91406 Federal Register / Vol. 89, No. 223 / Tuesday, November 19, 2024 / Notices 

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the listed drug was withdrawn from sale 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a listed drug was withdrawn from sale 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time after the drug has been withdrawn 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. 

HYDROCORTONE (hydrocortisone 

sodium phosphate) injection, EQ 50 mg 

base/mL, is the subject of NDA 012052, 

held by Merck & Co., Inc., and initially 

approved on June 8, 1960. 

HYDROCORTONE (hydrocortisone 

sodium phosphate) injection, EQ 50 mg 

base/mL, is synthetic glucocorticoid for 

use as an anti-inflammatory or 

immunosuppressant agent. 

The indications for glucocorticoid 

drugs, including HYDROCORTONE 

(hydrocortisone sodium phosphate) 

injection, EQ 50 mg base/mL (Merck 

Sharpe & Dohme (now Merck & Co., 

Inc.); NDA 012052) were reviewed for 

efficacy under the Drug Efficacy Study 

Implementation program. Under this 

program, which was implemented in 

response to the 1962 amendments to the 

FD&C Act requiring demonstration of 

effectiveness (Kefauver-Harris 

Amendments of 1962 (Pub. L. 87–781)), 

the National Academy of SciencesNational Research Council (NAS–NRC) 

studied about 4,000 drug formulations 

to assess the efficacy of the drug 

products. Upon consideration of the 

findings and recommendations of the 

NAS–NRC, FDA set forth in the Federal 

Register its conclusions and assessment 

of whether and under what 

circumstances the reviewed drug 

products are considered ‘‘effective’’ for 

use as required by the FD&C Act. In the 

Federal Register of February 19, 1972 

(37 FR 3775), FDA announced that 

preparations containing hydrocortisone 

sodium phosphate are effective or 

probably effective for parenteral use by 

the appropriate route of administration. 

FDA published a subsequent notice in 

the Federal Register of March 1, 1977 

(42 FR 11893), in which the Agency set 

forth the indications that it found to be 

effective for certain drug products, 

including for HYDROCORTONE 

(hydrocortisone sodium phosphate) 

injection, EQ 50 mg base/mL (NDA 

012052). The March 1, 1977, notice 

announced FDA was prepared to 

approve NDAs and supplements to 

previously approved NDAs under the 

conditions described in the notice, 

including the condition that the revised 

labeling include only the indications for 

which the drug was classified as 

effective set forth in that notice (42 FR 

11893 at 11894–5). 

HYDROCORTONE (hydrocortisone 

sodium phosphate) injection, EQ 50 mg 

base/mL, is currently listed in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. In a letter 

dated April 4, 2003, Merck & Co., Inc., 

notified FDA that HYDROCORTONE 

(hydrocortisone sodium phosphate) 

injection, EQ 50 mg base/mL, was 

discontinued effective September 20, 

2002. In the same letter, Merck & Co., 

Inc., also requested withdrawal of NDA 

012052 for HYDROCORTONE 

(hydrocortisone sodium phosphate), and 

FDA moved the drug product to the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. In the 

Federal Register of May 5, 2004 (69 FR 

25124), FDA announced that it was 

withdrawing approval of NDA 012052, 

effective June 4, 2004. 

Hyman, Phelps & McNamara, P.C., 

submitted an initial citizen petition 

dated September 21, 2020 (Docket No. 

FDA–2020–P–1991) as well as a second 

citizen petition dated August 25, 2021 

(Docket No. FDA–2021–P–0940), under 

21 CFR 10.30, requesting that the 

Agency determine whether 

HYDROCORTONE (hydrocortisone 

sodium phosphate) injection, EQ 50 mg 

base/mL, was withdrawn from sale for 

reasons of safety or effectiveness. 

