3878 Federal Register / Vol. 90, No. 9 / Wednesday, January 15, 2025 / Notices 

TABLE 1—NDAS FOR WHICH APPROVAL IS WITHDRAWN—Continued 

Application No. Drug Applicant 

NDA 211172 .......... Tegsedi (inotersen sodium) Solution for Injection, EQ 284 

mg base/1.5 mL.

Akcea Therapeutics, Inc., 2850 Gazelle Ct., Carlsbad, CA 

92010. 

NDA 212640 .......... Exservan (riluzole) Oral Film, 50 mg ..................................... Aquestive Therapeutics, 30 Technology Dr., Warren, NJ 

07059. 

NDA 213426 .......... Seglentis (celecoxib and tramadol HCl) 56 mg; 44 mg ......... Kowa Pharmaceuticals America, Inc., 530 Industrial Park 

Blvd., Montgomery, AL 36117. 

Therefore, approval of the 

applications listed in table 1, and all 

amendments and supplements thereto, 

is hereby withdrawn as of February 14, 

2025. Approval of each entire 

application is withdrawn, including any 

strengths and dosage forms included in 

the application but inadvertently 

missing from table 1. Introduction or 

delivery for introduction into interstate 

commerce of products listed in table 1 

without an approved NDA violates 

sections 505(a) and 301(d) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(a) and 331(d)). Drug products that 

are listed in table 1 that are in inventory 

on February 14, 2025 may continue to 

be dispensed until the inventories have 

been depleted or the drug products have 

reached their expiration dates or 

otherwise become violative, whichever 

occurs first. 

Dated: January 6, 2025. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2025–00743 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–2024–N–5716] 

High-Protein Yogurt; Request for 

Information 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for information. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

requesting information and data about 

the manufacturing processes and 

ingredients used to make certain dairy 

products referred to as high-protein 

yogurt, Greek yogurt, or Greek-style 

yogurt in this document. We are taking 

this action, in part, because the yogurt 

standard of identity may not align with 

certain manufacturing processes and 

ingredients used to concentrate protein 

to manufacture these products. We 

intend to use the information and data 

to help determine what type(s) of 

actions, if any, should be taken. 

DATES: Either electronic or written 

comments on the notice must be 

submitted by April 15, 2025. 

ADDRESSES: You may submit comments 

and information as follows. Please note 

that late, untimely filed comments will 

not be considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

April 15, 2025. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are received on or before 

that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

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

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment 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 

comments, that information will be 

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

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• 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 written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2024–N–5716 for ‘‘High-Protein Yogurt; 

Request for Information.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), 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 a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments 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.’’ We 

will review this copy, including the 

claimed confidential information, in our 

consideration of comments. 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. 

If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ 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://


lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 90, No. 9 / Wednesday, January 15, 2025 / Notices 3879 

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

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. 

FOR FURTHER INFORMATION CONTACT: Yan 

Peng, Office of Nutrition and Food 

Labeling, Human Foods Program, Food 

and Drug Administration, 5001 Campus 

Dr., College Park, MD 20740, 240–402– 

2371, or Holli Kubicki, Office of Policy, 

Regulations, and Information, Human 

Foods Program, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–2378. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Federal Food, Drug, and Cosmetic 

Act (FD&C Act) gives FDA the authority 

to establish definitions and standards of 

identity (SOIs) for foods whenever such 

action would promote honesty and fair 

dealing in the interest of consumers (see 

section 401 of the FD&C Act (21 U.S.C. 

341)). SOIs specify the ingredients, both 

mandatory and optional, of a 

standardized food, and sometimes 

describe the amount or proportion of 

each ingredient. Many SOIs also 

prescribe a method of production. 

The yogurt SOI is stated at 21 CFR 

131.200. There is not a separate SOI for 

high-protein yogurt, Greek yogurt, or 

Greek-style yogurt. For purposes of this 

document, high-protein yogurt, Greek 

yogurt, or Greek-style yogurt 

(collectively referred to in this 

document as ‘‘high-protein yogurt’’) 

generally refers to a dairy product 

cultured with, at minimum, 

Lactobacillus delbrueckii, subspecies 

bulgaricus, and Streptococcus 

thermophilus, which has undergone a 

manufacturing method to increase the 

protein level. 

