Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ALHEMO (concizumab-mtci), 3880 [2025-00750]
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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
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18:37 Jan 14, 2025
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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:
The Food and Drug
Administration (FDA) is announcing the
Frm 00094
Fmt 4703
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.
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/.
SUPPLEMENTARY INFORMATION:
Dated: January 8, 2025.
P. Ritu Nalubola,
Associate Commissioner for Policy.
[FR Doc. 2025–00750 Filed 1–14–25; 8:45 am]
Notice.
SUMMARY:
PO 00000
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.
Sfmt 9990
BILLING CODE 4164–01–P
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]]>Agencies
[Federal Register Volume 90, Number 9 (Wednesday, January 15, 2025)]
[Notices]
[Page 3880]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-00750]
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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 (concizumab-mtci), 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/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/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
