Federal Register / Vol. 87, No. 122 / Monday, June 27, 2022 / Notices 38161 

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. 

FOR FURTHER INFORMATION CONTACT: 

Rachel Showalter, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 240–994–7399, 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 extension 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. 

Regulations Restricting the Sale and 

Distribution of Cigarettes and 

Smokeless Tobacco To Protect Children 

and Adolescents—21 CFR Part 1140 

OMB Control Number 0910–0312— 

Extension 

This information collection supports 

regulatory requirements contained in 

part 1140 (21 CFR part 1140) authorized 

under Chapter IX of the FD&C Act. 

Regulations in part 1140 establish 

permissible forms of labeling and 

advertising and include reporting 

requirements directing persons to notify 

FDA if they intend to use a form of 

advertising that is not addressed in the 

regulations. Section 1140.30 requires 

manufacturers, distributors, and 

retailers to: (1) observe certain format 

and content requirements for labeling 

and advertising, and (2) notify FDA if 

they intend to use an advertising 

medium that is not listed in the 

regulations. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden 

per response 

Total hours 

1140.30—Scope of permissible forms of labeling and advertising ............................................................................ 25 1 25 1 25 

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

The burden hour estimates for this 

collection of information were based on 

submissions regarding cigarette and 

smokeless tobacco product advertising 

expenditures. 

FDA estimates that approximately 25 

respondents will submit an annual 

notice of alternative advertising, and the 

Agency has estimated it should take 1 

hour to provide such notice. Therefore, 

the total estimated time required for this 

collection of information is 25 hours. 

Based on a review of the information 

collection and the number of 

notifications received since 2018, we 

have made no adjustments to our 

burden estimate. 

Dated: June 21, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13630 Filed 6–24–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–0235] 

Clinical Pharmacology Considerations 

for the Development of 

Oligonucleotide Therapeutics; Draft 

Guidance for Industry; 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 a draft 

guidance for industry entitled ‘‘Clinical 

Pharmacology Considerations for the 

Development of Oligonucleotide 

Therapeutics.’’ This draft guidance 

describes FDA’s recommendations 

regarding clinical pharmacology 

considerations during the development 

of oligonucleotide therapeutics, 

including characterizing the potential 

for QT interval prolongation, performing 

immunogenicity risk assessment, 

characterizing the impact of hepatic and 

renal impairment, and assessing the 

potential for drug-drug interactions. The 

intent of this guidance is to assist 

industry in the conduct of these studies. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by September 26, 2022 to ensure that 

the Agency considers your comment on 

this draft guidance before it begins work 

on the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance 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. 


jspears on DSK121TN23PROD with NOTICES1
38162 Federal Register / Vol. 87, No. 122 / Monday, June 27, 2022 / Notices 

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 Docket No. FDA– 

2022–D–0235 for ‘‘Clinical 

Pharmacology Considerations for the 

Development of Oligonucleotide 

Therapeutics.’’ Received comments 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 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Anuradha Ramamoorthy, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 3118, 

Silver Spring, MD 20903, 

anuradha.ramamoorthy@fda.hhs.gov, 

240–402–6426. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Clinical Pharmacology Considerations 

for the Development of Oligonucleotide 

Therapeutics.’’ Oligonucleotide 

therapeutics are an emerging 

therapeutic modality with increasing 

numbers of drugs in development. 

While antisense and siRNA 

oligonucleotide therapeutics have been 

approved in recent years to treat rare 

diseases, many oligonucleotide 

therapeutics are in development to treat 

common chronic diseases. This 

guidance provides recommendations to 

assist industry in the development of 

oligonucleotide therapeutics. 

Specifically, this guidance represents 

FDA’s recommendations for certain 

pharmacokinetic and pharmacodynamic 

investigations including characterizing 

QT interval prolongation potential, 

performing immunogenicity risk 

assessment, characterizing the impact of 

hepatic and renal impairment, and 

assessing the potential for drug-drug 

interactions during oligonucleotide 

therapeutic development. This guidance 

provides recommendations on when 

these assessments may be appropriate 

and what types of assessments can help 

address these issues. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

This draft guidance, when finalized, 

will represent the current thinking of 

FDA on ‘‘Clinical Pharmacology 

Considerations for the Development of 

Oligonucleotide Therapeutics.’’ It does 

not establish any rights for any person 

and is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. 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 21 CFR 312 for 

investigational new drug applications 

and 21 CFR part 314 for new drug 

applications and abbreviated new drug 

applications have been approved under 

OMB control numbers 0910–0014 and 

0910–0001. The collections of 

information for biologics license 

applications have been approved under 

OMB control number 0910–0338. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs or https://

www.regulations.gov. 


jspears on DSK121TN23PROD with NOTICES1
Federal Register / Vol. 87, No. 122 / Monday, June 27, 2022 / Notices 38163 

Dated: June 21, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13606 Filed 6–24–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0150] 

Revocation of Two Authorizations of 

Emergency Use of In Vitro Diagnostic 

Devices for Detection and/or Diagnosis 

of COVID–19; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

revocation of the Emergency Use 

Authorizations (EUAs) (the 

Authorizations) issued to Quanterix 

Corp. for the Simoa Semi-Quantitative 

SARS–CoV–2 IgG Antibody Test and for 

the Simoa SARS–CoV–2 N Protein 

Antigen Test. FDA revoked these 

Authorizations under the Federal Food, 

Drug, and Cosmetic Act (FD&C Act). 

