16196 Federal Register / Vol. 87, No. 55 / Tuesday, March 22, 2022 / Notices 

fiscal and administrative management of 

early childhood programs and grants? 

• Given existing challenges with 

recruiting, hiring, and retaining 

qualified tribal early childhood program 

staff, what TA would be helpful to 

support tribal communities in building, 

supporting, strengthening, and 

maintaining an effective early childhood 

workforce? 

• What TA would be helpful to 

support tribal communities in planning 

for, developing, building, maintaining, 

and improving appropriate early care 

and education facilities? 

• What TA supports do tribal 

communities need or want around data 

collection and management, data 

systems, and data sovereignty in their 

early childhood programs and systems? 

• What TA would be helpful to 

support tribal communities in 

implementing continuous quality 

improvement and evaluation initiatives 

in their early childhood programs and 

systems? 

• What TA would be helpful to 

support tribal communities directly 

implementing high-quality early 

childhood programs and services 

(including evidence-based, 

developmentally appropriate practices, 

as well as infant and toddler programs 

and services to children with 

disabilities)? 

• What TA would be helpful to 

support tribal early childhood programs 

in implementation of health, behavioral 

health, nutrition services, as 

appropriate? 

• What TA would be helpful to 

support tribal early childhood programs 

and communities in effectively engaging 

families, elders, and community 

members and promoting family 

leadership (i.e., empowering families to 

have a voice in program planning, 

implementation, and evaluation and 

advocate for their children)? 

• What TA would be helpful to 

support tribal communities in 

developing, implementing, and 

overseeing (1) subsidy and certificate 

programs, (2) licensing programs, and 

(3) grants and contracts for early 

childhood services? 

• What TA would be helpful to better 

support (1) tribal-level coordination and 

integration of early childhood programs 

and supports and (2) development of 

early childhood systems? 

• What TA would be helpful to 

support tribes, when they desire, to 

collaborative effectively with states on 

implementation of early childhood 

programs and services? 

• Are there any other key topic areas 

where TA would be helpful to support 

tribal communities in implementation 

and coordination of early childhood 

programs and systems? Are there any 

specific considerations around 

implementing possible new child care 

or preschool programs? 

3.2 In your opinion, what is the 

ability and capacity of the current 

federal early childhood TA system to 

support tribal communities in the areas 

where TA is needed? 

• What are the strengths of the 

existing TA system? 

• Where are the gaps in the existing 

TA system? 

• What existing resources could be 

more fully leveraged or tailored to be 

responsive to tribal early childhood 

programs and the needs of tribal 

communities? 

3.3 In your opinion, what is the 

ideal structure of a TA network to 

provide support to tribal communities 

around implementation and 

coordination of early childhood 

programs and systems? 

• What is the ideal overall 

organization of a federal tribal early 

childhood TA system (e.g., national 

coordinating centers, regional-specific 

centers, topic-specific centers)? 

• What are the best ways to ensure 

that federal TA is well-coordinated? 

• What are the needed skills, 

background, capacities, experiences, 

and resources of entities and 

individuals providing TA to tribal 

communities implementing early 

childhood programs and systems? 

• What are the best strategies for 

providing TA to tribal communities to 

implement coordinated early childhood 

programs and supports (e.g., universal, 

targeted, intensive)? 

• What are the ideal methods for 

providing TA to tribal communities on 

early childhood programs (e.g., written 

resources, tools, webinars, trainings, 

meetings, site visits, peer learning and 

collaboration, coaching)? 

3.4 If new or expanded TA supports 

are needed to support tribal early 

childhood program implementation and 

coordination, in your opinion, in what 

ways can the field (including TA 

providers) build capacity to provide the 

needed TA to tribal communities? 

• Are there organizations or entities 

that are capable to serve as TA 

providers? 

• Is there a pool of people who have 

the skills and experience necessary, 

including understanding the context of 

tribal communities, tribal sovereignty, 

culture and language, and tribal early 

childhood programs, to provide the TA 

that is needed? 

• How can the TA system build 

capacity without negatively impacting 

tribal communities themselves (e.g., by 

hiring away experienced staff)? 

