82 FR 19052 - Issuance of Priority Review Voucher; Rare Pediatric Disease Product
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 78 (April 25, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 78 (April 25, 2017)
| Page Range | 19052-19052 | |
| FR Document | 2017-08309 |
[Federal Register Volume 82, Number 78 (Tuesday, April 25, 2017)] [Notices] [Page 19052] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-08309] [[Page 19052]] ----------------------------------------------------------------------- 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 (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 EMFLAZA (deflazacort) oral tablets, and oral suspension manufactured by Marathon Pharmaceuticals, LLC, meets the criteria for a priority review voucher. FOR FURTHER INFORMATION CONTACT: Larry Bauer, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4842, FAX: 301- 796-9858, 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 Emflaza (deflazacort) manufactured by Marathon Pharmaceuticals, LLC, meets the criteria for a priority review voucher. EMFLAZA (deflazacort) is indicated for the treatment of Duchenne Muscular Dystrophy in patients 5 years 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 EMFLAZA (deflazacort), go to the ``Drugs@FDA'' Web site at https://www.accessdata.fda.gov/scripts/cder/daf/. Dated: April 19, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-08309 Filed 4-24-17; 8:45 am] BILLING CODE 4164-01-P
![19052 Federal Register / Vol. 82, No. 78 / Tuesday, April 25, 2017 / Notices
DEPARTMENT OF HEALTH AND Dated: April 19, 2017. comments, that information will be
HUMAN SERVICES Anna K. Abram, posted on https://www.regulations.gov.
Deputy Commissioner for Policy, Planning, • If you want to submit a comment
Food and Drug Administration Legislation, and Analysis. with confidential information that you
[Docket No. FDA–2017–N–0809] [FR Doc. 2017–08309 Filed 4–24–17; 8:45 am] do not wish to be made available to the
BILLING CODE 4164–01–P public, submit the comment as a
Issuance of Priority Review Voucher; written/paper submission and in the
Rare Pediatric Disease Product manner detailed (see ‘‘Written/Paper
DEPARTMENT OF HEALTH AND Submissions’’ and ‘‘Instructions’’).
AGENCY: Food and Drug Administration, HUMAN SERVICES
HHS. Written/Paper Submissions
ACTION: Notice. Food and Drug Administration Submit written/paper submissions as
follows:
SUMMARY: The Food and Drug [Docket No. FDA–2010–N–0583] • Mail/Hand delivery/Courier (for
Administration (FDA) is announcing the written/paper submissions): Division of
issuance of a priority review voucher to Agency Information Collection
Activities; Proposed Collection; Dockets Management (HFA–305), Food
the sponsor of a rare pediatric disease and Drug Administration, 5630 Fishers
product application. The Federal Food, Comment Request; Radioactive Drug
Research Committees Lane, Rm. 1061, Rockville, MD 20852.
Drug, and Cosmetic Act (FD&C Act), as • For written/paper comments
amended by the Food and Drug AGENCY: Food and Drug Administration, submitted to the Division of Dockets
Administration Safety and Innovation HHS. Management, FDA will post your
Act (FDASIA), authorizes FDA to award ACTION: Notice. comment, as well as any attachments,
priority review vouchers to sponsors of except for information submitted,
approved rare pediatric disease product SUMMARY: The Food and Drug marked and identified, as confidential,
applications that meet certain criteria. Administration (FDA) is announcing an if submitted as detailed in
FDA is required to publish notice of the opportunity for public comment on the ‘‘Instructions.’’
award of the priority review voucher. proposed collection of certain Instructions: All submissions received
FDA has determined that EMFLAZA information by the Agency. Under the must include the Docket No. FDA–
(deflazacort) oral tablets, and oral Paperwork Reduction Act of 1995 2010–N–0583 for ‘‘Agency Information
suspension manufactured by Marathon (PRA), Federal Agencies are required to Collection Activities; Proposed
Pharmaceuticals, LLC, meets the criteria publish notice in the Federal Register Collection; Comment Request;
for a priority review voucher. concerning each proposed collection of Radioactive Drug Research
FOR FURTHER INFORMATION CONTACT: information, including each proposed Committees.’’ Received comments will
Larry Bauer, Center for Drug Evaluation extension of an existing collection of be placed in the docket and, except for
and Research, Food and Drug information, and to allow 60 days for those submitted as ‘‘Confidential
Administration, 10903 New Hampshire public comment in response to the Submissions,’’ publicly viewable at
Ave., Silver Spring, MD 20993–0002, notice. This notice solicits comments on https://www.regulations.gov or at the
301–796–4842, FAX: 301–796–9858, the information collection contained in Division of Dockets Management
email: larry.bauer@fda.hhs.gov. regulations governing the use of between 9 a.m. and 4 p.m., Monday
SUPPLEMENTARY INFORMATION: FDA is radioactive drugs for basic informational through Friday.
announcing the issuance of a priority research. • Confidential Submissions—To
review voucher to the sponsor of an DATES: Submit either electronic or submit a comment with confidential
approved rare pediatric disease product written comments on the collection of information that you do not wish to be
application. Under section 529 of the information by June 26, 2017. made publicly available, submit your
FD&C Act (21 U.S.C. 360ff), which was ADDRESSES: You may submit comments comments only as a written/paper
added by FDASIA, FDA will award as follows: submission. You should submit two
priority review vouchers to sponsors of copies total. One copy will include the
approved rare pediatric disease product Electronic Submissions information you claim to be confidential
applications that meet certain criteria. Submit electronic comments in the with a heading or cover note that states
FDA has determined that Emflaza following way: ‘‘THIS DOCUMENT CONTAINS
(deflazacort) manufactured by Marathon • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
Pharmaceuticals, LLC, meets the criteria https://www.regulations.gov. Follow the Agency will review this copy, including
for a priority review voucher. instructions for submitting comments. the claimed confidential information, in
EMFLAZA (deflazacort) is indicated for Comments submitted electronically, its consideration of comments. The
the treatment of Duchenne Muscular including attachments, to https:// second copy, which will have the
Dystrophy in patients 5 years of age and www.regulations.gov will be posted to claimed confidential information
older. the docket unchanged. Because your redacted/blacked out, will be available
For further information about the Rare comment will be made public, you are for public viewing and posted on http://
Pediatric Disease Priority Review solely responsible for ensuring that your www.regulations.gov. Submit both
Voucher Program and for a link to the comment does not include any copies to the Division of Dockets
full text of section 529 of the FD&C Act, confidential information that you or a Management. If you do not wish your
asabaliauskas on DSK3SPTVN1PROD with NOTICES
go to https://www.fda.gov/ForIndustry/ third party may not wish to be posted, name and contact information to be
DevelopingProductsforRareDiseases such as medical information, your or made publicly available, you can
Conditions/RarePediatricDiseasePriority anyone else’s Social Security number, or provide this information on the cover
VoucherProgram/default.htm. For confidential business information, such sheet and not in the body of your
further information about EMFLAZA as a manufacturing process. Please note comments and you must identify this
(deflazacort), go to the ‘‘Drugs@FDA’’ that if you include your name, contact information as ‘‘confidential.’’ Any
Web site at https://www.accessdata. information, or other information that information marked as ‘‘confidential’’
fda.gov/scripts/cder/daf/. identifies you in the body of your will not be disclosed except in
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Document Created: 2017-04-25 02:18:47
Document Modified: 2017-04-25 02:18:47
| 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 | Larry Bauer, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-4842, FAX: 301- 796-9858, email: [email protected] | |
| FR Citation | 82 FR 19052 |
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