83 FR 59386 - Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 226 (November 23, 2018)

Page Range		59386-59386
FR Document		2018-25480

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 AJOVY (fremanezumab-vfrm), approved September 14, 2018, meets the redemption criteria.

Federal Register, Volume 83 Issue 226 (Friday, November 23, 2018)

[Federal Register Volume 83, Number 226 (Friday, November 23, 2018)]
[Notices]
[Page 59386]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-25480]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1262]


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 AJOVY (fremanezumab-vfrm), approved September 14, 2018, 
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 AJOVY 
(fremanezumab-vfrm), approved September 14, 2018, 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 AJOVY (fremanezumab-vfrm) go to the ``Drugs@FDA'' 
website at https://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: November 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-25480 Filed 11-21-18; 8:45 am]
BILLING CODE 4164-01-P

59386 Federal Register / Vol. 83, No. 226 / Friday, November 23, 2018 / Notices

ACF to fulfill the ongoing legislative specified in the Foster Care leaders, partners and stakeholders, and
mandate for program evaluation Independence Act of 1999. front-line staff as well as young adults
Respondents: Semi-structured being served by the programs.
interviews will be held with program
ANNUAL BURDEN ESTIMATES
Annual Number of Average
Total number Annual burden
Instrument number of responses per burden hours
of respondents hours
respondents respondent per response

Outreach email for discussion with program administrators
and staff ............................................................................ 16 8 1 8 64
Outreach email for Focus Group Recruiters ....................... 12 6 1 8 48
Discussion Guide for program leaders ................................ 48 24 4 1 96
Discussion Guide for program partners and stakeholders .. 60 30 2 1 60
Discussion Guide for program front-line staff ...................... 104 52 1 1 52
Focus Group Guide for program participants ...................... 160 80 1 2 160
Compilation and Submission of Administrative Data Files .. 48 24 2 12 576

Estimated Total Annual Burden SUMMARY: The Food and Drug www.accessdata.fda.gov/scripts/cder/
Hours: 1,056. Administration (FDA) is announcing the daf/.
Additional Information: Copies of the issuance of approval of a product Dated: November 16, 2018.
proposed collection may be obtained by redeeming a priority review voucher. Leslie Kux,
writing to the Administration for The Federal Food, Drug, and Cosmetic
Associate Commissioner for Policy.
Children and Families, Office of Act (FD&C Act), as amended by the
Planning, Research and Evaluation, 330 [FR Doc. 2018–25480 Filed 11–21–18; 8:45 am]
Food and Drug Administration Safety
C Street SW, Washington, DC 20201, and Innovation Act (FDASIA), BILLING CODE 4164–01–P

Attn: OPRE Reports Clearance Officer. authorizes FDA to award priority review
All requests should be identified by the vouchers to sponsors of approved rare
title of the information collection. Email DEPARTMENT OF HEALTH AND
pediatric disease product applications
address: OPREinfocollection@ HUMAN SERVICES
that meet certain criteria. FDA is
acf.hhs.gov. required to publish notice of the Notice of Request for Information; A
OMB Comment: OMB is required to issuance of vouchers as well as the Notice by the Presidential Advisory
make a decision concerning the approval of products redeeming a Council on Combating Antibiotic-
collection of information between 30 voucher. FDA has determined that Resistant Bacteria
and 60 days after publication of this AJOVY (fremanezumab-vfrm), approved
document in the Federal Register. September 14, 2018, meets the AGENCY: Office of the Assistant
Therefore, a comment is best assured of redemption criteria. Secretary for Health, Office of the
having its full effect if OMB receives it FOR FURTHER INFORMATION CONTACT:
Secretary, Department of Health and
within 30 days of publication. Written Althea Cuff, Center for Drug Evaluation Human Services.
comments and recommendations for the and Research, Food and Drug ACTION: Notice.
proposed information collection should Administration, 10903 New Hampshire
be sent directly to the following: Office SUMMARY: The Presidential Advisory
Ave., Silver Spring, MD 20993–0002, Council on Combating Antibiotic-
of Management and Budget, Paperwork 301–796–4061, Fax: 301–796–9858,
Reduction Project, Email: OIRA_ Resistant Bacteria (Advisory Council)
email: althea.cuff@fda.hhs.gov. requests information from the general
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for SUPPLEMENTARY INFORMATION: Under public and stakeholders related to
Children and Families. section 529 of the FD&C Act (21 U.S.C. efforts and strategies to combat
360ff), which was added by FDASIA, Antibiotic Resistance (AR). Given the
Mary B. Jones, FDA will report the issuance of rare evolution of AR and the long-term
ACF/OPRE Certifying Officer. pediatric disease priority review nature of the problem, the Secretary of
[FR Doc. 2018–25548 Filed 11–21–18; 8:45 am] vouchers and the approval of products Health and Human Services (HHS)
BILLING CODE 4184–01–P for which a voucher was redeemed. tasked the Advisory Council with
FDA has determined that AJOVY identifying significant areas that have
(fremanezumab-vfrm), approved emerged since the release of the
DEPARTMENT OF HEALTH AND September 14, 2018, meets the National Action Plan (NAP) for
HUMAN SERVICES redemption criteria. Combatting Antibiotic-Resistant
For further information about the Rare Bacteria (CARB) in 2015. To aid in the
Food and Drug Administration Pediatric Disease Priority Review process of developing its response to the
[Docket No. FDA–2018–N–1262] Voucher Program and for a link to the Secretary’s task, the Advisory Council
full text of section 529 of the FD&C Act, has posted this Request for Information
amozie on DSK3GDR082PROD with NOTICES1

Approval of Product Under Voucher: go to https://www.fda.gov/ForIndustry/ (RFI) to hear from a wide range of
Rare Pediatric Disease Priority Review DevelopingProductsforRareDiseases stakeholders and sectors relevant to the
Voucher Conditions/RarePediatricDiseasePriority overall CARB effort. This RFI offers the
AGENCY: Food and Drug Administration, VoucherProgram/default.htm. For opportunity for the public, including
HHS. further information about AJOVY interested individuals, organizations,
(fremanezumab-vfrm) go to the ‘‘Drugs@ associations, industries, and others, to
ACTION: Notice.
FDA’’ website at https:// provide their input on new priority

VerDate Sep<11>2014 18:33 Nov 21, 2018 Jkt 247001 PO 00000 Frm 00033 Fmt 4703 Sfmt 4703 E:\FR\FM\23NON1.SGM 23NON1

Document Created: 2018-11-27 12:58:46
Document Modified: 2018-11-27 12:58:46

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
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]
FR Citation		83 FR 59386

83 FR 59386 - Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 226 (November 23, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration