106 Federal Register / Vol. 86, No. 1 / Monday, January 4, 2021 / Notices 

territorial, and tribal governments to 

monitor and measure progress in food 

defense. 

In 2015, the initial NAFDS Report to 

Congress detailed the specific Federal 

response to food and agriculture defense 

goals, objectives, key initiatives, and 

activities that HHS, USDA, DHS, and 

other stakeholders planned to 

accomplish to meet the objectives 

outlined in FSMA. The NAFDS charts a 

direction for how Federal Agencies, in 

cooperation with SLTT governments 

and private sector partners, protect the 

nation’s food supply against intentional 

contamination. Not later than 4 years 

after the initial NAFDS Report to 

Congress (2015), and every 4 years 

thereafter (i.e., 2019, 2023, 2027, etc.), 

HHS, USDA, and DHS are required to 

revise and submit an updated report to 

the relevant committees of Congress. 

FDA is the Agency primarily 

responsible for obtaining the 

information from Federal and SLTT 

partners to complete the NAFDS Report 

to Congress. An interagency working 

group will conduct the survey and 

collect and update the NAFDS as 

directed by FSMA, including 

developing metrics and measuring 

progress for the evaluation process. 

The survey of Federal and State 

partners will be used to determine what 

food defense activities, if any, Federal 

and/or SLTT agencies have completed 

(or are planning on completing) from 

2021 to 2025. Planning for the local, 

territorial, and tribal information 

collections will commence during this 

period of renewal. The survey will 

continue to be repeated approximately 

every 2 to 4 years, as described in 

section 108 of FSMA. The NAFDS 

survey is being administered for the 

purpose of monitoring progress in food 

and agricultural defense by government 

agencies. 

A purposive sampling strategy is 

employed, such that the government 

agencies participating in food and 

agricultural defense are asked to 

respond to the voluntary survey. Food 

defense leaders responsible for 

conducting food defense activities 

during a food emergency for their 

jurisdiction are identified and will 

receive an emailed invitation to 

complete the survey online; they will be 

provided with a web link to the survey. 

The survey will be conducted 

electronically on the FDA.gov web 

portal, and results will be analyzed by 

the interagency working group. 

Description of Respondents: 

Respondents to this collection are SLTT 

government representatives (survey 

respondents) who are food defense 

leaders responsible for conducting food 

defense activities during a food 

emergency for their jurisdictions. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total 

annual 

responses 

Average 

burden per 

response 

Total hours 

SLTT Surveys .......................................... 500 1 500 0.33 (20 minutes) ...... 165 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The FDA Office of Partnerships 

reviewed the questionnaire and 

provided the estimate of time to 

complete the survey. The total burden is 

based on our previous experiences 

conducting surveys. The burden has 

been revised to reflect the total number 

of states and possible number of local, 

tribal, and territorial entities that may 

partake of the survey. Based on a review 

of the information collection since our 

last request for OMB approval, we have 

increased our burden estimate by 149 

hours (from 16.17 to 165 hours) and 451 

respondents (from 49 to 500 

respondents). 

Dated: December 29, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–29082 Filed 12–31–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2020–D–1825 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 January 4, 2021. 

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. 

Federal Register / Vol. 86, No. 1 / Monday, January 4, 2021 / Notices 107 

1Secretary 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. 2Proclamation 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/. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the name of the guidance 

document that the comments address 

and the docket number for the guidance 

(see table 1). Received comments will be 

placed in the docket(s) and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see § 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 (HHS), 

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-2020- 

03-25/pdf/2020-06222.pdf), FDA 

announced procedures for making 

available FDA guidances related to the 

COVID–19 PHE. These procedures, 

which operate within FDA’s established 

good guidance practices regulations, are 

intended to allow FDA to rapidly 

disseminate Agency recommendations 

and policies related to COVID–19 to 

industry, FDA staff, and other 

stakeholders. The March 25, 2020, 

notice stated that due to the need to act 

quickly and efficiently to respond to the 

COVID–19 PHE, FDA believes that prior 

public participation will not be feasible 

or appropriate before FDA implements 

COVID–19-related guidances. Therefore, 

FDA will issue COVID–19-related 

guidances for immediate 

implementation without prior public 

comment (see section 701(h)(1)(C) of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 371(h)(1)(C)) and 

§ 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–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: 

108 Federal Register / Vol. 86, No. 1 / Monday, January 4, 2021 / Notices 

TABLE 1—GUIDANCES RELATED TO THE COVID–19 PUBLIC HEALTH EMERGENCY

Docket No. Center Title of guidance Contact information to request single copies 

FDA–2020–D–1825 CBER ..... Investigational COVID–19 Convalescent Plasma (Updated November 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. 

FDA–2020–D–1138 CDRH .... Notifying CDRH of a Permanent Discontinuance or 

Interruption in Manufacturing of a Device Under 

Section 506J of the FD&C Act During the COVID– 

19 Public Health Emergency (Revised) (November 

2020).

CDRH-Guidance@fda.hhs.gov. Please include the 

document number 20032–R2 and complete title of 

the guidance in the request. 

