83_FR_40682 83 FR 40524 - Issuance of Priority Review Voucher; Rare Pediatric Disease Product

83 FR 40524 - Issuance of Priority Review Voucher; Rare Pediatric Disease Product

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 158 (August 15, 2018)

Page Range40524-40524
FR Document2018-17527

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 CRYSVITA (burosamab-twza), manufactured by Ultragenyx Pharmaceutical, Inc., meets the criteria for a priority review voucher.

Federal Register, Volume 83 Issue 158 (Wednesday, August 15, 2018) 
[Federal Register Volume 83, Number 158 (Wednesday, August 15, 2018)]
[Notices]
[Page 40524]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-17527]


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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.

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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 CRYSVITA (burosamab-twza), manufactured by Ultragenyx 
Pharmaceutical, 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., 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 
CRYSVITA (burosamab-twza), manufactured by Ultragenyx Pharmaceutical, 
Inc., meets the criteria for a priority review voucher. CRYSVITA 
(burosamab-twza) is indicated for the treatment of X-linked 
hypophosphatemia in adult and pediatric patients 1 year of age and 
older.
    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 CRYSVITA (burosumab-twza), go to the ``[email protected]'' 
website at https://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: August 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17527 Filed 8-14-18; 8:45 am]
 BILLING CODE 4164-01-P

40524 Federal Register / Vol. 83, No. 158 / Wednesday, August 15, 2018 / Notices meetings. Please visit our website at the criteria for a priority review Electronic Submissions https://www.fda.gov/Advisory voucher. CRYSVITA (burosamab-twza) Submit electronic comments in the Committees/AboutAdvisoryCommittees/ is indicated for the treatment of X- following way: ucm111462.htm for procedures on linked hypophosphatemia in adult and • Federal eRulemaking Portal: public conduct during advisory pediatric patients 1 year of age and https://www.regulations.gov. Follow the committee meetings. older. instructions for submitting comments. Notice of this meeting is given under For further information about the Rare Comments submitted electronically, the Federal Advisory Committee Act (5 Pediatric Disease Priority Review including attachments, to https:// U.S.C. app. 2). Voucher Program and for a link to the www.regulations.gov will be posted to Dated: August 9, 2018. full text of section 529 of the FD&C Act, the docket unchanged. Because your Leslie Kux, go to https://www.fda.gov/ForIndustry/ comment will be made public, you are DevelopingProductsforRareDiseases solely responsible for ensuring that your Associate Commissioner for Policy. Conditions/RarePediatricDiseasePriority comment does not include any [FR Doc. 2018–17524 Filed 8–14–18; 8:45 am] VoucherProgram/default.htm. For confidential information that you or a BILLING CODE 4164–01–P further information about CRYSVITA third party may not wish to be posted, (burosumab-twza), go to the ‘‘Drugs@ such as medical information, your or FDA’’ website at https:// anyone else’s Social Security number, or DEPARTMENT OF HEALTH AND www.accessdata.fda.gov/scripts/cder/ confidential business information, such HUMAN SERVICES daf/. as a manufacturing process. Please note Food and Drug Administration Dated: August 8, 2018. that if you include your name, contact [Docket No. FDA–2017–N–0809] Leslie Kux, information, or other information that Associate Commissioner for Policy. identifies you in the body of your Issuance of Priority Review Voucher; [FR Doc. 2018–17527 Filed 8–14–18; 8:45 am] comments, that information will be Rare Pediatric Disease Product BILLING CODE 4164–01–P posted on https://www.regulations.gov. • If you want to submit a comment AGENCY: Food and Drug Administration, with confidential information that you HHS. do not wish to be made available to the DEPARTMENT OF HEALTH AND ACTION: Notice. HUMAN SERVICES public, submit the comment as a SUMMARY: The Food and Drug written/paper submission and in the Food and Drug Administration manner detailed (see ‘‘Written/Paper Administration (FDA) is announcing the issuance of a priority review voucher to [Docket No. FDA–2018–D–0943] Submissions’’ and ‘‘Instructions’’). the sponsor of a rare pediatric disease Written/Paper Submissions product application. The Federal Food, Elemental Impurities in Animal Drug Products—Questions and Answers; Submit written/paper submissions as Drug, and Cosmetic Act (FD&C Act), as Draft Guidance for Industry; follows: amended by the Food and Drug Availability; Reopening of the • Mail/Hand delivery/Courier (for Administration Safety and Innovation Comment Period written/paper submissions): Dockets Act (FDASIA), authorizes FDA to award Management Staff (HFA–305), Food and priority review vouchers to sponsors of AGENCY: Food and Drug Administration, Drug Administration, 5630 Fishers approved rare pediatric disease product HHS. Lane, Rm. 1061, Rockville, MD 20852. applications that meet certain criteria. ACTION: Notice of availability; reopening • For written/paper comments FDA is required to publish notice of the of the comment period. submitted to the Dockets Management award of the priority review voucher. Staff, FDA will post your comment, as FDA has determined that CRYSVITA SUMMARY: The Food and Drug well as any attachments, except for (burosamab-twza), manufactured by Administration (FDA or Agency) is information submitted, marked and Ultragenyx Pharmaceutical, Inc., meets reopening the comment period for the identified, as confidential, if submitted the criteria for a priority review notice of availability that published in as detailed in ‘‘Instructions.’’ voucher. the Federal Register on March 27, 2018. Instructions: All submissions received FOR FURTHER INFORMATION CONTACT: In that document, FDA requested must include the Docket No. FDA– Althea Cuff, Center for Drug Evaluation comments on the draft guidance for 2018–D–0943 for ‘‘Elemental Impurities and Research, Food and Drug industry (GFI) #255 entitled ‘‘Elemental in Animal Drug Products—Questions Administration, 10903 New Hampshire Impurities in Animal Drug Products— and Answers.’’ Received comments will Ave., Silver Spring, MD 20993–0002, Questions and Answers.’’ The Agency is be placed in the docket and, except for 301–796–4061, Fax: 301–796–9856, taking this action in response to those submitted as ‘‘Confidential email: althea.cuff@fda.hhs.gov. requests for an extension to allow Submissions,’’ publicly viewable at SUPPLEMENTARY INFORMATION: FDA is interested parties additional time to https://www.regulations.gov or at the announcing the issuance of a priority develop and submit comments. Dockets Management Staff between 9 review voucher to the sponsor of an DATES: FDA is reopening the comment a.m. and 4 p.m., Monday through approved rare pediatric disease product period on the notice of availability Friday. application. Under section 529 of the published March 27, 2018 (83 FR • Confidential Submissions—To FD&C Act (21 U.S.C. 360ff), which was 13134). Submit either electronic or submit a comment with confidential daltland on DSKBBV9HB2PROD with NOTICES added by FDASIA, FDA will award written comments on the draft guidance information that you do not wish to be priority review vouchers to sponsors of by October 15, 2018 to ensure that the made publicly available, submit your approved rare pediatric disease product Agency considers your comment on this comments only as a written/paper applications that meet certain criteria. draft guidance before it begins work on submission. You should submit two FDA has determined that CRYSVITA the final version of the guidance. copies total. One copy will include the (burosamab-twza), manufactured by ADDRESSES: You may submit comments information you claim to be confidential Ultragenyx Pharmaceutical, Inc., meets on any guidance at any time as follows: with a heading or cover note that states VerDate Sep<11>2014 18:28 Aug 14, 2018 Jkt 244001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\15AUN1.SGM 15AUN1


Document Created: 2018-08-15 01:26:24
Document Modified: 2018-08-15 01:26:24
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactAlthea 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]
FR Citation83 FR 40524 
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