In recent years, the yogurt industry 

has raised concerns that the existing, 

single yogurt SOI does not 

accommodate the current practices or 

technologies to manufacture highprotein yogurt. Specifically, FDA 

received comments from the yogurt 

industry during the FDA 2019 Public 

Meeting on Horizontal Approaches to 

Food Standards of Identity 

Modernization (84 FR 45497, August 29, 

2019 (Docket No. FDA–2018–N–2381)), 

and after the reopening of comments on 

the FDA 2005 proposed rule titled Food 

Standards; General Principles and Food 

Standards Modernization (85 FR 10107, 

February 21, 2020 (Docket No. FDA– 

1995–N–0062)), advocating for an 

additional SOI for strained, high-protein 

yogurt (which some comments referred 

to as Greek yogurt). The comments 

stated that a new SOI for strained, highprotein yogurt should include language 

that describes the authentic straining 

process, the characteristics of the 

product, and the distinguishing 

compositional nutritional elements of 

the product. 

We understand that since highprotein yogurt was introduced to the 

U.S. market, this category continues to 

expand substantially in product 

availability and variety, along with 

innovations in formulations and 

manufacturing processes. 

We also understand that there are 

different methods used by industry to 

increase the protein level of yogurt, 

some of which may not be consistent 

with the yogurt SOI. One method is to 

concentrate yogurt after culturing to 

remove liquid whey by a straining 

process (Refs. 1 and 2). The straining 

process can be done in a traditional way 

using cheesecloth, but is more 

commonly done commercially using a 

centrifugal separator (Refs. 1 and 2). 

Many yogurt manufacturers that use the 

straining process to make high-protein 

yogurt add cream after culturing and 

straining to achieve the desired fat 

content specified for the product. These 

manufacturers state that cream must be 

added after culturing and straining due 

to a variety of challenges that occur if 

cream is added before culturing, 

including reduced production efficiency 

due to clogging of centrifugal separators 

by fat, loss of fat in acid whey, and 

reduced ability to recycle acid whey 

with high fat content. 

Another method is the addition of 

milk-protein ingredients to milk prior to 

culturing (Refs. 1 and 2). This method 

is also known as the protein-fortified 

method, which allows for the 

production of high-protein yogurt on the 

same processing equipment used for 

yogurt not fortified with milk-protein 

ingredients, without the need for liquid 

whey removal after culturing (Refs. 1 

and 2). 

Yet another method is to concentrate 

protein in milk before or after culturing 

(e.g., membrane ultrafiltration (Refs. 1 

and 2)). (We note that FDA granted a 

temporary permit to Chobani to market 

test certain yogurt products deviating 

from the yogurt SOI by using 

ultrafiltered nonfat milk as a basic dairy 

ingredient before culturing (88 FR 

18322, March 28, 2023). 

II. Issues for Consideration and Request 

for Information 

FDA is issuing this request for 

information to better understand the 

current marketplace for high-protein 

yogurt products. In particular, FDA is 

interested in information that would 

help us determine whether there is a 

need for updating an existing, or 

establishing a new standard of identity 

for these products to promote honesty 

and fair dealing in the interest of 

consumers. We also request information 

and data about the various 

manufacturing processes and 

ingredients used to make high-protein 

yogurt. We specifically invite comment 

in response to the questions below. 

Please explain your answers and 

provide references and data, if possible. 

1. We seek input from all interested 

parties related to consumers’ 

understanding and expectations of highprotein yogurt, and the current industry 

practices and innovations. We are also 

interested in data and other information 

regarding usage of the various names for 

high-protein yogurt. 

2. If pasteurized cream is added after 

culturing, please specify the point at 

which cream is added during the 

manufacturing process (e.g., time, 

temperature, pH). What are the typical 

amount and the effects of adding 

pasteurized cream after culturing on 

yogurt attributes that are required by the 

SOI (e.g., pH, milk solids not fat level, 

level of live cultures, including 

Lactobacillus delbrueckii subsp. 

bulgaricus and Streptococcus 

thermophilus)? Please specify with data. 

What adjustments are needed, if any, to 

meet the levels required by the yogurt 

SOI? 

3. How are the characteristics of 

yogurt impacted by the point at which 

cream is added during the 

manufacturing process relative to 

culturing (i.e., adding cream to milk 

before culturing compared to adding 

cream after culturing)? Please explain 

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

properties, compositions, levels of live 

cultures) to compare the yogurt made by 

adding cream before culturing versus 

adding cream after culturing. 

4. There are different ways to achieve 

high-protein content in high-protein 

yogurt, such as membrane concentration 

of milk protein before culturing, 

straining of cultured yogurt after 

culturing, membrane separation of 

yogurt after culturing, or milk protein 

fortification. How do the high-protein 

yogurts made with these different 

processes differ in characteristics (e.g., 

pH, sensory properties, compositions, 

levels of live cultures, nutrient profile)? 


lotter on DSK11XQN23PROD with NOTICES1
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