Federal Register / Vol. 87, No. 55 / Tuesday, March 22, 2022 / Notices 16199 

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
16200 Federal Register / Vol. 87, No. 55 / Tuesday, March 22, 2022 / Notices 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3521), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘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 (44 

U.S.C. 3506(c)(2)(A) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed revision of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Medication Guide Requirements for 

Prescription Drug Product Labeling 

OMB Control Number 0910–0393— 

Extension 

This information collection supports 

FDA regulations pertaining to the 

distribution of patient labeling, called 

Medication Guides, for human 

prescription drug and biological 

products used primarily on an 

outpatient basis, and required for 

products that pose a serious and 

significant public health concern. 

Applicable regulations are codified at 21 

CFR part 208: Medication Guides for 

Prescription Drug Products, and set 

forth general content and format 

requirements, as well as provide for 

exemptions and deferrals. Medication 

Guides provide patients with important 

written information about drug 

products, including the drug’s approved 

uses, contraindications, adverse drug 

reactions, and cautions for specific 

populations, and are required in 

accordance with Agency regulations. 

To assist consumers and industry 

with understanding applicable 

regulatory requirements in 21 CFR part 

208 pertaining to developing, 

distributing, and submitting certain 

Medication Guides, we have developed 

the guidance document entitled 

‘‘Medication Guides—Distribution 

Requirements and Inclusion in Risk 

Evaluation and Mitigation Strategies 

(REMS)’’ (available at https://

www.fda.gov/media/79776/download). 

The guidance document includes a 

discussion of the applicable regulations; 

FDA enforcement policy with regard to 

Medication Guides associated with 

products dispensed to healthcare 

professionals, or patient caregivers, 

instead of being dispensed directly to 

the patient for self-administration; and 

Medication Guides required as part of a 

risk evaluation and mitigation strategy. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity; 21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Content and format of a Medication Guide; § 208.20 ......... 41 1 41 320 13,120 

Exemptions and deferrals; § 208.26(a) ................................ 1 1 1 4 4 

Total .............................................................................. ........................ ........................ 42 ........................ 13,124 

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

Upon evaluation of the information 

collection, we have removed burden we 

attributed to reporting associated with 

supplements and other changes to 

approved abbreviated new drug 

applications, new drug applications, 

and biologics license applications (21 

CFR 314.70(b)(3)(ii) and 601.12(f)). We 

now account for burden associated with 

these regulatory provisions in OMB 

control numbers 0910–0001 and 0910– 

0338 and have decreased the burden 

associated with this collection 

accordingly. 

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Activity; 21 CFR section Number of 

respondents 

Number of 

disclosures per 

respondent 

Total annual 

disclosures 

Average burden 

per disclosure 2 Total hours 

Distribute Medication Guides to authorized dispensers; § 208.24(c).191 9,000 1,719,000 1.25 ....................... 2,148,750 

Distribute and Dispense Medication Guides to Patients; § 208.24(e).88,000 5,705 502,040,000 0.05 (3 minutes) .... 25,102,000 

Total .................................................................... ........................ .......................... 503,759,000 ............................... 27,250,750 

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

2 Numbers may not sum due to rounding. 


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Federal Register / Vol. 87, No. 55 / Tuesday, March 22, 2022 / Notices 16201 

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. 

We have decreased our estimated 

burden associated with disclosures to 

reflect a decrease in related submissions 

over the past 3 years. 

Dated: March 14, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–06034 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–2021–N–0335] 

Authorization of Emergency Use of a 

Biological Product During the COVID– 

19 Pandemic; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of an Emergency Use 

Authorization (EUA) (the Authorization) 

under the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) for use during 

the COVID–19 pandemic. FDA has 

issued one Authorization for a 

biological product as requested by Eli 

Lilly and Company (Lilly). The 

Authorization contains, among other 

things, conditions on the emergency use 

of the authorized product. The 

Authorization follows 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 a novel (new) 

coronavirus. The virus, now named 

SARS–CoV–2, causes the illness 

COVID–19. On the basis of such 

determination, the Secretary of HHS 

declared on March 27, 2020, that 

circumstances exist justifying the 

authorization of emergency use of drugs 

and biological products during the 

COVID–19 pandemic, pursuant to the 

FD&C Act, subject to the terms of any 

authorization issued under that section. 

The Authorization, which includes an 

explanation of the reasons for issuance, 

is reprinted in this document. 

DATES: The Authorization is effective as 

of February 11, 2022. 

ADDRESSES: Submit written requests for 

a single copy of the 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: 

Michael Mair, Office of 

Counterterrorism and Emerging Threats, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 1, Rm. 

4340, 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 public health protections 

against biological, chemical, nuclear, 

and radiological 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 life-threatening 

diseases or conditions caused by 

biological, chemical, nuclear, or 

radiological agents when there are no 

adequate, approved, and available 

alternatives (among other criteria). 

II. Criteria for EUA Authorization 

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, 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 in 

an actual or potential emergency 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 

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

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

and 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), 


lotter on DSK11XQN23PROD with NOTICES1