The revocations, which include an 

explanation of the reasons for each 

revocation, are reprinted in this 

document. 

DATES: The Authorizations for the 

Simoa Semi-Quantitative SARS–CoV–2 

IgG Antibody Test and for the Simoa 

SARS–CoV–2 N Protein Antigen Test 

are revoked as of May 10, 2022. 

ADDRESSES: Submit written requests for 

a single copy of the revocations 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 selfaddressed adhesive label to assist that 

office in processing your request or 

include a fax number to which the 

revocations may be sent. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the revocations. 

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, 

240–402–8155 (this is not a toll-free 

number). 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 564 of the FD&C Act (21 

U.S.C. 360bbb–3) as amended by the 

Project BioShield Act of 2004 (Pub. L. 

108–276) and the Pandemic and AllHazards Preparedness Reauthorization 

Act of 2013 (Pub. L. 113–5) allows FDA 

to strengthen the 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. On 

December 23, 2020, FDA issued an EUA 

to Quanterix Corp. for the Simoa SemiQuantitative SARS–CoV–2 IgG 

Antibody Test, subject to the terms of 

the Authorization. Notice of the 

issuance of this Authorization was 

published in the Federal Register on 

April 23, 2021 (86 FR 21749), as 

required by section 564(h)(1) of the 

FD&C Act. On January 5, 2021, FDA 

issued an EUA to Quanterix Corp. for 

the Simoa SARS–CoV–2 N Protein 

Antigen Test, subject to the terms of the 

Authorization. Notice of the issuance of 

this Authorization was published in the 

Federal Register on April 23, 2021, as 

required by section 564(h)(1) of the 

FD&C Act. Subsequent updates to the 

Authorizations were made available on 

FDA’s website. The authorization of a 

device for emergency use under section 

564 of the FD&C Act may, pursuant to 

section 564(g)(2) of the FD&C Act, be 

revoked when the criteria under section 

564(c) of the FD&C Act for issuance of 

such authorization are no longer met 

(section 564(g)(2)(B) of the FD&C Act), 

or other circumstances make such 

revocation appropriate to protect the 

public health or safety (section 

564(g)(2)(C) of the FD&C Act). 

II. EUA Revocation Requests 

In requests received by FDA on May 

5, 2022, and May 9, 2022, Quanterix 

Corp. requested withdrawal of, and on 

May 10, 2022, FDA revoked, the 

Authorization for the Simoa SemiQuantitative SARS–CoV–2 IgG 

Antibody Test. Because Quanterix Corp. 

notified FDA that Quanterix Corp. did 

not distribute the authorized product in 

the United States and requested FDA to 

withdraw the authorization of the Simoa 

Semi-Quantitative SARS–CoV–2 IgG 

Antibody Test, FDA determined that it 

is appropriate to protect the public 

health or safety to revoke this 

Authorization. 

In requests received by FDA on May 

5, 2022, and May 9, 2022, Quanterix 

Corp. requested withdrawal of, and on 

May 10, 2022, FDA revoked, the 

Authorization for the Simoa SARS– 

CoV–2 N Protein Antigen Test. Because 

Quanterix Corp. notified FDA that 

Quanterix Corp. has discontinued 

distribution of the authorized product 

and requested FDA withdraw the 

authorization of the Simoa SARS–CoV– 

2 N Protein Antigen Test, FDA 

determined that it is appropriate to 

protect the public health or safety to 

revoke this Authorization. 

III. Electronic Access 

An electronic version of this 

document and the full text of the 

revocations are available on the internet 

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

IV. The Revocations 

Having concluded that the criteria for 

revocation of the Authorizations under 

section 564(g)(2)(C) of the FD&C Act are 

met, FDA has revoked the EUAs of 

Quanterix Corp. for the Simoa SemiQuantitative SARS–CoV–2 IgG 

Antibody Test and for the Simoa SARS– 

CoV–2 N Protein Antigen Test. The 

revocations in their entirety follow and 

provide an explanation of the reasons 

for each revocation, as required by 

section 564(h)(1) of the FD&C Act. 


jspears on DSK121TN23PROD with NOTICES1