• How could potential new TA 

investments be integrated into the 

existing network of federal tribal early 

childhood TA providers? 

3.5 In your opinion, do different 

types of tribal communities have 

different TA needs and priorities 

(topics, methods, strategies)? 

• Larger tribal communities? 

• Smaller tribal communities? 

• Alaska Native communities? 

• Urban Indian communities? 

• Tribes that are consolidating child 

care into their 102–477 employment, 

training, and related services plans? 

3.6 In your opinion, what are key 

challenges and lessons learned in 

providing effective TA to tribal 

communities to implement coordinated 

early childhood programs and systems? 

• What are the primary challenges or 

barriers? 

• For entities that have provided TA 

to tribal communities on these topics, 

what are some key lessons learned? 

Authority: Section 511, Title V of the 

Social Security Act (42 U.S.C. 711); 

Head Start Act, as amended (42 U.S.C. 

9801 et seq.); CCDB Act of 2014, as 

amended (Pub. L. 113–186). 

Katie Hamm, 

Deputy Assistant Secretary for Early 

Childhood Development Administration for 

Children and Families U.S. Department of 

Health and Human Services. 

[FR Doc. 2022–05962 Filed 3–21–22; 8:45 am] 

BILLING CODE 4184–74–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–1584] 

Authorization of Emergency Use of 

Certain Medical Devices During 

COVID–19; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the issuance of Emergency 

Use Authorizations (EUAs) (the 

Authorizations) for certain medical 

devices related to the Coronavirus 

Disease 2019 (COVID–19) public health 

emergency. FDA has issued the 

Authorizations listed in this document 

under the Federal Food, Drug, and 

Cosmetic Act (FD&C Act). These 

Authorizations contain, among other 

things, conditions on the emergency use 

of the authorized products. The 


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Federal Register / Vol. 87, No. 55 / Tuesday, March 22, 2022 / Notices 16197 

1 In the case of a determination by the Secretary 

of Defense, the Secretary of HHS shall determine 

within 45 calendar days of such determination, 

whether to make a declaration under section 

564(b)(1) of the FD&C Act, and, if appropriate, shall 

promptly make such a declaration. 

2The Secretary of HHS has delegated the 

authority to issue an EUA under section 564 of the 

FD&C Act to the Commissioner of Food and Drugs. 

Authorizations follow the February 4, 

2020, determination by the Secretary of 

Health and Human Services (HHS) that 

there is a public health emergency that 

has a significant potential to affect 

national security or the health and 

security of U.S. citizens living abroad 

and that involves the virus that causes 

COVID–19, and the subsequent 

declarations on February 4, 2020, March 

2, 2020, and March 24, 2020, that 

circumstances exist justifying the 

authorization of emergency use of in 

vitro diagnostics for detection and/or 

diagnosis of the virus that causes 

COVID–19, personal respiratory 

protective devices, and medical devices, 

including alternative products used as 

medical devices, respectively, subject to 

the terms of any authorization issued 

under the FD&C Act. These 

Authorizations, which include an 

explanation of the reasons for issuance, 

are listed in this document, and can be 

accessed on FDA’s website from the 

links indicated. 

DATES: These Authorizations are 

effective on their date of issuance. 

ADDRESSES: Submit written requests for 

single copies of an EUA to the Office of 

Counterterrorism and Emerging Threats, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 1, Rm. 

4338, Silver Spring, MD 20993–0002. 

Send one self-addressed adhesive label 

to assist that office in processing your 

request or include a fax number to 

which the Authorization may be sent. 

See the SUPPLEMENTARY INFORMATION

section for electronic access to the 

Authorization. 

FOR FURTHER INFORMATION CONTACT: 

Jennifer J. Ross, Office of 

Counterterrorism and Emerging Threats, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 1, Rm. 

4332, Silver Spring, MD 20993–0002, 

301–796–8510 (this is not a toll-free 

number). 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 564 of the FD&C Act (21 

U.S.C. 360bbb–3) allows FDA to 

strengthen the public health protections 

against biological, chemical, 

radiological, or nuclear agent or agents. 

