Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices 106521 

Health, Labour, and Welfare; and the 

Japanese Pharmaceutical Manufacturers 

Association. The Standing Members of 

the ICH Association include Health 

Canada and Swissmedic. ICH 

membership continues to expand to 

include other regulatory authorities and 

industry associations from around the 

world (refer to https://www.ich.org). 

ICH works by engaging global 

regulatory and industry experts in a 

detailed, science-based, and consensusdriven process that results in the 

development of ICH guidelines. The 

regulators around the world are 

committed to consistently adopting 

these consensus-based guidelines, 

realizing the benefits for patients and for 

industry. 

As a Founding Regulatory Member of 

ICH, FDA plays a major role in the 

development of each of the ICH 

guidelines, which FDA then adopts and 

issues as guidance for industry. FDA’s 

guidance documents do not establish 

legally enforceable responsibilities. 

Instead, they describe the Agency’s 

current thinking on a topic and should 

be viewed only as recommendations, 

unless specific regulatory or statutory 

requirements are cited. 

In November 2024, the ICH Assembly 

endorsed the draft guideline entitled 

‘‘E6(R3) Good Clinical Practice: Annex 

2’’ and agreed that the guideline should 

be made available for public comment. 

The draft guideline is the product of the 

Efficacy Expert Working Group of the 

ICH. FDA and the Efficacy Expert 

Working Group will consider comments 

on this draft. 

The draft guidance provides guidance 

on good clinical practices for trial 

design and conduct, with a focus on 

trials with decentralized and pragmatic 

elements as well as trials that utilize 

real-world data. Since the original E6 

guidance was published in 1996, 

clinical trials have evolved significantly 

with new designs and technological 

innovations. Annex 2 provides 

additional considerations to the 

previously published draft guidance 

entitled ‘‘E6(R3) Good Clinical Practice 

(GCP),’’ which includes a Principles 

document and Annex 1. This draft 

guidance, entitled ‘‘E6(R3) Good 

Clinical Practice: Annex 2,’’ is intended 

to be read and implemented with E6(R3) 

Principles and Annex 1. 

This draft guidance has been left in 

the original ICH format. The final 

guidance will be reformatted and edited 

to conform with FDA’s good guidance 

practices regulation (21 CFR 10.115) and 

style before publication. The draft 

guidance, when finalized, will represent 

the current thinking of FDA on ‘‘E6(R3) 

Good Clinical Practice: Annex 2.’’ 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 Act of 1995 (44 U.S.C. 3501– 

3502). The collections of information in 

21 CFR part 312.145 pertaining to good 

clinical practices have been approved 

under OMB control number 0910–0014. 

The collections of information in 21 

CFR parts 50 and 56 pertaining to 

protection of human subjects, 

institutional review boards, and 

informed consent have been approved 

under OMB control number 0910–0130. 

The collections of information in 21 

CFR part 11 pertaining to electronic 

records and electronic signatures have 

been approved under OMB control 

number 0910–0303. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.regulations.gov, https://

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

guidances-drugs, https://www.fda.gov/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, or https:// 

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents. 

Dated: December 20, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–31275 Filed 12–27–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–5702] 

Transfer of Regulatory Responsibility 

From the Center for Devices and 

Radiological Health to the Center for 

Biologics Evaluation and Research; 

Medical Maggots and Medicinal 

Leeches 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; announcement of 

transfer. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

transfer of regulatory responsibility for 

medical maggots and medicinal leeches 

to the Center for Biologics Evaluation 

and Research (CBER). These products 

are currently regulated by the Center for 

Devices and Radiological Health 

(CDRH). FDA is transferring regulatory 

responsibility of these products to CBER 

because these products are living 

organisms that more closely align with 

products regulated by CBER. This action 

affects only Center assignment and does 

not change requirements applicable to 

these products. 

DATES: FDA is transferring regulatory 

responsibility to CBER on December 30, 

2024. 

FOR FURTHER INFORMATION CONTACT: 

Annette Marthaler, Office of 

Combination Products, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Silver Spring, MD 20993, 

301–796–8930, annette.marthaler@

fda.hhs.gov or combination@fda.gov. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing the transfer of regulatory 

responsibility for medical maggots 

(Phaenicia sericacta (blow fly) larvae) 

and medicinal leeches (Hirudo 

medicinalis) from CDRH to CBER. 

