NHLBI Funding Opportunities and FDA Regulatory Guidance

national heart, lung and blood institute logo image

Office of Translational Alliances and Coordination

Today! Pre-proposal Webinar - HHS SBIR Contract Solicitation

Register HERE

 Today at 2:00 PM EST 

Proposals due October 21, 5:00 PM EST

The annual NIH and CDC SBIR Contract Solicitation (PHS2017-1) has been released (http://bit.ly/PHS2017-1). New electronic submission process for contract proposals through the Contract Proposal Submission (eCPS) website: https://ecps.nih.gov/sbirsttr. See NOT-OD-16-123 for all NIH and CDC topics, contracting officer contact information, and other details. 

NHLBI Topics for FY2017

  • 098 Testing and Validation of Technologies for Inclusion in the CART Demonstration Project for Collaborative Aging Research
  • 099 Inhalational 5A Apolipoprotein A-I Mimetic Peptide for the Treatment of Asthma (SBIR-TT)
  • 100 MRI Myocardial Needle Chemoablation Catheter
  • 101 Membranous Ventricular Septal Defect (pmVSD) Transcatheter Occluder System
  • 102  Transcatheter Occluder Device for Paravalvular Leaks

Please direct all inquiries on the contract process or topics to:

Mr. John Taylor, taylorjc@nhlbi.nih.gov

All questions must be submitted by September 1, 2016.


Tomorrow! Aug 25 Webinar – FDA 510 (k) Deciding When to Submit

Thursday, August 25

1:00 PM - 2:30 PM EST 

Webinar Details: HERE

On August 25, 2016, the FDA will hold a webinar for industry to discuss the draft guidance documents: 

Time: 1:00 -2:30 PM, Eastern Time.

NOTE: You must dial-in to hear the presentation and ask questions:  

Dial: 888-606-7035, passcode: 6372193

International Callers Dial: 1-517-308-9367 

View the slide presentation during the webinar: HERE

Conference Number: PW8727223 


FDA - New Guidance Document Information

Recently released - Adaptive Designs for Medical Device Clinical Studies

FDA recently held a webinar to answer questions about the new guidance document: Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.  Webinar materials and the recording (once posted) can be found: HERE

The Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) have issued draft guidance - Institutional Review Board (IRB) Written Procedures: Guidance for Institutions and IRBs. 

FY17 User Fees announced


Aug 30 Deadline – NIH Commercialization Accelerator Program for Phase II Awardees

Phase II SBIR/STTR Companies - Apply by August 30: HERE

The NIH Commercialization Accelerator Program (CAP) (https://sbir.nih.gov/cap) is designed to help HHS SBIR and STTR Phase II awardees transition their SBIR and STTR developed products into the marketplace. The CAP helps small businesses evaluate their commercialization options based on their specific technologies (including the need and prospect for investment, strategic partnerships, or licensing) and helps them develop a solid market-entry plan covering an 18-month period. More details can be found in NOT-OD-16-172: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-127.html.

Inquiries

Please direct all program inquiries to:

J.P. Kim, J.D., M.B.A., M.P.P., M.Sc., M.A., sbir@od.nih.gov

National Institutes of Health (NIH)

Please direct inquiries related to submission of the web application to:

Judy Hsieh, jhsieh@larta.org

Larta, Inc.


Sept 1 Webinar – FDA presents General Wellness: Policy for Low-Risk Devices

Thursday, September 1 

12:00 PM - 1:30 PM EST 

Webinar Details: HERE

The guidance, issued on July 28, explains that the FDA does not intend to actively regulate low-risk technologies that are intended only for general wellness use. The FDA encourages the development of general wellness technologies, such as fitness trackers or mobile apps, which can empower individuals to take a more active role in their health. The FDA will continue to focus its oversight on medical devices that may pose inherent risks to a user’s safety.

NOTE: You must dial-in to hear the presentation and ask questions:

Dial: 888-566-5974, passcode: 7768031

International Callers Dial: 1-210-234-0118 passcode: 7768031

View the slide presentation during the webinar: HERE

Conference number: PW9442410
Audience passcode: 7768031


Sept 6 Deadline for SBIR/STTR Funding

The next NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Omnibus funding opportunity deadline is September 6, 2016. The National Heart, Lung, and Blood Institute (NHLBI) welcomes all investigator-initiated projects within our mission through the Omnibus funding opportunities:  

  • SBIR (PA-16-302) and STTR (PA-16-303) Omnibus Solicitations for Phase I, Phase II, and Fast-Track applications
  • SBIR Direct-to-Phase II Pilot (PAR-14-088) for Direct to Phase II applications.

Note: the standard SBIR/STTR due date of September 5th falls on a Federal holiday, so the deadline for SBIR/STTR will be September 6th at 5 pm, your local time.