After considering the citizen petitions 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that HYDROCORTONE 

(hydrocortisone sodium phosphate) 

injection, EQ 50 mg base/mL, was not 

withdrawn for reasons of safety or 

effectiveness. The petitioner has 

identified no data or other information 

suggesting that HYDROCORTONE 

(hydrocortisone sodium phosphate) 

injection, EQ 50 mg base/mL, was 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of 

HYDROCORTONE (hydrocortisone 

sodium phosphate) injection, EQ 50 mg 

base/mL, from sale. We have also 

independently evaluated relevant 

literature and data for possible 

postmarketing adverse events. We have 

found no information that would 

indicate that this drug product was 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency will 

continue to list HYDROCORTONE 

(hydrocortisone sodium phosphate) 

injection, EQ 50 mg base/mL, 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 HYDROCORTONE (hydrocortisone 

sodium phosphate) injection, EQ 50 mg 

base/mL, may be approved by the 

Agency if 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: November 7, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–26916 Filed 11–18–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–3111] 

Ivette Maria Portela Martinez: Final 

Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing an 

order under the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) permanently 

debarring Ivette Maria Portela Martinez 

from providing services in any capacity 

to a person that has an approved or 

pending drug product application. FDA 

bases this order on a finding that Ms. 

Portela Martinez was convicted of two 

felonies under Federal law for conduct 

relating to the development or approval, 

including the process for development 

or approval, of any drug product. Ms. 

Portela Martinez was given notice of the 

proposed debarment and an opportunity 

to request a hearing within the 

timeframe prescribed by regulation. As 

of September 14, 2024 (30 days after 

receipt of the notice), Ms. Portela 

Martinez has not responded. Ms. Portela 

Martinez’s failure to respond and 

request a hearing constitutes a waiver of 

Ms. Portela Martinez’s right to a hearing 

concerning this matter. 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 89, No. 223 / Tuesday, November 19, 2024 / Notices 91407 

DATES: This order is applicable 

November 19, 2024. 

ADDRESSES: Any application by Ms. 

Portela Martinez for special termination 

of debarment under section 306(d)(4) of 

the FD&C Act (21 U.S.C. 335a(d)(4)) may 

be submitted at any time as follows: 

Electronic Submissions 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

An application submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

application will be made public, you are 

solely responsible for ensuring that your 

application 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 

application, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit an 

application with confidential 

information that you do not wish to be 

made available to the public, submit the 

application as a written/paper 

submission and in the manner detailed 

(see ‘‘Written/Paper Submissions’’ and 

‘‘Instructions’’). 

Written/Paper Submissions 

• 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 a written/paper application 

submitted to the Dockets Management 

Staff, FDA will post your application, as 

well as any attachments, except for 

information submitted, marked, and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All applications must 

include the Docket No. FDA–2024–N– 

3111. Received applications 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 an application with confidential 

information that you do not wish to be 

made publicly available, submit your 

application 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 your application. 

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. 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, 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 between 9 a.m. 

and 4 p.m., Monday through Friday, 

240–402–7500. Publicly available 

submissions may be seen in the docket. 

FOR FURTHER INFORMATION CONTACT: 

Jaime Espinosa, Division of Field 

Enforcement, Office of Field Regulatory 

Operations, Office of Inspections and 

Investigations, Food and Drug 

Administration, 240–402–8743, or 

debarments@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 306(a)(2)(A) of the FD&C Act 

requires debarment of an individual 

from providing services in any capacity 

to a person that has an approved or 

pending drug product application if 

FDA finds that the individual has been 

convicted of a felony under Federal law 

for conduct relating to the development 

or approval, including the process of 

development or approval, of any drug 

product. On November 30, 2023, Ms. 

Portela Martinez was convicted as 

defined in section 306(l)(1) of the FD&C 

Act in the U.S. District Court for the 

Southern District of Florida-Miami 

Division when the court entered 

judgment against her, after a jury trial, 

for one count of conspiracy to commit 

wire fraud in violation of 18 U.S.C. 1349 

and one count of wire fraud in violation 

of 18 U.S.C. 1343. 