Among other things, section 564 of the 

FD&C Act allows FDA to authorize the 

use of an unapproved medical product 

or an unapproved use of an approved 

medical product in certain situations. 

With this EUA authority, FDA can help 

ensure that medical countermeasures 

may be used in emergencies to diagnose, 

treat, or prevent serious or lifethreatening diseases or conditions 

caused by a biological, chemical, 

radiological, or nuclear agent or agents 

when there are no adequate, approved, 

and available alternatives. 

Section 564(b)(1) of the FD&C Act 

provides that, before an EUA may be 

issued, the Secretary of HHS must 

declare that circumstances exist 

justifying the authorization based on 

one of the following grounds: (1) A 

determination by the Secretary of 

Homeland Security that there is a 

domestic emergency, or a significant 

potential for a domestic emergency, 

involving a heightened risk of attack 

with a biological, chemical, radiological, 

or nuclear agent or agents; (2) a 

determination by the Secretary of 

Defense that there is a military 

emergency, or a significant potential for 

a military emergency, involving a 

heightened risk to U.S. military forces, 

including personnel operating under the 

authority of title 10 or title 50 of the 

U.S. Code, of attack with (A) a 

biological, chemical, radiological, or 

nuclear agent or agents; or (B) an agent 

or agents that may cause, or are 

otherwise associated with, an 

imminently life-threatening and specific 

risk to U.S. military forces; 1 (3) a 

determination by the Secretary of HHS 

that there is a public health emergency, 

or a significant potential for a public 

health emergency, that affects, or has a 

significant potential to affect, national 

security or the health and security of 

U.S. citizens living abroad, and that 

involves a biological, chemical, 

radiological, or nuclear agent or agents, 

or a disease or condition that may be 

attributable to such agent or agents; or 

(4) the identification of a material threat 

by the Secretary of Homeland Security 

pursuant to section 319F–2 of the Public 

Health Service (PHS) Act (42 U.S.C. 

247d–6b) sufficient to affect national 

security or the health and security of 

U.S. citizens living abroad. 

Once the Secretary of HHS has 

declared that circumstances exist 

justifying an authorization under 

section 564 of the FD&C Act, FDA may 

authorize the emergency use of a drug, 

device, or biological product if the 

Agency concludes that the statutory 

criteria are satisfied. Under section 

564(h)(1) of the FD&C Act, FDA is 

required to publish in the Federal 

Register a notice of each authorization, 

and each termination or revocation of an 

authorization, and an explanation of the 

reasons for the action. Under section 

564(h)(1) of the FD&C Act, revisions to 

an authorization shall be made available 

on the internet website of FDA. Section 

564 of the FD&C Act permits FDA to 

authorize the introduction into 

interstate commerce of a drug, device, or 

biological product intended for use 

when the Secretary of HHS has declared 

that circumstances exist justifying the 

authorization of emergency use. 

Products appropriate for emergency use 

may include products and uses that are 

not approved, cleared, or licensed under 

section 505, 510(k), 512, or 515 of the 

FD&C Act (21 U.S.C. 355, 360(k), 360b, 

or 360e) or section 351 of the PHS Act 

(42 U.S.C. 262), or conditionally 

approved under section 571 of the FD&C 

Act (21 U.S.C. 360ccc). FDA may issue 

an EUA only if, after consultation with 

the HHS Assistant Secretary for 

Preparedness and Response, the 

Director of the National Institutes of 

Health, and the Director of the Centers 

for Disease Control and Prevention (to 

the extent feasible and appropriate 

given the applicable circumstances), 

FDA 2 concludes: (1) That an agent 

referred to in a declaration of emergency 

or threat can cause a serious or lifethreatening disease or condition; (2) 

