SBIR - STTR: Advancing Medicine Through Innovation

Small Business Innovation Small Business Innovation Research Small Business Small Innovation Business Research Small Business Technology Research & Transfer Small Business Programs Technology Transfer Programs Technology Transfer Programs SBIR - STTR: Advancing Medicine Through Innovation The NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs award provide federal The NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs award federal research grants and development to small businesses funding to conducting U.S. Small biomedical Businesses, research. to explore The the purpose feasibility of these of innovation programs technologies is to spur technological have innovation a strong potential and help for the commercialization federal government and meet creating its research medical and solutions. development (R&D) needs, with the ultimate goal research grants to small businesses. The purpose of these programs is to spur technological innovation and help the that federal government meet its research and development (R&D) needs, with the ultimate goal being commercialization of being commercialization of these innovative technologies and improved public health. these innovative technologies and improved public health. Fast Track Register your business. Register your Register your business business Choose Program & Submit Application. Choose program Choose program & submit application submit application Phase Phase I FAST TRACK FAST TRACK Phase Phase II II II Niche Niche Niche CAP CAP CAP Phase Phase III III III NIH s SBIR and STTR Programs Can Help Your Small Business Receive R&D Funding NIH s SBIR and STTR Programs Can Help Your Small Business Receive R&D Funding Follow these steps to find out how to get started on your application: Follow these steps to find out how to get started on your application: Determine which Determine which Funding Opportunity Funding Opportunity is Best Suited for You is Best Suited for You Parent Funding Funding Opportunity Funding Opportunity Opportunity: SBIR Announcements (PA-13-234) and (FOAs): Announcements (FOAs): STTR (PA-13-235) SBIR (PA-14-071) and STTR SBIR (PA-13-234) and STTR (PA-14-072) (PA-13-235) NIH is interested in YOUR NIH is interested in YOUR research NIH is interested ideas - apply in YOUR using research ideas - apply using the research Omnibus ideas solicitation. - apply using the Omnibus solicitation the Omnibus solicitation. Targeted Funding Opportunity FOAs: Announcements Targeted Funding (FOAs): Opportunity Issued by NIH s Institutes and Announcements Issued by NIH s Institutes (FOAs): and Centers (ICs) Centers Issued by (ICs) NIH s Institutes and Centers (ICs) Decide between SBIR Decide between SBIR and STTR Funding and STTR Funding SBIR: SBIR: Principal Investigator: Must be Principal Investigator: Must be employed by the small business. employed by the small business. Research Partner: Research partner Research Partner: Research partner optional, (up total effort 1/3 for up Phase to 33% I and for optional (up to 1/3 for Phase I and 1/2 Phase for I Phase and 50% II) for Phase II 1/2 for Phase II) STTR: STTR: Principal Investigator: Can be Principal Investigator: Can be employed by the small business or employed by the small business or non-profit research institution. a non-profit research institution. Research Partner: Research Partner: Required. Formal collaborative Required. Formal collaborative effort between small business effort between small business (minimum 40%) and research (minimum 40%) and research institution (minimum 30%). institution (minimum 30%). Submit Your Submit Your Application Early Application Early The grants registration process The grants registration process can take 6-8 weeks! can take 6-8 weeks! There are required There are 5 required registrations: registrations: 1. DUNS 4. era Commons 1. DUNS 4. era Commons 2. Sam.gov 5. SBA Registry 2. Sam.gov 5. SBA Registry 3. Grants.gov 3. Grants.gov Standard Grant Due Dates: Standard Grant Due Dates: Phase and Phase II: Phase I and Phase II: April 5, August 5, December April 5, August 5, December 5 AIDs AIDS and AIDs-related: AIDS-related: AIDs and AIDs-related: May 7, September 7, January May 7, September 7, January 7 If you have questions about any of these steps, please contact sbir@od.nih.gov, or the program officer at the NIH IC If you have questions about any of these steps, please contact sbir@od.nih.gov, or the program officer at the NIH IC that s most clearly related to your research topic. Contact information is located in the SBIR/STTR Omnibus solicitations. that s most clearly related to your research topic. Contact information is located in the SBIR/STTR Omnibus solicitations. Stay Connected! Stay Connected! Subscribe to the SBIR/STTR listserv: Subscribe to the SBIR/STTR listserv: Email listserv@list.nih.gov with this text in the Email listserv@list.nih.gov with this text in the message body: subscribe SBIR-STTR your name message body: subscribe SBIR-STTR your name Contact Us: Us: Contact Us: sbir@od.nih.gov sbir@od.nih.gov Website: Website: sbir.nih.gov sbir.nih.gov Follow Follow us on us on Twitter: Follow us on Twitter: @NIHsbir @NIHsbir