Medical maggots (including maggots 

and larvae) (product code NQK) (also 

referred to as maggot therapy) are 

harvested and provided disinfected for 

use in debriding non-healing necrotic 

skin and soft tissue wounds, including 

pressure ulcers, venous stasis ulcers, 

neuropathic foot ulcers, and nonhealing traumatic or post-surgical 

wounds. Medicinal leeches (product 

code NRN) belong to the Annelida 

worm classification. The animal is a 

bloodsucking aquatic animal living in 

fresh water indicated as an adjunct to 

graft tissue healing when problems of 

venous congestion may delay healing, or 

to overcome the problem of venous 

congestion by creating prolonged 

localized bleeding. 

FDA is transferring the regulatory 

responsibility for medical maggots and 

medicinal leeches to CBER so that these 

products are regulated by the same 

Center that regulates other living 

organisms for human use. The transfer 

will help ensure the consistent and 

effective regulation of products that are 

living organisms for human use. This 

transfer affects only Center assignment 

and does not change requirements 

applicable to these products. 

For the transferred products, 

submissions, communications, and 

required reports should be directed to 

CBER after December 30, 2024. CDRH 

will continue to handle submissions 


ddrumheller on DSK120RN23PROD with NOTICES1
106522 Federal Register / Vol. 89, No. 249 / Monday, December 30, 2024 / Notices 

received (including those under review 

or on hold) until the publication date of 

this Federal Register document for 

transferred products and, if applicable, 

until a final decision on the submission 

is reached. For questions on any 

submissions with CDRH, please contact 

CDRH Product Jurisdiction at 

CDRHProductJurisdiction@fda.hhs.gov. 

For questions on submissions to CBER, 

please contact 

CBERProductJurisdiction@fda.hhs.gov. 

Dated: December 20, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–31266 Filed 12–27–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–3248] 

Fosun Pharma USA Inc., et al.; 

Withdrawal of Approval of 23 

Abbreviated New Drug Applications; 

Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice that appeared in the Federal 

Register on July 29, 2024. The 

document announced the withdrawal of 

approval of 23 abbreviated new drug 

applications (ANDAs) from multiple 

applicants, withdrawn as of August 28, 

2024. The document indicated that FDA 

was withdrawing approval of the 

ANDAs 073462 for tolmetin sodium 

capsules, equivalent to (EQ) 400 

milligrams (mg) base; 073588 for 

tolmetin sodium tablets, EQ 200 mg 

base; 074002 for tolmetin sodium 

tablets, EQ 600 mg base; 077040 for 

citalopram hydrobromide tablets, EQ 10 

mg base, EQ 20 mg base; EQ 40 mg base; 

085787 for trifluoperazine 

hydrochloride (HCl) concentrate, EQ 10 

mg base/milliliters (mL); 086808 for 

cyproheptadine HCl tablets, 4 mg; 

087774 for phenylbutazone capsules, 

100 mg; and 088602 for 

pseudoephedrine HCl; triprolidine HCl 

tablets, 60 mg/2.5.mg, held by Fosun 

Pharma USA Inc., 104 Carnegie Center, 

Suite 204, Princeton, NJ 08540. 

Additionally, ANDAS 075631 for 

ketorolac tromethamine injectable, 15 

mg/mL and 30 mg/mL; 076427 for 

milrinone lactate injectable, EQ 1 mg 

base/mL; 076791 for haloperidol lactate 

injectable, EQ 5 mg base/mL; 076828 

haloperidol lactate injectable, EQ 5 mg 

base/mL; 077947 for fluconazole 

injectable, 200 mg/100 mL (2 mg/mL) 

and 400 mg/200 mL (2 mg/mL); 078197 

for granisetron HCl injectable, EQ 0.1 

mg base/mL (EQ 0.1 mg base/mL); 