that, based on the totality of scientific 

evidence available to FDA, including 

data from adequate and well-controlled 

clinical trials, if available, it is 

reasonable to believe that (A) the 

product may be effective in diagnosing, 

treating, or preventing (i) such disease 

or condition; or (ii) a serious or lifethreatening disease or condition caused 

by a product authorized under section 

564, approved or cleared under the 

FD&C Act, or licensed under section 351 

of the PHS Act, for diagnosing, treating, 

or preventing such a disease or 

condition caused by such an agent; and 

(B) the known and potential benefits of 

the product, when used to diagnose, 

prevent, or treat such disease or 

condition, outweigh the known and 

potential risks of the product, taking 

into consideration the material threat 

posed by the agent or agents identified 

in a declaration under section 

564(b)(1)(D) of the FD&C Act, if 

applicable; (3) that there is no adequate, 

approved, and available alternative to 

the product for diagnosing, preventing, 

or treating such disease or condition; (4) 

in the case of a determination described 

in section 564(b)(1)(B)(ii), that the 

request for emergency use is made by 

the Secretary of Defense; and (5) that 

such other criteria as may be prescribed 

by regulation are satisfied. No other 

criteria for issuance have been 


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3As set forth in the EUAs for these products, FDA 

has concluded that: (1) SARS–CoV–2, the virus that 

causes COVID–19, can cause a serious or lifethreatening disease or condition, including severe 

respiratory illness, to humans infected by this virus; 

(2) based on the totality of scientific evidence 

available to FDA, it is reasonable to believe that the 

products may be effective in diagnosing COVID–19, 

and that the known and potential benefits of the 

products, when used for diagnosing COVID–19, 

outweigh the known and potential risks of such 

products; and (3) there is no adequate, approved, 

and available alternative to the emergency use of 

the products. 

4As set forth in the EUAs for these products, FDA 

has concluded that: (1) SARS–CoV–2 can cause a 

serious or life-threatening disease or condition, 

including severe respiratory illness, to humans 

infected by this virus; (2) based on the totality of 

scientific evidence available to FDA, it is reasonable 

to believe that the products may be effective in 

diagnosing recent or prior infection with SARS– 

CoV–2 by identifying individuals with an adaptive 

immune response to the virus that causes COVID– 

19, and that the known and potential benefits of the 

products when used for such use, outweigh the 

known and potential risks of the products; and (3) 

there is no adequate, approved, and available 

alternative to the emergency use of the products. 

5As set forth in the EUA, FDA has concluded 

that: (1) SARS–CoV–2 can cause a serious or lifethreatening disease or condition, including severe 

respiratory illness, to humans infected by this virus; 

(2) based on the totality of scientific evidence 

available to FDA, it is reasonable to believe that the 

product may be effective in diagnosing COVID–19 

through the simultaneous qualitative detection and 

differentiation of SARS–CoV–2, influenza A virus, 

and/or influenza B virus RNA and that the known 

and potential benefits of the product when used for 

diagnosing COVID–19, outweigh the known and 

potential risks of the product; and (3) there is no 

adequate, approved, and available alternative to the 

emergency use of the product. 

6As set forth in the EUA, FDA has concluded 

that: (1) SARS–CoV–2 can cause a serious or lifethreatening disease or condition, including severe 

respiratory illness, to humans infected by this virus; 

(2) based on the totality of scientific evidence 

available to FDA, it is reasonable to believe that the 

product may be effective in diagnosing COVID–19, 

through the simultaneous qualitative detection and 

differentiation of SARS–CoV–2, influenza A, 

influenza B, and/or RSV virus RNA, and that the 

known and potential benefits of the product when 

used for diagnosing COVID–19, outweigh the 

known and potential risks of the product; and (3) 

there is no adequate, approved, and available 

alternative to the emergency use of the product. 

7As set forth in the EUA, FDA has concluded 

that: (1) SARS–CoV–2 can cause a serious or lifethreatening disease or condition, including severe 

respiratory illness, to humans infected by this virus; 

(2) based on the totality of scientific evidence 

available to FDA, it is reasonable to believe that the 

product may be effective in diagnosing COVID–19, 

through the simultaneous qualitative detection and 

differentiation of RNA from SARS–CoV–2, 

influenza A virus, influenza B virus, and/or RSV, 

and that the known and potential benefits of your 

product when used for diagnosing COVID–19, 

outweigh the known and potential risks of your 

product; and (3) there is no adequate, approved, 

and available alternative to the emergency use of 

the product. 

