United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2019_register executive 2019-07-30 article Notices D09002ee1c7d2b250 D09002ee1c7d2b369 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Rare Pediatric Disease Priority Review Vouchers." This draft guidance is a revision of the guidance of the same title that published in 2014. This draft guidance provides information on the rare pediatric disease priority review voucher program under the Federal Food, Drug, and Cosmetic Act (FD&C Act), under which FDA will award priority review vouchers to sponsors of certain rare pediatric disease product applications that meet the relevant statutory criteria. These priority review vouchers can be used when submitting future human drug marketing applications that would not otherwise qualify for priority review. Because there exists a need for products for rare pediatric diseases, this program is intended to encourage development of new drug and biological products for prevention and treatment of certain rare pediatric diseases. 84 FR 36929 https://www.govinfo.gov/app/details/FR-2019-07-30/2019-16262 2019-16262 fr30jy19-64 4164-01-P Docket No. FDA-2014-D-1461 https://www.govinfo.gov/app/details/FR-2019-07-30/2019-16262 https://www.govinfo.gov/content/pkg/FR-2019-07-30/html/2019-16262.htm https://www.govinfo.gov/content/pkg/FR-2019-07-30/pdf/2019-16262.pdf 4 p. 36929 36932 84 FR 36929 Rare Pediatric Disease Pediatric Priority Review Vouchers; Draft Guidance for Industry; Availability; Federal Register Vol. 84, Issue NOTICE 2019-16262 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2019-09-30 Docket No. FDA-2014-D-1461 4164-01-P 2019-16262 Notice of availability.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Rare Pediatric Disease Priority Review Vouchers." This draft guidance is a revision of the guidance of the same title that published in 2014. This draft guidance provides information on the rare pediatric disease priority review voucher program under the Federal Food, Drug, and Cosmetic Act (FD&C Act), under which FDA will award priority review vouchers to sponsors of certain rare pediatric disease product applications that meet the relevant statutory criteria. These priority review vouchers can be used when submitting future human drug marketing applications that would not otherwise qualify for priority review. Because there exists a need for products for rare pediatric diseases, this program is intended to encourage development of new drug and biological products for prevention and treatment of certain rare pediatric diseases.

Submit either electronic or written comments on the draft guidance by September 30, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. Submit electronic or written comments on the information collection burden by September 30, 2019. Aaron Friedman, Office of Orphan Products Development, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5209, Silver Spring, MD 20993, 301-796-2989; Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911; 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; or Terrie Crescenzi, Office of Pediatric Therapeutics, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5126, Silver Spring, MD 20993, 301-796-8646. Guidance: Rare Pediatric Disease Pediatric Priority Review Vouchers , https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.regulations.gov Vol. 84, no. 146 Office of the Federal Register, National Archives and Records Administration 2019-07-30 continuing daily deposited born digital 256 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2019-07-30 P0b002ee1a24cada7 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr30jy19 https://www.govinfo.gov/app/details/FR-2019-07-30 https://www.govinfo.gov/content/pkg/FR-2019-07-30/pdf/FR-2019-07-30.pdf https://www.govinfo.gov/content/pkg/FR-2019-07-30/xml/FR-2019-07-30.xml fdlp 36813 37058 DGPO 2019-07-30 2024-05-31 FR-2019-07-30 machine generated eng FR FR-2019-07-30 84 146