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
Research
Research Project Grant
Exploratory/Developmental Research Grant
Small Grant
Training
F31
F30
F32
T32
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 timethe more people the betterWho: 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
Receipt date ScienJfic Merit Review Advisory Council Round Earliest Project Start Date Cycle 2
Cycle 3
February-­‐March June-­‐ July October-­‐November June -­‐ July October -­‐ November February -­‐ March October January May December April July 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 PatientOriented 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 $$
up to $50,000 DC
Research $$
up to $249,000 TC
R00
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. NIH SBIR/STTR 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 I [R41] 1 1 [R43] Phase I Phase 2 [R44] Phase II Phase II [R42] 2 FastTrack FastTrack Type 1 R44 Type 1 R42 NIH SBIR/STTR Budget Allocations FY2015
NIMHD NIAAA NIDCR NIAMS NHGRI NIDCD NINR ORIP NIBIB 2.9% SBIR $690M
0.40% STTR $95M
Total FY2015 $786M
NCCAM NLM NCI NIEHS NCATS NEI NIDA NIAID NIA NICHD NIMH NHLBI NINDS 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. New hfp//sbir.nih.gov 32 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 -- [email protected]
Oh, and…
Talk to your program officer!
STTR: Small Business Technology Transfer
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
•  Proof-­‐of-­‐Concept study •  $150,000 over 6 mo (SBIR), 1 year (STTR); max $225,000* NEW Direct-toPhase II
Phase I FEASIBILITY •  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
•  Technology valida-on & clinical transla-on •  Follow-­‐on funding for SBIR Phase II awardees •  Expecta-on that applicants will secure substan-al 3rd-­‐party investor funds •  $1M per year over 3 years-­‐ varies Phase II DEVELOPMENT Fast-Track Application
Combined Phase I & II
NCI SBIR Phase IIB Bridge Award Phase III COMMERCIALIZATION CROSSING THE VALLEY OF DEATH •  Commercializa-on stage •  Use of non-­‐SBIR/STTR funds •  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
FY16 SBIR/STTR
Funding
~$877M at NIH
~$13M at NIAAA
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
Small Business Innovation
Research & Small Business
Technology Transfer Programs
SBIR - STTR: Advancing Medicine Through Innovation
The NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs award federal
research grants to small businesses conducting biomedical research. The purpose of these programs is to spur technological innovation and help the federal government meet its research and development (R&D) needs, with the ultimate goal
being commercialization of these innovative technologies and improved public health.
FAST TRACK
Phase
I
Register your
business
Choose program &
submit application
Phase
III
Phase
II
Niche
CAP
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:
Determine which
Funding Opportunity
is Best Suited for You
Funding Opportunity
Announcements (FOAs):
SBIR (PA-14-071) and STTR
(PA-14-072)
NIH is interested in YOUR
research ideas - apply using
the Omnibus solicitation
FOAs:
Issued by NIH’s Institutes and
Centers (ICs)
Decide between SBIR
and STTR Funding
SBIR:
Principal Investigator: Must be
employed by the small business
Research Partner: Research partner
optional, total effort up to 33% for
Phase I and 50% for Phase II
STTR:
Principal Investigator: Can be
employed by the small business or
a non-profit research institution
Research Partner:
Required. Formal collaborative
effort between small business
(minimum 40%) and research
institution (minimum 30%)
Submit Your
Application Early
The grants registration process
can take 6-8 weeks!
There are 5 required
registrations:
1. DUNS
2. Sam.gov
3. Grants.gov
4. eRA Commons
5. SBA Registry
Standard Grant Due Dates:
Phase I and Phase II:
April 5, August 5, December 5
AIDS and AIDS-related:
May 7, September 7, January 7
If you have questions about any of these steps, please contact [email protected], 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.
Stay Connected!
Subscribe to the SBIR/STTR listserv:
Email [email protected] with this text in the
message body: “subscribe SBIR-STTR your name”
Contact Us:
[email protected]
Website:
sbir.nih.gov
Follow us on Twitter:
@NIHsbir
Follow the below steps to get started on the application process!
