Notice of Approval of Product U nder Voucher: Rare Pediatric Disease Priority Review Voucher, 33163 [2020-11681]
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Federal Register / Vol. 85, No. 105 / Monday, June 1, 2020 / Notices
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SUPPLEMENTARY INFORMATION:
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FOR FURTHER INFORMATION CONTACT:
I. Background
In the Federal Register of March 12,
2018 (83 FR 10732), FDA published the
notice of availability for a draft guidance
entitled ‘‘Proprietary Names for New
Animal Drugs,’’ giving interested
persons until May 11, 2018, to comment
on the draft guidance. FDA received
comments on the draft guidance, and
those comments were considered as the
guidance was finalized. Changes made
include revisions to the definitions. In
VerDate Sep<11>2014
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addition, editorial changes were made
to improve clarity. The guidance
announced in this notice finalizes the
draft guidance dated March 2018.
II. Significance of Guidance
This level 1 guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on proprietary names
for new animal drugs. 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.
III. Paperwork Reduction Act of 1995
FDA concludes that there are no
collections of information under the
Paperwork Reduction Act of 1995. This
guidance refers to previously approved
collections of information found in FDA
regulations. These collections of
information are 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
collections of information in 21 CFR
part 514 have been approved under
OMB control numbers 0910–0032 and
0910–0699; the collections of
information in 21 CFR part 511 have
been approved under OMB control
number 0910–0117.
IV. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm or
https://www.regulations.gov.
Dated: May 26, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–11679 Filed 5–29–20; 8:45 am]
BILLING CODE 4164–01–P
33163
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
NURTEC ODT (rimegepant), approved
February 27, 2020, 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 NURTEC ODT
(rimegepant), approved February 27,
2020, 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/
DevelopingProductsforRare
DiseasesConditions/RarePediatric
DiseasePriorityVoucherProgram/
default.htm. For further information
about NURTEC ODT (rimegepant),
approved February 27, 2020, go to the
‘‘Drugs@FDA’’ website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
Dated: May 26, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–11681 Filed 5–29–20; 8:45 am]
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.
The Food and Drug
Administration (FDA) is announcing the
issuance of approval of a product
redeeming a priority review voucher.
SUMMARY:
PO 00000
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BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–0837]
Rare Disease Clinical Trial Networks;
Request for Information and
Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; request for information
and comments.
ACTION:
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[Federal Register Volume 85, Number 105 (Monday, June 1, 2020)]
[Notices]
[Page 33163]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-11681]
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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 NURTEC ODT (rimegepant), approved February 27, 2020,
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 NURTEC ODT
(rimegepant), approved February 27, 2020, 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 NURTEC ODT (rimegepant), approved February 27, 2020,
go to the ``[email protected]'' website at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: May 26, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-11681 Filed 5-29-20; 8:45 am]
BILLING CODE 4164-01-P