The underlying facts supporting the 

conviction are as follows: as contained 

in the witness testimony reflected in the 

transcripts from her trial, Ms. Portela 

Martinez worked for AMB Research 

Center, Inc. (AMB), a medical clinic 

located in Miami, Florida. AMB 

conducted clinical trials of new drugs 

for pharmaceutical companies and other 

sponsors. At AMB, Ms. Portela Martinez 

served as recruiter, site manager, data 

entry specialist, and pharmacist. In 

March 2016, AMB entered into a 

Clinical Trial Agreement with a 

Contract Research Organization (CRO) 

that managed and oversaw a clinical 

trial designed to evaluate the safety and 

efficacy of an investigational drug 

intended to treat persons with 

Clostridium difficile-associated diarrhea 

(CDAD clinical trial) on behalf of a 

sponsor (a pharmaceutical company). 

Ms. Portela Martinez, along with her coconspirators, entered into a conspiracy 

to cause the sponsor and/or the CRO to 

make payments on the contracts for the 

CDAD clinical trial, by making false and 

fraudulent representations regarding, 

among other things, subject eligibility 

for and participation in the CDAD 

clinical trial, and falsifying and 

fabricating documents, data, and other 

items relating to the CDAD clinical trial 

including subject informed consent 

forms, case histories, and data. Ms. 

Portela Martinez participated with two 

other co-conspirators with falsifying and 

fabricating study documents. Ms. 

Portela Martinez and her coconspirators falsified the study data of 

subjects who did not participate in the 

CDAD clinical trial in full compliance 

with the protocol. Ms. Portela Martinez 

participated in falsifying the consent 

forms and falsifying subjects’ signatures 

to make it appear as though the patients 

had consented to participate in the 

clinical trial when they had not. 

For purposes of obtaining money from 

the sponsor and/or CRO, Ms. Portela 

Martinez, along with her coconspirators, created false and 

fraudulent study records, and submitted 

fraudulent stool and blood samples. For 

example, electronic case record files 

(eCRFs) falsely represented that the 

subjects completed the informed 

consent form (ICF) process with the 

Principal Investigator which required 

her to review the ICF with each subject 

and personally obtain the subject’s 

written informed consent. In fact, the 

Principal Investigator never completed 

the ICF process with subjects, and some 

subjects had never been to AMB or did 

not participate in the trial. Ms. Portela 

Martinez knew that false information 

and data was submitted in the case 

report forms and eCRFs including false 

information and data representing that 

subjects had satisfied eligibility criteria 


ddrumheller on DSK120RN23PROD with NOTICES1
91408 Federal Register / Vol. 89, No. 223 / Tuesday, November 19, 2024 / Notices 

to participate in the CDAD clinical trial, 

received and taken the study 

medication, provided stool samples, 

completed the required documents and 

journals, and participated in 

assessments conducted by the clinical 

investigator. In addition, Ms. Portela 

Martinez knew that 10 or more 

individuals’ means of identification 

were used unlawfully or without 

authority in furtherance of the 

conspiracy. Specifically, Ms. Portela 

Martinez, along with some of her coconspirators, used the means of 

identification of real persons, to create 

subject identification numbers for those 

persons, and then used those subject 

identification numbers to falsely portray 

the persons as legitimate subjects in the 

CDAD clinical trial, when in fact they 

were not. In addition, Ms. Portela 

Martinez along with her co-conspirators 

submitted her own stool and blood 

samples to make it appear as if they 

came from study participants. 

Furthermore, Ms. Portela Martinez 

was one of only two individuals who 

inputted CDAD clinical trial data in the 

Almac Clinical Technology Integrated 

Response Technology database (Almac 

database). The information in the Almac 

database was the foundation for all 

subsequent subject CDAD clinical trial 

data. Ms. Portela Martinez repeatedly 

entered false and fabricated subject 

screening and randomization 

information in the Almac database. 

Ms. Portela Martinez received $19,620 

in proceeds for the CDAD clinical trial. 

AMB received over $277,000 for the 

CDAD clinical trial. 

