27646 Federal Register / Vol. 87, No. 89 / Monday, May 9, 2022 / Notices 

Warning Plans for Cigarettes and 

Smokeless Tobacco Products’’ on 

September 9, 2011, which describes the 

information and format to be submitted 

for smokeless plans (https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents/ 

submission-warning-plans-cigarettesand-smokeless-tobacco-products). 

Submitters may also visit a web page 

that describes the smokeless tobacco 

labeling and warning statement 

requirements (https://www.fda.gov/ 

tobacco-products/labeling-and-warningstatements-tobacco-products/smokelesstobacco-labeling-and-warningstatement-requirements). Additionally, 

FDA considers a submission to be a 

supplement if the submitter is seeking 

approval of a change to an FDAapproved warning plan. Warning plans 

can be submitted either electronically or 

in paper format. The Center for Tobacco 

Products (CTP) Portal, available at 

https://ctpportal.fda.gov/ctpportal/ 

login.jsp, provides a secure online 

system for electronically submitting 

documents and receiving messages from 

CTP. 

Based on our experience with the 

information collection over the past 3 

years, we retain our estimate of 60 hours 

to complete an initial rotational plan. 

We estimate half this time for preparing 

and submitting a supplement to an 

approved plan (30 hours). 

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 

Submission of initial rotational plans for health warning 

statements ........................................................................ 1 1 1 60 60 

Supplement to approved plan .............................................. 4 1 4 30 120 

Total .............................................................................. ........................ ........................ ........................ ........................ 180 

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

FDA estimates a total of 1 respondent 

will submit a new original warning plan 

yearly and take 60 hours to complete a 

rotational warning plan for a total of 60 

burden hours. In addition, FDA 

estimates a total of 4 respondents will 

submit a supplement to an approved 

warning plan at 30 hours per response 

for a total of 120 hours. After receiving 

the initial influx of original warnings 

plans, FDA does not expect to receive as 

many original warning plans annually. 

We expect that a few supplements will 

continue to be received as new products 

are marketed or as warning plans are 

revised. Therefore, we have decreased 

our estimate burden by 360 hours. 

Dated: April 29, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09885 Filed 5–6–22; 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 Bio-Rad 

Laboratories, Inc., for the Bio-Rad 

Reliance SARS–CoV–2/FluA/FluB RT– 

PCR Assay Kit and to Applied DNA 

Sciences, Inc., for the Linea COVID–19 

Assay Kit. 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 Authorization for the BioRad Reliance SARS–CoV–2/FluA/FluB 

RT–PCR Assay Kit is revoked as of April 

15, 2022. The Authorization for the 

Linea COVID–19 Assay Kit is revoked as 

of April 20, 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 

February 11, 2021, FDA issued an EUA 

to Bio-Rad Laboratories, Inc., for the 

Bio-Rad Reliance SARS–CoV–2/FluA/ 

FluB RT–PCR Assay Kit, 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 May 13, 2020, FDA 

issued an EUA to Applied DNA 

Sciences, Inc. for the Linea COVID–19 

Assay Kit, subject to the terms of the 

Authorization. Notice of the issuance of 

this Authorization was published in the 

Federal Register on July 14, 2020 (85 FR 

42407), 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 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 89 / Monday, May 9, 2022 / Notices 27647 

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 a request received by FDA on 

March 17, 2022, Bio-Rad Laboratories, 

Inc., requested revocation of, and on 

April 15, 2022, FDA revoked, the 

Authorization for the Bio-Rad Reliance 

SARS–CoV–2/FluA/FluB RT–PCR 

Assay Kit. Because Bio-Rad 

Laboratories, Inc. notified FDA that it 

has ceased U.S. distribution of the 

Reliance SARS–CoV–2/FluA/FluB RT– 

PCR Assay Kit, has discontinued the 

assay, and requested FDA revoke the 

EUA for the Reliance SARS–CoV–2/ 

FluA/FluB RT–PCR Assay Kit, FDA 

determined that it is appropriate to 

protect the public health or safety to 

revoke this Authorization. 

In a request received by FDA on April 

7, 2022, Applied DNA Sciences, Inc., 

requested revocation of, and on April 

20, 2022, FDA revoked, the 

Authorization for the Linea COVID–19 

Assay Kit. Because Applied DNA 

Sciences, Inc. notified FDA that it has 

decided to discontinue distribution of 

the Linea COVID–19 Assay Kit and 

requested FDA withdraw the EUA for 

the Linea COVID–19 Assay Kit, 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 EUA of BioRad Laboratories, Inc., for the Bio-Rad 

Reliance SARS–CoV–2/FluA/FluB RT– 

PCR Assay Kit, and Applied DNA 

Sciences, Inc., for the Linea COVID–19 

Assay Kit. 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. 

BILLING CODE 4164–01–P 


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27648 Federal Register / Vol. 87, No. 89 / Monday, May 9, 2022 / Notices 


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April 14, 2022 

Eli1:iibetlt- Platt EdD1 MS, M13A 

Sr, Director, Reguiatory & Clinkal Attairs [ Americas 

Bio..:RadLabotatories, tnc. 