Follow the Follow below the steps below to get steps started to get on started the application the application process! process! Follow the below steps to get started on the application process! Confirm your small Confirm your small business concern (SBC) business concern (SBC) meets eligibility requirements meets eligibility requirements. Confirm your small Develop an business concern innovative research (SBC) meets eligibility idea for your SBC requirements. Five required registrations: 1. DUNS 4. era Commons 2. SAM.gov 5. SBA Registry CONTACT NIH BEFORE APPLYING 3. CHOOSE Grants.gov ONE FOA SBIR Omnibus (PA-13-234) SBIR Omnibus SBIR Omnibus (PA-14-071) (PA-13-234) STTR Omnibus (PA-13-235) STTR Omnibus STTR Omnibus (PA-14-072) Targeted (PA-13-235) SBIR/STTR FOAs CHOOSE ONE FOA Develop an innovative Develop an innovative research idea for research idea for your SBC your SBC $ Five required registrations: Five required registrations: 1. DUNS 4. era Commons 1. DUNS 4. era Commons 2. SAM.gov 5. SBA Registry 2. SAM.gov 5. SBA Registry 3. Grants.gov 3. Grants.gov Targeted Targeted SBIR/STTR FOAs SBIR/STTR FOAs Awardee conducts research Awardee Awardee conducts conducts research research Funding decisions and awards are made $ NIH Center for Scientific Review evaluates your grant on scientific merit and commercialization potential Submit your SBIR/STTR grant application to NIH electronically Funding decisions NIH Center for Scientific Review Funding decisions NIH Center for Scientific Review and awards are evaluates your grant on scientific and awards are evaluates your grant on scientific made merit and commercialization potential made merit and commercialization potential APPLICATION PROCESS 6-9 MONTHS APPLICATION PROCESS 6-9 MONTHS Submit your SBIR/STTR Submit your SBIR/STTR grant application to grant application to NIH electronically NIH electronically Phase I: Phase I Phase II: Feasibility Feasibility study for study months for 6 $150K months SBIR, - $150K $150K SBIR, STTR $150K STTR Feasibility study for 6 months - $150K SBIR, $150K STTR SUBMIT FOR PHASE IIB Phase IIB: Feasibility study for 6 months - $150K SBIR, $150K STTR OBTAIN OUTSIDE FUNDING SOURCES Phase OBTAIN III: OUTSIDE Feasibility FUNDING SOURCES study for 6 months - $150K SBIR, $150K STTR Phase Phase III III SUBMIT FOR PHASE II SUBMIT FOR PHASE II Commercialization Non-SBIR/STTR funds Commercialization - Non-SBIR/STTR funds Niche For active Niche Phase I For Awardees active Phase I Awardees SUBMIT FOR PHASE II Feasibility study for 6 months - $150K SBIR, $150K STTR Phase Phase Full R&D for years $1M SBIR, $1M STTR II Full R&D for 2 years - $1M SBIR, $1M STTR II CAP SUBMIT FOR SUBMIT FOR PHASE IIB IF APPLICABLE For Phase CAPII or IIB PHASE IIB For Awardees Phase II or IIB Awardees Phase $1M per year for up to years Must have initial Phase II to apply. Some NIH ICs offer Phase IIB Phase $1M per year for up to 3 years - Must have initial Phase II to apply. Some NIH ICs offer Phase IIB IIB awards for projects that require extraordinary time and effort in the R&D phase. IIB awards for projects that require extraordinary time and effort in the R&D phase. and and Phase II II that that is is submitted and and reviewed together. OBTAIN OUTSIDE FUNDING SOURCES Fast Track: One One application for for Phase I I NIH Technology Assistance Programs: Helping You Bridge the Gap Niche NIH Technology Assessment Assistance Program: Provides Programs: active Helping Phase I You awardees Bridge with the market Gap research, entry strategies consumer and and competition analysis. analysis. Niche Assessment Program: Provides active Phase I awardees with market entry strategies and competition analysis. Commercialization Assistance Program (CAP): Trains Helps Phase II awardees develop on developing a tailored tailored market-entry entry plan strategies, for their building specific Commercialization technology. strategic alliances Assistance The plan and will Program partnerships, help establish (CAP): and Helps milestones developing Phase and II FDA awardees budgets regulatory develop accomplish and reimbursement a tailored commercialization market-entry paths, as plan goals, well for as and their financing will specific provide technology. strategies guidance and The on expertise plan target will consumers, help intellectual establish potential milestones property investors matters. and and budgets industry to accomplish competitors. commercialization goals, and will provide guidance on target consumers, potential investors and industry competitors. Visit Visit sbir.nih.gov sbir.nih.gov for for more more information! information!

