances have been approved by OMB as listed in the following table: TABLE 2—CBER GUIDANCE AND COLLECTIONS CFR cite referenced in COVID–19 guidance COVID–19 guidance title Emergency Use Authorization for Vaccines to Prevent COVID–19 (October 2020). 21 21 21 21 21 B. CDRH Guidance While this guidance contains no collection of information, it does refer to previously approved FDA collections of CFR CFR CFR CFR CFR Another guidance title referenced in COVID–19 guidance 314.420 ...................................... part 312 ..................................... parts 210, 211, and 610 ............ part 600 ..................................... part 601 ..................................... OMB control No(s). .................................................................. .................................................................. .................................................................. .................................................................. .................................................................. Emergency Use Authorization of Medical Products and Related Authorities. information (listed in table 3). Therefore, clearance by OMB under the PRA is not required for this guidance. The previously approved collections of information are subject to review by 0910–0001 0910–0014 0910–0139 0910–0308 0910–0338 0910–0595 OMB under the PRA. The collections of information in the following FDA regulations have been approved by OMB as listed in the table below. TABLE 3—CDRH GUIDANCE AND COLLECTIONS COVID–19 guidance title CFR cite referenced in COVID–19 guidance Another guidance title referenced in COVID–19 guidance Enforcement Policy for Modifications to FDA—Cleared Molecular Influenza and RSV Tests During the Coronavirus Disease 2019 (COVID–19) Public Health Emergency (October 2020). 800, 801, and 809 .................. 807, subpart E ........................ 820 .......................................... N/A .......................................... ................................................. ................................................. khammond on DSKJM1Z7X2PROD with NOTICES IV. Electronic Access Persons with access to the internet may obtain COVID–19-related guidances at: • FDA web page entitled ‘‘COVID–19Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders,’’ available at https:// www.fda.gov/emergency-preparednessand-response/mcm-issues/covid-19related-guidance-documents-industryfda-staff-and-other-stakeholders; • FDA web page entitled ‘‘Search for FDA Guidance Documents’’ available at VerDate Sep<11>2014 17:59 Nov 17, 2020 Jkt 253001 OMB control No(s). 0910–0485 0910–0120 0910–0073 https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments; or • https://www.regulations.gov. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: November 13, 2020. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [Docket No. FDA–2013–D–0575] [FR Doc. 2020–25399 Filed 11–17–20; 8:45 am] BILLING CODE 4164–01–P PO 00000 Food and Drug Administration Agency Information Collection Activities; Proposed Collection; Comment Request; Expedited Programs for Serious Conditions— Drugs and Biologics AGENCY: Food and Drug Administration, HHS. Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\18NON1.SGM 18NON1

Agencies

[Federal Register Volume 85, Number 223 (Wednesday, November 18, 2020)]
[Notices]
[Pages 73485-73487]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25399]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2020-D-1137 and FDA-2020-D-1138]

Guidance Documents Related to Coronavirus Disease 2019;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of FDA guidance documents related to the Coronavirus
Disease 2019 (COVID-19) public health emergency (PHE). This notice of
availability (NOA) is pursuant to the process that FDA announced, in
the Federal Register of March 25, 2020, for making available to the
public COVID-19-related guidances. The guidances identified in this
notice address issues related to the COVID-19 PHE and have been issued
in accordance with the process announced in the March 25, 2020, notice.
The 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 November 18, 2020.

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

[[Page 73486]]

document that the comments address and the docket number for the
guidance (see table 1). Received comments will be placed in the
docket(s) and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see Sec.
10.115(g)(5) (21 CFR 10.115(g)(5))).
Submit written requests for single copies of these guidances to the
address noted in table 1. Send two self-addressed adhesive labels to
assist that office in processing your requests. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidances.

FOR FURTHER INFORMATION CONTACT: Stephen Ripley, Center for Biologics
Evaluation and Research (CBER), Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911, or 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.

