Issuance of Priority Review Voucher; Rare Pediatric Disease Product, 28860 [2017-13236]
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28860
Federal Register / Vol. 82, No. 121 / Monday, June 26, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
530.22(b), Submission(s) of Analytical Method ...................
1 There
Dated: June 20, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–13296 Filed 6–23–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0809]
Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
Food and Drug Administration,
HHS.
ACTION:
2
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 (the 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 Brineura
(cerliponase alfa) manufactured by
Biomarin Pharmaceuticals Inc., meets
the criteria for a priority review
voucher.
SUMMARY:
1
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA has determined that Brineura
(cerliponase alfa) manufactured by
Biomarin Pharmaceuticals Inc., meets
the criteria for a priority review
voucher. Brineura (cerliponase alfa) is
indicated to slow the progression of loss
of ambulation in symptomatic pediatric
patients 3 years of age and older with
late infantile neuronal ceroid
lipofuscinosis type 2 (CLN2), also
known as tripeptidyl peptidase 1 (TPP1)
deficiency.
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/
DevelopingProductsf
orRareDiseasesConditions/
RarePediatricDisease
PriorityVoucherProgram/default.htm.
For further information about Brineura
(cerliponase alfa) go to the ‘‘Drugs@
FDA’’ Web site at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
Dated: June 20, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–13236 Filed 6–23–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–1066]
FOR FURTHER INFORMATION CONTACT:
sradovich on DSK3GMQ082PROD with NOTICES
Average
burden per
response
Total annual
responses
2
4,160
Total hours
8,320
are no capital costs or operating and maintenance costs associated with this collection of information.
The burden for this information
collection has not changed since the last
OMB approval.
AGENCY:
Number of
responses per
respondent
Number of
respondents
21 CFR section
Althea Cuff, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 6484, Silver Spring,
MD 20993–0002, 301–796–4061, FAX:
301–796–9858, email: althea.cuff@
fda.hhs.gov.
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Annual Reporting
for Custom Device Exemption
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
ACTION:
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
17:04 Jun 23, 2017
Jkt 241001
AGENCY:
Food and Drug Administration,
HHS.
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
SUMMARY:
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by July 26,
2017.
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 0910–0767. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, 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.
Annual Reporting for Custom Device
Exemption OMB Control Number 0910–
0767—Extension
The custom device exemption is set
forth at section 520(b)(2)(B) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 360j(b)(2)(B)).
A custom device is in a narrow category
of device that, by virtue of the rarity of
the patient’s medical condition or
physician’s special need the device is
designed to treat, it would be
impractical for the device to comply
with premarket review regulations and
performance standards.
The Food and Drug Administration
Safety and Innovation Act (FDASIA)
implemented changes to the custom
device exemption contained in section
520(b) of the FD&C Act. The new
provision amended the existing custom
device exemption and introduced new
concepts and procedures for custom
devices, such as:
• Devices created or modified in
order to comply with the order of an
individual physician or dentist;
E:\FR\FM\26JNN1.SGM
26JNN1
]]>Agencies
[Federal Register Volume 82, Number 121 (Monday, June 26, 2017)]
[Notices]
[Page 28860]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-13236]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-0809]
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 (the 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 Brineura (cerliponase alfa) manufactured by
Biomarin Pharmaceuticals Inc., 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., Bldg. 22, Rm. 6484, Silver Spring, MD 20993-0002, 301-
796-4061, FAX: 301-796-9858, email: althea.cuff@fda.hhs.gov.
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
Brineura (cerliponase alfa) manufactured by Biomarin Pharmaceuticals
Inc., meets the criteria for a priority review voucher. Brineura
(cerliponase alfa) is indicated to slow the progression of loss of
ambulation in symptomatic pediatric patients 3 years of age and older
with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also
known as tripeptidyl peptidase 1 (TPP1) deficiency.
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 Brineura (cerliponase alfa) go to the ``Drugs@FDA''
Web site at https://www.accessdata.fda.gov/scripts/cder/daf/.
Dated: June 20, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-13236 Filed 6-23-17; 8:45 am]
BILLING CODE 4164-01-P