IC Program Contacts NIH SBIR/STTR https://sbir.nih.gov/engage/ic-contacts Page 1 of 2 2/17/2016 HHS SBIR/STTR Agency Contact Information Questions of a general nature about the HHS SBIR/STTR Program may be directed to the following: SBIR/STTR Program Office Fax: 301-480-0146 sbir@od.nih.gov National Institute on Aging http://www.nia.nih.gov Dr. Matthew Portnoy Mr. J.P. Kim Phone: 301-435-2688 Phone: 301-435-0189 mportnoy@mail.nih.gov jpkim@nih.gov National Institute on Alcohol Abuse and Alcoholism http://www.niaaa.nih.gov National Institute of Allergy and Infectious Diseases http://www.niaid.nih.gov National Institute of Arthritis and Musculoskeletal and Skin Diseases http://www.niams.nih.gov/ National Institute of Biomedical Imaging and Bioengineering http://www.nibib.nih.gov/ National Cancer Institute http://sbir.cancer.gov Eunice Kennedy Shriver National Institute of Child Health and Human Development http://www.nichd.nih.gov National Institute on Drug Abuse http://www.nida.nih.gov National Institute on Deafness and Other Communication Disorders http://www.nidcd.nih.gov National Institute of Dental and Craniofacial Research http://www.nidcr.nih.gov National Institute of Diabetes and Digestive and Kidney Diseases http://www.niddk.nih.gov National Institute of Environmental Health Sciences http://www.niehs.nih.gov National Eye Institute http://www.nei.nih.gov National Institute of General Medical Sciences http://www.nigms.nih.gov/ National Heart, Lung, and Blood Institute http://www.nhlbi.nih.gov/research/funding/sbir/ Mr. Robert Vinson Phone: 301-435-2713 vinsonr@mail.nih.gov Dr. Michael-David A.R.R. Kerns Phone: 301-402-7713 Fax: 301-402-2945 Email: Michael-David.Kerns@nih.gov Dr. Kathy Jung Phone: 301-443-8744 Fax: 301-594-0673 Email: jungma@mail.nih.gov Dr. Natalia Kruchinin Phone: 240-669-2919 Fax: 240-627-3162 Email: kruchininn@niaid.nih.gov Dr. Xibin Wang Phone: 301-451-3884 Fax: 301-480-1284 Email: wangx1@mail.nih.gov Mr. Todd Merchak Phone: 301-496-8592 Fax: 301-480-1614 Email: merchakt@mail.nih.gov Mr. Michael Weingarten Dr. Greg Evans Dr. Andrew Kurtz Phone: 240-276-5300 Fax: 240-276-5236 Email: ncisbir@mail.nih.gov Louis A. Quatrano, Ph.D. Phone: 301-402-4221 Fax: 301-402-0832 Email: Quatranol@mail.nih.gov Elena Koustova, Ph.D., MBA Phone: 301-496-8768 Email: koustovae@nida.nih.gov Dr. Roger L. Miller Phone: 301-402-3458 Fax: 301-402-6251 Email: Roger.Miller@nih.gov Dr. R. Dwayne Lunsford Phone: 301-594-2421 Fax: 301-480-8319 Email: lunsfordr@mail.nih.gov Ms. Christine Densmore Phone: 301-402-8714 Fax: 301-480-8300 Email: densmorec@niddk.nih.gov Dr. Daniel T. Shaughnessy Phone: 919-541-2506 Fax: 919-541-4606 Email: shaughn1@niehs.nih.gov Dr. Jerome Wujek Phone: 301-451-2020 Fax: 301-496-2297 Email: wujekjer@nei.nih.gov Dr. Scott Somers Phone: 301-594-3827 Fax: 301-480-2802 Email: somerss@nigms.nih.gov Dr. Jennifer Shieh Phone: 301-496-2149 Ms. Betty Royster Phone: 301-402-1632 betty.royster@nih.gov Contact Ms. Linda Whipp Phone: 301-496-1472 Fax: 301-402-3672 Email: Linda.Whipp@nih.gov Ms. Judy Fox Phone: 301-443-4704 Fax: 301-443-3891 Email: Judy.Fox@nih.gov Ms. Vandhana Khurana, MBA Phone: 240-669-2966 Fax: 301-493-0597 Email: khuranav@niaid.nih.gov Jason Lundgren Phone: 240-669-2973 Fax: 301-493-0597 Email: Jason.Lundgren@nih.gov Ms. Aleisha S. James Phone: 301-594-3968 Fax: 301-480-5450 Email: jamesaleisha@mail.nih.gov Mr. James Huff Phone: 301-451-4786 Fax: 301-451-5735 Email: huffj@mail.nih.gov Ms. Jacquelyn Boudjeda Phone: 240-276-6312 Fax: 240-276-7913 Email: boudjedaj@mail.nih.gov Mr. Ted Williams Phone: 301-326-6450 Fax: 301-451-5510 Email: williate@mail.nih.gov Ms. Diana Haikalis, M.B.A. Phone: 301-443-6710 Fax: 301-594-6849 Email: dhaikali@nida.nih.gov Mr. Christopher P. Myers Phone: 301-435-0713 Fax: 301-402-1758 Email: Christopher.Myers@nih.gov Ms. Diana Dede Rutberg Phone: 301-594-4798 Fax: 301-480-3562 Email: rutbergd@mail.nih.gov Ms. Pamela Love Phone: 301-435-6198 Email: lovepa@mail.nih.gov Ms. Julie Beaver Phone: 301-496-8807 julie.beaver@nih.gov Awarding Component Scientific/Research Contact Financial/Grants Mgmt Ms. Pam Clark Phone: 919-541-7629 Fax: 919-541-2860 Email: evans3@niehs.nih.gov Mr. William Darby Phone: 301-451-2020 Fax: 301-496-9997 Email: wwd@nei.nih.gov Ms. Patrice Molnar Phone: 301-594-5136 Fax: 301-480-2554 Email: molnarp@nigms.nih.gov Ms. Ann Marie Brasile Mejac, AA,CRA Phone: 301-435-0164 Fax: 301-451-5462 Email: brasilea@nhlbi.nih.gov