Confirm your small
business concern (SBC)
meets eligibility requirements
SBIR Omnibus
(PA-14-071)
STTR Omnibus
(PA-14-072)
CONTACT NIH BEFORE APPLYING
Develop an innovative
research idea for
your SBC
Five required registrations:
1. DUNS
4. eRA Commons
2. SAM.gov
5. SBA Registry
3. Grants.gov
CHOOSE
ONE
FOA
Targeted
SBIR/STTR FOAs
$
Awardee
conducts
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
APPLICATION PROCESS 6 - 9 MONTHS
Feasibility study for 6 months - $150K SBIR, $150K STTR
Full R&D for 2 years - $1M SBIR, $1M STTR
SUBMIT FOR PHASE IIB IF APPLICABLE
Phase
IIB
CAP
Fast Track:
SUBMIT FOR PHASE II
Phase
II
Niche
For active Phase I
Awardees
One application for Phase I
and Phase II that is submitted
and reviewed together.
Phase
I
For Phase II or IIB
Awardees
$1M per year for up to 3 years - Must have initial Phase II to apply. Some NIH ICs offer Phase IIB
awards for projects that require extraordinary time and effort in the R&D phase.
OBTAIN OUTSIDE FUNDING SOURCES
Phase
III
Commercialization - Non-SBIR/STTR funds
NIH Technology Assistance Programs: Helping You Bridge the Gap
Niche Assessment Program: Provides active Phase I awardees with market research, consumer and competition analysis.
Commercialization Assistance Program (CAP): Trains Phase II awardees on developing tailored market entry strategies,
building strategic alliances and partnerships, and developing FDA regulatory and reimbursement paths, as well as
financing strategies and expertise on intellectual property matters.
Visit sbir.nih.gov for more information!
IC Program Contacts | NIH SBIR/STTR
Page 1 of 2
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
[email protected]
Dr. Matthew Portnoy Mr. J.P. Kim
Phone: 301-435-2688 Phone: 301-435-0189
[email protected] [email protected]
Awarding Component
Mr. Robert Vinson
Phone: 301-435-2713
[email protected]
Scientific/Research Contact
Ms. Betty Royster
Phone: 301-402-1632
[email protected]
Ms. Julie Beaver
Phone: 301-496-8807
[email protected]
Financial/Grants Mgmt
Contact
National Institute on Aging
http://www.nia.nih.gov
Dr. Michael-David A.R.R. Kerns
Phone: 301-402-7713
Fax: 301-402-2945
Email: [email protected]
Ms. Linda Whipp
Phone: 301-496-1472
Fax: 301-402-3672
Email: [email protected]
National Institute on Alcohol Abuse and Alcoholism
http://www.niaaa.nih.gov
Dr. Kathy Jung
Phone: 301-443-8744
Fax: 301-594-0673
Email: [email protected]
Ms. Judy Fox
Phone: 301-443-4704
Fax: 301-443-3891
Email: [email protected]
National Institute of Allergy and Infectious Diseases
http://www.niaid.nih.gov
Dr. Natalia Kruchinin
Phone: 240-669-2919
Fax: 240-627-3162
Email: [email protected]
Ms. Vandhana Khurana, MBA
Phone: 240-669-2966
Fax: 301-493-0597
Email: [email protected]
Jason Lundgren
Phone: 240-669-2973
Fax: 301-493-0597
Email: [email protected]
National Institute of Arthritis and Musculoskeletal and
Skin Diseases
http://www.niams.nih.gov/
Dr. Xibin Wang
Phone: 301-451-3884
Fax: 301-480-1284
Email: [email protected]
Ms. Aleisha S. James
Phone: 301-594-3968
Fax: 301-480-5450
Email: [email protected]
National Institute of Biomedical Imaging and
Bioengineering
http://www.nibib.nih.gov/
Mr. Todd Merchak
Phone: 301-496-8592
Fax: 301-480-1614
Email: [email protected]
Mr. James Huff
Phone: 301-451-4786
Fax: 301-451-5735
Email: [email protected]
National Cancer Institute
http://sbir.cancer.gov
Mr. Michael Weingarten
Dr. Greg Evans
Dr. Andrew Kurtz
Phone: 240-276-5300
Fax: 240-276-5236
Email: [email protected]
Ms. Jacquelyn Boudjeda
Phone: 240-276-6312
Fax: 240-276-7913
Email: [email protected]
Eunice Kennedy Shriver
National Institute of Child Health and Human
Development
http://www.nichd.nih.gov
Louis A. Quatrano, Ph.D.
