3880 Federal Register / Vol. 90, No. 9 / Wednesday, January 15, 2025 / Notices 

Please explain and specify which 

characteristics differ. 

4.a. Membrane filtration (often 

ultrafiltration) can be used to 

concentrate milk prior to culturing. 

What are the specifications of the 

ultrafiltered milk (e.g., concentration 

factors; filtered milk pH; compositions, 

such as total solids, protein, lactose, fat, 

minerals, vitamins; other pertinent 

information) used to manufacture highprotein yogurt? 

4.b. Straining after culturing removes 

a portion of the liquid whey from the 

cultured yogurt to increase protein 

content in the finished yogurt product. 

What is the concentration factor or 

weight ratio of liquid whey versus 

concentrated yogurt after straining? 

What are important processing 

parameters, such as temperature, during 

the straining process? What are the 

characteristics of the liquid whey from 

the yogurt straining process and the 

concentrated yogurt (e.g., pH; levels of 

live cultures; compositions, including 

total solids, total protein, whey protein, 

casein, lactose, fat, minerals, vitamins; 

other pertinent information)? 

4.c. Membrane filtration of yogurt 

after culturing removes liquid whey to 

concentrate yogurt. What is the typical 

concentration factor or weight ratio of 

permeate (liquid whey) versus retentate 

(concentrated yogurt) after membrane 

filtration? What are important 

processing parameters, such as 

temperature, during the membrane 

filtration process? What are the 

characteristics of the liquid whey and 

concentrated yogurt after membrane 

filtration (e.g., pH; levels of live 

cultures; compositions, including total 

solids, total protein, whey protein, 

casein, lactose, fat, minerals, vitamins; 

other pertinent information)? 

4.d. Dairy protein fortification can 

also be used to increase the protein level 

in yogurt. Please describe the types of 

protein ingredient(s) (e.g., whey protein, 

casein protein, milk protein, caseinate) 

added during the manufacturing process 

to increase the protein level in yogurt. 

How are the dairy protein ingredients 

added (e.g., timing of the addition 

during processing, amounts added)? 

How are the characteristics of yogurts 

impacted by fortifying with different 

types of protein ingredients? Please 

explain and provide data (e.g., pH, 

sensory properties, levels of live 

cultures, composition) to compare the 

yogurts made by fortifying with 

different types of protein ingredients. 

5. As indicated earlier in this 

document, high-protein yogurt is also 

known as or referred to under different 

names, such as Greek yogurt and Greekstyle yogurt. Please provide relevant 

data and information regarding usage of 

the various names for high-protein 

yogurt (e.g., Greek yogurt and Greekstyle yogurt). Please also provide 

relevant data and information regarding 

the inclusion of the manufacturing 

process in the names for high-protein 

yogurt (e.g., ‘‘strained yogurt,’’ ‘‘strained 

Greek yogurt,’’ ‘‘ultrafiltered yogurt’’). 

Examples of relevant data and 

information may include specific firm 

practices, trade conventions, and 

consumer studies. 

III. References 

The following references marked with 

an asterisk (*) are on display at the 

Dockets Management Staff (see 

ADDRESSES) and are available for 

viewing by interested persons between 

9 a.m. and 4 p.m., Monday through 

Friday; they also are available 

electronically at https://

www.regulations.gov. References 

without asterisks are not on public 

display at https://www.regulations.gov 

because they have copyright restriction. 

Some may be available at the website 

address, if listed. References without 

asterisks are available for viewing only 

at the Dockets Management Staff. 

Although FDA verified the website 

addresses in this document, please note 

that websites are subject to change over 

time. 

1. Chandan, R.C. and A. Kilara, editors, 2013, 

Manufacturing Yogurt and Fermented 

Milks, Second Edition, John Wiley & 

Sons, Inc. Available at https://doi.org/ 

10.1002/9781118481301. 

2. *J<rgensen, C.E., R.K. Abrahamsen, E. 

Rukke, et al. ‘‘Processing High-Protein 

Yoghurt—A Review,’’ International 

Dairy Journal, 88: 42–59, 2019. Available 

at https://doi.org/10.1016/ 

j.idairyj.2018.08.002. 

Dated: January 8, 2025. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2025–00754 Filed 1–14–25; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–0026] 

Issuance of Priority Review Voucher; 

Rare Pediatric Disease Product; 

ALHEMO (concizumab-mtci) 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

issuance of a priority review voucher to 

the sponsor of a rare pediatric disease 

product application. The Federal Food, 

Drug, and Cosmetic Act (FD&C Act) 

authorizes FDA to award priority review 

vouchers to sponsors of approved rare 

pediatric disease product applications 

that meet certain criteria. FDA is 

required to publish notice of the award 

of the priority review voucher. FDA has 

determined that ALHEMO (concizumabmtci), approved on December 20, 2024, 

manufactured by Novo Nordisk, Inc., 

meets the criteria for a priority review 

voucher. 

FOR FURTHER INFORMATION CONTACT: 

Cathryn Lee, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–1394. 

SUPPLEMENTARY INFORMATION: FDA is 

announcing the issuance of a priority 

review voucher to the sponsor of an 

approved rare pediatric disease product 

application. Under section 529 of the 

FD&C Act (21 U.S.C. 360ff), FDA will 

award priority review vouchers to 

sponsors of approved rare pediatric 

disease product applications that meet 

certain criteria. FDA has determined 

that ALHEMO (concizumab-mtci), 

manufactured by Novo Nordisk, Inc., 

meets the criteria for a priority review 

voucher. ALHEMO (concizumab-mtci) 

injection is indicated for routine 

prophylaxis to prevent or reduce the 

frequency of bleeding episodes in adult 

and pediatric patients 12 years of age 

and older with hemophilia A 

(congenital factor VIII deficiency) with 

FVIII inhibitors and hemophilia B 

(congenital factor IX deficiency) with 

FIX inhibitors. 

For further information about the Rare 

Pediatric Disease Priority Review 

Voucher Program and for a link to the 

full text of section 529 of the FD&C Act, 

go to https://www.fda.gov/ForIndustry/ 

DevelopingProductsforRareDiseases

Conditions/RarePediatricDiseasePriority

VoucherProgram/default.htm. For 

further information about ALHEMO 

(concizumab-mtci), go to the ‘‘Drugs@

FDA’’ website at https://

www.accessdata.fda.gov/scripts/cder/ 

daf/. 

Dated: January 8, 2025. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2025–00750 Filed 1–14–25; 8:45 am] 

BILLING CODE 4164–01–P 


lotter on DSK11XQN23PROD with NOTICES1