IC Program Contacts NIH SBIR/STTR https://sbir.nih.gov/engage/ic-contacts Page 2 of 2 2/17/2016 Fax: 301-480-0422 Email: jennifer.shieh@nih.gov, nhlbi_sbir@mail.nih.gov Ms. Leslie West-Bushby Phone: 301-435-1498 Fax: 301-451-5462 Email: leslie.westbushby@nih.gov National Human Genome Research Institute http://www.genome.gov National Institute of Mental Health http://www.nimh.nih.gov National Institute on Minority Health and Health Disparities http://www.nimhd.nih.gov/ National Institute of Neurological Disorders and Stroke http://www.ninds.nih.gov National Institute of Nursing Research http://www.ninr.nih.gov/ National Center for Advancing Translational Sciences http://www.ncats.nih.gov National Center for Complementary and Integrative Health http://nccih.nih.gov National Library of Medicine http://www.nlm.nih.gov Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs http://dpcpsi.nih.gov/orip/index.aspx Centers for Disease Control and Prevention (CDC) http://www.cdc.gov Food and Drug Administration (FDA) http://www.fda.gov Administration for Children and Families http://www.acf.hhs.gov Dr. Michael W. Smith Phone: 301-496-7531 Fax: 301-480-2770 Email: smithmw@mail.nih.gov Dr. Margaret C. Grabb Phone: 301-443-3563 Fax: 301-443-1731 Email: mgrabb@mail.nih.gov Mr. Vincent A. Thomas, Jr. MSW, MPA Phone: 301-402-2516 Fax: 301-480-4049 Email: thomasvi@mail.nih.gov Ms. Stephanie Fertig Phone: 301-496-1779 Fax: 301-402-1501 Email: fertigs@ninds.nih.gov M r. Augusto Diana Phone: 301-402-6423 Fax: 301-480-8260 Email: augusto.diana@nih.gov Lili M. Portilla, MPA Phone : 301-217-2589 Fax : 301-480-3661 Email: Portilll@mail.nih.gov Dr. John S. Williamson Phone: 301-496-2583 Fax: 301-480-1552 Email: williamsonjs@mail.nih.gov Dr. Jane Ye Phone: 301-594-4882 Fax: 301-402-2952 Email: yej@mail.nih.gov Dr. Miguel Contreras Phone: 301-594-9410 Fax: 301-480-3819 Email: contre1@mail.nih.gov Overall CDC Coordinator: Mr. Sean David Griffiths Phone: 404.639.4641 Email: sqg3@cdc.gov Dr. Rachel Kaufmann (CSELS) Phone: 404-639-4641 Fax: 404-639-4903 Email: RKaufmann@cdc.gov Dr. Virginia Cain (NCHS) Phone: 301-458-4395 Fax: 301-458-4020 Email: VCain@cdc.gov Dr. Paul Smutz (NCIPC) Phone: 770-488-4850 Fax: 770-488-1665 Email: wsmutz@cdc.gov Dr. Steve Dearwent (NIOSH) Phone: 404-498-6382 Fax: 404-498-0751 Email: SDearwent@cdc.gov Ms. Monika Christman Phone: 301-435-7860 Fax: 301-451-5434 Email: monika_christman@nih.gov Ms. Rebecca Claycamp Phone: 301-443-2811 Fax: 301-443-6885 Email: rclaycam@mail.nih.gov Ms. Priscilla Grant, J.D. Phone: 301-594-8412 Fax: 301-480-4049 Email: Priscilla.Grant@nih.gov Ms. Tijuanna Decoster Phone: 301-496-9231 Fax: 301-402-4370 Email: decostert@mail.nih.gov Ms. Judy L. Sint Phone: 301-402-6959 Fax: 301-402-4502 Email: sintj@mail.nih.gov Ms. Artisha Y. Eatmon Phone: 301-435-0845 Fax: 301-480-3777 Email: artisha.eatmon@nih.gov Ms. Shelley Carow Phone: 301-594-3788 Fax: 301-480-1552 Email: carows@mail.nih.gov Mr. Dwight Mowery Phone: 301-496-4221 Fax: 301-402-0421 Email: moweryd@mail.nih.gov Ms. Artisha Y. Eatmon Phone: 301-435-0845 Fax: 301-480-3777 Email: artisha.eatmon@nih.gov Ms. Devi Hawkins (CSELS, NCIPC) Phone: 770-488-2543 Fax: 770-488-2670 Email: DHawkins@cdc.gov Sharron Orum (NCHS) Phone: 770-488-2716 Fax: 770-488-2847 Email: SOrum@cdc.gov Ms. Mary Pat Shanahan (NIOSH) Phone: 412-386-4453 Fax: 412-386-6429 Email: MShanahan@cdc.gov Ms. Kimberly Pendleton Chew Mr. Bryce Jones Phone: 301-827-9363 Phone: 240-402-2111 Fax: 301-827-0505 Email: Bryce.Jones@fda.hhs.gov Email: kimberly.pendleton@fda.hhs.gov Naomi Goldstein Phone: 202-401-9220 Fax: 202-205-3598 Email: naomi.goldstein@acf.hhs.gov Karl Koerper Phone: 202-401-9220 Fax: 202-205-3598 Email: karl.koeper@acf.hhs.gov