Phone: 301-402-4221
Fax: 301-402-0832
Email: [email protected]
Mr. Ted Williams
Phone: 301- 326-6450
Fax: 301- 451-5510
Email: [email protected]
National Institute on Drug Abuse
http://www.nida.nih.gov
Elena Koustova, Ph.D., MBA
Phone: 301-496-8768
Email: [email protected]
Ms. Diana Haikalis, M.B.A.
Phone: 301-443-6710
Fax: 301-594-6849
Email: [email protected]
National Institute on Deafness and Other
Communication Disorders
http://www.nidcd.nih.gov
Dr. Roger L. Miller
Phone: 301-402-3458
Fax: 301-402-6251
Email: [email protected]
Mr. Christopher P. Myers
Phone: 301-435-0713
Fax: 301-402-1758
Email: [email protected]
National Institute of Dental and Craniofacial Research
http://www.nidcr.nih.gov
Dr. R. Dwayne Lunsford
Phone: 301-594-2421
Fax: 301-480-8319
Email: [email protected]
Ms. Diana “Dede” Rutberg
Phone: 301-594-4798
Fax: 301-480-3562
Email: [email protected]
National Institute of Diabetes and Digestive and Kidney
Diseases
http://www.niddk.nih.gov
Ms. Christine Densmore
Phone: 301-402-8714
Fax: 301-480-8300
Email: [email protected]
Ms. Pamela Love
Phone: 301-435-6198
Email: [email protected]
National Institute of Environmental Health Sciences
http://www.niehs.nih.gov
Dr. Daniel T. Shaughnessy
Phone: 919-541-2506
Fax: 919-541-4606
Email: [email protected]
Ms. Pam Clark
Phone: 919-541-7629
Fax: 919-541-2860
Email: [email protected]
National Eye Institute
http://www.nei.nih.gov
Dr. Jerome Wujek
Phone: 301-451-2020
Fax: 301-496-2297
Email: [email protected]
Mr. William Darby
Phone: 301-451-2020
Fax: 301-496-9997
Email: [email protected]
National Institute of General Medical Sciences
http://www.nigms.nih.gov/
Dr. Scott Somers
Phone: 301-594-3827
Fax: 301-480-2802
Email: [email protected]
Ms. Patrice Molnar
Phone: 301-594-5136
Fax: 301-480-2554
Email: [email protected]
National Heart, Lung, and Blood Institute
http://www.nhlbi.nih.gov/research/funding/sbir/
Dr. Jennifer Shieh
Phone: 301-496-2149
https://sbir.nih.gov/engage/ic-contacts
Ms. Ann Marie Brasile Mejac, AA,CRA
Phone: 301-435-0164
Fax: 301-451-5462
Email: [email protected]
2/17/2016
IC Program Contacts | NIH SBIR/STTR
Page 2 of 2
Fax: 301-480-0422
Email: [email protected],
Ms. Leslie West-Bushby
Phone: 301-435-1498
Fax: 301-451-5462
Email: [email protected]
[email protected]
National Human Genome Research Institute
http://www.genome.gov
Dr. Michael W. Smith
Phone: 301-496-7531
Fax: 301-480-2770
Email: [email protected]
Ms. Monika Christman
Phone: 301-435-7860
Fax: 301-451-5434
Email: [email protected]
National Institute of Mental Health
http://www.nimh.nih.gov
Dr. Margaret C. Grabb
Phone: 301-443-3563
Fax: 301-443-1731
Email: [email protected]
Ms. Rebecca Claycamp
Phone: 301-443-2811
Fax: 301-443-6885
Email: [email protected]
National Institute on Minority Health and Health
Disparities
http://www.nimhd.nih.gov/
Mr. Vincent A. Thomas, Jr.
MSW, MPA
Phone: 301-402-2516
Fax: 301-480-4049
Email: [email protected]
Ms. Priscilla Grant, J.D.