091436 for levofloxacin injectable, EQ 

500 mg/20 mL (EQ 25 mg/mL); 207101 

for sumatriptan succinate injectable, EQ 

6 mg base/0.5 mL (EQ12 mg base/mL); 

and 215065 for methocarbamol solution, 

1gram/10 mL (100 mg/mL), held by 

Baxter Healthcare Corp., One Baxter 

Parkway, Deerfield, IL 60015; and the 

ANDAs 090367 for levofloxacin tablets, 

250 mg, 500 mg, 750 mg; and 211959 for 

clobazam tablets, 10 mg and 20 mg, held 

by Celltrion USA, Inc., U.S. Agent for 

Celltrion, Inc., One Evertrust Plaza, 

Suite 1207, Jersey City, NJ 07302; and 

the ANDA 212053 for chlorzoxazone 

tablet, 375 mg and 750 mg, held by i3 

Pharmaceuticals LLC, 200 Park Ave., 

Warminster, PA 18974. Before FDA 

withdrew the approval of these ANDAs, 

Fosun Pharma USA Inc.; Baxter 

Healthcare Corp.; Celltrion USA, Inc., 

U.S. Agent for Celltrion, Inc.; and i3 

Pharmaceuticals LLC, 200 Park Ave., 

Warminster, PA 18974, informed FDA 

that they did not want the approval of 

the ANDAs withdrawn. Because Fosun 

Pharma USA Inc.; Baxter Healthcare 

Corp.; Celltrion USA, Inc., U.S. Agent 

for Celltrion, Inc.; and i3 

Pharmaceuticals, LLC, timely requested 

that approval of their respective ANDAs 

not be withdrawn, the approvals are still 

in effect. This notice corrects these 

errors. 

FOR FURTHER INFORMATION CONTACT: 

Martha Nguyen, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1676, 

Silver Spring, MD 20993–0002, 301– 

796–3471, Martha.Nguyen@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of Monday, July 29, 

2024 (89 FR 60902), appearing on page 

60902 in FR Doc. 2024–16627, the 

following correction is made: 

On page 60902, in the table, the 

entries for ANDA 073462, ANDA 

073588, ANDA 074002, ANDA 075631, 

ANDA 076427, ANDA 076791, ANDA 

076828, ANDA 077040, ANDA 077947, 

ANDA 078197, ANDA 085787, ANDA 

086808, ANDA 087774, ANDA 088602, 

ANDA 090367, ANDA 091436 ANDA 

207101, ANDA 211959, ANDA 212053, 

and ANDA 215065 are removed. 

Dated: December 20, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–31307 Filed 12–27–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Update to the Health Resources and 

Services Administration-Supported 

Women’s Preventive Services 

Guidelines 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: The Health Resources and 

Services Administration (HRSA) 

published a Federal Register Notice on 

October 22, 2024, with proposed 

updates to the HRSA-supported 

Women’s Preventive Services 

Guidelines (Guidelines). The proposed 

updates specifically relate to 

recommendations for Screening and 

Counseling for Intimate Partner and 

Domestic Violence, Breast Cancer 

Screening for Women at Average Risk, 

and Patient Navigation Services for 

Breast and Cervical Cancer Screening. 

Recommendations to update the 

Guidelines are developed by the 

Women’s Preventive Services Initiative 

(WPSI) for consideration by HRSA. 

WPSI convenes expert health 

professionals to conduct rigorous 

reviews of the evidence following the 

National Academy of Medicine 

standards for establishing foundations 

for and rating strengths of 

recommendations, articulation of 

recommendations, and external reviews 

and it develops draft recommendations 

for HRSA’s consideration. After 

consideration of public comment, HRSA 

has accepted the recommendations as 

revised and detailed in this notice. 

Under applicable law, nongrandfathered group health plans and 

health insurance issuers offering nongrandfathered group and individual 

health insurance coverage must include 

coverage, without cost sharing, for 

certain preventive services, including 

those provided for in the HRSAsupported Guidelines. The Departments 

of Labor, Health and Human Services, 

and the Treasury have previously issued 

regulations describing how group health 

plans and health insurance issuers 

apply the coverage requirements. Please 

see https://www.hrsa.gov/womensguidelines for additional information. 

FOR FURTHER INFORMATION CONTACT: 

Kimberly Sherman, HRSA, Maternal 

and Child Health Bureau, telephone: 

(301) 443–2170, email: wellwomancare@

hrsa.gov. 


ddrumheller on DSK120RN23PROD with NOTICES1