SBIR: Small Business Innovation Research Set-aside program to fund small business early stage R&D For small business concerns (SBC) that are organized as for-profit USbased businesses with fewer than 500 employees SBC must do at least 2/3 of R&D work in Phase I, at least 1/2 in Phase II PI must be greater than 50% employed by SBC STTR: Small Business Technology Transfer Basic SBC eligibility same as SBIR Formal cooperative R&D effort with a US research institution SBC must do minimum 40% of work; research institution must do minimum 30% of work PI may be primarily employed by either SBC or research institution Proof- of- Concept study $150,000 over 6 mo (SBIR), 1 year (STTR); max $225,000* NEW Direct-to- Phase II Technology valida-on & clinical transla-on Follow- on funding for SBIR Phase II awardees Expecta-on that applicants will secure substan-al 3 rd - party investor funds $1M per year over 3 years- varies Phase I FEASIBILITY Phase II DEVELOPMENT Fast-Track Application Combined Phase I & II Research & Development Commercializa-on plan required $1M over 2 years; max $1.5M* Benefits of the SBIR/STTR Programs Funding is non-dilutive & doesn t impact company stock Awards are not loans; no repayment is required Intellectual property rights are retained by the small business Awards provide company recognition, verification, and visibility Projects are vetted through NIH s rigorous scientific peer review Can be used as leverage to attract additional funding NCI SBIR Phase IIB Bridge Award CROSSING THE VALLEY OF DEATH FY16 SBIR/STTR Funding ~$877M at NIH ~$13M at NIAAA Phase III COMMERCIALIZATION Commercializa-on stage Use of non- SBIR/STTR funds SBIR/STTR Program Goals Stimulate technological innovation Meet Federal R&D needs Foster & encourage participation in innovation & entrepreneurship by socially & economically disadvantaged persons Increase private-sector commercialization of innovations derived from Federal R&D funding

Peer Review & Grant Opportunities at NIH Abraham P. Bautista, Ph.D. Director, Office of Extramural Activities Executive Secretary NACAAA NIAAA/NIH/DHHS http://www.niaaa.nih.gov/

National Institutes of Health NIH s mission is 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 the burdens of illness and disability. NIH provides leadership and direction to programs designed to improve the health of the Nation by conducting (INTRAMURAL) and supporting (EXTRAMURAL) research

National Institutes of Health (OD) (27 Institutes and Centers) http://www.nih.gov/icd/index.html http://www.nih.gov/institutes-nih/directors-nih-institutes-centers NCI* NEI NHLBI NHGRI NIA NIAAA* NIAID NIAMS NIBIB NICHD NIDCD NIDCR NIDDK NIDA* NIEHS NIGMS NIMH NINDS NINR NLM CIT CSR FIC NCCIH NIMHD NCATS CC *Collaborative Research on Addiction at NIH (CRAN) - http://addictionresearch.nih.gov/

NIAAA VISION STATEMENT To support and promote the best science on alcohol and health for the benefit of all by: Increasing the understanding of normal and abnormal biological functions and behavior relating to alcohol use Improving the diagnosis, prevention, and treatment of alcohol use disorders Enhancing quality health care

Preparation and Submission of Grant Applications and Cooperative Agreements Federal Officials Program Officers/Directors (scientific programs) Scientific Review Officers (first level of review grants and cooperative agreements) Executive Secretaries of Advisory Councils (second level of review) Grants Management Specialists (grants management of funded grants only)

Funding Opportunity Announcements (FOA) RFA (Request for Applications) Set-asides RFA AA 11-001 PA (Program Announcement) No set-asides PA 06-181 PAS (PA) with set-asides PA 11-165 PAR (PA with receipt, referral, review info) May or may not have set-aside funding PAR 03-134 N.B. Applications not responding to an RFA are returned without review.

Grants Process at a Glance

How to read your Grant Number Type Activity IC Number Year 1 R21 AI 012345 01-A1 2 R01 AA 543210 06 3 R01 DA 543210 06-S1 9 R01 MH 543210 09 5 R01 CA 543210 06-S1

PEER REVIEW

NIH Tips for Applicants (YouTube Video) NIH Tips for Applicants: http://www.youtube.com/watch? v=9cnrmscgfho&feature=chann el

CENTER FOR SCIENTIFIC REVIEW (CSR) http://public.csr.nih.gov/pages/default.aspx http://cms.csr.nih.gov/ All applications go through the Division of Receipt and Referral CSR. Submission of e-grant applications, Grants.gov https://era.nih.gov/files/assist_user_guide.pdf Administrative Supplement applications are submitted through Grants.gov or era directly to the institute of the parent grant. (not subjected to peer review).