Get Ready

Additional Funding Opportunities Due Fall 2016 

  • September 6 - New Technologies for Viral Hepatitis (SBIR PA-15-077 STTR  PA-15-076)
  • September 6 - Commercialization Readiness Pilot (CRP) Program: Technical Assistance for Phase II Awardees - (SB1 PAR-16-026, Notice about NHLBI participation NOT-HL-15-283)
  • October 14 Bioreactors for Reparative Medicine (SBIR RFA-HL-15-008 STTR RFA-HL-15-004 D2P2 RFA-HL-15-017)
  • October 15 - Onsite Tools and Technologies for Heart, Lung, and Blood Clinical Research Point-of-Care (STTR RFA-HL-14-017)
  • November 9 Human Cellular Models for Predicting Individual Responses to Cystic Fibrosis Transmembrane Conductance Regulator- Directed Therapeutics (SBIR RFA-HL-15-027)

View all NHLBI targeted funding opportunities on our website (http://bit.ly/NHLBI-SBIR-FOA). 


NHLBI Small Business Topics of Special Interest (TOSI)

Read NOT-HL-16-332

The NHLBI accepts investigator-initiated grant applications relevant to the NHLBI mission through the Omnibus Grant Solicitations. NHLBI has identified specific Topics of Special Interest though we also encourage mission-aligned applications for innovative technologies outside these targeted areas. Applications for TOSI are submitted in response to the Omnibus Grant Solicitations (SBIR PA-16-302, STTR PA-16-303, and Direct to Phase II SBIR PAR-14-088). 

TOSI are not the same as the list of topics approved for awards over statutory budget limitations; for these waiver topics, please see Appendix A of the Program Descriptions and Research Topics document.


Sept 12 or 13 – Free FDA and NICHD Pediatric Clinical Investigator Training Public Workshop

Monday, Sept. 12 at 8:00 AM 

Tuesday, Sept. 13 at 8:00 AM 

Register HERE

The purpose of this workshop is to provide investigators with training and expertise in designing and conducting clinical trials in pediatric patients that will lead to appropriate labeling. Although we have learned a lot about conducting pediatric trials over the past two decades, there are still challenges that need to be addressed. The training course is intended to provide investigators with:

(1) A clear understanding of some of the challenges of studying products in the pediatric population, including: Pediatric study design, neonates, biomarkers, endpoints, orphan drugs and rare disease trial design, formulations;

(2) an overview of extrapolation as it relates to the pediatric population; and

(3) an overview of ethically appropriate methods related to the design of clinical trials in the pediatric population

Interested parties can attend in person (at the Bethesda Doubletree) or via webcast. 

DoubleTree by Hilton Hotel Bethesda - Washington DC
8120 Wisconsin Avenue, Bethesda, MD 20814 - View Map 

For more information, please visit U.S. Food and Drug Administration (FDA).


Sept 27 & 28 The FDA Small Business REdI Conference

Wednesday, September 28

Thursday, September 29 

Register for this FREE event HERE

Topics to be covered during this event include Drugs topics: Manufacturing Process Validation; Interactions with FDA; Emerging Technology and Inspection of NDA and BLA applications; Device topics: 510(k), De Novo, Design Controls, and Complaints. The plenary seminar will  focus on FDA Insights on Products for Rare Diseases and Pediatrics.  Attendance can be in person (in Silver Spring, Maryland) or virtual via interactive webcast.


    Available Now - Small Biz Hangout: De-mystifying Small Business Review

    Watch Demystifying Small Business Review on YouTube

    The June 21 Small Biz Hangout on De-mystifying Small Business Review is now live on YouTube. Hear from Scientific Review Officers from the NIH Center for Scientific Review and NHLBI Office of Scientific Review to learn about the NIH peer review process, differences between types of funding opportunities and where they are reviewed, how you can participate as a reviewer yourself, and more.

    The NHLBI Small Biz Hangouts are designed to help you understand aspects of product and company development that you didn’t learn in school.  The series covers topics such as: understanding intellectual property – what it is, and how to develop and defend it; how to write a strong application for NIH small business funding; how to identify your customer and talk with possible partners; FDA regulation of drugs and devices; and reimbursement basics for therapeutics.

    Check out other recently posted videos: 

    Demystifying Small Business Review, http://bit.ly/SBReviewHangout

    Integrating Your Regulatory and Research Plans, http://bit.ly/SBH-RegRes

    Reimbursement Basics, http://bit.ly/ReimbursementHangout

    How Pharma Evaluates New Therapeutic Opportunities, http://bit.ly/SBHangout-PharmaEval

    And the full YouTube playlist.

    We are always looking for ideas of what you would like to learn about and for presenters willing to share their knowledge – contact us and be part of the NHLBI Small Biz Hangouts.


    Meet NHLBI Small Business Experts

    9/13 -  RESI 2016 – Boston, MA

    9/19 - 9/20 -  Arizona Bioscience Week (AZBio) – Phoenix, AZ

    9/29 - 9/30 - 14th Annual Dartmouth Device Development Symposium – Woodstock, VT

    10/17 - 10/19 -  AdvaMed 2016 – Minneapolis, MN

    10/18 - 10/19 -  BIO Investor Forum – San Francisco, CA

    11/1 - NHLBI Innovation Conference – New York City, NY

    11/1 - 11/3 -  SSTi 2016 Annual Conference – Columbus, OH

    11/2 - 11/3 - Life Sciences Summit – New York City, NY

    11/13 - 11/15 - Partnering for Cures – New York City, NY

    11/15 - 11/17 - 18th Annual HHS SBIR/STTR Conference - Orlando, FL