14272 Federal Register / Vol. 87, No. 49 / Monday, March 14, 2022 / Notices 

fellowship data in real time; moreover, 

data cleaning and manipulation do not 

need to be done outside the system, 

which will increase the security of these 

data. These increased functionalities 

will facilitate the enhanced use of 

administrative data collections for 

program improvement and evidence 

building activities across CDC and other 

federal agencies. The update to the 

software platform will also make it 

easier for additional fellowships to opt 

in to use FMS, expanding the benefits 

of the system to a broader set of CDC 

programs. Finally, the platform change 

should also enhance user experience. 

This Revision does not propose 

substantive changes to the nature or 

extent of information collected from 

respondents, and will allow all 

respondents—fellowship applicants, 

public health agencies hosting 

fellowship participants, and fellowship 

alumni—the continued use of FMS for 

submission of electronic data with 

increased efficiency and reduced 

burdens. 

The burden table reflects OMBapproved changes since 2020 and 

anticipated growth in fellowships from 

2022 onward. CDC requests approval for 

an estimated total of 14,914 annual 

burden hours. There is no cost to 

respondents other than their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total 

burden 

(in hours) 

Fellowship applicants ........................ FMS Fellowship Application Information Collection Instrument.5146 1 87/60 7,462 

Reference Letter Writers ................... FMS Fellowship Application Information Collection Instrument.6842 1 15/60 1,711 

Public Health Agency or Organization Staff.FMS Host Site Information Collection Instrument.960 1 75/60 1,200 

Public Health Agency or Organization Staff.FMS Activity Tracking Information 

Collection Instrument.

555 2 30/60 555 

Fellowship Alumni ............................. FMS Alumni Tracking Information 

Collection Instrument.

6463 1 37/60 3,986 

Total ........................................... ........................................................... ........................ ........................ ........................ 14,914 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2022–05302 Filed 3–11–22; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–P–0959] 

Determination That MPI DMSA KIDNEY 

REAGENT (Technetium Tc-99m 

Succimer Kit), Injectable, Was Not 

Withdrawn From Sale for Reasons of 

Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) 

has determined that MPI DMSA 

KIDNEY REAGENT (Technetium Tc99m Succimer Kit), Injectable, was not 

withdrawn from sale for reasons of 

safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for Technetium 

Tc-99m Succimer Kit, Injectable, if all 

other legal and regulatory requirements 

are met. 

FOR FURTHER INFORMATION CONTACT: 

Michelle Weiner, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6208, 

Silver Spring, MD 20993–0002, 240 

402–0374, Michelle.Weiner@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Section 

505(j) of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

355(j)) allows the submission of an 

ANDA to market a generic version of a 

previously approved drug product. To 

obtain approval, the ANDA applicant 

must show, among other things, that the 

generic drug product: (1) Has the same 

active ingredient(s), dosage form, route 

of administration, strength, conditions 

of use, and (with certain exceptions) 

labeling as the listed drug, which is a 

version of the drug that was previously 

approved, and (2) is bioequivalent to the 

listed drug. ANDA applicants do not 

have to repeat the extensive clinical 

testing otherwise necessary to gain 

approval of a new drug application 

(NDA). 

Section 505(j)(7) of the FD&C Act 

requires FDA to publish a list of all 

approved drugs. FDA publishes this list 

as part of the ‘‘Approved Drug Products 

With Therapeutic Equivalence 

Evaluations,’’ which is known generally 

as the ‘‘Orange Book.’’ Under FDA 

regulations, drugs are removed from the 

list if the Agency withdraws or 

suspends approval of the drug’s NDA or 

ANDA for reasons of safety or 

effectiveness or if FDA determines that 

the listed drug was withdrawn from sale 

for reasons of safety or effectiveness (21 

CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

MPI DMSA KIDNEY REAGENT 

(Technetium Tc-99m Succimer Kit), 

Injectable, is the subject of NDA 

N017944, held by GE Healthcare, and 

initially approved on May 18, 1982. MPI 

DMSA KIDNEY REAGENT is indicated 

to be used as an aid in the scintigraphic 

evaluation of renal parenchymal 

disorders. MPI DMSA KIDNEY 

REAGENT (Technetium Tc-99m 

Succimer Kit), Injectable, is currently 

listed in the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. 