Locus of Review IC Reviews Vs. CSR Reviews Standing study section Vs. Special Emphasis Panel (Rosters of all NIH review panels are available at https://public.era.nih.gov/pubroster/

Integrated Review Groups (CSR), Examples Related Research (AARR) IRG-Study Sections AIDS Immunology & Pathogenesis (AIP) NeurAIDS oaids and End Organ (NAED) AIDS Clinical and Epidemiology (ACE) Risk Prevention Health Behavior (RPHB) IRG-Study Sections Risk, Prevention and Intervention for Addictions (RPIA) Psychosocial Development, Risk and Prevention (PDRP)

NIAAA REVIEW SUBCOMMITTEES http://www.niaaa.nih.gov/grant-funding/application-process/niaaa-scientific-reviewgroup-rosters AA-1 Biomedical Sciences (non-brain) AA-2 Prevention and Epidemiology AA-3 Clinical, Treatment and Health Services AA-4 Neuroscience and Behavior ZAA-1 (Special Emphasis Panel for grants and contracts) ZAA-1 (Special Emphasis Panel for Fellowship applications) ZAA-1 (Special Emphasis Panel for T32/T35 Centers NIAAA & NIDA) ZAA1 SRC 99 is not a study section

Review Meetings (Standing IRG, SEP or Editorial Board) Face to face meeting Site visits, reverse site visits included. Internet Assisted Meeting Video Conference Teleconference Mail Review/Editorial Board

Review Criteria (R01, R03, U01) Significance Investigators Innovation Approach Environment

Review Criteria (R24, U24) Resource Mechanisms Investigators Approach/Innovation Environment

SCORING

Review Criteria (Fellowships) Candidate Sponsors/Mentors Research Training Plan Training Potential Institutional Support Non-scorable criterion: Training in Responsible Conduct of Research

At the Review Meeting Scientific Review Officer: Responsible for the administrative issues. Chairperson and Members: Responsible for the scientific issues.

At the Review Meeting Federal Requirement: Confidentiality Conflict of Interest Scientific Misconduct Review Order Discussion of the upper half, scored Streamlining lower half not discussed, no assigned priority score

Percentiling R01s are percentiled R01s in RFAs are not percentiled Percentile is the assigned rank of an application based on the scoring pattern of a Study Section (at least 20 applications during the last 3 rounds). E.g. Priority score of 30 may have a percentile of 20%. Priority score of 10 is assigned a percentile of 1%

After the review Summary Statements are released within 30 days after the review, or at least 30 days before the Council Meeting, which ever is earlier Scores are released within 3 business days Second Level of Review by the IC s National Advisory Council Funding Recommendation to the IC Directors Grants Management Office for the Issuance of NGA (Notice of Grant Award) Description/Abstract/Total Cost of funded grants reported in http://www.projectreporter.nih.gov/reporter.cfm for public information

Fiscal Year 2015 Funding Update From NIAAA Director s Report to Council http://www.niaaa.nih.gov/about-niaaa/our-work/advisory-council/directorsreports-council/niaaa-directors-report-institute-11 NIAAA s final appropriation for NIAAA was $447.2 million. NIAAA awarded 668 research project grants (RPGs), including 156 competing awards, which corresponds to a success rate of 18 percent. NIAAA funded 18 research centers for $28.0 million. NIAAA funded 135 other research grants for $37.2 million, including career awards, one cooperative clinical agreement, and several resource and conference grant awards. NIAAA supported 277 full-time training positions for $12.7 million. NIAAA funding for its research and development contract portfolio was $36.6 million. NIAAA support for intramural research totaled $49.5 million.

FISCAL YEAR 2016 NIH received $32.3 billion ($ 2 billion above 2015) NIAAA received $ 467.7 M ($ 20.5 million or 4.9 % over 2015)

NIAAA 2015 Success Rate R01-15% R03-14% R21-14% F30-71% F31-45% F32-24%

NIH RePORTER

Unfunded Applications remain confidential and are not public information

RECENT NIH UPDATES Enhancing Reproducibility through Rigor and Transparency ( http://grants.nih.gov/grants/guide/notice-files/not-od-15-103.html) One of NIH s four stated goals is to exemplify and promote the highest level of scientific integrity, public accountability, and social responsibility in the conduct of science (see http://www.nih.gov/about/mission.htm).

Enhancing Reproducibility through Rigor and Transparency Review criteria will focus on 1. the scientific premise of the proposed research, 2. rigorous experimental design for robust and unbiased results, 3. consideration of relevant biological variables, 4. authentication of key biological and/or chemical resources. Timeline: Guidelines for reviewers will be available before the review of applications for October 2016 Council Cycle.