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\ Secretary of Health and Human Services Alex M. Azar, II,
Determination that a Public Health Emergency Exists (originally
issued on January 31, 2020, and subsequently renewed), 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 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 (21 U.S.C.
371(h)(1)(C)) and Sec. 10.115(g)(2)). The guidances are available on
FDA's web pages 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)
and ``Search for FDA Guidance Documents'' (available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents).
The March 25, 2020, notice further stated that, in general, rather
than publishing a separate NOA for each COVID-19-related guidance, FDA
intends to publish periodically a consolidated NOA announcing the
availability of certain COVID-19-related guidances that FDA issued
during the relevant period, as included in table 1. This notice
announces COVID-19-related guidances that are posted on FDA's website.

II. Availability of COVID-19-Related Guidance Documents

Pursuant to the process described in the March 25, 2020, notice,
FDA is announcing the availability of the following COVID-19-related
guidances:

Table 1--Guidances Related to the COVID-19 Public Health Emergency
----------------------------------------------------------------------------------------------------------------
Contact information to
Docket No. Center Title of guidance request single copies
----------------------------------------------------------------------------------------------------------------
FDA-2020-D-1137....................... CBER Emergency Use Office of Communication,
Authorization for Outreach and
Vaccines to Prevent Development, 10903 New
COVID-19 (October 2020). Hampshire Ave., Bldg.
71, Rm. 3128, Silver
Spring, MD 20993-0002;
1-800-835-4709 or 240-
402-8010; email
[email protected].

[[Page 73487]]

FDA-2020-D-1138....................... CDRH Enforcement Policy for [email protected]
Modifications to FDA ov/.
Cleared Molecular Please include the
Influenza and RSV Tests document number 20046
During the Coronavirus and complete title of
Disease 2019 (COVID-19) the guidance in the
Public Health Emergency request.
(October 2020).
----------------------------------------------------------------------------------------------------------------

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 Guidance

While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information (listed in
table 2). Therefore, clearance by the Office of Management and Budget
(OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-
3521) is not required for this guidance. The previously approved
collections of information are subject to review by OMB under the PRA.
The collections of information in the following FDA regulations and
guidances have been approved by OMB as listed in the following table:

Table 2--CBER Guidance and Collections
----------------------------------------------------------------------------------------------------------------
Another guidance title
COVID-19 guidance title CFR cite referenced in referenced in COVID-19 OMB control
COVID-19 guidance guidance No(s).
----------------------------------------------------------------------------------------------------------------
Emergency Use Authorization for Vaccines 21 CFR 314.420............ .......................... 0910-0001
to Prevent COVID-19 (October 2020). 21 CFR part 312........... .......................... 0910-0014
21 CFR parts 210, 211, and .......................... 0910-0139
610.
21 CFR part 600........... .......................... 0910-0308
21 CFR part 601........... .......................... 0910-0338
Emergency Use 0910-0595
Authorization of Medical
Products and Related
Authorities.
----------------------------------------------------------------------------------------------------------------

B. CDRH Guidance

While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information (listed in
table 3). Therefore, clearance by OMB under the PRA is not required for
this guidance. The previously approved collections of information are
subject to review by OMB under the PRA. The collections of information
in the following FDA regulations have been approved by OMB as listed in
the table below.

Table 3--CDRH Guidance and Collections
----------------------------------------------------------------------------------------------------------------
Another guidance title
COVID-19 guidance title CFR cite referenced in referenced in COVID-19 OMB control
COVID-19 guidance guidance No(s).
----------------------------------------------------------------------------------------------------------------
Enforcement Policy for Modifications to 800, 801, and 809......... N/A....................... 0910-0485
FDA--Cleared Molecular Influenza and 807, subpart E............ .......................... 0910-0120
RSV Tests During the Coronavirus 820....................... .......................... 0910-0073
Disease 2019 (COVID-19) Public Health
Emergency (October 2020).
----------------------------------------------------------------------------------------------------------------

IV. Electronic Access

Persons with access to the internet may obtain COVID-19-related
guidances at:
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;
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: November 13, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-25399 Filed 11-17-20; 8:45 am]
BILLING CODE 4164-01-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.