8As set forth in the EUA, FDA has concluded 

that: (1) SARS–CoV–2 can cause a serious or lifethreatening disease or condition, including severe 

respiratory illness, to humans infected by this virus; 

(2) based on the totality of scientific evidence 

available to FDA, it is reasonable to believe that the 

product may be effective in diagnosing COVID–19 

by serving as an appropriate means to collect and 

prescribed by regulation under section 

564(c)(4) of the FD&C Act. 

II. Electronic Access 

An electronic version of this 

document and the full text of the 

Authorizations are available on the 

internet and can be accessed from 

https://www.fda.gov/emergencypreparedness-and-response/mcm-legalregulatory-and-policy-framework/ 

emergency-use-authorization. 

III. The Authorizations 

Having concluded that the criteria for 

the issuance of the following 

Authorizations under section 564(c) of 

the FD&C Act are met, FDA has 

authorized the emergency use of the 

following products for diagnosing, 

treating, or preventing COVID–19 

subject to the terms of each 

Authorization. The Authorizations in 

their entirety, including any authorized 

fact sheets and other written materials, 

can be accessed from the FDA web page 

entitled ‘‘Emergency Use 

Authorization,’’ available at https://

www.fda.gov/emergency-preparednessand-response/mcm-legal-regulatoryand-policy-framework/emergency-useauthorization. The lists that follow 

include Authorizations issued from 

September 11, 2021, through January 24, 

2022, and we have included 

explanations of the reasons for their 

issuance, as required by section 

564(h)(1) of the FD&C Act. In addition, 

the EUAs that have been reissued can be 

accessed from FDA’s web page: https:// 

www.fda.gov/emergency-preparednessand-response/mcm-legal-regulatoryand-policy-framework/emergency-useauthorization. 

FDA is hereby announcing the 

following Authorizations for molecular 

diagnostic and antigen tests for COVID– 

19, excluding multianalyte tests: 3

• Life Sciences Testing Center’s Life 

Sciences Testing Center COVID–19 Test, 

issued September 22, 2021; 

• ANP Technologies, Inc.’s NIDS 

COVID–19 Antigen Rapid Test Kit, 

issued September 24, 2021; 

• Cleveland Clinic Robert J. Tomsich 

Pathology and Laboratory Medicine 

Institute’s SelfCheck cobas SARS–CoV– 

2 Assay, issued September 29, 2021; 

• ACON Laboratories, Inc.’s Flowflex 

COVID–19 Antigen Home Test, issued 

October 4, 2021; 

• Xtrava Health’s SPERA COVID–19 

Ag Test, issued October 12, 2021; 

• LMSI, LLC’s (d/b/a Lighthouse Lab 

Services) CovidNow SARS–CoV–2 

Assay, issued October 14, 2021; 

• Celltrion USA, Inc.’s Celltrion 

DiaTrust COVID–19 Ag Home Test, 

issued October 21, 2021; 

• Detect, Inc’s Detect Covid–19 Test, 

issued October 28, 2021; 

• Talis Biomedical Corporation’s 

Talis One COVID–19 Test System, 

issued November 5, 2021; 

• iHealth Labs, Inc.’s iHealth COVID– 

19 Antigen Rapid Test, issued 

November 5, 2021; 

• Meridian Bioscience, Inc.’s 

Revogene SARS–CoV–2, issued 

November 9, 2021; 

• InBios International Inc.’s SCoV–2 

Ag Detect Rapid Self-Test, issued 

November 22, 2021; 

• Nano-Ditech Corp.’s Nano-Check 

COVID–19 Antigen Test, issued 

December 6, 2021; 

• UCSD BCG EXCITE Lab’s UCSD 

EXCITE COVID–19 Test, issued 

December 17, 2021; 

• SD Biosensor, Inc.’s COVID–19 AtHome Test, issued December 24, 2021; 

• Siemens Healthineers’ CLINITEST 

Rapid COVID–19 Antigen Self-Test, 

issued December 29, 2021; 

• Premier Medical Laboratory 

Services’ PMLS SARS–CoV–2 Assay, 

issued January 7, 2022; 

• iHealth Labs, Inc.’s iHealth COVID– 

19 Antigen Rapid Test Pro, issued 

January 14, 2022; 

• Maxim Biomedical, Inc.’s 

MaximBio ClearDetect COVID–19 

Antigen Home Test, issued January 19, 

2022; and 

• Mammoth Biosciences, Inc.’s 

DETECTR BOOST SARS–CoV–2 

Reagent Kit, issued January 21, 2022. 