NIAAA Contact Information Office of the Director (George F. Koob, Ph.D, Director, NIAAA) Patricia Powell, Ph.D., Acting Deputy Director NIAAA Kendall Bryant, Ph.D., AIDS/HIV Coordinator Judy Arroyo, Ph.D., Diversity Coordinator Margaret Murray, Ph.D., International Liaison Officer Office of Extramural Activities, NIAAA Abraham P. Bautista, Ph.D., Director (301 443 9737) bautista@mail.nih.gov Judy Fox, Chief, Grants Management Branch Ranga Srinivas, Ph.D., Chief Extramural Project Review Branch Division Directors, NIAAA Antonio Noronha, Ph.D. (DNB) Gary Murray, Ph.D. (DMHE) M. Katherine Jung, Ph.D. (NIAAA Small Business Liaison Officer) Ralph Hingson, D. Sc. (DEPR) Robert Huebner, Ph.D. (DTRR) Raye Litten, Ph.D. (DMD)

NIAAA-SUPPORTED RESEARCH OVERVIEW M. Katherine Jung, Ph.D. NIAAA Mississippi State University February 24, 2016

NIAAA areas of interest DMHE Scientific Programs (1) Alcoholic liver disease occurs in a subset of chronic drinkers, with the progression: steatosis, steatohepatitis, fibrosis, cirrhosis, hepatocellular carcinoma; and in some cases acute hepatitis Alcohol adversely affects the function, homeostasis and integrity of other organs, including: the lung, the gut, pancreas, cardiovascular system, kidney, bone, and muscle Alcohol consumption interferes with immune function, resulting in: increased rates of infection, unchecked inflammation leading to tissue damage, impaired healing, enhanced viral hepatitis, and HIV progression Maternal alcohol consumption during pregnancy can lead to Fetal Alcohol Spectrum Disorders

NIAAA areas of interest DMHE Scientific Programs (2) Alcohol intake is associated with specific cancers, including: head and neck, liver, colon, and breast cancers Molecular and cellular processes altered or impaired by alcohol metabolism that may underlie the clinically observed health effects include: organelle stress in mitochondria, endoplasmic reticulum, and proteasomes; oxidative imbalances; epigenetic modifications, inflammation and other metabolic disruptions Biomarkers are needed for early diagnosis of alcohol consumption and alcohol-induced organ damage Director: Dr. Gary Murray (Acting)

NIAAA areas of interest Division of Epidemiology and Prevention Research. seeks to reduce alcohol-related mortality and morbidity and other alcohol-related problems and consequences through the integration and application of epidemiology and prevention science. Director: Dr. Ralph Hingson

NIAAA areas of interest Division of Neuroscience and Behavior promotes research on ways in which neuronal and behavioral systems are influenced by genetic, developmental, and environmental factors in conjunction with alcohol exposure to engender alcohol abuse and alcoholism. Director: Dr. Antonio Noronha

NIAAA areas of interest Division of Treatment and Recovery Research. supports research to better understand the natural history of excessive drinking and alcohol use disorders and factors associated with positive change. Director: Dr. Robert Huebner (Acting)

NIAAA areas of interest Division of Medications Development focuses on pharmacological treatment for alcohol use disorder (AUD) and supports clinical research programs. Director: Dr. Raye Litten (Acting)

Grant Mechanisms R01 R21 R03 F31 F30 F32 T32 Research Research Project Grant Exploratory/Developmental Research Grant Small Grant Training Individual Predoc Individual MD/PhD Predoc Individual Postdoc Institutional Training Grant Career Development K99/R00 NIH Pathway to Independence Award K01 Mentored Research K02 Independent Scientist K08 Mentored Clinical Scientist Research K23 Mentored Patient-Oriented Research K24 Midcareer Investigator Award in Patient-Oriented Research

Research grants R01 Research Project Grant Single project New and established investigators R21 Exploratory/Developmental Research Grant High risk/high yield Limited time and $$ No pilot data necessary R03 Small Grant Pilot project Limited time and $$

For everyone Contact your program officer Before you start to write a grant application To see if the topic area is of interest to, is a priority for, NIAAA (Funding is limited.) For advice on choice of mechanism (R21 vs R01, which F grant or K grant) While preparing the application With questions that arise along the way

For everyone Contact your program officer After you have received funding With any questions that arise Only exception: After application submission and until review has been completed, your point of contact is the Scientific Review Officer (SRO).

Getting started The mechanics of applying Register early at grants.gov and ecommons Can take 8 weeks SF-424 Form and Instructions for your mechanism Page limits, specific requirements Your university submits the grant to NIH, so work with your grants office ahead of time.

Getting started The mechanics of applying Read Instructions carefully Who will be responsible for completing the different forms within the application? When must your grants office receive the forms in order to submit on time? Submit well before the deadline, in case of glitches

Getting started Strategies for a competitive application State rationale clearly Be organized, lucid, succinct Never assume reviewers will know what you mean Present a thorough and accurate literature review Propose work that can be realistically completed within the project s time-frame Perform power analysis Publish regularly in high quality journals Recruit expert collaborators to the project when needed (and obtain letters from collaborators)

Getting started Strategies for a competitive application Ask others to review your application ahead of time- the more people the better- Who: Colleagues in your lab, in your department, outside your department, those in a different field. Listen to the advice and be willing to make necessary changes.