FDA–2020–D–1138 CDRH .... Enforcement Policy for Bioburden Reduction Systems 

Using Dry Heat to Support Single-User Reuse of 

Certain Filtering Facepiece Respirators During the 

Coronavirus Disease 2019 (COVID–19) Public 

Health Emergency (November 2020).

CDRH-Guidance@fda.hhs.gov. Please include the 

document number 20044 and complete title of the 

guidance in the request. 

FDA–2020–D–1138 CDRH .... Enforcement Policy for the Quality Standards of the 

Mammography Quality Standards Act During the 

COVID–19 Public Health Emergency (December 

2020).

CDRH-Guidance@fda.hhs.gov. Please include the 

document number 20047 and complete title of the 

guidance in the request. 

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). 

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

COVID–19 guidance title CFR cite referenced in COVID–19 guidance 

Another guidance 

title referenced 

in COVID–19 

guidance 

OMB control 

No(s). 

Investigational COVID–19 Convalescent Plasma 

(Updated November 2020).

21 CFR part 312 ......................................................

21 CFR parts 610, 606, and 630 .............................

................................

................................

0910–0014 

0910–0116 

Form FDA 3926 ..... 0910–0814 

B. CDRH Guidances 

While these guidances contain no 

collection of information, they do refer 

to previously approved FDA collections 

of information (listed in table 3). 

Therefore, clearance by OMB under the 

PRA (44 U.S.C. 3501–3521) is not 

required for these guidances. These 

previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in the following FDA 

statutory provision, regulations and 

guidances have been approved by OMB 

as listed in the following table. These 

guidances also contain a collection of 

information that has been granted a PHE 

waiver from the PRA by HHS on March 

19, 2020, under section 319(f) of the 

PHS Act. Information concerning the 

PHE PRA waiver can be found on the 

HHS website at https://aspe.hhs.gov/ 

public-health-emergency-declarationpra-waivers. 

TABLE 3—CDRH GUIDANCES AND COLLECTIONS

COVID–19 guidance title 

Citation 

referenced in 

COVID–19 

guidance 

Another guidance referenced 

in COVID–19 guidance 

OMB control 

No(s). 

New collection covered by 

PHE PRA waiver 

Notifying CDRH of a Permanent Discontinuance or Interruption 

in Manufacturing of a Device Under Section 506J of the 

FD&C Act During the COVID–19 Public Health Emergency 

(Revised) (November 2020).

Section 506J 

(21 

U.S.C.356j) 

of the FD&C 

Act.

.................................................. 0910–0491 

21 CFR Part 

807, subparts 

A through D.

.................................................. 0910–0625 

Federal Register / Vol. 86, No. 1 / Monday, January 4, 2021 / Notices 109 

TABLE 3—CDRH GUIDANCES AND COLLECTIONS—Continued 

COVID–19 guidance title 

Citation 

referenced in 

COVID–19 

guidance 

Another guidance referenced 

in COVID–19 guidance 

OMB control 

No(s). 

New collection covered by 

PHE PRA waiver 

Emergency Use Authorization 

of Medical Products and Related Authorities; Guidance 

for Industry and Other 

Stakeholders.

0910–0595 

Updates to FDA every 6 weeks 

after initial notification on the 

shortage situation. 

Voluntary submission of other 

information. 

Enforcement Policy for Bioburden Reduction Systems Using 

Dry Heat to Support Single-User Reuse of Certain Filtering 

Facepiece Respirators During the Coronavirus Disease 

2019 (COVID–19) Public Health Emergency (November 

2020).

......................... Emergency Use Authorization 

of Medical Products and Related Authorities; Guidance 

for Industry and Other 

Stakeholders.

0910–0595 

Labeling of the bioburden reduction system. 

Enforcement Policy for the Quality Standards of the Mammography Quality Standards Act [MQSA] During the COVID–19 

Public Health Emergency (December 2020).

21 CFR Part 

900.

.................................................. 0910–0309 

Document the time period that 

the facility was temporarily 

closed and present information during the facility’s 

MQSA inspection. 

Document and provide the circumstances re: lack of medical physicist survey within 

14 months of the last annual 

survey. 

Information on inability to meet 

the survey timeframes described in the guidance. 

Provide documentation of the 

dates and events that led to 

noncompliance and that facility will ensure compliance 

as soon as possible after 

COVID–19 restrictions are 

lifted. 

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-preparednessand-response/mcm-issues/covid-19- 

related-guidance-documents-industryfda-staff-and-other-stakeholders; 

• FDA web page entitled ‘‘Search for 

FDA Guidance Documents’’ available at 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments; or 

• https://www.regulations.gov. 

Dated: December 29, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–29058 Filed 12–31–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–1414] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Class II Special 

Controls Guidance Document: 

Labeling Natural Rubber Latex 

Condoms 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the information 

collection for the labeling of natural 

rubber latex condoms. 

DATES: Submit either electronic or 

written comments on the collection of 

information by March 5, 2021. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before March 5, 

2021. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of March 5, 2021. Comments 

received by mail/hand delivery/courier 

(for written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

Electronic Submissions 

Submit electronic comments in the 

following way: