82 FR 12614 - Issuance of Priority Review Voucher; Rare Pediatric Disease Product

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 42 (March 6, 2017)

Page Range		12614-12614
FR Document		2017-04228

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 rare pediatric disease product applications that meet certain criteria. FDA has determined that SPINRAZA (nusinersen), manufactured by Biogen Inc., meets the criteria for a priority review voucher.

Federal Register, Volume 82 Issue 42 (Monday, March 6, 2017)

[Federal Register Volume 82, Number 42 (Monday, March 6, 2017)]
[Notices]
[Page 12614]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-04228]


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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 rare pediatric disease product 
applications that meet certain criteria. FDA has determined that 
SPINRAZA (nusinersen), manufactured by Biogen Inc., meets the criteria 
for a priority review voucher.

FOR FURTHER INFORMATION CONTACT: Larry Bauer, Rare Diseases Program, 
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 a 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 rare pediatric disease product applications that meet 
certain criteria. FDA has determined that SPINRAZA (nusinersen), 
manufactured by Biogen Inc., meets the criteria for a priority review 
voucher. SPINRAZA (nusinersen) is indicated for the treatment of spinal 
muscular atrophy in pediatric and adult patients.
    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 http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/RarePediatricDiseasePriorityVoucherProgram/default.htm. For further 
information about SPINRAZA (nusinersen), go to the ``[email protected]'' Web 
site at http://www.accessdata.fda.gov/scripts/cder/daf/.

    Dated: February 28, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-04228 Filed 3-3-17; 8:45 am]
 BILLING CODE 4164-01-P

12614 Federal Register / Vol. 82, No. 42 / Monday, March 6, 2017 / Notices

sale. We have also independently Administration, 10903 New Hampshire FOR FURTHER INFORMATION CONTACT:
evaluated relevant literature and data Ave., Silver Spring, MD 20993–0002, Designated Federal Officer, 2018
for possible postmarketing adverse 301–796–4842, FAX: 301–796–9858, Physical Activity Guidelines Advisory
events. We have found no information email: larry.bauer@fda.hhs.gov. Committee, Richard D. Olson, M.D.,
that would indicate that this drug SUPPLEMENTARY INFORMATION: FDA is M.P.H. and/or Alternate Designated
product was withdrawn from sale for announcing the issuance of a priority Federal Officer, Katrina L. Piercy, Ph.D.,
reasons of safety or effectiveness. review voucher to the sponsor of a rare R.D., Office of Disease Prevention and
Accordingly, the Agency will pediatric disease product application. Health Promotion (ODPHP), Office of
continue to list prescription FLONASE Under section 529 of the FD&C Act (21 the Assistant Secretary for Health
(fluticasone propionate) Nasal Spray, U.S.C. 360ff), which was added by (OASH), HHS; 1101 Wootton Parkway,
0.05 mg, in the ‘‘Discontinued Drug FDASIA, FDA will award priority Suite LL–100; Rockville, MD 20852;
Product List’’ section of the Orange review vouchers to sponsors of rare Telephone: (240) 453–8280. Additional
Book. The ‘‘Discontinued Drug Product pediatric disease product applications information is available at
List’’ delineates, among other items, that meet certain criteria. FDA has www.health.gov/paguidelines.
drug products that have been determined that SPINRAZA SUPPLEMENTARY INFORMATION: The
discontinued from marketing for reasons (nusinersen), manufactured by Biogen inaugural Physical Activity Guidelines
other than safety or effectiveness. Inc., meets the criteria for a priority for Americans (PAG), issued in 2008,
ANDAs that refer to prescription review voucher. SPINRAZA represents the first comprehensive
FLONASE (fluticasone propionate) (nusinersen) is indicated for the guidelines on physical activity issued
Nasal Spray, 0.05 mg, may be approved treatment of spinal muscular atrophy in by the federal government. The PAG
by the Agency as long as they meet all pediatric and adult patients. serves as the benchmark and primary,
other legal and regulatory requirements For further information about the Rare authoritative voice of the federal
for the approval of ANDAs. If FDA Pediatric Disease Priority Review government for providing science-based
determines that labeling for this drug Voucher Program and for a link to the guidance on physical activity, fitness,
product should be revised to meet full text of section 529 of the FD&C Act, and health for Americans. Five years
current standards, the Agency will go to http://www.fda.gov/ForIndustry/ after the first edition was released,
advise ANDA applicants to submit such DevelopingProductsforRareDiseases ODPHP, in collaboration with the
labeling. Conditions/RarePediatricDiseasePriority Centers for Disease Control and
Dated: February 28, 2017. VoucherProgram/default.htm. For Prevention (CDC), the National
Leslie Kux, further information about SPINRAZA Institutes of Health (NIH), and the
Associate Commissioner for Policy. (nusinersen), go to the ‘‘Drugs@FDA’’ President’s Council on Fitness, Sports,
[FR Doc. 2017–04231 Filed 3–3–17; 8:45 am] Web site at http://www.accessdata.fda. and Nutrition (PCFSN) led development
gov/scripts/cder/daf/. of the PAG Midcourse Report: Strategies
BILLING CODE 4164–01–P
to Increase Physical Activity Among
Dated: February 28, 2017.
Youth. The second edition of the PAG
Leslie Kux, will build upon the first edition and
DEPARTMENT OF HEALTH AND Associate Commissioner for Policy.
HUMAN SERVICES provide a foundation for federal
[FR Doc. 2017–04228 Filed 3–3–17; 8:45 am] recommendations and education for
Food and Drug Administration BILLING CODE 4164–01–P physical activity programs for
Americans, including those at risk for
[Docket No. FDA–2017–N–0809]
chronic disease.
DEPARTMENT OF HEALTH AND Appointed Committee Members: The
Issuance of Priority Review Voucher; HUMAN SERVICES
Rare Pediatric Disease Product Secretary of HHS appointed 17
individuals to serve as members of the
AGENCY: Food and Drug Administration, Meeting of the 2018 Physical Activity 2018 PAGAC in June 2016. Information
HHS. Guidelines Advisory Committee on Committee membership is available
ACTION: Notice. AGENCY: U.S. Department of Health and at www.health.gov/paguidelines/second-
Human Services, Office of the Secretary, edition/committee/.
SUMMARY: The Food and Drug Office of the Assistant Secretary for Committee’s Task: The work of the
Administration (FDA) is announcing the Health, Office of Disease Prevention and 2018 PAGAC will be time-limited and
issuance of a priority review voucher to Health Promotion. solely advisory in nature. The
the sponsor of a rare pediatric disease Committee will develop
product application. The Federal Food, ACTION: Notice.
recommendations based on the
Drug, and Cosmetic Act (FD&C Act), as preponderance of current scientific and
amended by the Food and Drug SUMMARY: As stipulated by the Federal
Advisory Committee Act (FACA), the medical knowledge using a systematic
Administration Safety and Innovation review approach. The Committee will
Act (FDASIA), authorizes FDA to award U.S. Department of Health and Human
Services (HHS) is hereby giving notice examine the current PAG, take into
priority review vouchers to sponsors of consideration new scientific evidence
rare pediatric disease product that the third meeting of the 2018
Physical Activity Guidelines Advisory and current resource documents, and
applications that meet certain criteria. develop a scientific report to the
asabaliauskas on DSK3SPTVN1PROD with NOTICES

FDA has determined that SPINRAZA Committee (2018 PAGAC or Committee)
will be held. This meeting will be open Secretary of HHS that outlines its
(nusinersen), manufactured by Biogen science-based advice and
Inc., meets the criteria for a priority to the public via videocast.
recommendations for development of
review voucher. DATES: The meeting will be held on the second edition of the PAG. The
FOR FURTHER INFORMATION CONTACT: March 23, 2017, from 8:00 a.m. E.T. to Committee will hold approximately five
Larry Bauer, Rare Diseases Program, 5:30 p.m. E.T. public meetings to review and discuss
Center for Drug Evaluation and ADDRESSES: The meeting will be recommendations. The first meeting was
Research, Food and Drug accessible by videocast on the Internet. held in July 2016 and the second in

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Document Created: 2017-03-04 00:06:26
Document Modified: 2017-03-04 00:06:26

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, Rare Diseases Program, 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 12614

82 FR 12614 - Issuance of Priority Review Voucher; Rare Pediatric Disease Product

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 42 (March 6, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration