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Overview of the  Dept. of Health & Human Services Overview of the  Dept. of Health & Human Services

Overview of the Dept. of Health & Human Services - PowerPoint Presentation

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Overview of the Dept. of Health & Human Services - PPT Presentation

Overview of the Dept of Health amp Human Services SBIRSTTR Programs Jennifer C Shieh PhD Small Business Coordinator amp Program Director National Heart Lung and Blood Institute National Institutes of Health ID: 765776

nih phase sbir national phase nih national sbir institute funding health sttr gov review amp research grants years center

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Overview of the Dept. of Health & Human Services SBIR/STTR Programs Jennifer C. Shieh, Ph.D. Small Business Coordinator & Program Director National Heart, Lung, and Blood Institute National Institutes of Health @ NIHsbir @NHLBI_SBIR

Tips: Take 5HHS and NIH are made up of distinct units, but there are many similarities (like siblings). We fund grants AND contracts. Read the Funding Opportunity Announcement (FOA)!Scientific peer review is critical.You can and should contact us (early)!Questions about who to contact? Email sbir@od.nih.gov 2

HHS Program Funding 2016 Budget SBIR STTR NIH National Institutes of Health $763M $114M CDC Centers for Disease Control & Prevention $9M N/A ACL (NIDILRR) Administration for Community Living National Institute on Disability, Independent Living, & Rehabilitation Research $2.7M N/A FDA Food and Drug Administration $1.55M N/A ACF Administration for Children and Families $93.5K N/A

NIH Mission To seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability .

No funding authority Office of Research Infrastructure Programs National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute of Allergy and Infectious Diseases National Institute of Arthritis and Musculoskeletal and Skin Diseases National Cancer Institute National Institute of Child Health and Human Development National Institute on Deafness and Other Communication Disorders National Institute of Dental and Craniofacial Research National Institute of Diabetes and Digestive and Kidney Diseases National Institute on Drug Abuse National Institute of Environmental Health Sciences National Eye Institute National Institute of General Medical Sciences National Heart, Lung, and Blood Institute National Human Genome Research Institute National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Institute of Nursing Research National Institute on Minority Health and Health Disparities National Center for Complementary and Integrative Health Fogarty International Center National Center for Advancing Translational Sciences National Library of Medicine National Institute of Biomedical Imaging and Bioengineering Office of the Director NIH Clinical Center Center for Information Technology Center for Scientific Review National Institutes of Health http://www.nih.gov/icd

NIH SBIR/STTR 3-Phase Program Feasibility Discovery Phase I Full R/D Phase I Phase II Fast-Track $3M for up to 3 years Development Phase II Commercialization Phase III Competing Renewal Award Phase IIB Additional R/D Only Some ICs Participate Direct to Phase II Up to $225K 6-12 months NIH is not usually the end customer Up to $1.5M 2 years

NIH SBIR/STTR Fast-Track Feasibility Discovery Phase I Full R/D Phase I Phase II Fast-Track $3M for up to 3 years Development Phase II Commercialization Phase III Competing Renewal Award Phase IIB Additional R/D Only Some ICs Participate Direct to Phase II Up to $225K 6-12 months NIH is not usually the end customer Up to $1.5M 2 years Simultaneous submission and review of Phase I and II Phase I is awarded Milestones/aims of Phase I are assessed by program staff BEFORE Phase II is awarded

NIH SBIR/STTR Direct to Phase II Feasibility Discovery Phase I Full R/D Phase I Phase II Fast-Track $3M for up to 3 years Development Phase II Commercialization Phase III Competing Renewal Award Phase IIB Additional R/D Only Some ICs Participate Direct to Phase II Up to $225K 6-12 months NIH is not usually the end customer Up to $1.5M 2 years SBIR only Bypass Phase I grant Must have completed Phase-I-type R&D (i.e. feasibility) to move directly into a Phase-II SEPARATE FOAs: https://sbir.nih.gov/funding#phase2 Not all ICs Participate

Phase IIB Competing Renewal Award Discovery Phase I $3M for up to 3 years Development Phase II Commercialization Phase III Competing Renewal Award Phase IIB SBIR/STTR Phase II awardee Technologies that require extraordinary time/effort to develop, and often require FDA regulatory approval Awards up to $1M/year for up to 3 years IC must accept Competing Renewal applications ( NIA, NIAAA, NIAID, NICHD, NIDA, NIDCD, NIDDK, NEI, NIGMS, NHLBI, NIMH, NINDS, NCATS, ORIP, NCI ) Contact NIH Program Staff to discuss!

NIH SBIR/STTR FOAs Funding Opportunity A nnouncements https://sbir.nih.gov/funding

Multiple Types of Funding OpportunitiesInvestigator Initiated Grants – Omnibus Solicitations Targeted Grant Funding OpportunitiesContract Funding Opportunities 11

Investigator Initiated Grants We encourage applications for any topic within the NIH mission Read the “ Program Descriptions and Research Topics ” Check out http://projectreporter.nih.gov Due September 5 , January 5 , April 5 Omnibus Solicitations (Phase I, Phase II, Fast-Track) PA-16-302 (SBIR) and PA-16-303 (STTR) Direct to Phase II Solicitation PAR-14-088 (SBIR only) – Expires January 2017 12

13 Targeted Grant Funding Opportunities Release dates, topics, and receipt dates vary Check the NIH Guide – published weekly Check your relevant IC’s website Sign up for your relevant IC’s listserv (e.g. http://bit.ly/NHLBI-SBIR-Updates ) http://grants.nih.gov/grants/guide IC’s = Institutes and Centers http://sbir.nih.gov/funding#targeted

14 Contract Solicitation for NIH & CDC Only 1 per year Targeted, milestone-driven topics Different application & award process from grants SBIR only Most recent solicitation - PHS 2017-1 Release: August 1, 2016 Close : October 21, 2016 (5pm EDT)

NIH Application & Review Process Applicant initiates research idea Small Business Concern confirms Eligibility Submits SBIR/STTR grant application to NIH electronically Scientific Review Group evaluates scientific merit Advisory Council or Board recommend Approval IC staff prepare funding plan for IC Director IC allocates funds Grantee conducts research NIH Center for Scientific Review assigns to IC and IRG 1-2 Months 3 Months 2-4 Months Jan 5 Feb/Mar May/June July

Review CriteriaOverall Impact Score Scored Review Criteria (score 1-9)Significance (Real Problem/Commercial Potential)Investigators (PI and team)Innovation (New or Improved?)Approach (Research Design, Feasible) Environment (Facilities/Resources) Additional Review Criteria (not scored individually) Protection of Human Subjects Inclusion of Women, Minorities & Children Vertebrate Animals Biohazards

Tips: Take 5HHS and NIH are made up of distinct units, but there are many similarities (like siblings). We fund grants AND contracts. Read the Funding Opportunity Announcement (FOA)!Scientific peer review is critical.You can and should contact us (early)!Questions about who to contact? Email sbir@od.nih.gov 17

More InformationGet Connected! Subscribe to the SBIR/STTR Listserv: Email LISTSERV@LIST.NIH.GOV with the following text in the message body: subscribe SBIR-STTR your name NIH Guide for Grants and Contracts (weekly notification) Follow us on Twitter: @ NIHsbir Read our NIH SBIR/STTR Notable Successes Connect with Us - http://sbir.nih.gov Email: sbir@od.nih.gov