Issuance of Priority Review Voucher; Rare Pediatric Disease Product, 57864 [2020-20387]
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57864
Federal Register / Vol. 85, No. 180 / Wednesday, September 16, 2020 / Notices
Estimated Total Annual Burden
Hours: 6,160.
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: 42 U.S.C. 1397 through 1397e.
John M. Sweet Jr.,
ACF/OPRE Certifying Officer.
[FR Doc. 2020–20447 Filed 9–15–20; 8:45 am]
BILLING CODE 4184–24–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
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Dated: September 10, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–20387 Filed 9–15–20; 8:45 am]
BILLING CODE 4164–01–P
Notice.
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), 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
award of the priority review voucher.
FDA has determined that KOSELUGO
(selumetinib, AZD6244), manufactured
by AstraZeneca Pharmaceuticals, LP,
meets the criteria for a priority review
voucher.
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: 301–796–9856,
email: althea.cuff@fda.hhs.gov.
SUMMARY:
jbell on DSKJLSW7X2PROD with NOTICES
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), which was
added by FDASIA, FDA will award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA has determined that KOSELUGO
(selumetinib, AZD6244), manufactured
by AstraZeneca Pharmaceuticals, LP,
meets the criteria for a priority review
voucher.
KOSELUGO (selumetinib, AZD6244)
is indicated for the treatment of
pediatric patients 2 years of age and
older with neurofibromatosis type 1
who have symptomatic, inoperable
plexiform neurofibromas.
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 KOSELUGO
(selumetinib, AZD6244), go to the
‘‘Drugs@FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
18:20 Sep 15, 2020
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–D–1621]
Geriatric Information in Human
Prescription Drug and Biological
Product Labeling; Draft Guidance for
Industry; Availability
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice of availability.
AGENCY:
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Geriatric
Information in Human Prescription
Drug and Biological Product Labeling.’’
This draft guidance is intended to assist
applicants of human prescription drug
and biological products in determining
the appropriate placement and content
of geriatric information in labeling. The
goal of this draft guidance is to provide
SUMMARY:
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Fmt 4703
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recommendations to help ensure that
appropriate information on the use of
prescription drugs and biological
products in geriatric patients is
consistently placed in the proper
sections and subsections within labeling
so that the information is clear and
accessible to health care practitioners
and includes content that guides the
safe and effective use in geriatric
patients. This draft guidance provides
additional examples of geriatric use
statements in labeling and examples of
when the labeling regulations authorize
FDA to permit applicants to omit or
revise specific information otherwise
required in the Geriatric Use subsection.
We are withdrawing the guidance for
industry entitled ‘‘Content and Format
for Geriatric Labeling’’ (October 2001)
and replacing it with this draft
guidance.
Submit either electronic or
written comments on the draft guidance
by November 16, 2020 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
DATES:
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
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manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
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written/paper submissions): Dockets
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]]>Agencies
[Federal Register Volume 85, Number 180 (Wednesday, September 16, 2020)]
[Notices]
[Page 57864]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20387]
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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
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), 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 award of the priority review voucher. FDA has determined
that KOSELUGO (selumetinib, AZD6244), manufactured by AstraZeneca
Pharmaceuticals, LP, meets the criteria for a priority review voucher.
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-
796-9856, email: [email protected].
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), which was added by FDASIA, FDA will award priority review
vouchers to sponsors of approved rare pediatric disease product
applications that meet certain criteria. FDA has determined that
KOSELUGO (selumetinib, AZD6244), manufactured by AstraZeneca
Pharmaceuticals, LP, meets the criteria for a priority review voucher.
KOSELUGO (selumetinib, AZD6244) is indicated for the treatment of
pediatric patients 2 years of age and older with neurofibromatosis type
1 who have symptomatic, inoperable plexiform neurofibromas.
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 KOSELUGO (selumetinib, AZD6244), go to the
``[email protected]'' website at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: September 10, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-20387 Filed 9-15-20; 8:45 am]
BILLING CODE 4164-01-P
