Federal Register / Vol. 89, No. 223 / Tuesday, November 19, 2024 / Notices 91405 

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copies of the draft guidance to the Office 

of Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist the office in processing your 

requests. The draft guidance may also be 

obtained by mail by calling CBER at 1– 

800–835–4709 or 240–402–8010. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Myrna Hanna, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft document entitled ‘‘Frequently 

asked Questions—Developing Potential 

Cellular and Gene Therapy Products.’’ 

The draft guidance document provides 

industry with answers to FAQs and 

commonly faced issues that arise during 

the development of CGT products. The 

FAQs represent common questions 

directed to the Agency and span 

multiple disciplines, including 

regulatory review; CMC; pharmacology/ 

toxicology; clinical; and clinical 

pharmacology. 

The guidance was created as part of 

FDA’s response to the PDUFA VII 

commitment to increase efficiency and 

to support development of CGT 

products by providing a repository of 

common questions posed to the Office 

of Therapeutic Products by sponsors 

and other key stakeholders. The Agency 

compiled FAQs received from a variety 

of sources, including FDA interactions 

with sponsors in development 

programs. 

The guidance covers relevant, current, 

and timely topics related to the 

development of CGT products, which 

may be updated to include additional 

FAQs as appropriate. Sponsors are 

encouraged to visit the Cellular and 

Gene Therapy Guidances web page on 

the FDA website for a full list of 

finalized as well as draft guidances 

relevant to the development of CGT 

products. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on ‘‘Frequently asked Questions— 

Developing Potential Cellular and Gene 

Therapy Products.’’ 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. The previously approved 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Action of 1995 (44 U.S.C. 

3501–3521). The collections of 

information in 21 CFR part 312 

pertaining to investigational new drug 

applications, clinical trials and clinical 

trial design, meetings with FDA, and 

Form FDA 1571, have been approved 

under OMB control number 0910–0014. 

The collections of information in 

section 402(j)(5)(B) of the Public Health 

Service Act (42 U.S.C. 282(j)(5)(B)), 

which requires certification that all 

applicable requirements of section 

402(j) have been met on Form FDA 

3674, and the collections of information 

in 21 CFR part 601 pertaining to the 

submission of biologics license 

applications and Form FDA 356h have 

been approved under OMB control 

number 0910–0338. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/vaccines-blood-biologics/ 

guidance-compliance-regulatoryinformation-biologics/biologicsguidances, https://www.fda.gov/ 

regulatory-information/search-fdaguidance-documents, or https://

www.regulations.gov. 

Dated: November 7, 2024. 

Kimberlee Trzeciak, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs. 

[FR Doc. 2024–26918 Filed 11–18–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2020–P–1991 and FDA– 

2021–P–0940] 

Determination That HYDROCORTONE 

(Hydrocortisone Sodium Phosphate) 

Injection, Equivalent to 50 Milligrams 

Base/Milliliter, 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 or Agency) has 

determined that HYDROCORTONE 

(hydrocortisone sodium phosphate) 

injection, equivalent to (EQ) 50 

milligrams (mg) base/milliliter (mL), 

was not withdrawn from sale for reasons 

of safety or effectiveness. This 

determination will allow FDA to 

approve abbreviated new drug 

applications (ANDAs) for 

HYDROCORTONE (hydrocortisone 

sodium phosphate) injection, EQ 50 mg 

base/mL, if all other legal and regulatory 

requirements are met. 

FOR FURTHER INFORMATION CONTACT: Beth 

Holck, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6280, Silver Spring, 

MD 20993–0002, 240–402–7133, 

Beth.Holck@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 


ddrumheller on DSK120RN23PROD with NOTICES1
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