Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher, 25815 [2019-11522]
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Federal Register / Vol. 84, No. 107 / Tuesday, June 4, 2019 / Notices
khammond on DSKBBV9HB2PROD with NOTICES
CONFIDENTIAL INFORMATION.’’ The
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except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
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the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
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received, go to https://
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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copies of the draft guidance to the
Center for Food Safety and Applied
Nutrition, Food and Drug
Administration, 5001 Campus Dr.,
College Park, MD 20740. Send two selfaddressed adhesive labels to assist that
office in processing your request. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance.
FOR FURTHER INFORMATION CONTACT:
Fazila Shakir, Center for Food Safety
and Applied Nutrition, Food and Drug
Administration, 5001 Campus Dr.,
College Park, MD 20740, 240–402–1355.
SUPPLEMENTARY INFORMATION:
I. Background
We are announcing the availability of
a draft guidance for industry entitled
‘‘Evaluating Alternate Curricula for the
Growing, Harvesting, Packing, and
Holding of Produce for Human
Consumption: Guidance for Industry.’’
We are issuing the draft guidance
consistent with our good guidance
practices regulation (21 CFR 10.115).
VerDate Sep<11>2014
17:16 Jun 03, 2019
Jkt 247001
The draft guidance, when finalized, will
represent the current thinking of FDA
on this topic. It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternate approach if it satisfies the
requirements of the applicable statutes
and regulations. This guidance is not
subject to Executive Order 12866.
The Produce Safety Rule established
science-based minimum standards for
the safe growing, harvesting, packing,
and holding of produce grown for
human consumption. Subpart C of the
rule includes the specific requirements
for personnel qualifications and
training, including the requirement for
at least one supervisor or responsible
party from a farm to successfully
complete food safety training at least
equivalent to that received under the
standardized curriculum recognized as
adequate by FDA (§ 112.22(c) (21 CFR
112.22(c))). For farms covered by the
Produce Safety Rule, version 1.1 of the
standardized curriculum developed by
the Produce Safety Alliance is adequate
as the standardized curriculum in
§ 112.22(c). The purpose of this draft
guidance is to provide
recommendations on the factors that
covered farms should consider if they
are using an alternate curriculum
training to satisfy the requirements of
§ 112.22(c) and for educators when
developing or evaluating alternate
curricula.
II. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/food/guidanceregulation-food-and-dietarysupplements/guidance-documentsregulatory-information-topic-food-anddietary-supplements or https://
www.regulations.gov. Use the FDA
website listed in the previous sentence
to find the most current version of the
guidance.
Dated: May 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–11603 Filed 6–3–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
issuance of approval of a product
redeeming a priority review voucher.
The Federal Food, Drug, and Cosmetic
Act (FD&C Act), as amended by the
Food and Drug Administration Safety
and Innovation Act (FDASIA),
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
issuance of vouchers as well as the
approval of products redeeming a
voucher. FDA has determined that
MAYZENT (siponimod) approved
March 26, 2019, meets the redemption
criteria.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Althea Cuff, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–4061, Fax: 301–796–9858,
email: althea.cuff@fda.hhs.gov.
Under
section 529 of the FD&C Act (21 U.S.C.
360ff), which was added by FDASIA,
FDA will report the issuance of rare
pediatric disease priority review
vouchers and the approval of products
for which a voucher was redeemed.
FDA has determined that MAYZENT
(siponimod), approved March 26, 2019,
meets the redemption criteria.
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 MAYZENT
(siponimod) approved March 26, 2019,
go to the ‘‘Drugs@FDA’’ website at
https://www.accessdata.fda.gov/scripts/
cder/daf/.
SUPPLEMENTARY INFORMATION:
Dated: May 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–11522 Filed 6–3–19; 8:45 am]
BILLING CODE 4164–01–P
[Docket No. FDA–2018–N–1262]
Notice of Approval of Product Under
Voucher: Rare Pediatric Disease
Priority Review Voucher
AGENCY:
Food and Drug Administration,
HHS.
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[Federal Register Volume 84, Number 107 (Tuesday, June 4, 2019)]
[Notices]
[Page 25815]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11522]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1262]
Notice of Approval of Product Under Voucher: Rare Pediatric
Disease Priority Review Voucher
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
issuance of approval of a product redeeming a priority review voucher.
The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the
Food and Drug Administration Safety and Innovation Act (FDASIA),
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 issuance of vouchers
as well as the approval of products redeeming a voucher. FDA has
determined that MAYZENT (siponimod) approved March 26, 2019, meets the
redemption criteria.
FOR FURTHER INFORMATION CONTACT: Althea Cuff, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4061, Fax: 301-
796-9858, email: [email protected].
SUPPLEMENTARY INFORMATION: Under section 529 of the FD&C Act (21 U.S.C.
360ff), which was added by FDASIA, FDA will report the issuance of rare
pediatric disease priority review vouchers and the approval of products
for which a voucher was redeemed. FDA has determined that MAYZENT
(siponimod), approved March 26, 2019, meets the redemption criteria.
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 MAYZENT (siponimod) approved March 26, 2019, go to
the ``[email protected]'' website at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: May 29, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-11522 Filed 6-3-19; 8:45 am]
BILLING CODE 4164-01-P