FDA is hereby announcing the 

following Authorizations for serology 

tests: 4

• EUROIMMUN US, Inc.’s 

EUROIMMUN Anti-SARS–CoV–2 S1 

Curve ELISA (IgG), issued October 4, 

2021; 

• InBios International, Inc.’s SCoV–2 

Detect Neutralizing Ab ELISA, issued 

October 22, 2021. 

FDA is hereby announcing the 

following Authorizations for 

multianalyte in vitro diagnostics: 

• Laboratory Corporation of 

America’s Labcorp SARS–CoV–2 & 

Influenza A/B Assay, issued September 

30, 2021; 5

• PerkinElmer, Inc.’s PKamp 

Respiratory SARS–CoV–2 RT–PCR 

Panel 1, issued October 6, 2021; 6 and 

• Applied BioCode, Inc.’s BioCode 

CoV–2 Flu Plus Assay, issued December 

15, 2021 7 FDA is hereby announcing 

the following Authorizations for other 

medical devices: 

• Quest Diagnostics Infectious 

Disease, Inc.’s Quest Diagnostics 

Collection Kit for COVID–19, issued 

October 8, 2021; 8


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transport human specimens so that an authorized 

laboratory can detect SARS–CoV–2 RNA from the 

collected human specimen, and that the known and 

potential benefits of the product when used for 

such use, outweigh the known and potential risks 

of the product; and (3) there is no adequate, 

approved, and available alternative to the 

emergency use of the product. 

9As set forth in the EUA, FDA has concluded 

that: (1) SARS–CoV–2 can cause a serious or lifethreatening disease or condition, including severe 

respiratory illness, to humans infected by this virus; 

(2) based on the totality of scientific evidence 

available to FDA, it is reasonable to believe that the 

product may be effective in diagnosing COVID–19 

by serving as an appropriate means to collect and 

transport human specimens so that an authorized 

laboratory can detect SARS–CoV–2 RNA from the 

collected human specimen, and that the known and 

potential benefits of the product when used for 

such use, outweigh the known and potential risks 

of the product; and (3) there is no adequate, 

approved, and available alternative to the 

emergency use of the product. 

10FDA concluded that establishing additional 

conditions on the EUAs within the scope of the 

letter is appropriate to protect the public health or 

safety and revised all such EUAs pursuant to 

Section 564(g)(2)(C) of the FD&C Act to establish 

the three additional conditions set forth in the letter 

as permitted by Section 564(e) of the FD&C Act. 

• Audere’s HealthPulse@home, 

issued November 30, 2021; 9

In addition, on September 23, 2021, 

FDA issued a letter to Developers of 

Certain Molecular, Antigen and 

Serology In Vitro Diagnostics (IVDs) 

Authorized for Emergency Use for 

Coronavirus Disease 2019 (COVID–19) 

as of Today’s Date (September 23, 2021) 

for Establishing additional Conditions of 

Authorization for the EUAs of Certain 

Molecular, Antigen and Serology IVDs 

related to viral mutations.10

Dated: March 14, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–06008 Filed 3–21–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0902] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Medication Guides 

for Prescription Drug Products 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) 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 revision of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on information 

collection associated with Medication 

Guides for prescription drug products. 

DATES: Submit either electronic or 

written comments on the collection of 

information by May 23, 2022. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

May 23, 2022. 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: 

• 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 Docket No. FDA–2011–N– 

0902 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Medication Guide Requirements for 

Prescription Drug Product Labeling.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), will be 

placed in the docket 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 


lotter on DSK11XQN23PROD with NOTICES1