4000 Alfred Nobel Orive 

aercules, CA92§47 

R~; Revo~ation of ElJA202965 

I)eat Ik :Platt: 

This letter is in :r:~ppi;,:se to the requ_e$± :(rom Bio-Rad Laboraiori~ m,c., received vi11. email o_n 

March 17,2022~ thatthe U.S. Food and DrugAchriin:istration(FDA)rev:o:ke the.EVA, with an 

effective date of April 15~ 2022; forthe Bio-Rad Reliance S.AR:S-CoV~2/FluA!FluB R'fc'PCR 

Assay Kit isroed on Febmaty n, 2021, attd atrtended on September 13, M:Zl. Bio-Rad 

Labontt◊ri~, Inc, ceased·u.s, clisttil:rution of.the Reliance sARS~CoV,2/FJ:uNFluB RT~CR 

Assey Kit on March 2, 2022, and has discontinμeq this asS11.y, 

The au:thorizalion of a db<ice £&t emetgertcy use urtdet section :%4 of:"ihe Fede:tal Food, Drug, 

and Ct1s:m:e:iic Act (the Act) (21 u.s.c. 360bbb-3) may, pursuant to section 564(&)(2) oftheAet; 

be revoked :i;yh(lll ci.rc\l.ltlStart~_ ~e such revoc11.tion 11.pprop:riate to prQtect the pμblic health QT 

safely (s:eclion 564(g)(2)(C) oftheAct). Because Bio-Rad Laboratories, 1nc; has notified FDA 

thatit has ceased US. distribution of the Reliance SARS-CoV-2/FluA/l11uB RT-PCR. Assay Kit, 

has discbntinued the assay~ and requested FDA tev<>ke the lWA for the Re.lian.ce S.ARS..•C6V~ 

2/Fll.lAIFh-lB RT•PCRAssay Kit, FD:A has determined thatit is- approptiate to protect me public 

health or Sl;lfety to revoke this ~1:1thgnza:iion, A:gcQrdingiy, peryour reqμest, effective April 15, 

2022.. FDA herebv revokes EUA202965 for-the Reliance S.ARS-CoV-2/FluAlFluB RT-PCR 

Assay l<it,-pufSu:ltl)t to sectlon 564(g)(2)(C) of the Act Effective as of April 15, 2022, the 

Reli'ance SARS~CoV ~2/ElttAJFiuB RT~PCR Assay Kit is no longer author.i.zed for emergency use 

b-yFDA 

Notice of this revocation vdff be published in the FederalRegtster, pursuantto section 564-(h}(I) 

ofthe:Act 

i~c4ueiiiie A.o· sh~hnessy, Ph.n. 

Acting Chief Scientist · 

Food and P:rug Adil1.inisttati.011 
Federal Register / Vol. 87, No. 89 / Monday, May 9, 2022 / Notices 27649 


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April 20, 2022 

Clay D, Shorrock, Esq. 

Chief Legal Officer and Exec. Dir., Business Development 

Applied DNA Sciehces, lnc. 

50 Health Sciences I>:rive 

Stony Brook, NY 11790 

Re: Revocation of KUA200474 

Dear MY Shorrock: 

This letteris in: resppnse to the request from Applied DNA Sciences, Inc,, received on April 7, 

2022,.that :the U.S. Food and Drug Administration (FDA)' withdraw the EUA for the Linea 

COVTD-19 Assay Kit issued on Ma;y 13, 2020, re~issued on May 11, 2021, and amended on July 

8, 2020, July 30, 2020, September 25,. 2020, November 21, 2020, July 21, 2021, and September 

23, 2021. Applied DNA Sciences, ltl¢;c indicated that it is no longer distri bUting or utilizing the 

Linea COVIU-19 Assay Kit,. Applied.DNA Sciem;es, Inc. has transitioned to the use of the.Linea 

2,0 COVIb~l9 Assay and other EU A-authorized tests. 

The a;uthorization of a device for emergency use under section 564 ofthe Federal Food, Drug, 

and Cosmetic Act (the Act) (21 U S.C, 360bbb-3) may, pursuantto .section 564(g)(2) ofthe Act, 

be revoked when circumstances make such rev-ocation appropriate to protect the public health or 

safety (section 564(g){2)(-C) of the Act). Because Applied DNA Sciences, Inc. has notified FDA 

thatit has decided to discontinue distribution of the Linea COVID· 19 Assay Kit and requested 

FDA withdr:aw the EU A for the Linea COVID-19 Assay Kit, FDA has detenrtiried thatit is 

appropriate to protect the public health or safety to revoke thts atithonzation. Accordingly, FDA 

hereby revokes EUA200474for the LineaCOVlD-19 Assa;y Kit, pursuant to section 

564(g)(2)(CJ ofthe- Act. As of the date of this letter~ the LirteaCOVTD-19 Assay Kit is no longer 

authorized for ertl.etgency use by FDA 

Notice of tht1, revocation: :wi.11 be published in the FederalRegiscer; pursuant to section 564(h)(l) 

oftheAct 

Sincerely, 

ls/ 

Jacqueline A O' Shaughnessy, Ph.D, 

Acting Chief Scientist 

food and Drug Administration 
27650 Federal Register / Vol. 87, No. 89 / Monday, May 9, 2022 / Notices 