Hyman, Phelps, & McNamara, P.C. 

submitted a citizen petition dated 

August 27, 2021 (Docket No. FDA– 


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Federal Register / Vol. 87, No. 49 / Monday, March 14, 2022 / Notices 14273 

2021–P–0959), under 21 CFR 10.30, 

requesting that the Agency determine 

whether MPI DMSA KIDNEY REAGENT 

(Technetium Tc-99m Succimer Kit), 

Injectable, was withdrawn from sale for 

reasons of safety or effectiveness. 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that MPI DMSA KIDNEY 

REAGENT (Technetium Tc-99m 

Succimer Kit), Injectable, was not 

withdrawn for reasons of safety or 

effectiveness. The petitioner has 

identified no data or other information 

suggesting that MPI DMSA KIDNEY 

REAGENT (Technetium Tc-99m 

Succimer Kit), Injectable, was 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of MPI 

DMSA KIDNEY REAGENT (Technetium 

Tc-99m Succimer Kit), Injectable, from 

sale. We have also independently 

evaluated relevant literature and data 

for possible postmarketing adverse 

events. We have reviewed the available 

evidence and determined that this drug 

product was not withdrawn from sale 

for reasons of safety or effectiveness. 

Accordingly, the Agency will 

continue to list MPI DMSA KIDNEY 

REAGENT ((Technetium Tc-99m 

Succimer Kit), Injectable, in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

delineates, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. ANDAs that refer 

to MPI DMSA KIDNEY REAGENT 

((Technetium Tc-99m Succimer Kit), 

Injectable, may be approved by the 

Agency as long as they meet all other 

legal and regulatory requirements for 

the approval of ANDAs. If FDA 

determines that labeling for this drug 

product should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: March 7, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–05324 Filed 3–11–22; 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 LifeHope Labs 

for the LifeHope 2019-nCoV Real-Time 

RT–PCR Diagnostic Panel, and 

Omnipathology Solutions Medical 

Corporation for the Omni COVID–19 

Assay by RT–PCR. 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 

LifeHope 2019-nCoV Real-Time RT– 

PCR Diagnostic Panel is revoked as of 

February 7, 2022. The Authorization for 

the Omni COVID–19 Assay by RT–PCR 

is revoked as of February 14, 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 June 

29, 2020, FDA issued an EUA to 

LifeHope Labs for the LifeHope 2019- 

nCoV Real-Time RT–PCR Diagnostic 

Panel, subject to the terms of the 

Authorization. Notice of the issuance of 

this Authorization was published in the 

Federal Register on November 20, 2020 

(85 FR 74346), as required by section 

564(h)(1) of the FD&C Act. On June 17, 

2020, FDA issued an EUA to 

Omnipathology Solutions Medical 

Corporation for the Omni COVID–19 

Assay by RT–PCR, subject to the terms 

of the Authorization. Notice of the 

issuance of this Authorization was 

published in the Federal Register on 

November 20, 2020 (85 FR 74346), 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 a request received by FDA on 

January 6, 2022, LifeHope Labs 

requested discontinuation of, and on 

February 7, 2022, FDA revoked, the 

Authorization for the LifeHope 2019- 

nCoV Real-Time RT–PCR Diagnostic 

Panel. Because LifeHope Labs notified 

FDA that it is no longer using the 

LifeHope 2019-nCoV Real-Time RT– 

PCR Diagnostic Panel and requested 

FDA discontinue the LifeHope 2019- 

nCoV Real-Time RT–PCR Diagnostic 

Panel, FDA has determined that it is 

appropriate to protect the public health 

or safety to revoke this Authorization. 

In requests received by FDA on 

February 7, 2022, and February 9, 2022, 

Omnipathology Solutions Medical 

Corporation requested revocation of, 

and on February 14, 2022, FDA revoked, 

the Authorization for the Omni COVID– 

19 Assay by RT–PCR. Because 

Omnipathology Solutions Medical 

Corporation notified FDA that it is no 

longer using the Omni COVID–19 Assay 

by RT–PCR and requested FDA revoke 

the EUA for the Omni COVID–19 Assay 

by RT–PCR, FDA has determined that it 


jspears on DSK121TN23PROD with NOTICES1