FDA sent Ms. Portela Martinez, by 

certified mail, on August 12, 2024, a 

notice proposing to permanently debar 

her from providing services in any 

capacity to a person that has an 

approved or pending drug product 

application. The proposal was based on 

a finding, under section 306(a)(2)(A) of 

the FD&C Act, that Ms. Portela Martinez 

was convicted of a felony under Federal 

law for conduct relating to the 

development or approval, including the 

process of development or approval, of 

any drug product. The proposal 

informed Ms. Portela Martinez of the 

proposed debarment and offered her an 

opportunity to request a hearing, 

providing her 30 days from the date of 

receipt of the letter in which to file the 

request, and advised her that failure to 

request a hearing constituted a waiver of 

the opportunity for a hearing and of any 

contentions concerning this action. Ms. 

Portela Martinez received the proposal 

and notice of opportunity for a hearing 

on August 15, 2024. Ms. Portela 

Martinez failed to request a hearing 

within the timeframe prescribed by 

regulation and has, therefore, waived 

her opportunity for a hearing and 

waived any contentions concerning her 

debarment (21 CFR part 12). 

II. Findings and Order 

Therefore, the Division of Field 

Enforcement Director, Office of 

Inspections and Investigations, under 

section 306(a)(2)(A) of the FD&C Act, 

under authority delegated to the 

Division of Field Enforcement Director, 

finds that Ms. Ivette Maria Portela 

Martinez has been convicted of a felony 

under Federal law for conduct relating 

to the development or approval, 

including the process of development or 

approval, of any drug product. 

As a result of the foregoing finding, 

Ms. Portela Martinez is permanently 

debarred from providing services in any 

capacity to a person with an approved 

or pending drug product application, 

effective (see DATES) (see sections 

306(a)(2)(A) and 306(c)(2)(A)(ii) of the 

FD&C Act). Any person with an 

approved or pending drug product 

application who knowingly employs or 

retains as a consultant or contractor, or 

otherwise uses in any capacity the 

services of Ms. Portela Martinez during 

her debarment, will be subject to civil 

money penalties (section 307(a)(6) of the 

FD&C Act (21 U.S.C. 335b(a)(6))). If Ms. 

Portela Martinez provides services in 

any capacity to a person with an 

approved or pending drug product 

application during her period of 

debarment, she will be subject to civil 

money penalties (section 307(a)(7) of the 

FD&C Act). In addition, FDA will not 

accept or review any abbreviated new 

drug application from Ms. Portela 

Martinez during her period of 

debarment, other than in connection 

with an audit under section 306 of the 

FD&C Act (section 306(c)(1)(B) of the 

FD&C Act). Note that, for purposes of 

sections 306 and 307 of the FD&C Act, 

a ‘‘drug product’’ is defined as a ‘‘drug 

subject to regulation under section 505, 

512, or 802 of the FD&C Act [(21 U.S.C. 

355, 360b, 382)] or under section 351 of 

the Public Health Service Act [(42 

U.S.C. 262)]’’ (section 201(dd) of the 

FD&C Act (21 U.S.C. 321(dd))). 

Dated: November 7, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–26912 Filed 11–18–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–1178] 

Kevin Sheng Hsiang Fang: Final 

Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing an 

order under the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) debarring 

Kevin Sheng Hsiang Fang for a period 

of 5 years from importing articles of 

food or offering such articles for 

importation into the United States. FDA 

bases this order on a finding that Mr. 

Fang was convicted of a felony count 

under Federal law for conduct relating 

to the importation into the United States 

of an article of food. Mr. Fang was given 

notice of the proposed debarment and 

an opportunity to request a hearing 

within the timeframe prescribed by 

regulation. As of July 1, 2024 (30 days 

after receipt of the notice), Mr. Fang has 

not responded. Mr. Fang’s failure to 

respond and request a hearing 

constitutes a waiver of Mr. Fang’s right 

to a hearing concerning this matter. 

DATES: This order is applicable 

November 19, 2024. 

ADDRESSES: Any application by Mr. 

Fang for termination of debarment 

under section 306(d)(1) of the FD&C Act 

(21 U.S.C. 335a(d)(1)) may be submitted 

at any time as follows: 

Electronic Submissions 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

An application submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

application will be made public, you are 

solely responsible for ensuring that your 

application 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 

application, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit an 

application with confidential 

information that you do not wish to be 

made available to the public, submit the 


ddrumheller on DSK120RN23PROD with NOTICES1