Review and Award Cycles Cycle 1 Cycle 2 Cycle 3 Receipt date ScienJfic Merit Review Advisory Council Round Earliest Project Start Date February- March June- July October- November June - July October - November October January May December April July February - March

Career development Career Development Awards K99/R00 NIH Pathway to Independence Award K01 Mentored Research Scientist K02 Independent Scientist K08 Mentored Clinical Scientist Research K23 Mentored Patient-Oriented Research K24 Midcareer Investigator Award in Patient- Oriented Research

Career development K99/R00 NIH Pathway to Independence Award Eligibility < 4 years post-doc research Duration 1-2 years mentored post-doc; 3 years independent support K99 Salary up to $90,000 DC Research $$ up to $50,000 DC R00 Research $$ up to $249,000 TC

Training Support National Research Service Awards (NRSA) Pre- doctoral InsJtuJonal T32 Individual F30 F31 Max 5 years of aggregate NRSA support, any combinajon of T32 and individual grant. Post- doctoral InsJtuJonal T32 Individual F32 Max 3 years of aggregate NRSA support, any combinajon of T32 and individual grant.

Training Support Fellowship review criteria Applicant Sponsor Research training plan Training potenjal InsJtuJonal and Training environment Also Human subjects/vertebrate animals Training in the responsible conduct of research

Training Support Fellowship review criteria Important factors: Commitment of the trainee to alcohol research Mentor s success in the alcohol field and in mentoring trainees

Updates Changes in Biosketch Contents NOT-OD-15-085 Length up to 5 pages!!! A. Personal Statement: aspects training; previous work & technical experase; collaborators or scienafic environment; past performance. B. PosiJons and Honors C. ContribuJons to Science Briefly describe up to five of your most significant contribuaons to science. Up to 4 relevant peer- reviewed publicaaons for each contribuaon. D. Research Support

What does it mean to be compliant with the new biosketch policy? CompleAng each secaon (A - Personal Statement; B PosiAons and Honors; C ContribuAons to Science; D Research Support or ScholasAc Performance) Including no more than 5 contribuaons to science with no more than 4 citaaons per contribuaon Ensuring that if you include the opaonal link to a full list of your published work in a site like My Bibliography that the URL is public, that it meet all requirements in the instrucaons.

What does it mean to be compliant with the new biosketch policy? (2) Refraining from including informaaon, such as preliminary data, that belongs elsewhere in the applicaaon Following NIH guidance on font type, font size, paper size, and margins (See secaon 2.6 of applicaaon guide) Using PDF format for your biosketch a[achment LimiAng the length of your biosketch to 5 pages or less

Update No limit on resubmission NOT-OD-14-074 following an unsuccessful resubmission (A1) application, applicants may submit the same idea as a new (A0) application for the next appropriate due date.

SBIR/STTR SBIR Small Business InnovaAon Research STTR Small Business Technology Transfer

SBIR/STTR SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM Set- aside program for small business concerns to engage in Federal R&D - - with potenjal for commercializajon. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM Set- aside program to facilitate cooperajve R&D between small business concerns and U.S. research insjtujons - - with potenjal for commercializajon.

SBIR/STTR NIH SBIR/STTR 3- Phase Program PHASE I Feasibility Study Budget Guide: $150K (SBIR); $150K (STTR) Total Costs $225K Project Period: 6 months (SBIR); 1 year (STTR) Flexible PHASE II Full Research/R&D $1M (STTR), $1M (SBIR) over two years $1.5M, years flexible PHASE IIB CompeAng Renewal/R&D Clinical R&D; Complex InstrumentaAon/Tools to FDA Many, but not all, ICs paracipate NIAAA parjcipates Varies ~$1M/year; 3 years To be determined case by case PHASE III CommercializaAon Stage NIH, generally, not the customer Consider partnering and exit strategy early

SBIR/STTR SBIR STTR 1 [R43] Phase I Phase I [R41] 1 2 [R44] Phase II Phase II [R42] 2 FastTrack Type 1 R44 FastTrack Type 1 R42

NIH SBIR/STTR Budget Allocations FY2015 NIAMS NIEHS NHGRI NIAAA NIMHD NIDCR NIDCD NIBIB ORIP NINR NCCAM NLM NCI 2.9% SBIR $690M 0.40% STTR $95M Total FY2015 $786M NCATS NEI NIDA NIA NIAID NICHD NIMH NINDS NHLBI NIDDK NIGMS

Small businesses must be up- to- date on FIVE registrajons 1) SAM = System for Award Management (formerly CCR) MUST BE RENEWED ANNUALLY 2) DUNS 3) Grants.gov 4) era Commons 5) Small Business AdministraJon (SBA) Company Registry If the SBC moves, changes their address, or changes their name, they will have to go into all of the systems and update their informajon.

32 New hfp//sbir.nih.gov

SBIR/STTR New SBIR/STTR Standard Due Dates * EffecJve September 5, 2015 Cycle I Due Date Cycle II Due Date Cycle III Due Date September 5 January 5 April 5

Thank you For more information, please contact: Kathy Jung -- Kathy.jung@nih.gov--301-443-8744 Oh, and Talk to your program officer!