Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher, 68462 [2019-27054]
Download as PDF
<![CDATA[
68462
Federal Register / Vol. 84, No. 241 / Monday, December 16, 2019 / Notices
Radiological Health oversight, which are
not addressed in section 507.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on ‘‘Qualification Process for Drug
Development Tools.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This draft guidance contains
information collection that is subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3521). The information collection has
been approved under OMB control
numbers 0910–0001 and 0910–0014.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics, or https://
www.regulations.gov.
Dated: December 11, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–26994 Filed 12–13–19; 8:45 am]
BILLING CODE 4164–01–P
issuance of vouchers as well as the
approval of products redeeming a
voucher. FDA has determined that
BEOVU (brolucizumab-dbll), approved
October 7, 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: althea.cuff@fda.hhs.gov.
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 BEOVU
(brolucizumab-dbll), approved October
7, 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/
DevelopingProductsfor
RareDiseasesConditions/
RarePediatricDiseasePriority
VoucherProgram/default.htm. For
further information about BEOVU
(brolucizumab-dbll), approved October
7, 2019, go to the ‘‘Drugs@FDA’’ website
at https://www.accessdata.fda.gov/
scripts/cder/daf/.
Dated: December 9, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–27054 Filed 12–13–19; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4164–01–P
Food and Drug Administration
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2018–N–1262]
Food and Drug Administration
Notice of Approval of Product Under
Voucher: Rare Pediatric Disease
Priority Review Voucher
AGENCY:
[Docket No. FDA–2019–N–3077]
Food and Drug Administration,
HHS.
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
lotter on DSKBCFDHB2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:21 Dec 13, 2019
Jkt 250001
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Obtaining
Information To Understand Challenges
and Opportunities Encountered by
Compounding Outsourcing Facilities
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
SUMMARY:
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
the Paperwork Reduction Act of 1995
(PRA).
DATES: Fax written comments on the
collection of information by January 15,
2020.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910-New and
title ‘‘Obtaining Information to
Understand Challenges and
Opportunities Encountered by
Compounding Outsourcing Facilities’’.
Also include the FDA docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Obtaining Information To Understand
Challenges and Opportunities
Encountered by Compounding
Outsourcing Facilities
OMB Control Number 0910–NEW
This information collection supports
Agency-sponsored research. Drug
compounding is generally the practice
of combining, mixing, or altering
ingredients of a drug to create a
medication tailored to the needs of an
individual patient. Although
compounded drugs can serve an
important medical need for certain
patients when an approved drug is not
medically appropriate, they also present
a risk to patients. Compounded drugs
are not FDA-approved. Therefore, they
do not undergo premarket review by
FDA for safety, effectiveness, and
quality. Since compounded drugs are
subject to a lower regulatory standard
than approved drugs, Federal law places
conditions on compounding that are
designed to protect the public health.
The Drug Quality and Security Act of
2013 created ‘‘outsourcing facilities’’—a
new industry sector of drug
compounders held to higher quality
standards to protect patient health.
Outsourcing facilities are intended to
offer a more reliable supply of
E:\FR\FM\16DEN1.SGM
16DEN1
]]>Agencies
[Federal Register Volume 84, Number 241 (Monday, December 16, 2019)]
[Notices]
[Page 68462]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27054]
-----------------------------------------------------------------------
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 BEOVU (brolucizumab-dbll), approved October 7, 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 BEOVU
(brolucizumab-dbll), approved October 7, 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 BEOVU (brolucizumab-dbll), approved October 7, 2019,
go to the ``[email protected]'' website at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: December 9, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-27054 Filed 12-13-19; 8:45 am]
BILLING CODE 4164-01-P