Dated: May 3, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–09887 Filed 5–6–22; 8:45 am] 

BILLING CODE 4164–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–1112] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Interstate Shellfish 

Dealer’s Certificate and Participation in 

the National Shellfish Sanitation 

Program 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by June 8, 

2022. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0021. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

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: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Interstate Shellfish Dealer’s Certificate 

and Participation in the National 

Shellfish Sanitary Program 

OMB Control Number 0910–0021— 

Extension 

Under section 243 of the Public 

Health Service Act (42 U.S.C. 243), FDA 

is required to cooperate with and aid 

State and local authorities in the 

enforcement of their health regulations 

and is authorized to assist States in the 

prevention and suppression of 

communicable diseases. Under this 

authority, FDA participates with State 

regulatory agencies, some foreign 

nations, and the U.S. molluscan 

shellfish industry in the National 

Shellfish Sanitation Program (NSSP). 

The NSSP is a voluntary, cooperative 

program to promote the safety of 

molluscan shellfish by providing for the 

classification and patrol of shellfish 

growing waters and for the inspection 

and certification of shellfish dealers. 

Each participating State and foreign 

nation monitors its molluscan shellfish 

production and issues certificates for 

those dealers that meet the State or 

foreign shellfish control authority’s 

criteria. Each participating State and 

nation provides a certificate of its 

certified shellfish dealers to FDA on 

Form FDA 3038, ‘‘Interstate Shellfish 

Dealer’s Certificate’’ (available at 

https://www.fda.gov/media/72094/ 

download). FDA uses this information 

to publish the ‘‘Interstate Certified 

Shellfish Shippers List (ICSSL),’’ a 

monthly comprehensive listing of all 

molluscan shellfish dealers certified 

under the cooperative program 

(available at https://www.fda.gov/food/ 

federalstate-food-programs/interstatecertified-shellfish-shippers-list). If FDA 

did not collect the information 

necessary to compile this list, 

participating States would not be able to 

identify and prevent the distribution in 

the United States of shellfish processed 

by uncertified dealers. Consequently, 

the NSSP would not be able to control 

the distribution of uncertified and 

possibly unsafe shellfish in interstate 

commerce. Without the ICSSL, the 

effectiveness of the NSSP would be 

nullified. The ICSSL is also used to 

identify U.S. shellfish dealers eligible to 

obtain health certificates and export to 

certain countries or regions. 

FDA has been collecting information 

to construct the ICSSL since 2001. FDA 

is seeking to add one new data field to 

Form FDA 3038, the ‘‘FDA 

Establishment Identifier’’ (FEI number). 

The FEI number is a unique number 

assigned by FDA to identify FDAregulated facilities. FDA will explore 

whether the FEI can be used to retrieve 

data on shellfish dealers from existing 

FDA systems, which could reduce the 

number of required data elements that 

firms have to submit on Form FDA 

3038. 

The information collection also 

includes providing certain documents 

demonstrating compliance with the 

NSSP. When a competent authority in 

another country conducts an evaluation 

to determine whether the U.S. food 

safety control measures for molluscan 

shellfish are equivalent to their system 

of controls, the competent authority 

may require FDA to provide information 

and records demonstrating compliance 

with the provisions of the NSSP. Only 

those firms that comply with the NSSP 

would be permitted to export molluscan 

shellfish to a country whose competent 

authority determined that the U.S. 

system of controls is equivalent to their 

own controls. FDA uses this information 

to support the export of U.S. shellfish to 

countries whose competent authorities 

have determined the U.S. system of food 

safety controls to be equivalent to their 

own system of controls by 

demonstrating that the exporter is in 

compliance with the U.S. system of 

controls specified in the NSSP. 

For example, to implement the 

European Commission’s (EC) 

determination that the U.S. system of 

food safety controls for raw bivalve 

molluscan shellfish is equivalent to the 

European Union’s (EU) system of 

controls, the EC is requiring FDA to 

provide documentation collected from 

NSSP-participating shellfish control 

authorities with firms seeking to export 

raw molluscan shellfish to the EU. This 

documentation includes, but is not 

limited to: 

• A list of growing areas with an 

Approved classification; 

• the most recent sanitary survey for 

each growing area with an Approved 

classification; and 

• the most recent inspection report 

for each firm seeking to export shellfish 

to the EU. 

Some competent authorities may 

require additional information to 

conduct an equivalence assessment or to 

implement an equivalence 

determination, or both. We plan to 

provide respondents with information 

about the specific documentation that is 

required for each equivalence 

assessment. For those competent 

authorities that recognize the U.S. 

system as equivalent, additional 

documentation may be needed to 

implement that determination. 

Description of Respondents: 

Respondents to this collection are 

participating State and local regulatory 

agencies and foreign nations. 


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