Phone: 301-594-8412
Fax: 301-480-4049
Email: [email protected]
National Institute of Neurological Disorders and Stroke
http://www.ninds.nih.gov
Ms. Stephanie Fertig
Phone: 301-496-1779
Fax: 301-402-1501
Email: [email protected]
Ms. Tijuanna Decoster
Phone: 301-496-9231
Fax: 301-402-4370
Email: [email protected]
National Institute of Nursing Research
http://www.ninr.nih.gov/
Mr. Augusto Diana
Phone: 301-402-6423
Fax: 301-480-8260
Email: [email protected]
Ms. Judy L. Sint
Phone: 301-402-6959
Fax: 301-402-4502
Email: [email protected]
National Center for Advancing Translational Sciences
http://www.ncats.nih.gov
Lili M. Portilla, MPA
Phone : 301-217-2589
Fax : 301-480-3661
Email: [email protected]
Ms. Artisha Y. Eatmon
Phone: 301-435-0845
Fax: 301-480-3777
Email: [email protected]
National Center for Complementary and Integrative
Health
http://nccih.nih.gov
Dr. John S. Williamson
Phone: 301-496-2583
Fax: 301-480-1552
Email: [email protected]
Ms. Shelley Carow
Phone: 301-594-3788
Fax: 301-480-1552
Email: [email protected]
National Library of Medicine
http://www.nlm.nih.gov
Dr. Jane Ye
Phone: 301-594-4882
Fax: 301-402-2952
Email: [email protected]
Mr. Dwight Mowery
Phone: 301-496-4221
Fax: 301-402-0421
Email: [email protected]
Division of Program Coordination, Planning and
Strategic Initiatives, Office of Research Infrastructure
Programs
http://dpcpsi.nih.gov/ORIP/index.aspx
Dr. Miguel Contreras
Phone: 301-594-9410
Fax: 301-480-3819
Email: [email protected]
Ms. Artisha Y. Eatmon
Phone: 301-435-0845
Fax: 301-480-3777
Email: [email protected]
Centers for Disease Control and Prevention (CDC)
http://www.cdc.gov
Overall CDC Coordinator:
Mr. Sean David Griffiths
Phone: 404.639.4641
Email: [email protected]
Dr. Rachel Kaufmann (CSELS)
Phone: 404-639-4641
Fax: 404-639-4903
Email: [email protected]
Dr. Virginia Cain (NCHS)
Phone: 301-458-4395
Fax: 301-458-4020
Email: [email protected]
Dr. Paul Smutz (NCIPC)
Phone: 770-488-4850
Fax: 770-488-1665
Email: [email protected]
Dr. Steve Dearwent (NIOSH)
Phone: 404-498-6382
Fax: 404-498-0751
Email: [email protected]
Ms. Devi Hawkins (CSELS, NCIPC)
Phone: 770-488-2543
Fax: 770-488-2670
Email: [email protected]
Sharron Orum (NCHS)
Phone: 770-488-2716
Fax: 770-488-2847
Email: [email protected]
Ms. Mary Pat Shanahan (NIOSH)
Phone: 412-386-4453
Fax: 412-386-6429
Email: [email protected]
Food and Drug Administration (FDA)
http://www.fda.gov
Ms. Kimberly Pendleton Chew
Mr. Bryce Jones
Phone: 301-827-9363
Phone: 240-402-2111
Fax: 301-827-0505
Email: [email protected]
Email: [email protected]
Administration for Children and Families
http://www.acf.hhs.gov
Naomi Goldstein
Phone: 202-401-9220
Fax: 202-205-3598
Email: [email protected]
https://sbir.nih.gov/engage/ic-contacts
Karl Koerper
Phone: 202-401-9220
Fax: 202-205-3598
Email: [email protected]
2/17/2016
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
• R03
• R21
- 15%
- 14%
- 14%
• F30
• F31
• F32
- 71%
- 45%
- 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. 
2. 
3. 
4. 
the scientific premise of the proposed research,
rigorous experimental design for robust and unbiased results,
consideration of relevant biological variables,
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) [email protected]
–  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)